Dulcolax 5mg suppositories

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Bisacodyl

Διαθέσιμο από:

Sanofi Consumer Healthcare

Φαρμακολογική κατηγορία (ATC):

A06AB02

INN (Διεθνής Όνομα):

Bisacodyl

Δοσολογία:

5mg

Φαρμακοτεχνική μορφή:

Suppository

Οδός χορήγησης:

Rectal

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 01060200; GTIN: 5012917076752

Φύλλο οδηγιών χρήσης

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
DULCOLAX
® 5 MG SUPPOSITORIES &
DULCOLAX
® 10 MG SUPPOSITORIES
bisacodyl
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your
doctor or pharmacist.
-
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dulcolax Suppositories is and what it is
used for
2.
What you need to know before you use
Dulcolax Suppositories
3. How to use Dulcolax Suppositories
4. Possible side effects
5. How to store Dulcolax Suppositories
6. Contents of the pack and other 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 to treat
constipation
• Dulcolax Suppositories are also used to clear
the bowel before surgery, X-rays or other tests
• Dulcolax Suppositories stimulate the muscles
of the bowel (large intestine). They have
a
laxative effect usually within 10 to 30 minutes
• This medicine does not help with weight loss
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 material is not easily eliminated
from the body
T

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
DULCOLAX 5 mg Suppositories for Children
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Smooth white torpedo shaped suppositories, each containing 5 mg of
bisacodyl
3
PHARMACEUTICAL FORM
Suppositories for rectal administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Constipation, either chronic or of recent onset, whenever a stimulant
laxative is
required.
Bowel clearance before surgery or radiological investigation.
Replacement of the
evacuant enema in all its indications.
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.
Children aged 4 -10 years of age: 1 coated tablet (5 mg) in the
evening and 1
suppository (5 mg) on the following morn