BISOLVON CHESTY KIDS STRAWBERRY FLAVOUR bromhexine hydrochloride 0.8mg/mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bromhexine hydrochloride, Quantity: 0.8 mg/mL

Available from:

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

INN (International Name):

Bromhexine hydrochloride

Pharmaceutical form:

Oral Liquid

Composition:

Excipient Ingredients: maltitol solution; hyetellose; benzoic acid; sucralose; purified water; Flavour

Administration route:

Oral

Units in package:

250 mL, 100 mL, 200 mL, 125 mL, 60 mL

Prescription type:

(S2) Pharmacy Medicine

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 the respiratory tract or in other conditions where excess mucus is produced.

Product summary:

Visual Identification: Clear to almost clear and colourless to almost colourless solution; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2011-04-28

Patient Information leaflet

BISOLVON
® CHESTY KIDS ORAL LIQUID
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ACTIVE INGREDIENT(S): Bromhexine hydrochloride
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Bisolvon Chesty Kids Oral Liquid. YOU SHOULD ALSO SPEAK
TO YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER
INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS
ABOUT USING BISOLVON CHESTY KIDS ORAL LIQUID.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using Bisolvon Chesty Kids Oral Liquid?
2. What should I know before I use Bisolvon Chesty Kids Oral
Liquid?
3. What if I am taking other medicines?
4. How do I use Bisolvon Chesty Kids Oral Liquid?
5. What should I know while using Bisolvon Chesty Kids Oral
Liquid?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING BISOLVON CHESTY KIDS ORAL
LIQUID?
BISOLVON CHESTY KIDS ORAL LIQUID CONTAINS THE ACTIVE
INGREDIENT BROMHEXINE HYDROCHLORIDE. Bromhexine
hydrochloride thins and loosens mucus to help clear chest
congestion.
It relieves chesty coughs and breathing difficulties due to
excess mucus in cold, flu and respiratory tract infections.
BISOLVON CHESTY KIDS ORAL LIQUID IS USED IN CONDITIONS
WHERE BREATHING IS DIFFICULT BECAUSE THERE ARE A LOT
OF SECRETIONS (ALSO REFERRED TO AS MUCUS) IN YOUR AIR
PASSAGES. SUCH CONDITIONS INCLUDE:
• COMMON COLD
• FLU
• INFECTIONS OF THE RESPIRATORY TRACT
2.
WHAT SHOULD I KNOW BEFORE I USE BISOLVON
CHESTY KIDS ORAL LIQUID?
WARNINGS
DO NOT USE BISOLVON CHESTY KIDS ORAL LIQUID IF:
•
YOU ARE ALLERGIC TO BROMHEXINE, OR ANY OF THE
INGREDIENTS IN BISOLVON CHESTY KIDS ORAL LIQUID.
If you are not sure if you have these allergies you should
raise those concerns with your doctor or pharmacist.
•
DO NOT TAKE BISOLVON CHESTY KIDS ORAL LIQUID IF YOU
HAVE FRUCTOSE INTOLERANCE.
If you are not sure if you have this condition you should
raise those concerns with your doctor or pharmacist.
•
Always check the ingredients to make sure you can use
this medicine.
•
DO NOT USE BISOLVON

Summary of Product characteristics

bischesty-ccdsv7-piv9-13may21
Page 1 of 10
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
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.
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 the respiratory tract or in other conditions where
excess mucus is produced.
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Page 2 of 10
4.2
DOSE AND METHOD OF ADMINISTRATION
BISOLVON CHESTY ORAL LIQUID AND BISOLVON CHESTY KIDS ORAL LIQUID
Adults & Children 12 years and over: 10 mL (8 mg) three times a day
when necessary. May
be increased to 20 mL (16 mg) three times a day for the first seven
days.
Children 6 - 11 years: 10 mL (8 mg) three times a day when necessary.
BISOLVON CHESTY FORTE ORAL LIQUID
Adults & Children 12 years and over: 5 mL (8 mg) three