MALIX TABLETS 5.0MG
Active substance(s): GLIBENCLAMIDE / GLIBENCLAMIDE / GLIBENCLAMIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Malix Tablets 2.5mg and 5mg
Read all of this leaflet carefully before you start taking
this medicine because it contains important information
! 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 to your doctor or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. 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
5. How to store Malix Tablets
6. Contents of the pack and other information
1. WHAT MALIX TABLETS ARE AND WHAT THEY ARE
Malix Tablets belong to a group of therapeutic medicines
called 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
do not respond adequately to diet changes alone.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
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
! Have diabetes and have had ketosis or have experienced
! Have thyroid problems
! Have kidney problems or liver disease
! Have functional problems with your adrenal glands
! Are pregnant, after delivery of your baby glibenclamide
therapy may be started or resumed
! Have a blood condition called porphyria
! Are breastfeeding
! Are currently being treated with the medicine bosentan
! 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
accident or severe infection, which can affect your diabetes.
Warnings and precautions
Talk to your doctor or pharmacist before taking Malix Tablets if
! Start to have symptoms of jaundice 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 lower your blood sugar too much.
Other medicines and Malix Tablets
Please inform your doctor or pharmacist if you are taking or
have recently taken any other medicines, even those not
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
! 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,
! Medicines used to treat tuberculosis.
These medicines may decrease the hypoglycaemic effect of
glibenclamide:! Diuretics e.g thiazide diuretics, furosemide, ethacrynic
! Phenothiazines used to treat schizophrenia
! Oral contraceptives containing oestrogen
! 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 of these 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 of sugar), if you have
been told by your doctor that you have an intolerance to some
sugars talk to your doctor about taking this medicine.
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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
! Take this medicine by mouth
! Take with or immediately after food.
The usual dose for:
New diabetics: 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.
The maximum daily dose is 15mg.
Patients changing from other sulphonylureas: the transfer can
usually be carried out without a break in treatment. Initial
treatment with glibenclamide is 5mg daily. If necessary this
can be increased in steps of 2.5mg or 5mg. A dose of 5mg
glibenclamide is equivalent to 1,000mg tolbutamide, 250mg
chlorpropamide, 25mg glibornuride and 5mg glipizide.
Patients changing from biguanides: Glibenclamide treatment
should be started with 2.5mg of glibenclamide and biguanide
withdrawn. The dosage should then be adjusted by
increments of 2.5mg to achieve control.
Children: Malix Tablets are unsuitable for children.
If 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 or 3 or 4 lumps
of table sugar in water. If the patient is comatose, glucose can
be administered as an intravenous infusion.
If you stop taking Malix Tablets
Keep taking your tablets until your doctor tells you to stop. Do
not 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
If you have forgotten to take a dose, leave out that dose
completely. Take your next dose at the normal time. If you
have trouble remembering to take the tablets, tell your doctor
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everyone gets them.
If you experience any of the following then STOP taking
the medicine and contact a doctor immediately
! Allergic reactions may occur rarely, with symptoms such
as rash, itching, swelling of the face, wheeziness,
shortness of breath, tightness in the chest, fever, low
blood pressure and feeling dizzy particularly when
! 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
! Liver damage or jaundice may occur with symptoms such
as yellowing of the skin or the whites of the eyes
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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 have bleeding gums or you 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.
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
! 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
! Temporary changes in sight have also been reported
! A rise in the 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.
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
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
Keep out of the sight and reach of children
6. CONTENTS OF THE PACK AND OTHER
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
The tablets are pack sizes of 28, 30, 56, 60, 84, 90, 100, 112,
120, 250, 500 and 1000.
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
This leaflet was last revised in March 2014.
SIZE : 160 X 270 (mm) Back
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.