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

Individual events of myalgias and of reversible rhabdomyolysis have been reported, particularly in elderly patients under multiple drug treatment.

In cases of unexplained muscular pain or if myopathy is diagnosed the patient should discontinue the treatment and consult the physician. The level of creatinine phosphokinase (CPK) should be assessed as an elevation may indicate the presence of rhabdomyolysis, a serious condition which may lead to renal failure. These muscular manifestations may indicate genetic abnormalities of the muscular oxidative mechanism and should be carefully assessed. Persons predisposed to malignant hyperthermia should not be treated with Spasmopriv Forte, as these inherited genetic abnormalities are linked to those causing rhabdomyolysis.

Caution should be exercised in prescribing Spasmopriv Forte to patients over 60 years and in patients under multiple drug treatment.

Spasmopriv Forte must not be administered to patients with renal or hepatic insufficiency, or mitochondria! myopathy.

Keep the drug out of the reach of children.

There are no known interactions with other drugs during concomitant therapy.

However, administration together with other medications should be performed under careful medical monitoring.

The use of Spasmopriv Forte is not recommended during pregnancy, as its effects have not been fully established. Administration of Spasmopriv Forte during breast-feeding is not recommended as the possible excretion into the mother’s milk has not been determined.

Spasmopriv Forte is not known to influence driving and the use of machines.

The most common side effects observed are:

• effects on the gastro-intestinal tract: occasional stomach upset, bad taste in the mouth.

The above-mentioned side effects resolved in 24-48 hours, without terminating the treatment.

Rare side effects are:

• hypersensitivity reactions: skin rash
• effects on the renal system: brown urine
• effects on the skeletomuscular system: muscle pain (myalgia), reversible muscle degeneration (rhabdomyolysis).

Individual events of myalgias and of reversible rhabdomyolysis were reported, particularly in elderly patients under multiple drug treatment. Rhabdomyolysis is often associated with renal insufficiency. Rhabdomyolysis is a potential adverse event of many therapeutic classes, and commonly seen with cholesterol-lowering agents. It is also known, however, to be genetically determined in subjects with inherited predisposition to malignant hyperthermia, and in subjects with inherited predisposition to myoglobinuria. All monitored events occurred in elderly patients (>65 years), and/or in patients with severely impaired liver function (liver cancer, terminal cirrhosis). All were under multiple treatments, and in almost all cases given a very high dose of fenoverine. These are conditions known to facilitate the occurrence of any kind of adverse events, including rhabdomyolysis. When the contraindications specified are followed (avoid administration to the elderly; in cases of liver insufficiency such as those due to hepatitis, cirrhosis, addiction to alcohol or narcotics; concomitantly with drugs that overload the metabolic capacity of the liver; to patients with renal failure) the risk is dramatically decreased. When these precautions have been followed, no events of rhabdomyolysis have been reported.

If side effects occur, the physician should carefully consider whether or not to discontinue treatment.

None known.