Colofac 135mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Mebeverine hydrochloride

Prieinama:

Viatris UK Healthcare Ltd

ATC kodas:

A03AA04

INN (Tarptautinis Pavadinimas):

Mebeverine hydrochloride

Dozė:

135mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 01020000; GTIN: 5012781015505

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
_COLOFAC_
_®_
_ _
_135MG TABLETS _
(mebeverine hydrochloride)
1. WHAT COLOFAC IS AND WHAT IT IS USED
FOR
Colofac contains 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 depends on the way IBS
affects you. If you find that certain foods bring on
the symptoms, then it makes sense not to eat
them. A high fibre diet may help, but ask your
pharmacist for more information.
Some people find that learning to relax can help to
lessen their symptoms of IBS. You may find it
helpful to set aside a few moments each day to
relax and gently unwind.
2. BEFORE YOU TAKE COLOFAC
DO NOT TAKE COLOFAC IF:

You are allergic to any of the tablet ingredients
(see section 6 for a list of ingredients).
If any of the above applies to you, do not take this
medicine and talk to your doctor or pharmacist.
TAKE SPECIAL CARE WITH COLOFAC
Check with your doctor or pharmacist before
taking your medicine if:

You have developed new symptoms or

Prekės savybės

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-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 excipients.
4.4
SPE