Bisolvon 4mg/5ml Oral Solution

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Bromhexine hydrochloride

Tersedia dari:

Sanofi-Aventis Ireland Limited T/A SANOFI

Kode ATC:

R05CB; R05CB02

INN (Nama Internasional):

Bromhexine hydrochloride

Dosis:

4 mg/5ml

Bentuk farmasi:

Oral solution

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Mucolytics; bromhexine

Status otorisasi:

Marketed

Tanggal Otorisasi:

1984-11-14

Selebaran informasi

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.
IF YOU THINK THIS MEDICINE IS NOT
WORKING WELL ENOUGH
If your medicine does not seem to be
working for you, talk to your doctor as
soon as possible. Do not take extra
BISOLVON unless your doctor tells you to.
IF YOU TAKE MORE BISOLVON THAN YOU
SHOULD
If you take more of this medicine than
you should, talk to a d

Karakteristik produk

Health Products Regulatory Authority
19 March 2020
CRN009J5T
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisolvon 4mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains bromhexine hydrochloride 4 mg.
Excipients: contains maltitol liquid
For a 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: _
Recommended total daily dose
Recommended maximum daily dose
10 ml (8 mg) three times daily
15 ml (12 mg) four times daily
The recommended maximum daily dose which may be needed at the
commencement of treatment should not be exceeded.
_Children over 5 to ≤ 12 years: _ Recommended total daily dose 5 ml
(4 mg) four times daily.
_Children 2 to ≤ 5 years: _Recommended total daily dose 5 ml (4 mg)
twice daily.
The measuring cup provided should be used for dosing.
_ _
BISOLVON can be taken with or without food (see section 5.2).
Additional information on specific populations
BISOLVON Oral Solution is sugar free and therefore suitable for
diabetes patients.
4.3 CONTRAINDICATIONS
Bisolvon Oral Solution is contraindicated in patients known to be
hypersensitive to bromhexine or other excipients of the
formulation.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bromhexine should be used with caution in patients with a history of,
or existing, peptic ulceration.
Health Products Regulatory Authority
19 March 2020
CRN009J5T
Page 2 of 5
There have been reports of severe skin reactions such as erythema
multiforme, Stevens-Johnson syndrome (SJS)/ toxic
epidermal necrolysis (TEN) and acute generalised exanthematous
pustulosis (AGEP) associated with the administration of
bromhexine hydrochloride. If symptoms or