SPASMOPRIV FORTE Capsule Ref.[50726] Active ingredients: Fenoverine

Source: Web Search  Revision Year: 2018  Publisher: Eurodrug Laboratories S.A., Kortrijksesteenweg 214, 9830 Sint-Martens-Latem, Belgium

4.1. Therapeutic indications

Spasmopriv Forte is indicated for the treatment of:

Disorders of the colon: such as irritable colon, and acute, spastic and inflammatory colitis.

Gastrointestinal disorders: such as vomiting, oesophageal spasm. Disorders of the GI-motility following gastric surgery.

Gynaecological disorders: such as dysmenorrhoea, pelvic pain and spasms, including post-partum spasms.

4.2. Posology and method of administration

Adults: The recommended dosage is 1 capsule two times daily at meals during not more than 6 weeks. In severe cases or resistant patients, the dosage can safely be increased up to 1 capsule three times daily, according to medical prescription.

The longest period of treatment documented in clinical trials to date is 6 weeks.

Elderly patients: In elderly patients the standard dosage (1 capsule b.i.d. during not more than 6 weeks) should not be exceeded. In patients above 60 years, special care should be taken.

Children (12-18 years): The normal adult dose (1 capsule b.i.d. during not more than 6 weeks) may be used.

Children (less than 12 years): Spasmopriv Forte should not be administered to children less than 12 years.

4.9. Overdose

No cases of overdosage have been reported to date. In the event of overdosage the usual measures should be taken (the stomach should be emptied by induced vomiting or by gastric lavage; the patient should be kept under close observation and adequate fluid intake should be maintained).

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

PVC/Alu blister pack.

Box containing 10 or 20 capsules.

6.6. Special precautions for disposal and other handling

No special instructions are provided.

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