PHARMACOLOGICAL CLASSIFICATION: Category A 10.2.2 Medicines acting on the respiratory system. Other.
PHARMACOLOGICAL ACTION: Carbocysteine reduces the viscosity of non-infected secretions from mucous cells in the respiratory tract.
INDICATIONS: Adjunctive therapy in respiratory tract disorders characterised by excessive viscous mucous in the absence of infection.
CONTRA-INDICATIONS: Active peptic ulcer. Hypersensitivity to any of the ingredients.
DOSAGE AND DIRECTIONS FOR USE: Adults: Two to three medicine measurefuls (10 mL 15 mL) three times daily.
Children: 5 12 years One medicine measureful (5 mL) three times daily.
2 5 years Half a medicine measureful (2,5 mL) given twice to four times daily. (according to age)
SIDE EFFECTS & SPECIAL PRECAUTIONS: Nausea, diarrhoea and headache may occur. Gastro-intestinal bleeding, skin rash, palpitations, dizziness and heartburn have been reported.
CO-FLEM should be administered with caution to patients with a history of gastric or duodenal ulcer. The safety of CO-FLEM in pregnancy has not been established.
SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT: Nauseae and vomiting. Treatment is symptomatic and supportive.
IDENTIFICATION: Clear orange syrup.
PRESENTATION: 200 mL amber glass bottles, and 2,5 L in plastic containers.
STORAGE INSTRUCTIONS: Store below 25°C, and protect from light. Keep out of the reach of children.
REGISTRATION NUMBER: V/10.2.2/291
NAME AND BUSINESS ADDRESS OF APPLICANT: COMPU Pharmaceutical Products Ltd
476 Kings Highway