(and dosage form):
Each 5 mL of syrup contains: Carbocisteine 250 mg
Preservative: Methyl hydroxybenzoate 0,17% m/v
A 10.2.2. Medicines acting on respiratory system: Other
Mucoflem reduces the viscosity of non-infected secretions from mucous cells in the respiratory tract.
Adjunctive therapy in respiratory tract disorders characterised by excessive viscous mucous in the absence of infection.
Hypersensitivity to any of the ingredients. Active peptic ulcer. Children under 2 years of age. Safety in pregnancy and lactation has not been established.
DOSAGE AND DIRECTIONS FOR USE:
Adults: Two to three medicine measuresful (10 mL to 15 mL), three times daily.
Children 6 - 12 years: One medicine measureful (5 mL) three times daily.
Children 2 - 5 years: Half a medicine measureful (2,5 mL) two to four times daily, according to age.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, diarrhoea and headache may occur. Gastro-intestinal bleeding, skin rash, palpitations, dizziness and heartburn have been reported. Mucoflem should be administered with caution to patients with a history of gastric or duodenal ulcer.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Refer to "Side-effects arid special precautions". Treatment is supportive and symptomatic.
Mucoflem is a clear red syrupy liquid with a pleasant cherry flavour.
200 mL bottles.
Store in a cool place, below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
XIXIA Pharmaceuticals (Pty) Ltd
15 Thora Crescent
Wynberg Ext. 3
P.O. Box 2080, Gallo Manor, 2052
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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