Dulcolax 5mg Gastro-resistant Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bisacodyl

Available from:

Opella Healthcare France SAS T/A Sanofi

ATC code:

A06AB; A06AB02

INN (International Name):

Bisacodyl

Dosage:

5 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Therapeutic area:

Contact laxatives; bisacodyl

Authorization status:

Marketed

Authorization date:

1986-06-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Dulcolax 5mg Gastro-resistant tablets
bisacodyl
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 for you, it is best that your bowel movement has a regular
pattern.
• Constipation is an occasional proble

Summary of Product characteristics

Health Products Regulatory Authority
15 November 2023
CRN00DRFC
Page 1 of 6
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) daily for
immediate effect.
Children 4 – 10 years: 1 coated tablet (5 mg) daily before bedtime,
or 1 suppository (5 mg) daily 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
morning and 2 coated tablets (10 mg) in the evening and 1
suppository (10 mg) on the following morning is recommended.
Health Products Regulatory Authori