TESAVEL 50 mg film-coated tablets

TESAVEL 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.

TESAVEL 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 TESAVEL is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur.

Your doctor has prescribed TESAVEL to help lower your blood sugar, which is too high because of your type 2 diabetes. TESAVEL 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.

Do not take TESAVEL

• if you are allergic (hypersensitive) to sitagliptin or any of the other ingredients of TESAVEL.

Take special care with TESAVEL

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving TESAVEL. Pancreatitis can be a serious, potentially life-threatening medical condition. Stop taking TESAVEL and call your doctor if you experience severe and persistent stomach pain, with or without vomiting, because you could have pancreatitis.

Tell your doctor if you have or have had:

• pancreatitis, gallstones, alcoholism or very high triglycerides. These medical conditions can increase your chance of getting pancreatitis, or getting it again.
• 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, TESAVEL may not be the right medicine for you.
• an allergic reaction to TESAVEL

If you are taking a sulphonylurea or insulin with TESAVEL you may experience low blood sugar. Your doctor may reduce the dose of your sulphonylurea or insulin medicine.

Taking other medicines
TESAVEL 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 TESAVEL with food and drink
You can take TESAVEL 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 TESAVEL. You should not use TESAVEL during pregnancy.

It is not known if TESAVEL passes into breast milk. You should not use TESAVEL if you are breast-feeding or plan to breast-feed.

Driving and using machines
TESAVEL has no known influence on the ability to drive and use machines. However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.

Taking TESAVEL in combination with medicines called sulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.

Always take TESAVEL 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 TESAVEL alone or with certain other medicines that lower blood sugar.

Continue to take TESAVEL 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 TESAVEL.

If you take more TESAVEL than you should
If you take more than the prescribed dosage of TESAVEL, contact your doctor immediately.

If you forget to take TESAVEL
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 TESAVEL.

Like all medicines, TESAVEL 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 1,000 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 TESAVEL in combination with a sulphonylurea:
Common: low blood sugar

Some patients have experienced the following side effects while taking TESAVEL in combination with a sulphonylurea and metformin:
Very common: low blood sugar
Common: constipation

Some patients have experienced the following side effects while taking TESAVEL and pioglitazone: Common: low blood sugar and flatulence. In addition, some patients have reported foot swelling while taking TESAVEL 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 TESAVEL 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 TESAVEL 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 TESAVEL alone: Common: low blood sugar, headache
Uncommon: dizziness, constipation

In addition, some patients have reported the following side effects while taking TESAVEL: Common: upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain.

During post-approval use of TESAVEL by itself and/or with other diabetes medicines additional 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 TESAVEL and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes. Other side effects that have been reported include: inflammation of the pancreas; kidney problems (sometimes requiring dialysis); vomiting.

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.

Keep out of the reach and sight of children.

Do not use TESAVEL 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 medicine 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.

What TESAVEL contains

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 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 TESAVEL looks like and contents of the pack

Round, light beige film-coated tablet with ?112?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 Merck Sharp Dohme Ltd. Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom The Manufacturer is Merck Sharp Dohme Italia S.p.A. Via Emilia, 21 27100 - Pavia Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiqueBelgiëBelgien Merck Sharp Dohme B.V. Succursale belgeBelgisch bijhuis TélTel 32 0 800 38693 MSDBelgiuminfomerck.com LuxembourgLuxemburg Merck Sharp Dohme B.V. Succursale belgeBelgisch bijhuis Tél 32 0 800 38693 MSDBelgiuminfomerck.com

. 359 2 819 3740 info-msdbgmerck.com Magyarország MSD Magyarország Kft. Tel. 36 1 888 53 00 hungarymsdmerck.com

eská republika Merck Sharp Dohme IDEA, Inc., org. sl. Tel. 420 233 010 111 msdcrmerck.com Malta Merck Sharp Dohme Cyprus Limited Tel 357 22866700 maltainfomerck.com ipru

Danmark Merck Sharp Dohme Tlf 45 43 28 77 66 dkmailmerck.com Nederland Merck Sharp Dohme BV Tel 0800 99 99 000 medicalinfo.nlmerck.com

Deutschland MSD SHARP DOHME GMBH Tel 49 0 89 4561 2612 Infocentermsd.de Norge MSD Norge AS Tlf 47 32 20 73 00 msdnorgemsd.no

Eesti Merck Sharp Dohme OÜ Tel. 372 613 9750 msdeestimerck.com Österreich Merck Sharp Dohme G.m.b.H. Tel 43 0 1 26 044 msd-medizinmerck.com

E BIANE . 3 0210 80091 11 Mailboxvianex.gr Polska MSD Polska Sp. z o.o. Tel. 48 22 549 51 00 msdpolskamerck.com

España Almirall, S.A. Tel 34 93 291 30 00 comercialalmirall.es Portugal Merck Sharp Dohme, Lda Tel 351 21 4465700 informacaodoentemerck.com

France Laboratoires Merck Sharp Dohme Chibret Tél 33 0 1 47 54 87 00 contactmsd-france.com România Merck Sharp Dohme Romania S.R.L. Tel 4021 529 29 00 msdromaniamerck.com

Ireland Merck Sharp and Dohme Ireland Human Health Limited Tel 353 01 2998700 medinfoirelandmerck.com Slovenija Merck Sharp Dohme, inovativna zdravila d.o.o. Tel 386 1 5204201 msdsloveniamerck.com

Ísland Icepharma hf. Sími 354 540 8000 ISmailmerck.com Slovenská republika Merck Sharp Dohme IDEA, Inc. Tel. 421 2 58282010 msdskmerck.com

talia Addenda Pharma S.r.l. Tel. 39 06 91393303 infoaddenda.it SuomiFinland MSD Finland Oy PuhTel 358 0 9 804650 infomsd.fi

Merck Sharp Dohme Cyprus Limited 357 22866700 cyprusinfomerck.com Sverige Merck Sharp Dohme Sweden AB Tel 46 0 8 626 14 00 medicinskinfomerck.com

Latvija SIA Merck Sharp Dohme Latvija Tel 371 67364 224 msdlvmerck.com United Kingdom Merck Sharp and Dohme Limited Tel 44 0 1992 467272 medicalinformationukmerck.com

Lietuva
UAB ?Merck Sharp & Dohme?
Tel.: +370 5 278 02 47msd_lietuva@merck.com

This leaflet was last approved in {MM/YYYY}.

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