TRISUL

Cotrimoxazole (trimethoprim/sulphamethoxazole)

480mg Tablets and 240mg/5mL Suspension

What is in this leaflet

This leaflet answers some common questions about TRISUL. It does not contain
all the information available on this medicine. It does not take the place of
talking to your doctor or pharmacist. All medicines have risks and benefits.
Your doctor has weighed the risks of using TRISUL against the benefits expected
it will have for you. If you have any concerns about using this medicine, ask
your doctor or pharmacist.

Keep this leaflet. You may want to read it again.

What TRISUL is used for and how it works

TRISUL contains two active ingredients, trimethoprim and sulphamethoxazole.
They belong to a group of medicines known as antibiotics and work by stopping
the growth of bacteria that is causing your infection.

TRISUL is used to treat infections of the urinary tract, upper and lower
respiratory tract and bowel.

Your doctor may, however, prescribe TRISUL for another reason. Ask your
doctor if you have any questions about why TRISUL has been prescribed for you.

There is no evidence that TRISUL is addictive.

TRISUL is available on prescription from your doctor.

Before you take TRISUL

When you must not take it

Do not take TRISUL if:

• You are allergic to trimethoprim, sulphamethoxazole (or any other
  sulphonamide - sulphur containing antibiotic) or any other ingredients listed
  at the end of this leaflet
• You have a low red blood cell count (anaemia)
• You have a low white blood cell count
• You have a low platelet count
• TRISUL should not be given to premature babies or to full term infants
  under 6 weeks of age.

Symptoms of an allergic reaction may include shortness of breath, wheezing or
difficulty breathing, swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the skin.

Before you take it

Tell your doctor:

• If you are allergic to diuretics (fluid tablets), medicines used to treat
  diabetes or medicines used to treat an overactive thyroid
• If you have any type of blood disorder (including porphyria and
  glucose-6-phosphate dehydrogenase deficiency)
• If you have liver or kidney problems
• If you suffer from epilepsy (fits)
• If you have allergic conditions or asthma
• If you have rheumatoid arthritis
• If you have malabsorption syndrome or suffer from malnutrition
• If you have a folate deficiency
• If you plan on becoming pregnant or are pregnant
• If you are currently breastfeeding or plan to breastfeed

Taking other medicines

If you are taking any other medicines, including any you get without a
prescription from a pharmacy, supermarket or health food shop, tell your doctor
or pharmacist.

Medicines that may interfere with TRISUL include:

• Sulphonylureas, medicines used to treat diabetes
• Diuretics (fluid tablets), mainly thiazide type diuretics
• Phenytoin, a medicine used to control epilepsy (fits or seizures)
• Rifampicin, an antibiotic
• Warfarin, a medicine used to treat blood clots
• Pyrimethamine, a medicine used to prevent malaria
• Cyclosporin, a medicine used to help prevent organ transplant rejection or
  to treat certain problems with the immune system
• Methotrexate, a medicine used to treat arthritis, psoriasis and some
  cancers
• Digoxin, a medicine used to treat heart failure or to control a fast
  irregular heart beat
• Procainamide, a medicine used to correct an irregular heart beat or to
  slow an overactive heart beat
• Amantadine, a medicine used to treat Parkinson's disease

These medicines may be affected by TRISUL or may affect how well TRISUL
works. You may need different amounts of your medicines or you may need to take
different medicines.

Your doctor or pharmacist has more information which medicines you need to be
careful with or avoid while you are taking TRISUL.

How to take TRISUL properly

How much to take

Your doctor will tell you how much TRISUL you need to take each day. It is
important that you take TRISUL as directed by your doctor. Do not take more than
the recommended dose.

Take TRISUL with some food or drink. This will lessen the chance of stomach
upset.

The usual dose for adults and children over 12 years is two TRISUL tablets
every 12 hours. For children under 12 years, the dose of TRISUL suspension will
depend on the child's age and weight.

Your doctor may tell you to take different doses to these. If so, follow
their instructions. The dose may vary due to the type of infection you have.

The elderly and people with kidney problems may need smaller doses.

Some people may need to take folate supplements while taking TRISUL. These
people may include the elderly, people with folate deficiency and people taking
certain medicines.

How long to take it

Your doctor will tell you how long they wish for you to continue TRISUL
treatment. Most infections need treatment for at least 5 days.

Some conditions may however, may require treatment to be longer than this for
a cure. Check with your doctor if you are unsure how long you should take TRISUL
for.

If you forget a dose

If you forget a dose, just take the next dose when it is due. Do not take
more than one dose at a time to make up for missed doses.

Taking your medicine at the same time each day may help you to remember to
take it regularly. If you have trouble remembering to take your medicine, ask
your pharmacist for some hints.

While you are taking TRISUL

Tell all doctors, dentists and pharmacists who are treating you that you are
taking TRISUL.

Tell your doctor or pharmacist that you are taking TRISUL before you start
any new medicine.

Tell your doctor if you develop a skin rash or hives, or you become pregnant
while taking TRISUL.

If you are going to have surgery, tell the surgeon or anaesthetist that you
are taking TRISUL.

If you are going to have any blood tests, tell your doctor that you are
taking TRISUL.

Do not take TRISUL to treat any other complaints unless your doctor tells you
to.

Do not stop taking TRISUL or lower the dose without first checking with your
doctor.

Do not give this medicine to anyone else, even if their symptoms seem similar
to yours.

Side effects

Tell your pharmacist or doctor as soon as possible if you do not feel well
while you are taking TRISUL.

All medicines can have some unwanted effects. Sometimes they are serious,
most of the time they are not. You may need medical treatment if you get some of
the side effects.

Tell your doctor or pharmacist if you notice any of the following and
they worry you:

• Feeling sick, vomiting, stomach upset
• Loss of appetite
• Oral thrush (white, furry sore tongue and mouth)
• Vaginal thrush (sore and itchy vagina, vaginal discharge)
• Skin rashes

Tell your doctor immediately if you experience:

• Watery and severe diarrhoea, which may also be bloody
• Severe stomach cramps
• Unusual tiredness or weakness and looking pale
• Bruising or bleeding more easily than normal
• Signs of frequent infections such as fever, chills, sore throat or mouth
  ulcers
• Yellowing of the eyes or skin (jaundice)
• Passing very little or no urine
• Painful, swollen joints
• Fits
• Symptoms of sunburn (such as redness, itching, swelling, blistering) which
  may occur more quickly than normal
• Severe and persistent headache
• Pins and needles in the hands and feet
• Cough, shortness of breath

These side effects are rare but serious. You may need urgent medical
attention.

The list of side effects mentioned above is not complete. If you should
suffer from any of these side effects or any other undesired effect please tell
your doctor or pharmacist.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

In case of overdose

You should only take the number of tablets or amount of suspension that you
have been told.

Immediately contact your doctor or the National Poisons Information Centre
(0800 POISON or 0800 764 766) or go to the Emergency department at your nearest
hospital, if you think that you may have taken too much, or if anyone else has
taken any TRISUL by mistake. Do this even if there are no signs of discomfort or
poisoning. You may need urgent medical attention. Take the container of
TRISUL with you if you can.

Keep telephone numbers for these places handy.

Storage conditions

Do not take this medicine after the expiry date shown on the label or if the
packaging shows signs of tampering.

Keep your TRISUL in the container until it is time to take them.

TRISUL tablets should be stored below 25°C and out of reach of children.
TRISUL suspension should be stored below 30°C and out of reach of children.
Protect from light and avoid exposure to heat and moisture.

Do not store TRISUL, or any other medicine, in the bathroom or near a sink.

Disposal

If your doctor tells you to stop taking TRISUL or if the tablets or
suspension have passed the expiry date, ask your pharmacist what to do with the
remaining medicine.

Product Description

What TRISUL looks like

TRISUL 480mg tablets are white, round tablets marked "CE 80/400" with a
bisect, on the same side.

TRISUL 240mg/5ml suspension is a pink liquid with an aniseed smell and
flavour.

Ingredients

TRISUL tablets and suspension contain the active ingredients trimethoprim and
sulphamethoxazole.

Each TRISUL tablet also contains docusate sodium, magnesium stearate,
povidone and sodium starch glycollate.

TRISUL suspension also contains sorbitol, polysorbate 80, carmellose sodium,
alcohol, glycerol, saccharin sodium, dispersible cellulose, purified water,
methyl hydroxybenzoate, propyl hydroxybenzoate, anise oil, licosoft, amaranth
and ponceau 4R.