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PACKAGE LEAFLET:
INFORMATION FOR THE USER
BISOLVON®
4 MG/5 ML
ORAL SOLUTION
(bromhexine hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed
for you. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets
troublesome or serious, or if you
notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What BISOLVON 4 mg/5 ml Oral
Solution is and what it is used for
2. Before you take BISOLVON
4 mg/5 ml Oral Solution
3. How to take BISOLVON 4 mg/5 ml
Oral Solution
4. Possible side effects
5. How to store BISOLVON 4 mg/5 ml
Oral Solution
6. Further information
1. WHAT BISOLVON 4 MG/5 ML ORAL
SOLUTION IS AND WHAT IT IS
USED FOR
The name of your medicine is
BISOLVON 4 mg/5 ml Oral Solution
(called BISOLVON in this leaflet).
BISOLVON contains a medicine called
bromhexine. This belongs to a group of
medicines called mucolytic agents.
BISOLVON helps you to breathe more
easily when you have breathing
problems such as bronchitis or
sinusitis. It works by making your
mucus thinner so that you can get rid
of it more easily.
2. BEFORE YOU TAKE BISOLVON
4 MG/5 ML ORAL SOLUTION
DO NOT TAKE BISOLVON IF:
• You are allergic (hypersensitive) to
bromhexine or any of the other
ingredients of BISOLVON (listed in
Section 6 below)
• You are pregnant, likely to get
pregnant or are breast-feeding
Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist.
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Page 1 of 6
1.
NAME OF THE MEDICINAL PRODUCT
Bisolvon® 4 mg/5 ml Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains Bromhexine Hydrochloride 4 mg.
Excipients: Contains Maltitol Liquid
For full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Oral Solution
A clear to almost clear, colourless to almost colourless solution with
a fruity aromatic odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As a mucolytic in the management of viscid mucoid secretions
associated with bronchitis,
bronchiectasis, sinusitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral
_Adults and children over 12 years: _2 × 5 ml three times
daily to 3 × 5 ml four times daily.
_Children 5 - 12 years:_
1 × 5 ml four times daily
_Children 2 - 5 years: _
1 × 5 ml twice daily.
_ _
Bisolvon Oral Solution is sugar free and
therefore suitable for diabetics.
4.3
CONTRAINDICATIONS
BISOLVON Oral Solution should not be used in patients known to
be hypersensitive to
bromhexine or other components of the formulation.
In case of rare hereditary conditions that may be incompatible
with an excipient of the
product (please refer to “Special warnings
and precautions”) the use of this product is
contraindicated.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bromhexine should be used with caution in patients with
a history of, or existing, peptic
ulceration.
There have been very few reports of severe skin lesions such as
Stevens-Johnson syndrome
and toxic epidermal necrolysis (TEN) in temporal association
with the administration of
expectorants such as bromhexine. Mostly these could be explained
by the patient’s
underlying disease and/or concomitant medication. In addition
during the early phase of a
Stevens-Johnson syndrome or TEN a
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