BISOLVON 4 MG/5ml Oral Solution

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

BROMHEXINE HYDROCHLORIDE

Dostupné z:

Boehringer Ingelheim Limited

ATC kód:

R05CB02

INN (Medzinárodný Name):

BROMHEXINE HYDROCHLORIDE

Dávkovanie:

4 MG/5ml

Forma lieku:

Oral Solution

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Mucolytics

Stav Autorizácia:

Authorised

Dátum Autorizácia:

1984-11-14

Príbalový leták

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.
abcd
3168
58-011
1
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

Súhrn charakteristických

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.
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.
_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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 29/04/2016_
_CRN 2173773_
_page number: 1_
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 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 administra