Dulcolax Twelve Plus 10mg suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bisacodyl

Available from:

Sanofi Consumer Healthcare

ATC code:

A06AB02

INN (International Name):

Bisacodyl

Dosage:

10mg

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01060200; GTIN: 5012917077049

Patient Information leaflet

439185/GB/3
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU:
-
Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information
or advice.
- 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 Twelve Plus Suppositories are and
what they are used for
2.
What you need to know before you use Dulcolax
Twelve Plus Suppositories
3. How to use Dulcolax Twelve Plus Suppositories
4. Possible side effects
5. How to store Dulcolax Twelve Plus Suppositories
6. Contents of the pack and other information
1.
WHAT DULCOLAX TWELVE PLUS SUPPOSITORIES ARE
AND WHAT THEY ARE USED FOR.
Dulcolax Twelve Plus Suppositories are used for the
short-term relief of occasional constipation. Dulcolax
Twelve Plus Suppositories contain bisacodyl which
belongs to a group of medicines known as stimulant
laxatives, which increase bowel movements. 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
The cause of constipation is often not known. It can
be associated with:
• Sudden change of diet
• A diet with not enough fibre
• Not drinking enough fluids
• Loss of ‘tone’ of the bowel muscles in older people
• Pregnancy
• Medicines such as

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dulcolax Twelve Plus 10 mg Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Smooth white torpedo shaped suppositories, each containing 10 mg of
bisacodyl.
3
PHARMACEUTICAL FORM
Suppositories for rectal administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the short-term relief of occasional constipation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 12 years: one 10 mg suppository daily for
immediate
effect.
Should not be used in children and adolescents under the age of 12
years.
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.
INSTRUCTIONS FOR USE:
Suppositories are usually effective in about 20 minutes (usual range
10 to 30
minutes). Rarely the laxative effect has been reported 45 minutes
after
administration. They should be unwrapped and inserted into the rectum
pointed end first.
No specific information on the use of this product in the elderly is
available.
Clinical trials have included patients over 65 years and no adverse
reactions
specific to this age group have been reported.
4.3
CONTRAINDICATIONS
DULCOLAX is contraindicated in patients with ileus, intestinal
obstruction, acute
abdominal conditions including appendicitis, acute inflammatory bowel
diseases, and
severe abdominal pain associated with nausea and vomiting which may be
indicative
of the aforementioned severe conditions.
DULCOLAX is also contraindicated in severe dehydration and in patients
with
known hypersensitivity to bisacodyl or any other component of the
product.
DULCOLAX Suppositories should not be used when anal fissures or
ulcerative
proctitis with mucosal damage are present.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Should not be used in children and adolescents under the age of 12
years.
As with all laxatives, bisacodyl should not be taken on a continuous
daily basis
for more than five days without i