MUSCUREL Capsule Ref.[116547] Active ingredients: Thiocolchicoside

• In patients with epilepsy or seizure risks, as thiocolchicoside may predispose to seizures, it is recommended to evaluate the risk-benefit ratio of thiocolchicoside and to increase clinical monitoring. Any occurrence of seizures requires discontinuation of the treatment.
• Some cases of liver conditions (such as cytolytic or cholestatic hepatitis) have been reported with thiocolchicoside during post-market use. Serious cases (fulminant hepatitis) have been reported in patients taking NSAIDs or paracetamol concomitantly. Patients must discontinue treatment and contact their physician if any signs or symptoms of hepatic conditions develop (see Section 4.8).
• In case of diarrhoea, reduce the posology. As an option, the capsules may be ingested with a gastric dressing.
• Preclinical studies have shown that one of thiocolcoside metabolites (SL59.0955) induced aneuploidy (i.e. an abnormal number of chromosomes in cells after cell division) at concentrations close to those observed in humans exposed to twice-daily oral doses of 8 mg (see Section 5.3). Aneuploidy is considered as a risk factor for teratogenesis, embryo/foetotoxicité, spontaneous miscarriage, and impairment of male fertility, as well as a potential risk factor for cancer. As a precautionary measure, any use of this product at doses higher than the recommended dose, or for long-term treatment, should be avoided (see Section 4.2). Patients are to be carefully informed of the potential risk of a possible pregnancy and efficient contraceptive measures to be followed.
• This medicine contains lactose monohydrate. Patients with an intolerance to galactose, total lactase deficiency, or glucose and galactose malabsorption syndrome (rare hereditary diseases) should not take this medicine.
• This medicine contains carmoisine which may cause allergic reaction.

General information

Based on clinical experimentation, thiocolchicoside is used successfully and safely in combination with nonsteroidal anti-inflammatory drugs, phenylbutazone, analgesics and preparations used for the treatment of neuritis, anabolic steroids, sedatives, barbiturates and succinylcholine.

It is not recommended to use thiocolchicoside concomitantly with other medicines which have a muscle-relaxing effect on the muscular-skeletal system, as these may increase one another's impact. For the same reason, when thiocolchicoside is used with another medicine which produces effects on the smooth muscles, one should beware of a possible increase in the incidence rate of side effects, and ensure that the patient is monitored.

Additional information on special populations

No study on interaction with special populations has been reported.

Paediatric population

No study on the paediatric population has been reported.

Pregnancy

There is limited available data on the use of thiocolchicoside in pregnant women. As a result, the potential risks for the embryo and the foetus are unknown. Animal studies have shown teratogenic effects (see Section 5.3).

Muscurel is contra-indicated during pregnancy and in women of childbearing age who are not using contraceptives (see Section 4.3).

Lactation

As thiocolchicoside passes into breast milk, its use is contra-indicated during breast-feeding (see Section 4.3).

Fertility

In a toxicity study on fertility in rats, no impairment of fertility was observed at doses up to 12 mg/kg, which matches dose levels with no clinical effect. Thiocolchicoside and its metabolites exert aneugenic activity at different dose levels, which is a risk factor for impairment of fertility in males (see Section 5.3).

Clinical studies have not demonstrated any psychomotor impairments related to thiocolchicoside. However, drowsiness may commonly occur; this should be considered in vehicle drivers and machine operators.

Adverse events are classified per frequency as follows: Very Common (≥1/10), Common (≥1/100 and <1/10), Uncommon (≥1/1000 and <1/100), Rare (≥1/10000 and <1/1000), Very Rare (<1/10000), not known (cannot be estimated from the available data).

Not applicable.