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Patient Information Leaflet 3280/2/AC

Actavis

Trimethoprim 50mg/5ml Oral Suspension

This leaflet contains important information about Actavis Trimethoprim Oral Suspension (now called Trimethoprim Oral Suspension throughout the leaflet). 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 further questions, please ask your doctor or your 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 get serious, or if you have any side effects not listed in this leaflet,

please tell your doctor or pharmacist._

In this leaflet

1.    What is Trimethoprim Oral Suspension and what it is used for

2.    Before taking Trimethoprim Oral Suspension

3.    How to take Trimethoprim Oral Suspension

4.    Possible side effects

5.    Storing Trimethoprim Oral Suspension

6.    Further information

1. What is Trimethoprim Oral

Suspension and what it is used for

Trimethoprim belongs to a group of medicines called antibiotics. These are used to help fight infections caused by bacteria and other sensitive organisms.

It can be used for a wide range of infections including urinary and chest infections. This medicine is also sometimes prescribed for people who suffer from urinary infections a lot, to stop an infection in the first place.

2. Before taking Trimethoprim Oral Suspension

□ Do not use this medicine if you.....

•    have ever had a bad reaction to trimethoprim or any of the ingredients listed in section 6 (Further Information).

•    have a blood disorder or anaemia.

•    think you may be pregnant, or are planning to become pregnant.

•    have liver or kidney problems.

,Ajake special care with Trimethoprim Oral

Suspension:

•    If you have been told your liver or kidneys are not working properly.

•    If you have been told you have low levels of folic acid in your blood.

•    If you are at greater risk of high levels of potassium (hyperkalaemia), e.g. the elderly or those on higher doses.

•    If you suffer from porphyria (a disorder that causes skin sensitivity to light, pain attacks and muscle weakness).

You should let your doctor know and ask his/ her advice if you suffer from or have ever had any of the above.

^^Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including herbal medicines and those that you may have bought yourself.

Trimethoprim can affect some of the medicines you may be taking. The following drugs can cause some problems when taken together with Trimethoprim:

•    Medicines to treat cancer, which can depress bone marrow production such as methotrexate and mercaptopurine

•    Medicines for epilepsy such as phenytoin

•    Medicines for the heart such as digoxin and procainamide

•    Medicine to thin the blood such as warfarin and other coumarins

•    Repaglinide (antidiabetic)

•    Rifampicin and dapsone (for treating infections)

•    Pyrimethamine (for treating malaria)

•    Diuretics (e.g. water tablets such as frusemide or eplerenone)

•    Medicines for organ transplant or psoriasis such as cyclosporin and azathioprine

A Pregnancy and Breast-feeding

•    Trimethoprim may be harmful to the unborn baby. If you are pregnant, think you may be pregnant or are trying for a baby you should tell your doctor or pharmacist before you take this medicine.

•    Trimethoprim is present in the breast milk. If you are breast feeding you should tell your doctor or pharmacist before you take this medicine.

A. Driving and using machines

•    Your medicine is unlikely to affect your ability to drive or to operate machinery.

Qlmportant information about some of the

ingredients of Trimethoprim Oral Suspension

•    Maltitol liquid: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

•    Sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217): May cause allergic reactions (possibly delayed).

3. How to take Trimethoprim Oral Suspension

Trimethoprim Oral Suspension should be swallowed. Shake the bottle well before measuring the dose.

Follow your doctor's instructions about when and how to take your medicine. Also read the label. Your pharmacist can also help if you are not sure.

Your doctor will have decided what dose you should take each day depending on your condition. The usual dosages are:

DOSAGE
Under 6 weeks:	Not recommended
6 weeks - 5 months:	2.5ml every 12 hours
6 months - 5 years:	5m 1 every 12 hours
6 years -12 years:	10ml every 12 hours
Adults:	20ml every 12 hours

Severe or sudden infections:

Your doctor will decide how long you should continue to take this medicine. This will depend on the type and severity of infection. Your doctor may also double your first dose.

For elderly people with a kidney complaint, the doctor will decide the dose.

Treatment is usually for one to two weeks.

Make sure you finish all the doses prescribed for you. If you do not finish the treatment, the infection may come back or get worse.

Long-term treatment and prevention therapy:

DOSAGE
6 months - 5 years:	2.5 ml at night
6 years -12 years:	5 ml at night
Adults:	10 ml at night

Treatment should continue for as long as your doctor feels it is needed.

Dialysis patients:

Trimethoprim is removed by dialysis. Blood tests will be necessary to check your blood levels before and after dialysis.

A If you have been taking Trimethoprim Oral Suspension for long term treatment

If you have been taking trimethoprim for a long time and get the following signs you must speak to your doctor immediately:

•    high temperature (fever)

•    sore throat

•    rash

•    sore mouth (mouth ulcers)

•    red or purple spots (purpura)

•    bruising or bleeding

These effects happen because of problems with your blood and you must see a doctor immediately.

A If you forget to take Trimethoprim Oral Suspension

If you forget to take your medicine, take your dose as soon as you remember, unless it is nearly time for your next dose. Then take your next dose at the usual time. Don't take two doses at the same time. If you are worried, ask your doctor or pharmacist for advice.

If you have kidney problems

If you suffer from kidney problems and forget to take a dose, ask your doctor or pharmacist for advice.

please turn over.

Ajf you take more Trimethoprim Oral Suspension than you should

If you accidentally take an overdose of your medicine, either call your doctor straight away or go to your nearest hospital casualty department. Always take any remaining medicine, the container and the label with you, so that the medicine can be identified.

4. Possible side effects

Like all medicines, Trimethoprim Oral Suspension can have side effects.

A few people can be allergic to some medicines; if any of the following side effects occur soon after taking the oral suspension, STOP taking the medicine and tell your doctor immediately:

•    Difficulty breathing

•    Chest pain

•    Swelling of the eyelids, tongue, face or lips

•    Blistering/peeling of the skin

•    Skin eruptions/lesions

•    Lumpy skin rash (‘hives’) anywhere on the body

•    Unexplained high temperature (fever)

•    Feeling faint, especially on standing up.

Tell your doctor or pharmacist if you notice any of the following side effects:

Very Common (occurs in more than 1 in 10 people)

•    High levels of potassium in your blood, which can cause abnormal heart beats (palpitations).

Common (may affect up to 1 in 10 people)

•    feeling and being sick

•    diarrhoea

•    headache

•    skin rashes

•    anaemia (may cause you to feel tired and look pale)

•    sore throats or mouth ulcers (due to a decrease in white blood cells)

•    thrush

Very rare (may affect up to 1 in 10,000 people)

•    constipation

•    severe watery/bloody diarrhoea

•    liver problems which may cause jaundice (yellowing of the skin or whites of the eyes)

•    kidney problems (signs may include painful urination or blood in the urine)

•    dizziness

•    tiredness

•    loss of consciousness

•    convulsions

•    involuntary movements

•    pins and needles

•    shakiness

•    ringing in the ears

•    vertigo

•    uveitis (signs may include blurred vision, eye redness and pain)

•    increased sensitivity of the skin to the sun

•    low blood sugar

•    low levels of sodium in the blood (may cause nausea, tiredness, muscle cramping)

•    anorexia

•    depression

•    anxiety

•    sleeping difficulties

•    confusion

•    hallucinations

•    agitation

•    abnormal behaviour

•    nightmares

•joint and muscle ache

•    wheezing

•    cough

•    shortness of breath

•    nosebleeds

•    elevation of serum transaminases (an indication of liver damage)

•    elevation of bilirubin levels

•    severe skin reactions (signs may include blistering)

•    Stevens-Johnson Syndrome

•    pancreatitis (signs may include a sudden, severe upper abdominal pain)

•    meningitis (signs may include stiff neck, fever and vomiting)

•    lupus erythematosus (an auto-immune disorder)

•    decrease in blood cells, which can make the skin pale or yellow, cause fever, sore throat, mild mouth ulcers, flu-like symptoms, exhaustion or weakness, easy bruising, or bleeding from the skin or nose.

Not known (frequency cannot be estimated from the available data)

•    sore tongue and mouth

•    itching

Do not be alarmed by this list of possible events. You may not have any of them.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

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.

5. Storing Trimethoprim Oral Suspension

•    Keep out of the sight and reach of children.

•    Do not store above 25°C. Store in the outer carton.

•    Do not use Trimethoprim Oral Suspension after the expiry date which is stated on the bottle after Exp:. The expiry date refers to the last day of that month.

•    Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

•    Always keep the medicine in the bottle in which it was originally given to you.

You may wish to read the leaflet again. Do not

throw it away until you have finished your

medicine.

6. Further information

Trimethoprim Oral Suspension is a white suspension with a smell of Aniseed.

Each 5ml of Trimethoprim Oral Suspension contains 50mg Trimethoprim.

It also contains Xanthan gum(E415), maltitol liquid (E965), polysorbate 80, microcrystalline cellulose (E460), sodium carboxymethylcellulose(E466), saccharin sodium(E954), citric acid monohydrate, sodium methyl parahydroxybenzoate(E219), sodium propyl parahydroxybenzoate(E217), aniseed flavour and purified water.