Syrup: Each teaspoonful (5 ml) contains 7.5 mg of butamirate citrate.
Excipients with known effect: sorbitol, ethanol and sodium (saccharin sodium, sodium hydroxide).
Tablet: Each sustained-release film-coated tablet contains 50 mg of butamirate citrate.
Excipients with known effect: lactose monohydrate.
Symptomatic treatment of cough of various origins.
For oral administration only. Do not take for more than 7 days without speaking to a doctor. Use the smallest dose needed to treat symptoms and use the medicine for the shortest period of time necessary. Do not exceed the stated dose.
Syrup: Children 3 to 6 years of age: One (1) teaspoonful (5 ml) 3 times daily.
Maximum daily dose: 15ml (22.5 mg).
Children 6 to 12 years of age: Two (2) teaspoonfuls (10 ml) 3 times daily.
Maximum daily dose: 30ml (45 mg).
Adolescents over 12 years of age: One (1) tablespoonful (15 ml) 3 times daily.
Maximum daily dose: 45ml (67.5 mg).
Adults: One (1) tablespoonful (15 ml) 4 times daily.
Maximum daily dose: 60ml (90 mg).
Tablet: Adolescents over 12 years of age: 1 tablet twice daily. To be swallowed whole.
Maximum daily dose: 2 tablets (100 mg).
Adults: 1 tablet 3 times daily (at least 8 hours between doses). To be swallowed whole.
Maximum daily dose: 3 tablets (150 mg).
Overdose with butamirate (Sinecod) may cause the following symptoms: somnolence, nausea, vomiting, diarrhea, dizziness and low blood pressure.
Treatment: Further management should be as clinically indicated or as recommended by the national poison centers, where available. There is no specific treatment for an overdose of butamirate. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. If the patient takes more Butamirate Citrate (Sinecod Forte) than they should have, seek medical advise immediately.
If patient is allergic to butamirate citrate or any of the other ingredients.
Do not use with other expectorant medicines. If symptoms persist or do not improve, speak to a doctor.
Information concerning excipients: Syrup: Sorbitol: This medicine contains 284 mg of Sorbitol in each ml. Sorbitol is a source of fructose. If the patient has an intolerance to some sugars or if patient has been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to the doctor before taking or receiving this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Ethanol: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Tablet: Lactose monohydrate: If the patient has intolerance to some sugars, contact the doctor before taking this medicinal product.
Effects on Ability to Drive and Use Machines: Butamirate Citrate (Sinecod Forte) in rare cases may cause some people to become less alert than they are normally. If this occurs, you should use with caution when driving or operating machines.
If the patient is pregnant or breast-feeding, do not use Butamirate Citrate (Sinecod Forte) unless recommended by the doctor.
The following side effects may occur in rare cases: Somnolence, itchy skin rashes, nausea, and diarrhea.
For the first sign of adverse drug reaction, seek medical attention immediately.
Avoid taking simultaneously other cough medicines, because it may lead to accumulation of bronchial secretions in your lungs. Tell the doctor or pharmacist before use if patient is taking, or have recently taken, any regular medication on prescription or over-the-counter products.
Store at temperatures not exceeding 30°C.
R05DB13 - butamirate ; Belongs to the class of other cough suppressants.
SR tab 50 mg (brick red, lacquered, round, biconvex) x 100's, 160's. Syr (clear, colorless with vanilla aroma, sweet and slightly bitter) 120 mL.