25 mg, 50 mg, 100 mg film-coated tablets
sitagliptin
What Januvia is and what it is used for
Januvia contains the active substance sitagliptin, which belongs to a group of medicines that lower blood sugar levels in adult patients with type 2 diabetes mellitus. These are called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
This drug helps to increase the insulin levels produced after a meal and reduces the amount of sugar that is formed in the body.
Your doctor has prescribed this medicine to help lower your blood sugar, which is too high due to your type 2 diabetes. This medicine can be used alone or in combination with certain other blood sugar-lowering medicines ( insulin, metformin, sulphonylureas, or glitazones) that you may already be taking for your diabetes and with a diet and exercise program.
What is type 2 diabetes?
Type 2 diabetes is a condition that means that your body does not produce enough insulin and 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 you take Januvia
Do not use Januvia:
- if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Cases of inflammation of the pancreas ( pancreatitis ) have been reported in patients receiving Januvia (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 Januvia.
Tell your doctor if you have or have had:
- a disease of the pancreas (such as pancreatitis )
- Gallstones , alcohol dependence or very high levels of triglycerides (a type of fat) in the blood. These medical conditions may increase the risk of developing pancreatitis (see section 4).
- type 1 diabetes
- increased levels of ketones in the blood and urine (diabetic ketoacidosis; a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting)
- any past or present kidney problems
- an allergic reaction to Januvia (see section 4).
This medicine does not work when your blood sugar is low and therefore is not likely to cause too low blood sugar. However, when this medicine is used in combination with sulphonylurea or insulin, low blood sugar (hypoglycemia) may occur. Your doctor may then reduce the dose of one of your sulphonylureas or your insulin.
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 Januvia
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 heartbeat and other heart problems). The level of digoxin in the blood may need to be checked if taken with Januvia.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 use this medicine during pregnancy.
It is not known if this medicine passes into breast milk. You should not use this medicine if you are breastfeeding or planning to breastfeed.
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, which may affect your ability to drive and use machines.
Concomitant use of this medicine with medicines called sulphonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive or use machines.
Januvia contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free.
How to take Januvia
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual recommended dose is:
- a 100 mg film-coated tablet
- once daily
- through the mouth.
If you have kidney problems, your doctor may prescribe a lower dose for you (such as 25 mg or 50 mg).
You can take this medicine with or without food and drink.
Your doctor may prescribe this medicine alone or in combination with some other medicines that lower your blood sugar.
Diet and exercise can help your body make better use of your blood sugar. It is important to continue with the diet and exercise recommended by your doctor while you are taking Januvia.
If you take more Januvia than you should
Contact a doctor immediately if you have taken more than the prescribed dose of one of these medicines.
If you forget to take Januvia
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 with the usual dosing schedule. Do not take a double dose of this medicine in one day.
If you stop taking Januvia
To keep your blood sugar under control, you should continue to take this medicine for as long as your doctor prescribes the treatment. You should not stop taking this medicine without talking to your doctor first.
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 Januvia 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 ).
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 have experienced the following side effects when adding sitagliptin to metformin:
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 different types of stomach upset when starting combination therapy with sitagliptin and metformin together (reported frequency: common).
Some patients have experienced the following side effects while taking sitagliptin in combination with a sulphonylurea and metformin:
Very common (may affect more than 1 user in 10): low blood sugar
Common: constipation
Some patients have experienced the following side effects while taking sitagliptin and pioglitazone:
Common: flatulence, swollen hands, and legs
Some patients have experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:
Common: swollen hands and legs
Some patients have experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin ):
Common: flu
Uncommon: dry mouth
Some patients have experienced the following side effects when taking sitagliptin alone in clinical trials or at follow-up after authorization when using sitagliptin alone and/or in combination with other diabetes 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).
How to store Januvia
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 carton after “EXP” and “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
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
Content declaration
- The active substance is sitagliptin:
- Each Januvia 25 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 25 mg sitagliptin.
- Each Januvia 50 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 50 mg sitagliptin.
- Each Januvia 100 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin.
- Other ingredients are:
- Tablet core: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341), croscarmellose sodium (E468), magnesium stearate (E470b) and sodium stearyl fumarate.
- Film coating: poly (vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
What the medicine looks like and contents of the pack
- Januvia 25 mg film-coated tablets are round, pink, film-coated tablets marked “221” on one side.
- Januvia 50 mg film-coated tablets are round, light beige film-coated tablets marked “112” on one side.
- Januvia 100 mg film-coated tablets are round, beige film-coated tablets marked “277” on one side.
Opaque blister (PVC / PE / PVDC and aluminum). Packs containing 14, 28, 30, 56, 84, 90 or 98 film-coated tablets and 50×1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
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