Mebeverine 135mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Mebeverine hydrochloride

Commercializzato da:

Milpharm Ltd

Codice ATC:

A03AA04

INN (Nome Internazionale):

Mebeverine hydrochloride

Dosaggio:

135mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 01020000; GTIN: 8901175028184

Foglio illustrativo

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

Scheda tecnica

OBJECT 1
MEBEVERINE 135MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 17-Jan-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
When marketed by Generics [UK] Limited as [POM] will be called
Mebeverine 135 mg film-coated
tablets
When marketed by Generics [UK] Limited as [P] will be called Mylan IBS
Relief Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains mebeverine hydrochloride 135 mg.
Excipient with known effect:
Each tablet contains 100 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
10 mm normal convex white film-coated tablets marked "MV135" on one
side.
4. Clinical particulars
4.1 Therapeutic indications
Mebeverine 135 mg film-coated tablets:
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. Mebeverine
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.
Mylan IBS Relief Tablets:
For the symptomatic relief of irritable bowel syndrome.
4.2 Posology and method of administration
Mebeverine 135 mg Film-Coated tablets:
Posology
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 film-coated tablets are not recommended for use in
children and adolescents below
18 years, due to insufficient data on safety and efficacy.
_Special population:_
No posology studies in elderly, renal and/or