Package leaflet: Information for the patient Gliclazide 80mg tablets Read all of this leaflet carefully before you • have an inherited condition where your red blood cells don’t start taking this medicine because it contains produce enough of the enzyme G6PD (glucose 6 phosphate important information for you. dehydrogenase) • Keep this leaflet. You may need to read it again. • suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal • If you have any further questions, ask your doctor cortex) or pharmacist. • are at risk of developing low blood sugar (hypoglycaemia) • This medicine has been prescribed for you only. - take meals irregularly or skip meals altogether, are fasting, Do not pass it on to others. It may harm them, malnourished, change your diet, increase your physical activity even if their signs of illness are the same as yours. and carbohydrate intake does not match this increase, drink • If you get any side effects, talk to your doctor or alcohol, especially in combination with skipped meals pharmacist. This includes any possible side effects • take other medicines or natural remedies at the same time not listed in this leaflet. See section 4. • take too high doses of gliclazide. You should observe the treatment plan prescribed by your What is in this leaflet doctor to achieve proper blood sugar levels. This means, apart 1 What Gliclazide tablets are and what from regular tablet intake, to observe the dietary regiment, have physical exercise and, where necessary, reduce weight. During they are used for gliclazide treatment, regular monitoring of your blood (and 2 What you need to know before you take possibly urine) sugar level and also your glycated haemoglobin Gliclazide tablets (HbA1c) is necessary. 3 How to take Gliclazide tablets Cases of acute porphyria have been described with some other sulfonylurea drugs, in patients who have porphyria (inherited 4 Possible side effects genetic disorders with accumulation in the body of porphyrins or 5 How to store Gliclazide tablets porphyrin precursors). 6 Contents of the pack and other Other medicines and Gliclazide tablets information Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including 1 What Gliclazide tablets are and what they are medicines obtained without a prescription. Especially: used for • other medicines used to treat high blood sugar (oral Gliclazide is one of a group of medicines called sulfonylureas antidiabetic, GLP-1 receptor inhibitors or insulin) that are used to lower the blood sugar level. • antibiotics (sulfonamides, clarithromycin) Gliclazide tablets are used to treat maturity onset diabetes in • medicines to treat high blood pressure such as beta blockers patients that is not controlled by diet alone. (e.g. propranolol, atenolol), ACE inhibitors (e.g. captopril), They are not for use in children or in patients with diabetes Angiotensin-II antagonists (e.g. losartan), nifedipine, diazoxide requiring insulin. • medicines used to treat infections such as co-trimoxazole, fluconazole, rifampicin, chloramphenicol, oral forms of 2 What you need to know before you take miconazole (see section 2), sulfonamides such as Gliclazide tablets sulfafurazole or tetracycline compounds (e.g. tetracycline) Do not take Gliclazide tablets and tell your doctor if • medicines used to prevent blood clotting (e.g. warfarin) you: • medicines used to treat depression such as monoamine oxidase • are allergic to gliclazide or any of the ingredients of this inhibitors (MAOIs e.g. moclobemide) medicine (listed in section 6), to other medicines of the same • medicines used to treat mental health problems such as lithium, group (sulfonylureas) or other related medicines (hypoglycaemic phenothiazine derivatives (e.g. prochlorperazine) sulfonamides). An allergic reaction may include a rash, itching, • corticosteroids (e.g. prednisolone), glucocorticoids and difficulty breathing or swelling of the face, lips, throat or tongue tetracosactrin used to reduce inflammation in the body • are breast feeding • phenylbutazone, azapropazone and other NSAIDs (non- • have severe liver or kidney disease steroidal anti-inflammatory drugs) • have porphyria (a hereditary disease affecting the liver or bone • diuretics (water tablets) such as bendroflumethiazide, marrow) hydrochlorothiazide, furosemide • have ever had a severe diabetic reaction (such as “acidosis” or • oral contraceptives (the “pill”) diabetic coma). • salicylates (e.g. aspirin used for muscular or skeletal disorders) • have Type I diabetes • sulfinpyrazone (used for gout) • are diabetic and need an operation, suffered a severe trauma • aminoglutethimide (used to treat breast or prostate cancer) or infection • hormones such as testosterone, octreotide or thyroid hormones • take miconazole (for fungal infections). (e.g. thyroxine) • cimetidine (used to treat stomach ulcers) Warnings and precautions • clofibrate (used to treat high cholesterol in the blood) Talk to your doctor or pharmacist before taking Gliclazide tablets • disopyramide (for irregular heartbeats) if you: • laxatives • have liver or kidney problems • other medicines used to treat high blood sugar Continued top of next column • medicines containing alcohol Continued over page 148x210 Leaflet Reel Fed Profile (BST) Gliclazide BP, Tablets, 80mg, Gliclazide 80mg Tablets PIL - UK 28s & 60s - UK JDE No.: 50999668 approved for print/date Item number: BBBB1095 Colours Non Printing Colours 1. Black 1. Profile Originator: NM Dimensions: 148x210 Dimensions: 148x210 (Reel Fed) 2. 2. Origination Date: 07/04/2021 Min Body Text Size: 7.5pts Revision Date: Supplier: Accord Barnstaple 3. 3. Component: Leaflet for Blisters Revised By: 4. 5. Pharmacode: Proof Round 1450 Technical Date sent: N/A 6. 01 Approval Date received: Date Sent: 29-03-21 [email protected] Technologist: RH Cartons and label leaflets only (labels only when specified) Technically Approved * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 • chlorpromazine to treat disorders of the central nervous system • Angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, • medicines to treat asthma or used during labour (intravenous tongue or throat that may result in breathing difficulty). salbutamol, ritodrine and terbutaline) • Signs of severe hypersensitivity reactions (DRESS) (initially as flu-like • danazol to treat breast disorders, heavy menstrual bleeding and symptoms and a rash on the face then an extended rash with a high endometriosis temperature). • St John’s Wort (Hypericum perforatum) preparations • A rash progressing to widespread blistering or peeling of the skin. Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called • Symptoms of low blood sugar level (hypoglycaemia) (sweating, fluoroquinolones is taken at the same time as Gliclazide tablets, clammy skin, trembling, weakness, double vision, palpitations, especially in elderly patients. confusion, headache, hunger, feeling or being sick, sleep disorders, feeling agitated, unable to concentrate, drowsiness, loss of Gliclazide tablets with alcohol consciousness, slowed reactions, depression, trouble seeing or Patients should not consume alcohol in combination with Gliclazide speaking, paralysis, numbness, dizziness, loss of self-control, sensing or tablets. seeing things that are not there, difficulty breathing, slowed or faster heartbeat, chest pains (angina)). Pregnancy and breast-feeding Gliclazide tablets are not recommended for use during pregnancy. If you • Hepatitis or liver failure causing fatigue, weakness, loss of appetite, are pregnant, think you may be pregnant or are planning to have a baby, weight loss, fever, changes in liver enzymes (seen in tests), jaundice ask your doctor for advice before taking this medicine. (yellowing of the skin or whites of the eyes). You must not take Gliclazide tablets while you are breastfeeding. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: Driving and using machines Provided your blood glucose levels are satisfactorily controlled on Gastrointestinal - feeling or being sick, abdominal pain or discomfort, Gliclazide tablets, your ability to drive or use machines should not be indigestion, diarrhoea, constipation. affected. However, if your blood glucose levels become too low, this Skin - skin rashes or pale skin, redness, itching and hives. could adversely affect your concentration, and therefore your ability to Blood - gliclazide may affect the cells in your blood, which can cause perform these tasks. anaemia or mean that you are more likely to catch infections or have a Ask your doctor whether you can drive a car if you: fever or sore throat, or develop bruising or bleeding. • have frequent episodes of low blood sugar (hypoglycaemia), Eye disorders - Your vision may be affected for a short time, especially at • have few or no warning signals of low blood sugar. the start of treatment. This effect is due to changes in blood sugar levels. Other - general feeling of being unwell, reduction in blood sodium 3 How to take Gliclazide tablets Always take this medicine exactly as your doctor or pharmacist has told (hyponatraemia). you. Check with your doctor