PACKAGE LEAFLET: INFORMATION FOR USER

Gliclazide 40mg Tablets Gliclazide

Read all of this leaflet carefully before you start taking this medicine. Even if you have used this medicine or a similar product before, you should read this text carefully as the information may have changed.

•    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. What is in this leaflet:

1.    What Gliclazide Tablets are and what they are used for

2.    What you need to know before you take Gliclazide Tablets

3.    How to take Gliclazide Tablets

4.    Possible side effects

5.    How to store Gliclazide Tablets

6.    Contents of the pack and other information

1. What Gliclazide Tablets are and _what they are used for_

•    Gliclazide belongs to a group of medicines called sulphonylureas that work by lowering the blood glucose (sugar) level.

•    Gliclazide Tablets are used in the treatment of diabetes mellitus

when insulin is not necessary and when diet alone fails to lower blood glucose (sugar). _

2. What you need to know before you take

_Gliclazide Tablets_

Do not take these Tablets if you:

•    have ever had an allergic reaction to Gliclazide, any of the ingredients (these are listed in Section 6, Contents of the pack and other information), sulphonylureas or other related drugs

•    are undergoing surgery, after trauma or if you have an infection

•    suffer from severe kidney or liver problems

•    suffering from diabetes complicated with ketosis or acidosis

•    are taking medicines to treat fungal infections (miconazole, see section “Other medicines and Gliclazide Tablets”)

This medicine should NOT be given to treat diabetes in children.

Other medicines and Gliclazide Tablets:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, for example, herbal remedies and health supplements from a pharmacy, supermarket or health food shop, as these tablets may interact with this medicine.

Some medicines may be affected by Gliclazide or may affect how well it works.

These include:

•    Other antidiabetic agents (insulins, acarbose, biguanides) used to treat high blood sugar.

•    Salicylates and NSAID’s (e.g. aspirin) used for pain relief.

•    Sulphonamide drugs (used to treat infections).

•    Coumarin drugs (e.g. Warfarin) used to thin the blood.

•    Monoamine oxidase inhibitors, also known as MAOI's (used to treat depression).

•    Beta-blockers (used to treat high blood pressure).

•    angiotensin converting enzyme (ACE) inhibitors such as captopril, or enalapril (used to treat high blood pressure and heart failure).

•    Tetracycline drugs (antibiotics used to treat infections).

•    Corticosteroids & Glucocorticoids (used to treat diseases that are caused by an overactive immune system, such as allergies, asthma, autoimmune disease and sepsis).

•    Thiazide diuretics, also known as water tablets (used to increase urine output).

•    Phenothiazine derivatives (used as sedatives).

•    Other drugs such as Phenylbutazone (used to treat arthritis), chloramphenicol (an antibiotic used to treat infection), clofibrate (used to reduce high levels of cholesterol), disopyramide (used to treat an irregular or fast heart beat), miconazole and fluconazole (when taken orally to treat fungal infections), cimetidine (used to treat stomach ulcers), thyroid hormones or if you overuse laxatives.

•    Chlorpromazine (used to treat severe mania in people with bipolar disorder and uncontrolled hiccups)

•    Ritodrine (used for muscle relaxation).

•    Salbutamol (used for the relief of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease)

•    Terbutaline (used to treat as a short term asthma treatment)

•    Danazol (indicated for the treatment of endometriosis amenable to hormonal management)

•    Oral contraceptives

•    Anticoagulant therapy (e.g. Warfarin): Sulphonylureas may lead to potentiation of anti-coagulation during concurrent treatment.

•    Alcohol: increases the hypoglycaemic reaction (by inhibiting compensatory reactions) that can lead to the onset of hypoglycaemic coma.

•    As with all diabetic medicines, it is possible that your blood sugar level may become too low (a condition known as hypoglycaemia). This is more likely to occur if your dietary intake is reduced, you suffer from impaired liver or kidney function, you are elderly or if you accidentally take too much of your medicine.

•    If you suffer from a fever, an infection, and trauma or undergo surgery your diabetes may not be controlled. Please ensure you tell your doctor, as your dose or medication may need to be changed.

Gliclazide Tablets with Alcohol

•    You are advised NOT to drink alcohol with this medicine. Discuss this with your doctor if you have any questions.

Pregnancy, breast feeding and fertility

•    Do NOT take this medicine if you are pregnant, think you have become pregnant or intend to become pregnant whilst taking these tablets or are breast - feeding.

•    Always ask your doctor or pharmacist for advice before taking any other medicine.

Driving and using machines

•    If your diabetes is not satisfactorily controlled, your concentration may be effected. Therefore do NOT drive or operate machinery if affected.

Gliclazide Tablets contain lactose

•    This medicine contains Lactose.

•    If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

|    3. How to take Gliclazide Tablets    |

•    Always take these tablets exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.

•    Swallow the tablets with a glass of water.

Adults

•    The total daily dose of Gliclazide may vary from 40mg to 320mg

and the dose required will be adjusted according to your response.    *

•    Initially, a daily dose of 40mg-80mg will be prescribed. This |

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dose will gradually be increased by your doctor until adequate control is achieved.

•    A single dose should not exceed 160mg.

•    When higher doses are required, the tablets should be taken twice a day with the main meals of the day.

Children

•    Gliclazide Tablets are NOT recommended for use in children.

If you take more Gliclazide Tablets than you should

•    Contact your nearest hospital casualty (A&E) or your doctor immediately.

•    If you take too many tablets it may cause hypoglycaemia (too low a level of blood sugar); symptoms may include weakness, headache, sweating, feelings of hunger, raised pulse rate, breathlessness, tremor, problems with vision, loss of muscle co-ordination or anxiety.

•    This condition can be improved by taking glucose or sweet drinks.

•    Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

If you forget to take Gliclazide Tablets

•    If you miss a dose: Take the missed dose as soon as you remember, take your next dose when it is due.

DO NOTTAKE ADOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE

I    4. Possible side effects    |

Like all medicines, Gliclazide Tablets may sometimes cause side effects, although not everybody gets them.

STOP TAKING this medicine and contact the casualty department at your nearest hospital if you suffer from any of the following:

The most commonly observed side effect is low blood sugar (hypoglycaemia).

If you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness, and helplessness.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heart beat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).

If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self

control, your breathing may be shallow and your heart beat slowed down, you may become unconscious.

If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.

Blood disorders:

Decrease in the number of cells in the blood has been reported (e.g. platelets, red and white blood cells).

This may cause:

-    Paleness

-    Prolonged bleeding

-    Bruising

-    Sore throat

-    Fever

These symptoms usually vanish when the treatment is discontinued. Liver disorders:

There have been isolated reports of abnormal liver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment. Skin disorders:

Skin reactions have been reported such as:

-    Rash

-    Redness

-    Itching

-    Hives

Severe reactions may also appear.

Digestive disorders:

-    Stomach pain or discomfort

-    Feeling or being sick

-    Indigestion

-    Diarrhoea

-    Constipation

These effects are reduced when Gliclazide 40mg is taken with a meal as recommended, See Section 3 “HOW TO TAKE”.

Eye disorders:

Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.

With sulphonylureas, cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels have been described. Symptoms of liver impairment (e.g. jaundice)

have been observed which in most cases disappeared after withdrawal of the sulphonylureas, but may lead to life threatening liver failure in isolated cases.

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 Tablets    |

•    Keep this medicine out of the sight and reach of children.

•    Blisters and Containers: Do not store above 25°C. Store in the original package to protect from moisture. Keep the container tightly closed.

•    Do not use the tablets after the expiry date shown on the label. The expiry date refers to the last date 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 medicines will help to protect the environment.

6. Contents of the pack and other information

What Gliclazide Tablets contain

•    The active substance is Gliclazide.

•    The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate, purified talc, croscarmellose sodium and povidone.

What Gliclazide Tablets look like and contents of the pack

•    Gliclazide 40mg Tablets are round, white or off white coloured, uncoated tablets with '40' on one side.

•    The tablets are supplied to your pharmacist in packs containing 20,28, 56, 60, 84,100,250,500 or 1000 tablets who will then provide you with the required number of tablets as prescribed by your doctor. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,

HP41EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

Gliclazide 40mg Tablets; PL 17907/0428    |

This leaflet was last revised in July 2012 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

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