Velmetia 50 mg/850 mg film-coated tablets

The name of your tablet is Velmetia. It contains two different medicines called sitagliptin and metformin.

• sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• metformin belongs to a class of medicines called biguanides.

They work together to control blood sugar levels in patients with a form of diabetes called ?type 2 diabetes mellitus?. Velmetia helps to improve the levels of insulin after a meal and lowers the amount of sugar made by your body.

Along with diet and exercise, this medicine helps lower your blood sugar. Velmetia can be used alone or with certain other medicines for diabetes (insulin, sulphonylureas, or glitazones).

What is type 2 diabetes?

Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM. 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 Velmetia:

• if you are allergic (hypersensitive) to sitagliptin or metformin or any of the other ingredients of Velmetia (listed in section 6)
• if you have diabetic ketoacidosis (a complication of diabetes with rapid weight loss, nausea or vomiting) or have had a diabetic coma
• if you have problems with your kidneys
• if you have a severe infection or are dehydrated
• if you are going to have an X-ray where you will be injected with a dye. You will need to stop taking Velmetia at the time of the X-ray and for a few days after
• if you have recently had a heart attack or have severe circulatory problems, such as ?shock? or breathing difficulties
• if you have liver problems
• if you drink alcohol to excess (either every day or only from time to time)
• if you are breast-feeding

Do not take Velmetia if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Velmetia.

Take special care with Velmetia

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

Check with your doctor or pharmacist before taking your medicine:

• if you have or had pancreatitis, gallstones, alcoholism or very high triglycerides. These medical conditions can increase your chance of getting pancreatitis, or getting it again.
• if you have type 1 diabetes. This is sometimes called insulin-dependent diabetes
• if you experience some of the following symptoms: feeling cold or uncomfortable, severe nausea or vomiting, abdominal pain, unexplained weight loss, muscular cramps, or rapid breathing. Metformin hydrochloride, one of theingredients in Velmetia, can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. If you experience some of the symptoms of lactic acidosis stop taking Velmetia and consult a doctor immediately
• During treatment with Velmetia, your doctor will check your kidney function at least once a year and more frequently if you are elderly or if your kidney function is borderline or at risk of worsening
• if you have or have had an allergic reaction to sitagliptin, metformin, or Velmetia
• if you are taking a sulphonylurea or insulin, diabetes medicines, together with Velmetia, as you may experience low blood sugar levels (hypoglycaemia). Your doctor may reduce the dose of your sulphonylurea or insulin
• if you are going to have an operation undergeneral, spinal or epidural anaesthetic. You may need to stop taking Velmetia for a couple of days before and after the procedure
• if you are under 18 years of age

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Velmetia.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

The following medicines are particularly important:

• medicines used to treat diseases that involve inflammation, like asthma and arthritis (corticosteroids)
• specific medicines for the treatment of high blood pressure (ACE inhibitors)
• medicines which increase urine production (diuretics)
• specific medicines for the treatment of bronchial asthma (?-sympathomimetics)
• iodinated contrast agents or alcohol-containing medicines.

Taking Velmetia with food and drink
Take Velmetia with meals to lower your chance of an upset stomach.

Pregnancy and breast-feeding

Women who are pregnant or plan to become pregnant should talk to their doctor before taking Velmetia. You should not use Velmetia during pregnancy.

Metformin passes into human milk in small amounts. It is not known whether sitagliptin passes into human milk. It is not known if Velmetia passes into human breast milk. You must not use Velmetia if you are breast-feeding or plan to breast-feed.

Driving and using machines
Velmetia 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 with sitagliptin.

Taking Velmetia 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 Velmetia exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

• Velmetia should be taken:
• twice daily by mouth
• with meals to lower your chance of an upset stomach.
• Your doctor may need to increase your dose to control your blood sugar.
• Continue to take Velmetia as long as your doctor prescribes it so you can continue to help control your blood sugar.

You should continue your diet during treatment with Velmetia and take care that your carbohydrate intake is equally distributed over the day. If you are overweight continue your energy-restricted diet as instructed.

Velmetia alone is unlikely to cause abnormally low blood sugar (hypoglycaemia). When Velmetia is used with a sulphonylurea medicine or with insulin, low blood sugar can occur and your doctor may reduce the dose of your sulphonylurea or insulin.

Sometimes you may need to stop taking your medicine for a short time. Talk to your doctor for instructions if you:

• have a condition that may be associated with dehydration (large loss of body fluids) such as being sick with severe vomiting, diarrhoea or fever, or if you drink fluids a lot less than normal
• plan to have surgery
• are due to get an injection of dye or contrast agent as part of an X-ray

If you take more Velmetia than you should

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

If you forget to take Velmetia
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 Velmetia.

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

Like all medicines, Velmetia may cause side effects, although not everybody gets them.

Very rarely patients taking metformin (one of the active substances of Velmetia) have experienced a serious condition called lactic acidosis (too much lactic acid in your blood). This is more common in people whose kidneys are not working properly. Stop taking Velmetia and see a doctor straight away if you notice any of the following symptoms:

• feeling sick (nausea) or being sick (vomiting), abdominal pain, muscular cramps, unexplained weight loss, rapid breathing, and feeling cold or uncomfortable.

Very common side effects (likely to occur in more than 1 per 10 patients).
Common side effects (likely to occur in less than 1 per 10 but more than 1 per 100 patients). Uncommon side effects (likely to occur in less than 1 per 100 but more than 1 per 1,000 patients). Rare side effects (likely to occur in less than 1 per 1,000 but more than 1 per 10,000). Very rare side effects (likely to occur in less than 1 per 10,000).

Some patients taking metformin have experienced the following side effects after starting sitagliptin: 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 Velmetia with a sulphonylurea:
Very common: low blood sugar
Common: constipation

Some patients have experienced the following side effects while taking Velmetia in combination with rosiglitazone:
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 Velmetia in combination with insulin:
Very common: low blood sugar
Uncommon: dry mouth, headache

Some patients have experienced the following side effects while taking sitagliptin alone: Common: low blood sugar, headache
Uncommon: dizziness, constipation

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

During post-approval use with Velmetia or sitagliptin, one of the medicines in Velmetia, additional side effects have also been reported (frequency not known). These side effects have been reported when Velmetia or sitagliptin have been used alone and/or as part of combination therapy: 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 Velmetia 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.

Some patients have experienced the following side effects while taking metformin alone: Very common: nausea, vomiting, diarrhoea, abdominal pain and loss of appetite
Common: a metallic taste
Very rare: decreased vitamin B12 levels, hepatitis (a problem with your liver), redness of the skin (rash) or itching, lactic acidosis (excess of lactic acid in your blood) particularly in patients whose kidneys are not working properly. The symptoms include feeling cold or uncomfortable, severe nausea or vomiting, abdominal pain, unexplained weight loss, or rapid breathing

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 Velmetia after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of the month.

Do not store above 30°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 to protect the environment.

What Velmetia contains

• The active substances are sitagliptin and metformin. Each film-coated tablet contains 50 mg of sitagliptin (as phosphate monohydrate) and 850 mg of metformin hydrochloride.
• The other ingredients are: microcrystalline cellulose (E460), povidone K 29/32 (E1201), sodium lauril sulfate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172).

What Velmetia looks like and contents of the pack

Capsule-shaped, pink film-coated tablet with ?515? debossed on one side.

Opaque blisters (PVC/PE/PVDC and aluminum). Packs of 14, 28, 56, 112, 168, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) film-coated tablets. Pack of 50 x 1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Manufacturer Merck Sharp Dohme BV Waarderweg 39 2031 BN, Haarlem, Netherlands Marketing Authorisation Holder Merck Sharp Dohme Ltd. Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom

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

BelgiëBelgiqueBelgien Merck Sharp Dohme B.V. Succursale belgeBelgisch bijhuis TélTel 32 0 800 386 93 MSDBelgiuminfomerck.com LuxembourgLuxemburg Merck Sharp Dohme B.V. Succursale belge Tél 32 0 800 386 93 MSDBelgiuminfomerck.com

. 359 2 819 3740 info-msdbgmerck.com Magyarország EGIS Gyógyszergyár NyRT Tel. 36 1 265 55 55 mailboxegis.hu

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 BERLIN-CHEMIE AG Tel 49 0 30 67070 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 Ferrer Internacional, S.A. Tel 34 93 600 37 00 medicaldepferrergrupo.com Portugal LABORATÓRIO MEDINFAR, Produtos, Farmacêuticos, SA Tel 351 800204661 medinfarmedinfar.pt

France Pierre Fabre Médicament Tél 33 0 1 49 10 80 00 România Merck Sharp Dohme Romania S.R.L. Tel 4021 529 29 00 msdromaniamerck.com

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

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

SuomiFinland Orion Oyj Puh.Tel 358 10 4261 talia Istituto Gentili S.p.A. Tel 39 06 361911 doccenmerck.com

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 7364 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}.