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nogen PharmaI

PACKAGE LEAFLET: INFORMATION FORTHE USER

TRIMOGAL® TABLETS 100MG and 200MG

| (trimethoprim)

fcead all ofthis leaflet carefully before you start taking this medicine because it contains important information for you.

|* Keep this leaflet. You may need to read it again.

|* If you have any further questions, ask your doctor, or pharmacist or nurse.

|* This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same l as yours.

I If you get any side effects, talk to your doctor, i pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section

^hat is in this leaflet:

1. What Trimogal Tablets are and what they are used for

. What you need to know before you take Trimogal Tablets ,3. How to take Trimogal Tablets 4. Possible side effects |5. Howtostore Trimogal Tablets 6. Contents of the pack and other information

1. WHAT TRIMOGAL TABLETS ARE AND WHAT THEY ARE USED FOR

frrimogal Tablets contain the active ingredient trimethoprim. Trimethoprim is a type of antibacterial medicine which works by killing |bacteria.

|Trimogal is most commonly used for prevention and treatment of infections of the urinary tract and Respiratory tract (for example in the chest).

•    Digoxin, to treat certain heart conditions

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

•    Rifampicin, used to treat TB

•    Anticoagulants (to prevent clots from forming in the blood e.g. warfarin)

•    Phenytoin to treat epilepsy

•    Pyrimethamine and dapsone, used to treat malaria

•    Immunosuppressnat drugs - used in cancer treatment (e.g. methotrexate) or to treat organ rejection after transplant (e.g. azathioprine or ciclosporin).

Pregnancy and Breast-feeding:

This medicine should not be taken during pregnancy. Ask your doctor or pharmacist for advice ifyou are pregnant or planning on becoming pregnant or are breast-feeding long term.

Driving and using machines:

Taking this medicine should not affect your ability to drive or operate machinery, however, if you think you are affected you should not drive or operate machinery until you feel better.

Trimogal Tablets contain lactose:

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars you should speak to your doctor before taking this medicine.

3. HOW TO TAKE TRIMOGAL TABLETS

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIMOGAL TABLETS

.Do not take Trimogal Tablets if:

L You are pregnant or might be pregnant, or if you are breast-feeding long-term

•    You are allergic (hypersensitive) to trimethoprim or any of the other ingredients in this medicine (listed in section 6)

|* You have anaemia or other serious blood disorders

L You have severe liver or kidney problems.

Warnings and precautions:

Talk to your doctor, or pharmacist or nurse before taking Trimogal Tablets:

|. If you have folate deficiency anaemia (e.g. especially in the elderly)

|* Ifyou have, or might have had acute Porphyria (blood disorders)

I* If you suffer from kidney problems

•    If you are at greater risk of high levels of potassium in yourblood (hyperkalaemia), e.g.

I the elderly or those on higher doses L if you are also taking repaglinide (medicine for treating diabetes).

[Tour doctor may wish to do regular blood tests if you need long-term treatment or are prone to Anaemia.

Other medicines and Trimogal Tablets:

Tell your doctor or pharmacist ifyou are taking, nave recently taken or might take any other medicines. In particular:

•    Repaglinide, used to treat diabetes

|. Procainamide, to treat abnormal heart rhythm

Always take Trimogal Tablets exactly as your doctor has told you. Check with your doctor or pharmacist ifyou are not sure.

Swallow the tablets with a little water.

The normal daily dose of Trimogal for different conditions is shown below:

Urinary Tract Infections

Adults, the elderly and children over 12 years

Treatment:

200mg daily taken either as two 100mg tablets or

one 200mg tablet

Prevention of recurrent infection:

100mg once a day at bedtime

Children aged 4 months to 12 years*

Treatment:

6mg/kg body weight daily, subdivided into 2 equal doses (see * below)

Prevention:

2.5mg/kg body weight daily, given as a single dose at bedtime (see * below)

To treat Chest Infections Adults and Children over 12 years

200mg daily

Children aged 6 years to 12 years

100mg twice a day

Children aged 6 months to 6 years*

50mg twice a day (see * below)

*For children a lower strength tablet or a syrup may be more suitable, especially for smaller children.

Trimogal Tablets are not suitable for children under 4 months unless under close supervision from a doctor.

^our doctor may prescribe a different dose depending on yourcondition. You should always follow your doctor's instructions on taking your |medicine. Exactly how many tablets, and how often you must take them, will be written on the label. Please read the label carefully.

Ilfyou take more Trimogal Tablets than you should

Ilfyou accidently take one extra dose, this should pot be a problem. If you (or someone else) swallows a lot of tablets all together, or if you think p child has swallowed any of the tablets, contact your nearest hospital casualty department or doctor immediately.

Ilfyou forget to take Trimogal Tablets

Take the missed dose as soon as you remember. If your next dose is due at this time, double the usual dose to make up the missed dose. Take the remaining tablets at the correct times. If you are concerned about this, consult your doctor or pharmacist.

ifyou stop taking Trimogal Tablets

f/ou must continue to take the complete course of tablets that your doctor has prescribed for you. If ^ou stop taking the tablets before the course is finished your original symptoms may return.

I|f you have any further questions on the use of this product, ask your doctor or pharmacist.

Low blood sugar    .

Low levels of sodium in the blood    ¹

(may cause nausea, tiredness,    i

muscle cramping)

Anorexia    |

Depression, anxiety, sleeping difficulties

Confusion, hallucinations Elevation of serum transaminases (an I indication of liver damage)    _L

Elevation of bilirubin levels    1

Joint and muscle ache    ,

Wheezing, nosebleeds    '

Meningitis (signs may include stiff neck, fever i and vomiting)

Lupus erythematosus (an auto-immune disorder).

Your doctor might carry out some blood tests while you are taking this medicine to check the levels in your blood.

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.

5. HOW TO STORE TRIMOGAL TABLETS

4. POSSIBLE SIDE EFFECTS

|Like all medicines, Trimogal Tablets can cause side effects, although not everybody gets them.

|Contact your doctor at once if you get an allergic reaction such as swelling of the face, lips, tongue or throat, difficulty breathing, shock or collapse. Aseptic meningitis can occur in some patients. This may show as a combination of symptoms such as headache, fever, stiff neck, tiredness, feeling ill and your eyes become very sensitive to bright light.

^Severe skin reactions such as erythema |multiforme (circular, irregular red patches), Stevens-Johnson syndrome (severe skin rash with flushing, fever, blisters and ulcers), toxic epidermal pecrolysis (severe rash involving reddening, peeling and swelling of the skin that resembles severe burns), may also be signs ofan allergic reaction.

^Tell your doctor or pharmacist ifyou notice any |of the following side effects:

Common (occurs in more than 1in10 and less |than 1 in 100 people)

•    Feeling and being sick, diarrhoea L Headache

•    Skin rashes

l High levels of potassium in the blood (may i result in abnormal heart rhythm)

•    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 (occurs in less than 1 in 10,000 people) l Constipation, severe watery/bloody diarrhoea

•    Sore tongue and mouth

•    Cough

|* Agitation

•    Abnormal behaviour

|* Jaundice (yellowing of the skin or whites of the eyes)

I* Kidney problems (signs may include painful urination or blood in the urine)

L Dizziness, tiredness

•    Convulsions

l Involuntary movements » Pins and needles, shakiness

•    Ringing in the ears, vertigo |* Eye redness and pain

•    Increased sensitivity of the skin to the sun

Keep out of the sight and reach of children.

Do not use Trimogal Tablets after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month. If you have any medicines which are out of date, return them to your pharmacist for disposal.

These tablets should be stored below 25°C. Keep them in the packaging they came in. Do not transfer them to another container.

Do not use Trimogal Tablets if you notice any visible signs ofdeterioration, such as chipped or broken tablets. Take them to your pharmacist for advice.

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

6. CONTENTS OF THE PACK AND OTHER , INFORMATION

k_J

What Trimogal Tablets contain:

Trimogal Tablets 100mg contain 100mg ofthe active ingredient, trimethoprim BP.

Trimogal Tablets 200mg contain 200mg of the active ingredient, trimethoprim BP.

The other ingredients are lactose, povidone, microcrystalline cellulose, sodium starch glycollate and magnesium stearate.

What Trimogal Tablets looks like and the contents of the pack:

Trimogal Tablets 100mg are white, round, flat bevelled edge tablets with breakline, coded 'LAGAP' above and 'TMP' below.

Trimogal Tablets 200mg are white, round, biconvex, scored tablet.

Trimogal Tablets are available in securitainer packs of 100 tablets.

Marketing Authorisation Holderand Manufacturer

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

This leaflet was last revised in April 2015