CO-TRIMOXAZOLE TABLETS BP (400/80)
Active substance: TRIMETHOPRIM
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Co-trimoxazole Tablets BP (400/80)
Sulfamethoxazole, Trimethoprim
Read all of this leaflet carefully before you start taking this medicine.
iKeep this leaflet. You may need to read it again. iIf you have any further questions, ask your doctor or pharmacist. iThis 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. iIf 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 this medicine is and what it is used for 2. Before you take 3. How to take 4. Possible side effects 5. How to store 6. Further information
79/L/e/7
Taking Co-trimoxazole tablets long term If you are taking Co-trimoxazole for long periods, blood tests may be carried out. The doctor may also prescribe an additional drug,folic acid, for you to take. If you take more than you should If you take more tablets than you should you may feel nauseous (sick) and confused. 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately. 2. Take the container and any remaining tablets with you so that people can see what you have taken. 3. Do this even if feel well. If you forget to take If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for a missed dose. If you stop taking Do not stop just because you feel better. If you stop too soon, the infection may come back. Keep taking the tablets until the prescribed course is finished. If you have any further questions on the use of this product, ask your doctor or pharmacist.
1. What this medicine is and what it is used for
Co-trimoxazole tablets contain sulfamethoxazole and trimethoprim. These are antibiotics. Together they work by stopping the growth of bacteria which cause infections such as: ipneumonia, bronchitis, chest infections iurinary tract infections iear infections iskin infections ibrain infections
4. Possible side effects
Like all medicines, Co-trimoxazole tablets can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them. STOP taking the tablets and seek medical help immediately if you have any of the following allergic reactions: idifficulty breathing or swallowing, swelling of the face, lips, tongue or throat isevere itching of the skin, with a red rash or raised lumps iblistering of the mouth, eyes, or genital region, patchy areas of rash, peeling skin. Seek immediate medical attention if you have any of the following symptoms: isudden headache, stiff neck, fever, sensitivity to bright light, drowsiness and muscle pain, with or without a rash ipinpoint red spots on the skin, unusual purple bruise-like rash on the skin or in the mouth, unusual or heavy bleeding ifever, sore throat, mouth ulcers, repeated infections or infections that will not go away icough, feeling breathless, chest pain iswollen legs or joints, feeling tired ipain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever isevere stomach cramps, watery and severe diarrhoea which may be bloody iyellowing of the skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness iseizures (fits). Tell your doctor if you get any of the following side effects: Very common side effects (in more than 1 in 10 people): iincreased amount of potassium in the blood. You cannot feel or see this but your doctor may test your blood for this. Common side effects (in less than 1 in 10 people): iheadache inausea idiarrhoea iskin rashes ioral thrush (white, furry sore tongue and mouth) ivaginal thrush (sore, itchy vagina with vaginal discharge) ithrush affecting the penis. Uncommon side effects (in less than 1 in 100 people): ivomiting. Very rare side effects (in less than 1 in 10 000 people): ireactions to the sun. Skin may become red, painful and swollen - do not sunbathe, use a sun-bed or expose your skin to UV light iallergic-like reaction (skin rash, hives, fever and joint pain) which may happen after you stop taking Co-trimoxazole ifever idepression or hallucinations itingling or numbness in the hands and feet ifeeling unsteady or dizzy, head-spins, lack of co-ordination iringing in the ears iinflamed and sore tongue, sore mouth, difficulty chewing and eating ibutterfly-shaped rash over the nose and cheeks, made worse by exposure to the sun. Tiredness and joint pains ilow sugar level (feeling hungry, nervous, sweating, trembling) ilow sodium level (headache, nausea, vomiting, lethargy, muscle cramps). Blood may be tested for this ilack of appetite, weight loss imuscle weakness or pain ijoint pain ikidney changes. Blood and urine may be tested for this. If any of the side effects get troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
2. Before you take
Do NOT take Co-trimoxazole tablets if you: iare allergic to sulfamethoxazole, trimethoprim, or any other sulphonamide, or to any of the other ingredients (see Section 6) ihave liver disease ihave a blood disorder ihave severe kidney problems. Do not give Co-trimoxazole to very young babies (less than 6 weeks old) unless it is prescribed by a doctor for pneumonia. If any of the above apply to you, speak to your doctor or pharmacist. Take special care with Co-trimoxazole tablets Before taking the tablets, tell your doctor if you: ihave lung problems (e.g. asthma) ihave severe allergies (e.g. hayfever) iare over 65 years of age, as the elderly may get more side effects ihave a folic acid deficiency icould be suffering from malnutrition (e.g. due to dieting or bowel problems) ihave glucose-6-phosphate dehydrogenase (G6PD) deficiency isuffer from phenylketonuria (an enzyme deficiency) and are not on a special diet ihave porphyria (a metabolism disorder which causes abdominal pains and mental disorder) ihave HIV (Human Immunodeficiency Virus) ihave a bacterial throat infection called streptococcal pharyngitis iever had high blood potassium levels iare taking pyrimethamine, a medicine for malaria. 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, and herbal preparations. Some medicines may be affected by Co-trimoxazole or they may affect how well Co-trimoxazole will work. Tell your doctor or pharmacist if you are taking: idiuretics (water tablets) idigoxin, used to treat heart conditions imedicines likely to increase the amount of potassium in your blood (e.g. ACE-inhibitors) imedicines for diabetes imedicines that thin the blood e.g. warfarin imethotrexate, a medicine used to treat arthritis or cancer iciclosporin, a medicine used to suppress the immune system iphenytoin, a medicine used in the treatment of epilepsy iHIV medicines, such as zidovudine and lamivudine iprocainamide, a medicine used to treat certain heart conditions iamantadine, a medicine used to treat the flu and also Parkinson's Disease ipyrimethamine, a medicine for malaria. Pregnancy and breast-feeding DO NOT take Co-trimoxazole if you are pregnant, especially in early or late pregnancy, or while breast-feeding unless advised by your doctor. Ask your doctor for advice before taking any medicine. Driving and using machines Co-trimoxazole may cause dizziness, head-spins and lack of co-ordination. If this occurs do not drive, use machinery, or perform any tasks that may require you to be alert.
3. How to take
Always take Co-trimoxazole tablets exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure. iSwallow the tablets with plenty of water, after a meal to prevent upset stomach. It is important to drink plenty of fluids while you are taking Co-trimoxazole. Doses to treat infections Adults: the usual dose is two tablets twice a day (every 12 hours). Children 6 to 12 years: one tablet twice a day (every 12 hours). Children under 6 years: this medicine is NOT suitable for children under 6 years. Treatment will normally be given for 1- 5 days. If no improvement is seen after 7 days the doctor will reassess you. Doses to treat Pneumocystis jiroveci (P.carinii) lung infection (PCP) Your doctor may prescribe higher doses than usual for more than 7 days. Doses to prevent Pneumocystis infections Adults: itwo tablets once a day on each day of the week; or itwo tablets three times a week taken on alternate days; or itwo tablets twice daily three times a week taken on alternate days. Children 6 to 12 years: ione tablet twice daily on each day of the week; or ione tablet twice daily three times a week on alternate days; or ione tablet twice daily three times a week on consecutive days; or itwo tablets once a day three times a week on consecutive days. Patients with kidney problems If your kidneys are not working very well, your doctor may change the dose and test your blood to see if the medicine is working properly. Elderly Care should be taken as the elderly may get more side effects, which could be serious if they have existing conditions or are taking other medicines.
Continued over page
5. How to store
iKeep out of the reach and sight of children. iDo not take after the expiry date which is stated on the label and on the carton. The expiry date refers to the last day of that month. iStore in a dry place, away from heat and light. iDo not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
6. Further information
What Co-trimoxazole Tablets contain iThe active ingredients are sulfamethoxazole (400 mg) and trimethoprim (80 mg). iThe other ingredients are: starch, magnesium stearate, sodium starch glycollate and colloidal silica. What Co-trimoxazole Tablets look like and contents of the pack Co-trimoxazole Tablets are white bi-convex tablets with a breakline on one side. They are available in packs of 28, 100, 500 or 1000 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Chemidex Pharma Ltd., trading as Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB. Manufacturer Dales Pharmaceuticals Ltd., Snaygill Industrial Estate, Keighley Road, Skipton, Yorkshire BD23 2RW. This leaflet was last revised in November 2008
79/L/e/7
Sulfamethoxazole, Trimethoprim
Read all of this leaflet carefully before you start taking this medicine.
iKeep this leaflet. You may need to read it again. iIf you have any further questions, ask your doctor or pharmacist. iThis 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. iIf 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 this medicine is and what it is used for 2. Before you take 3. How to take 4. Possible side effects 5. How to store 6. Further information
79/L/e/7
Taking Co-trimoxazole tablets long term If you are taking Co-trimoxazole for long periods, blood tests may be carried out. The doctor may also prescribe an additional drug,folic acid, for you to take. If you take more than you should If you take more tablets than you should you may feel nauseous (sick) and confused. 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately. 2. Take the container and any remaining tablets with you so that people can see what you have taken. 3. Do this even if feel well. If you forget to take If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for a missed dose. If you stop taking Do not stop just because you feel better. If you stop too soon, the infection may come back. Keep taking the tablets until the prescribed course is finished. If you have any further questions on the use of this product, ask your doctor or pharmacist.
1. What this medicine is and what it is used for
Co-trimoxazole tablets contain sulfamethoxazole and trimethoprim. These are antibiotics. Together they work by stopping the growth of bacteria which cause infections such as: ipneumonia, bronchitis, chest infections iurinary tract infections iear infections iskin infections ibrain infections
4. Possible side effects
Like all medicines, Co-trimoxazole tablets can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them. STOP taking the tablets and seek medical help immediately if you have any of the following allergic reactions: idifficulty breathing or swallowing, swelling of the face, lips, tongue or throat isevere itching of the skin, with a red rash or raised lumps iblistering of the mouth, eyes, or genital region, patchy areas of rash, peeling skin. Seek immediate medical attention if you have any of the following symptoms: isudden headache, stiff neck, fever, sensitivity to bright light, drowsiness and muscle pain, with or without a rash ipinpoint red spots on the skin, unusual purple bruise-like rash on the skin or in the mouth, unusual or heavy bleeding ifever, sore throat, mouth ulcers, repeated infections or infections that will not go away icough, feeling breathless, chest pain iswollen legs or joints, feeling tired ipain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever isevere stomach cramps, watery and severe diarrhoea which may be bloody iyellowing of the skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness iseizures (fits). Tell your doctor if you get any of the following side effects: Very common side effects (in more than 1 in 10 people): iincreased amount of potassium in the blood. You cannot feel or see this but your doctor may test your blood for this. Common side effects (in less than 1 in 10 people): iheadache inausea idiarrhoea iskin rashes ioral thrush (white, furry sore tongue and mouth) ivaginal thrush (sore, itchy vagina with vaginal discharge) ithrush affecting the penis. Uncommon side effects (in less than 1 in 100 people): ivomiting. Very rare side effects (in less than 1 in 10 000 people): ireactions to the sun. Skin may become red, painful and swollen - do not sunbathe, use a sun-bed or expose your skin to UV light iallergic-like reaction (skin rash, hives, fever and joint pain) which may happen after you stop taking Co-trimoxazole ifever idepression or hallucinations itingling or numbness in the hands and feet ifeeling unsteady or dizzy, head-spins, lack of co-ordination iringing in the ears iinflamed and sore tongue, sore mouth, difficulty chewing and eating ibutterfly-shaped rash over the nose and cheeks, made worse by exposure to the sun. Tiredness and joint pains ilow sugar level (feeling hungry, nervous, sweating, trembling) ilow sodium level (headache, nausea, vomiting, lethargy, muscle cramps). Blood may be tested for this ilack of appetite, weight loss imuscle weakness or pain ijoint pain ikidney changes. Blood and urine may be tested for this. If any of the side effects get troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
2. Before you take
Do NOT take Co-trimoxazole tablets if you: iare allergic to sulfamethoxazole, trimethoprim, or any other sulphonamide, or to any of the other ingredients (see Section 6) ihave liver disease ihave a blood disorder ihave severe kidney problems. Do not give Co-trimoxazole to very young babies (less than 6 weeks old) unless it is prescribed by a doctor for pneumonia. If any of the above apply to you, speak to your doctor or pharmacist. Take special care with Co-trimoxazole tablets Before taking the tablets, tell your doctor if you: ihave lung problems (e.g. asthma) ihave severe allergies (e.g. hayfever) iare over 65 years of age, as the elderly may get more side effects ihave a folic acid deficiency icould be suffering from malnutrition (e.g. due to dieting or bowel problems) ihave glucose-6-phosphate dehydrogenase (G6PD) deficiency isuffer from phenylketonuria (an enzyme deficiency) and are not on a special diet ihave porphyria (a metabolism disorder which causes abdominal pains and mental disorder) ihave HIV (Human Immunodeficiency Virus) ihave a bacterial throat infection called streptococcal pharyngitis iever had high blood potassium levels iare taking pyrimethamine, a medicine for malaria. 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, and herbal preparations. Some medicines may be affected by Co-trimoxazole or they may affect how well Co-trimoxazole will work. Tell your doctor or pharmacist if you are taking: idiuretics (water tablets) idigoxin, used to treat heart conditions imedicines likely to increase the amount of potassium in your blood (e.g. ACE-inhibitors) imedicines for diabetes imedicines that thin the blood e.g. warfarin imethotrexate, a medicine used to treat arthritis or cancer iciclosporin, a medicine used to suppress the immune system iphenytoin, a medicine used in the treatment of epilepsy iHIV medicines, such as zidovudine and lamivudine iprocainamide, a medicine used to treat certain heart conditions iamantadine, a medicine used to treat the flu and also Parkinson's Disease ipyrimethamine, a medicine for malaria. Pregnancy and breast-feeding DO NOT take Co-trimoxazole if you are pregnant, especially in early or late pregnancy, or while breast-feeding unless advised by your doctor. Ask your doctor for advice before taking any medicine. Driving and using machines Co-trimoxazole may cause dizziness, head-spins and lack of co-ordination. If this occurs do not drive, use machinery, or perform any tasks that may require you to be alert.
3. How to take
Always take Co-trimoxazole tablets exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure. iSwallow the tablets with plenty of water, after a meal to prevent upset stomach. It is important to drink plenty of fluids while you are taking Co-trimoxazole. Doses to treat infections Adults: the usual dose is two tablets twice a day (every 12 hours). Children 6 to 12 years: one tablet twice a day (every 12 hours). Children under 6 years: this medicine is NOT suitable for children under 6 years. Treatment will normally be given for 1- 5 days. If no improvement is seen after 7 days the doctor will reassess you. Doses to treat Pneumocystis jiroveci (P.carinii) lung infection (PCP) Your doctor may prescribe higher doses than usual for more than 7 days. Doses to prevent Pneumocystis infections Adults: itwo tablets once a day on each day of the week; or itwo tablets three times a week taken on alternate days; or itwo tablets twice daily three times a week taken on alternate days. Children 6 to 12 years: ione tablet twice daily on each day of the week; or ione tablet twice daily three times a week on alternate days; or ione tablet twice daily three times a week on consecutive days; or itwo tablets once a day three times a week on consecutive days. Patients with kidney problems If your kidneys are not working very well, your doctor may change the dose and test your blood to see if the medicine is working properly. Elderly Care should be taken as the elderly may get more side effects, which could be serious if they have existing conditions or are taking other medicines.
Continued over page
5. How to store
iKeep out of the reach and sight of children. iDo not take after the expiry date which is stated on the label and on the carton. The expiry date refers to the last day of that month. iStore in a dry place, away from heat and light. iDo not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
6. Further information
What Co-trimoxazole Tablets contain iThe active ingredients are sulfamethoxazole (400 mg) and trimethoprim (80 mg). iThe other ingredients are: starch, magnesium stearate, sodium starch glycollate and colloidal silica. What Co-trimoxazole Tablets look like and contents of the pack Co-trimoxazole Tablets are white bi-convex tablets with a breakline on one side. They are available in packs of 28, 100, 500 or 1000 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Chemidex Pharma Ltd., trading as Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB. Manufacturer Dales Pharmaceuticals Ltd., Snaygill Industrial Estate, Keighley Road, Skipton, Yorkshire BD23 2RW. This leaflet was last revised in November 2008
79/L/e/7
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.
