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Gliclazide 80mg Tablets

Document: leaflet MAH GENERIC_PL 44473-0001 change

Gliclazide 80mq 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

In this leaflet:

1.    What Gliclazide is and what it is used for

2.    Before you take Gliclazide

3.    How to take Gliclazide

4.    Possible side effects

5.    How to store Gliclazide

6.    Further information

1. What Gliclazide is and what it is used for

Gliclazide belongs to a group of medicines called ‘sulphonylureas'.

•    Gliclazide is used for a type of diabetes that does not normally require insulin. This is called ‘Type 2 diabetes' or ‘non-insulin dependent diabetes'

•    Gliclazide works by lowering the amount of sugar in your blood

•    This medicine is given if diet and exercise alone has not been able to control your blood sugar levels

2. Before you take Gliclazide

Do not take Gliclazide if:

•    You are allergic (hypersensitive) to Gliclazide or any of the other ingredients in this medicine (listed in Section 6)

•    You are allergic (hypersensitive) to other medicines in the ‘sulphonylurea' group or similar medicines

•    You are under 18 years old

•    You have ever had severe kidney or liver problems

•    You have too much protein in your blood (ketoacidosis)

•    You have a fever (you may have an infection)

•    You have a severe injury or are about to have surgery

•    You have ever fainted or fallen into a coma from your diabetes (diabetic precoma or coma)

•    You are pregnant, might become pregnant or are breast-feeding

Do not take Gliclazide if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Gliclazide.

Take special care with Gliclazide

Check with your doctor or pharmacist before taking your medicine if any of the following apply to you. You may need to be given a different dose or a different medicine:

•    You have kidney or liver problems

•    You are aged over 70 years

•    You are on a low calorie diet

•    You have ever had mild symptoms of low blood sugar levels such as sweating, hunger pangs, feeling generally unwell, pale skin or a change in your heart beat

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Gliclazide.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription or herbal medicines. This is because Gliclazide can affect the way some other medicines work. Also some other medicines can affect the way Gliclazide works.

Please tell your doctor or pharmacist if you are taking any of the following:

•    Antibiotics for an infection such as tetracycline or sulphonamide antibiotics or chloramphenicol

•    Certain Non Steroidal Anti-Inflammatory Drugs (NSAIDs) which are used to reduce swelling and pain such as phenylbutazone or salicylate medicines like aspirin

•    Medicines for constipation (laxatives) when overused

•    Medicines for mental health problems such as monoamine oxidase inhibitors (MAOIs) or phenothiazines

•    Medicines for heart problems such as water tablets (thiazide diuretics), beta-blockers such as bisoprolol or disopyramide

•    Medicines for lowering cholesterol levels in the blood such as clofibrate

•    Medicines to thin the blood such as warfarin

•    Hormones including the contraceptive pill, steroids or medicines for thyroid problems

•    Cimetidine - for stomach problems

•    Miconazole - when taken by mouth for fungal infections

If any of the above apply to you (or you are not sure), please tell your doctor or pharmacist before taking Gliclazide.

Tests and operations

Tell your doctor or nurse that you are taking Gliclazide if you are going to have an operation. Your doctor may tell you to stop taking Gliclazide before, during and after the operation for a short time or may change the number of tablets you are taking over this period.

Taking Gliclazide with food and drink

Aim to eat a similar amount of food each day to keep your blood sugar levels constant. Your blood sugar levels will become low if you do not eat enough food on a particular day.

Pregnancy and breast-feeding

Do not take Gliclazide if you are pregnant, might become pregnant or are breast-feeding.

Driving and using machines

Gliclazide may affect your concentration if your diabetes is not satisfactorily controlled, especially at the beginning of treatment. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Gliclazide

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Gliclazide

Always take Gliclazide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

•    Swallow with a glass of water

•    Take with or just after food

How much to take

•    The usual starting dose is half a tablet or one tablet each day

•    Your doctor may slowly increase the amount you take until the right dose for you is found

•    Do not take more than two tablets at a time

•    If you need to take more than two tablets a day, take half your daily dose in the morning and the other half in the evening instead

If you take more Gliclazide than you should

If you take more Gliclazide than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. Try and have a sweet drink if possible.

If you have taken more of this medicine than you should, you may:

•    Feel hungry, cold, sweaty, confused, tired or dizzy

•    Have a slow pulse or become unconscious

If you forget to take Gliclazide

•    If you forget 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 have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gliclazide can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Stop taking Gliclazide and see a doctor or go to a hospital straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:

•    Sweating, hunger pangs, feeling generally unwell, pale skin, a change in your heart beat, feeling faint or loss of consciousness. These could be signs of low blood sugar levels (hypoglycaemia)

•    Yellowing of your skin or the whites of your eyes. This could be a sign of a liver problem

•    Feeling more tired than usual or bruising more easily than usual. These could be signs of a blood problem

Talk to your doctor if any of the following side effects gets serious or lasts longer than a few days:

•    Feeling sick (nausea) or being sick (vomiting)

•    Indigestion (dyspepsia), constipation or diarrhoea

•    Rash

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.

5. How to store Gliclazide

•    Keep out of the reach and sight of children

•    Do not use Gliclazide after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month

•    Do not store the tablets above 30oC

•    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 protect the environment

6. Further information

What Gliclazide contains

•    The active substance is Gliclazide. Each Gliclazide tablet contains 80mg

•    The other ingredients are lactose, maize starch, povidone, talc and magnesium stearate

What Gliclazide looks like and contents of the pack

Gliclazide tablets are white with a breakline and marked ‘GLI80'. They are available in packs of 28 and 60 tablets.

Marketing Authorisation Holder

EcoGen Europe Ltd, Old Police Station, Church Street, Swadlincote, DE11 8LN, UK Manufacturer

IPG Pharma Limited, Atrium Court, The Ring, Bracknell, RG12 1BW, UK.

Date leaflet last revised: July 2015

A425/UK/C