Co-Trimoxazole Tablets Bp 80/400mg
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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.
Index
T| What Co-trimoxazole tablets are and what they are used for
Before you take How to take Possible side effects T| How to store
Further information
T| What Co-trimoxazole tablets are and what they are used for
Co-trimoxazole is a type of antibacterial medicine, which works by killing bacteria. Co-trimoxazole tablets are used to treat:
• or prevent lung infections caused by Pneumocystis jiroveci (Pcarinii)
• or prevent toxoplasmosis (passed through undercooked meat or cat faeces)
• nocardiosis (bacterial infection causing abscesses)
• urinary tract infections (e.g. cystitis) or worsening of long-term bronchitis
• ear infections ( actute otitis media).
Before you take
Do not take Co-trimoxazole tablets and tell your doctor if you:
• are allergic (hypersensitive) to trimethoprim, sulphonamides or any of the other ingredients (see section 6)
• have sever liver damage or jaundice
• have any blood disorder or porphyria (a genetic disease)
• have severe kidney disease
• are pregnant or planning to become pregnant
• Co-trimoxazole should not be given to newborn babies under 6 weeks old except for Pneumocystis jiroveci (Pcarinii) infection.
Check with your doctor or pharmacist
before taking Co-trimoxazole tablets if you:
• have a history of severe allergic reactions or bronchial asthma
• have a reduced amount of the enzyme glucose 6 phosphate dehydrogenase (G6PD). You may react badly when you eat certain types of foods such as fava beans
• have a protein disorder called phenylketonuria
• have Group A beta-haemolytic streptococcia (a bacterial infection)
• have malnutrition
• are elderly (as you may suffer with more side effects).
Skin reactions - if you develop a rash or any of the following symptoms, seek immediate advice from a doctor and tell them that you are taking this medicine:
• potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Co-trimoxazole, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
• additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
• these potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.
• the highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
• if you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Co-trimoxazole, you must not be re-started on Co-trimoxazole at any time.
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. Especially:
• ACE inhibitors (to treat high blood pressure e.g. captopril, lisinopril)
• amantidine (to treat parkinsonism or some viral infections)
• anaesthetics such as prilocaine
• antiarrhythmics such as procainamide, amiodorone, dofetilide (to treat some heart conditions)
• antibiotics such as rifampicin, dapsone, methenamine
• anticoagulants to prevent your blood clotting such as warfarin
• antivirals such as lamivudine, zidovudine, zalcitabine
• ciclosporin (to prevent rejection after transplantation)
• clozapine (to treat mental health problems)
• cytotoxic drugs such as methotrexate, azathioprine, mercaptopurine (to treat some cancers, severe psoriasis or severe rheumatoid arthritis)
• digoxin (to treat heart conditions)
• diuretics ('water tablets') such as bendroflumethiazide
• phenytoin (to treat epilepsy)
• pyrimethamine (to treat malaria)
• potassium aminobenzoate (to treat scleroderma, Peyronie's disease)
• sulphonylureas (to treat diabetes)
Pregnancy and breast-feeding
Co-trimoxazole should not be used in pregnancy. If you are breast-feeding, ask your doctor for advice before taking this medicine.
Driving and using machines
Co-trimoxazole tablets may make you feel drowsy or dizzy or cause hallucinations, ringing in the ears or sleeplessness. Make sure you are not affected before you drive or operate machinery.
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AAAG9469 50809414
Blood tests
If you see another doctor or go into hospital, let them know you are taking Co-trimoxazole, as it can affect the results of some blood tests. If you are having treatment over a long time, your doctor may carry out regular blood counts.
How to take
Always take Co-trimoxazole tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Swallow the tablets preferably with food or a drink at
the same times each day.
Doses:
• Usual doses:
Adults and children 12 years and over: two tablets twice a day
Children 6-11 years: one tablet twice a day Children under 6 years: another form of this medicine may be more suitable.
Elderly: take the tablets exactly as prescribed.
• Treatment of Pneumocystis jiroveci (P.carinii): the dose will depend upon your weight, the usual dose is 20mg trimethoprim and 100mg sulfamethoxole per kg body weight each day in several small doses.
• Prevention of Pneumocystis jiroveci (P.carinii) or treatment and prevention of Toxoplasmosis: your doctor may choose one of the following:
1. Two tablets a day for 7 days
2. Two tablets a day three times a week on alternate days
3. Two tablets twice a day three times a week on alternate days
• Treatment of Nocardiosis: six to eight tablets a day for up to 3 months.
If you take more than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include dizziness, feeling or being sick, rash, headache, unsteady movements, drowsiness, difficulty urinating, swelling of the face, weakness and confusion.
If you forget to take the tablets
If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop taking the tablets
Do not stop taking Co-trimoxazole tablets because you feel better. Take the tablets for as long as your doctor has told you or your problem may come back.
"4 Possible side effects
Like all medicines, Co-trimoxazole tablets can cause side-effects, although not everbody gets them.
Stop taking the tablets and contact a doctor at once
if you get a skin rash, or severe allergic reaction such as swelling of the face, lips, tongue or throat, difficulty breathing, fever, inflamed heart or blood vessels (chest pain, fever, a fast heartbeat, tiredness), systemic lupus erythematosus (SLE-skin rash, hair loss, difficulty breathing and joint pains), Stevens-Johnson syndrome (severe skin rash with flushing, fever, blisters or ulcers) or toxic epidermal necrolysis (severe rash involving reddening, peeling and swelling of the skin that ressembles severe burns).
Aseptic meningitis can occur in some patients as a combination of symptoms such as headache, fever, stiff neck, tiredness, feeling ill and sensitivity of eyes to bright light.
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Tell your doctor if you notice any of the following side-effects or notice any other effects not listed:
Blood: altered number and type of certain blood cells. If you get increased bruising, nose bleeds, sore throats or infections, consult your doctor.
Nervous system: headaches, depression, dizziness, hallucinations, fits, lack of co-ordination, numbness of fingers or toes, drowsiness, fatigue, sleeplessness. Stomach: feeling or being sick, diarrhoea, loss of appetite, pseudomembranous colitis (causing severe and painful diarrhoea).
Liver: jaundice (yellowing of the skin or whites of the eyes), changes in liver function, liver damage (fatigue, weakness, loss of appetite, weight loss, abdominal pain, fever) or inflammation of the pancreas (pancreatitis -abdominal pain just below the ribs, being sick, fever and generally feeling unwell).
Other: sore throat or mouth, cough, inflamed skin, sensitivity to light, disorder with blood spots, bruising and discolouration to the skin, joint inflammation and stomach pain (Henoch-Schonlein purpura), 'spinning' sensation, ringing in the ears, muscle or joint pain, fungal infections, kidney problems and crystals in the urine (this can be avoided by drinking plenty of water), changes in levels of body chemicals especially sodium and potassium.
The following side effects are more common in patients with AIDS being treated for Pneumocystis jiroveci (P.carinii): rashes, fever, decrease in the number of some blood cells, changes in levels of liver enzymes, high levels of potassium in the blood and low levels of sodium in the blood.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at:
By reporting side effects you can help provide more
information on the safety of this medicine.
How to store
Keep out of the reach and sight of children.
Store below 25°C in a dry place and protect
from light.
Do not use Co-trimoxazole tablets after the expiry date stated on the label/carton/bottle.
The expiry date refers to the last day of that month.
Ask your pharmacist how to dispose of medicines no longer required.
"6 Further information
What Co-trimoxazole tablets contain
• The active substances (the ingredients that make the tablets work) are 80mg of trimethoprim and 400mg of sulfamethoxazole.
• The other ingredients are docusate sodium, magnesium stearate, maize starch, silica, sodium lauryl sulphate and stearic acid.
What Co-trimoxazole tablets look like and contents of the pack
Co-trimoxazole tablets are white, circular, biconvex uncoated tablets. Pack sizes are 28 tablets.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in May 2014
Actavis, Barnstaple, EX32 8NS, UK AAAG9469 50809414