Artwork No. - Colours Used Customer Accord Pantone Black Description Glimepiride Market UK-IE Language English Size 170 x 550 mm (PIL) Min. Font Size 9 Version No. 10 (Page 1 of 2) (IB026) Date 25/07/14 (Glimepiride (ACC-UK-IE)NEW-IB026-VAR-PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance You should therefore always take some form of • have frequent episodes of hypoglycaemia • Feeling or being sick, diarrhoea, feeling full or sugar with you (e.g. sugar cubes). Remember • have fewer or no warning signals of bloated, and abdominal pain that artificial sweeteners are not effective. Please hypoglycaemia • Decrease in the amount of sodium level in your Package leaflet: Information for the user contact your doctor or go to the hospital if taking blood (shown by blood tests) sugar does not help or if the symptoms recur. Glimepiride Tablets contains lactose Glimepiride 1 mg Tablets If you have been told by your doctor that you Not known (frequency cannot be estimated Glimepiride 2 mg Tablets Laboratory Tests cannot tolerate some sugars, contact your doctor from the available data) The level of sugar in your blood or urine should before taking this medicinal product. • Allergy (hypersensitivity) of the skin may occur Glimepiride 3 mg Tablets be checked regularly. Your doctor may also take such as itching, rash, hives and increased blood tests to monitor your blood cell levels and sensitivity to sun. Some mild allergic reactions Glimepiride 4 mg Tablets liver function. 3. How to take Glimepiride Tablets may develop into serious reactions with Glimepiride swallowing or breathing problems, swelling of Always take this medicine exactly as described in your lips, throat or tongue. Therefore in the Children and adolescents this leaflet or as your doctor or pharmacist has Read all of this leaflet carefully before you start event of one of these side effects, tell your Glimepiride Tablets is not recommended for use told you. Check with your doctor or pharmacist if taking this medicine because it contains in children under 18 years of age. doctor immediately. important information for you. you are not sure • Allergic reactions with sulfonylureas, • Keep this leaflet. You may need to read it again. Other medicines and Glimepiride tablets: sulfonamides, or related drugs may occur • If you have any further questions, ask your Taking this medicine • Problems with your sight may occur when Tell your doctor or pharmacist if you are taking, • Take this medicine by mouth just before or with doctor or pharmacist. have recently taken or might take any other beginning treatment with Glimepiride Tablets. • This medicine has been prescribed for you only. the first main meal of the day (usually breakfast). This is due to changes in blood sugar levels medicines, including medicines obtained without If you do not have breakfast you should take the Do not pass it on to others. It may harm them, a prescription. and should soon improve even if their signs of illness are the same as yours. product on schedule as prescribed by your • Increased liver enzymes • If you get any side effects, talk to your doctor or doctor. It is important not to leave out any meal • Severe unusual bleeding or bruising under the skin Your doctor may wish to change your dose of when you are on Glimepiride Tablets pharmacist. This includes any possible side Glimepiride tablets if you are taking other effects not listed in this leaflet. See section 4. • Swallow the tablets whole with at least half Reporting of side effects medicines, which may weaken or strengthen the glass of water. Do not crush or chew the tablets effect of Glimepiride tablets on the level of sugar If you get any side effects, talk to your doctor or What is in this leaflet in your blood. pharmacist. This includes any possible side 1. What Glimepiride Tablets is and what it is used for How much to take effects not listed in this leaflet. By reporting side The dose of Glimepiride Tablets depends on your 2. What you need to know before you take The following medicines can increase the effects you can help provide more information on Glimepiride Tablets needs, condition and results of blood and urine the safety of this medicine. blood sugar lowering effect of Glimepiride sugar tests and is determined by your doctor. Do not 3. How to take Glimepiride Tablets tablets. This can lead to a risk of 4. Possible side effects take more tablets than your doctor has prescribed. For UK - You can also report side effects directly hypoglycaemia (low blood sugar): • The usual starting dose is one Glimepiride 1 mg via the Yellow Card Scheme at: 5. How to store Glimepiride Tablets • Medicines to treat pain and inflammation 6. Contents of the pack and other information tablet once a day. www.mhra.gov.uk/yellowcard (phenylbutazone, azopropazone, • If necessary, your doctor may increase the dose oxyphenbutazone, aspirin-like medicines) after each 1 - 2 weeks of treatment. For Ireland - You can also report side effects • 1. What Glimepiride Tablets is Other medicines to treat diabetes mellitus (such • The maximum recommended dose is 6 mg directly via HPRA Pharmacovigilance as insulin or metformin) Glimepiride tablet per day. Earlsfort Terrace and what it is used for • Medicines supporting muscle build up (anabolics) • A combination therapy of glimepiride plus IRL - Dublin 2 • Medicines to inhibit blood clotting (coumarin Glimepiride is an orally active blood sugar metformin or of glimepiride plus insulin may be Tel: +353 1 6764971, Fax: +353 1 6762517 derivatives such as warfarin) lowering drug. This drug belongs to a blood sugar started . In such a case your doctor will Website: www.hpra.ie • Medicines used to reduce weight (fenfluramine) lowering group of medicines called sulfonylureas. determine the proper doses of glimepiride, e-mail: [email protected] • Medicines called anti-arrhythmic agents used to Glimepiride works by increasing the amount of metformin or insulin individually for you control abnormal heart beat (disopyramide) insulin released from your pancreas. The insulin • Your dose of Glimepiride tablets may need to be • Medicines lowering high cholesterol level (fibrates) 5. How to store Glimepiride then lowers your blood sugar levels. adjusted if you change weight, change your • Medicines lowering high blood pressure (ACE lifestyle, or if you are under a lot of stress. Tablets inhibitors) What Glimepiride Tablets is used for: Please speak to your doctor if any of these • Medicines to treat depression (fluoxetine, MAO • Glimepiride Tablets is used to treat a certain form situations apply to you. Keep this medicine out of the sight and reach of inhibitors) of diabetes (type 2 diabetes mellitus) when diet, • If you feel the effect of your medicine is too children • Medicines to treat gout (allopurinol, • physical exercise and weight reduction alone have weak or too strong do not change the dose This medicinal product does not require any probenecid, sulfinpyrazone) not been able to control your blood sugar levels. yourself, but ask your doctor special temperature storage condition. Store in • Medicines to treat cancer (cyclophosphamide , the original package in order to protect from ifosfamide, trofosfamide) If you take more Glimepiride Tablets than you moisture. Keep the blister in the outer carton. 2. What you need to know before • Medicines to treat bacterial and fungal infections • should Do not use this medicine after the expiry date (tetracyclines, chloramphenicol, fluconazole, you take Glimepiride Tablets If you happen to have taken too much which is stated on the carton (EXP). The expiry miconazole, quinolones, clarithromycin) Glimepiride Tablets or an additional dose there is date refers to the last day of that month. • Do not take Glimepiride Tablets and tell your Medicines to treat nasal allergies such as hay a danger of hypoglycaemia and therefore you • Do not use this medicine if you notice visible doctor if: fever (tritoqualine) should instantly consume enough sugar (e.g. a signs of deterioration. • • You are allergic (hypersensitive) to Glimepiride Medicines to increase circulation when given in small bar of sugar cubes, sweet juice, sweetened • Do not throw away any medicines via wastewater or other sulfonylureas (medicines used to lower a high dose intravenous infusion (pentoxifylline) tea) and inform a doctor immediately. When or household waste. Ask your pharmacist how to • your blood sugar such as glibenclamide) or Medicines to treat urinary infections (such as treating hypoglycaemia due to accidental intake throw away medicines you no longer use. These sulfonamides (medicines for bacterial infections some long acting sulfonamides) in children, the quantity of sugar given must be measures will help protect the environment. • such as sulfamethoxazole) or any of the other Medicines used for male sex hormone carefully controlled to avoid the possibility of ingredients of this medicine (listed in section 6 replacement therapy producing dangerous hyperglycaemia. Persons in • 6. Contents of the pack and what Glimepiride tablets contains). Medicines called sympatholytics to treat high blood a state of unconsciousness must not be given • You have insulin dependent diabetes pressure, heart failure, or prostate symptoms food or drink. other information (type 1 diabetes mellitus) • You have diabetic ketoacidosis ( a complication The following medicines may decrease the What Glimepiride Tablets contains: Since the state of hypoglycaemia may last for The active substance is Glimepiride. of diabetes when your acid level is raised in blood sugar lowering effect of Glimepiride some time it is very important that the patient is your body and you may have some of the Tablets. This can lead to a risk of For 1 mg: Each tablet contains 1 mg of glimepiride. carefully monitored until there is no more danger. For 2 mg: Each tablet contains 2 mg of glimepiride. following signs: fatigue, feeling sick (nausea), hyperglycaemia (high blood sugar level): Admission into hospital may be necessary, also frequent urination and muscular stiffness) • Medicines containing female sex hormones For 3 mg: Each tablet contains 3 mg of glimepiride.