XELEVIA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Xelevia 25mg film-coated tablets

Xelevia 50mg film-coated tablets

Xelevia 100mg film-coated tablets

sitagliptin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Xelevia and what is it used for
2. What you need to know before you take Xelevia
3. How to take Xelevia
4. Possible side effects
5. Storing Xelevia

1. Contents of the pack and further information

1. What is Xelevia and what is it used for

Xelevia contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes.

This medicine helps to increase the amount of insulin produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medicine to help you reduce your blood sugar level, which is too high due to your type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas or glitazones) that reduce blood sugar levels, and that you may already be taking for your diabetes, together with a diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a condition where your body does not produce enough insulin, and the insulin that it does produce does not work as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) builds up in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

2. What you need to know before you take Xelevia

Do not take Xelevia

• if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) in patients taking Xelevia (see section 4).

If you notice blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking Xelevia.

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 your risk of developing pancreatitis (see section 4)
• type 1 diabetes
• diabetic ketoacidosis (a complication of diabetes that causes high blood sugar levels, rapid weight loss, nausea, or vomiting)
• any current or past kidney problems
• an allergic reaction to Xelevia (see section 4)

It is unlikely that this medicine will cause low blood sugar because it does not work when your blood sugar levels are low. However, when this medicine is used in combination with a medicine that contains a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medicine.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Xelevia

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). Your doctor may need to check the level of digoxin in your blood if you are taking Xelevia.

Pregnancy and breast-feeding

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.

This medicine should not be taken during pregnancy.

It is not known if this medicine passes into breast milk. You should not take this medicine if you are breast-feeding or planning to breast-feed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

Also, taking this medicine with sulfonylureas or with insulin may cause low blood sugar (hypoglycemia), which may affect your ability to drive or use machines or work without a safe support.

Xelevia contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Xelevia

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, ask your doctor or pharmacist again.

The recommended dose is:

• one 100 mg film-coated tablet
• once a day
• by mouth

If you have kidney problems, your doctor may prescribe a lower dose (such as 25 mg or 50 mg).

You can take this medicine with or without food and drinks.

Your doctor may prescribe this medicine alone or with other medicines that also reduce blood sugar levels, and that you may already be taking for your diabetes, together with a diet and exercise program.

Diet and exercise may help your body use sugar better. It is important that you follow the diet and exercise recommended by your doctor while taking Xelevia.

If you take more Xelevia than you should

If you take more of this medicine than you should, contact your doctor immediately.

If you forget to take Xelevia

If you forget to take a dose, take it as soon as you remember. If you do not remember until the time for the next dose, then skip the missed dose and continue with your normal routine. Do not take a double dose of this medicine.

If you stop taking Xelevia

Keep taking this medicine while your doctor recommends it to help keep your blood sugar levels under control. You should not stop taking this medicine without first talking to your doctor.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking Xelevia and contact a doctor immediatelyif you notice any of the following serious side effects:

• Severe and persistent pain in the abdomen (stomach area) that may radiate to the back, with or without nausea and vomiting, as these may be signs of pancreatitis.

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blisters on the skin/peeling of the 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 will prescribe a medicine to treat the allergic reaction and will change your diabetes treatment.

Some patients reported the following side effects after adding sitagliptin to their treatment with 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 pain, diarrhea, constipation, somnolence.

Some patients reported different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency classified as common).

Some patients reported the following side effects while taking sitagliptin in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar

Common: constipation

Some patients reported the following side effects while taking sitagliptin and pioglitazone:

Common: flatulence, swelling of hands or feet

Some patients reported the following side effects while taking sitagliptin and pioglitazone and metformin:

Common: swelling of hands or feet

Some patients reported the following side effects while taking sitagliptin in combination with insulin (with or without metformin):

Common: flu

Uncommon: dry mouth

Some patients reported the following side effects while taking sitagliptin alone during clinical trials, or during use after approval alone and/or with other diabetes medicines:

Common: low blood sugar, headache, infection of the upper respiratory tract, nasal congestion or runny nose, and sore throat, osteoarthritis, pain in the arm or leg

Uncommon: dizziness, constipation, itching

Rare: reduced number of platelets

Frequency not known: kidney problems (which may require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition)

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.

5. Storing Xelevia

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. The expiry date refers to the last day of the month shown.

Store below 25°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 protect the environment.

6. Contents of the pack and further information

What Xelevia contains

• The active substance is sitagliptin:

• Each Xelevia 25 mg film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.
• Each Xelevia 50 mg film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.
• Each Xelevia 100 mg film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.

• The other ingredients are:

• Tablet core: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341), sodium carmellose (E468), magnesium stearate (E470b), sodium stearyl fumarate, and propyl gallate.
• Film coating: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Appearance and packaging

• Xelevia 25 mg film-coated tablets are round, pink, with "221" on one side.
• Xelevia 50 mg film-coated tablets are round, light beige, with "112" on one side.
• Xelevia 100 mg film-coated tablets are round, beige, with "277" on one side.

Opaque blisters (PVC/PE/PVDC and aluminum). Packs of 14, 28, 30, 56, 84, 90, or 98 film-coated tablets and 50 x 1 film-coated tablets in unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

For further information about this medicine, contact your local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet:{MM/AAAA}.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.