SYMPRAMOL Coated tablet (2013)

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1. Name of the medicinal product

Sympramol 50 mg coated tablets. Opipramol Dihydrochloride

2. Qualitative and quantitative composition

1 tablet contains 50 mg opipramol dihydrochloride. Excipients: lactose 45.6 mg sucrose 81.3 mg For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Coated tablet. Reddish and round coated tablet.

4.1. Therapeutic indications

Generalised anxiety disorders and somatoform disorders.

4.2. Posology and method of administration

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 ...

4.3. Contraindications

hypersensitivity to opipramol dihydrochloride, tricyclic antidepressants or to any of the excipients acute alcohol, hypnotic, analgesic and psychotropic intoxication acute urinary retention acute delirium ...

4.4. Special warnings and precautions for use

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, ...

4.5. Interaction with other medicinal products and other forms of interaction

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 ...

4.6. Pregnancy and lactation

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 ...

4.7. Effects on ability to drive and use machines

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.

4.8. Undesirable effects

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 ...

4.9. Overdose

Symptoms of intoxication Drowsiness, insomnia, dizziness, agitation, coma, stupor, temporary confusional states, increased anxiety, ataxia, convulsions, oliguria, anuria, tachy-/bradycardia, arrhythmia, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Sedative/Anxiolytic Mechanism of action Opipramol has high affinity for the sigma binding sites (type 1 and type 2) and has an antagonistic effect at the type 1 histamine ...

5.2. Pharmacokinetic properties

Following oral ingestion, opipramol is absorbed rapidly and completely. Partial metabolism to dehydroxyethyl-opipramol takes place during its passage through the liver. The plasma protein binding is about ...

5.3. Preclinical safety data

The acute toxicity is relatively low. Intoxication symptoms affect the CNS predominantly (see section 4.9). Subchronic and chronic administration of very high doses causes CNS symptoms, liver and lung ...

6.1. List of excipients

Tablet core: Maize starch Lactose monohydrate Povidone K 30 Microcrystalline cellulose Talcum Magnesium stearate Tablet coating: Shellac Talcum Calcium carbonate Sucrose Kaolin white (white ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

18 months.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Aluminium/PVC/PVDC blister. Pack sizes: 20, 40, 50, 60, 90, 100, 120. Hospital pack: 30 20. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

SymPhar Sp. z o.o., ul.Włoska 1, 00-777 Warsaw, Poland

8. Marketing authorization number(s)

12777

9. Date of first authorization / renewal of the authorization

06.04.2007

10. Date of revision of the text

04/2013