sitagliptin: package leaflet

Januvia contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body.
Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine 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 Januvia
- if you are allergic to sitagliptin or 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 receiving Januvia (see section 4).

If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid.
Your doctor may ask you to stop Januvia.
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 form of fat) in your blood.
These medical conditions can increase your chance of getting pancreatitis (see section 4).
- type 1 diabetes
- diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting)
- any past or present kidney problems
- an allergic reaction to Januvia (see section 4)
This medicine is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when this medicine is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur. Your doctor may reduce the dose of your sulphonylurea or insulin medicine.
Children and adolescents
Children and adolescents below 18 years should not use this medicine. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years.
Other medicines and Januvia
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). The level of digoxin in your blood may need to be checked if taking with Januvia.
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.
You should not take this medicine 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 plan 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 drowsiness have been reported, which may affect your ability to drive or use machines.
Taking this medicine 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.
Januvia contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual recommended dose is:
− one 100 mg film-coated tablet
− once a day
− by mouth
If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You can take this medicine with or without food and drink.
Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar.
Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet and exercise recommended by your doctor while taking Januvia.
If you take more Januvia than you should
If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
If you forget to take Januvia
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 this medicine.
If you stop taking Januvia
Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Januvia and contact a doctor immediately if you notice any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).
If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Some patients have experienced the following side effects after adding sitagliptin to 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 ache, diarrhoea, constipation, drowsiness Some patients have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency is common).
Some patients have experienced the following side effects while taking sitagliptin in combination with a sulphonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation

Some patients have experienced the following side effects while taking sitagliptin and pioglitazone:
Common: flatulence, swelling of the hands or legs
Some patients have experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of the hands or legs
Some patients have experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):
Common: flu
Uncommon: dry mouth
Some patients have experienced the following side effects while taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other diabetes medicines:
Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain Uncommon: dizziness, constipation, itching Rare: reduced number of platelets Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister) 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.

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 the carton after ‘EXP’.
The expiry date refers to the last day of that month.
Store below 25 °C.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Januvia contains
- The active substance is sitagliptin:
o
Each Januvia 25 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
o
Each Januvia 50 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
o
Each Januvia 100 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
- The other ingredients are:
o
Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), sodium stearyl fumarate and propyl gallate.

o
Film coating: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
What Januvia looks like and contents of the pack
- Januvia 25 mg film-coated tablets are round, pink film-coated tablets with “221” on one side.
- Januvia 50 mg film-coated tablets are round, light beige film-coated tablets with “112” on one side.
- Januvia 100 mg film-coated tablets are round, beige film-coated tablets with “277” on one side.
Opaque blisters (PVC/PE/PVDC and aluminium). Packs of 14, 28, 30, 56, 84, 90 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
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
MSD Belgium
Tél/Tel: +32(0)27766211 dpoc_belux@msd.com
Lietuva
UAB Merck Sharp & Dohme
Tel. +370 5 2780 247 dpoc_lithuania@msd.com
България
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737 info-msdbg@msd.com
Luxembourg/Luxemburg
MSD Belgium
Tél/Tel: +32(0)27766211 dpoc_belux@msd.com
Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 277 050 000 dpoc_czechslovak@msd.com
Magyarország
MSD Pharma Hungary Kft.
Tel.: +36 1 888 5300 hungary_msd@msd.com
Danmark
MSD Danmark ApS
Tlf.: +45 4482 4000 dkmail@msd.com
Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558) dpoccyprus@msd.com
Deutschland
MSD Sharp & Dohme GmbH
Tel.: +49 (0) 89 20 300 4500 medinfo@msd.de
Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000
(+31 23 5153153) medicalinfo.nl@msd.com
Eesti
Merck Sharp & Dohme OÜ
Tel: +372 614 4200 dpoc.estonia@msd.com
Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00 medinfo.norway@msd.com

Eλλάδα
MSD Α.Φ.Ε.Ε
Τηλ: +30 210 98 97 300 dpoc.greece@msd.com
Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044 dpoc_austria@msd.com
España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00 msd_info@msd.com
Polska
MSD Polska Sp. z o.o.
Tel.: +48 22 549 51 00 msdpolska@msd.com
France
MSD France
Tél: +33 (0)1 80 46 40 40
Portugal
Merck Sharp & Dohme, Lda
Tel.: +351 21 4465700 inform_pt@msd.com
Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: +385 1 6611 333 dpoc.croatia@msd.com
România
Merck Sharp & Dohme Romania S.R.L.
Tel.: +40 21 529 29 00 msdromania@msd.com
Ireland
Merck Sharp & Dohme Ireland (Human Health)
Limited
Tel: +353 (0)1 2998700 medinfo_ireland@msd.com
Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386 1 520 4201 msd.slovenia@msd.com
Ísland
Vistor ehf.
Sími: +354 535 7000
Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel.: +421 2 58282010 dpoc_czechslovak@msd.com
Ιtalia
MSD Italia S.r.l.
Tel: 800 23 99 89 (+39 06 361911) dpoc.italy@msd.com
Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650 info@msd.fi
Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700) dpoccyprus@msd.com
Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488 medicinskinfo@msd.com
Latvija
SIA Merck Sharp & Dohme Latvija
Tel.: +371 67025300 dpoc.latvia@msd.com
This leaflet was last revised in {MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

Ristaben contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body.
Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine 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 Ristaben
- if you are allergic to sitagliptin or 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 receiving Ristaben (see section 4).

If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid.
Your doctor may ask you to stop Ristaben.
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 form of fat) in your blood.
These medical conditions can increase your chance of getting pancreatitis (see section 4).
- type 1 diabetes
- diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting)
- any past or present kidney problems
- an allergic reaction to Ristaben (see section 4)
This medicine is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when this medicine is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur. Your doctor may reduce the dose of your sulphonylurea or insulin medicine.
Children and adolescents
Children and adolescents below 18 years should not use this medicine. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than10 years.
Other medicines and Ristaben
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). The level of digoxin in your blood may need to be checked if taking with Ristaben.
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.
You should not take this medicine 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 plan 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 drowsiness have been reported, which may affect your ability to drive or use machines.
Taking this medicine 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.
Ristaben contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual recommended dose is:
− one 100 mg film-coated tablet
− once a day
− by mouth
If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You can take this medicine with or without food and drink.
Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar.
Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet and exercise recommended by your doctor while taking Ristaben.
If you take more Ristaben than you should
If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
If you forget to take Ristaben
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 this medicine.
If you stop taking Ristaben
Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Ristaben and contact a doctor immediately if you notice any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).
If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Some patients have experienced the following side effects after adding sitagliptin to 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 ache, diarrhoea, constipation, drowsiness Some patients have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency is common).
Some patients have experienced the following side effects while taking sitagliptin in combination with a sulphonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation

Some patients have experienced the following side effects while taking sitagliptin and pioglitazone:
Common: flatulence, swelling of the hands or legs
Some patients have experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of the hands or legs
Some patients have experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):
Common: flu
Uncommon: dry mouth
Some patients have experienced the following side effects while taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other diabetes medicines:
Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain Uncommon: dizziness, constipation, itching Rare: reduced number of platelets Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister) 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.

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 the carton after 'EXP'.
The expiry date refers to the last day of that month.
Store below 25 °C.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ristaben contains
- The active substance is sitagliptin:
o
Each Ristaben 25 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
o
Each Ristaben 50 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
o
Each Ristaben 100 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
- The other ingredients are:
o
Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), sodium stearyl fumarate and propyl gallate.

o
Film coating: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
What Ristaben looks like and contents of the pack
- Ristaben 25 mg film-coated tablets are round, pink film-coated tablets with “221” on one side.
- Ristaben 50 mg film-coated tablets are round, light beige film-coated tablets with “112” on one side.
- Ristaben 100 mg film-coated tablets are round, beige film-coated tablets with “277” on one side.
Opaque blisters (PVC/PE/PVDC and aluminium). Packs of 14, 28, 30, 56, 84, 90 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
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
MSD Belgium
Tél/Tel: +32(0)27766211 dpoc_belux@msd.com
Lietuva
UAB Merck Sharp & Dohme
Tel. +370 5 2780 247 dpoc_lithuania@msd.com
България
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737 info-msdbg@msd.com
Luxembourg/Luxemburg
MSD Belgium
Tél/Tel: +32(0)27766211 dpoc_belux@msd.com
Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 277 050 000 dpoc_czechslovak@msd.com
Magyarország
MSD Pharma Hungary Kft.
Tel.: +36 1 888 5300 hungary_msd@msd.com
Danmark
MSD Danmark ApS
Tlf.: +45 4482 4000 dkmail@msd.com
Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558) dpoccyprus@msd.com
Deutschland
MSD Sharp & Dohme GmbH
Tel.: +49 (0) 89 20 300 4500 medinfo@msd.de
Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000
(+31 23 5153153) medicalinfo.nl@msd.com
Eesti
Merck Sharp & Dohme OÜ
Tel: +372 614 4200 dpoc.estonia@msd.com
Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00 medinfo.norway@msd.com

Eλλάδα
MSD Α.Φ.Ε.Ε.
Τηλ: +30 210 98 97 300 dpoc.greece@msd.com
Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044 dpoc_austria@msd.com
España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00 msd_info@msd.com
Polska
MSD Polska Sp. z o.o.
Tel.: +48 22 549 51 00 msdpolska@msd.com
France
MSD France
Tél: +33 (0)1 80 46 40 40
Portugal
Merck Sharp & Dohme, Lda
Tel.: +351 21 4465700 inform_pt@msd.com
Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: +385 1 6611 333 dpoc.croatia@msd.com
România
Merck Sharp & Dohme Romania S.R.L.
Tel.: +40 21 529 29 00 msdromania@msd.com
Ireland
Merck Sharp & Dohme Ireland (Human Health)
Limited
Tel: +353 (0)1 2998700 medinfo_ireland@msd.com
Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386 1 520 4201 msd.slovenia@msd.com
Ísland
Vistor ehf.
Sími: +354 535 7000
Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel.: +421 2 58282010 dpoc_czechslovak@msd.com
Ιtalia
MSD Italia S.r.l.
Tel: 800 23 99 89 (+39 06 361911) dpoc.italy@msd.com
Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650 info@msd.fi
Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700) dpoccyprus@msd.com
Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488 medicinskinfo@msd.com
Latvija
SIA Merck Sharp & Dohme Latvija
Tel.: +371 67025300 dpoc.latvia@msd.com
This leaflet was last revised in {MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

Tesavel contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body.
Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine 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 to sitagliptin or 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 receiving Tesavel (see section 4).

If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid.
Your doctor may ask you to stop 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 form of fat) in your blood.
These medical conditions can increase your chance of getting pancreatitis (see section 4).
- type 1 diabetes
- diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting)
- any past or present kidney problems
- an allergic reaction to Tesavel (see section 4)
This medicine is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when this medicine is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur. Your doctor may reduce the dose of your sulphonylurea or insulin medicine.
Children and adolescents
Children and adolescents below 18 years should not use this medicine. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years.
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). The level of digoxin in your blood may need to be checked if taking with Tesavel.
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.
You should not take this medicine 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 plan 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 drowsiness have been reported, which may affect your ability to drive or use machines.
Taking this medicine 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.
Tesavel contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual recommended dose is:
− one 100 mg film-coated tablet
− once a day
− by mouth
If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You can take this medicine with or without food and drink.
Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar.
Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet and exercise recommended by your doctor while taking Tesavel.
If you take more Tesavel than you should
If you take more than the prescribed dosage of this medicine, 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 this medicine.
If you stop taking Tesavel
Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Tesavel and contact a doctor immediately if you notice any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).
If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Some patients have experienced the following side effects after adding sitagliptin to 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 ache, diarrhoea, constipation, drowsiness Some patients have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency is common).
Some patients have experienced the following side effects while taking sitagliptin in combination with a sulphonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation

Some patients have experienced the following side effects while taking sitagliptin and pioglitazone:
Common: flatulence, swelling of the hands or legs
Some patients have experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of the hands or legs
Some patients have experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):
Common: flu
Uncommon: dry mouth
Some patients have experienced the following side effects while taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other diabetes medicines:
Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain Uncommon: dizziness, constipation, itching Rare: reduced number of platelets Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister) 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.

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 the carton after 'EXP'.
The expiry date refers to the last day of that month.
Store below 25 °C.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tesavel contains
- The active substance is sitagliptin:
o
Each Tesavel 25 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
o
Each Tesavel 50 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
o
Each Tesavel 100 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
- The other ingredients are:
o
Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), sodium stearyl fumarate and propyl gallate.

o
Film coating: poly(vinyl 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
- Tesavel 25 mg film-coated tablets are round, pink film-coated tablets with “221” on one side.
- Tesavel 50 mg film-coated tablets are round, light beige film-coated tablets with “112” on one side.
- Tesavel 100 mg film-coated tablets are round, beige film-coated tablets with “277” on one side.
Opaque blisters (PVC/PE/PVDC and aluminium). Packs of 14, 28, 30, 56, 84, 90 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
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
MSD Belgium
Tél/Tel: +32(0)27766211 dpoc_belux@msd.com
Lietuva
UAB Merck Sharp & Dohme
Tel. +370 5 2780 247 dpoc_lithuania@msd.com
България
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737 info-msdbg@msd.com
Luxembourg/Luxemburg
MSD Belgium
Tél/Tel: +32(0)27766211 dpoc_belux@msd.com
Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 277 050 000 dpoc_czechslovak@msd.com
Magyarország
MSD Pharma Hungary Kft.
Tel.: +36 1 888 5300 hungary_msd@msd.com
Danmark
MSD Danmark ApS
Tlf.: +45 4482 4000 dkmail@msd.com
Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558) dpoccyprus@msd.com
Deutschland
MSD Sharp & Dohme GmbH
Tel.: +49 (0) 89 20 300 4500 medinfo@msd.de
Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000
(+31 23 5153153) medicalinfo.nl@msd.com
Eesti
Merck Sharp & Dohme OÜ
Tel: +372 614 4200 dpoc.estonia@msd.com
Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00 medinfo.norway@msd.com

Eλλάδα
MSD Α.Φ.Ε.Ε.
Τηλ: +30 210 98 97 300 dpoc.greece@msd.com
Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044 dpoc_austria@msd.com
España
Almirall, S.A.
Tel: +34 93 291 30 00 info.spain@almirall.com
Polska
MSD Polska Sp. z o.o.
Tel.: +48 22 549 51 00 msdpolska@msd.com
France
MSD France
Tél: +33 (0)1 80 46 40 40
Portugal
Merck Sharp & Dohme, Lda
Tel.: +351 21 4465700 inform_pt@msd.com
Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: +385 1 6611 333 dpoc.croatia@msd.com
România
Merck Sharp & Dohme Romania S.R.L.
Tel.: +40 21 529 29 00 msdromania@msd.com
Ireland
Merck Sharp & Dohme Ireland (Human Health)
Limited
Tel: +353 (0)1 2998700 medinfo_ireland@msd.com
Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386 1 520 4201 msd.slovenia@msd.com
Ísland
Vistor ehf.
Sími: +354 535 7000
Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel.: +421 2 58282010 dpoc_czechslovak@msd.com
Ιtalia
MSD Italia S.r.l.
Tel: 800 23 99 89 (+39 06 361911) dpoc.italy@msd.com
Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650 info@msd.fi
Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700) dpoccyprus@msd.com
Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488 medicinskinfo@msd.com
Latvija
SIA Merck Sharp & Dohme Latvija
Tel.: +371 67025300 dpoc.latvia@msd.com
This leaflet was last revised in {MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

Xelevia contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body.
Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine 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 Xelevia
- if you are allergic to sitagliptin or 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 receiving Xelevia (see section 4).

If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid.
Your doctor may ask you to stop 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 form of fat) in your blood.
These medical conditions can increase your chance of getting pancreatitis (see section 4).
- type 1 diabetes
- diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting)
- any past or present kidney problems
- an allergic reaction to Xelevia (see section 4)
This medicine is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when this medicine is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur. Your doctor may reduce the dose of your sulphonylurea or insulin medicine.
Children and adolescents
Children and adolescents below 18 years should not use this medicine. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years.
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). The level of digoxin in your blood may need to be checked if taking with 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.
You should not take this medicine 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 plan 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 drowsiness have been reported, which may affect your ability to drive or use machines.
Taking this medicine 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.
Xelevia contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual recommended dose is:
− one 100 mg film-coated tablet
− once a day
− by mouth
If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
You can take this medicine with or without food and drink.
Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar.
Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet and exercise recommended by your doctor while taking Xelevia.
If you take more Xelevia than you should
If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
If you forget to take Xelevia
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 this medicine.
If you stop taking Xelevia
Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Xelevia and contact a doctor immediately if you notice any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).
If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Some patients have experienced the following side effects after adding sitagliptin to 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 ache, diarrhoea, constipation, drowsiness Some patients have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency is common).
Some patients have experienced the following side effects while taking sitagliptin in combination with a sulphonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation

Some patients have experienced the following side effects while taking sitagliptin and pioglitazone:
Common: flatulence, swelling of the hands or legs
Some patients have experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of the hands or legs
Some patients have experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):
Common: flu
Uncommon: dry mouth
Some patients have experienced the following side effects while taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other diabetes medicines:
Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain Uncommon: dizziness, constipation, itching Rare: reduced number of platelets Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister) 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.

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 the carton after ‘EXP’.
The expiry date refers to the last day of that month.
Store below 25 °C.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Xelevia contains
- The active substance is sitagliptin:
o
Each Xelevia 25 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
o
Each Xelevia 50 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
o
Each Xelevia 100 mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
- The other ingredients are:
o
Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), sodium stearyl fumarate and propyl gallate.

o
Film coating: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
What Xelevia looks like and contents of the pack
- Xelevia 25 mg film-coated tablets are round, pink film-coated tablets with “221” on one side.
- Xelevia 50 mg film-coated tablets are round, light beige film-coated tablets with “112” on one side.
- Xelevia 100 mg film-coated tablets are round, beige film-coated tablets with “277” on one side.
Opaque blisters (PVC/PE/PVDC and aluminium). Packs of 14, 28, 30, 56, 84, 90 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
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
MSD Belgium
Tél/Tel: +32(0)27766211 dpoc_belux@msd.com
Lietuva
UAB Merck Sharp & Dohme
Tel. +370 5 2780 247 dpoc_lithuania@msd.com
България
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737 info-msdbg@msd.com
Luxembourg/Luxemburg
MSD Belgium
Tél/Tel: +32(0)27766211 dpoc_belux@msd.com
Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 277 050 000 dpoc_czechslovak@msd.com
Magyarország
MSD Pharma Hungary Kft.
Tel.: +36 1 888 5300 hungary_msd@msd.com
Danmark
MSD Danmark ApS
Tlf.: +45 4482 4000 dkmail@msd.com
Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558) dpoccyprus@msd.com
Deutschland
BERLIN-CHEMIE AG
Tel: +49 (0) 30 67070
Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000
(+31 23 5153153) medicalinfo.nl@msd.com
Eesti
Merck Sharp & Dohme OÜ
Tel: +372 614 4200 dpoc.estonia@msd.com
Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00 medinfo.norway@msd.com

Eλλάδα
MSD Α.Φ.Ε.Ε.
Τηλ: +30 210 98 97 300 dpoc.greece@msd.com
Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044 dpoc_austria@msd.com
España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00 msd_info@msd.com
Polska
MSD Polska Sp. z o.o.
Tel.: +48 22 549 51 00 msdpolska@msd.com
France
MSD France
Tél: +33 (0)1 80 46 40 40
Portugal
Merck Sharp & Dohme, Lda
Tel.: +351 21 4465700 inform_pt@msd.com
Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: +385 1 6611 333 dpoc.croatia@msd.com
România
Merck Sharp & Dohme Romania S.R.L.
Tel.: +40 21 529 29 00 msdromania@msd.com
Ireland
Merck Sharp & Dohme Ireland (Human Health)
Limited
Tel: +353 (0)1 2998700 medinfo_ireland@msd.com
Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386 1 520 4201 msd.slovenia@msd.com
Ísland
Vistor ehf.
Sími: +354 535 7000
Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel.: +421 2 58282010 dpoc_czechslovak@msd.com
Ιtalia
Neopharmed Gentili S.p.A.
Tel: +39 02891321 regulatory@neogen.it
Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650 info@msd.fi
Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700) dpoccyprus@msd.com
Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488 medicinskinfo@msd.com
Latvija
SIA Merck Sharp & Dohme Latvija
Tel.: +371 67025300 dpoc.latvia@msd.com
This leaflet was last revised in {MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.