Tesavel 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tesavel 25mg film-coated tablets

Tesavel 50mg film-coated tablets

Tesavel 100mg film-coated tablets

sitagliptin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Tesavel is and what it is used for

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

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

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

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin, and the insulin your body 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 taking Tesavel

Do not take Tesavel

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

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with Tesavel (see section 4).

If you develop blisters on the skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Tesavel.

Tell your doctor if you have or have had:

• a pancreatic disease (such as pancreatitis)
• gallstones, alcohol addiction, or very high blood levels of triglycerides (a type of fat). These medical conditions may increase your likelihood of developing pancreatitis (see section 4)
• type 1 diabetes
• diabetic ketoacidosis (a diabetes complication causing high blood sugar levels, rapid weight loss, nausea or vomiting)
• any kidney problems currently or in the past
• an allergic reaction to Tesavel (see section 4)

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

Children and adolescents

Children and adolescents under 18 years of age must not use this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is unknown whether this medicine is safe and effective 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 need to 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 digoxin blood levels may need to be monitored if you are taking Tesavel.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine must not be taken during pregnancy.

It is unknown whether this medicine passes into breast milk. You must not take this medicine if you are breastfeeding or planning to breastfeed.

Driving and using machines

The effect of this medicine on the ability to drive or operate machinery is negligible or none. However, dizziness and somnolence have been reported, which may affect your ability to drive or operate machinery.

Also, taking this medicine together with medicines called sulphonylureas or with insulin may cause hypoglycaemia, which may affect your ability to drive and use machines or work without secure 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

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• taken orally

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

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

Your doctor may prescribe this medicine alone or together with other medicines that also lower blood sugar.

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

If you take more Tesavel than you should

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

If you forget to take Tesavel

If you forget a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, then 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 for as long as your doctor continues to prescribe it, so that it can continue helping to control your blood sugar. You should not stop taking this medicine without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

STOP taking Tesavel and contact your doctor immediately if you notice any of the following serious adverse effects:

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

If you have a severe allergic reaction (frequency not known), including rash, hives, skin blisters/skin peeling, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and will switch your diabetes treatment.

Some patients experienced the following adverse effects after adding sitagliptin to metformin treatment:

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, diarrhoea, constipation, drowsiness.

Some patients experienced various types of stomach discomfort when starting combination treatment with sitagliptin and metformin together (classified as common frequency).

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

Common: flatulence, swelling of hands or legs

Some patients experienced the following adverse effects while taking sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or legs

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

Common: flu

Uncommon: dry mouth

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

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

Uncommon: dizziness, constipation, itching

Rare: reduction in platelet count

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the blister and outer packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tesavel

• The active substance is sitagliptin:

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

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

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

• The other components are:

• Tablet core: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341), sodium croscarmellose (E468), magnesium stearate (E470b), stearoyl fumarate and sodium propyl gallate.

• Film coating: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).

Appearance of the product and contents of the pack

• The film-coated Tesavel 25 mg tablets are round, pink in colour, marked with “221” on one side.
• The film-coated Tesavel 50 mg tablets are round, light beige in colour, marked with “112” on one side.
• The film-coated Tesavel 100 mg tablets are round, beige in colour, marked with “277” on one side.

Opaque blisters (PVC/PE/PVDC and aluminium). Packs containing 14, 28, 30, 56, 84, 90 or 98 film-coated tablets and 50 x 1 film-coated tablets in pre-cut single-dose blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Further information on this medicinal product is available from the Marketing Authorization Holder's local representative:

Date of the most recent review of this leaflet: {MM/YYYY}.

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