SIMECRIN 50CPR MAST 40MG

SIMECRIN

active ingredients

Simecrin 40 mg chewing tablets One tablet contains: Active ingredient: symeticone mg 40 Eccipiente with known effects: 158,8 mg lactose. Simecrin 80 mg chewing tablets One tablet contains Active ingredient: symeticone mg 80 Excipient with known effects: 317.6 mg lactose. Simecrin 120 mg chewing tablets One tablet contains: Active ingredient: symeticone mg 120 Excipient with known effects: 476,4 mg lactose. Simecrin 80 mg/ml oral emulsion 1 ml of emulsion contains: Active Ingredient: symeticons mg 80 Excipients with known effect: methyl benzoate paraidrosis 0.9 mg, propile benzoate paraidrosis 0.1 mg and sodium 2.71 mg. See paragraph 6.1 for the full list

Excellent

Chewable tablets Mannitol (E421), colloidal silica moisturizes, Pregelatinized starch, Lactose monohydrate, Polyvinylpyrrolidone K30, Crospovidone, Talco, Magnesium stearate, Aroma mint. Oral emulsion: Monohydrate citric acid, Citrate sodium, Carbomeri, Sodium saccharin, Ipromellosa, Parahydroxybenzoate methyl, Propile parahydroxybenzoato, Aroma allfrutti, Purified water.

Therapeutic indications

Syntomatic treatment of gastro-enteric meteorism and adult aerophagia.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Generally contraindicated in pregnancy (see paragraph 4.6).

Population

Adults: Simecrin 40 mg Chewable tablets: 4 tablets daily (two at the end of each main meal). Simecrin 80 mg Chewable tablets: 2 tablets daily (one at the end of each main meal). Simecrin 120 mg Chewable tablets: 2 tablets daily (one at the end of each main meal). Tablets must be chewed. Simecrin 80 mg/ml oral emulsion: 1-1.5 ml (at the end of each main meal). The prescribed amount of oral emulsion should be taken with the dosing syringe and dispersed in a glass of water.

Conservation

Chewable tablets: store the medicine in the original packaging to repair the product from light and moisture.

Warnings

Do not exceed the recommended doses. After a short period of treatment without appreciable results, consult the Doctor. Important information about some excipients Chewable tablets contain lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine. Oral emulsion contains para-hydroxybenzoates that can cause allergic reactions (also delayed). The oral emulsion contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially ‘without sodium’.

Interactions

They are not known, nor have they been reported, interactions with other drugs.

Effects

Undesirable effects due to Simecrin have not been highlighted. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

There were no overdose phenomena with the use of Simecrin.

Pregnancy

There is no adequate data on the use of Simecrin in pregnant women, so it should not be used in pregnancy unless a real need and after risk/benefit assessment by the doctor.

Food

It is not known whether symeticons are excreted in breast milk. The excretion of symeticons in breast milk was not studied in animals. The decision whether to continue/interrupt breastfeeding or continue/interrupts semeticon therapy should be taken taking into consideration the benefit of breastfeeding for the newborn and the treatment based on symeticons for the woman.

Source: Farmadati