Dulcolax 5mg Gastro-resistant Tablets

Страна: Мальта

мова: англійська

Джерело: Malta Medicines Authority

Активний інгредієнт:

BISACODYL

Доступна з:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

Код атс:

A06AB02

ІПН (Міжнародна Ім'я):

BISACODYL 5 mg

Фармацевтична форма:

GASTRO-RESISTANT TABLET

Склад:

BISACODYL 5 mg

Тип рецепту:

OTC

Терапевтична области:

DRUGS FOR CONSTIPATION

Статус Авторизація:

Authorised

Дата Авторизація:

2006-05-23

інформаційний буклет

5 MG GASTRO-RESISTANT TABLETS
BISACODYL
PACKAGE 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 take DULCOLAX Tablets 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 five days
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 Tablets are and what they are used for
2.
Before you take DULCOLAX Tablets
3.
How to take DULCOLAX Tablets
4.
Possible side effects
5.
How to store DULCOLAX Tablets
6.
Further information
1.
WHAT DULCOLAX TABLETS ARE AND WHAT THEY
Whatever the cause, constipation can be uncomfortable. It
may make you feel bloated and heavy or generally “off
colour”. Sometimes it causes headaches.
These healthy tips are recommended to try to prevent
constipation happening:
•
Eat a balanced diet including fresh fruit and vegetables
•
Drink enough water so that you do not become
dehydrated
•
Keep up your exercise and stay fit
•
Make time to empty your bowels when your body tells
you
2.
BEFORE YOU TAKE DULCOLAX TABLETS
DO NOT TAKE DULCOLAX TABLETS IF:
•
You are allergic (hypersensitive) to bisacodyl or any of
the other ingredients in the product (listed in Section 6:
Further information)
•
You are intolerant to or cannot digest some sugars (as
the tablet contains a small amount of lactose and
sucrose)
•
You have severe dehydration
•
You have a bowel condition called “ileus” (blockage in
ARE USED FOR
•
DULCOLAX Tablets contain a medicine called bisacodyl.
the intestine)
•
You have a serious
appendicitis
abdominal condition such as
This belongs to a group of medicin

Характеристики продукта

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Dulcolax

5 mg Gastro-resistant Tablets
2
.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of bisacodyl.
Excipients:
Lactose monohydrate 34.90 mg
Sucrose
23.38 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet).
Circular, biconvex, yellow, sugar-coated, enteric-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For evacuation of the colon in constipation and in preparation for
radiological investigation.
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.
Page 2 of 7
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
even