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Patient Information Leaflet Sitagliptin Grindeks 100 mg film-coated tablets sitagliptin 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, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See paragraph 4. What is in this leaflet 1. What Sitagliptin Grindeks is and what it is used for 2. What you need to know before you take Sitagliptin Grindeks 3. How to take Sitagliptin Grindeks 4. Possible side effects 5. How to store Sitagliptin Grindeks 6. Contents of the pack and other information 1. What Sitagliptin Grindeks is and what it is used for Sitagliptin Grindeks contains the active substance sitagliptin, which belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which lower blood sugar levels in adult patients with type 2 diabetes mellitus. This medicine helps to increase the level of insulin produced after a meal and to decrease the amount of sugar produced by the body. Your doctor has prescribed this medicine to help lower your blood sugar level, which is too high due to your type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylurea or glitazone) that lower blood sugar levels, which you may already be taking for your diabetes, along with diet and exercise. What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not produce enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also produce too much sugar. When this happens, sugar (glucose) builds up in your blood. This can lead to serious medical problems, such as heart disease, kidney disease, blindness, and amputation. 2. What you need to know before you take Sitagliptin Grindeks Do not take Sitagliptin Grindeks - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in paragraph 6). Warnings and precautions Cases of inflammation of the pancreas (pancreatitis) have been reported in patients taking Sitagliptin Grindeks (see paragraph 4). If you develop blisters on your skin, this may be a condition called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptin Grindeks. Tell your doctor if you have or have had: - pancreas disease (such as pancreatitis) - gallstones, alcohol dependence or very high levels of triglycerides (a form of obesity) in your blood. These medical conditions can increase the chance of developing pancreatitis (see paragraph 4). - type 1 diabetes - diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting) - any kidney problems now or in the past - an allergic reaction to Sitagliptin Grindeks (see paragraph 4) This medicine will not cause low blood sugar levels as it does not work when your blood sugar level is low. However, when this medicine is used in combination with sulfonylurea or insulin, a lowering of blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medicine. Children and adolescents Adolescents and children under 18 years of age should not use this medicine. It is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective for use in children under 10 years of age. Other medicines and Sitagliptin Grindeks Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heart rhythm and other heart-related problems). When taken with Sitagliptin Grindeks, digoxin blood levels need to be checked. Pregnancy and breastfeeding If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy. It is not known if this medicine is excreted in breast milk. You should not take this medicine if you are breastfeeding or plan to breastfeed. Driving and using machines This medicine has no effect on your ability to drive or use machines. However, cases of dizziness and drowsiness have been reported, which can affect your ability to drive or use machines. Taking this medicine in combination with sulfonylurea or insulin may cause hypoglycemia, which can affect your ability to drive and operate machinery or work without a safety support. Sitagliptin Grindeks contains sodium This medicinal product contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially 'sodium-free'. 3. How to take Sitagliptin Grindeks Always take this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist. The usual recommended dose is - one 100 mg film-coated tablet - once a day - by mouth If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg). You can take this medicine with or without food and drink. Sitagliptin Grindeks 50 mg and 100 mg film-coated tablets have a score line on one side. This line is only intended to make it easier to break the tablet for easier swallowing and not to divide it into equal doses. Your doctor may prescribe this medicine alone, or together with other specific medicines that lower blood sugar levels. Diet and exercise can help your body use sugar in the blood better. It is important to follow the diet and exercise plan recommended by your doctor while taking Sitagliptin Grindeks. If you take more Sitagliptin Grindeks than you should If you take more of this medicine than prescribed, contact your doctor immediately. If you forget to take Sitagliptin Grindeks If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your regular schedule. Do not take a double dose of this medicine. If you stop taking Sitagliptin Grindeks Continue to take this medicine until your doctor tells you to stop, so that you can continue to control your blood sugar levels. You should not stop taking this medicine without talking to your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Sitagliptin Grindeks and contact your doctor immediately if you notice any of the following serious side effects: - Severe and persistent abdominal pain (stomach), which may radiate to your back, with or without nausea or vomiting, as this may be a sign of inflammation of the pancreas (pancreatitis). If you have a serious allergic reaction (frequency unknown), including rash, hives, blisters on the skin/peeling skin, and swelling of the face, lips, tongue and throat, which may cause difficulty breathing or swallowing, stop taking this medicine and call a doctor immediately. Your doctor may prescribe medicine to treat the allergic reaction and another medicine for your diabetes. Some patients developed the following side effects after adding sitagliptin to metformin: Frequently (may affect up to 1 in 10 people): low blood sugar, nausea, gas, vomiting Infrequently (may affect up to 1 in 100 people): abdominal pain, diarrhoea, constipation, drowsiness Some patients experienced various types of abdominal discomfort when starting the combination of sitagliptin and metformin (frequency frequent). Some patients developed the following side effects when taking sitagliptin in combination with sulfonylurea and metformin: Very frequently (may affect more than 1 in 10 people): low blood sugar Frequently: constipation Some patients developed the following side effects when taking sitagliptin and pioglitazone: Frequently: gas, swelling of hands or feet Some patients developed the following side effects when taking sitagliptin in combination with pioglitazone and metformin: Frequently: swelling of hands or feet Some patients developed the following side effects when taking sitagliptin in combination with insulin (with or without metformin): Frequently: flu Infrequently: dry mouth Some patients developed the following side effects when taking sitagliptin alone in clinical trials or post-marketing use, alone and/or with other anti-diabetic medicines: Frequently: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in the hip or leg Infrequently: dizziness, constipation, itching Rare: decrease in platelet count Frequency unknown: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 5. How to store Sitagliptin Grindeks Keep this medicine out of the sight and reach of children. Store below 30 °C. Do not use this medicine after the expiry date which is stated on the blister and carton after 'EXP'. The expiry date is the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Sitagliptin Grindeks contains - The active substance is sitagliptin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg, 50 mg or 100 mg of sitagliptin. - The other ingredients are: tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate (E341), croscarmellose sodium (E468), sodium stearyl fumarate (E485), magnesium stearate (E572). film-coating: 100 mg tablets: macrogol poly(vinyl alcohol) graft copolymer (E1209) talc (E553b) titanium dioxide (E171) glycerol monocaprylocaprate (type 1) (E471) poly(vinyl alcohol) (E1203) iron oxide yellow (E172) What Sitagliptin Grindeks looks like and contents of the pack Sitagliptin Grindeks 100 mg are yellow, round, biconvex film-coated tablets, marked '100' on one side and with a score line on the other side. The tablet size is approximately 10.0 mm in diameter. Sitagliptin Grindeks 25 mg, 50 mg and 100 mg film-coated tablets are available in blisters of 28, 56 or 98 tablets. Not all pack sizes may be marketed.
