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DIABREZIDE

Active substance(s): GLICLAZIDE

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Package Leaflet: Information for the user
Gliclazide 80mg Tablets
Read all of this leaflet carefully before you start taking this medicine.

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

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

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist. See section 4.
In this leaflet:
1.
What Gliclazide Tablets are and what they are used for
2.
Before you take Gliclazide Tablets
3.
How to take Gliclazide Tablets
4.
Possible side effects
5.
How to store Gliclazide Tablets
6.
Further information

1. What Gliclazide Tablets are and what they are used for
The name of your medicine is Gliclazide Tablets. Gliclazide Tablets contain a medicine called gliclazide. This
belongs to a group of medicines called ‘sulphonylureas’. It works by controlling sugar (glucose) levels in the
blood.
Gliclazide Tablets are used for the sort of diabetes called ‘Type 2 diabetes’. This is when insulin is not needed,
but diet and exercise alone do not lower sugar levels in the blood. People usually need treatment for diabetes for
the rest of their life.

2. Before you take Gliclazide Tablets
Do not take Gliclazide Tablets if:
• you are allergic to gliclazide or any of the other ingredients in Gliclazide Tablets (listed in section 6)
• you are allergic to ‘sulphonylureas’, ‘sulphonamides’ or any other similar medicines
• you have used ‘sulphonylureas’ before, but they have stopped working for you
• you have ‘Type 1 diabetes’ (this is when you need to use insulin to control your diabetes)
• you have a very high blood sugar which is life threatening (‘diabetic ketoacidosis’)
• you are going to have an operation, have recently had a serious accident or been very stressed
• you have a serious infection
• you have a severe liver or kidney problem
• the patient is unconscious or in a coma (diabetic coma)
• the patient is a child.
Do not take Gliclazide Tablets if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking Gliclazide Tablets.
Take special care with Gliclazide Tablets
Check with your doctor or pharmacist before taking your medicine if:
• you are on or are planning to go on a special diet, such as a low calorie diet. See ‘Taking Gliclazide Tablets
with food and alcohol’ for more information
• you exercise a lot
• you have an untreated ‘thyroid’ problem
• you have moderate liver or kidney problems. You will need to be monitored more.
• you are elderly, ill or very thin. You will need to be monitored more.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Gliclazide
Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes
medicines you get without a prescription, including herbal medicines. This is because Gliclazide Tablets can
affect the way some other medicines work. Also some other medicines can affect the way Gliclazide Tablets
work.
Some medicines may increase the effect of Gliclazide Tablets. This can cause low blood sugar. These
medicines include:

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other medicines for diabetes such as ‘insulin’, ‘acarbose’, ‘biguanides’ or other ‘sulphonylureas’

medicines used to thin the blood such as ‘coumarins’

medicines used to lower uric acid such as ‘allopurinol’

medicines used to lower cholesterol (‘fibrates’)

medicines for depression called ‘Mono Amine Oxidase Inhibitors’ (MAOIs)

medicines for heart problems such as ‘beta blockers’

some medicines for high blood pressure (‘ACE inhibitors’)

some medicines for fungal and bacterial infections such as ‘miconazole’, ‘ketoconazole’ or ‘chloramphenicol’

anti-bacterial medicines called ‘sulphonamides’

a medicine for cancer called ‘cyclophosphamide’

caffeine which you get in some medicines for migraine and coffee, tea or some fizzy drinks

‘theophyline’ used for asthma

anti-inflammatory medicines such as aspirin or ‘phenylbutazone’

anabolic steroids

male sex hormones.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Gliclazide
Tablets.
Some medicines may lower the effect of Gliclazide Tablets. This can raise your blood sugar. These medicines
include:

medicines that raise blood pressure in serious conditions of low blood pressure such as ‘diazoxide’

some medicines for epilepsy such as ‘phenytoin’ or ‘barbiturates’

corticosteroids or corticotropin

female sex hormones

oral contraceptives

thyroid hormones

water tablets (‘diuretics’)

‘phenothiazine’ used for mental problems

‘rifampicin’ used for tuberculosis (TB).
Cimetidine and ranitidine may either increase or lower blood sugar.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Gliclazide
Tablets.
Taking Gliclazide Tablets with food and alcohol
Do not skip meals or start a special diet while taking Gliclazide Tablets. This is because if you eat less food than
normal, your blood sugar will become too low. Talk to your doctor or dietician if you are not sure.

Take the medicine 30 minutes before meals (see ‘Taking this medicine’ in section 3).

Talk to your doctor about drinking alcohol with this medicine. This is because drinking alcohol can affect how
well your diabetes is controlled.
Pregnancy and breast-feeding

Do not take Gliclazide Tablets if you are pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.
Driving and using machines
You may feel less alert while taking Gliclazide Tablets. If this happens do not drive or use any tools or machines.
This is more likely to happen if your diabetes is not controlled properly. Make sure your blood sugar is not low
before you drive.
Important information about some of the ingredients of Gliclazide Tablets
Gliclazide Tablets contains lactose. If you have been told by your doctor that you cannot tolerate or digest some
sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

3. How to take Gliclazide Tablets
Always take Diabrezide Tablets as your doctor has told you. You should check with your doctor or pharmacist if
you are not sure.
Taking this medicine

Take this medicine by mouth.

Take the medicine 30 minutes before a meal.

Swallow the tablets whole with a glass of water.

Do not crush or chew the tablets.
How much to take

The doctor will decide how much of this medicine you should take.

The starting dose is usually half to one tablet each day, taken before breakfast.

This may be increased every 7 to 14 days until your blood sugar levels are controlled.

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The usual dose is one to two tablets each day. This is usually split into two doses, take it:
30 minutes before breakfast and
30 minutes before your evening meal.

The maximum dose is 4 tablets each day.
Your doctor will give you advice on when you will need to have blood or urine tests to measure your blood sugar
levels.
Elderly patients or patients with liver or kidney problems
Your doctor may prescribe a lower dose.
Children
This medicine should not be given to children.
Do not take Gliclazide Tablets if you have insulin dependent (type 1) diabetes.
If you take more Gliclazide Tablets than you should

If you take too much of this medicine, talk to your doctor or go to a hospital straight away.

The signs of taking too much are the symptoms of low blood sugar (hypo-glycaemia). These include
sweating, looking pale, feeling cold, shivering, a fast heart beat, temporary difficulty with seeing or talking.

These symptoms can be helped by having sugar or sweet drinks.

You should carry at least 1-2 lumps of sugar all the time. You can also have a sugary drink instead of sugar.
This includes lemonade, but not diet lemonade.
If you forget to take Gliclazide Tablets

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose,
skip the missed dose.

Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide Tablets
Do not stop taking Gliclazide Tablets without talking to your doctor.

4. Possible side effects
Like all medicines, Gliclazide Tablets cause side effects, although not everybody gets them. The following side
effects may happen with this medicine:
Common side effects (affects less than 1 in 10 people):

low blood sugar (hypo-glycaemia). Signs may include sweating, looking pale, feeling cold, shivering, a fast
heart beat, temporary difficulty with seeing or talking. If this happens, tell your doctor or go to hospital
straight away

feeling sick, being sick, stomach pain, diarrhoea or constipation. These side effects can be lowered if you
take this medicine 30 minutes before meals.
Rare side effects (affects less than 1 in 1,000 people):

feeling dizzy

headaches

skin rashes or reddening of the skin

changes in the way your liver works, including hepatitis. Signs may include yellow colouring of the skin or
eyes

low number of red blood cells (anaemia). Signs may include feeling tired or dizzy

low number of white blood cells (leucopoenia, agranulocytosis). Signs may include a high temperature
(fever) or getting more infections than normal

low number of platelets in the blood (thrombocytopenia). Signs may include bruising or bleeding more easily.
Reporting of side effects.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website:
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 Gliclazide Tablets




Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Gliclazide Tablets after the expiry date which is stated on the carton. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.

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6. Further Information



The active substance is gliclazide. Each tablet contains 80 mg of gliclazide.
The other ingredients are lactose monohydrate, microcrystalline cellulose PH101, povidone K30, sodium
starch glycolate type A, magnesium stearate.

What Gliclazide Tablets look like and contents of the pack
Gliclazide Tablets are white, circular compressed tablets with flat levelled edges and breakline scoring on one
face.
They come in cartons of 28 and 60 tablets.
Marketing Authorisation Holder
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
Strada Statale 67, Località Granatieri
Scandicci (Firenze), Italy
Manufacturer
Abiogen Pharma S.p.A.
Via Meucci 36, Ospedaletto
Pisa, Italy
Distributed in the UK by:
Apotex (UK) Limited
6 Ridgeway Court, Grovebury Road
Leighton Buzzard
Bedfordshire
LU7 4SF, United Kingdom.
This package leaflet was last revised in June 2014.

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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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