MEBECON 135 Milligram Coated Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

MEBEVERINE HYDROCHLORIDE

可用日期:

Abbott Healthcare Products Ltd

INN（国际名称）:

MEBEVERINE HYDROCHLORIDE

剂量:

135 Milligram

药物剂型:

Coated Tablets

处方类型:

Product subject to prescription which may be renewed (B)

授权状态:

Withdrawn

授权日期:

2013-04-30

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER 

MEBECON 135 MG COATED TABLETS 
Mebeverine hydrochloride 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU.  
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or pharmacist
or nurse. 
• This medicine has been prescribed for you only. Do not pass it
on to others. It may 
harm them, even if their signs of illness are the same as yours. 
If you get any side effects, talk to your doctor or pharmacist or
nurse.  This includes any 
possible side effects not listed in this leaflet. 

WHAT IS IN THIS LEAFLET: 
1. What Mebecon is and what it is used for 
2. What you need to know before you take Mebecon 
3. How to take Mebecon 
4. Possible side effects 
5. How to store Mebecon 
6. Contents of the pack and other information 

1. WHAT MEBECON IS AND WHAT IT IS USED FOR 
WHAT MEBECON IS 
The name of your medicine is Mebecon 135 mg coated tablets_ _(called
Mebecon in this 
leaflet). Mebecon contains a medicine called mebeverine
hydrochloride. This belongs to 
a group of medicines called antispasmodics, which act on your 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.
This medicine works by 
relieving the spasm and pain. 
WHAT MEBECON IS USED FOR 
Mebecon is used to relieve the symptoms of irritable bowel syndrome
(IBS). These 
symptoms vary from person to person but can include: 
• stomach pain and cramps 
• feeling bloated and having wind 
• diarrhoea, constipation or a combination of both 
• small, hard, pellet-like or ribbon-like stools (faeces). 
Mebecon is also used to relieve cramps and pain in your stomach or gut
caused by other 
medical conditions. 

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEBECON 
DO NOT TAKE MEBECON: 
• if you a

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mebecon 135 mg Coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains Mebeverine hydrochloride 135 mg.
Excipients: also includes Lactose monohydrate 97.0 mg per tablet and sucrose 79.0 mg per tablet.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Coated Tablet.
White, circular, sugar coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of irritable bowel syndrome (particularly gastrointestinal spasm).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
The coated tablets should be swallowed with a sufficient amount of water (at least 100ml water). They should not be
chewed because of the unpleasant taste.
Adults and children over 10 years:
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.
Duration of use is not limited. However, after a period of several weeks when the desired effect has been obtained, the
dosage may be gradually reduced.
In case of missed dose(s), the patient should continue with the next dose as prescribed; do not take the missed dose(s)
in addition to the regular dose.
Children under 10 years:
Mebecon should not be used in children aged 3 years and younger as no clinical data is available for this age group. For
children from 3 – 10 years mebeverine 135mg tablets should not be used due to the high content of the active
substance.
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