Dulcolax Suppositories 10mg

Држава: Малта

Језик: Енглески

Извор: Malta Medicines Authority

Активни састојак:

BISACODYL

Доступно од:

Sanofi Malta Limited

АТЦ код:

A06AB02

INN (Међународно име):

BISACODYL

Фармацеутски облик:

SUPPOSITORY

Састав:

BISACODYL 10 mg

Тип рецептора:

OTC

Терапеутска област:

DRUGS FOR CONSTIPATION

Статус ауторизације:

Authorised

Информативни летак

DULCOLAX
® (LETTER O IS YING/YANG SYMBOL)
10 MG SUPPOSITORIES
_AND _
5 MG SUPPOSITORIES
FOR CHILDREN
BISACODYL
Picture of one suppository
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 the short-term
relief from occasional 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). 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

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
DULCOLAX 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
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) for immediate effect.
Children 4 – 10 years: 1 coated tablet (5 mg) daily before bedtime,
or
1 suppository (5 mg) 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.
Page 1 of 7
FOR PREPARATION OF DIAGNOSTIC PROCEDURES AND PREOPERATIVELY
For preparation of diagnostic procedures, in pre- and postoperative
treatment and in
medical conditions which require defaecation 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
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