Patient leaflet - Mebeverine Hydrochloride 135 mg coated tablets
1. What this medicine is and what it is used for
This medicine contains an active substance called Mebeverine hydrochloride, which 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. What you need to know before you take this medicine
Do not take this medicine:
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
- You have developed new symptoms or your symptoms have become worse; • You have liver or kidney problems.
If the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Taking with food and drink
You can drink alcohol while you are taking this medicine.
Pregnancy and breast-feeding
You should talk to your doctor or pharmacist before taking this medicine if you are pregnant or might become pregnant. There is only limited information about the safety of Mebeverine for pregnant women. Your doctor may advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant. This medicine should not be used during breast-feeding.
Driving and using machines
This medicine is not likely to affect you being able to drive or use any tools or machines.
This medicine contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take this medicine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is
Adults and the elderly:
- Take 1 tablet 3 times a day
- The number of tablets you take can be lowered if your symptoms improve • Do not take more than 3 tablets per day.
Use in Children and adolescents
Do not give this medicine to children or adolescents younger than 18 years. 10 mm
430 x 160mm
Back
Route and method of administration
- Swallow the tablet whole with water. Do not chew the tablet.
- Try to take the tablet twenty minutes before a meal - some people find their symptoms to be strongest after they have eaten.
If you take more of this medicine than you should
If you or someone else takes too many tablets (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take this medicine
If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take your next dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking this medicine
Do not stop taking your tablets unless your doctor tells you to, even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of these serious side effects, stop taking the tablets. See a doctor at once if you have:
- Difficulty in breathing, swelling of face, neck, tongue or throat (severe allergic reactions)
These other effects are less serious. If they bother you talk to a pharmacist:
- Skin rash, red itchy skin
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store this medicine
- Keep this medicine out of the sight and reach of children.
- This medicinal product does not require any special storage conditions.
- Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What this medicine contains
- The active substance is 135 mg of Mebeverine hydrochloride.
The other ingredients are:
Tablet core: Lactose monohydrate, Maize starch, Povidone K 30, Purified talc, Isopropyl alcohol, Magnesium stearate (E470b).
Tablet coat: Sucrose, Gelatin, Purified talc, Ethanol, Shellac (E904), Carnauba wax yellow (E903), Beeswax white (E901).
What this medicine looks like and contents of the pack
- The tablets are round, white to off-white, sugar coated tablets, plain on both sides. • This medicine is available in packs containing 10, 15, 84 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
E-mail: info@bristol-labs.co.uk
V8 01-06-22 D0
Manufacturer
Bristol Laboratories Ltd.
Laporte Way, Luton,
LU4 8WL, United Kingdom.
Manufacturer
Bristol Laboratories Ltd,
Unit 5, Traynor Way,
Whitehouse Business Park,
Peterlee, SR8 2RU, United Kingdom.
UK: Mebeverine 135 mg coated tablets; PL 17907/0430
This leaflet was last revised in May 2022
To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.