Prospect: 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 this prospect carefully before starting to take this medicine, as it contains important information for you.

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

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

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

3.How to take Sitagliptin SUN

4.Possible adverse effects

5.Storage of Sitagliptin SUN

6.Contents of the package and additional information

Sitagliptina SUN contains the active ingredient sitagliptin, which belongs to a class of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes mellitus.

This medication helps to increase the levels of insulin produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medication to help you reduce your blood sugar, which is too high due to your type 2 diabetes. This medication may be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones) that reduce blood sugar, and 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 disease that consists of your body not producing enough insulin, and the insulin it produces not working as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) accumulates in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

Do not take Sitagliptina SUN

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

Warnings and precautions

Cases of pancreatitis have been reported in patients treated with sitagliptin (see section 4).

If you notice blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptina SUN.

Inform your doctor if you have or have had:

• a pancreatic disease (such as pancreatitis)
• gallstones, alcohol addiction, or very high levels of triglycerides in the blood (a type of fat). 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 kidney problem you currently have or have had in the past
• an allergic reaction to sitagliptin (see section 4)

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

Children and adolescents

Children and adolescents under 18 years old should not use this medication. It is not effective in children and adolescents aged 10 to 17 years. The safety and efficacy of this medication in children under 10 years old are unknown.

Use of Sitagliptina SUN with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor if you are taking digoxin (a medication used to treat irregular heartbeat and other heart problems). Your digoxin level in the blood may need to be checked if you are taking sitagliptin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. This medication should not be taken during pregnancy.

The safety of this medication during breastfeeding is unknown. Do not take this medication if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

The influence of this medication on the ability to drive or operate machinery is negligible. However, dizziness and somnolence have been reported, which may affect your ability to drive or operate machinery.

Additionally, taking this medication with medications called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work safely without support.

Sitagliptina SUN contains sodium

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

Sitagliptina SUN contains hydrogenated castor oil

It may cause stomach discomfort and diarrhea.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual recommended dose is:

-one film-coated tablet of 100 mg

-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 medication with or without food.

Your doctor may prescribe this medication alone or with other medications that also lower blood sugar.

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

If you take more Sitagliptina SUN than you should

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

If you forget to take Sitagliptina SUN

If you forget a dose, take it as soon as you remember. If you do not remember until the time of the next dose, then skip the missed dose and continue with your regular schedule. Do not take a double dose of this medication.

If you interrupt treatment with Sitagliptina SUN

Continue taking this medication as long as your doctor prescribes it for you to continue helping to control your blood sugar. You should not stop taking this medication without first consulting your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

STOP taking sitagliptin and see your doctor immediately if you notice any of the following serious side effects:

• Intense and persistent pain in the abdomen (stomach area) that can reach the back with or without nausea and vomiting, as these can be signs of pancreatitis inflammation.

If you have a severe allergic reaction (unknown frequency), including skin rash, urticaria, blisters on the skin/skin peeling and swelling of the face, lips, tongue, and throat that can 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 the medicine for diabetes treatment.

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

Frequent (can affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting

Infrequent (can affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.

Some patients experienced different types of stomach discomfort when they started taking sitagliptin and metformin together (classified as frequent).

Some patients experienced the following side effects while taking sitagliptin with a sulfonylurea and metformin:

Very frequent (can affect more than 1 in 10 people): low blood sugar Frequent: constipation

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

Frequent: flatulence, swelling of hands or feet

Some patients experienced the following side effects while taking sitagliptin with pioglitazone and metformin:

Frequent: swelling of hands or feet

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

Frequent: flu

Infrequent: dry mouth

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

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity and sore throat, arthritis, arm or leg pain Infrequent: dizziness, constipation, itching

Rare: reduction in platelet count

Unknown frequency: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blister on the skin)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the carton after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Sitagliptin SUN

• The active ingredient is sitagliptin:

orEach Sitagliptin SUN 25 mg film-coated tablet contains

sitagliptin fumarate equivalent to 25 mg of sitagliptin.

or Each Sitagliptin SUN 50 mg film-coated tablet contains sitagliptin fumarate equivalent to 50 mg of sitagliptin.

or Each Sitagliptin SUN 100 mg film-coated tablet contains sitagliptin fumarate equivalent to 100 mg of sitagliptin.

• The other components are:

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

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

Appearance of the product and contents of the pack

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

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

The film-coated tablets of Sitagliptin SUN are also available in packs containing a HDPE bottle with 90 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Responsible Person

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Terapia S.A.

Str. Fabricii nr. 124

Cluj-Napoca, 400632

Romania

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Deutschland

Sun Pharmaceuticals Germany GmbH

Hemmelrather Weg 201

51377 Leverkusen

Germany

Phone +49 214 403 990

España

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Phone +34 93 342 78 90

France

Sun Pharma France

31 rue des Poissonniers

92200 Neuilly-sur-Seine France

Phone +33 1 41 44 44 50

Italia

Sun Pharma Italia Srl

Viale Giulio Richard, 1

20143 Milano

Italy

Phone +39 02 33 49 07 93

Polska

Ranbaxy (Poland) Sp. z o. o.

ul. Idzikowskiego

16 00-710 Warszawa Polska

Phone +48 22 642 07 75

România

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Judetul Cluj

Romania

Phone +40 (264) 501 500

Last update of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.