Dulcolax 5mg Gastro-resistant Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Bisacodyl

Disponible desde:

Sanofi-Aventis Ireland Limited T/A SANOFI

Código ATC:

A06AB; A06AB02

Designación común internacional (DCI):

Bisacodyl

Dosis:

5 milligram(s)

formulario farmacéutico:

Gastro-resistant tablet

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Contact laxatives; bisacodyl

Estado de Autorización:

Marketed

Fecha de autorización:

1986-06-05

Información para el usuario

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 problem for some people.
For others, it may happen more often
• It happens when the normal mus

Ficha técnica

Health Products Regulatory Authority
10 December 2020
CRN009ZLJ
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