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Co-Trimoxazole Forte 160mg/800mg Tablets

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PATIENT INFORMATION LEAFLET


Co-Trimoxazole belongs to a group of medicines called antibacterials. This medicine contains two active ingredients, trimethoprim and sulfamethoxazole and is used to treat certain types of infections caused by bacteria.

Co-Trimoxazole can be used to treat or prevent:

■    Lung infections (pneumonia) caused by pneumocytosis carinii/pneumocytosis jiroveci (fungus)

■    Infections caused by the bacteria toxoplasma (toxoplasmosis)

Co-Trimoxazole can also be used to treat:

■    Urinary tract infections

■    Worsening of long-term bronchitis

■    Short-lived ear infections in children (acute otitis media)

■    A rare infection of the lungs, brain or skin (nocardiosis)

What you need to know before you take Co-Trimoxazole

Do not take Co-Trimoxazole if:

■    You are allergic (hypersensitive) to sulfonamide, trimethoprim, other antibacterial agents or any of the other ingredients of this medicine (see section 6 "Contents of the pack and other information”)

■    You have severe liver failure, liver damage or jaundice (yellowing of the skin or whites of the eyes)

■    You have severe kidney problems

■    It is for a child and they are less than 6 weeks old or were premature. Unless it is for the treatment or prevention of lung infections caused by pneumocytosis carinii/pneumocytosis jiroveci (fungus). In this case, babies should be at least 4 weeks old

■    You are pregnant (see 'Pregnancy and breast-feeding' section)

Warnings and precautions

Talk to your doctor before taking Co-Trimoxazole if:

■    You develop a skin rash or blood disorder as Co trimoxazole should be discontinued

■    You have a history of allergies or asthma

■    You have kidney problems

■    You do not have enough folic acid (vitamin) in your body

■    You are known to have a glucose-6-phosphate dehydrogenase deficiency. It is a hereditary condition which causes the red blood cells to break down. when the body is exposed to infections or certain medicines

■    You have a metabolism disorder called phenylketonuria and you are not on a special diet to control your condition

■    You are older, you are more prone to side effects, especially if you have kidney and/or liver problems and/or are taking other medicines

■    You have a bacterial infection known as Group A beta-haemolytic streptococci

■    You are known to be at risk of having hyperkalaemia and hyponaturaemia, as your blood potassium and sodium (salt) levels should be closely monitored

■    You are suffering from malnutrition

■    You are known or suspected to be at risk of porphyria (a group of rare inherited or acquired disorders where there is a problem with the production of haem (used to make haemoglobin in red blood cells) within the body)

■    Your treatment with Co-Trimoxazole is prolonged, especially if you have low folate levels or you are older as it is recommended that complete blood counts be performed at monthly intervals

Other medicines and Co-Trimoxazole

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Medicines which may interact with or be affected by

Co-Trimoxazole:

■    Warfarin or acencoumarol, used to prevent the blood from clotting (anticoagulants)

■    Phenytoin, used to treat epilepsy

■    Digoxin used to treat heart conditions

■    Procainamide, amiodarone or dofetilide, used to treat an irregular heart beat

■    Amantadine, used to treat some viral infections and also Parkinson's disease

■    Medicines for diabetes, such as glibenclamide, glipizide or tolbutamide (sulphonylurea hypoglycaemic medicines)

■    Methotrexate, mercaptopurine and azathioprine, used to treat immune disorders

■    Cyclosporin, used after transplant operations or for your immune system

■    Pyrimethamine, used to prevent malaria

■    ACE inhibitors, used to treat high blood pressure, such as captopril or lisinopril

■    Anaesthetics, such as prilocaine

■    Rifampicin, dapsone or methenamine, used to treat bacterial infections (antibiotics)

■    Lamivudine, zidovudine and zalcitabine, used to treat viral infections

■    Clozapine, used to treat mental health problems

■    Potassium aminobenzoate, used to treat scleroderma (Peyronie's disease)

If you are older and are taking the following:

■    Diuretics (water tablets), which help increase the amount of urine produced. In particular, thiazides, such as bendroflumethiazide

Laboratory tests

If you need to have laboratory tests, let your doctor know that you are taking Co-Trimoxazole as it may affect the results.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

■    Co-Trimoxazole should not be used during pregnancy particularly in the first trimester (first 3 months of

Breast-feeding:

■    Both sulfamethoxazole and trimethoprim (the active ingredients in Co-Trimoxazole) are passed into the breast milk.

■    Co-Trimoxazole should be avoided where the breast-feeding mother or infant has, or is at risk of developing a condition in which there is too much bilirubin in the blood (hyperbilirubinaemia), particularly in infants younger than eight weeks old as they are more at risk of developing this condition.

Driving and using machines

Co-Trimoxazole may make you feel dizzy, sleepy, see or hear things that are not real (hallucinations), have ringing in your ears (tinnitus) or difficulty sleeping (insomnia). If affected, you should not drive or operate machinery.

How to take Co-Trimoxazole

Always take Co-Trimoxazole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

■    These tablets are to be taken orally

■    The tablets should be taken with some food or drink

■    The score line on the tablet is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses

■    Treatment should be continued until you have been free from symptoms for 2 days. It is likely you will require treatment for at least 5 days. If there is no improvement after 7 days of treatment, you should be reassessed by your doctor

Adults and children over 12 years

■    If you suffer from kidney problems you may be given a lower dose of Co-Trimoxazole. Your doctor may also test your blood to ensure your medicine is working.

■    If you suffer from chronic prostatitis (long-term inflammation of the prostate), it may be necessary to take a higher dose of Co-Trimoxazole to start with. The course of treatment should last for 3 months to reduce the risk of relapse.

■    If you suffer from acute brucellosis (a bacterial infection which can be passed to humans either by contact with infected farm animals or by drinking non-pasteurised contaminated milk), it may be necessary to take a higher dose of Co-Trimoxazole to start with. Treatment should continue for a period of at least 4 weeks and repeated courses may be necessary.

■    If you carry typhoid or paratyphoid, treatment should be continued for at least 1-3 months.

■    For treatment of lung infections (pneumonia) caused by pneumocytosis carinii/pneumocytosis jiroveci (fungus) a higher dose using 20mg of trimethoprim and 100mg of sulfamethoxazole per kg body weight per day in 2 or more divided doses for 2 weeks is recommended.

■    For the treatment of nocardiosis (a rare infection of the lungs, brain or skin) adult doses of 6-8 tablets daily for up to 3 months have been used.

Co-Trimoxazole 80/400mg Tablets:

■    The usual dose is 2 tablets twice a day.

■    For severe infections the dose may be increased to 3 tablets twice a day.

■    For long-term prevention of urine infections the usual dose is 1 tablet at night. Treatment may be continued for 3-12 months or more as required.

■    In uncomplicated cases of gonorrhoea (a sexually transmitted disease), 4 tablets every 12 hours for 2 days may be given or 5 tablets followed by a further dose of 5 tablets 8 hours later.

■    For prevention of lung infections (pneumonia) caused by pneumocytosis carinii/pneumocytosis jiroveci (fungus) and/or prevention of toxoplasmosis, ONE of

the following doses may be used: o 2 tablets (160mg trimethoprim/800mg sulfamethoxazole) daily for 7 days o 2 tablets (160mg trimethoprim/800mg

sulfamethoxazole) 3 times a week on alternate days

o 2 tablets (160mg trimethoprim/800mg

sulfamethoxazole) twice daily, 3 times a week on alternate d ays

Co-Trimoxazole Forte 160/800mg Tablets:

■    The usual dose is 1 tablet twice a day.

■    For severe infections the dose may be increased to 240mg trimethoprim/1200mg sulfamethoxazole (equivalent to 1'A tablets) twice a day.

■    For prevention of lung infections (pneumonia) caused by pneumocytosis carinii/pneumocytosis jiroveci (fungus) and/or prevention of toxoplasmosis, ONE of the following doses may be used:

o 1 tablet (160mg trimethoprim/800mg sulfamethoxazole) daily for 7 days o 1 tablet (160mg trimethoprim/800mg

sulfamethoxazole) 3 times a week on alternate days

o 1 tablet (160mg trimethoprim/800mg

sulfamethoxazole) twice daily, 3 times a week on alternate days

Use in children

■    Co-Trimoxazole 80/400mg is not recommended for children under 12 years of age with kidney failure.

■    Co-Trimoxazole Forte 160/800mg is not recommended for children under 12 years of age.

Prevention of lung infections (pneumonia) caused by

pneumocytosis carinii/pneumocytosis jiroveci

(fungus)

ONE of the following doses may be used:

■    The usual recommended dose (depending on age of child) taken in 2 divided doses, 7 days per week.

■    The usual recommended dose (depending on age of child) taken in 2 divided doses, 3 times per week on alternate days.

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