Dulcolax 5mg Suppositories for Children

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Bisacodyl

Inapatikana kutoka:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC kanuni:

A06AB; A06AB02

INN (Jina la Kimataifa):

Bisacodyl

Kipimo:

5 milligram(s)

Dawa fomu:

Suppository

Dawa ya aina:

Product not subject to medical prescription

Eneo la matibabu:

Contact laxatives; bisacodyl

Idhini hali ya:

Not marketed

Idhini ya tarehe:

1986-06-05

Taarifa za kipeperushi

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 occasional problem for some people;
for others, it may happen more often
• It happens when the normal muscle actions in the bowel
(large intestine) slow down. This can mean that the

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dulcolax 5mg Suppositories for Children
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 5 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:
Children 4 – 10 years: 1 suppository (5 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 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.
Children aged 4 - 10 years of age: 1 coated tablet (5 mg) in the
evening and 1 suppository (5 mg) on the following
morning is recommended.
For adults and children over 10 years of age the SmPC for Dulcolax 10
mg Suppositories 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 amount of fluid.
The coated tablets should not be taken together with products which
reduce the acidity of the upper gastrointestinal
tract, such as milk, antacids or proton pump inhibitors, in order not
to prematurely dissolve the enteric coating.
Suppositories are usually effective in about 20 mi