Gliclazide 40Mg Tablets Gliclazide Tablets Are Taken with a Meal As After the Expiry Date Stated on the Carton

or prolonged, even if it is temporarily controlled By reporting side effects you can help provide by eating sugar, you should seek immediate more information on the safety of this medicine. medical attention. 5 How to store Gliclazide tablets Package leaflet: Other side effects Keep this medicine out of the sight and reach of Information for the patient • Digestive disorders: Abdominal pain, children. nausea, vomiting, indigestion, diarrhoea and This medicine does not require any special constipation. These effects are reduced when storage conditions. Do not use this medicine Gliclazide 40mg Tablets Gliclazide tablets are taken with a meal as after the expiry date stated on the carton. The recommended. expiry date refers to the last day of that month. • Skin disorders: Skin reactions such as rash, Do not throw away any medicines via Read all of this leaflet carefully before 6), to other medicines of the same group redness, itching, hives, blisters, angioedema wastewater or household waste. Ask your you start taking this medicine because it (sulfonylureas), to other related medicines (rapid swelling of tissues such as eyelids, face, pharmacist how to throw away medicines you (hypoglycaemic sulfonamides) lips, mouth, tongue or throat that may result in contains important information for you. no longer use. These measures will help protect • Keep this leaflet. You may need to read it • have insulin-dependent diabetes (type 1) breathing difficulty) have been reported. The the environment. • have ketone bodies and sugar in your urine rash may progress to widespread blistering again. (this may mean you have keto-acidosis), a or peeling of the skin. Exceptionally, signs of 6 Contents of the pack and other • If you have any further questions, ask your diabetic pre-coma and coma severe hypersensitivity reactions (DRESS) have information doctor, pharmacist or nurse. • have severe kidney or liver disease been reported: initially as flu-like symptoms • This medicine has been prescribed for you • are taking miconazole (a treatment for fungal and a rash on the face then an extended rash What Gliclazide tablets contain • The active substance is gliclazide. Each tablet only. Do not pass it on to others. It may infections. See Other medicines and Gliclazide with a high temperature. harm them, even if their signs of illness are tablets) • Blood disorders: Decrease in the number contains 40mg of gliclazide. • The other ingredients are microcrystalline the same as yours. • are breast-feeding (see Pregnancy and breast- of cells in the blood (e.g. platelets, red and feeding). white blood cells) which may cause paleness, cellulose, pregelatinised starch, maize starch, • If you get any side effects, talk to your stearic acid, magnesium stearate. doctor, pharmacist or nurse. This includes prolonged bleeding, bruising, sore throat and Warnings and precautions fever. These symptoms usually stop when the any possible side effects not listed in this What Gliclazide tablets look like and Talk to your doctor or pharmacist before taking treatment is discontinued. leaflet. See section 4. Gliclazide tablets. You should observe the • Liver disorders: There have been isolated contents of the pack treatment plan prescribed by your doctor to reports of abnormal liver function which can Gliclazide tablets are white, circular, flat, What is in this leaflet achieve proper blood sugar levels. This means, cause yellow skin and eyes. If you get this, bevelled-edge uncoated tablet plain on one face 1 apart from regular tablet intake, you observe the and the identifying letters “GU” on the reverse. What Gliclazide tablets are and what see your doctor immediately. The symptoms they are used for dietary regime, have physical exercise and where generally disappear if the drug is stopped. necessary, reduce weight. Your doctor will decide whether to stop your Pack size 28. 2 What you need to know before you treatment. take Gliclazide tablets During gliclazide treatment, regular monitoring • Eye disorders: Your vision may be affected Marketing Authorisation Holder 3 How to take Gliclazide tablets of your blood (and possibly urine) sugar level for a short time, especially at the start of Accord Healthcare Limited 4 and also your glycated haemoglobin (HbA1c) is Sage House Possible side effects treatment. This effect is due to changes in 5 necessary. blood sugar levels. 319 Pinner Road How to store Gliclazide tablets 6 North Harrow Contents of the pack and other In the first few weeks of treatment the As for other sulfonylureas, the following adverse Middlesex information risk of having reduced blood sugar levels events have been observed: cases of severe HA1 4HF (hypoglycaemia) may be increased. So changes in the number of blood cells and United Kingdom 1 What Gliclazide tablets are and what particularly close medical monitoring is allergic inflammation of the wall of blood necessary. vessels, reduction in blood sodium Manufacturer they are used for Gliclazide belongs to a group of medicines called (hyponatraemia), symptoms of liver impairment Accord, Barnstaple, EX32 8NS, UK sulfonylureas that are used to lower the blood Low blood sugar may occur: (e.g. jaundice) which in most cases disappeared sugar level. • if you have meals irregularly, skip meals after withdrawal of the sulfonylurea, but may This leaflet was last revised in March 2021 Gliclazide tablets are used in the treatment of altogether or are fasting lead to life threatening liver failure in isolated diabetes mellitus when diet, physical exercise • if you are malnourished cases. If you would like a and weight loss alone fails to lower blood • if you change your diet leaflet with larger text, glucose (sugar). They are not for use in children • if you increase your physical activity and Reporting of side effects or in patients with diabetes requiring insulin. carbohydrate intake does not match this If you get any side effects, talk to your doctor, please contact increase pharmacist or nurse. This includes any possible 01271 385257. 2 What you need to know before you • if you drink alcohol, especially in combination side effects not listed in this leaflet. You can also with skipped meals report side effects directly via the Yellow Card take Gliclazide tablets • if you take other medicines or natural remedies Scheme website: www.mhra.gov.uk/yellowcard Do not take Gliclazide tablets and tell at the same time or search for MHRA Yellow Card in the Google your doctor if you: • if you take too high doses of gliclazide Play or Apple App Store. • are allergic to gliclazide or any of the other • if you suffer from particular hormone-induced ingredients of this medicine (listed in section disorders (functional disorders of the thyroid Continued top of next column gland, of the pituitary gland or adrenal cortex) 50996619 BBBB0279 Accord Healthcare Ltd, North Harrow, HA1 4HF, UK Continued top of next column Continued over page

296x210 Leaflet Reel Fed Bi Fold Profile (BST) page 4 page 1

Gliclazide, Tablets, 40mg, Gliclazide 40mg x 28 Tablets PIL - UK 28s - UK JDE No.: 50996619 approved for print/date Item number: BBBB0279 Colours Non Printing Colours 1. Black 1. Profile Dimensions: 296x210 (Reel Fed) Originator: NM Dimensions: 296x210mm 2. 2. Component: Leaflet for Blisters Origination Date: 12/01/2021 Min Body Text Size: 9 pts Revision Date: 30/03/2021 Supplier: Accord Barnstaple 3. 3. Pharmacode: 3699 Revised By: NM 4. 5. Date Sent: 17-12-2020 Proof Round Technical Date sent: N/A 6. Technologist: RH 05 Approval Date received: Technically Approved [email protected]

Cartons and label leaflets only (labels only when specified) * 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 • if your kidney function or liver function is While taking Gliclazide tablets you should: • medicines reducing inflammation Do not take more than the maximum of 160mg severely decreased. • follow a regular diet: it is important to eat (corticosteroids) as single dose. For doses of 320mg this will be regular meals, including breakfast and never to • medicines to treat asthma or used during split over the day. If you have low blood sugar you may have the miss or delay a meal labour (intravenous salbutamol, ritodrine and following symptoms: headache, intense hunger, • take your medicine regularly (see section 3 terbutaline) If a combination therapy of Gliclazide tablets nausea, vomiting, weariness, sleep disorders, ‘How to take Gliclazide tablets’) • medicines to treat breast disorders, heavy with metformin, an alpha glucosidase inhibitor, restlessness, aggressiveness, poor concentration, • check your blood glucose regularly as menstrual bleeding and endometriosis a thiazolidinedione, a dipeptidyl peptidase-4 reduced alertness and reaction time, depression, recommended by your doctor. (danazol). inhibitor, a GLP-1 receptor agonist or insulin confusion, speech or visual disorders, tremor, is initiated, your doctor will determine the sensory disturbances, dizziness and If you have a family history of or know you have Gliclazide tablets may increase the effects of proper dose of each medicine individually for helplessness. the hereditary condition glucose-6-phosphate medicines which reduce blood clotting (e.g. you. lf you notice that your blood sugar levels dehydrogenase (G6PD) deficiency (abnormality warfarin). are high although you are taking the medicine The following signs and symptoms may also of red blood cells), contact your doctor before as prescribed, you should contact your doctor or occur: sweating, clammy skin, anxiety, fast or taking this medicinal product. Consult your doctor before you start taking pharmacist. irregular heartbeat, high blood pressure, sudden another medicinal product. If you go into strong pain in the chest that may radiate into Cases of acute porphyria have been described hospital, tell the medical staff you are taking Use in children nearby areas (angina pectoris). with some other sulfonylurea drugs, in patients Gliclazide tablets. Not recommended. who have porphyria (inherited genetic disorders If blood sugar levels continue to drop you may with accumulation in the body of porphyrins or Gliclazide tablets with food, drink and If you take more Gliclazide tablets than suffer from considerable confusion (delirium), porphyrin precursors). alcohol you should develop convulsions, lose self control, your Gliclazide can be taken with food and non- If you take too many tablets, contact your doctor breathing may be shallow and your heartbeat Other medicines and Gliclazide tablets alcoholic drinks. Drinking alcohol is not or the nearest hospital Accident & Emergency slowed down, you may become unconscious. Tell your doctor or pharmacist if you are taking, recommended as it can alter the control of your department immediately. The signs of overdose have recently taken or might take any other diabetes. are those of low blood sugar described in In most cases the symptoms of low blood sugar medicines. Section 2. The symptoms can be helped by vanish very quickly when you consume some The blood sugar lowering effect of gliclazide Pregnancy and breast-feeding taking sugar (4 to 6 lumps) or sugary drinks form of sugar, e.g. glucose tablets, sugar cubes, may be strengthened and signs of low blood Gliclazide tablets are not recommended for use straight away, followed by a substantial snack or sweet juice, sweetened tea. You should therefore sugar levels may occur when one of the during pregnancy. If you are pregnant, think you meal. If the patient is unconscious, immediately always carry some form of sugar with you following medicines is taken: may be pregnant or are planning to have a baby, inform a doctor and call the emergency services. (glucose tablets, sugar cubes). Remember that • other medicines used to treat high blood ask your doctor for advice before taking this artificial sweeteners are not effective. sugar (oral antidiabetics, GLP-1 receptor medicine. You must not take Gliclazide tablets If you forget to take Gliclazide tablets inhibitors or insulin) while you are breast-feeding. Take it as soon as you remember, unless it is Please contact your doctor or the • antibiotics (e.g. sulfonamides, clarithromycin) nearly time for your next dose. Then carry on as nearest hospital if taking sugar does not • medicines to treat high blood pressure or Driving and using machines before. Do not take a double dose to make up help or if the symptoms recur. heart failure (beta blockers, ACE-inhibitors Provided your blood glucose levels are for a forgotten dose. such as captopril or enalapril) satisfactorily controlled on Gliclazide tablets, Symptoms of low blood sugar may be absent, • medicines to treat fungal infections your ability to drive or use machines should not If you stop taking Gliclazide tablets less obvious or develop very slowly or you are (miconazole, fluconazole) be affected. However, if your blood glucose As the treatment for diabetes is usually life long, not aware in time that your blood sugar level • medicines to treat ulcers in the stomach or levels become too low, this could adversely you should discuss with your doctor before has dropped. This may happen if you are duodenum (H2 receptor antagonists) affect your concentration, and therefore your stopping this medicinal product. Stopping could an elderly patient taking certain medicines (e.g. • medicines to treat depression (monoamine ability to perform these tasks. cause high blood sugar (hyperglycaemia) which those acting on the central nervous system and oxidase inhibitors) Ask your doctor whether you can drive a car if increases the risk of developing complications beta blockers). • painkiller or antirheumatics (phenylbutazone, you: of diabetes. ibuprofen) • have frequent episodes of low blood sugar If you are in stressful situations (e.g. accidents, • medicines containing alcohol • have few or no warning signals of low blood If you have any further questions on the use of surgical operations, fever etc.) your doctor may • St John’s Wort (Hypericum perforatum) sugar. this medicine, ask your doctor, pharmacist or temporarily switch you to insulin therapy. preparations. nurse. 3 How to take Gliclazide tablets Symptoms of high blood sugar Blood glucose disturbance (low blood sugar and Always take this medicine exactly as your doctor 4 Possible side effects (hyperglycaemia) may occur when gliclazide high blood sugar) can occur when a medicine or pharmacist has told you. Check with your Like all medicines, this medicine can cause side has not yet sufficiently reduced the blood sugar, belonging to a class of antibiotics called doctor or pharmacist if you are not sure. effects although not everybody gets them. when you have not complied with the treatment fluoroquinolones is taken at the same time as plan prescribed by your doctor or in especially Gliclazide tablets, especially in elderly patients. These tablets should be taken with a glass of Low blood sugar stressful situations. These may include thirst, water before meals. The most commonly observed side effect is frequent urination, dry mouth, dry itchy skin, The blood glucose lowering effect of gliclazide low blood sugar. For symptoms and signs see skin infections and reduced performance. may be weakened and raised blood sugar levels Recommended doses: section Warnings and Precautions. may occur when one of the following medicines Adults and the elderly If left untreated, these symptoms could progress is taken: The starting dose is usually 40-80mg once daily to drowsiness, loss of consciousness or possibly • medicines to treat disorders of the central and may be increased to a total daily dose of coma. If an episode of low blood sugar is severe nervous system (chlorpromazine) 320mg. Continued top of next column Continued top of next column Continued top of next column Continued over page

296x210 Leaflet Reel Fed Bi Fold Profile (BST) page 2 page 3

Cartons and label leaflets only (labels only when specified) * 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 or prolonged, even if it is temporarily controlled By reporting side effects you can help provide by eating sugar, you should seek immediate more information on the safety of this medicine. medical attention. 5 How to store Gliclazide tablets Package leaflet: Other side effects Keep this medicine out of the sight and reach of Information for the patient • Digestive disorders: Abdominal pain, children. nausea, vomiting, indigestion, diarrhoea and This medicine does not require any special constipation. These effects are reduced when storage conditions. Do not use this medicine Gliclazide 40mg Tablets Gliclazide tablets are taken with a meal as after the expiry date stated on the carton. The recommended. expiry date refers to the last day of that month. • Skin disorders: Skin reactions such as rash, Do not throw away any medicines via Read all of this leaflet carefully before 6), to other medicines of the same group redness, itching, hives, blisters, angioedema wastewater or household waste. Ask your you start taking this medicine because it (sulfonylureas), to other related medicines (rapid swelling of tissues such as eyelids, face, pharmacist how to throw away medicines you (hypoglycaemic sulfonamides) lips, mouth, tongue or throat that may result in contains important information for you. no longer use. These measures will help protect • Keep this leaflet. You may need to read it • have insulin-dependent diabetes (type 1) breathing difficulty) have been reported. The the environment. • have ketone bodies and sugar in your urine rash may progress to widespread blistering again. (this may mean you have keto-acidosis), a or peeling of the skin. Exceptionally, signs of 6 Contents of the pack and other • If you have any further questions, ask your diabetic pre-coma and coma severe hypersensitivity reactions (DRESS) have information doctor, pharmacist or nurse. • have severe kidney or liver disease been reported: initially as flu-like symptoms • This medicine has been prescribed for you • are taking miconazole (a treatment for fungal and a rash on the face then an extended rash What Gliclazide tablets contain • The active substance is gliclazide. Each tablet only. Do not pass it on to others. It may infections. See Other medicines and Gliclazide with a high temperature. harm them, even if their signs of illness are tablets) • Blood disorders: Decrease in the number contains 40mg of gliclazide. • The other ingredients are microcrystalline the same as yours. • are breast-feeding (see Pregnancy and breast- of cells in the blood (e.g. platelets, red and feeding). white blood cells) which may cause paleness, cellulose, pregelatinised starch, maize starch, • If you get any side effects, talk to your stearic acid, magnesium stearate. doctor, pharmacist or nurse. This includes prolonged bleeding, bruising, sore throat and Warnings and precautions fever. These symptoms usually stop when the any possible side effects not listed in this What Gliclazide tablets look like and Talk to your doctor or pharmacist before taking treatment is discontinued. leaflet. See section 4. Gliclazide tablets. You should observe the • Liver disorders: There have been isolated contents of the pack treatment plan prescribed by your doctor to reports of abnormal liver function which can Gliclazide tablets are white, circular, flat, What is in this leaflet achieve proper blood sugar levels. This means, cause yellow skin and eyes. If you get this, bevelled-edge uncoated tablet plain on one face 1 apart from regular tablet intake, you observe the and the identifying letters “GU” on the reverse. What Gliclazide tablets are and what see your doctor immediately. The symptoms they are used for dietary regime, have physical exercise and where generally disappear if the drug is stopped. necessary, reduce weight. Your doctor will decide whether to stop your Pack size 28. 2 What you need to know before you treatment. take Gliclazide tablets During gliclazide treatment, regular monitoring • Eye disorders: Your vision may be affected Marketing Authorisation Holder 3 How to take Gliclazide tablets of your blood (and possibly urine) sugar level for a short time, especially at the start of Accord Healthcare Limited 4 and also your glycated haemoglobin (HbA1c) is Sage House Possible side effects treatment. This effect is due to changes in 5 necessary. blood sugar levels. 319 Pinner Road How to store Gliclazide tablets 6 North Harrow Contents of the pack and other In the first few weeks of treatment the As for other sulfonylureas, the following adverse Middlesex information risk of having reduced blood sugar levels events have been observed: cases of severe HA1 4HF (hypoglycaemia) may be increased. So changes in the number of blood cells and United Kingdom 1 What Gliclazide tablets are and what particularly close medical monitoring is allergic inflammation of the wall of blood necessary. vessels, reduction in blood sodium Manufacturer they are used for Gliclazide belongs to a group of medicines called (hyponatraemia), symptoms of liver impairment Accord, Barnstaple, EX32 8NS, UK sulfonylureas that are used to lower the blood Low blood sugar may occur: (e.g. jaundice) which in most cases disappeared sugar level. • if you have meals irregularly, skip meals after withdrawal of the sulfonylurea, but may This leaflet was last revised in March 2021 Gliclazide tablets are used in the treatment of altogether or are fasting lead to life threatening liver failure in isolated diabetes mellitus when diet, physical exercise • if you are malnourished cases. If you would like a and weight loss alone fails to lower blood • if you change your diet leaflet with larger text, glucose (sugar). They are not for use in children • if you increase your physical activity and Reporting of side effects or in patients with diabetes requiring insulin. carbohydrate intake does not match this If you get any side effects, talk to your doctor, please contact increase pharmacist or nurse. This includes any possible 01271 385257. 2 What you need to know before you • if you drink alcohol, especially in combination side effects not listed in this leaflet. You can also with skipped meals report side effects directly via the Yellow Card take Gliclazide tablets • if you take other medicines or natural remedies Scheme website: www.mhra.gov.uk/yellowcard Do not take Gliclazide tablets and tell at the same time or search for MHRA Yellow Card in the Google your doctor if you: • if you take too high doses of gliclazide Play or Apple App Store. • are allergic to gliclazide or any of the other • if you suffer from particular hormone-induced ingredients of this medicine (listed in section disorders (functional disorders of the thyroid Continued top of next column gland, of the pituitary gland or adrenal cortex) 50996619 BBBB0279 Accord Healthcare Ltd, North Harrow, HA1 4HF, UK Continued top of next column Continued over page

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