BISOLVON CHESTY FORTE SOLUBLE bromhexine hydrochloride 8 mg soluble tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bromhexine hydrochloride

Available from:

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

INN (International Name):

Bromhexine hydrochloride

Authorization status:

Registered

Summary of Product characteristics

bischesty-
ccds
0052-09-piv8-25oct19
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION – BISOLVON
® CHESTY
(BROMHEXINE HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Bromhexine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BISOLVON CHESTY ORAL LIQUID contains 4 mg/5mL of bromhexine
hydrochloride
BISOLVON CHESTY KIDS ORAL LIQUID contains 4 mg/5mL of bromhexine
hydrochloride
BISOLVON CHESTY FORTE ORAL LIQUID contains 8 mg/5mL of bromhexine
hydrochloride
BISOLVON CHESTY FORTE TABLETS contains 8 mg per tablet of bromhexine
hydrochloride
BISOLVON CHESTY FORTE LIQUID ON-THE-GO SACHETS contains 4 mg/5mL of
bromhexine
hydrochloride
BISOLVON CHESTY FORTE SOLUBLE TABLETS contains 4 mg/5mL of bromhexine
hydrochloride
Excipients with known effect: sugars, sucralose, maltitol and
benzoates.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
BISOLVON CHESTY ORAL LIQUID is a clear to almost clear and colourless
to almost colourless
solution with an aroma of chocolate and cherry.
BISOLVON CHESTY KIDS ORAL LIQUID is a clear to almost clear and
colourless to almost
colourless solution with a fruity aromatic odour of strawberry.
BISOLVON CHESTY FORTE ORAL LIQUID is a clear to almost clear and
colourless to almost
colourless solution with an aroma of chocolate and cherry.
BISOLVON CHESTY FORTE TABLETS are round, white and bevel-edged
tablets. One side is
scored and impressed with ‘51B’ on both sides of the score.
BISOLVON CHESTY FORTE LIQUID ON-THE-GO SACHETs is a clear to almost
clear and
colourless to almost colourless solution with an aroma of chocolate
and cherry
BISOLVON CHESTY FORTE SOLUBLE TABLETS the tablets are square,
cushion-shaped, shallowly
convex, beige-yellow tablets with rounded edges and orange dots.
bischesty-
ccds
0052-09-piv8-25oct19
Page 2 of 11
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For use as a mucolytic to break down mucus and help clear the chest in
conditions
accompanied by excessive mucus secretions, such as in the common cold,
influenza,
infections of