Simalvia 60 mg/300 mg Capsule

Relief of abdominal pain in irritable bowel syndrome.

SimAlvia, soft capsule is indicated in adults only.

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.

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.

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. These elevations may be associated with a concomitant elevation in total serum bilirubin (see section 4.8). 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.

None known.

Pregnancy

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

A moderate amount of data on pregnant women indicate no malformative or feto/ neonatal toxicity of alverine citrate. There are no data from the use of simeticone or the combination in pregnant women.

As a precautionary measure, it is preferable to avoid the use of SimAlvia, soft capsules during pregnancy.

Breastfeeding

It is unknown whether alverine citrate or simeticone and their metabolites are excreted in human milk. This medicinal product should be avoided during breastfeeding.

Fertility

There are no data on the effects of alverine citrate or simeticone on human fertility.

Alverine/simeticone has a minor influence on the ability to drive and use machines. Adverse effects such as vertigo have been reported in some patients (see sections 4.8 and 4.9). These types of disorders may affect the ability to drive and use machines.

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).

Due to the presence of alverine:

Hepatobiliary disorders

Very rare

Cytolytic hepatitis (see section 4.4).

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. Healthcare professionals are asked to report any suspected adverse reactions via the MHRA Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Cases of vertigo have been reported when a higher-than-recommended dosage is taken.

Pharmacotherapeutic group: Musculotropic antispasmodic / Anti-flatulent, ATC code: A03AX58

Alverine citrate is a non-atropinic, papaverine-like musculotropic antispasmodic.

Simeticone is an inert substance which has a physical action by altering the surface tension of gas bubbles, leading to their coalescence.

Simeticone is not absorbed from the gastrointestinal tract. Following oral administration, it is eliminated in unchanged form in the faeces.

A clinical study confirmed that alverine crosses the gastro-intestinal barrier with inter-individual variability. However in most patients, plasma concentrations were lower than 1ng/ml.

Steady-state for plasma concentrations of alverine were reached within 5 days, therefore no more increase in plasma levels is expected in case of repeated administration for a period of time longer than 7 days.

Non clinical studies of single and repeated dose toxicity, genotoxicity, toxicity to reproduction and development provide evidence that alverine citrate has no significant systemic toxicity potential.

Simeticone is not absorbed from the intestinal lumen. Systemic effects are therefore not expected.

No long term studies to evaluate carcinogenicity have been performed in animals with alverine citrate or with the combination of alverine citrate and simeticone.

Simeticone was shown to have no carcinogenicity potential.

Soft capsule shell:

Gelatin

Glycerol

Titanium dioxide (E171).

External lubricant composition:

Soya lecithin

Fractionated coconut oil.

Not applicable.

30 months

Store below 25°C.

Keep in outer carton in order to protect from light.

PVC/Aluminium thermoformed blister of 10 soft capsules.

Pack sizes of 10, 20, 30, 40, 60 or 90 capsules.

Not all pack sizes may be marketed.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.