JANUMET 50/1000 MG 56 TAB

Sitagliptin /Metformin 50 mg/1,000 mg film-coated tablets

• This medicine contains two different medicines called sitagliptin and metformin.
• sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• metformin belongs to a class of medicines called biguanides.
• They work together to control blood sugar levels in adult patients with a form of diabetes called ‘type 2 diabetes mellitus’.
• This medicine helps to increase the levels of insulin produced after a meal and lowers the amount of sugar made by your body.

• if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine 
• if you have severely reduced kidney function
• if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis or ketoacidosis. 
• if you have a severe infection or are dehydrated
• if you are going to have an X-ray where you will be injected with a dye. You will need to stop taking at the time of the X-ray and for 2 or more days after as directed by your doctor, depending on how your kidneys are working
• if you have recently had a heart attack or have severe circulatory problems, such as ‘shock’ or breathing difficulties
• if you have liver problems
• if you drink alcohol to excess (either every day or only from time to time)
• if you are breastfeeding

• Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving this medicine.
• If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop this medicine.
• Risk of lactic acidosis.
• Talk to your doctor or pharmacist before taking:
• if you have or have had a disease of the pancreas (such as pancreatitis)
• if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood. 
• if you have type 1 diabetes. This is sometimes called insulin-dependent diabetes
• if you have or have had an allergic reaction to sitagliptin, metformin
• if you are taking a sulphonylurea or insulin, diabetes medicines, together with it

• Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing.
• Stop using the product if you develop hives or itching of the face or body. 

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage. It is especially important to mention the following:
• medicines (taken by mouth, inhalation, or injection) used to treat diseases that involve inflammation, like asthma and arthritis (corticosteroids)
• medicines which increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
• certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific medicines for the treatment of bronchial asthma (β-sympathomimetics)
• iodinated contrast agents or alcohol-containing medicines
• certain medicines used to treat stomach problems such as cimetidine
• ranolazine, a medicine used to treat angina
• dolutegravir, a medicine used to treat HIV infection
• vandetanib.

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Take one tablet:
• twice daily by mouth
• with meals to lower your chance of an upset stomach.
• Your doctor may need to increase your dose to control your blood sugar.
• If you have reduced kidney function, your doctor may prescribe a lower dose.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister and the carton after 'EXP'.
• The expiry date refers to the last day of the month.
• Do not store above 30°C.