Bisolvon 4mg/5ml Oral Solution

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

bromhexine hydrochloride 4 mg/5ml

제공처:

Boehringer Ingelheim Limited

ATC 코드:

R05CB02

INN (International Name):

bromhexine hydrochloride

약제 형태:

oral solution

승인 상태:

Authorised

승인 날짜:

2006-11-27

환자 정보 전단

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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제품 특성 요약

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