TRIMETHOPRIM TABLETS 100MG
Active substance: TRIMETHOPRIM
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BLACK
PAGE 1: FRONT FACE (INSIDE OF REEL)
PAGE 2: REAR FACE (OUTSIDE OF REEL)
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.
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.
5
HOW TO STORE TRIMETHOPRIM
IN THIS LEAFLET:
1. What Trimethoprim is and what it is used for 2. Before you take Trimethoprim 3. How to take Trimethoprim 4. Possible side effects 5. How to store Trimethoprim 6. Further information
If you are taking oral contraceptives (the pill) and have diarrhoea, this could cause contraceptive failure. It is recommended that you use other forms of contraception such as the diaphragm or condom while you are taking trimethoprim, and for 7 days after the course has been completed. Pregnancy and breast-feeding Do not take trimethoprim if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Important information about some of the ingredients of Trimethoprim Patients who are intolerant to lactose should note that Trimethoprim tablets contain a small amount of 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.
You should continue to take these tablets for as long as your doctor tells you to. Take the full course. Even if you start to feel better the original infection may still be present and may recur if treatment is stopped. You may need to have blood tests if you take Trimethoprim for a long time or if your doctor thinks you are at special risk. If you take more Trimethoprim than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. 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.
Keep out of the reach and sight of children. Do not take Trimethoprim after the expiry date that is stated on the outer packaging. 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.
6
FURTHER INFORMATION
1
WHAT TRIMETHOPRIM IS AND WHAT IT IS USED FOR
Trimethoprim belongs to a group of medicines called antibacterials. Trimethoprim is used for the prevention and treatment of infections, particularly in the urinary and respiratory tracts.
What Trimethoprim contains: The active ingredient is Trimethoprim 100 or 200 mg. Each tablet contains 100 or 200 mg of the active substance, trimethoprim. The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (Type A), povidone, colloidal anhydrous silica, magnesium stearate and stearic acid.
2
BEFORE YOU TAKE TRIMETHOPRIM
Always take Trimethoprim 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 with a drink of water. The usual dose is: Severe or sudden infections: Adults and children over 12 years of age: 200 mg twice a day. Children aged 6 to 12: Take special care with Trimethoprim 100 mg twice a day. Tell your doctor before you start to take this medicine Children 6 months to 5 years: if you: 50 mg twice a day. Have kidney problems Elderly: Have folate-deficiency anaemia (a decrease in red The adult dose may need to be reduced depending blood cells due to a poor diet, which can cause on how well your kidneys function. Your doctor will tiredness, headache, a sore mouth and tongue and advise you. pale skin). The treatment should continue for at least one week but no longer than two weeks. Taking other medicines Please tell your doctor or pharmacist if you are taking For long term treatment and for the prevention of or have recently taken any other medicines, including infections: medicines obtained without a prescription. Adults and children over 12 years of age: The effect of Trimethoprim may be increased or 100 mg at night. decreased by other medicines and vice versa. Your doctor will advise you on the dosage for children between 6 12 years of age.
Do NOT take Trimethoprim: If you are allergic (hypersensitive) to trimethoprim or any of the other ingredients of this medicine If you are pregnant or breast-feeding If you have any blood disorders If you suffer from severe liver problems If you suffer from severe kidney problems, unless your doctor is checking the levels of trimethoprim in your blood.
3
HOW TO TAKE TRIMETHOPRIM
If you forget to take Trimethoprim What Trimethoprim looks like and contents of the pack: If you forget to take a tablet, take one as soon as you The name of your medicine is Trimethoprim 100 remember, unless it is nearly time to take the next one. or 200 mg Tablets Do not take a double dose to make up for a forgotten Trimethoprim 100 mg Tablets are white, normal tablet. Take the remaining doses at the correct time. biconvex tablets, engraved Berk 2H7 or 2H7 with a breakline on reverse If you have any further questions on the use of this Trimethoprim 200 mg Tablets are white, normal product, ask your doctor or pharmacist. biconvex tablets, engraved Berk 3H7 or 3H7 with a breakline on the reverse POSSIBLE SIDE EFFECTS The 100 mg product is available in pack sizes of 7, 10, 14, 20, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, Like all medicines, Trimethoprim can cause side 120, 150, 160, 168, 500 and 5000 tablets effects,although not everybody gets them. The 200 mg product is available in pack sizes of 7, 10, 14, 21, 24, 28, 30, 50, 56, 60, 70, 84, 90, 100, If the following happens, stop taking Trimethoprim 110, 112, 120, 150, 160, 168 and 500 tablets. and tell your doctor immediately or go to the Not all pack sizes may be marketed. casualty department at your nearest hospital: Difficulty in breathing and swelling of the lips, Marketing Authorisation Holder and face and neck. Manufacturer Severe skin reactions, including blistering/bleeding Marketing Authorisation holder and company of the lips, eyes, nose, mouth and genitals, or the responsible for manufacture: TEVA UK Limited, skin peeling off. Eastbourne, BN22 9AG. These are very serious but rare side effects. You may need urgent medical attention or hospitalisation. This leaflet was last revised: June 2009
4
Other side effects may include: Stomach upset, abdominal pain Headache Feeling sick or being sick Changes in how your body makes new blood cells
PL 00289/0196-7
76470-W
Pharma code 235
TRIMETHOPRIM 100 and 200 mg TABLETS
These medicines include: Azathioprine (used following organ transplant and for arthritis) Ciclosporin (used to prevent organ rejection after transplant surgery) Digoxin or procainamide (used to treat heart problems) Mercaptopurine or methotrexate (used as bone marrow depressants) Phenytoin (used to treat epilepsy) Pyrimethamine (used to treat malaria) Rifampicin (used to treat infections) Warfarin (used to prevent blood clots).
Trimethoprim suspension is available for use in children. Elderly: The adult dose may need to be reduced depending on how well your kidneys function. Your doctor will advise you. Renal impairment: It may be necessary to reduce the dosage if you are suffering from kidney problems. Your doctor will advise you. Dialysis patients: Dialysis removes trimethoprim. Blood tests will be carried out before and after dialysis.
Skin redness, skin rashes and itching Sensitivity to light Anaemia (characterised by tiredness, headache, a sore mouth and tongue) Sudden severe headache or stiffness of the neck accompanied by a high temperature.
Top of page cut-off to middle of registration mark: 21mm. Registration Pitch: 210mm -0.45mm (Sheet depth / cut-off length: 210mm)
Pharma code 235
PAGE 1: FRONT FACE (INSIDE OF REEL)
PAGE 2: REAR FACE (OUTSIDE OF REEL)
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.
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.
5
HOW TO STORE TRIMETHOPRIM
IN THIS LEAFLET:
1. What Trimethoprim is and what it is used for 2. Before you take Trimethoprim 3. How to take Trimethoprim 4. Possible side effects 5. How to store Trimethoprim 6. Further information
If you are taking oral contraceptives (the pill) and have diarrhoea, this could cause contraceptive failure. It is recommended that you use other forms of contraception such as the diaphragm or condom while you are taking trimethoprim, and for 7 days after the course has been completed. Pregnancy and breast-feeding Do not take trimethoprim if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Important information about some of the ingredients of Trimethoprim Patients who are intolerant to lactose should note that Trimethoprim tablets contain a small amount of 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.
You should continue to take these tablets for as long as your doctor tells you to. Take the full course. Even if you start to feel better the original infection may still be present and may recur if treatment is stopped. You may need to have blood tests if you take Trimethoprim for a long time or if your doctor thinks you are at special risk. If you take more Trimethoprim than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. 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.
Keep out of the reach and sight of children. Do not take Trimethoprim after the expiry date that is stated on the outer packaging. 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.
6
FURTHER INFORMATION
1
WHAT TRIMETHOPRIM IS AND WHAT IT IS USED FOR
Trimethoprim belongs to a group of medicines called antibacterials. Trimethoprim is used for the prevention and treatment of infections, particularly in the urinary and respiratory tracts.
What Trimethoprim contains: The active ingredient is Trimethoprim 100 or 200 mg. Each tablet contains 100 or 200 mg of the active substance, trimethoprim. The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (Type A), povidone, colloidal anhydrous silica, magnesium stearate and stearic acid.
2
BEFORE YOU TAKE TRIMETHOPRIM
Always take Trimethoprim 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 with a drink of water. The usual dose is: Severe or sudden infections: Adults and children over 12 years of age: 200 mg twice a day. Children aged 6 to 12: Take special care with Trimethoprim 100 mg twice a day. Tell your doctor before you start to take this medicine Children 6 months to 5 years: if you: 50 mg twice a day. Have kidney problems Elderly: Have folate-deficiency anaemia (a decrease in red The adult dose may need to be reduced depending blood cells due to a poor diet, which can cause on how well your kidneys function. Your doctor will tiredness, headache, a sore mouth and tongue and advise you. pale skin). The treatment should continue for at least one week but no longer than two weeks. Taking other medicines Please tell your doctor or pharmacist if you are taking For long term treatment and for the prevention of or have recently taken any other medicines, including infections: medicines obtained without a prescription. Adults and children over 12 years of age: The effect of Trimethoprim may be increased or 100 mg at night. decreased by other medicines and vice versa. Your doctor will advise you on the dosage for children between 6 12 years of age.
Do NOT take Trimethoprim: If you are allergic (hypersensitive) to trimethoprim or any of the other ingredients of this medicine If you are pregnant or breast-feeding If you have any blood disorders If you suffer from severe liver problems If you suffer from severe kidney problems, unless your doctor is checking the levels of trimethoprim in your blood.
3
HOW TO TAKE TRIMETHOPRIM
If you forget to take Trimethoprim What Trimethoprim looks like and contents of the pack: If you forget to take a tablet, take one as soon as you The name of your medicine is Trimethoprim 100 remember, unless it is nearly time to take the next one. or 200 mg Tablets Do not take a double dose to make up for a forgotten Trimethoprim 100 mg Tablets are white, normal tablet. Take the remaining doses at the correct time. biconvex tablets, engraved Berk 2H7 or 2H7 with a breakline on reverse If you have any further questions on the use of this Trimethoprim 200 mg Tablets are white, normal product, ask your doctor or pharmacist. biconvex tablets, engraved Berk 3H7 or 3H7 with a breakline on the reverse POSSIBLE SIDE EFFECTS The 100 mg product is available in pack sizes of 7, 10, 14, 20, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, Like all medicines, Trimethoprim can cause side 120, 150, 160, 168, 500 and 5000 tablets effects,although not everybody gets them. The 200 mg product is available in pack sizes of 7, 10, 14, 21, 24, 28, 30, 50, 56, 60, 70, 84, 90, 100, If the following happens, stop taking Trimethoprim 110, 112, 120, 150, 160, 168 and 500 tablets. and tell your doctor immediately or go to the Not all pack sizes may be marketed. casualty department at your nearest hospital: Difficulty in breathing and swelling of the lips, Marketing Authorisation Holder and face and neck. Manufacturer Severe skin reactions, including blistering/bleeding Marketing Authorisation holder and company of the lips, eyes, nose, mouth and genitals, or the responsible for manufacture: TEVA UK Limited, skin peeling off. Eastbourne, BN22 9AG. These are very serious but rare side effects. You may need urgent medical attention or hospitalisation. This leaflet was last revised: June 2009
4
Other side effects may include: Stomach upset, abdominal pain Headache Feeling sick or being sick Changes in how your body makes new blood cells
PL 00289/0196-7
76470-W
Pharma code 235
TRIMETHOPRIM 100 and 200 mg TABLETS
These medicines include: Azathioprine (used following organ transplant and for arthritis) Ciclosporin (used to prevent organ rejection after transplant surgery) Digoxin or procainamide (used to treat heart problems) Mercaptopurine or methotrexate (used as bone marrow depressants) Phenytoin (used to treat epilepsy) Pyrimethamine (used to treat malaria) Rifampicin (used to treat infections) Warfarin (used to prevent blood clots).
Trimethoprim suspension is available for use in children. Elderly: The adult dose may need to be reduced depending on how well your kidneys function. Your doctor will advise you. Renal impairment: It may be necessary to reduce the dosage if you are suffering from kidney problems. Your doctor will advise you. Dialysis patients: Dialysis removes trimethoprim. Blood tests will be carried out before and after dialysis.
Skin redness, skin rashes and itching Sensitivity to light Anaemia (characterised by tiredness, headache, a sore mouth and tongue) Sudden severe headache or stiffness of the neck accompanied by a high temperature.
Top of page cut-off to middle of registration mark: 21mm. Registration Pitch: 210mm -0.45mm (Sheet depth / cut-off length: 210mm)
Pharma code 235
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.
