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

The treatment must always be under medical supervision.

The dosage in adults is usually 50 mg opipramol dihydrochloride in the morning and at midday and 100 mg opipramol dihydrochloride at night.

Depending on efficacy and tolerability, the dose can be reduced to 50 mg – 100 mg opipramol dihydrochloride once daily, preferably at night, or increased to 100 mg opipramol dihydrochloride up to 3 times a day.

Children over 6 years are given 3 mg opipramol dihydrochloride/kg body weight. As experiences with opipramol are limited in paediatrics, this dosage recommendation is for guidance only.

Opipramol Dihydrochloride 50 mg coated tablets should be taken with some liquid (water, fruit juice).

As the effect of opipramol is not apparent suddenly and the overall alteration in mood occurs gradually, this medicinal product should be taken regularly for at least 2 weeks.

An average treatment period of 1-2 months is advisable.

Symptoms of intoxication

Drowsiness, insomnia, dizziness, agitation, coma, stupor, temporary confusional states, increased anxiety, ataxia, convulsions, oliguria, anuria, tachy-/bradycardia, arrhythmia, AV block, hypotension, shock, respiratory depression, rarely cardiac arrest.

Treatment of intoxication

A specific antidote is not available. The harmful agent should be removed by vomiting and/or gastric lavage. The patient should be admitted to hospital with vital functions protected. Cardiovascular monitoring should be continued for at least 48 hours.

In the case of overdose, the following measures should be instituted:

• Respiratory insufficiency: intubation and artificial ventilation
• Severe hypotension: appropriate positioning, plasma expanders, dopamine or dobutamine as drip infusion.
• Cardiac arrhythmias: individual treatment; if necessary cardiac pacemaker, correction of low potassium levels and possible acidosis.
• Convulsions: injection of diazepam intravenously or a different anticonvulsant agent such as phenobarbital or paraldehyde (caution: possible intensification of existing respiratory insufficiency, hypotension or coma by these substances).
• Dialysis and haemodialysis are of hardly any benefit.

As children react much more sensitively to acute overdoses of tricyclic antidepressants/anxiolytics than adults and as serious incidents have been reported, all possible measures should be taken to prevent overdose; if they occur nevertheless, the symptoms of overdose must be taken seriously and treated carefully.

18 months.

Do not store above 25°C.

Aluminium/PVC/PVDC blister.

Pack sizes: 20, 40, 50, 60, 90, 100, 120.

Hospital pack: 30 × 20.

Not all pack sizes may be marketed.

No special requirements.