BISOLVON CHESTY FORTE bromhexine hydrochloride 8mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bromhexine hydrochloride, Quantity: 8 mg

Available from:

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

INN (International Name):

Bromhexine hydrochloride

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; maize starch

Administration route:

Oral

Units in package:

50, 10, 100, 20, 30

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: Round, white tablets, both sides with bevelled edges; one face is scored and impressed with ?51B? on both sides of the score; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-01-25

Patient Information leaflet

BISOLVON
® CHESTY FORTE TABLETS
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ACTIVE INGREDIENT: _Bromhexine hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Bisolvon Chesty Forte Tablets. 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 FORTE TABLETS.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using Bisolvon Chesty Forte Tablets?
2. What should I know before I use Bisolvon Chesty Forte
Tablets?
3. What if I am taking other medicines?
4. How do I use Bisolvon Chesty Forte Tablets?
5. What should I know while using Bisolvon Chesty Forte
Tablets?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING BISOLVON CHESTY FORTE
TABLETS?
Bisolvon Chesty Forte Tablets contain the active ingredient
bromhexine hydrochloride. Bromhexine hydrochloride thins
and loosens mucus to help clear stubborn chest congestion.
It relives chesty coughs and breathing difficulties due to
excess mucus in cold, flu and respiratory tract infections.
BISOLVON CHESTY FORTE TABLETS ARE 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 FORTE TABLETS?
WARNINGS
DO NOT USE BISOLVON CHESTY FORTE TABLETS IF:
•
YOU ARE ALLERGIC TO BROMHEXINE HYDROCHLORIDE, OR ANY
OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET.
•
Always check the ingredients to make sure you can use
this medicine.
•
DO NOT TAKE BISOLVON CHESTY FORTE TABLETS IF YOU
HAVE GALACTOSE INTOLERANCE.
•
IF YOU ARE NOT SURE IF YOU HAVE THESE ALLERGIES OR THIS
CONDITION, YOU SHOULD RAISE THOSE CONCERNS WITH YOUR
DOCTOR OR PHARMACIST.
•
The maximum recommended adult daily dose of Bisolvon
Chesty Forte Tablets contains 444mg of lactose.
•
DO NOT USE BISOLVON CHE

Summary of Product characteristics

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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