Simethicone Angenerico 42 mg Meteorism 50 Chewable Tablets

Simethicone-based tablets.

Therapeutic indications

Simethicone Angenerico is used in the symptomatic treatment of gastrointestinal bloating and adult aerophagia.

Dosage and Posology

The drug should be taken according to the following doses and methods: the use of Simethicone Angenerico is limited to adults. Take 2 tablets, 4 times a day, after meals. Given the lack of intestinal absorption, no particular precautions are required in elderly patients or in case of renal or hepatic insufficiency.

Oral use The tablets must be chewed. The duration of treatment should not exceed 10 days.

Overdose

No cases of overdose have been reported.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Side effects

Due to the absence of intestinal absorption, the risk of side effects with simethicone is limited. The incidence of adverse events in published clinical studies is low (1.6%, out of approximately 2500 exposed patients) and is mainly represented by gastrointestinal disorders (overall incidence of 1%). Undesirable effects are classified according to the MedDRA convention by system organ class and frequency as follows: Very frequent (≥ 1/10) Frequent (≥ 1/100 to <1/10) Infrequent (≥ 1/1000 to < 1/100) Rare (≥ 1/10 000 to <1/1000) Very rare (<1/10000), not known (cannot be estimated from the available data).

- Gastrointestinal disorders

• Infrequent: diarrhea, abdominal pain, ileus, nausea, vomiting

- Diseases of the immune system

• Rare: Hypersensitivity reactions such as rash, itching, edema of the face and tongue or difficulty in breathing have been reported with the use of simethicone.

Pregnancy and breastfeeding

There are no clinical data regarding the exposure of pregnant women related to simethicone. Studies conducted on animals are insufficient with regard to pregnancy, embryo-fetal development, parturition or post-natal development. Since simethicone is not absorbed from the gastrointestinal tract, the potential risk for humans is very low. Since there is no experience of the use of simethicone during pregnancy, Simethicone Angeneric should not be administered unless clinically warranted.

There is no known excretion of simethicone into human milk. However, since simethicone is not absorbed from the gastrointestinal tract, the potential risk is very low. Simethicone Angenerico, during lactation, should be used only when the risk / benefit ratio is favorable.

Special warnings

The tablets should be chewed and not swallowed whole. Simethicone Angeneric tablets are not recommended for children due to limited information on their safety. Simethicone Angenerico contains sucrose. Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicinal product. In case of persistence or worsening of symptoms or in case of prolonged constipation, the patient should consult the doctor. Do not use in case of suspected intestinal perforation or ileus.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store below 30 ° C.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

One tablet of Mylicongas contains:

Active principle

Simethicone (activated dimethylpolysiloxane) 40 mg

Excipients

Sucrose, povidone, anhydrous colloidal silica, magnesium stearate, vanillin