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The product code for this leaflet is: PL 00142/0400

 

Gliclazide Tablets 80mg

Company Details

Actavis UK Ltd


Whiddon ValleyBarnstapleDevonEX32 8NS
Telephone:
Fax:
Medical Information Direct Line:
Medical Information e-mail:medinfo@actavis.co.uk
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PATIENT INFORMATION LEAFLET

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.

Index

1 What Gliclazide tablets are and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

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1 What Gliclazide tablets are and what they are used for

Gliclazide is one of a group of medicines called sulphonylureas that are used to lower the blood sugar level.

Gliclazide tablets are used to treat maturity onset diabetes in patients that is not controlled by diet alone.

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

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2 Before you take

Do not take Gliclazide tablets and tell your doctor if you:

  • have ever had an allergic reaction to Gliclazide tablets or any of the ingredients in the tablet (Please refer to section 6, further information) An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue
  • are breast feeding.
  • have severe liver or kidney disease.
  • have porphyria (a hereditary disease affecting the liver or bone marrow).
  • have ever had a severe diabetic reaction (such as “acidosis” or diabetic coma).
  • have Type I diabetes.
  • are diabetic and need an operation, suffered a severe trauma or infection, tell your doctor you are taking Gliclazide tablets.
  • take miconazole (for fungal infections)

Check with your doctor or pharmacist before taking Gliclazide tablets if you:

  • 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 or skip 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

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Especially:

  • medicines to treat high blood pressure such as beta blockers (eg propranolol, atenolol), ACE inhibitors (eg captopril), Angiotensin-II antagonists (eg losartan), nifedipine, diazoxide
  • medicines used to treat infections such as co-trimoxazole, fluconazole, rifampicin, chloramphenicol, oral forms of miconazole (see section 2), sulphonamides such as sulphafurazole or tetracycline compounds (eg tetracycline)
  • medicines used to prevent blood clotting (eg warfarin)
  • medicines used to treat depression such as monoamine oxidase inhibitors (MAOIs eg moclobamide)
  • medicines used to treat mental health problems such as lithium, phenothiazine derivatives (eg prochlorperazine)
  • corticosteroids used to reduce inflammation in the body (eg prednisolone)
  • phenylbutazone, azapropazone and other NSAIDs (non steroidal anti-inflammatory pain killers)
  • diuretics (water tablets) such as bendroflumethiazide, hydrochlorothiazide, furosemide
  • oral contraceptives (the “pill”)
  • salicylates (used for muscular or skeletal disorders eg aspirin)
  • sulfinpyrazone (used for gout)
  • aminoglutethimide (used to treat breast or prostate cancer)
  • hormones such as testosterone, octreotide or thyroid hormones (eg thyroxine)
  • cimetidine (used to treat stomach ulcers)
  • clofibrate (used to treat high cholesterol in the blood)
  • 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

Patients should not consume alcohol in combination with Gliclazide tablets.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine. Patients breast-feeding should not take this medicine (see section 2).

Driving and using machines

Make sure your blood sugar levels are under control before you drive or operate machinery.

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3 How to take

Always take Gliclazide tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

These tablets should be taken with a glass of water before meals. The tablet can be cut in half.

Doses:

Adults and the elderly

The starting dose is usually 40-80mg once daily and may be increased to a total daily dose of 40-320mg.

Do not take more than the maximum of 160mg as single dose, for doses of 320mg this will be split over the day.

Children

Not recommended.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include symptoms of low blood sugar such as sweating, trembling, weakness, double vision, palpitations, confusion.

If you forget to take the tablets

Take it as soon as you remember, unless it is nearly time for your next dose. Then carry on as before. Do not take a double dose to make up for a missed dose.

If you stop taking the tablets

Talk to your doctor before you stop taking the tablets and follow their advice.

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4 Possible side effects

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

Contact your doctor at once if you experience:

  • An allergic reaction: skin rash, swelling of the face, 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 of the skin or whites of the eyes).

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

Blood - Gliclazide may rarely affect the cells in your blood, which can cause anaemia or mean that you are more likely to catch infections or have a fever or sore throat, or develop bruising or bleeding.

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 or faster heart beat, chest pains (angina).

Other - general feeling of being unwell.

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

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

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5 How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place.

Do not use Gliclazide tablets after the expiry date stated on the label/carton/bottle. 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

What Gliclazide tablets contain

  • The active substance (the ingredient that makes the tablets work) is gliclazide. Each tablet contains 80mg of gliclazide.
  • The other ingredients are maize starch, stearic acid, magnesium stearate, microcrystalline cellulose (E460).

What Gliclazide tablets look like and size of the pack

Gliclazide tablets are white circular uncoated tablets.

Pack sizes are 28 and 60.

Marketing Authorisation Holder and Manufacturer

Actavis
Barnstaple
EX32 8NS
UK
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Date of last revision: January 2011

Actavis
Barnstaple
EX32 8NS
UK

50502210


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