DULCOLAX 5 Milligram Tablets Gastro-Resistant

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

BISACODYL

Доступно од:

Boehringer Ingelheim Limited

АТЦ код:

A06AB02

INN (Међународно име):

BISACODYL

Дозирање:

5 Milligram

Фармацеутски облик:

Tablets Gastro-Resistant

Тип рецептора:

Product not subject to medical prescription

Терапеутска област:

Contact laxatives

Статус ауторизације:

Authorised

Датум одобрења:

1996-06-05

Информативни летак

PACKAGE 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 take DULCOLAX Tablets 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 five days  
 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 Tablets are and what they are used for
2. Before you take DULCOLAX Tablets
3. How to take DULCOLAX Tablets 
4. Possible side effects
5. How to store DULCOLAX Tablets
6. Further information
1. WHAT DULCOLAX TABLETS ARE AND WHAT THEY  
   ARE USED FOR
•  DULCOLAX Tablets contain a medicine called bisacodyl.  
  This belongs to a group of medicines called laxatives 
•  DULCOLAX Tablets are used for relief of constipation
•  This medicine does not help with weight loss
•  DULCOLAX Tablets can also be used in a hospital to  
  empty a person’s bowel before child birth, surgery or  
  radiological investigations
•  DULCOLAX Tablets gently stimulate the muscles of the  
  bowel (large intestine). This brings predictable, overnight  
  relief from constipation, helping to return the body to its  
  natural rhythm 
•  DULCOLAX Tablets are gastro-resistant tablets which  
  have a special coating that helps to ensure the medicine  
  works only where it is needed
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

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dulcolax 5mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of bisacodyl.
Excipients:
Lactose monohydrate 34.90mg
Sucrose 23.38mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet).
Circular, biconvex, yellow, sugar-coated, enteric-coated tablets.
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 to 2 coated tablets (5 - 10 mg) daily before bedtime, or 1 suppository (10 mg) for
immediate effect.
Children 4 – 10 years: 1 coated tablet (5 mg) daily before bedtime, or 1 suppository (5 mg) for immediate effect.
It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to
produce regular stools. 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 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�