Bisacodyl 5mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bisacodyl

Available from:

A A H Pharmaceuticals Ltd

ATC code:

A06AB02

INN (International Name):

Bisacodyl

Dosage:

5mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01060200; GTIN: 5025903015444 5025903012443 5025903016595

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION LEAFLET FOR THE USER
Bisacodyl 5mg Gastro-resistant Tablets
(Bisacodyl)
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.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days of treatment.
What is in this leaflet
1.
What Bisacodyl is and what it is used for
2.
What you need to know before you take Bisacodyl
3.
How to take Bisacodyl
4.
Possible side effects
5.
How to store Bisacodyl
6.
Contents of the pack and other information
1. WHAT BISACODYL IS AND WHAT IT IS USED FOR
•
Bisacodyl 5mg Gastro-resistant tablets contain a medicine called
bisacodyl. This belongs to a group of
medicines called stimulant laxatives
•
Bisacodyl is used for the short-term relief from occasional
constipation.
•
Bisacodyl gently stimulate the muscles of the bowel (large intestine).
This brings predictable relief from
constipation.
•
Bisacodyl 5mg Gastro-resistant Tablets have a special coating that
helps to ensure the medicine works
only where it is needed.
•
Bisacodyl 5mg Gastro-resistant Tablets do 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. Th

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bisacodyl 5 mg, gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Bisacodyl 5 mg.
Excipients: This product contains 64.42 mg lactose monohydrate, 53.00
mg sucrose
and
0.04 mg tartrazine lake (E102) per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablets for oral administration.
Yellow shiny biconvex sugar coated and enteric coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For short-term relief of occasional constipation.
Constipation, either chronic or of recent onset,
whenever a stimulant laxative
is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ROUTE OF ADMINISTRATION:
Oral.
Short-term treatment for constipation:
_Adults and children over 12 years_: 1 – 2 tablets (5 – 10 mg)
daily._ _
It is recommended to start with the lowest dose. The dose might 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.
Bisacodyl 5 mg gastro-resistant tablets should not be used in children
and
adolescents under the age of 12 years .
Method of administration
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.
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
Bisacodyl 5 mg, gastro-resistant tablets are contrainidicated in
patients with
ileus, intestinal obstruction, acute abdominal conditions including
appendicitis, acute inflammatory bow