Amitriptyline hydrochloride 10 mg film-coated tablets

• Hypersensitivity to the active substance (s) 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 comb …

… f 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 (s) 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 …

… e 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.

… ve substance (s) 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. Treatmen …

… ve substance (s) 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. Treatmen …

… 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 ca …

… . 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; i …

… in children and adolescents concerning growth, maturation and cognitive and behavioural development are not available (see section 4.2). Excipients Amitriptyline hydrochloride contains lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine. Amitriptyline hydrochloride contains Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

… in children and adolescents concerning growth, maturation and cognitive and behavioural development are not available (see section 4.2). Excipients Amitriptyline hydrochloride contains lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine. Amitriptyline hydrochloride contains Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

… 4.5). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms. Nocturnal enuresis An ECG should be performed …

… ide should be withdrawn immediately, treatment with amitriptyline hydrochloride 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 pat …

… Paediatric population Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are not available (see section 4.2). Excipients Amitriptyline hydrochloride contains lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine. Amitriptyline hydrochloride contains So …

… ents with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine. Amitriptyline hydrochloride contains Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

… 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 Depr …

… s 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 occ …

… ide should be withdrawn immediately, treatment with amitriptyline hydrochloride 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 pat …

… otension. 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 hype …

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 …

… ch as fluconazole and terbinafine increase serum concentrations of tricyclics and accompanying toxicity. Syncope and torsade de pointes have occurred. Combinations requiring precautions for use CNS depressants: Amitriptyline may enhance the sedative effects of alcohol, barbiturates and other CNS depressants. Amitriptyline should be used cautiously when co-administered with: • Serotonergic medicinal products, such as MAO inhibitors, selective serotonin re-uptake inhibitors (SSRIs), serotonin norepine …

… 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 …

… 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 …

… 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 …

… ntinue 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 duri …

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