PACKAGE LEAFLET: INFORMATION FOR THE USER

GLICLAZIDE 80 mg TABLETS

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.

-    This medicine has been prescribed for you only. Do

not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If you get any side effects, talk to your doctor or

pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.___{_}

WHAT IS IN THIS LEAFLET

1.    What Gliclazide is and what it is used for

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

3.    How to take Gliclazide

4.    Possible side effects

5.    How to store Gliclazide

6.    Contents of the pack and other information

1. WHAT GLICLAZIDE IS AND WHAT IS IT USED FOR

Gliclazide belongs to a group of medicines called sulfonylureas, which reduce blood sugar levels.

It can be used to treat maturity onset diabetes, (‘Type 2’ diabetes), which is not controlled by diet, exercise and weight loss alone.

They are not for use in children or in patients with diabetes requiring insulin.

2. WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE GLICLAZIDE

Do not take Gliclazide if you:

•    are allergic to Gliclazide, or other drugs in the same group (sulfonylureas and sulfonamides), or any of the other ingredients in the tablets (listed in section 6 of this leaflet). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips throat or tongue.

•    have severe liver or kidney problems

•    have Type 1 diabetes

•    have had serious problems with your diabetes, which resulted in rapid weight loss, nausea or vomiting (diabetic ketoacidosis)

•    have recently had a severe infection, injury or trauma

•    have ever become unconscious from altered blood sugar levels (diabetic coma)

•    are pregnant, planning a pregnancy or are breast-feeding, (see the section ‘Pregnancy and Breast-feeding’ below)

•    have a hereditary disease affecting the liver or bone marrow (porphyria)

•    are taking miconazole for a fungal infection.

Warning and precautions

Talk to your doctor or pharmacist before you take this medicine if you:

•    are at risk of developing low blood sugar levels, (hypoglycaemia). This may occur if you:

-    take meals irregularly or skip meals altogether

-    are fasting

-    are malnourished

-    change your diet

-    increase your physical activity and your carbohydrate intake does not match this increase

-    drink alcohol, especially in combination with skipped meals

-    take other medicines or natural remedies at the same time (see ‘Taking other medicines’ below)

-    take too high doses of Gliclazide

•    suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex)

•    kidney and liver problems

•    have an inherited condition where your red blood cells don’t produce enough of the enzyme G6PD (glucose-6-phosphate dehydrogenase).

Tests and Operations

•    If you are going to have an operation, tell the doctor, dentist or nurse that you are taking Gliclazide.

•    During treatment with Gliclazide, the level of sugar in your blood or urine should be checked regularly. Your doctor may also take blood tests to monitor your blood cell levels and liver function.

Other medicines and Gliclazide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Gliclazide tablets work:

•    Oral forms of Miconazole and Fluconazole to treat fungal infections

•    Medicines for high blood pressure or heart failure such as Diazoxide, calcium-channel blockers (e.g. Amlodipine and Nifedipine), beta-blockers (e.g. Propranolol and Atenolol), or ACE inhibitors (e.g. Captopril and Enalapril), Angiotensin-II antagonists (e.g. Losartan)

•    Medicines to increase urine production (diuretics), such as Bendroflumethiazide, Indapamide, Furosemide, Bumetanide or Hydrochlorothiazide

•    Medicines to treat stomach ulcers such as Cimetidine

•    Medicines used to thin the blood and prevent clots from forming, such as coumarins (e.g. Warfarin)

•    Medicines used to treat mental health problems such as Lithium or phenothiazine derivatives (e.g. Prochlorperazine)

•    Chlorpromazine to treat disorders of the central nervous system

•    Medicines known as beta-2 agonists used to treat asthma or used during labour, such as intravenous Salbutamol,

Ritodrine or Terbutaline

•    Antibiotics, such as Chloramphenicol, Co-trimoxazole, Tetracycline, Sulfonamides or Rifampicin, to treat bacterial infections

•    Fibrates, such as Clofibrate, used to lower high cholesterol in the blood

•    Hormones such as Testosterone, Oestrogens or Progestogens (including the contraceptive ‘pill’ and hormone replacement therapy), or thyroid hormones (e.g. Thyroxine)

•    Octreotide or Aminoglutethimide to treat cancer

•    Other medicines for diabetes such as Insulin, Acarbose or Metformin

•    Monoamine oxidase inhibitors (MAOIs), such as Moclobemide used to treat depression

•    Phenylbutazone, Azapropazone and other non-steroidal antiinflammatory drugs (NSAIDs) to treat pain and inflammation

•    Salicylates, such as Aspirin, used to relieve pain and lower fever

•    Steroids, such as Hydrocortisone or Prednisolone, to treat inflammation and allergies

•    Danazol to treat endometriosis, heavy menstrual bleeding and breast cysts in women

•    Disopyramide to treat irregular or uneven heartbeat

•    Laxatives for constipation

•    Sulfinpyrazone used to treat gout

•    Medicines containing alcohol.

Gliclazide with food, drink and alcohol

Patients should not consume alcohol when taking Gliclazide.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Patients breast-feeding should not take this medicine.

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar levels are not under control. If this happens, do not drive or operate machinery.

Gliclazide contains lactose

Gliclazide 80 mg tablets contain lactose. If you know you have an intolerance to lactose or other sugars contact your doctor before taking this medicine.

3. HOW TO TAKE GLICLAZIDE

Always take Gliclazide tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablet with a glass of water. Take with or just after food, as this lowers the chance of getting an upset stomach. The tablet can be divided into equal doses.

Dosage

Adults and the elderly: The recommended starting dose is 40 -80 mg once daily. This may be increased to a total daily dose of 40 - 320 mg.

Do not take more than 160 mg in a single dose, when the total daily dose exceeds 160 mg it should be divided into two equal doses taken according to the main meals of the day.

Use in children:

Not recommended.

If you take more Gliclazide than you should

Contact your doctor or the nearest hospital casualty department immediately. Take this leaflet and the package with you so they know what has been taken.

You are at risk of developing low blood sugar levels, (hypoglycaemia), symptoms of which include sweating, trembling, weakness, palpitations, visual disturbances and confusion (see Section 4 ‘Possible side effects’).

If you forget to take Gliclazide

Do not worry. Take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gliclazide

You should be aware that the blood sugar lowering effect will not be achieved and that the disease may get worse. Talk to your doctor before you stop taking the tablets and follow their advice.

Tell your doctor or pharmacist if you get any of these side effects:

Effects on the stomach or intestines: stomach pain, nausea, vomiting, indigestion, diarrhoea or constipation These side effects are most likely to happen at the start of the treatment. They usually last for a short time. It helps to take the tablets with or after meals.

Effects on skin: skin rashes or pale skin, redness, itching, hives or blisters, skin sensitivity to sunlight.

Symptoms of low blood sugar level (hypoglycaemia):

•    hunger, nausea, vomiting

•    sleep disorders, restlessness, aggressiveness, weakness, impaired concentration, reduced alertness and reaction time, depression, confusion, loss of self control, sensing or seeing things that are not there

•    headache, weariness, visual and speech disorders, difficulty using or understanding language, shaking, partial paralysis, numbness, sensory disturbances, dizziness, fits, drowsiness, loss of consciousness, anxiety

•    difficulty breathing

•    slowed or faster heartbeat, palpitations, chest pains (angina), high blood pressure

•    sweating, clammy skin

•    general feeling of being unwell

•    feeling agitated.

Reporting of side effects

If you get any of the side effects talk 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 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 GLICLAZIDE

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

Do not store above 25°C. Store in the original package.

Do not use this medicine after the expiry date which is stated on the package or container. The expiry date refers to the last day of that month.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gliclazide can cause side effects, although not everybody gets them.

If you get the following side effect, STOP TAKING Gliclazide and seek immediate medical help:

•    an allergic reaction to Gliclazide, which may cause symptoms such as skin rash, swelling of the face, lips, tongue or throat, and difficulty breathing or swallowing

•    altered numbers of certain cells in your blood, which can make your skin pale and cause tiredness and breathlessness, (anaemia), or mean you are more likely to catch infections, or have a fever or sore throat or develop bruising and bleeding

•    abnormal liver function tests, inflammation of the liver, (hepatitis), which causes or liver failure causing fatigue, weakness, loss of appetite, weight loss, fever, yellowing of the skin or white of the eyes (jaundice), darker urine or paler stools.

What Gliclazide Tablets contain

The active ingredient, the ingredient that makes the tablet work, is Gliclazide. Each tablet contains 80 mg of Gliclazide.

The other ingredients are lactose monohydrate, silicon dioxide, pre-gelatinised maize starch, talc and magnesium stearate.

What Gliclazide Tablets look like and contents of the pack

Gliclazide 80 mg tablets are white round tablets, scored on one side and marked MP90 on the other.

The tablets come in blister packs of 28 and 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genethics Europe Limited,

41 - 43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road, London SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 08/2016.

GE0057/O/PIL/GE1