DULCOLAX 10 Milligram Suppositories

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

BISACODYL

Available from:

Boehringer Ingelheim Limited

ATC code:

A06AB02

INN (International Name):

BISACODYL

Dosage:

10 Milligram

Pharmaceutical form:

Suppositories

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Contact laxatives

Authorization status:

Authorised

Authorization date:

1996-06-05

Patient Information leaflet

                                PATIENT INFORMATION LEAFLET: 
INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
This medicine is available without prescription. You need to 
use DULCOLAX Suppositories as instructed in this leaflet to 
get the best results from it.
•  Keep this leaflet. You may need to read it again
•  Ask your pharmacist if you need more information or    
 advice
•  You must contact your pharmacist or doctor if your  
 
  symptoms worsen or do not improve after 5 days of  
 
 treatment 
•  If a side effect occurs and gets troublesome, or seems    
  serious to you, or if you experience any side effect not    
  listed in this leaflet, please tell your pharmacist or doctor
IN THIS LEAFLET:
1. What DULCOLAX Suppositories are and what they are    
   used for
2. Before you use DULCOLAX Suppositories
3. How to use DULCOLAX Suppositories
4. Possible side effects
5. How to store DULCOLAX Suppositories
6. Further information
1. WHAT DULCOLAX SUPPOSITORIES ARE AND WHAT  
   THEY ARE USED FOR
DULCOLAX Suppositories contain a medicine called 
bisacodyl. This belongs to a group of medicines called 
laxatives.
•  DULCOLAX Suppositories are used for relief of  
 
 constipation
•  This medicine does not help with weight loss
•  DULCOLAX Suppositories are also used in hospitals to    
  clear the bowel before surgery, X-rays or other tests
•  DULCOLAX Suppositories stimulate the muscles of the   
  bowel (large intestine), helping to return the body to its  
  natural rhythm. They have a laxative effect usually within  
  10 to 30 minutes 
WHAT IS CONSTIPATION?
Normal and regular bowel movement is important for most 
people. However, what is “normal and regular” varies from 
person to person. Some may have a bowel movement every 
day, others less often. Whatever it is like for you, it is best 
that your bowel movement has a regular pattern.
•  Constipation is an occa
                                
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Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dulcolax 10mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 10 mg of bisacodyl.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
Smooth, white torpedo-shaped suppositories.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For evacuation of the colon in constipation and in preparation for radiological investigations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
SHORT-TERM TREATMENT FOR CONSTIPATION:
Adults and children over 10 years: 1 suppository (10 mg) daily for immediate effect.
The maximum daily dose should not be exceeded.
In the management of constipation, once regularity has been restarted dosage should be reduced and can usually be
stopped.
Children aged 10 years or younger with chronic or persistent constipation should only be treated under the guidance of
a physician. Bisacodyl should not be used in children aged 4 years or younger.
FOR PREPARATION OF DIAGNOSTIC PROCEDURES AND PREOPERATIVELY
For preparation of diagnostic procedures, in pre- and postoperative treatment and when defaecation needs to be
facilitated, DULCOLAX should be used under medical supervision. The tablets should be combined with
suppositories in order to achieve complete evacuation of the intestine.
Adults and children over 10 years: 2 coated tablets (10 mg) in the morning and 2 coated tablets (10 mg) in the evening
and 1 suppository (10 mg) on the following morning is recommended.
For children 4 - 10 years of age the SmPC for Dulcolax 5 mg Suppositories for Children should be consulted.
INSTUCTIONS FOR USE:
It is recommended to take the coated tablets at night to have a bowel movement the following morning. They should
be swallowed whole with an adequate amo
                                
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