Co-Trimoxazole Tablets Bp (400/80)
ESSENTIAL GENERICS
F1239 79/L/e/8
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 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
Co-trimoxazole tablets contain sulfamethoxazole and trimethoprim. These are antibiotics.
Together they work by stopping the growth of bacteria which cause infections such as:
• pneumonia, bronchitis, chest infections • urinary tract infections
• ear infections • skin infections
• brain infections
Do NOT take Co-trimoxazole tablets if you:
• are allergic to sulfamethoxazole, trimethoprim, or any other sulphonamide, or to any of the other ingredients (see Section 6)
• have liver disease
• have a blood disorder
• have 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:
• have lung problems (e.g. asthma)
• have severe allergies (e.g. hayfever)
• are over 65 years of age, as the elderly may get more side effects
• have a folic acid deficiency
• could be suffering from malnutrition (e.g. due to dieting or bowel problems)
• have glucose-6-phosphate dehydrogenase (G6PD) deficiency
• suffer from phenylketonuria (an enzyme deficiency) and are not on a special diet
• have porphyria (a metabolism disorder which causes abdominal pains and mental disorder)
• have HIV (Human Immunodeficiency Virus)
• have a bacterial throat infection called streptococcal pharyngitis
• have ever had high blood potassium levels
• are 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:
• diuretics (water tablets)
• digoxin, used to treat heart conditions
• medicines likely to increase the amount of potassium in your blood (e.g. ACE-inhibitors)
• medicines for diabetes
• medicines that thin the blood e.g. warfarin
• methotrexate, a medicine used to treat arthritis or cancer
• ciclosporin, a medicine used to suppress the immune system
• phenytoin, a medicine used in the treatment of epilepsy
• HIV medicines, such as zidovudine and lamivudine
• procainamide, a medicine used to treat certain heart conditions
• amantadine, a medicine used to treat the flu and also Parkinson's Disease
• pyrimethamine, 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.
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.
• Swallow 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:
• two tablets once a day on each day of the week; or
• two tablets three times a week taken on alternate days; or
• two tablets twice daily three times a week taken on alternate days. Children 6 to 12 years:
• one tablet twice daily on each day of the week; or
• one tablet twice daily three times a week on alternate days; or
• one tablet twice daily three times a week on consecutive days; or
• two 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
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.
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:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps
• blistering 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:
• sudden headache, stiff neck, fever, sensitivity to bright light, drowsiness and muscle pain, with or without a rash
• pinpoint red spots on the skin, unusual purple bruise-like rash on the skin or in the mouth, unusual or heavy bleeding
• fever, sore throat, mouth ulcers, repeated infections or infections that will not go away
• cough, feeling breathless, chest pain
• swollen legs or joints, feeling tired
• pain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever
• severe stomach cramps, watery and severe diarrhoea which may be bloody
• yellowing of the skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness
• seizures (fits).
Tell your doctor if you get any of the following side effects:
Very common side effects (in more than 1 in 10 people):
• increased 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):
• headache
• nausea
• diarrhoea
• skin rashes
• oral thrush (white, furry sore tongue and mouth)
• vaginal thrush (sore, itchy vagina with vaginal discharge)
• thrush affecting the penis.
Uncommon side effects (in less than 1 in 100 people):
• vomiting.
Very rare side effects (in less than 1 in 10 000 people):
• reactions to the sun. Skin may become red, painful and swollen - do not sunbathe, use a sun-bed or expose your skin to UV light
• allergic-like reaction (skin rash, hives, fever and joint pain) which may happen after you stop taking Co-trimoxazole
• fever
• depression or hallucinations
• tingling or numbness in the hands and feet
• feeling unsteady or dizzy, head-spins, lack of co-ordination
• ringing in the ears
• inflamed and sore tongue, sore mouth, difficulty chewing and eating
• butterfly-shaped rash over the nose and cheeks, made worse by exposure to the sun. Tiredness and joint pains
• low sugar level (feeling hungry, nervous, sweating, trembling)
• low sodium level (headache, nausea, vomiting, lethargy, muscle cramps). Blood may be tested for this
• lack of appetite, weight loss
• muscle weakness or pain
• joint pain
• kidney changes. Blood and urine may be tested for this.
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: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
• Keep out of the reach and sight of children.
• Do 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.
• Store in a dry place, away from heat and light.
• Do 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.
What Co-trimoxazole Tablets contain
• The active ingredients are sulfamethoxazole (400 mg) and trimethoprim (80 mg).
• The 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 06/2015.
F1239 79/L/e/8 ESSENTIAL GENERICS