1. NAME OF THE MEDICINAL PRODUCT Relaxine ampoule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml ampoule contains: Active ingredients: Thiocolchicoside 4 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for intramuscular injection in ampoule. Clear yellow Solution free from any visible particulate matter. 4. CLINICAL DATA 4.1. Therapeutic indications Adjunctive treatment of acute painful muscle contractures in spinal pathology in adults and adolescents aged 16 and over. 4.2. Dosage and method of administration Dosage It is not recommended for longer-term treatment of chronic conditions. The recommended and maximum dose is 4 mg (one ampoule) every 12 hours (i.e. 8 mg per day). The duration of treatment is limited to 5 consecutive days. Doses higher than recommended or long-term use should be avoided (see section 4.4). Pediatric population RELAXINE should not be used in children and adolescents aged less than 16 years for safety reasons. Mode of administration Intramuscular route only. 4.3. Contraindications This medicine is contraindicated in cases of: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Hypersensitivity to colchicine. • Pregnancy and lactation (see section 4.6). • in women of childbearing potential not using effective contraception during treatment with RELAXINE and for 1 month after stopping treatment (see sections 4.4 and 4.6); • In men of childbearing potential who are not using effective contraception during treatment with RELAXINE and for 3 months after stopping treatment (see sections 4.4 and 4.6); • Hemostasis disorders or ongoing anticoagulant treatment (contraindication linked to the intramuscular route).
