SYMPRAMOL Coated tablet Ref.[11015] Active ingredients: Opipramol

Opipramol should not be used with prostatic hypertrophy without residual urine, manifest hepatic and renal disease, increased tendency to seizures (e.g. with brain damage of various aetiology, epilepsy, alcoholism), cerebrovascular insufficiency and previous cardiac damage, particularly conduction disorders. Patients with pre-existing first-degree AV block or other conduction disorders should be treated only with frequent ECG monitoring (for higher-degree AV block, see section 4.3).

As alterations in the blood count (neutropenia, agranulocytosis) can occur very rarely, the blood count should be measured during treatment with opipramol, particularly if fever, flu-like infections and sore throat occur.

Opipramol can cause hypersensitivity reactions, including delayed reactions. If allergic skin reactions occur, opipramol must be discontinued.

During prolonged treatment, it is advisable to measure the liver function tests.

Patients with the rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, fructose intolerance or sucraseisomaltase insufficiency should not take this medicine.

Treatment with opipramol does not preclude additional therapy with neuroleptics, hypnotics and tranquilizers (e.g. benzodiazepines). It should be noted that a few specific effects, particularly centrally depressant effects, can be intensified with combined medication. The same applies for sedation after systemic anaesthetics.

The effect particularly of strong anticholinergics, such as antiparkinson agents and phenotiazines, can be intensified.

Concomitant treatment with serotonin reuptake inhibitors and opipramol can lead to additive effects on the serotoninergic system. With fluoxetine and fluvoxamine there can be an increase in the plasma concentrations of tricyclic psychotropic substances and an associated intensification of the undesirable effects. If necessary, the dose of opipramol should be reduced.

Combination with alcohol can lead to drowsiness.

MAO inhibitors should be stopped at least 14 days before treatment with opipramol. The same applies for opipramol when MAO inhibitors are given afterwards.

Concomitant use of beta-blockers (e.g. propanolol), class Ic antiarrhythmics and substances from the group of the tricyclic antidepressants and preparations that affect the microsomal enzyme system of the liver can lead to a change in the plasma concentration of these substances and of opipramol. Barbiturates and anticonvulsants can reduce the plasma concentration of opipramol and thus diminish the therapeutic effect. Concomitant administration of neuroleptics (e.g. haloperidol, risperidone) can increase the plasma concentration of opipramol. If necessary, appropriate dose adjustments should be made.

There are no data on exposed pregnant women for opipramol. Animal studies do not permit conclusions on harmful effects of opipramol on embryonic development or fertility (see section 5.3). Opipramol should be prescribed during pregnancy, particularly the first trimester, only if strictly indicated.

Opipramol should not be used during the lactation period as the active substance passes into breast milk in small amounts. If strictly indicated, breast-feeding should be discontinued.

The ability to react can be altered with correct use of opipramol dihydrochloride so that the ability to drive or use machines is impaired, particularly in combination with alcohol.

Rates of incidence: common (≥1/100, <1/10); uncommon (≥1/1,000, ≤1/100); rare (≥1/10,000, ≤1/1,000); very rare (≤1/10,000).

Blood and the lymphatic system disorders

Rare: Blood count changes, especially leucopenia

Very rare: Agranulocytosis

Nervous system disorders

Common: Particularly at the start of treatment fatigue, dry mouth, blocked nose

Uncommon: Vertigo, drowsiness, disorders of micturition, disorders of accommodation, tremor, weight gain, sensation of thirst

Rare: Excitation states, headache, paraesthesias, particularly in elderly patients, confusional states and delirium, particularly with sudden discontinuation of more prolonged high-dose therapy, agitation, sweating and sleep disorders

Very rare: Cerebral seizures, motor disorders (akathisia, dyskinesias), ataxia, polyneuropathies, sudden glaucoma, anxiety states

Cardiac disorders

Common: Particularly at the start of treatment hypotension and orthostatic dysregulation

Uncommon: Tachycardia, palpitations

Rare: Collapse states, conduction disorders, intensification of existing heart failure

Gastrointestinal disorders

Uncommon: Constipation

Rare: Gastrointestinal disorders, taste disorders, paralytic ileus, particularly with sudden discontinuation of more prolonged high-dose therapy, nausea and vomiting

Hepato-biliary disorders

Uncommon: Temporary rises in liver enzyme activity

Very rare: Severe liver function disorders, after long-term treatment icterus and chronic liver damage

Skin and subcutaneous tissue disorders

Uncommon: Allergic skin reactions (exanthem, urticaria)

Rare: Oedema

Very rare: Hair loss

Renal and urinary disorders

Rare: Urinary retention

Reproductive system and breast disorders

Uncommon: Ejaculation disorders, erectile impotence

Rare: Galactorrhoea

Not applicable.