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MALIX TABLETS 2.5MG

Active substance(s): GLIBENCLAMIDE

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e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

131011/19

Colours Used

Customer

Ennogen

Black

Description

Glibenclamide Leaflet

Keyline

Market

UK

Language

English

Size

160 x 270 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

12

Date

19-03-14

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glibenclamide Tablets 2.5mg and 5mg
[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 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 Glibenclamide Tablets are and what they are
used for
2. What you need to know before you take Glibenclamide
Tablets
3. How to take Glibenclamide Tablets
4. Possible side effects
5. How to store Glibenclamide Tablets
6. Contents of the pack and other information
1. WHAT GLIBENCLAMIDE TABLETS ARE AND WHAT
THEY ARE USED FOR
Glibenclamide belongs to a group of therapeutic medicines
called sulphonylureas which are used for lowering your blood
sugar. Glibenclamide 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
GLIBENCLAMIDE TABLETS
Do not take Glibenclamide Tablets if you:
! Are hypersensitive (allergic) to glibenclamide or any of the
other ingredients of Glibenclamide 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
! 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 Glibenclamide
Tablets if you:
! 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 Glibenclamide Tablets
Please inform your doctor or 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 of these then you should not drive or
operate machinery.
Taking Glibenclamide 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.
Glibenclamide 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.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

131011/19

Colours Used

Customer

Ennogen

Black

Description

Glibenclamide Leaflet

Keyline

Market

UK

Language

English

Size

160 x 270 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

12

Date

19-03-14

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

3. HOW TO TAKE GLIBENCLAMIDE TABLETS
Always take Glibenclamide 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: Glibenclamide Tablets are unsuitable for children.
If you take more Glibenclamide 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 Glibenclamide 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 Glibenclamide 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 or
pharmacist.
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 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 skin
surface)
! Liver damage or jaundice may occur with symptoms such
as yellowing of the skin or the whites of the eyes

Quality Control (QC)

!

Production

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
Glibenclamide 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
Glibenclamide Tablets
! 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 GLIBENCLAMIDE 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
the environment.
Keep out of the sight and reach of children
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Glibenclamide Tablets contain:
Glibenclamide Tablets contain the active substance
glibenclamide.
The other ingredients are: lactose, maize starch, gelatin,
sodium carboxymethylcellulose, talc and magnesium stearate.
What Glibenclamide Tablets look like and contents of the
pack
Glibenclamide Tablets 2.5mg have G1 on one side and a
breakline on the other side.
Glibenclamide Tablets 5mg have G2 on one side and plain on
the other side.
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

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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.

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