Xelevia

Do not take it if

From the package leaflet in EMA’s product information, p. 33.

How to take it

These directions are for this exact strength and form. Another one is different.

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• The usual recommended dose is:
• − one 100 mg film-coated tablet − once a day − by mouth If you have kidney problems, your doctor may prescribe lower doses (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 with certain other medicines that lower blood sugar.
• Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet and exercise recommended by your doctor while taking Xelevia.
• If you take more Xelevia than you should If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
• If you forget to take Xelevia 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 this medicine.
• If you stop taking Xelevia Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor first.
• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 34–35.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 33–34.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 34.

Other medicines

From the package leaflet in EMA’s product information, p. 34.

Driving and using machines

• This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.
• Taking this medicine in combination with medicines called s ulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.
• Xelevia contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essenti ally ‘sodium-free’.

From the package leaflet in EMA’s product information, p. 34.

Side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• STOP taking Xelevia and contact a doctor immediately if you notice any of the following serious side effects:
• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).
• If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
• Some patients have experienced the following side effects after adding sitagliptin to metformin:
• Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache , diarrhoea, constipation, drowsiness Some patients have experienced different types of stomach discomfort whe n starting the combination of sitagliptin and metformin together (frequency is 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 in 10 people): low blood sugar Common: constipation Some patients have experienced the following side effects while taking sitagliptin and pioglitazone:
• Common: flatulence, swelling of the hands or legs Some patients have experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:
• Common: swelling of the hands or 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 while taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other diabetes medicines:
• Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain Uncommon: dizziness, constipation, itching Rare: reduced number of platelets Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease , bullous pemphigoid (a type of skin blister)
• Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 35–36.

How to store it

• 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 that month.
• Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

From the package leaflet in EMA’s product information, p. 36.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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