Patient leaflet - Mebeverine Hydrochloride Ibs 135 mg film-coated tablets
1. What Mebeverine Tablets are and what they are used for
Mebeverine Hydrochloride IBS 135 mg Film-coated Tablets contain the active ingredient mebeverine hydrochloride. This belongs to agroup of medicines called antispasmodics.
This medicine is used to treat symptoms of irritable bowel syndrome (IBS). This is avery common condition which causes sp asm and pain in the gut or intestine.
The intestine is along 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 and pain.
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 you develop new symptoms or if these symptoms continue for more than 14 days.
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 things bring on the symptoms, then it makes sense not to eat them. Ahigh 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 afew moments each day to relax and gently unwind.
2. What you need to know before you take Mebeverine Tablets
Do not take Mebeverine Tablets if
- you are allergic to mebeverine hydrochloride or any of the other ingredients of this medicine (listed in section 6),
- you are younger than 18 years of age.
If any of the above applies to you, do not take this medicine and talk to your doctor or pharmacist.
Warnings and precautions
See your doctor before using any IBS treatment if you:
- have not suffered from IBS before or,
- have developed new symptoms or your symptoms have become worse, • have liver or kidney problems.
Talk to your doctor or pharmacist if any of the following applies to you: • You are 40 years of age or over and your symptoms have changed or it has been some time since you last had IBS.
- You have blood in your stools (faeces).
- You are feeling sick (nauseous) or are sick (vomiting).
- You are looking pale and feeling tired.
- You have constipation.
- You have afever.
- You have recently travelled abroad.
You are pregnant, or planning to become pregnant.
- You are awoman and you have unusual bleeding or discharge from your vagina. • You have difficulty or pain when passing water (urinating).
Your doctor will tell you whether it is safe for you to start taking Mebeverine Tablets.
Mebeverine Tablets with food and drink
You can drink alcohol while you are taking Mebeverine Tablets.
Other medicines and Mebeverine Tablets
Mebeverine is not known to interact with other medicines but you should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is only limited information about the safety of Mebeverine Tablets for pregnant women. Your doctor may advise you to stop taking Mebeverine Tablets before you become pregnant or as soon as you know you are pregnant. Mebeverine Tablets 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.
Mebeverine Tablets contain lactose and sodium
Lactose - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Sodium - This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free’.
3. How to take Mebeverine Tablets
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Try to take the tablet twenty minutes before a meal - some people find their symptoms to be strongest after they have eaten.
Swallow the tablet whole with a glass of water. Do not chew the tablet.
How much Mebeverine Tablets to take
Adults (including the elderly):
- The recommended dose is one tablet three times aday.
- Do not take more than three tablets per day.
- The number of tablets you take may be lowered if your symptoms improve.
Children and adolescents: Mebeverine Tablets are not recommended for use in children and adolescents below 18 years of age.
If you take more Mebeverine Tablets than you should
If you or someone else takes too many Mebeverine Tablets (an overdose), talk to a doctor or go to ahospital s traight away. Take the medicine pack with you.
If you forget to take Mebeverine Tablets
If you miss atablet, wait until the next dose is due. Do n ot try to make up for the dose you have missed. Do not double dose to make up for aforgotten dose.
If you stop taking Mebeverine Tablets
You can lower the dose if your symptoms get 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 notice the following, stop taking the tablets and go to your doctor immediately, or your nearest hospital.
- Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions).
These other effects are less serious. If they bother you talk to apharmacist:
- 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Mebeverine Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package.
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 Mebeverine Tablets contain
The active substance is mebeverine hydrochloride. Each film-coated tablet contains 135 mg mebeverine hydrochloride.
The other ingredients are:
Tablet core: lactose monohydrate, silicified microcrystalline cellulose, sodium starch glycolate (Type A), povidone, talc (E553b), and magnesium stearate. Tablet coating: poly (vinyl alcohol) - part hydrolyzed (E1203), talc (E553b), titanium dioxide (E171), glycerol monocaprylocaprate (type I), and sodium laurilsulfate.
What Mebeverine Tablets look like and contents of the pack
Mebeverine Hydrochloride 135mg Film-coated Tablets are white to off-white, round film-coated tablets, 10 mm diameter, debossed with M135 on one side and plain on other side.
The tablets are packaged in PVC/PVdC-Alu blister packs.
Pack sizes: 7, 10, 12, 14, 15, 18, 20, 21, 28, 30, 56, 60, 84, 90 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd.
Unit C, Harcourt Way
Leicester, LE19 1WP, UK
Manufacturer
Morningside Pharmaceuticals Ltd.
5 Pavilion Way
Loughborough, LE11 5GW, UK
This leaflet was last revised in November 2021.
PACKAGE LEAFLET: INFORMATION FOR THE USER