Mebeverine Tablets Bp 135mg
TEVA UK Ref: 231 -30-63134-ZA LEA MEBEVERINE 135 mg TAB REEL
Version: 1
21 May 2015
REG0066404 Version 1.7 Approved Page 1 of 3
MEBEVERINE 135 mg TABLETS BP
PACKAGE LEAFLET: INFORMATION _FORTHE USER_
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 sa me as you rs,
* If you get any side effects, talk to your doctor or pharmacist,This includes any possible side effects not listed in this leaflet. See section 4.
INTHIS LEAFLET:
1. What Mebeverine is and what it is used for
2. Before you take Mebeverine
3. How to take Mebeverine
4. Possible side effects
5. How to store Mebeverine
6. Further information
OWHAT MEBEVERINE IS AND WHAT IT IS USED FOR
Mebeverine is an anti-spasm drug,
Mebeverine is used to treat:
* spasms in the gut
* irritable bowel syndrome and other similar conditions.
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Do NOT take Mebeverine if you:
* are allergic (hypersensitive) to mebeverine hydrochloride or any of the other ingredients of this medicine
* have paralytic ileus (paralysis of part of the gut),
Take special care with Mebeverine Talk to your doctor before you start to take this medicine if you:
* suffer from acute porphyria (an enzyme deficiency),
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription,
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor for advice before taking this medicine.
Driving and using machines
Mebeverine is not known to affect your ability to drive or operate machinery,
Important information about some of the ingredients of Mebeverine
Patients who are intolerant to lactose and sucrose should note that MebeverineTablets contain a small amount of 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 medicinal product.
You should also note that Mebeverine contains propylene glycol (E1520), which may cause alcohol-like symptoms and the preservative methyl
parahydroxybenzoate (E218), which may cause delayed allergic reactions, mainly affecting the skin,
^ HOWTOTAKE MEBEVERINE
Always take Mebeverine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure,The tablets should be swallowed preferably with a drink of water.The usual dose is:
Adults (including the elderly):
1 tablet three times a day preferably about 20 minutes before eating,
After several weeks, once the desired effect has been achieved, your doctor may gradually reduce your dose,
Children and adolescents under 18 years of age:
Mebeverine is not recommended.
If you take more Mebeverine than you should
If you (or someone else) swallow a lot of the tablets ail together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining
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t
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tablets and the container with you to the hospital or doctor so that they know which tablets were consumed,
If you forget to take Mebeverine
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose,Take the remaining doses at the correct time.
If you stop taking Mebeverine
Do not stop taking your medicine without talking to your doctor first even if you feel better.
If you have any further questions on the use of this product, askyour doctor or pharmacist,
Q POSSIBLE SIDE EFFECTS
Like ail medicines, Mebeverine can cause side effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
* an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect,You may need urgent medical attention or hospitalisation,
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 theYellow Card Scheme at: www, mhra,gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine,
HOWTO STORE MEBEVERINE
Keep out of the reach and sight of children. MebeverineTablets should be stored in a dry place at or below 20°C protected from light in the package or container supplied, Do not transfer them to another container. Do not use Mebeverine after the expiry date that is
stated on the outer packaging,The expiry date refers to the last day of that month,
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required,These measures will help to protect the environment,
Q FURTHER INFORMATION
What MebeverineTablets contain:
* The active ingredient is mebeverine hydrochloride,
* The other ingredients are lactose monohydrate, potato starch, sodium starch glycolate, povidone K30, purified talc (E553), magnesium stearate (E572).The tablet coating contains: sucrose, purified talc (E553), calcium carbonate, macro glyceryl ricinoieate, titanium dioxide (E171), acacia, magnesium stearate, methyl parahydroxybenzoate (E218) and white beeswax (E901).The printing ink contains: shellac, black iron oxide (E172) and propylene glycol (E1520),
What MebeverineTablets look like and contents of the pack:
* MebeverineTablets are white or almost white, biconvex, sugar coated tablets,They are plain on one side and printed 135/4301 on the reverse,
* MebeverineTablets are available in pack sizes of 7, 10, 14, 21, 28, 30, 56,
60, 84, 90, 100, 110, 112, 120, 150, 160 and 168 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:TEVA UK Limited, Eastbourne, BN22 9AG,
This leaflet was last revised:
May 2015
PL 00289/0095
TFTVn
TEVA UK Limited
63134-ZA