CO-TRIMOXAZOLE FORTE 160MG/800MG TABLETS

Active substance: TRIMETHOPRIM

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PATIENT INFORMATION LEAFLET

Co-trimoxazole 80/400mg Tablets
Co-trimoxazole Forte 160/800mg Tablets

(trimethoprim and sulphamethoxazole)
Please read this entire leaflet carefully before you start taking these tablets.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1
2
3

1

What this medicine is and what it is used for
Before you take
How to take

4
5
6

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)

What this medicine is and what it is
used for

Co−trimoxazole Tablets belong to a group of medicines
called antibacterials. The medicine contains two active
ingredients trimethoprim and sulphamethoxazole 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)
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 (acute otitis media)
a rare infection of the lungs, brain, or skin (nocardosis)

2

Before you take

Do not take Co−trimoxazole if:
you are allergic (hypersensitive) to sulphonamide,
trimethoprim, Co−trimoxazole or any of the other
ingredients (see section 6: Further information)
you have severe liver failure, liver damage or jaundice
you have severe kidney problems
you have a serious problem with your blood or porphyria
(a genetic disease)
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). In this case, babies
should be at least 4 weeks old
you are pregnant (see section 2 ’Pregnancy and
breast−feeding’)

If you are elderly and taking the following:
Diuretics (water tablets), which help increase the
amount of urine produced. In particular, thiazides, such
as bendroflumethiazide
Pregnancy and breast−feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
Co−trimoxazole should not be used during pregnancy.
If you are breast−feeding, ask your doctor for advice before
taking this medicine.
Driving or operating machinery
Co−trimoxazole may make you feel dizzy, sleepy, see or
hear things that are not real (hallucinations), have ringing
in your ears or difficulty sleeping. If affected, you should
not drive or operate machinery.
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.

3

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.
In particular, tell your doctor or pharmacist if you are taking
the following:
Warfarin or acencoumarol, used to prevent the blood
from clotting (anticoagulant)
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 cancer or for your immune system
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

Hard to Read?

How to take

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 for oral administration
The tablets should be swallowed with a little water and
with some food

If any of the above apply to you, talk to your doctor or
pharmacist before taking this medicine.
Take special care with Co−trimoxazole
Before you take this medicine, tell your doctor if:
you have a history of allergies or asthma
you have kidney problems
you do not have enough folic acid (vitamin) in your
body − which can make your skin pale and make you
feel tired, weak and breathless. This is known as anaemia
you are known to have a reduced amount of the
enzyme glucose 6 phosphate dehydrogenase (G6PD).
It is a hereditary condition which causes the red blood
cells to break down. It can cause fever and anaemia
(see bullet above) and can be triggered by infections,
certain foods (such as fava beans) and medicines
you have a problem with your metabolism called
phenylketonuria and you are not on a special diet to
help your condition
you are elderly. Especially if you have kidney or liver
problems
you have a bacterial infection known as Group A beta−
haemolytic streptococci
you are known to be at risk of having hyperkalaemia,
which can cause abnormal heart rhythm due to high
levels of blood potassium
you have malnutrition

Possible side effects
How to store
Further information

Usual dose
Adults and children over 12 years
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.
Co−trimoxazole Forte 160/800mg Tablets: The usual dose
is 1 tablet twice a day.
For severe infections the dose may be increased to 1½
tablets twice a day.
Children 6 − 12 years
Co−trimoxazole 80/400mg Tablets: The usual dose is 1
tablet twice a day.
Co−trimoxazole Forte 160/800mg Tablets is not
recommended for children under 12 years.
Children 6 weeks − 5 years
(another form of this medicine may be used)
6 weeks − 5 months: 120mg twice daily
6 months − 5 years: 240mg twice daily
Premature babies or babies under 6 weeks
Co−trimoxazole should not be given to premature babies
or infants under six weeks, except for the treatment of
Pneumocytosis carinii (Pneumocytosis jiroveci). In this
case, babies should be at least 4 weeks old.
Special dose
The dose of Co−trimoxazole and how long you need to
take it depends on the infection you have and how bad it
is. Your doctor may prescribe a different dose and the
length of treatment may vary for the following:
Long term prevention of urinary tract (water) infections
Treatment of long term inflammation of the prostate
Treatment and prevention of lung infections caused by
Pneumocytosis carinii (Pneumocytosis jiroveci)
Treatment of gonorrhoea (sexually transmitted disease)
Treatment of acute brucellosis (bacterial infection which
can be passed to humans either by contact with infected
farm animals or by drinking non−pasteurised
contaminated milk)
Treatment of nocardiosis
Treatment or prevention of toxoplasmosis
Treatment of patients carrying typhoid and paratyphoid
Patients with kidney problems
If you have kidney problems you may be given a lower
dose. Your doctor may also take blood to test whether the
medicine is working properly.

Phone

continued....

0800 970 6115

for help
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Elderly
If you are elderly, it is particularly important to take this
medicine exactly as directed by the doctor, especially if you
have kidney or liver problems and/or are taking other
medicines.
Taking Co−trimoxazole for a long time
If you take Co−trimoxazole for a long time your doctor may
take blood to test whether the medicine is working properly.
You may be prescribed folic acid (vitamin) to take at the
same time.
If you take more Co−trimoxazole that you should
If you (or someone else) take more Co−trimoxazole than
you should, talk to your doctor or go to your nearest
hospital immediately. Take this leaflet and any remaining
tablets with you.
Symptoms of an overdose may include feeling or being
sick, stomach pain, dizziness, confusion, rashes,
headache, difficulty in controlling movements, sleepiness,
painful or difficult urination, swelling of the face and
weakness.
If you forget to take Co−trimoxazole
If you forget to take a dose, take it as soon as you
remember, unless it is nearly time to take the next one. Do
not take a double dose to make up for a forgotten dose.
Take the remaining doses at the correct time.
If you stop taking Co−trimoxazole
You should finish all the tablets your doctor has prescribed.
It can be dangerous to stop taking the medicine without
your doctor’s advice.

4

Possible side effects

Co−trimoxazole, like most other medicines, may cause side
effects in some patients, although not everyone gets them.
Serious side effects
Stop taking the tablets and contact your doctor
immediately if you have the following side effects:
Skin reactions
Blistering of the skin, mouth, eyes and genitals
Scaling of the skin

Blood disorder reactions
Increased risk of bleeding or bruising, due to a reduction
in blood platelets
Skin rash resulting from bleeding into the skin from
small blood vessels
Mouth ulcers, inflammation of the mucous lining of the
mouth or lung problems, due to a reduction in white
blood cells
Increased risk of infections, due to a reduction in the
number of white blood cells
High dosage reactions for treatment of Pneumocytosis
carinii (Pneumocytosis jiroveci)
Abnormal heart rhythm, due to high levels of blood
potassium
Tiredness and confusion, muscle twitching, fits and
coma, due to low blood levels of sodium
Bone marrow depression requiring folate supplements
Increased risk of infections, due to a reduction in the
number of white blood cells
Increased risk of bleeding or bruising, due to a reduction
in blood platelets
Raised liver enzymes (detected through blood tests)
Below are other possible side effects
Less common
Pale yellow skin, weakness, bruising, breathlessness,
tiredness, headache, dizziness, sore mouth and tongue
or increased risk of infections, due to a reduction in
blood cells (anaemia)
Rare
Abdominal pain or cramps, diarrhoea (sometimes
watery and bloody) or fever, due to inflammation of the
colon
Yellow skin and whites of the eyes, dark urine, light and
foul smelling stools, due to abnormal bile flow
Inflammation of the mucous lining of the mouth
Loss of appetite
Severe pain in the abdomen and back, due to
inflammation of the pancreas
Passing of more urine at night, tiredness, feeling or
being sick or itching, due to inflammation of the kidney
Crystals in the urine (detected through a urine test),
which can be avoided by adequate fluid intake
Very rare
Liver failure
Increased level of liver enzymes and bilirubin (detected
by blood test)
Bone marrow depression, especially in the elderly

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Rev #
Last updated
No. of Colours

If any of the side effects become serious or you notice
any not listed, please tell your doctor or pharmacist.

5

How to store

Keep out of reach and sight of children.

Allergic reactions
Fever
Skin rash
Difficulty in breathing or dizziness
Swelling of the face or throat
Joint pain
Cough
Irregular or rapid heart beat, shortness of breath,
swollen legs or heart failure, due to inflammation of the
heart
Fever, tiredness, weakness, loss of appetite, weight
loss, muscle/joint pain, skin rashes or high blood
pressure, due to swollen and damaged arteries

Hard to Read?

Other reported side effects
Feeling sick
Being sick
Diarrhoea
Inflammation of the tongue
Increased sensitivity of the skin to sunlight
Skin rashes
Sore mouth
Yellowing of the skin or whites of the eyes caused by
liver or blood problems (jaundice)
Inflammation of the lining of the brain (aseptic
meningitis) which may cause headache, fever, stiff
neck, tiredness, feeling ill and sensitivity of the eyes to
bright light
Fits
Weakness, tingling or numbness, due to nerve disorder
Difficulty in controlling movements
A feeling of dizziness or "spinning"
Ringing in the ears
Headache
Depression
Dizziness
Seeing or hearing things that are not real (hallucinations)
Joint or muscle pain
An infection called thrush or candidiasis which can
affect your mouth or vagina. It is caused by a fungus
Kidney problems
Joint inflammation and stomach pain (Henoch−
Schonlein purpura)
Increase in a certain type of white blood cell
(eosinophilia − diagnosed through blood test)
Feeling sleepy or tired
Difficulty sleeping
Changes in the level of body chemicals
Increased production of metabolic acids, which may
cause rapid breathing or confusion

Do not take after the expiry date, printed on the label after
EXP. The expiry date refers to the last day of that month.
These tablets should be stored in a dry place below 25°C,
protected from heat, light and moisture. Store in the
original container.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
protect the environment.

6

What Co−trimoxazole Tablets contain
Active ingredient:
Co−trimoxazole 80/400mg Tablets contain 80mg of
trimethoprim and 400mg of sulphamethoxazole
Co−trimoxazole Forte 160/800mg Tablets contain
160mg of trimethoprim and 800mg of
sulphamethoxazole
Other ingredients:
microcrystalline cellulose, Sta−RX 1500 (pregelatinised
maize starch), maize starch, nipastat, magnesium
stearate, primojel (sodium starch glycollate), purified
water.
Co−trimoxazole 80/400mg Tablets also contain
hydrogenated castor oil.
Co−trimoxazole Forte 160/800mg Tablets also contain
hydrogenated vegetable oil.
What Co−trimoxazole Tablets look like and the
contents of the pack
Co−trimoxazole 80/400mg Tablets are white, round, flat
bevel edged tablets marked "COT 480" on one side and a
cross breakline on the other.
Co−trimoxazole Forte 160/800mg Tablets are white oblong
shaped tablets marked "COT 960"on one side and a
breakline on the other.
Co−trimoxazole 80/400mg Tablets are available in packs of
4, 8, 12, 16, 20, 28, 50, 100, 250, 500 or 1000 tablets
Co−trimoxazole Forte 160/800mg Tablets are available in
packs of 2, 4, 6, 8, 10, 14, 100, 250, 500 and 1000 tablets
Not all sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon
St. Neots
Cambridgeshire PE19 8ET
United Kingdom
Product Licence Numbers
PL 11311/0352 (80/400mg)
PL 11311/0354 (160/800mg)
Date of last revision: January 2013

Phone

Co−trimoxazole tablets
80/400mg & 160/800mg Tabs
PIL
175 x 400 mm
Font SansSerif − Min. Text 8pt
Till−Ver.7.1s
08/01/2013
Pantone Black CVC

Further Information

0800 970 6115

for help
Till−Ver.7.1s

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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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