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Logo BRONKESE® 4 TABLETS
BRONKESE® 8 TABLETS
BRONKESE® SOLUTION

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BRONKESE® 4 TABLETS
BRONKESE® 8 TABLETS
BRONKESE® SOLUTION

COMPOSITION:
Tablets containing:
  Bromhexine Hydrochloride 4,00 mg
  Bromhexine Hydrochloride 8,00 mg
Solution containing:
Each 5 mL contains:
  Bromhexine Hydrochloride 10,00 mg
  Preservative: 
  Methyl Hydroxybenzoate 0,10 %m/v.
PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and Expectorants.

PHARMACOLOGICAL ACTION:
BRONKESE® is a mucolytic which changes the structure of uninfected bronchial secretions and reduces the viscosity of sputum.

INDICATIONS:
BRONKESE® reduces the viscosity of uninfected bronchial secretions in bronchial asthma, chronic bronchitis, cystic fibrosis and pulmonary emphysema.

CONTRA-INDICATIONS:
None.

WARNING:
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
Tablets 4 mg:
Children 5 - 10 years:
        Take 1 tablet three or four times a day.

Tablets 8 mg:
Adults:
        Take 1 - 2 tablets three or four times a day.

Solution 10 mg/5 mL:
Adults and children over 10 years:
        Take 5 - 10 mL three times a day.
Children under 10 years:        Take 2,5 - 5 mL three times a day.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal side-effects may occur occasionally and a transient rise in serum transaminase has been reported.

Special Precautions:
Since Bromhexine may disrupt the gastric mucosal barrier it should be given cautiously to patients with gastric and duodenal ulceration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
None.

IDENTIFICATION:
4 mg tablets:        Flat, white tablets with bevelled edges, bisected on one side.
8 mg tablets:        Flat, yellow tablets with bevelled edges, bisected on one side.
Solution:        Clear colourless solution.

PRESENTATION:
4 mg tablets:        Packs of 100 tablets.
8 mg tablets:        Packs of 100 tablets.
Solution:        Bottles containing 50 mL and 200 mL.

STORAGE INSTRUCTIONS:
Store below 25
°C. Keep container tightly closed. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
4 mg TABLETS:
        L/10.1/242
8 mg TABLETS:        L/10.1/243
SOLUTION:        L/10.1/191

NAME AND BUSINESS ADDRESS OF APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
Co. Reg. No. 92/04769/07
Robbie de Lange Road, Wilsonia, EAST LONDON, 5201
P O Box 422, EAST LONDON, 5200

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
16 January 1981

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