MEBEVERINE TABLETS BP 135MG
Active substance: MEBEVERINE HYDROCHLORIDE
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PAGE 1: FRONT FACE (INSIDE OF REEL)
PAGE 2: REAR FACE (OUTSIDE OF REEL)
MEBEVERINE 135 mg TABLETS BP
PACKAGE LEAFLET: INFORMATION FOR THE 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 same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS 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
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 Mebeverine Tablets 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.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
3
HOW TO TAKE MEBEVERINE
1
WHAT 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.
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 all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
2
BEFORE YOU TAKE MEBEVERINE
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.
If you forget to take Mebeverine If you forget to take a tablet, take one as FURTHER INFORMATION soon as you remember, unless it is nearly time to take the next one. Do not take a What Mebeverine Tablets contain: double dose to make up for a forgotten The active ingredient is mebeverine dose. Take the remaining doses at the hydrochloride. correct time. The other ingredients are lactose monohydrate, potato starch, sodium If you stop taking Mebeverine starch glycolate, povidone K30, Do not stop taking your medicine without purified talc (E553), magnesium talking to your doctor first even if you stearate (E572). The tablet coating feel better. contains: sucrose, purified talc (E553), calcium carbonate, macro glyceryl If you have any further questions on the ricinoleate, titanium dioxide (E171), use of this product, ask your doctor or acacia, magnesium stearate, methyl pharmacist. parahydroxybenzoate (E218) and white beeswax (E901). The printing ink POSSIBLE SIDE EFFECTS contains: shellac, black iron oxide (E172) and propylene glycol (E1520). Like all medicines, Mebeverine can cause side effects, although not everybody gets What Mebeverine Tablets look like and them. contents of the pack: Mebeverine Tablets are white or If the following happens, stop taking the almost white, biconvex, sugar coated tablets and tell your doctor immediately tablets. They are plain on one side and or go to the casualty department at your printed 135/4301 on the reverse. nearest hospital: Mebeverine Tablets are available in an allergic reaction (swelling of the pack sizes of 7, 10, 14, 21, 28, 30, 56, lips, face or neck leading to severe 60, 84, 90, 100, 110, 112, 120, 150, 160 difficulty in breathing; skin rash or and 168 tablets. hives). Not all pack sizes may be marketed. This is a very serious but rare side effect. You may need urgent medical attention Marketing Authorisation Holder and or hospitalisation. Manufacturer Marketing Authorisation holder: TEVA If you notice any other side effects, UK Limited, Eastbourne, BN22 9AG. please tell your doctor or pharmacist. This leaflet was last revised: May 2011
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.
Top of page cut-off to middle of registration mark: 21mm. Registration Pitch: 210mm -0.45mm (Sheet depth / cut-off length: 210mm)
6
(Main)
Pharma code 416
4
5
HOW TO STORE MEBEVERINE
Keep out of the reach and sight of children. Mebeverine Tablets should be stored in a dry place at or below 20C 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.
PL 00289/0095
TEVA UK Limited
63134-Y
PAGE 2: REAR FACE (OUTSIDE OF REEL)
MEBEVERINE 135 mg TABLETS BP
PACKAGE LEAFLET: INFORMATION FOR THE 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 same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS 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
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 Mebeverine Tablets 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.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
3
HOW TO TAKE MEBEVERINE
1
WHAT 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.
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 all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
2
BEFORE YOU TAKE MEBEVERINE
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.
If you forget to take Mebeverine If you forget to take a tablet, take one as FURTHER INFORMATION soon as you remember, unless it is nearly time to take the next one. Do not take a What Mebeverine Tablets contain: double dose to make up for a forgotten The active ingredient is mebeverine dose. Take the remaining doses at the hydrochloride. correct time. The other ingredients are lactose monohydrate, potato starch, sodium If you stop taking Mebeverine starch glycolate, povidone K30, Do not stop taking your medicine without purified talc (E553), magnesium talking to your doctor first even if you stearate (E572). The tablet coating feel better. contains: sucrose, purified talc (E553), calcium carbonate, macro glyceryl If you have any further questions on the ricinoleate, titanium dioxide (E171), use of this product, ask your doctor or acacia, magnesium stearate, methyl pharmacist. parahydroxybenzoate (E218) and white beeswax (E901). The printing ink POSSIBLE SIDE EFFECTS contains: shellac, black iron oxide (E172) and propylene glycol (E1520). Like all medicines, Mebeverine can cause side effects, although not everybody gets What Mebeverine Tablets look like and them. contents of the pack: Mebeverine Tablets are white or If the following happens, stop taking the almost white, biconvex, sugar coated tablets and tell your doctor immediately tablets. They are plain on one side and or go to the casualty department at your printed 135/4301 on the reverse. nearest hospital: Mebeverine Tablets are available in an allergic reaction (swelling of the pack sizes of 7, 10, 14, 21, 28, 30, 56, lips, face or neck leading to severe 60, 84, 90, 100, 110, 112, 120, 150, 160 difficulty in breathing; skin rash or and 168 tablets. hives). Not all pack sizes may be marketed. This is a very serious but rare side effect. You may need urgent medical attention Marketing Authorisation Holder and or hospitalisation. Manufacturer Marketing Authorisation holder: TEVA If you notice any other side effects, UK Limited, Eastbourne, BN22 9AG. please tell your doctor or pharmacist. This leaflet was last revised: May 2011
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.
Top of page cut-off to middle of registration mark: 21mm. Registration Pitch: 210mm -0.45mm (Sheet depth / cut-off length: 210mm)
6
(Main)
Pharma code 416
4
5
HOW TO STORE MEBEVERINE
Keep out of the reach and sight of children. Mebeverine Tablets should be stored in a dry place at or below 20C 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.
PL 00289/0095
TEVA UK Limited
63134-Y
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
