Janumet® XR extended-release Tablets 50 mg/500 mg, 50mg/1000mg & 100mg/1000mg Sitagliptin and metformin hydrochloride 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. What Janumet XR is and what it is used for: Janumet XR is a tablet that contains two prescription medicines, sitagliptin phosphate and metformin Sitagliptin, a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), and metformin, A member of the biguanide class of medicines, work together to control blood sugar levels in patients with type 2 diabetes mellitus Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM Your doctor has prescribed Janumet XR to help lower your blood sugar, which is too high because of your type 2 diabetes and cannot be controlled with diet and exercise alone Janumet XR helps to improve the levels of insulin after a meal and decrease the amount of sugar made by the body Janumet XR helps the body respond better to the insulin it makes naturally Janumet XR may only be taken on prescription of the doctor When should I not use Janumet XR: Do not take Janumet XR if you are allergic to the active ingredient or any inactive ingredient. Have type 1 diabetes, have conditions called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine) or if you have severe kidney function problems Also do not take Janumet XR if you have: Conditions that can lead to kidney problems such as certain heart diseases, certain types of serious infections with for example high fever, diarrhea and/or vomiting (large loss of body fluids). Going to get or receive a n injection of dye or contrast agent for an x-ray procedure. talk to your doctor about when to stop janumet xr and when to start again. When should I be careful taking Janumet XR: Tell your doctor if you: Have kidney problems Have liver problems Have heart problems, including congestive heart failure (when the heart does not pump blood adequately) Drink alcohol a lot (all the time or short-term “binge” drinking) Are pregnant or planning to become pregnant Are breast-feeding Have a condition that may be associated with dehydration (large loss of body fluids) such as being sick with severe vomiting, diarrhea or fever, or if you drink fluids a lot less than normal Have to undergo surgery While taking Janumet XR Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Janumet XR Pancreatitis can be a serious, potentially life-threatening medical condition. Stop taking Janumet XR and call your doctor if you experience severe and persistent stomach pain, with or without vomiting, because you could have pancreatitis. Consult your doctor immediately if you: Experience unexplained muscle pain, tenderness or weakness In rare occasions, muscle problems can be serious, including muscle breakdown that can result in kidney damage The risk can be higher in patients with abnormal kidney function Cases of a skin reaction called bullous pemphigoid that can require treatment in a hospital have been reported in patients receiving Janumet XR Visit your doctor if you develop blisters or the breakdown of your skin (erosion) Your doctor may decide that you need to stop taking Janumet XR This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’ Use in children and adolescents: Janumet XR has not been studied in children and adolescent patients under 18 years of age and should not be taken by them Use in the elderly Janumet XR should be used in elderly patients only under regular medical supervision Inform your doctor or pharmacist if you Are suffering from other illnesses, have allergies or Are also taking other drugs (including those bought over the counter without prescription!) May I take Janumet XR during pregnancy or lactation? Women who are pregnant or plan to become pregnant should consult with their doctor before taking Janumet XR Janumet XR is not recommended for use during pregnancy It is not known if Janumet XR passes into breast milk You should not use Janumet XR if you a re breast-feeding or plan to breast-feed Talk to your doctor How to take Janumet XR: Take Janumet XR exactly as your doctor has prescribed Your doctor will tell you how many Janumet XR tablets to take. Your doctor may need to increase your dose to control your blood sugar. Your doctor may prescribe Janumet XR along with a sulfonylurea or insulin (other medicines to lower blood sugar). Take Janumet XR once a day with the evening meal to lower your chance of an upset stomach. If you take Janumet XR, swallow the Janumet XR tablets whole Do not chew, cut, or crush the tablets Tell your doctor if you cannot swallow Janumet XR whole You may see something that looks like the Janumet XR tablet in your stool (bowel movement) I f you see tablets in your stool several times, talk to your doctor Do not stop taking Janumet XR without talking to your doctor Continue to take Janumet XR as long as your doctor prescribes it so you can continue to help control your blood sugar You may need to stop Janumet XR for a short time Call your doctor for instructions if you: Have a condition that may be associated with dehydration (large loss of body fluids) such a s being sick with severe vomiting, diarrhea or fever, or if you drink fluids a lot less than normal Plan to have surgery Are going to get or receive an injection of dye or contrast agent for an x-ray procedure Diet and exercise can help your body use its blood sugar better it is important to stay on your doctor recommended diet, exercise and weight loss program while taking janumet xr If you take more than the prescribed dosage of janumet xr, contact your doctor immediately If you miss a dose, take it as soon as you remember if you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule do not take a double dose of janumet xr Do not change the dose of Janumet XR prescribed by your physician Talk to your doctor or pharmacist if you feel that the drug is ineffective or too strong Possible side effects: In rare cases, metformin, one of the medicines in Janumet XR, can cause a serious side effect called lactic acidosis Lactic acidosis is a medical emergency that can cause death and must be treated in the hospital Lactic acidosis is caused by a build-up of lactic acid in your blood. Stop taking Janumet XR if you get the following symptoms of lactic acidosis: You feel very weak and tired. You have unusual (not normal) muscle pain. You have trouble breathing. You have stomach pain with nausea and vomiting, or diarrhea. You feel cold, especially in your arms and legs. You feel dizzy or lightheaded. You have a slow or irregular heartbeat. Your medical condition suddenly changes. You have a higher chance of getting lactic acidosis if you: Have severe kidney problems. Have liver problems. Have congestive heart failure that requires treatment with medicines Drink a lot of alcohol (very often or short-term “binge” drinking) Get dehydrated (lose a large amount of body fluids) this can happen if you are sick with a fever, vomiting, or diarrhea dehydration can also happen when you sweat a lot with activity or exercise and don’t drink enough fluids. Have certain x-ray tests with injectable dyes or contrast agents used. Have surgery. Have a heart attack, severe infection, or stroke. Other common side effects in patients taking Janumet XR include: Headache, low blood sugar (hypoglycemia), and gastrointestinal symptoms including diarrhea, nausea, dyspepsia, flatulence, vomiting, metallic taste, stomach pain, loss of appetite. In most cases these side effects occur at the beginning of the therapy and disappear without discontinuation of the treatment If you are treated over a longer time with metformin, your doctor will test your blood regularly because a reduction of vitamin B12 may occur In rare cases white blood cells and platelets may decrease There may occur as well stuffy or running nose and sore throat, upper respiratory tract infection, and headache Taking Janumet XR with meals can help reduce stomach problems However, if you have unusual and/or unexpected stomach problems, talk with your doctor Stomach problems that start up later during treatment may be a sign of something more serious When Janumet XR is used with a sulfonylurea medicine or with insulin, low blood sugar (hypoglycemia), due to the sulfonylurea or insulin, can occur Your doctor will reduce the dosage of the sulfonylurea medicine or insulin In addition, when Janumet XR is used with a sulfonylurea medicine, constipation may occur Additional side effects have been reported in general use with Janumet XR or sitagliptin. one of the medicines of Janumet XR These side effects have been reported when Janumet XR has been used by themself and/or with other diabetes medicines: Allergic reactions which may be serious including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing If you have an allergic reaction. stop taking Janumet XR and call your doctor right away Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes Inflammation of the pancreas Stop taking Janumet XR and call your doctor right away if you experience severe and persistent stomach pain, with or without vomiting. Kidney problems (sometimes requiring dialysis). Joint pain. Muscle aches. Arm or leg pain. Back pain. Blisters on the skin. Contact your doctor immediately if you experience muscle pain. Tenderness or weakness This is because in rare occasions the muscle problems can be serious. Including the breakdown of muscle fibers that can lead to kidney damage and furthermore to death This risk may be greater in older patients (65 years and older). Female gender, patients with kidney dysfunction, and patients with thyroid problems Other side effects not listed above may also occur in some patients: Tell your doctor or pharmacist if you notice side effects which are not described here. if you develop unusual symptom, or if any known symptom continues or worsens. Reporting of side effects: If you get any side effects, talk to your doctor This includes any possible side effects not listed in this leaflet. You can also report side effects directly via National Pharmacovigilance and Drug Safety Centre (NPC), SFDA By reporting side affects you can help provide more information on the safety of this medicine. How to store Janumet XR: Keep out of the reach and sight of children. Store below 30°C. Do not use this medicine after the expiry date which is stated on the label after EXP. 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. Contents of the pack and other information: What Janumet XR contains: Active Ingredients: Sitagliptin as sitagliptin phosphate monohydrate, metformin hydrochloride Janumet XR 50 mg/500 mg contains 50 mg sitagliptin as sitagliptin phosphate monohydrate and 500 mg metformin as metformin hydrochloride Janumet XR 50 mg/1000 mg contains 50 mg sitagliptin as sitagliptin phosphate monohydrate and 1000 mg metformin as metformin hydrochloride Janumet XR 100 mg/1000 mg contains 100 mg sitagliptin as sitagliptin phosphate monohydrate and 1000 mg metformin as metformin hydrochloride What Janumet XR looks like and contents of the pack: Janumet XR 50 mg/500 mg is available in bottles of 56 film-coated tablets. 50 mg/500 mg tablets are light blue, bi-convex oval, film-coated tablets with “78” debossed on one side. Janumet XR 50 mg/1000 mg is available in bottles of 56 film-coated tablets 50 mg/1000 mg tablets are light green, bi-convex oval, film-coated tablets with “80” debossed on one side. Janumet XR 100 mg/1000 mg is available in bottles of 28 film-coated tablets. 100 mg/1000 mg tablets are blue, bi-convex oval, film-coated tablets with “81” debossed on one side.

More Information