a

- — — — — i

nogen PharmaI

PACKAGE LEAFLET: INFORMATION FORTHE USER

I Malix Tablets 2.5mg and 5mg

I [glibenclamide]

|Read all of this 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 as yours

•    If you get any side effects, talk toyour doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

ll. What Malix Tablets are and what they are used for

2.    What you need to know before you take Malix Tablets

3.    How to take Malix Tablets

4.    Possible side effects

b. How to store Malix Tablets

6. Contents of the pack and other information

1. WHATMALIXTABLETSAREANDWHAT THEY ARE USED FOR

Malix Tablets belong to a group of therapeutic medicines palled sulphonylureas which are used for lowering your blood sugar. Malix Tablets are used for treatment of patients with |Type II maturity onset and non-insulin dependent diabetes that ao not respond adequately to diet changes alone.

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

|Do not take Malix Tablets if you:

•    Are hypersensitive (allergic) to glibenclamide or any of the other ingredients of Malix Tablets (listed in section 6)

•    Have type 1/juvenile diabetes or your diabetes is not | stabilised

•    Have diabetes and have had ketosis or have experienced diabetic coma

•    Have thyroid problems

L    Have kidney problems or liver disease

•    Have functional problems with your adrenal glands

L Are pregnant, after delivery of your baby glibenclamide therapy may be started or resumed L Have a blood condition called porphyria

•    Are breastfeeding

l Are currently being treated with the medicine bosentan I* Have insulin dependant diabetes.

You should talk to your doctor before taking this medicine if you are going to have an operation, if you have a serious pccident or severe infection, which can affect your diabetes.

Warnings and precautions

Talk to your doctor or pharmacist before taking Malix Tablets if you:

•    Start to have symptoms ofjaundice such as yellowing of the eyes and skin. Your doctor may stop your medication

•    Are elderly, seriously ill or malnourished as taking this medicine may loweryour blood sugar too much.

Other medicines and Malix Tablets

Please inform yourdoctoror pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

In particular tell your doctor if you are taking a medicine called bosentan which is used to treat high blood pressure.

These medicines may increase the effect that glibenclamide has on lowering your blood sugar:

•    Anabolic steroids e.g nandrolone

•    Medicines used to treat heart conditions such as ACE inhibitors or beta-blockers e.g captopril, atenolol

•    Analgesics used to treat pain e.g aspirin, paracetamol and other Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen

•    Anticoagulants to reduce blood clotting e.g warfarin and coumarin derivatives

•    Antibacterials or antifungals e.g fluconazole, miconazole, sulphonamides, chloramphenicol

•    Cimetidine used to treat ulcers

•    Sulphinpyrazone used to treat gout

•    Monoamine-oxidase inhibitors used to treat depression

•    Medicines used to treat arthritis e.g cyclophosphamide, phenylbutazone

•    Medicines used to treat tuberculosis.

These medicines may decrease the hypoglycaemic effect of glibenclamide:-

•    Diuretics e.g thiazide diuretics, furosemide, ethacrynic acid

•    Phenothiazines used to treat schizophrenia

•    Oral contraceptives containing oestrogen

•    Corticosteroids

•    Rifampicin, an antibiotic used to treat infections

•    Ciclosporin, a medicine used after organ transplants.

These medicines may lower the body's tolerance to glucose:

•    Calcium blockers used to treat heart conditions

•    Lithium used to treat depression.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice if you are pregnant or planning on becoming pregnant before taking this medicine. Consult your doctor if you are breast feeding or plan to breastfeed as small amounts of this medicine may pass into the mother's milk.

Driving and using machines

This medicine may make you feel dizzy, shaky, confused, weak and sleepy. These are some of the signs of low blood sugar. If you experience any ofthese then you should not drive or operate machinery.

Taking Malix Tablets with food and drink

Drinking alcohol while taking this medicine may affect the way that it works. Talk to your doctor if you want to drink alcohol while taking this medicine.

Malix Tablets contains lactose

This medicine contains lactose (a type ofsugar), if you have been told by your doctor that you have an intolerance to some sugars talk to your doctor about taking this medicine.

3. HOW TO TAKE MALIX TABLETS

Always take Malix Tablets exactly as your doctor has Instructed you. You should check with your doctor or pharmacist if you are unsure.

Taking this medicine

L Take this medicine by mouth • Take with or immediately after food.

• There have been rare reports of changes to the blood including thrombocytopenia, agranulocytosis and anaemia. If you notice that you have started to bruise more easily, you nave bleeding gums oryou bleed for a long time after injury and you feel very tired and are pale, you should contact your doctor AS SOON AS POSSIBLE. If you become more susceptible to infections and develop mouth and throat ulcers, you should contact your doctor straight away.

The usual dose for:

Newdiabetics: Patients should be started with 5mg daily or 2.5mg with elderly or ill patients. The doses may be increased by 2.5mg at intervals of one week as directed by your doctor. jThe maximum daily dose is 15mg.

Patients changing from other sulphonvlureas: the transfer can usually be carried out without a breakin treatment. Initial treatment with glibenclamide is 5mg daily. If necessary this can be increased in steps of2.5mg or 5mg. Adose of5mg glibenclamide is equivalent to 1,000mg tolbutamide, 250mg chlorpropamide, 25mg glibornuride and 5mg glipizide.

Ipatients changing from biauanides: Glibenclamide treatment should be started with 2.5mg of glibenclamide and biguanide withdrawn. The dosage should then be adjusted by increments of2.5mg to achieve control.

Children: Malix Tablets are unsuitable for children.

Other side effects:

•    There have been reports of skin rashes whilst taking Malix Tablets. This includes itchy skin and being more prone to sunlight

•    Low blood sugar levels (dizziness, confusion, shaking, increased sweating, sleepiness, feeling weak) in patients whose diet has not been adequately considered may occur

•    Low blood sugar (hypoglycaemia) is more likely to occur in elderly or unwell/weak patients

•    Stomach problems such as feeling sick (nausea), being sick (vomiting), stomach pain, diarrhoea, heartburn, loss of appetite, metallic taste in the mouth and a feeling of fullness have also been reported whilst taking Malix Tablets

•    Temporary changes in sight have also been reported

•    A rise in tne sodium levels in the blood may occur. This will be seen in a blood test

•    An increased appetite and weight gain have also been seen with these tablets.

Jf you take more Malix Tablets than you should

This medicine is to be taken at regular intervals, as determined by the physician. If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you. Low blood sugar (hypoglycaemia) may be treated in the conscious patient by administration of glucose or3or4 lumps of table sugar in water. If the patient is comatose, glucose can be administered as an intravenous infusion.

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 MALIX TABLETS

ilf you stop taking Malix Tablets

Keep taking your tablets until your doctor tells you to stop. Do pot stop taking your tablets just because you feel better. If you stop taking this medicine your symptoms may come back.

if you forget to take Malix Tablets

ilfyou have forgotten to take a dose, leave out that dose completely. Take your next dose at the normal time. If you pave trouble remembering to take the tablets, tell your doctor or pharmacist.

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

Do not store above 25°C. Store in the original package.

In case of any visible signs of deterioration, you should discard the package.

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

Keep out of the sight and reach of children

4. POSSIBLESIDEEFFECTS

6. CONTENTSOFTHEPACKANDOTHER INFORMATION

Like all medicines, this medicine can cause side effects, plthough not everyone gets them.

ilf you experience any of the following then STOP taking the medicine and contact a doctor immediately

i* Allergic reactions may occur rarely, with symptoms such as rash, itching, swelling of the face, wheeziness, i shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy particularly when standing up

•    Allergic skin rashes may also occur such as erythema multiforme (red bulls eye/target lesions with dark centre surrounded by pale pink ring and bright red outer ring, which may appear on the palms or soles of the feet). Stevens-Johnson syndrome (rash with flushing, fever, blisters or ulcers), toxic epidermal necrolysis (reddening, peeling and swelling that resembles burns) exfoliative dermatitis (peeling of the skin over large areas of the body) and erythema nodosum (red lumps underneath the

I skin surface)

•    Liver damage or jaundice may occur with symptoms such as yellowing of the skin or the whites of the eyes

What Malix Tablets contain:

Malix Tablets contain the active substance glibenclamide.

The other ingredients are: lactose, maize starch, gelatin, sodium carboxymethylcellulose, talc and magnesium stearate.

What Malix Tablets look like and contents of the pack

Malix Tablets 2.5mg have G1 on one side and a break line on the other side.

Malix Tablets 5mg have G2 on one side and plain on the other side.

The tablets are pack sizes of28,30,56,60,84,90,100,112, 120, 250, 500 and 1000.

Marketing Authorisation Holder

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

RiversideWay, Dartford, DA1 5BS, UK.

This leaflet was last revised in March 2014.

SIZE :160X 270 (mm) Back