Gliclazide 80mg Tablets

Glidazide

Relon an

PACKAGE LEAFLET: INFORMATION FORTHE USER

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.

•    Your doctor has prescribed these tablets for you only.

Do not pass them on to others. They may harm them even if their signs of illness are the same as yours.

•    If you get any side effects, talk toyour 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 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 is one of a group of medicines called oral hypoglycaemics which work by reducing the level of sugar in the blood.

What are Gliclazide Tablets for?

Gliclazide is an anti-diabetic medicine used to treat Type 2 (non-insulin dependent) diabetes. This is the type of diabetes that usually develops in adulthood. This type of diabetes is not severe enough to need insulin but does not respond to dietary measures alone.

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

Do not take Gliclazide Tablets:

•    If you are allergic (hypersensitive) to sulphonylureas or related drugs with symptoms such as skin rash, hives, swelling offace or throat or difficulty breathing.

•    If you have a problem with your liver or kidneys.

•    Ifyou have diabetic ketoacidosis (complication of diabetes with rapid weight loss, nausea or vomiting), or have suffered a diabetic coma.

•    Ifyouarepregnant.

•    Ifyou have Type 1 Diabetes.

•    If you have had or about to have surgery under general anaesthetic after severe trauma or infection. Your doctor will advise you when it is safe to start taking them again after the surgery.

•    Ifyou take miconazole (forfungal infections).

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

If you have been told byyour doctor that you have an intolerance to some sugars (eg glucose, lactose, galactose), contact your doctor before taking this medicinal product.

Warnings and Precautions

Tell your doctor before you start taking these tablets ifyou:

•    have liver or kidney problems

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

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

•    are at risk of developing low blood sugar (hypoglycaemia) - take meals irregularly orskip meals altogether, are fasting, malnourished, change your diet, increase your physical activity and 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

•    take too high doses of gliclazide

Other medicines and Gliclazide Tablets

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

medicines:

•    Salicylates or pyrazolone- anf/'-Mammafory pa/'rt /(///ere.

•    Atenolol or metoprolol- Befa b/ockere used for treating hypertension (high blood pressure) and irregular heart rhythms.

•    D/'uref/'cs (water tablets) help to remove excess water from the body by increasing the amount lost by urine.

•    Clofibrate used to lower blood cholesterol.

•    Cimetidine used to reduce stomach acid

•    Contraception 'pill' or HRT treatment.

•    Prednisolone, betamethasone or dexamethasone -Glucocorticoids (steroids) since these can also affect the levels ofsugar in the blood.

•    Antibiotics -chloramphenicol

•    Phenylbutazone

•    Sulphonamides

•    Coumarin derivatives used to thin the blood e.g warfarin

•    MAOIs (monoamineoxidase inhibitors)used for depression e.g phenelzine

•    Phenothiazine drugs to help with schizophrenia and agitation e.g chlorpromazine, promazine

•    St.John's Wort

•    medicines used to treat infections such as co-trimoxazole, fluconazole, rifampicin.chloramphenicol, oral forms of miconazole (see section 2).

•    sulfinpyrazone (used for gout)

•    aminoglutethimide (used to treat breast or prostate cancer)

•    hormones such as testosterone, octreotide or thyroid hormones (eg thyroxine)

•    disopyramide (for irregular heart beats)

•    laxatives.

•    other medicines used to treat high blood sugar

•    medicines containing alcohol

•    chlorpromazine to treat disorders of the central nervous system.

•    medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)

•    danazol to treat breast disorders, heavy menstrual bleeding and endometriosis

Taking Gliclazide Tablets with food and drink:

It is recommended to take tablets either with or just after

food to reduce the chance ofan upset stomach.

Patients should not consume alcohol in combination with

Gliclazide tablets.

Pregnancyand Breast-feeding:

Tell your doctor ifyou are, you think you might be orare planning to become pregnant. Your doctor will advise you to discontinue these tablets. You should not use Gliclazide Tablets if you are breast-feeding or are planning to breastfeed your baby.

Driving and using machines:

Gliclazide Tablets on their own should not affect your ability to drive, but ifyou are also taking any other medicines which lower the blood sugar it is possible that their combined effects could make you feel faint, dizzy, weak or jittery. If this happens you should not drive or operate any machinery until you have recovered.

Important information about some ofthe ingredients of Gliclazide tablets:

These tablets contain lactose. Ifyou have been told byyour doctor you have intolerance to lactose let your doctor know before taking these tablets.

3.    How to take Gliclazide Tablets

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

The usual oral dose is 40-80mg (7₂ -1 tablet). Your doctor may then increase the dose in a stepwise manner until the right dose for you is found. After a while your doctor may then be able to reduce the dose. The dose needed varies between different people.

The total daily dose may vary from 40 to 320mg.

The maximum single dose should be 160mg (2 tablets), but if a higher dose is required this is split and taken twice daily.

The tablets should be taken with a glass ofwater during or after meals.

Do not chew the tablets but swallow them whole.

Ifyou take more Gliclazide Tablets than you should:

Ifyou swallow too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

If forget to take Gliclazide Tablets:

Try to take Gliclazide Tablets daily as prescribed. However, if you miss a dose take it as soon as you remember unless it is nearly time for the next dose. Do not take a double dose to make up for the forgotten one.

Ifyou stop taking Gliclazide Tablets:

Do not stop taking Gliclazide Tablets without first discussing it with your doctor.

Ifyou have any further questions on the use of Gliclazide Tablets ask your doctor or pharmacist.

4.    Possible side Effects

Like all medicines, this medicine can cause side-effects although not everybody gets them.

Contact your doctor at once ifyou experience:

Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually stop when the treatment is discontinued.

An allergic reaction: skin rash, swelling oftheface, lips, tongue or throat, or difficulty breathing or swallowing.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Gastrointestinal - feeling or being sick, abdominal pain or discomfort, indigestion, diarrhoea, constipation.

Liver - hepatitis or liver failure causing fatigue, weakness, loss of appetite, weight loss, fever, changes in liver enzymes (seen in tests), jaundice (yellowing ofthe skin orwhites of the eyes).

Skin - skin rashes or pale skin, redness, itching and hives, skin reactions to sunlight.

Symptoms of hypoglycaemia (low blood sugar level) sweating, clammy skin, trembling, weakness, double vision, palpitations, confusion, headache, hunger, feeling or being sick, sleep disorders, feeling agitated, unable to concentrate, drowsiness, loss of consciousness, slowed reactions, depression, trouble seeing or speaking, paralysis, numbness, dizziness, loss of self control, sensing or seeing things that are not there, difficulty breathing, slowed orfaster heart beat, chest pains (angina).

Other - general feeling of being unwell.

Ifyou have an infection, an operation or a serious injury, tell your doctor that you take gliclazide.

Reporting of side effects

Ifyou 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 Website 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 GliclazideTablets

Keep out of the sight and reach of children.

Do not use Gliclazide Tablets after the expiry date which is stated on the carton.

Do not keep the tablets above 25°C.

6.    Contents of the pack and other information

What Gliclazide Tablets contain

The active substance is Gliclazide.

Each tablet contains 80mg Gliclazide.

The other ingredients are lactose monohydrate, silicon dioxide, pregelatinized maize starch, talc, magnesium stearate.

What Gliclazide Tablets look like and contents ofthe pack

Gliclazide tablets are white, round, scored on one side and embossed “G03” on the reverse side.

The tablets are packaged in blister foil packs, in boxes of 28 and 60 tablets. Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited Cheshire House, Gorsey Lane Widnes, Cheshire, WA8 ORP, UK

Date leaflet revised: May 2016.

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PL 20395/0046