Esmo may be available in the countries listed below.
Ingredient matches for Esmo
Isosorbide Mononitrate
Isosorbide Mononitrate is reported as an ingredient of Esmo in the following countries:
- Bangladesh
International Drug Name Search
Friday, September 30, 2016
Thursday, September 29, 2016
Spasmonal Forte 120mg
1. Name Of The Medicinal Product
SPASMONAL Forte 120 mg, Hard capsules.
2. Qualitative And Quantitative Composition
Each capsule contains 120 mg alverine citrate.
3. Pharmaceutical Form
An opaque, size 1 capsule with a grey cap and blue body, marked “SP120”.
4. Clinical Particulars
4.1 Therapeutic Indications
The relief of smooth muscle spasm in conditions such as irritable bowel syndrome, painful diverticular disease of the colon and primary dysmenorrhoea.
4.2 Posology And Method Of Administration
Recommended dose and dosage schedules:
Adults (including the elderly): 1 capsule one to three times daily.
Children below the age of 12 years: Not recommended.
4.3 Contraindications
Paralytic ileus or known hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
Additional warnings to be included in the Patient Information Leaflet:
If this is the first time you have had these symptoms, consult your doctor before using any treatment.
If any of the following apply do not use SPASMONAL Forte 120 mg, it may not be the right treatment for you. See your doctor as soon as possible if:
- you are aged 40 years or over
- you have passed blood from the bowel
- you are feeling sick or vomiting
- you have lost your appetite or lost weight
- you are looking pale and feeling tired
- you are suffering from severe constipation
- you have a fever
- you have recently travelled abroad
- you are or may be pregnant
- you have abnormal vaginal bleeding or discharge
- you have difficulty or pain passing urine.
Consult your doctor if you have developed new symptoms or if your symptoms worsen, or if they do not improve after 2 weeks treatment.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None stated.
4.6 Pregnancy And Lactation
Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in preclinical studies is limited.
4.7 Effects On Ability To Drive And Use Machines
None.
4.8 Undesirable Effects
Possible side effects may include nausea, headache, dizziness, itching, rash and allergic reactions including anaphylaxis.
There have been isolated reports of jaundice due to hepatitis which have been immune-mediated; but this adverse reaction resolved on cessation of alverine treatment.
4.9 Overdose
Can produce hypotension and atropine-like toxic effects. Management is as for atropine poisoning with supportive therapy for hypotension.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Alverine citrate is a spasmolytic which has a specific action on the smooth muscle of the alimentary tract and uterus without affecting the heart, blood vessels and tracheal muscle at therapeutic doses.
5.2 Pharmacokinetic Properties
After oral administration, alverine is rapidly converted to its primary active metabolite, which is then further converted to two secondary metabolites. There is a high renal clearance of all metabolites indicating that they are eliminated by active renal secretion. The peak plasma level of the most active metabolite occurs between 1 and 1½ hours after oral dosing. The plasma half-life averages 0.8 hours for alverine and 5.7 hours for the active primary metabolite.
5.3 Preclinical Safety Data
Preclinical studies provide evidence that alverine citrate has no significant systemic toxicity potential at the proposed dosage.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Maize starch
Magnesium stearate
Capsule shell: gelatine, E132, E171, E172
6.2 Incompatibilities
None stated.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Store in a dry place. Do not store above 25°C.
6.5 Nature And Contents Of Container
A box of aluminium foil/UPVC blister strip packs containing 2, 10, 20, 30, 60 or 90 capsules, in strips of 10 capsules as appropriate.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Norgine Limited
Chaplin House
Widewater Place
Moorhall Road
Harefield
UXBRIDGE
Middlesex, UB9 6NS
United Kingdom
8. Marketing Authorisation Number(S)
PL 00322/0075
9. Date Of First Authorisation/Renewal Of The Authorisation
09 October 1997/ 04 April 2003
10. Date Of Revision Of The Text
June 2009
Legal category: P
Silkis 3 micrograms per g ointment
1. Name Of The Medicinal Product
Silkis 3 micrograms per g ointment
2. Qualitative And Quantitative Composition
One gram of ointment contains 3 micrograms of calcitriol (INN).
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Ointment
White, translucent ointment
4. Clinical Particulars
4.1 Therapeutic Indications
Topical treatment of mild to moderately severe plaque psoriasis (psoriasis vulgaris) with up to 35% of body surface area involvement.
4.2 Posology And Method Of Administration
Silkis Ointment should be applied to the psoriasis affected areas twice per day, once in the morning and once in the evening before retiring and after washing. It is recommended that not more than 35% of the body surface be exposed to daily treatment. Not more than 30 g of ointment should be used per day. There is limited clinical experience available for the use of this dosage regimen of more than 6 weeks.
There is no experience of the use of Silkis in children (see 4.4. Special Warnings and Precautions for Use). Patients with kidney or liver dysfunction should not use Silkis (see also 4.3. Contra-indications).
4.3 Contraindications
Patients on systemic treatment of calcium homeostasis.
Patients with kidney or liver dysfunction.
Patients with hypercalcaemia and patients known to suffer from abnormal calcium metabolism.
Silkis must not be used in patients known to be hypersensitive to the active substance or to any of the excipients.
4.4 Special Warnings And Precautions For Use
The ointment can be applied to the face with caution, as there is an increased risk of irritation in this area. Contact with the eyes should be avoided. The hands should be washed after applying the ointment in order to avoid unintentional application to non lesional areas. Not more than 35% of the body surface should be exposed to daily treatment. Not more than 30g of ointment should be used per day.
Due to potential effects on calcium metabolism, substances which stimulate absorption must not be added to the ointment, and the ointment must not be covered with an occlusive dressing.
In case of severe irritation or contact allergy, the treatment with Silkis should be discontinued and the patient should obtain medical advice. If contact allergy is demonstrated this discontinuation is definitive.
In view of the particular sensitivity of neonatal versus adult rodents to the toxic effects of calcitriol, exposure of children to calcitriol ointment should be avoided (see also 4.2. Posology and Method of administration)
Although no clinically significant hypercalcaemia was observed in clinical studies with a dosage under 30 g/day of Silkis ointment, some absorption of calcitriol through the skin does occur and excessive use of the ointment can lead to systemic side-effects, such as an increase in urine and serum calcium levels.
There is no information about the use of Silkis in other clinical forms of psoriasis (other than plaque psoriasis) i.e. Psoriasis guttata acuta, pustular psoriasis, psoriasis erythrodermica and rapid progressive plaque psoriasis.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Silkis must be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics. Caution must also be exercised in patients receiving calcium supplements or high doses of vitamin D. There is no experience of the concurrent use of calcitriol and other medications for the treatment of psoriasis.
Information of interaction of systemic medications after the use of calcitriol ointment is limited. As no relevant elevation of plasma level is seen after the use of calcitriol on the skin, interaction with systemic medication is unlikely.
Silkis Ointment has a slight irritant potential, and therefore, it is possible that concomitant use of peeling agents, astringents or irritants products may produce additive irritant effects.
4.6 Pregnancy And Lactation
Use during Pregnancy:
There are no adequate data from the use of Silkis in pregnant women. Studies in animals have shown developmental toxicity at doses which caused maternal toxicity (see section 5.3). The potential risk for humans is unknown.
Silkis should only be used during pregnancy in restricted amounts when clearly necessary. Calcium levels should be monitored.
Use during Lactation:
Calcitriol has been found in milk of lactating dams. Due to the lack of human data, it should not be used during breastfeeding.
4.7 Effects On Ability To Drive And Use Machines
No effects on ability to drive and use machines have been observed.
4.8 Undesirable Effects
Between 10% and 20% of patients can be expected to experience adverse reactions. Adverse reactions are usually localised to the application site and mild to moderate in nature.
| ||
|
|
|
|
|
|
|
| |
|
|
*Adverse reactions reported from post marketing surveillance
In case of severe irritation or contact allergy, the treatment with Silkis should be discontinued and the patient should obtain medical advice. If contact allergy is demonstrated this discontinuation is definitive.
4.9 Overdose
The most common symptoms which may occur after accidental administration are anorexia, nausea, vomiting, constipation, hypotonia and depression. Lethargy and coma are occasionally observed. If hypercalcaemia or hypercalciuria occurs, the use of Silkis should be discontinued until the serum or urinary calcium levels have returned to normal.
If the medication is applied excessively no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC code: D 05AX03
Calcitriol inhibits the proliferation and stimulates differentiation of keratinocytes. Calcitriol inhibits proliferation of T-cells and normalises the production of various inflammation factors.
Topical administration of Silkis Ointment to patients with plaque psoriasis results in an improvement of the skin lesions. This effect is noted from 4 weeks after the start of treatment.
5.2 Pharmacokinetic Properties
The mean absorption of calcitriol is estimated at around 10%. Following absorption, both unchanged calcitriol and metabolites have been demonstrated in plasma. The effect of the metabolites on calcium homeostasis is negligible. In most patients, circulating levels of exogenous calcitriol are below the level of detection (2pg/ml).
In clinical trials, no relevant increase in plasma calcitriol levels after treatment of large body surface areas of up to 6000 cm2 (35% body surface area) was noted.
5.3 Preclinical Safety Data
Animal studies show that repeated excessive exposure to calcitriol leads to renal failure and tissue calcification due to hypervitaminosis D associated with hypercalciuria, hypercalcaemia, and hyperphosphataemia.
No indication of teratogenicity was observed in embryofoetal toxicity studies designed to assess the teratogenic potential of calcitriol. Some evidence of developmental toxicity was obtained in a cutaneous rabbit study at doses which caused maternal toxicity. No such effect was found in rats.
Local toxicity studies in animals with Calcitriol showed slight skin and eye irritation.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Liquid paraffin, white soft paraffin and alpha- tocopherol.
6.2 Incompatibilities
There are no relevant data on the compatibility of Silkis with other medicinal products. Therefore, Silkis should be used according to the posology and method of administration provided above (Section 4.2), and should not be mixed with other medicinal products.
6.3 Shelf Life
3 years
Shelf life after first opening : 8 weeks.
6.4 Special Precautions For Storage
No special precautions for storage.
6.5 Nature And Contents Of Container
The product is packaged in collapsible aluminium tubes coated internally with an epoxy - phenolic resin and fitted with a white high density polyethylene or polypropylene screw cap. Tubes contain either 15, 30 or 100g of ointment.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Galderma (UK) Limited
Meridien House
69-71 Clarendon Road
Watford
Herts
WD17 1DS
UK
8. Marketing Authorisation Number(S)
PL 10590/0047
9. Date Of First Authorisation/Renewal Of The Authorisation
10.07.1995 / 09.02.2004
10. Date Of Revision Of The Text
July 2009
Wednesday, September 28, 2016
Sertraline 50mg and 100mg Film-Coated Tablets
1. Name Of The Medicinal Product
Sertraline 50mg Film-Coated Tablets
Sertraline 100mg Film-Coated Tablets
2. Qualitative And Quantitative Composition
Each tablet contains 50mg of sertraline (as hydrochloride)
Each tablet contains 100mg of sertraline (as hydrochloride)
For excipients see 6.1
3. Pharmaceutical Form
Film coated tablet
Sertraline 50mg Tablets are white film-coated oblong, biconvex tablets, scored on one side.
Sertraline 100mg Tablets are white film-coated oblong, biconvex tablets.
4. Clinical Particulars
4.1 Therapeutic Indications
Sertraline is indicated for the treatment of symptoms of depressive illness, including accompanying symptoms of anxiety. Following satisfactory response, continuation with sertraline therapy is effective in preventing relapse of the initial episode of depression or recurrence of further depressive episodes, including accompanying symptoms of anxiety.
Sertraline is also indicated for the treatment of obsessive compulsive disorder (OCD). Following initial response, sertraline has been associated with sustained efficacy, safety and tolerability in up to two years treatment of OCD.
Sertraline is also indicated for the treatment of paediatric patients with OCD.
Clinical trials in post-traumatic stress disorder (PTSD) demonstrated efficacy in female patients but no evidence of efficacy was seen in males. Treatment with sertraline cannot normally therefore be recommended for male patients with PTSD. A therapeutic trial in males might on occasion be justified, but treatment should subsequently be withdrawn unless there is clear evidence of therapeutic benefit.
Sertraline is not indicated for use in children and adolescents under the age of 18 years with Major Depressive Disorder.
In particular, controlled clinical studies failed to demonstrate efficacy and do not support the use of sertraline in the treatment of children and adolescents with Major Depressive Disorder (See sections 4.3, Contra-Indications and 4.8, Undesirable effects).
4.2 Posology And Method Of Administration
Sertraline should be given as a single daily dose. Sertraline 50mg Tablets can be administered with or without food.
Adults
Depression (including accompanying symptoms of anxiety): The starting dose is 50mg daily and the usual antidepressant dose is 50mg daily. In some patients, doses higher than 50mg may be required.
Obsessive Compulsive Disorder: The starting dose is 50mg daily, and the therapeutic dose range is 50-200mg daily.
Post-Traumatic Stress Disorder: Treatment for PTSD should be initiated at 25mg/day. After one week, the dose should be increased to 50mg once daily. PTSD is a heterogeneous illness and some patient groups fulfilling the criteria for PTSD do not appear to be responsive to treatment with sertraline. Dosing should be reviewed periodically by the prescribing physician to determine response to therapy and treatment should be withdrawn if there is no clear evidence of efficacy.
Depression (including accompanying symptoms of anxiety), OCD and PTSD: In some patients doses higher than 50mg daily may be required. In patients with incomplete response but good toleration at lower doses, dosage adjustments should be made in 50mg increments over a period of weeks to a maximum of 200mg daily.
Once optimal therapeutic response is achieved the dose should be reduced, depending on therapeutic response, to the lowest effective level. Dosage during prolonged maintenance therapy should be kept at the lowest effective level, with subsequent adjustments depending on therapeutic response. The onset of therapeutic effect may be seen within seven days, although two to four weeks (and even longer in OCD) are usually necessary for full activity. A longer treatment period, even beyond 12 weeks in some cases, may be required in the case of a therapeutic trial in PTSD.
Use in children aged 6-17 years: Treatment should only be initiated by specialists. The safety and efficacy of sertraline has been established in paediatric OCD patients (aged 6-17). The administration of sertraline to paediatric OCD patients (aged 13-17) should commence at 50 mg/day. Therapy for paediatric OCD patients (aged 6-12) should commence at 25mg/day increasing to 50mg/day after 1 week. Subsequent doses may be increased in case of lack of response in 50mg/day increments up to 200mg/day as needed. However, the generally lower body weights of children compared to adults should be taken into consideration in advancing the dose from 50mg, in order to avoid excessive dosing. Given the 24 hour elimination half-life of sertraline, dose changes should not occur at intervals of less than one week.
The efficacy and safety of sertraline in children and adolescents under the age of 18 years with Major Depressive Disorder have not been established. Controlled clinical studies failed to demonstrate efficacy and do not support the use of sertraline in the treatment of children and adolescents with Major Depressive Disorder (See sections 4.3, Contra-Indications and 4.8, Undesirable effects).
Children aged less than six years: Sertraline is not recommended in children under six years of age since safety and efficacy have not been established. See also 'Pharmacological Properties'.
Use in the elderly: No special precautions are required. The usual adult dose is recommended. Several hundred elderly patients have participated in clinical studies with sertraline. The pattern and incidence of adverse reactions in the elderly is similar to that in younger patients.
Sertraline 50mg Tablets are for oral administration only.
Withdrawal symptoms seen on discontinuation of SSRI:Abrupt discontinuation should be avoided. When stopping treatment with SSRIs the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see section 4.4 Special Warnings and Special Precautions for Use and section 4.8 Undesirable Effects). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
4.3 Contraindications
Sertraline is contra-indicated in patients with a known hypersensitivity to sertraline or any of the excipients.
Monoamine oxidase inhibitors: Cases of serious and sometimes fatal reactions have been reported in patients receiving an SSRI in combination with a monoamine oxidase inhibitor (MAOI), including the selective MAOI selegiline and the reversible MAOI (RIMA) moclobemide and in patients who have recently discontinued an SSRI and have been started on a MAOI.
Some cases presented with features resembling serotonin syndrome. Symptoms of a drug interaction with a MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability and extreme agitation progressing to delirium and coma.
Sertraline should not be used in combination with a MAOI. Sertraline may be started 14 days after discontinuing treatment with an irreversible MAOI and at least one day after discontinuing treatment with the reversible MAOI (RIMA), moclobemide. At least 14 days should elapse after discontinuing sertraline treatment before starting a MAOI or RIMA.
Use in hepatic impairment: There is insufficient clinical experience in patients with significant hepatic dysfunction and accordingly sertraline should not be used in such patients.
Concomitant use in patients taking pimozide is contra-indicated (see Section 4.5 - Interaction with other medicinal products and other forms of interaction.
Sertraline should not be used in children and adolescents under the age of 18 years with Major Depressive Disorder (See section 4.8, Undesirable effects) but are used to treat obsessive compulsive disorder (OCD) in children of six years and over (See Section 4.2. Posology and method of administration).
4.4 Special Warnings And Precautions For Use
Monoamine oxidase inhibitors: See Section 4.3 Contra-indications.
Use in patients with renal or hepatic impairment: As with many other medications, sertraline should be used with caution in patients with renal and hepatic impairment (see Section 4.3 Contra-indications).
Since sertraline is extensively metabolised, excretion of unchanged drug in urine is a minor route of elimination. In patients with mild to moderate renal impairment (creatinine clearance 20-50ml/min) or severe renal impairment (creatinine clearance <20ml/min), single dose pharmacokinetic parameters were not significantly different compared with controls. However, steady state pharmacokinetics of sertraline have not been adequately studied in this patient population and caution is advised when treating patients with renal impairment.
Sertraline is extensively metabolised by the liver. A multiple dose pharmacokinetic study in subjects with mild, stable cirrhosis demonstrated a prolonged elimination half-life and approximately three-fold greater AUC and Cmax in comparison with normal subjects. There were no significant differences in plasma protein binding observed between the two groups. The use of sertraline in patients with hepatic disease should be approached with caution. A lower or less frequent dose should be used in patients with hepatic impairment.
Diabetes: In patients with diabetes, treatment with an SSRI may alter glycaemic control, possibly due to improvement of depressive symptoms. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
Seizures: Seizures are a potential risk with antidepressant or antiobsessional drugs. The drug should be discontinued in any patient who develops seizures. Sertraline should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. Sertraline should be discontinued if there is an increase in seizure frequency.
Electroconvulsive therapy (ECT): Since there is little clinical experience of concurrent administration of sertraline and ECT, caution is advisable.
Mania: sertraline should be used with caution in patients with a history of mania/hypomania. Sertraline should be discontinued in any patient entering a manic phase.
Suicide/suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Other psychiatric conditions for which sertraline is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Use in children and adolescents under 18 years of age:
Sertraline should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Haemorrhage: There have been reports of cutaneous bleeding abnormalities such as ecchymoses and purpura with SSRIs.
Caution is advised in patients taking SSRIs, particularly in concomitant use with drugs known to affect platelet function (e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, aspirin and non-steroidal anti-inflammatory drugs (NSAIDs)) as well as in patients with a history of bleeding disorders.
Psychomotor restlessness: The use of SSRIs has been associated with the development of psychomotor restlessness, which clinically may be very similar to akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental and it may be necessary to review the use of SSRIs.
Use in the elderly: Several hundred elderly patients have participated in clinical studies with sertraline. The pattern and incidence of adverse reactions in the elderly is similar to that in younger patients.
Use in Children: More than 250 paediatric OCD patients have been exposed to sertraline in completed and ongoing studies. The safety profile of sertraline in these paediatric studies is comparable to that observed in the adult OCD studies. The efficacy of sertraline in paediatric patients with depression or panic disorder has not been demonstrated in controlled trials. Safety and effectiveness in paediatric patients below the age of six have not been established.
There is limited knowledge with respect to an effect on sexual development in children.
Sodium content: Sertraline 50mg Tablets contain approximately 0.3mg of sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.
Withdrawal symptoms seen on discontinuation of SSRI treatment:
Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8 Undesirable effects). In clinical trials adverse events seen on treatment discontinuation occurred in approximately 20% of patients treated with SSRIs.
The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported reactions. Generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity. They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose. Generally these symptoms are self-limiting and usually resolve within two weeks, though in some individuals they may be prolonged (two to three months or more). It is therefore advised that SSRIs should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient's needs (see "Withdrawal Symptoms Seen on Discontinuation of SSRIs", Section 4.2 Posology and Method of Administration).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Monoamine oxidase inhibitors: See Section 4.3 Contra-indications.
Centrally active medication: Caution is advised if sertraline is administered with other centrally active medication. In particular, SSRIs have the potential to interact with tricyclic antidepressants leading to an increase in plasma levels of the tricyclic antidepressant. A possible mechanism for this interaction is the inhibitory effect of SSRIs on the CYP2D6 isoenzyme. There is variability among the SSRIs in the extent to which they inhibit the activity of CYP2D6. The clinical significance of this depends on the extent of inhibition and the therapeutic index of the co-administered drug. In formal interaction studies, chronic dosing with sertraline 50mg daily showed minimal elevation (mean 23-37%) of steady state plasma desipramine levels (a marker of CYP2D6 isoenzyme activity).
Pimozide: Increased pimozide levels have been demonstrated in a study of a single low dose of pimozide (2mg) with sertraline coadministration. These increased levels were not associated with any changes in ECG. While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide, concomitant use of pimozide and sertraline is contra-indicated.
Alcohol: In 11 healthy subjects administered sertraline (200mg daily) for nine days, there was no adverse effect on cognitive or psychomotor performance relative to placebo, following a single dose of 500mg/kg alcohol. However, the concomitant use of sertraline and alcohol in depressed patients is not recommended.
Lithium and tryptophan: In placebo-controlled trials in normal volunteers, the co-administration of sertraline and lithium did not significantly alter lithium pharmacokinetics. Co-administration of sertraline with lithium did result in an increase in tremor relative to placebo, indicating a possible pharmacodynamic interaction. There have been other reports of enhanced effects when SSRIs have been given with lithium or tryptophan and therefore the concomitant use of SSRIs with these drugs should be undertaken with caution.
Serotonergic drugs: There is limited controlled experience regarding the optimal timing of switching from other antidepressant or antiobsessional drugs to sertraline. Care and prudent medical judgement should be exercised when switching, particularly from long-acting agents. The duration of washout period which should intervene before switching from one selective serotonin reuptake inhibitor (SSRI) to another has not been established.
Until further data are available, serotonergic drugs, such as tramadol, sumatriptan or fenfluramine, should not be used concomitantly with sertraline, due to a possible enhancement of 5-HT associated effects.
St John's Wort: Concomitant use of the herbal remedy St John's Wort (Hypericum perforatum) in patients receiving SSRIs should be avoided since there is a possibility of serotonergic potentiation.
Drugs that affect platelet function, such as NSAIDs: See Section 4.4 Special warnings and precautions for use (Haemorrhage)'.
Other drug interactions: Since sertraline is bound to plasma proteins, the potential of sertraline to interact with other plasma protein bound drugs should be borne in mind.
Formal drug interaction studies have been performed with sertraline. Co-administration of sertraline (200mg daily) with diazepam or tolbutamide resulted in small, statistically significant changes in some pharmacokinetic parameters. Co-administration with cimetidine caused a substantial decrease in sertraline clearance. The clinical significance of these changes is unknown. Sertraline had no effect on the beta-adrenergic blocking ability of atenolol. No interaction with sertraline (200mg daily) was observed with glibenclamide or digoxin.
Co-administration of sertraline (200mg daily) with warfarin resulted in a small but statistically significant increase in prothrombin time, the clinical significance of which is unknown. Accordingly, prothrombin time should be carefully monitored when sertraline therapy is initiated or stopped.
Sertraline (200mg daily), did not potentiate the effects of carbamazepine, haloperidol or phenytoin on cognitive and psychomotor performance in healthy subjects.
4.6 Pregnancy And Lactation
Pregnancy: Although animal studies did not provide any evidence of teratogenicity, the safety of sertraline during human pregnancy has not been established. As with all drugs sertraline should only be used in pregnancy if the potential benefits of treatment to the mother outweigh the possible risks to the developing foetus.
Lactation: Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with sertraline is considered necessary, discontinuation of breast-feeding should be considered.
4.7 Effects On Ability To Drive And Use Machines
Clinical pharmacology studies have shown that sertraline has no effect on psychomotor performance. However, since antidepressant or antiobsessional drugs may impair the abilities required to perform potentially hazardous tasks such as driving a car or operating machinery, the patient should be cautioned accordingly. Sertraline should not be administered with benzodiazepines or other tranquillizers in patients who drive or operate machinery.
4.8 Undesirable Effects
Side-effects which occurred significantly more frequently with sertraline than placebo in multiple dose studies were: nausea, diarrhoea/loose stools, anorexia, dyspepsia, tremor, dizziness, insomnia, somnolence, increased sweating, dry mouth and sexual dysfunction (principally ejaculatory delay in males).
The side-effect profile commonly observed in double-blind, placebo-controlled studies in patients with OCD and PTSD was similar to that observed in patients with depression.
Post-marketing spontaneous reports include the following:
Cardiovascular: Blood pressure disturbances including postural hypotension, tachycardia.
Eye disorders: Abnormal vision.
Gastro-intestinal: Vomiting, abdominal pain.
Nervous system: Amnesia, headache, drowsiness, movement disorders, paraesthesia, hypoaesthesia, depressive symptoms, hallucinations, aggressive reaction, agitation, anxiety, psychosis, depersonalisation, nervousness, panic reaction and signs and symptoms associated with serotonin syndrome which include fever, rigidity, confusion, agitation, diaphoresis, tachycardia, hypertension and diarrhoea.
There have also been reports of manic reaction, although this phenomenon may be part of the underlying disease.
Cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation (see section 4.4).
Convulsions (Seizures): Sertraline should be discontinued in any patient who develops seizures (See Section 4.4 Special warnings and precautions for use').
Musculoskeletal: Arthralgia, myalgia.
Hepatic/pancreatic: Rarely, pancreatitis and serious liver events (including hepatitis, jaundice and liver failure). Asymptomatic elevations in serum transaminases (SGOT and SGPT) have been reported in association with sertraline administration (0.8 – 1.3%), with an increased risk associated with the 200mg daily dose. The abnormalities usually occurred within the first one to nine weeks of drug treatment and promptly diminished upon drug discontinuation.
Renal & urinary disorders: Urinary retention.
Reproductive: Hyperprolactinemia, galactorrhoea, menstrual irregularities, anorgasmy.
Skin and allergic reactions: Rash (including rare reports of erythema multiforme, photosensitivity), angioedema, ecchymoses, pruritus and anaphylactoid reactions.
Metabolic: Rare cases of hyponatremia have been reported and appeared to be reversible when sertraline was discontinued. Some cases were possibly due to the syndrome of inappropriate antidiuretic hormone secretion. The majority of reports were associated with older patients, and patients taking diuretics or other medications.
Haematologic: There have been rare reports of altered platelet function and/or abnormal clinical laboratory results in patients taking sertraline. While there have been reports of thrombocytopenia, abnormal bleeding or purpura in several patients taking sertraline, it is unclear whether sertraline had a causative role. See also Section 4.4 'Special warnings and precautions for use'.
General: Malaise.
Other: Withdrawal reactions have been reported with sertraline. Common symptoms include dizziness, paraesthesia, headache, anxiety and nausea. Abrupt discontinuation of treatment with sertraline should be avoided. The majority of symptoms experienced on withdrawal of sertraline are non-serious and self-limiting.
Rare: psychomotor restlessness/akathisia (see section 4.4 Special Warnings and Precautions for Use)
Adverse events from paediatric clinical trials: In paediatric clinical trials in depression the following adverse events were reported at a frequency of at least 2% of patients and occurred at a rate of at least twice that of placebo: dry mouth (2.1% vs 0.5%), hyperkinesia (2.6% vs 0.5%), tremor (2.1% vs 0%), diarrhoea (9.5% vs 1.6%), vomiting (4.2% vs 1.1%), agitation (6.3% vs 1.1%), anorexia (5.3% vs 1.1%) and urinary incontinence (2.1% vs 0%).
Suicidal thoughts and suicide attempts were mainly observed in clinical trials with Major Depressive Disorder.
Sertraline has been evaluated in paediatric OCD patients aged 6 to 17 in a 12 week placebo-controlled study. Therapy for paediatric OCD patients (aged 6-12) commenced at 25mg/day increasing to 50mg/day after 1 week. Side-effects which occurred significantly more frequently with sertraline than placebo were: headache, insomnia, agitation [6-12 years]; insomnia, anorexia, tremor [13-17 years]. Most were of mild to moderate severity. There is limited evidence of efficacy and safety beyond 12 weeks of treatment.
Withdrawal symptoms seen on discontinuation of SSRI treatment:
Discontinuation of SSRIs (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache are themost commonly reported reactions. Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged. It is therefore advised that when SSRI treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see section 4.2 Posology and Method of Administration and section 4.4 Special Warnings and Special Precautions for use).
4.9 Overdose
On the evidence available, sertraline has a wide margin of safety in overdose. Overdoses of sertraline alone of up to 8g have been reported. Deaths involving overdoses of sertraline in combination with other drugs and/or alcohol have been reported. Therefore, any overdosage should be treated aggressively.
Symptoms of overdose include serotonin-mediated side-effects such as somnolence, gastrointestinal disturbances (such as nausea and vomiting), tachycardia, tremor, agitation and dizziness. Less frequently reported was coma.
No specific therapy is recommended and there are no specific antidotes to sertraline. Establish and maintain an airway, ensure adequate oxygenation and ventilation. Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage, and should be considered in treating overdose. Cardiac and vital signs monitoring is recommended along with general symptomatic and supportive measures. Due to the large volume of distribution of sertraline, forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic Group: Monoamine oxidase inhibitors, non-selective
ATC Code: N06A F
Sertraline is a potent and specific inhibitor of neuronal serotonin (5-HT) uptake in vitro and in vivo, but is without affinity for muscarinic, serotonergic, dopaminergic, adrenergic, histaminergic, gamma-aminobutyric acid (GABA) or benzodiazepine receptors.
Sertraline is devoid of stimulant, sedative or anticholinergic activity or cardiotoxicity in animals.
Unlike tricyclic antidepressants, no weight gain is observed with treatment for depression.
Sertraline has not been observed to produce physical or psychological dependence.
5.2 Pharmacokinetic Properties
Sertraline exhibits dose proportional pharmacokinetics over a range of 50-200mg. After oral administration of sertraline in man, peak blood levels occur at about 4.5 - 8.4 hours. Daily doses of sertraline achieve steady-state after one week. Sertraline has a plasma half-life of approximately 26 hours with a mean half-life for young and elderly adults ranging from 22-36 hours. Sertraline is approximately 98% bound to plasma proteins. The principal metabolite, N-desmethylsertraline, is inactive in in vivo models of depression and has a half-life of approximately 62-104 hours. Sertraline and N-desmethylsertraline are both extensively metabolised in man and the resultant metabolites excreted in faeces and urine in equal amounts. Only a small amount (<0.2%) of unchanged sertraline is excreted in the urine.
The pharmacokinetics of sertraline in paediatric OCD patients have been shown to be comparable with adults (although paediatric patients metabolise sertraline with slightly greater efficiency). However, lower doses may be advisable for paediatric patients given their lower body weights (especially 6-12 years), in order to avoid excessive plasma levels.
A clear relationship between sertraline concentration and the magnitude of therapeutic response has not been established.
The pharmacokinetics of sertraline in elderly patients are similar to younger adults.
Food does not significantly change the bioavailability of sertraline tablets.
5.3 Preclinical Safety Data
Extensive chronic safety evaluation studies in animals show that sertraline is generally well tolerated at doses that are appreciable multiples of those that are clinically effective.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Tablet core
Microcrystalline cellulose
Dibasic calcium phosphate dihydrate
Hydroxypropylcellulose
Sodium starch glycolate
Magnesium stearate
Tablet coating
Opadry White YS-1R-7003 - | Hydroxypropyl methylcellulose 2910, 3cP |
- Hydroxypropyl methylcellulose 2910, 5cP | |
- Polyethylene glycol 400 | |
- Titanium dixide | |
- Polysorbate 80 | |
Opadry Clear YS-1R-7006 - | Hydroxypropyl methylcellulose 2910, 5cP |
- Polyethylene glycol 400 | |
- Polyethylene glycol 6000 |
6.2 Incompatibilities
None
6.3 Shelf Life
Two years
6.4 Special Precautions For Storage
Do not store above 25°C.
Keep out of the reach and sight of children.
6.5 Nature And Contents Of Container
PVC/PVDC/aluminium foil opaque blister packs containing 7, 14, 28, 30 or 100* tablets.
*Not all pack sizes may be marketed
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK
8. Marketing Authorisation Number(S)
50mg - PL 29831/0184
100mg - PL 29831/0183
9. Date Of First Authorisation/Renewal Of The Authorisation
2nd November 2007
10. Date Of Revision Of The Text
January 2009.
Ezy-Dose Dogs
Ezy-Dose Dogs may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Ezy-Dose Dogs
Praziquantel
Praziquantel is reported as an ingredient of Ezy-Dose Dogs in the following countries:
- Australia
Pyrantel
Pyrantel embonate (a derivative of Pyrantel) is reported as an ingredient of Ezy-Dose Dogs in the following countries:
- Australia
International Drug Name Search
Tesin
Tesin may be available in the countries listed below.
Ingredient matches for Tesin
Terazosin
Terazosin hydrochloride (a derivative of Terazosin) is reported as an ingredient of Tesin in the following countries:
- Poland
International Drug Name Search
Tuesday, September 27, 2016
Closantel Sodium
Closantel Sodium may be available in the countries listed below.
Ingredient matches for Closantel Sodium
Closantel
Closantel Sodium (BANM) is also known as Closantel (Rec.INN)
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Ferrous Fumarate 140mg / 5ml Oral Suspension
1. Name Of The Medicinal Product
Ferrous Fumarate 140mg/5ml Oral Suspension
2. Qualitative And Quantitative Composition
Each 5ml of suspension contains 140mg ferrous fumarate.
For excipients, see 6.1.
3. Pharmaceutical Form
Oral Suspension
A smooth brown suspension with an odour of elderberry.
4. Clinical Particulars
4.1 Therapeutic Indications
Prophylaxis and treatment of iron deficiency states.
For prophylaxis during pregnancy, a combination of iron and folic acid is usually recommended.
4.2 Posology And Method Of Administration
Shake the bottle before use.
Adults and the elderly: Two 5ml spoonfuls of syrup twice a day. Dose may be increased to four 5ml spoonfuls twice a day, if required.
Children: Full term infants and young children-half to one 5ml spoonful twice a day.
Premature infants: 0.6ml/kg day to 2.4 ml/kg/day.
Method of administration: Oral
4.3 Contraindications
Known hypersensitivity to any of the ingredients of the product.
Must not be used in anaemia's other than those due to iron deficiency.
Iron preparations are contra-indicated in patients with:
• Paroxysmal nocturnal haemoglobinuria. Haemosiderosis, haemochromatosis.
• In patients with active peptic ulcer, regional enteritis and ulcerative colitis.
• In patients receiving repeated blood transfusions.
• When used concomitantly with parental iron therapy.
4.4 Special Warnings And Precautions For Use
Before starting treatment, it is important to exclude any underlying cause of the anaemia (e.g. gastric erosion, colonic carcinoma).
Because anaemia due to combined iron and Vitamin B12 or folate deficiencies may be microcytic in type, patients with microcytic anaemia resistant to treatment with iron alone should be screened for Vitamin B12 or folate deficiency.
Duration of treatment of uncomplicated iron deficiency anaemia should not usually exceed 6 months (3 months after reversal of the anaemia has been achieved).
Oral iron, particularly modified-release preparations may exacerbate diarrhoea in patients with inflammatory bowel disease.
As with all iron preparations, ferrous fumarate should be used with care in patients with known or suspected gastrointestinal strictures or intestinal diverticular disease.
Some post-gastrectomy patients show poor absorption of iron.
Care is required when treating patients with iron deficiency anaemia who have treated or controlled peptic ulceration.
This product contains liquid glucose and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Long-term treatment with Ferrous Fumarate 140mg/5ml Oral Suspension can increase the risk of dental caries. Adequate dental hygiene must be maintained. Since Ferrous Fumarate 140mg/5ml oral suspension contains sugar, care must be exercised when using in patients with diabetes mellitus.
Aspiration of iron preparations induces inflammatory lesions at the site of iron deposit and may cause bronchial stenosis.
This product also contains Sodium metabisulphite and parahydroxybenzoates. Sodium metabisulphite may rarely cause severe hypersensitivity reactions and bronchospasm. Parahydroxybenzoates may cause allergic reactions (possibly delayed).
The label will state
“Important warning: Contains iron. Keep out of the reach and sight of children, as overdose may be fatal.”
This will appear on the front of the pack within a rectangle, in which there is no other information.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Iron inhibits the absorption of tetracyclines from the gastrointestinal tract and tetracycline inhibits the absorption of iron. If both drugs must be given, tetracyclines should be taken three hours after or two hours before oral iron supplements.
Iron reduces the absorption of penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine) (give at least 2 hours apart), moxifloxacin, mycophenolate, norfloxacin, ofloxacin, zinc.
Concurrent administration of oral iron preparations with tea, coffee, eggs, food or medications containing bicarbonates, carbonate, oxalates or phosphates, milk or milk products, whole grain breads and cereals and dietary fibre, may decrease iron absorption.
The absorption of ferrous fumarate is reduced by magnesium trisilicate, calcium salts, trientine and cholestyramine.
Chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Avoid concomitant use of iron with dimercaprol.
Ferrous fumarate also reduces the hypotensive effect of methyldopa.
Absorption of iron salts is enhanced by ascorbic acid and meat.
4.6 Pregnancy And Lactation
Pregnancy
Ferrous fumarate suspension can be used during pregnancy if clinically indicated.
Lactation
No adverse effects of ferrous sulphate have been shown in breastfed infants of treated mothers. Ferrous fumarate suspension can be used during breast-feeding if clinically indicated.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
The commonest side effects relate to gastrointestinal irritation (nausea, epigastric pain, constipation or diarrhoea). In the event of these ADRs, it may be helpful to reduce the dose or switch to an alternative iron salt.
Darkening of stools, black discoloration of the teeth and allergic reactions (due to metabisulphite in the syrup vehicle) may also occur
4.9 Overdose
Symptoms:
Ingestion of 20 mg/kg elemental iron is potentially toxic and 200-250 mg/kg is potentially fatal. No single method of assessment is entirely satisfactory - clinical features as well as laboratory analysis must be taken into account. The serum iron taken at about 4 hours after ingestion is the best laboratory measure of severity.
|
|
|
|
|
|
|
|
Early signs and symptoms include nausea, vomiting, abdominal pain and diarrhoea. The vomit and stools may be grey or black. In mild cases early features improve but in more serious cases there may be evidence of hypoperfusion (cool peripheries and hypotension), metabolic acidosis and systemic toxicity. In serious cases there can be recurrence of vomiting and gastrointestinal bleeding, 12 hours after ingestion. Shock can result from hypovolaemia or direct cardiotoxicity.
Evidence of hepatocellular necrosis appears at this stage with jaundice, bleeding, hypoglycaemia, encephalopathy and positive anion gap metabolic acidosis. Poor tissue perfusion may lead to renal failure. Rarely, gastric scarring causing stricture or pyloric stenosis (alone or in combination) may lead to partial or complete bowel obstruction 2-5 weeks after ingestion.
Management:
Supportive and symptomatic measures include ensuring a clear airway, monitor cardiac rhythm, BP and urine output, establishing IV access and administering sufficient fluids to ensure adequate hydration. Consider whole bowel irrigation. If metabolic acidosis persists despite correction of hypoxia and adequate fluid resuscitation, an initial dose of 50 mmol sodium bicarbonate may be given and repeated as necessary, for adults guided by arterial blood gas monitoring (aim for a pH of 7.4). Consider the use of desferrioxamine, if /the patient is symptomatic (other than nausea), serum iron concentration is between 3-5 mg/L (55-90 micromol/L) and still rising. Haemodialysis does not remove iron effectively but should be considered on a supportive basis for acute renal failure as this will facilitate removal of the iron-desferrioxamine complex.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC code: B03A A02 Iron bivalent, oral preparations
Iron is an essential constituent of the body, and is necessary for haemoglobin formation and for the oxidative processes of living tissues. Iron and iron salts should be given for the treatment or prophylaxis of iron deficiency anaemias.
Preparations of iron are administered by mouth, by intramuscular or intravenous injection.
Soluble ferrous salts are most effective by mouth. Ferrous fumarate is an easily absorbed source of iron for replacement therapy. It is a salt of ferrous iron with an organic acid and is less irritant to the gastrointestinal tract than salts with inorganic acids.
5.2 Pharmacokinetic Properties
In the acid conditions of the gastric contents, ferrous fumarate is dissociated and ferrous ions are liberated. These ions are absorbed in the proximal portion of the duodenum.
The ferrous iron absorbed by the mucosal cells of the duodenum is oxidised to the ferric form, and this is bound to protein to form Ferritin.
Ferritin in the mucosal cells release's iron into the blood, where it is bound to transferrin and passed into the iron stores - liver, spleen, and bone marrow.
These stores are a reserve of iron for synthesis of haemoglobin, myoglobin, and iron containing enzymes.
Iron is lost from the body through loss of cells in urine, faeces, hair, skin, sputum, nails, and mucosal cells, and through blood loss.
Ferrous fumarate has the same pattern of absorption and excretion as dietary iron.
5.3 Preclinical Safety Data
No further data.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Nipastat GL 75
Methylcellulose
Glucose Liquid
Sucrose
Granular Lecithin
Elderberry flavour
Sodium metabisulphite
Purified water
6.2 Incompatibilities
None.
6.3 Shelf Life
24 months
6.4 Special Precautions For Storage
Keep the bottle in the outer carton in order to protect from light.
Do not store above 25°C.
6.5 Nature And Contents Of Container
Amber glass bottle with polypropylene cap and melinex/pulpboard/aluminium wad containing 200 ml of oral suspension.
6.6 Special Precautions For Disposal And Other Handling
Shake the bottle before use.
No Data Held
7. Marketing Authorisation Holder
Goldshield Pharmaceutical Ltd
NLA Tower, 12-16 Addiscombe Road
Croydon, Surrey CR0 0XT
United Kingdom
8. Marketing Authorisation Number(S)
PL 12762/0083
9. Date Of First Authorisation/Renewal Of The Authorisation
17th June 2005
10. Date Of Revision Of The Text
05/11/2010
Ondavell
Ondavell may be available in the countries listed below.
Ingredient matches for Ondavell
Ondansetron
Ondansetron is reported as an ingredient of Ondavell in the following countries:
- Indonesia
International Drug Name Search
Symbicort Turbohaler 400 / 12, Inhalation powder.
Symbicort Turbohaler
400/12, inhalation powder
budesonide, formoterol fumarate dihydrate
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Symbicort Turbohaler is and what it is used for
- 2. Before you use Symbicort Turbohaler
- 3. How to use Symbicort Turbohaler
- 4. Possible side effects
- 5. How to store Symbicort Turbohaler
- 6. Further information
What Symbicort Turbohaler is and what it is used for
Symbicort Turbohaler is an inhaler. It contains two different medicines: budesonide and formoterol fumarate dihydrate.
- Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing and preventing swelling and inflammation in your lungs.
- Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting beta-agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This helps you to breathe more easily.
Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).
Asthma
For asthma, your doctor will prescribe two asthma inhalers: Symbicort Turbohaler and a separate ‘reliever inhaler’.
- Use Symbicort Turbohaler every day. This helps to prevent asthma symptoms from happening.
- Use your ‘reliever inhaler’ when you get asthma symptoms, to make it easier to breathe again.
Do not use Symbicort Turbohaler 400/12 as a ‘reliever inhaler’.
Chronic obstructive pulmonary disease (COPD)
Symbicort Turbohaler can also be used to treat the symptoms of severe COPD in adults. COPD is a long-term disease of the airways in the lungs, which is often caused by cigarette smoking.
Before you use Symbicort Turbohaler
Do not use Symbicort Turbohaler if:
- You are allergic (hypersensitive) to budesonide, formoterol, or the other ingredient, which is lactose (which contains small amounts of milk proteins).
Take special care with Symbicort Turbohaler
Before you use Symbicort Turbohaler, tell your doctor or pharmacist if:
- You are diabetic.
- You have a lung infection.
- You have high blood pressure or you have ever had a heart problem (including an uneven heart beat, a very fast pulse, narrowing of the arteries or heart failure).
- You have problems with your thyroid or adrenal glands.
- You have low levels of potassium in your blood.
- You have severe liver problems.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Beta-blocker medicines (such as atenolol or propranolol for high blood pressure), including eyedrops (such as timolol for glaucoma).
- Medicines for a fast or uneven heart beat (such as quinidine).
- Medicines like digoxin, often used to treat heart failure.
- Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood pressure.
- Steroid medicines that you take by mouth (such as prednisolone).
- Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.
- Other bronchodilators (such as salbutamol).
- Tricyclic anti-depressants (such as amitriptyline).
- Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as phenelzine).
- Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
- Medicines called ‘protease inhibitors’ (such as ritonavir) to treat HIV infection.
- Medicines to treat fungal infections (such as itraconazole and ketoconazole).
- Medicines for Parkinson’s disease (such as leva-dopa).
- Medicines for thyroid problems (such as levo-thyroxine).
If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Symbicort Turbohaler.
Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an operation or for dental work.
Pregnancy and breast-feeding
- If you are pregnant, or planning to get pregnant, talk to your doctor before using Symbicort Turbohaler - do not use Symbicort Turbohaler unless your doctor tells you to.
- If you get pregnant while using Symbicort Turbohaler, do not stop using Symbicort Turbohaler but talk to your doctor immediately.
- If you are breast-feeding, talk to your doctor before using Symbicort Turbohaler.
Driving and using machines
Symbicort Turbohaler is not likely to affect your ability to drive or to use tools or machines.
Important information about some of the ingredients of Symbicort Turbohaler
Symbicort Turbohaler contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant. The excipient lactose contains small amounts of milk proteins, which may cause an allergic reaction.
How to use Symbicort Turbohaler
- Always use Symbicort Turbohaler exactly as your doctor, nurse or pharmacist has told you. Ask one of them for advice if you are not sure.
- It is important to use Symbicort Turbohaler every day, even if you have no asthma or COPD symptoms at the time.
- If you are using Symbicort Turbohaler for asthma, your doctor will want to regularly check your symptoms.
Important information about your asthma or COPD symptoms
If you feel you are getting breathless or wheezy while using Symbicort Turbohaler, you should continue to use Symbicort Turbohaler but go to see your doctor as soon as possible, as you may need additional treatment.
Contact your doctor immediately if:
- Your breathing is getting worse or you often wake up at night with asthma.
- Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.
These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.
Asthma
Use your Symbicort Turbohaler 400/12 every day.
This helps to prevent asthma symptoms from happening.
Adults (18 years and above)
- The usual dose is 1 inhalation, twice a day.
- Your doctor may increase this to 2 inhalations, twice a day.
- If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.
Adolescents (12 to 17 years)
- The usual dose is 1 inhalation, twice a day.
- If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.
A lower strength of Symbicort Turbohaler is available for children aged from 6 to 11 years.
Your doctor (or asthma nurse) will help you to manage your asthma. They will adjust the dose of this medicine to the lowest dose that controls your asthma. However, do not adjust the dose without talking to your doctor (or asthma nurse) first.
Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen. Always keep your ‘reliever inhaler’ with you to use when you need it.
Do not use Symbicort Turbohaler 400/12 to treat asthma symptoms - use your separate ‘reliever inhaler’.
Chronic Obstructive Pulmonary Disease (COPD)
- Only to be used by adults (aged 18 years and above).
- The usual dose is 1 inhalation twice a day.
Preparing your new Symbicort Turbohaler
Before using your new Symbicort Turbohaler for the first time, you need to prepare it for use as follows:
- Unscrew the cover and lift it off. You may hear a rattling sound.
- Hold your Turbohaler upright with the red grip at the bottom.
- Turn the red grip as far as it will go in one direction. Then turn it as far as it will go in the other direction (it does not matter which way you turn it first). You should hear a click sound.
- Do this again, turning the red grip in both directions.
- Your Turbohaler is now ready for use.
How to take an inhalation
Every time you need to take an inhalation, follow the instructions below.
- 1. Unscrew the cover and lift it off. You may hear a rattling sound.
2. Hold your Turbohaler upright with the red grip at the bottom.- 3. Do not hold the mouthpiece when you load your Turbohaler. To load your Turbohaler with a dose, turn the red grip as far as it will go in one direction. Then turn it as far as it will go in the other direction (it does not matter which way you turn it first). You should hear a click sound. Your Turbohaler is now loaded and ready to use. Only load your Turbohaler when you need to use it.
- 4. Hold your Turbohaler away from your mouth. Breathe out gently (as far as is comfortable). Do not breathe out through your Turbohaler.
- 5. Place the mouthpiece gently between your teeth. Close your lips. Breathe in as deeply and as hard as you can through your mouth. Do not chew or bite on the mouthpiece.
6. Remove your Turbohaler from your mouth. Then breathe out gently. The amount of medicine that is inhaled is very small. This means you may not be able to taste it after inhalation. If you have followed the instructions, you can still be confident that you have inhaled the dose and the medicine is now in your lungs.- 7. If you are to take a second inhalation, repeat steps 2 to 6.
- 8. Replace the cover tightly after use.
- 9. Rinse your mouth with water after your daily morning and/or evening doses, and spit it out.
Do not try to remove or twist the mouthpiece. It is fixed to your Turbohaler and must not be taken off. Do not use your Turbohaler if it has been damaged or if the mouthpiece has come apart from your Turbohaler.
Cleaning your Turbohaler
Wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or liquids.
When to start using a new Turbohaler
- The dose indicator tells you how many doses (inhalations) are left in your Turbohaler, starting with 60 doses when it is full.
- The dose indicator is marked in intervals of 10 doses. Therefore it does not show every dose.
- When you first see a red mark at the edge of the indicator window, there are approximately 20 doses left. For the last 10 doses, the background of the dose indicator is red. When the ‘0’ on the red background has reached the middle of the window, you must start using your new Turbohaler.
Note:
- The grip will still twist and ‘click’ even when your Turbohaler is empty.
- The sound that you hear as you shake your Turbohaler is produced by a drying agent and not the medicine. Therefore the sound does not tell you how much medicine is left in your Turbohaler.
- If you load your Turbohaler more than once by mistake before taking your dose, you will still only receive one dose. However, the dose indicator will register all the loaded doses.
If you use more Symbicort Turbohaler than you should
If you use more Symbicort Turbohaler than you should, contact your doctor or pharmacist for advice.
The most common symptoms that may occur if you use more Symbicort Turbohaler than you should are trembling, headache or a rapid heart beat.
If you forget to use Symbicort Turbohaler
- If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.
- Do not take a double dose to make up for a forgotten dose.
Possible side effects
Like all medicines, Symbicort Turbohaler can cause side effects, although not everybody gets them.
If either of the following happen to you, stop using Symbicort Turbohaler and talk to your doctor immediately:
- Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty swallowing) or hives together with difficulty breathing (angioedema) and/or sudden feeling of faintness. This may mean that you are
having an allergic reaction. This happens rarely, affecting less than 1 in 1,000 people. - Sudden wheezing after inhaling your medicine.
This happens very rarely, affecting less than 1 in 10,000 people.
Other possible side effects:
Common (affects less than 1 in 10 people)
- Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use Symbicort Turbohaler.
- Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water after using your Turbohaler.
- Mild sore throat, coughing and a hoarse voice.
- Headache.
Uncommon (affects less than 1 in 100 people)
- Feeling restless, nervous or agitated.
- Disturbed sleep.
- Feeling dizzy.
- Nausea (feeling sick).
- Fast heart beat.
- Bruising of the skin.
- Muscle cramps.
Rare (affects less than 1 in 1,000 people)
- Rash, itching.
- Bronchospasm (tightening of the muscles in the airways which causes wheezing). If the wheezing comes on suddenly after using Symbicort Turbohaler stop using Symbicort Turbohaler and talk to your doctor immediately.
- Low levels of potassium in your blood.
- Uneven heart beat.
Very rare (affects less than 1 in 10,000 people)
- Depression.
- Changes in behaviour, especially in children.
- Chest pain or tightness in the chest (angina pectoris).
- An increase in the amount of sugar (glucose) in your blood.
- Taste changes, such as an unpleasant taste in the mouth.
- Changes in your blood pressure.
Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:
- changes in bone mineral density (thinning of the bones)
- cataract (clouding of the lens in the eye)
- glaucoma (increased pressure in the eye)
- a slowing of the rate of growth of children and adolescents
- an effect on the adrenal gland
(a small gland next to the kidney).
These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.
If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Symbicort Turbohaler
- Keep out of the reach and sight of children.
- Do not store above 30°C.
- When not in use, Symbicort Turbohaler should be stored with the cover tightened, in order to protect from moisture.
- Do not use Symbicort Turbohaler after the expiry date printed on the carton or on the label of your Turbohaler. The expiry date refers to the last day of that month.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.
Further information
What Symbicort Turbohaler 400/12 contains
The active substances are budesonide and formoterol.
Each inhaled dose contains 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
The other ingredient is lactose monohydrate (which contains milk proteins).
What Symbicort Turbohaler 400/12 looks like and contents of the pack
Symbicort Turbohaler 400/12 is an inhaler containing your medicine. The inhalation powder is white in colour. Each Turbohaler contains 60 doses and has a white body with a red turning grip.
Symbicort Turbohaler 400/12 is available in packs of 1, 2, 3, 10 or 18 Turbohalers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Symbicort Turbohaler 400/12 is held by
AstraZeneca UK Ltd
600 Capability Green
Luton
LU1 3LU
UK
Symbicort Turbohaler 400/12 is manufactured by
AstraZeneca AB
S-151 85 Södertälje
Sweden
Symbicort Turbohaler is authorised in the Member States of the EEA under the following names:
Symbicort Turbohaler and Symbicort Turbuhaler. In some countries, the dosage strength refers to the metered dose (400/12), in others the delivered dose (320/9).
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Symbicort Turbohaler 400/12
Reference number
17901/0200
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last approved in February 2010
© AstraZeneca 2010
Symbicort and Turbohaler are trade marks of the AstraZeneca group of companies.
RSP 10 0007
6804040.28
Subscribe to:
Posts (Atom)