MALIX TABLETS 5.0MG
Active substance(s): GLIBENCLAMIDE
Some patients have experienced the following side
Take this medicine by mouth
effects whilst taking this medicine.
Take with or immediately after food.
Tell your doctor if you experience any of the
PACKAGE LEAFLET: INFORMATION FOR THE USER
The usual dose for:
New diabetics: Patients should be started with 5mg daily or
Lower blood sugar than normal
2.5mg with elderly or ill patients. The doses may be increased
(hypoglycaemia) (see section 2)
by 2.5mg at intervals of one week as directed by your doctor.
Stomach upsets such as nausea, vomiting,
The maximum daily dose is 15mg.
abdominal pain, diarrhoea, loss of appetite or
a metallic taste. Taking doses with food may
Patients changing from other sulphonylureas: The transfer can
reduce these problems. They often get better
usually be carried out without a break in treatment. Initial
Read all of this leaflet carefully before you start taking
important that relatives and close work mates know that you
spontaneously so you should continue to take
treatment with glibenclamide is 5mg daily. If necessary this
this medicine because it contains important information
have diabetes and are taking medication so that they can
the tablets unless your stomach is upset and shows no
can be increased in steps of 2.5mg or 5mg. A dose of 5mg
recognize the symptoms of hypoglycaemia and help if
sign of getting better after a few days
glibenclamide is equivalent to 1,000mg tolbutamide, 250mg
Keep this leaflet. You may need to read it again.
Increased appetite and weight gain
chlorpropamide, 25mg glibornuride and 5mg glipizide.
If you have any further questions, ask your doctor,
Decrease in the amount of sodium in your blood (shown
pharmacist or nurse.
Other medicines and Malix Tablets
by blood tests)
Patients changing from biguanides: Glibenclamide treatment
This medicine has been prescribed for you only. Do not
Tell your doctor or pharmacist if you are taking, have recently
Temporary vision problems
should be started with 2.5mg of glibenclamide and biguanide
pass it on to others. It may harm them, even if their signs
taken or might take any other medicines, even those not
Sensitivity to light (photosensitivity)
withdrawn. The dosage should then be adjusted by
of illness are the same as yours.
increments of 2.5mg to achieve control.
If you get any side effects, talk to your doctor, pharmacist
In particular tell your doctor if you are taking a medicine called
If any of the side effects get serious or if you notice any side
or nurse. This includes any possible side effects not listed
bosentan which is used to treat high blood pressure.
effects not listed in this leaflet, please tell your doctor or
Use in children
in this leaflet. See section 4.
Malix Tablets are unsuitable for children.
These medicines may increase the effect that glibenclamide
What is in this leaflet
has on lowering your blood sugar:
Reporting of side effects
If you take more Malix Tablets than you should
1. What Malix Tablets are and what they are used for
Anabolic steroids e.g nandrolone
If you get any side effects, talk to your doctor, pharmacist or
This medicine is to be taken at regular intervals, as
2. What you need to know before you take Malix Tablets
Medicines used to treat heart conditions such as ACE
nurse. This includes any possible side effects not listed in this
determined by the physician. If you take too many tablets by
3. How to take Malix Tablets
inhibitors or beta-blockers e.g captopril, atenolol
leaflet. You can also report side effects directly via the Yellow
mistake contact your nearest hospital casualty department or
4. Possible side effects
Analgesics used to treat pain e.g aspirin, paracetamol
Card Scheme at: www.mhra.gov.uk/yellowcard or search for
5. How to store Malix Tablets
and other Non-steroidal anti-inflammatory drugs (NSAIDs)
MHRA Yellow Card in the Google Play or Apple App Store.
Low blood sugar (hypoglycaemia) may be treated in the
6. Contents of the pack and other information
such as ibuprofen
By reporting side effects you can help provide more
Anticoagulants to reduce blood clotting e.g warfarin and
information on the safety of this medicine.
of table sugar in water. If the patient is comatose, glucose can
1. WHAT MALIX TABLETS ARE AND WHAT THEY ARE
Antibacterials or antifungals e.g fluconazole,
5. HOW TO STORE MALIX TABLETS
miconazole, sulphonamides, chloramphenicol
If you stop taking Malix Tablets
Malix Tablets belong to a group of therapeutic medicines
Cimetidine used to treat ulcers
Keep this medicine out of the sight and reach of children.
Keep taking your tablets until your doctor tells you to stop. Do
called sulphonylureas which are used for lowering your blood
Sulphinpyrazone used to treat gout
Do not use this medicine after the expiry date which is stated
not stop taking your tablets just because you feel better. If you
sugar. Malix Tablets are used for treatment of patients with
Medicines used to treat arthritis e.g cyclophosphamide,
on the carton or label. The expiry date refers to the last day of
Type II maturity onset and non-insulin dependent diabetes that
do not respond adequately to diet changes alone.
Medicines used to treat tuberculosis
Store below 25°C. Store in the original package in order to
Anti-depressants e.g. MAOIs, nortriptyline
protect from light.
If you have forgotten to take a dose, leave out that dose
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
Medicines used to reduce weight e.g fenfluramine.
In case of any visible signs of deterioration, you should
completely. Do not take a double dose to make up for a
discard the package.
forgotten dose. Take your next dose at the normal time. If you
These medicines may decrease the hypoglycaemic effect of
Do not throw away any medicines via wastewater or
have trouble remembering to take the tablets, tell your doctor
Do not take Malix Tablets if you:
glibenclamide:household waste. Ask your pharmacist how to throw away
Are allergic to glibenclamide or any of the other
Diuretics e.g thiazide diuretics, furosemide, ethacrynic
medicines you no longer use. These measures will help
If you have any further questions on the use of this medicine,
ingredients of this medicine (listed in section 6)
protect the environment.
ask your doctor or pharmacist.
Have type 1/juvenile diabetes or your diabetes is not
Phenothiazines used to treat schizophrenia
Oral contraceptives containing oestrogen
4. POSSIBLE SIDE EFFECTS
Have diabetes and have had ketosis or have experienced
6. CONTENTS OF THE PACK AND OTHER
Rifampicin, an antibiotic used to treat infections
Like all medicines, this medicine can cause side effects,
Have thyroid problems
Ciclosporin, a medicine used after organ transplants.
although not everybody gets them.
Have kidney problems or liver disease
What Malix Tablets contain
Have functional problems with your adrenal glands
These medicines may lower the body's tolerance to glucose:
The active substance is glibenclamide. Each 2.5mg and 5mg
If the following happens, stop taking this medicine and
Are pregnant, after delivery of your baby glibenclamide
Calcium blockers used to treat heart conditions
tablet contains 2.5mg and 5mg of glibenclamide respectively.
tell your doctor immediately or go to the casualty
therapy may be started or resumed
Lithium used to treat depression.
department at your nearest hospital:
Have a blood condition called porphyria
The other ingredients are: lactose (see section 2), maize
Allergic reactions (including inflammation of blood
Malix Tablets with food and alcohol
starch, gelatin, sodium carboxymethylcellulose, talc and
vessels, often with skin rash) which may develop into
Are currently being treated with the medicine bosentan
Malix Tablets should be taken with or immediately after food.
serious reactions with difficulty in breathing, fall in blood
Have insulin dependant diabetes
Drinking alcohol while taking this medicine may affect the way
pressure and sometimes progressing to shock
Are under unusual stress such as surgery, trauma or
it works. Talk to your doctor if you want to drink alcohol while
What Malix Tablets look like and contents of the pack
Abnormal liver function including yellowing of the skin and
taking this medicine.
Malix Tablets 2.5mg have G1 on one side and a break line on
eyes (jaundice), problems with the bile flow (cholestasis),
the other side.
inflammation of the liver (hepatitis) or liver failure
You should talk to your doctor before taking this medicine if
Pregnancy and breast-feeding
Malix Tablets 5mg have G2 on one side and plain on the other
you are going to have an operation, if you have a serious
Ask your doctor or pharmacist for advice if you are pregnant
multiforme (red bullseye/target lesions with dark centre
accident or severe infection, which can affect your diabetes.
or planning on becoming pregnant before taking this medicine.
Consult your doctor if you are breast-feeding or plan to breastMalix Tablets are available in packs containing 28, 30, 56, 60,
which may appear on the palms or soles of the feet).
Warnings and precautions
feed as small amounts of this medicine may pass into the
84, 90, 100, 112, 120, 250, 500 and 1000 tablets.
Talk to your doctor or pharmacist before taking Malix Tablets if
Not all pack sizes may be marketed.
peeling and swelling that resembles burns), exfoliative
Start to have symptoms of jaundice such as yellowing of
Driving and using machines
Marketing Authorisation Holder and Manufacturer
dermatitis (peeling of the skin over large areas of the
the eyes and skin. Your doctor may stop your medication
This medicine may make you feel dizzy, shaky, confused,
Ennogen Pharma Limited
body) and erythema nodosum (red lumps underneath the
Are elderly, seriously ill or malnourished as taking this
weak and sleepy. These are some of the signs of low blood
Unit G4, Riverside Industrial Estate,
medicine may lower your blood sugar too much
sugar. If you experience any of these then you should not
Riverside Way, Dartford, DA1 5BS, UK.
Severe hypoglycaemia including loss of consciousness,
Are about to do strenuous exercises as this medicine can
drive or operate machinery.
seizures or coma. Other signs of severe hypoglycaemia
cause blood sugar levels to get too low known as
can include sweating, clammy skin, anxiety, high blood
This leaflet was last revised in March 2018.
"hypoglycaemia". Early warning symptoms of low blood
Malix Tablets contain lactose
pressure, chest pains (angina) and faster, stronger or
sugar include faintness, sweating, trembling, confusion or
If you have been told by your doctor that you have an
irregular heart beat.
headache. You will need to eat and drink something
intolerance to some sugars, contact your doctor before taking
There have been reports of changes to the blood
including thrombocytopenia, agranulocytosis and
Have been told that you have problems with your adrenal
anaemia. If you notice that you have started to bruise
or pituitary glands
3. HOW TO TAKE MALIX TABLETS
more easily, you have bleeding gums or you bleed for a
Have kidney problems, your doctor may give you a lower
long time after injury and you feel very tired and are pale,
dose and monitor your response to Malix Tablets.
Always take this medicine exactly as your doctor has told you.
you should contact your doctor as soon as possible. If you
Check with your doctor or pharmacist if you are not sure.
become more susceptible to infections and develop
Ask your doctor for more information about the symptoms of
mouth and throat ulcers, you should contact your doctor
hypoglycaemia and what you should do if it happens. It is
Malix Tablets 2.5mg and 5mg