Januvia 100 mg film-coated tablets
Sitagliptin
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- 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.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Januvia is and what it is used for
- 2. Before you take Januvia
- 3. How to take Januvia
- 4. Possible side effects
- 5. How to store Januvia
- 6. Further information
What Januvia Is And What It Is Used For
Januvia is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus. Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM.
Januvia helps to improve the levels of insulin after a meal and decreases the amount of sugar made by the body. It is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when Januvia is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur.
Your doctor has prescribed Januvia to help lower your blood sugar, which is too high because of your type 2 diabetes. Januvia can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan.
What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.
Before You Take Januvia
Do not take Januvia
- if you are allergic (hypersensitive) to sitagliptin or any of the other ingredients of Januvia.
Take special care with Januvia
Tell your doctor if you have or have had:
- type 1 diabetes
- diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting)
- any kidney problems, or any past or present medical problems. If you have kidney problems, Januvia may not be the right medicine for you.
- an allergic reaction to Januvia.
If you are taking a sulphonylurea or insulin with Januvia you may experience low blood sugar. Your doctor may reduce the dose of your sulphonylurea or insulin medication.
Taking other medicines
Januvia may be taken with most medicines. Tell your doctor or pharmacist about all the medicines you take or have recently taken. This includes prescription and non-prescription medicines, and herbal supplements.
Taking Januvia with food and drink
You can take Januvia with or without food and drink.
Pregnancy and breast-feeding
Women who are pregnant or plan to become pregnant should consult their doctor before taking Januvia. You should not use Januvia during pregnancy.
It is not known if Januvia passes into breast milk. You should not use Januvia if you are breast-feeding or plan to breast-feed.
Driving and using machines
Januvia is not expected to interfere with your ability to drive or to use machines. However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.
How To Take Januvia
Always take Januvia exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
- one 100 mg film-coated tablet
- once a day
- by mouth
Your doctor may prescribe Januvia alone or with certain other medicines that lower blood sugar.
Continue to take Januvia as long as your doctor prescribes it so you can continue to help control your blood sugar.
Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet, exercise and weight loss program recommended by your doctor while taking Januvia.
If you take more Januvia than you should
If you take more than the prescribed dosage of Januvia, contact your doctor immediately.
If you forget to take Januvia
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 Januvia.
Possible Side Effects
Like all medicines, Januvia may cause side effects, although not everybody gets them.
Very common side effects (more than 1 per 10 patients)
Common side effects (less than 1 per 10 but more than 1 per 100 patients)
Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
Some patients have experienced the following side effects after adding sitagliptin to metformin:
Common: nausea
Uncommon: weight loss, loss of appetite, abdominal pain, diarrhoea, low blood sugar, drowsiness.
Some patients have experienced stomach discomfort when starting the combination of sitagliptin and metformin together.
Some patients have experienced the following side effects while taking Januvia in combination with a sulphonylurea:
Common: low blood sugar
Some patients have experienced the following side effects while taking Januvia in combination with a sulphonylurea and metformin:
Very common: low blood sugar
Common: constipation
Some patients have experienced the following side effects while taking Januvia and pioglitazone:
Common: low blood sugar and flatulence. In addition, some patients have reported foot swelling while taking Januvia and pioglitazone. These side effects may be seen with sitagliptin and any glitazone (e.g., rosiglitazone).
Some patients have experienced the following side effects while taking Januvia in combination with rosiglitazone and metformin:
Common: headache, cough, diarrhoea, vomiting, low blood sugar, fungal skin infection, upper respiratory infection, swelling of the hands or legs.
Some patients have experienced the following side effects while taking Januvia in combination with insulin (with or without metformin):
Common: headache, low blood sugar and flu
Uncommon: dry mouth, constipation
Some patients have experienced the following side effects while taking Januvia alone:
Common: low blood sugar, headache
Uncommon: dizziness, constipation
In addition, some patients have reported the following side effects while taking Januvia:
Common: upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain.
During post-marketing experience the following side effects have also been reported (frequency not known): 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 Januvia 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 has also been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Januvia
Keep out of the reach and sight of children.
Do not use Januvia after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
Further Information
What Januvia contains
- The active substance is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
- The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), and sodium stearyl fumarate. The tablet film coating contains: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
What Januvia looks like and contents of the pack
Round, beige film-coated tablet with “277” on one side.
Opaque blisters (PVC/PE/PVDC and aluminum). Packs of 14, 28, 56, 84 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
The Manufacturer is:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
This leaflet was last approved in November 2009.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
denotes registered trademark of
© Merck Sharp & Dohme Limited 2009. All rights reserved.
PIL.JAN.09.UK.3169 II-011 F.T.131109
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