Butamirate 1.7 mg - cough suppressant syrup 125 ml

Product Description

Syrup

Composition:

BUTAMIRATE MYLAN GENERICS 2 mg/ml oral drops, solution: 1 ml of solution (equal to 20 drops) contains: active ingredient: Butamirate citrate 2 mg (equivalent to butamirate 1.3 mg). BUTAMIRATE MYLAN GENERICS 1.7 mg/5 ml syrup: 100 ml of syrup contains: Active ingredient: Butamirate citrate 34.5 mg (equivalent to butamirate 21.3 mg).

Excipients

BUTAMIRATE MYLAN GENERICS 2 mg/ml oral drops, solution: Citric acid, glycerol; 70% sorbitol; anethole; vanillin; methyl p-hydroxybenzoate; purified water. BUTAMIRATE MYLAN GENERICS 1.7 mg/5ml syrup Citric acid; glycerol; 70% sorbitol; vanillin; methyl p-hydroxybenzoate; purified water.

Therapeutic indications

Cough sedative.

Contraindications

Hypersensitivity to the components or closely related substances from a chemical point of view. Pregnancy and breastfeeding (see section 4.6). Children under 2 years of age. The product contains sorbitol: therefore, it is contraindicated in cases of hereditary fructose intolerance.

Dosage

BUTAMIRATE MYLAN GENERICS 2 mg/ml oral drops, solution Children 2-5 years: 15 drops every 8-6 hours. School-age children (6-12 years): 20 drops every 8-6 hours. Adults: 40 drops every 6-5 hours. BUTAMIRATE MYLAN GENERICS 1.7 mg/5 ml syrup Children 2-6 years: 5 ml every 8-6 hours. School-age children (6-12 years): 10 ml every 8-6 hours. Adults: 15 ml every 8-6 hours. Do not exceed the recommended dose.

Warnings and precautions

In subjects with severe renal and/or hepatic insufficiency. BUTAMIRATE MYLAN GENERICS should be administered only in case of real need and under the direct supervision of a doctor, taking into account that effective plasma levels of butamirate citrate may be higher and/or longer lasting than in subjects with normal hepatic and/or renal function. The product contains glycerol: it can be dangerous at high doses; it can cause serious side effects. May cause migraine, gastric problems, and diarrhea. The product contains sorbitol, which can cause gastric problems and diarrhea. The product contains parahydroxybenzoate, which can cause delayed-type allergic reactions such as contact dermatitis; more rarely, it can cause immediate-type reactions with urticaria and bronchospasm.

Interactions

None known to date.

Side effects

The tolerability of BUTAMIRATE MYLAN GENERICS is good. In rare cases, nausea, anorexia, transient gastric disturbances (diarrhea), skin rashes, and dizziness have been reported. These effects disappear following a reduction in dosage or discontinuation of the drug.

Pregnancy and breastfeeding

BUTAMIRATE MYLAN GENERICS should not be used during pregnancy and breastfeeding. Use should also be avoided if pregnancy is suspected or if a pregnancy is being planned.