CO-TRIMOXAZOLE TABLETS BP (400/80)

Active substance: TRIMETHOPRIM

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Co-trimoxazole
Tablets BP (400/80)

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.

Sulfamethoxazole, Trimethoprim

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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

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

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.

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.

5. How to store

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

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

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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