Bisolvon 4mg/5ml Oral Solution

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Bromhexine hydrochloride

Tilgjengelig fra:

Opella Healthcare France SAS T/A Sanofi

ATC-kode:

R05CB; R05CB02

INN (International Name):

Bromhexine hydrochloride

Dosering :

4 mg/5ml

Legemiddelform:

Oral solution

Terapeutisk område:

Mucolytics; bromhexine

Autorisasjon status:

Marketed

Autorisasjon dato:

1984-11-14

Informasjon til brukeren

1
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 signs of illness 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.
TAKE SPECIAL CARE WITH BISOLVON
Check with your doctor or pharmacist before taking your medicine if:
•
You have or have ever had a stomach ulcer
If this applies to you (or you are not sure), talk to your doctor or
pharmacist before taking
BISOLVON.
There have been reports of severe skin reactions a

Preparatomtale

Health Products Regulatory Authority
15 November 2023
CRN00DRFC
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
15 November 2023
CRN00DRFC
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 sympto