Colofac 135mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Mebeverine hydrochloride

Prieinama:

Waymade Healthcare Plc

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

Pakuotės lapelis

PATIENT INFORMATION LEAFLET
COLOFAC
®
135MG TABLETS
(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 135mg tablets are and what they are used for
2) Before you take Colofac 135mg tablets
3) How to take Colofac 135mg tablets
4) Possible side effects
5) How to store Colofac 135mg tablets
6) Further information
1) WHAT COLOFAC 135MG TABLETS ARE AND WHAT THEY
ARE USED FOR
Colofac 135mg tablets 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 depends on the way IBS a

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