SITAGLIPTIN SUN 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sitagliptin SUN 25 mg film-coated tablets

Sitagliptin SUN 50 mg film-coated tablets

Sitagliptin SUN 100 mg 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 Sitagliptin SUN and what is it used for
2. What you need to know before you take Sitagliptin SUN
3. How to take Sitagliptin SUN
4. Possible side effects
5. Storage of Sitagliptin SUN
6. Contents of the pack and other information

1. What is Sitagliptin SUN and what is it used for

Sitagliptin SUN 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, which 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 where 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 cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

2. What you need to know before you take Sitagliptin SUN

Do not take Sitagliptin SUN

• 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 sitagliptin (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 Sitagliptin SUN.

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 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 sitagliptin (see section 4)

It is unlikely that this medicine will cause low blood sugar because it does not work when 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.

Using Sitagliptin SUN with other medicines

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 your digoxin blood levels if you are taking sitagliptin.

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. 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 breastfeeding or planning to breastfeed.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible or minimal. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

Also, taking this medicine with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive or use machines or work without a secure support.

Sitagliptin SUN contains sodium

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

Sitagliptin SUN contains hydrogenated castor oil

It may cause stomach upset and diarrhea.

3. How to take Sitagliptin SUN

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The 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.

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

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

If you take more Sitagliptin SUN than you should

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

If you forget to take Sitagliptin SUN

If you forget a dose, take it as soon as you remember. If you do not remember until the time of 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 Sitagliptin SUN

Continue taking this medicine as long as your doctor prescribes it to you to help control your blood sugar levels. You should not stop taking this medicine without consulting your doctor first.

If you have any other questions about 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 sitagliptin and contact your doctor immediatelyif you notice 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 consult your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and change your medicine for 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, somnolence.

Some patients experienced different types of stomach discomfort when starting the combination of 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 in combination with 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 after approval, alone and/or with other diabetes medicines:

Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion, and sore throat, arthrosis, pain in the arm or leg Uncommon: dizziness, constipation, itching

Rare: reduced platelet count

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

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 Sitagliptin SUN

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 is the last day of the month stated.

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 protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin SUN

• The active substance is sitagliptin:

o Each Sitagliptin SUN 25 mg film-coated tablet contains sitagliptin phosphate equivalent to 25 mg of sitagliptin.

o Each Sitagliptin SUN 50 mg film-coated tablet contains sitagliptin phosphate equivalent to 50 mg of sitagliptin.

o Each Sitagliptin SUN 100 mg film-coated tablet contains sitagliptin phosphate equivalent to 100 mg of sitagliptin.

• The other ingredients are:

o Tablet core: calcium phosphate (E341), crospovidone type A (E1202), hydrogenated castor oil, glycerol dibehenate, magnesium stearate (E470b).

o Film coating: hypromellose 2910/5 (E464), titanium dioxide (E171), macrogol 6000 (E1521), talc (E553b), red iron oxide (E172), and yellow iron oxide (E172).

Appearance and packaging

• Sitagliptin SUN 25 mg film-coated tablets are round, light pink, approximately 6 mm x 3 mm in size, engraved with F1 on one side and smooth on the other.
• Sitagliptin SUN 50 mg film-coated tablets are round, light beige, approximately 8 mm x 4 mm in size, engraved with F2 on one side and smooth on the other.
• Sitagliptin SUN 100 mg film-coated tablets are round, beige, approximately 10 mm x 4.5 mm in size, engraved with F3 on one side and smooth on the other.

Sitagliptin SUN film-coated tablets are packaged in PA/Alu/PE + desiccant/HDPE/Alu blisters. They are available in packs of 28, 56, or 98 film-coated tablets.

Sitagliptin SUN film-coated tablets are also available in packs of 90 film-coated tablets in an HDPE bottle.

Not all pack sizes may be marketed.

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Terapia S.A.

Str. Fabricii nr. 124

Cluj-Napoca, 400632

Romania

You can request more information about this medicine from your local representative of the marketing authorisation holder:

Germany

Sun Pharmaceuticals Germany GmbH

Hemmelrather Weg 201

51377 Leverkusen

Germany

Tel. +49 214 403 990

Spain

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Tel. +34 93 342 78 90

France

Sun Pharma France

31 rue des Poissonniers

92200 Neuilly-sur-Seine France

Tel. +33 1 41 44 44 50

Italy

Sun Pharma Italia Srl

Viale Giulio Richard, 1

20143 Milano

Italy

Tel. +39 02 33 49 07 93

Poland

Ranbaxy (Poland) Sp. z o. o.

ul. Idzikowskiego

16 00-710 Warszawa Poland

Tel. +48 22 642 07 75

Romania

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Judetul Cluj

Romania

Tel. +40 (264) 501 500

Date of last revision of this leaflet:

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