MUCOFLEM SYRUP

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

MUCOFLEM SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

MUCOFLEM SYRUP

COMPOSITION:
Each 5 mL of syrup contains: Carbocisteine 250 mg
Preservative: Methyl hydroxybenzoate 0,17% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.2.2. Medicines acting on respiratory system: Other

PHARMACOLOGICAL ACTION:
Mucoflem 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:
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.

IDENTIFICATION:
Mucoflem is a clear red syrupy liquid with a pleasant cherry flavour.

PRESENTATION:
200 mL bottles.

STORAGE INSTRUCTIONS:
Store in a cool place, below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
27/10.2.2/0230

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
XIXIA Pharmaceuticals (Pty) Ltd
15 Thora Crescent
Wynberg Ext. 3
Sandton
P.O. Box 2080, Gallo Manor, 2052

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

6/1/93	93E0693
	P1343