Colofac Tablets 135mg Coated tablets

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

MEBEVERINE HYDROCHLORIDE

Доступна з:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Код атс:

A03AA04

ІПН (Міжнародна Ім'я):

MEBEVERINE HYDROCHLORIDE 135 mg

Фармацевтична форма:

COATED TABLET

Склад:

MEBEVERINE HYDROCHLORIDE 135 mg

Тип рецепту:

POM

Терапевтична области:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Статус Авторизація:

Withdrawn

Дата Авторизація:

2007-05-16

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
_COLOFAC_
_®_
_TABLETS 135 MG_
MEBEVERINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
•
If any of the side effects becomes serious, or if you notice any side
effects not listed
in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1 WHAT COLOFAC TABLETS 135 MG ARE AND WHAT THEY ARE USED FOR
2 BEFORE YOU TAKE COLOFAC TABLETS 135 MG
3 HOW TO TAKE COLOFAC TABLETS 135 MG
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE COLOFAC TABLETS 135 MG
6 FURTHER INFORMATION
1.WHAT COLOFAC TABLETS 135 MG ARE AND WHAT THEY ARE USED FOR
Colofac Tablets 135 mg contain Mebeverine hydrochloride. This belongs
to a group of
medicines called antispasmodics.
This medicine is used to treat symptoms of irritable bowel syndrome
(IBS) and similar
problems such as chronic irritable colon, spastic constipation, mucous
colitis and spastic
colitis.
Irritable bowel syndrome (IBS) is a very common condition which causes
spasm and pain in
the gut or intestine.
The intestine is a long muscular tube which food passes down so it can
be digested. If the
intestine goes into spasm and squeezes too tightly, you get pain. The
way this medicine
works is by relieving the spasm, pain and other symptoms of IBS.
The main symptoms of irritable bowel syndrome (IBS) include:
•
stomach pain and spasm
•
feeling bloated and having wind
•
having diarrhoea (with or without constipation)
•
small, hard, pellet-like or ribbon-like stools (faeces)
These symptoms may vary from person to person.
Talk to your doctor if these symptoms do not improve after a while, if
you develop new
symptoms or you are concerned about your symptoms.
YOUR DIET AND LIFESTYLE CAN ALSO HELP TREAT IBS:
How you restrict your diet depend

Характеристики продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Colofac Tablets 135 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mebeverine hydrochloride 135mg.
Excipients with known effect : Lactose and Sucrose
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Coated tablets (Tablets).
Round white sugar coated tablets, with no superficial markings.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic treatment of irritable bowel syndrome and other
conditions usually included in
this grouping, such as: chronic irritable colon, spastic constipation,
mucous colitis, spastic colitis.
Colofac is effectively used to treat the symptoms of these conditions,
such as: colicky abdominal pain
and cramps, persistent, non-specific diarrhoea (with or without
alternating constipation) and flatulence.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
The coated tablets should be swallowed with a sufficient amount of
water (at least 100 ml water). They
should not be chewed because of the unpleasant taste.
Duration of use is not limited.
If one or more doses are missed, the patient should continue with the
next dose as prescribed; the
missed dose(s) should not be taken in addition to the regular dose.
_Adults (including the elderly): _
One tablet three times a day, preferably 20 minutes before meals.
After a period of several weeks,
when the desired effect has been obtained, the dosage may be gradually
reduced.
_Paediatric Population _
Mebeverine 135 mg tablets are not recommended for use in children and
adolescents below 18, due to
insufficient data on safety and efficacy.
_Special Population _
No posology studies in elderly, renal and/or hepatic impaired patients
have been performed. No
specific risk for elderly, renal and/or hepatic impaired patients
could be identified from available post-
2
marketing data. No dosage adjustment is deemed necessary in elderly,
renal and/or hepatic impaired
patients.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the e