MUSCUREL Capsule Ref.[116547] Active ingredients: Thiocolchicoside

Source: Marketing Authorisation Holder  Revision Year: 2018  Publisher: Dafra Pharma GmbH, Mühlenberg 7, 4052 Basel, Switzerland Manufacturer: Bilim Pharmaceuticals, GOSB 41480 Gebze, Kocaeli, Turkey

4.1. Therapeutic indications

Add-on therapy for painful muscle contractures in acute spinal pathology in adults and adolescents 16 years of age and older.

4.2. Posology and method of administration

The recommended and maximum dose is 8 mg every 12 hours (i.e. 16 mg daily). The length of treatment is limited to 7 consecutive days.

Doses higher than the recommended doses or long-term use should be avoided (see Section 4.4).

Paediatric population

Muscurel should not be used in children or adolescents less than 16 years of age because of safety concerns (see Section 5.3).

Method of administration

Oral use.

The capsules must be swallowed with a glass of water.

4.9. Overdose

Signs and symptoms

Digestive signs of the diarrhoea or vomiting type are possible.

Treatment

In case of an overdose, monitoring by a physician and symptomatic treatment are recommended.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 30°C.

6.5. Nature and contents of container

Cardboard box with one transparent PVC/Al blister package of 10 capsules.

6.6. Special precautions for disposal and other handling

No special requirements.

Any unused product or waste material should be disposed of in accordance with the regulations in force.

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