SIMALVIA

Posology Paediatric population The safety and efficacy of SimAlvia, soft capsules in children under 18 years of age have not been established. Method of administration For oral administration Adults (including the elderly 1 soft capsule two to three times daily at the beginning of meals.

The side effects listed below have been reported at frequencies corresponding to: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000) and not known frequency (cannot be estimated on the basis of the available data).

4). Investigation Not known Elevated transaminases, alkaline phosphatase, and bilirubin.

Skin and subcutaneous tissue disorders:

Not known Angioedema, skin rash, urticaria, and pruritus. Immune system disorders Very rare Anaphylactic type reactions, and anaphylactic shock. Ear and labyrinth disorders Not known Vertigo. Nervous system disorders Not known Headache.

Gastrointestinal disorders Not known Nausea. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Other causes of gastro intestinal pathology should be outruled, and patients not improving after 2 weeks of treatment should be reviewed by physician.

Liver function:

Elevations in ALT (Alanine Aminotransferase) and AST (Aspartate Aminotransferase) > twice the upper limit of normal (ULN) have been reported in patients receiving treatment with alverine/simeticone. 8). In case of an elevation in hepatic aminotransferases > 3 times the ULN and/or in the case of jaundice, treatment with alverine/simeticone should be discontinued.

Patients should be warned to report immediately any signs and symptoms of unexplained persistent nausea, decreased appetite, fatigue, vomiting, right upper abdominal pain, or jaundice, dark urine or pale faeces. Patients with these symptoms should discontinue taking SimAlvia and the patient's hepatic function should be immediately evaluated.

Paralytic ileus Intestinal obstruction Use in pregnancy and lactation History of allergic reaction or intolerance to alverine or to any of the excipients Hypersensitivity to peanut or soya.