50 mg / 850 mg, 50 mg / 1,000 mg film-coated tablets
sitagliptin / metformin hydrochloride
What Janumet is and what it is used for
Janumet contains two active substances called sitagliptin and metformin .
- sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
- metformin belongs to a group of medicines called biguanides.
Both of these substances help regulate blood sugar levels in adult patients with a type of diabetes called type 2 diabetes mellitus . This drug helps to increase the levels of insulin produced after a meal and reduces the amount of sugar that is formed in the body.
Along with diet and exercise, this drug is used to help lower your blood sugar. This medicine can be taken alone or with certain other medicines used to treat diabetes ( insulin , sulphonylureas or glitazones).
What is type 2 diabetes ?
Type 2 diabetes is a condition that means that your body does not produce enough insulin and that the insulin that the body produces does not work as well as it should. Your body can also produce too much sugar. When this happens, sugar ( glucose ) accumulates in the blood. This can lead to serious medical problems such as heart disease, kidney disease, blindness and amputation.
What you need to know before taking Janumet
Do not take Janumet
- if you are allergic to sitagliptin, metformin or any of the other ingredients of this medicine (listed in section 6)
- if you have severe renal impairment
- if you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis . Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or that your breath gets a different, fruity smell
- if you have a severe infection or if you are dehydrated
- if you are going to have a contrast X-ray with an injection of a dye. You will need to take a treatment break with Janumet for 2 or more days after the procedure according to the doctor’s instructions, depending on how your kidneys work.
- if you have recently had a heart attack or have severe problems with your blood circulation or difficulty breathing
- if you have liver problems
- if you drink too much alcohol (either you do it every day or only periodically)
- if you are breast-feeding.
Do not take Janumet if any of the above apply to you and talk to your doctor about other ways to manage your diabetes . If you are not sure, talk to your doctor, pharmacist or nurse before taking Janumet.
Warnings and cautions
Cases of inflammation of the pancreas ( pancreatitis ) have been reported in patients receiving Janumet (see section 4).
If you get blisters on your skin, it could be a sign of a condition called bullous pemphigoid . Your doctor may tell you to stop taking Janumet.
Risk of lactic acidosis
Janumet may cause a very rare, but very serious side effect a lactic acidosis , particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes , severe infections , prolonged fasting or alcohol intake, dehydration (see more information below), liver problems and conditions where part of the body has reduced oxygen supply (including acute severe heart disease).
If any of the above apply to you, talk to your doctor for further information.
Stop taking Janumet for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhea, fever, exposure to heat or if you drink less fluid than normal. Talk to a doctor for further instructions.
Stop taking Janumet and contact your doctor or nearest hospital immediately if you get any of the symptoms of lactic acidosis as the condition may lead to coma .
The symptoms of lactic acidosis include:
- abdominal pain (stomach pain)
- muscle cramps
- a general feeling of not feeling well and pronounced fatigue
- hard to breathe
- lowered body temperature and heart rate .
Lactic acidosis is an acute medical condition that must be treated in a hospital.
Talk to your doctor or pharmacist before taking Janumet:
- if you have or have had a disease of the pancreas (eg pancreatitis )
- if you have or have had gallstones , alcohol dependence or very high levels of triglycerides (a type of fat) in your blood. These medical conditions may increase the risk of developing pancreatitis (see section 4).
- if you have type 1 diabetes . This is also called insulin-dependent diabetes .
- if you have or have had an allergic reaction to sitagliptin, metformin or Janumet (see section 4).
- if you are taking a sulphonylurea or insulin , medicines for diabetes , together with Janumet, as you may experience low blood sugar levels ( hypoglycemia ). Your doctor may reduce the dose of one of your sulphonylureas or your insulin .
- if you are going to have a major operation, you must stop taking Janumet during the operation and for a certain period of time after it. Your doctor will decide when to stop taking Janumet and when to start taking it again.
If you are not sure if any of the above applies to you, contact your doctor or pharmacist before taking Janumet.
During treatment with Janumet, your doctor will check your kidney function at least once a year or more often if you are older and / or if your kidney function is deteriorating.
Children and young people
Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents between 10 and 17 years of age. It is not known if this medicine is safe and effective when used in children and adolescents under 10 years of age.
Other medicines and Janumet
If you need to get an injection in the blood with contrast media that contains iodine, for example in connection with X-rays or computed tomography , you must stop taking Janumet before or at the time of injection . Your doctor will decide when to stop taking Janumet and when to start taking it again.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
You may need to do more blood sugar and kidney function tests, or your doctor may need to adjust the dose of Janumet. It is especially important that you mention the following:
- medicines (taken by mouth, inhalation or injection ) used to treat inflammation such as asthma and arthritis ( glucocorticoids )
- drugs that increase urine production ( diuretics )
- drugs used to treat pain and inflammation ( NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
- certain medicines for high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
- specific drugs used to treat respiratory problems (beta-2 agonists )
- iodinated contrast media or drugs containing alcohol
- certain medicines used to treat stomach problems, such as cimetidine
- ranolazine, a medicine used to treat angina
- dolutegravir, a drug used in the treatment of HIV – infection
- vandetanib, a medicine used in a specific type of thyroid cancer (medullary thyroid cancer)
- digoxin (for the treatment of irregular heartbeat and other heart problems). The level of digoxin in the blood may need to be checked if it is taken with Janumet.
Janumet with alcohol
Avoid high alcohol intake while taking Janumet as alcohol may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, 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 or if you are breast-feeding. See section 2, Do not take Janumet.
Driving and using machines
This medicine has no or negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported with the use of sitagliptin, which may affect your ability to drive or use machines.
Concomitant use of this medicine with medicines called sulphonylureas or with insulin may cause hypoglycaemia , which may affect your ability to drive or use machines.
Janumet contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium -free’. is next to “sodium-free”.
How to take Janumet
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- Take one tablet:
- twice daily by mouth
- at mealtime. This reduces the risk of stomach upset.
- Your doctor may need to increase the dose one to check your blood sugar.
- If you have impaired kidney function, your doctor may prescribe a lower dose .
You should continue with the diet recommended by your doctor during treatment with this medicine and make sure that your carbohydrate intake is evenly distributed throughout the day.
This medicine alone is not likely to cause abnormally low blood sugar ( hypoglycaemia ). However, when this medicine is taken with a sulphonylurea or with insulin , low blood sugar ( hypoglycaemia ) may occur. Your doctor may then need to lower the dose of one of your sulphonylureas or your insulin .
If you take more Janumet than you should
Contact a doctor immediately if you have taken more than the prescribed dose of one of these medicines. See hospitalization if you have symptoms of lactic acidosis , such as feeling frozen or not feeling well, severe nausea or vomiting, abdominal pain, unexplained weight loss, muscle cramps or rapid breathing (see section “Warnings and precautions”).
If you forget to take Janumet
If you forget to take a dose , take it as soon as you remember. If you do not remember it until it is time for the next dose , do not take the missed dose but continue according to the usual dosing schedule. Do not take double dose of this medicine in one day.
If you stop taking Janumet
Keep taking this medicine for as long as your doctor prescribes it, so that you can continue to control your blood sugar. You should not stop taking this medicine without talking to a doctor first. If you stop taking Janumet, your blood sugar may rise again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Janumet and contact your doctor immediately if you notice any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach) that may radiate to the back, with or without nausea and vomiting, as these may be signs of an inflamed pancreas ( pancreatitis ).
Janumet can cause the very rare (may affect up to 1 in 10,000) but very serious side effect a lactic acidosis (see section “Warnings and Precautions”). If this happens to you, you must stop taking Janumet and contact your doctor or nearest hospital immediately as lactic acidosis may lead to coma.
If you get a severe allergic reaction (no known frequency), such as rash, hives, blisters on the skin / scaly skin and swelling of the face, lips, tongue and throat that may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor. immediately. Your doctor may prescribe a medicine to treat your allergic reaction and another medicine for your diabetes .
Some patients who have been treated with metformin and sitagliptin adjunctive therapy have experienced the following side effects:
Common (may affect less than 1 in 10 people): low blood sugar, nausea, flatulence, vomiting
Uncommon (may affect less than 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness
Some patients have experienced diarrhea, nausea, flatulence, constipation, abdominal pain or vomiting when starting treatment with sitagliptin and metformin together (reported frequency: common).
Some patients have experienced the following side effects when taking this medicine in combination with a sulphonylurea such as glimepiride:
Very common (may affect more than 1 user in 10): low blood sugar
Some patients have experienced the following side effects while taking this medicine in combination with pioglitazone:
Common: swollen hands and legs
Some patients have experienced the following side effects while taking this medicine in combination with insulin:
Very common: low blood sugar
Uncommon: dry mouth , headache
Some patients have experienced the following side effects in clinical trials when taking sitagliptin alone (one of the substances in Janumet), or at follow-up after authorization, when using Janumet or sitagliptin alone or in combination with other antidiabetic medicines:
Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis , pain in arms or legs
Uncommon: dizziness, constipation, pruritus
Rare: decreased platelet count
Not known: kidney problems (sometimes requiring dialysis ), vomiting, joint pain, muscle aches, back pain, interstitial lung disease, bullous pemphigoid (a type of blister on the skin).
Some patients have experienced the following side effects when taking metformin alone:
Very common: nausea, vomiting, diarrhea, abdominal pain and loss of appetite. These symptoms may occur when you start taking metformin and usually go away.
Common: metallic taste in the mouth
Very rare: decreased vitamin B 12 levels, hepatitis ( inflammation of the liver), hives , redness of the skin (rash) or itching .
How to store Janumet
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 after EXP and the carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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
- The active substances are sitagliptin and metformin .
- Each Janumet 50 mg / 850 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 50 mg sitagliptin and 850 mg metformin hydrochloride.
- Each Janumet 50 mg / 1,000 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 50 mg sitagliptin and 1,000 mg metformin hydrochloride.
- Other ingredients are:
- Tablet core: microcrystalline cellulose (E460), povidone K29 / 32 (E1201), sodium lauryl sulphate and sodium stearyl fumarate.
- Film coating: poly (vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172).
What the medicine looks like and contents of the pack
- Janumet 50 mg / 850 mg film-coated tablets are capsule-shaped, pink film-coated tablets marked “515” on one side.
- Janumet 50 mg / 1,000 mg film-coated tablets are capsule-shaped, red film-coated tablets marked “577” on one side.
Opaque blister pack (PVC / PE / PVDC and aluminum). Packs of 14, 28, 56, 60, 112, 168, 180, 196 film-coated tablets, multiple packs containing 196 (2 packs of 98) and 168 (2 packs of 84) film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
|Merck Sharp & Dohme BVWaarderweg 392031 BN HaarlemNetherlands|
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