Amitriptyline Hydrochloride 50mg/5ml Oral Solution

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Recent myocardial infarction. Any degree of heart block or disorders of cardiac rhythm and coronary artery insufficiency. Concomitant treatment with MAOIs (monoamine oxidase inhibitors) is contra-indicated (see section 4.5). Simultaneous administration of amitriptyline and MAOIs may cause serotonin syndrome (a combinat …

… on of irreversible non-selective MAOIs and minimum one day after discontinuation of the reversible moclobemide. Treatment with MAOIs may be introduced 14 days after discontinuation of amitriptyline. Severe liver disease. In children under 6 years of age.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Recent myocardial infarction. Any degree of heart block or disorders of cardiac rhythm and coronary artery insufficiency. Concomitant treatment with MAOIs (monoamine oxidase inhibitors) is contra-i …

… selective MAOIs and minimum one day after discontinuation of the reversible moclobemide. Treatment with MAOIs may be introduced 14 days after discontinuation of amitriptyline. Severe liver disease. In children under 6 years of age.

… to the active substance or to any of the excipients listed in section 6.1. Recent myocardial infarction. Any degree of heart block or disorders of cardiac rhythm and coronary artery insufficiency. Concomitant treatment with MAOIs (monoamine oxidase inhibitors) is contra-indicated (see section 4.5). Simultaneous administration of amitriptyline and MAOIs may cause serotonin syndrome (a combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia). Treatment with amitriptyline may be instituted 14 days after discontinuation of irreversible non-selective MAOIs and minimum one day after discontinuation of the reversible moclobemide. Treatment wi …

… to the active substance or to any of the excipients listed in section 6.1. Recent myocardial infarction. Any degree of heart block or disorders of cardiac rhythm and coronary artery insufficiency. Concomitant treatment with MAOIs (monoamine oxidase inhibitors) is contra-indicated (see section 4.5). Simultaneous administration of amitriptyline and MAOIs may cause serotonin syndrome (a combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia). Treatment with amitriptyline may be instituted 14 days after discontinuation of irreversible non-selective MAOIs and minimum one day after discontinuation of the reversible moclobemide. Treatment wi …

… r more may have a mild laxative effect. Calorific value 2.3 kcal/g maltitol. Methyl and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed). This product contains small amounts of ethanol (alcohol), less than 100mg per dose. This product contains 100 mg propylene glycol in each 5ml dose which is equivalent to 20mg/ml.

… quid maltitol. Patients with rare hereditary problems of fructose should not take this medicine. Daily quantities of 10g or more may have a mild laxative effect. Calorific value 2.3 kcal/g maltitol. Methyl and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed). This product contains small amounts of ethanol (alcohol), less than 100mg per dose. This product contains 100 mg propylene glycol in each 5ml dose which is equivalent to 20mg/ml.

… t the patient is being so treated. Great care is necessary if amitriptyline is administered to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop. Elderly patients are particularly susceptible to orthostatic hypotension. This medical product should be used with caution in patients with convulsive disorders, urinary retention, prostatic hypertrophy, hyperthyroidism, paranoid symptomatology and advanced hepatic or car …

… ). Cardiac arrhythmias and severe hypotension are likely to occur with high dosage. They may also occur in patients with pre-existing heart disease taking normal dosage. QT interval prolongation Cases of QT interval prolongation and arrhythmia have been reported during the post-marketing period. Caution is advised in patients with significant bradycardia, in patients with uncompensated heart failure,or in patients concurrently taking QT-prolonging drugs. Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) are known to be conditions increasing the proarrythmic risk. Anaesthetics given during tri/tetracyclic antidepressant therapy may increase the risk of arrhythmias and hypotension. If possible, discontinue this medicinal product several days before surgery; if …

… tric population Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are not available (see section 4.2). Excipient Warnings This product contains liquid maltitol. Patients with rare hereditary problems of fructose should not take this medicine. Daily quantities of 10g or more may have a mild laxative effect. Calorific value 2.3 kcal/g maltitol. Methyl and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed). This product contains small amounts of ethanol (alcohol), less than 100mg pe …

… ar, amitriptyline should be withdrawn immediately, treatment with amitriptyline must not be restarted in this patient at any time and, an alternative treatment should be considered (as appropriate). Cardiac arrhythmias and severe hypotension are likely to occur with high dosage. They may also occur in patients with pre-existing heart disease taking normal dosage. QT interval prolongation Cases of QT interval prolongation and arrhythmia have been reported during the post-marketing period. Caution is advised in patients with significant bradycardia, in pati …

… e is administered to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop. Elderly patients are particularly susceptible to orthostatic hypotension. This medical product should be used with caution in patients with convulsive disorders, urinary retention, prostatic hypertrophy, hyperthyroidism, paranoid symptomatology and advanced hepatic or cardiovascular disease, pylorus stenosis and paralytic ileus. In patients with the rare condition of shallow anterior chamber and narrow chamber angle, attacks of acute glaucoma due to dilation of the pupil may be provoked. Suicide/suicidal thoughts Depres …

… ts with convulsive disorders, urinary retention, prostatic hypertrophy, hyperthyroidism, paranoid symptomatology and advanced hepatic or cardiovascular disease, pylorus stenosis and paralytic ileus. In patients with the rare condition of shallow anterior chamber and narrow chamber angle, attacks of acute glaucoma due to dilation of the pupil may be provoked. Suicide/suicidal thoughts Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occu …

… tric population Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are not available (see section 4.2). Excipient Warnings This product contains liquid maltitol. Patients with rare hereditary problems of fructose should not take this medicine. Daily quantities of 10g or more may have a mild laxative effect. Calorific value 2.3 kcal/g maltitol. Methyl and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed). This product contains small amounts of ethanol (alcohol), less than 100mg pe …

… and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed). This product contains small amounts of ethanol (alcohol), less than 100mg per dose. This product contains 100 mg propylene glycol in each 5ml dose which is equivalent to 20mg/ml.

… ar, amitriptyline should be withdrawn immediately, treatment with amitriptyline must not be restarted in this patient at any time and, an alternative treatment should be considered (as appropriate). Cardiac arrhythmias and severe hypotension are likely to occur with high dosage. They may also occur in patients with pre-existing heart disease taking normal dosage. QT interval prolongation Cases of QT interval prolongation and arrhythmia have been reported during the post-marketing period. Caution is advised in patients with significant bradycardia, in pati …

… potension. If possible, discontinue this medicinal product several days before surgery; if emergency surgery is unavoidable, the anaesthetist should be informed that the patient is being so treated. Great care is necessary if amitriptyline is administered to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop. Elderly patients are particularly susceptible to orthostatic hypotension. This medical product should be used with caution in patients with convulsive disorders, urinary retention, prostatic hypert …

Severe cutaneous reactions Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in association with am …

… traindicated combinations MAOIs (non-selective as well as selective A (moclobemide) and B (selegiline)) - risk of “serotonin syndrome” (see section 4.3). Combinations that are not recommended Sympathomimetic agents: Amitriptyline may potentiate the cardiovascular effects of adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (e.g. as contained in local and general anaesthetics and nasal decongestants). Adrenergic neurone blockers: Tricyclic antidepressants may counteract the antihypertensive effects of centrally acting antihypertensives such as guanethidine, betanidine, reserpine, clonidine and m …

… ting antihypertensives such as guanethidine, betanidine, reserpine, clonidine and methyldopa. It is advisable to review all antihypertensive therapy during treatment with tricyclic antidepressants. Anticholinergic agents: Tricyclic antidepressants may potentiate the effects of these drugs on the eye, central nervous system, bowel and bladder; concomitant use of these should be avoided due to an increased risk of paralytic ileus, hyperpyrexia, etc. Drugs which prolong the QT-interval including antiarrhythmics such as quinidine, the antihistamines astemizole and terfenadine, some antipsychotics (notably pimozide and sertindole), cisapride, hal …

… traindicated combinations MAOIs (non-selective as well as selective A (moclobemide) and B (selegiline)) - risk of “serotonin syndrome” (see section 4.3). Combinations that are not recommended Sympathomimetic agents: Amitriptyline may potentiate the cardiovascular effects of adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (e.g. as contained in local and general anaesthetics and nasal decongestants). Adrenergic neurone blockers: Tricyclic antidepressants may counteract the antihypertensive effects of centrally acting antihypertensives such as guanethidine, betanidine, reserpine, clonidine and m …

… l symptoms can occur. This may include irritability, hypertonia , tremor, irregular breathing, poor drinking and loud crying and possibly anticholinergic symptoms (urinary retention, constipation). Breast-feeding Amitriptyline and its metabolites are excreted into breast milk (corresponding to 0.6 % - 1 % of the maternal dose). A risk to the suckling child cannot be excluded. A decision must be made whether …

… ontinue breast-feeding or to discontinue/abstain from the therapy of this medicinal product taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility Amitriptyline reduced the pregnancy rate in rats (see section 5.3). No data on the effects of amitriptyline on human fertility are available.

Pregnancy For amitriptyline only limited clinical data are available regarding exposed pregnancies. Animal studies have shown reproductive toxicity (see section 5.3). Amitriptyline is not recommended during …

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Not found in the sections read for this label. Not the same as the label being silent.