SIMETICONE ANG * 50CPR MAST 42MG

SIMETICONE ANG * 50CPR MAST 42MG

Therapeutic indications

Treatment of symptoms related to gas formation (abdominal swelling, flatulence, meteorism). Simethicone Angelini is indicated in children aged 12 and over and in adults.

Dosage and method of use

Dosage: The use of SIMETICONE ANGELINI is limited to children aged 12 and over and adults. Children aged 12 and over: 1 or 2 tablets, three or four times a day, after meals. Children under the age of 12 should not use Angelini Simeticone. Adults: 2 tablets, four 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.Method of administration: Oral use. The tablets must be chewed. The duration of treatment should not exceed 10 days

Contraindications

Hypersensitivity to the active substance (simethicone) 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 disturbances (overall incidence of 1%). Undesirable effects are classified according to the MedDRA convention by system organ class and frequency as follows: Very common (≥ 1/10); Common (≥ 1/100 to Gastrointestinal disorders. Uncommon: diarrhea, abdominal pain, ileus, nausea, vomiting.Disorders of the immune system. Rare: Hypersensitivity reactions such as rash, itching, swelling of the face and tongue or difficulty in breathing have also been reported with the use of simethicone.Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

The tablets should be chewed and not swallowed whole. SIMETICONE ANGELINI tablets are not recommended for children under the age of 12 due to the limited information on their safety. SIMETICONE ANGELINI contains sucrose (see section 6.1). 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.

Pregnancy and breastfeeding

Pregnancy: No clinical data on the exposure of pregnant women are available for simethicone. Studies conducted on animals are insufficient with regard to pregnancy, embryo-fetal development, childbirth 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, SIMETICONE ANGELINI should not be administered unless clinically justified.Feeding time: Excretion of simethicone into human milk is not known. However, since simethicone is not absorbed from the gastrointestinal tract, the potential risk is very low. SIMETICONE ANGELINI, during breastfeeding, must be used only when the risk / benefit ratio is favorable.Fertility:Non-clinical data obtained with simethicone reveal no special hazard for humans (see section 5.3).

Expiration and retention

Store below 30 ° C.

Interactions with other drugs

It is possible that SIMETICONE ANGELINI may modify the bioavailability of other medicines taken at the same time. The simultaneous intake of SIMETICONE ANGELINI and laxatives based on mineral oils (paraffin) is not recommended, since the combination of these two products reduces their effectiveness.

Overdose

No cases of overdose have been reported.

Active principles

Each tablet contains 42 mg of simethicone. Excipients with known effect: each tablet contains 435 mg of sucrose. For the full list of excipients, see section 6.1.

Excipients

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