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?
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 Chesty products in children under 6 years of age.
You should not use Bisolvon Chesty Kids Oral Liquid after the EXPIRY DATE on the carton
or bottle.
If you take this medicine after the expiry date, it may not work as well.
Do not use Bisolvon Chesty Kids Oral Liquid if the cap seal is broken or the packaging
is torn or shows signs of tampering.
Check with your doctor or pharmacist if you:
have a persistent or chronic cough such as coughs occurring with smoking, asthma,
chronic bronchitis, emphysema or cough accompanied by excess phlegm, consult your
doctor before taking Bisolvon Chesty Kids Oral Liquid.
have, or have had, any of the following conditions:
liver problems
kidney problems
stomach ulcers.
If you are not sure if you have, or have had, any of these conditions, you should
raise those concerns with your doctor or pharmacist.
Before taking Bisolvon Chesty Kids Oral Liquid, it is important to tell your doctor
or pharmacist if you are taking any other medicines, obtained with or without a doctor’s
prescription.
Bisolvon Chesty Kids Oral Liquid may increase the amount of antibiotic penetration.
Antibiotics are medicines used to treat infections.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.
Special care is recommended during pregnancy. The benefits of Bisolvon Chesty Kids
Oral Liquid must be assessed against any risks. Your doctor will discuss the risks
and benefits of using Bisolvon Chesty Kids Oral Liquid while you are pregnant.
The use of Bisolvon Chesty Kids Oral Liquid during the first trimester is not recommended.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
Bisolvon Chesty Kids Oral Liquid is expected to enter the breast milk.
It is not recommended that Bisolvon Chesty Kids Oral Liquid be taken by women who
are breastfeeding.
Children
Do not use Bisolvon Chesty Kids Oral Liquid in children under 6 years of age. Use
in children 6 – 11 years only on the advice of a doctor, pharmacist or nurse practitioner.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Bisolvon Chesty Kids Oral Liquid.
4. How do I use Bisolvon Chesty Kids Oral Liquid?
Use the enclosed measuring cup to measure the doses correctly.
How much to take
Children 6 - 11 years:
10 mL three times a day when necessary.
Adults and children 12 years and over:
10 mL three times a day when necessary.
This dose can be increased to 20 mL three times a day for the first 7 days.
Ask your doctor or pharmacist for more information if you have been advised to take
a different dose.
Follow the instructions provided with the medicine.
Do not exceed the recommended dosage.
If you use too much Bisolvon Chesty Kids Oral Liquid
If you think that you have used too much Bisolvon Chesty Kids Oral Liquid, you may
need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26 in Australia), or
contact your doctor or pharmacist, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Bisolvon Chesty Kids Oral Liquid?
When you take Bisolvon Chesty Kids Oral Liquid, you may notice an increase in thin
watery mucus from your air passages. This is common when you take Bisolvon Chesty
Kids Oral Liquid and is due to the way Bisolvon Chesty Kids Oral Liquid works, helping
to remove mucus by making it easier to cough up.
The maximum recommended daily dose of Bisolvon Chesty Kids Oral Liquid for children
6 - 11 years of age (30 mL) contains at least 7.5 g of maltitol and up to 1.2 g of
sorbitol.
The maximum recommended adult daily dose (60 mL) of Bisolvon Chesty Kids Oral Liquid
contains at least 15 g of maltitol and up to 2.4 g of sorbitol.
Products containing maltitol and sorbitol may have a laxative effect or cause diarrhoea
in some people. This is more likely if several products containing maltitol, sorbitol
or related substances are consumed at the same time.
Things you should do
If your symptoms persist, you should contact your doctor for further advice.
Your doctor will assess your condition and decide if you should continue to take Bisolvon
Chesty Kids Oral Liquid or if a new treatment plan is needed.
Stop taking Bisolvon Chesty Kids Oral Liquid and contact your doctor immediately if
you experience any skin reaction with severe blisters and bleeding in the lips, eyes,
mouth, nose or genitals. These may be symptoms of a severe allergic reaction that
requires urgent medical attention.
There have been very rare reports of severe skin reactions such as Stevens Johnson
Syndrome and Lyell’s Syndrome with products containing bromhexine.
Remind any doctor, dentist or pharmacist you visit that you are using Bisolvon Chesty
Kids Oral Liquid.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Bisolvon
Chesty Kids Oral Liquid affects you.
When used as recommended, and when there are no side effects, Bisolvon Chesty Kids
Oral Liquid is not known to have any effect on the ability to drive or operate machinery.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Bisolvon Chesty Kids Oral Liquid should be kept in a cool dry place where the temperature
stays below 25°C
Store in a cool, dry place away from moisture, heat or sunlight; for example, do not
store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects from taking Bisolvon Chesty Kids Oral
Liquid.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell during or after taking Bisolvon Chesty Kids Oral Liquid.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
7. Product details
This medicine is available over-the-counter without a doctor's prescription.
What Bisolvon Chesty Kids Oral Liquid contains
|
Active ingredient
(main ingredient)
|
Bromhexine hydrochloride - each 5 mL of Bisolvon Chesty Kids Oral Liquid contains
4 mg bromhexine hydrochloride.
|
|
Other ingredients
(inactive ingredients)
|
maltitol solution
sucralose
benzoic acid
hydroxyethylcellulose
strawberry flavour -12006M
cherry flavour 96323-33
purified water
|
Do not take this medicine if you are allergic to any of these ingredients.
What Bisolvon Chesty Kids Oral Liquid looks like
Bisolvon Chesty Kids Oral Liquid is the brand name of your medicine. The Oral Liquid
is a clear to almost clear and colourless to almost colourless solution with a fruity
aromatic odour of strawberry.
Bisolvon Chesty Kids Oral Liquid is available in bottles containing 200 mL, with a
tamper-evident cap.
Each carton is labelled with the Australian Registration Number AUST R 182576.
Who distributes Bisolvon Chesty Kids Oral Liquid
Bisolvon Chesty Kids Oral Liquid is made in France.
Bisolvon Chesty Kids Oral Liquid is supplied in Australia by:
Sanofi Consumer Healthcare,
87 Yarraman Place, Virginia,
Qld 4014 Australia.
Toll-free: 1800 818 806
Registration No AUST R 182576
Date of preparation: June 2021
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