TESAVEL 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tesavel 25mg film-coated tablets

Tesavel 50mg film-coated tablets

Tesavel 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

1. What is Tesavel and what is it used for
2. What you need to know before you take Tesavel
3. How to take Tesavel
4. Possible side effects
5. Storage of Tesavel
6. Contents of the pack and other information

1. What is Tesavel and what is it used for

Tesavel 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 mellitus.

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, along with your diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce enough insulin, and the insulin 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 lead to serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

2. What you need to know before you take Tesavel

Do not take Tesavel

• 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 treated with Tesavel (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 Tesavel.

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 Tesavel (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 Tesavel

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 Tesavel.

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.

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 breastfeeding or planning to breastfeed.

Driving and using machines

The ability to drive or use machines may be unaffected or slightly affected by this medicine. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.

Also, taking this medicine with the medicines called 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.

Tesavel contains sodium

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

3. How to take Tesavel

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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, along with your diet and exercise program.

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

If you take more Tesavel than you should

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

If you forget to take Tesavel

If you forget to take 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 continue with your regular schedule. Do not take a double dose of this medicine.

If you stop taking Tesavel

Keep taking this medicine while your doctor tells you to, so that you can continue to control your blood sugar levels. You should not stop taking this medicine without first talking to your doctor.

If you have any further questions on 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 Tesavel and contact a doctor immediatelyif you experience any of the following serious side effects:

• Severe and persistent abdominal pain (in the 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 change your diabetes treatment.

Some patients experienced 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, drowsiness.

Some patients experienced different types of stomach discomfort when they started taking sitagliptin and metformin together (frequency classified as common).

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

Common: flatulence, swelling of hands or feet

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

Common: swelling of hands or feet

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

Common: flu

Uncommon: dry mouth

Some patients experienced 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, upper respiratory tract infection, 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 blister on the skin)

Reporting of side effects

If you experience 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. Storage of Tesavel

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 other information

What Tesavel contains

• The active substance is sitagliptin:

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

• The 25 mg film-coated tablets of Tesavel are round, pink, with "221" on one side.
• The 50 mg film-coated tablets of Tesavel are round, light beige, with "112" on one side.
• The 100 mg film-coated tablets of Tesavel 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 authorization holder and manufacturer

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Netherlands

For further information on this medicine, contact the local representative of the marketing authorization holder:

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

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