Package Insert: Information for the Patient

Sitagliptin Alter 25 mg Film-Coated Tablets

Sitagliptin Alter 50 mg Film-Coated Tablets

Sitagliptin Alter 100 mg Film-Coated Tablets

Sitagliptin

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others 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 package insert. See section 4.

Contents of the package and additional information

Sitagliptina Alter 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 insulin levels 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 can 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 Alter

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take sitagliptin.

Cases of pancreatitis (inflammation of the pancreas) 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 this medication.

Inform your doctor if you have or have had:

• pancreatitis (such as pancreatitis)
• gallstones, alcohol addiction, or very high levels of triglycerides (a type of fat) in your 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 kidney problems 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 work 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 known if this medication is safe and effective when used in children and adolescents under 18 years old.

Other medications and Sitagliptina Alter

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 your 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.

It is unknown if this medication passes into breast milk. Do not take this medication if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

The influence of this medication on your ability to drive or operate machinery is negligible or insignificant. 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 without a secure support point.

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 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 medication with or without food and drinks.

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 essential that you follow the diet and exercise recommended by your doctor while taking sitagliptin.

If you take more Sitagliptina Alter than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20, consult your doctor or pharmacist.

If you forget to take Sitagliptina Alter

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 to compensate for the missed doses.

If you interrupt treatment with Sitagliptina Alter

Continue taking this medication as long as your doctor prescribes it so that it can continue to help 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 medications, this medication may cause side effects, although not everyone will experience them.

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

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

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 may cause difficulty breathing or swallowing, stop taking this medication and consult your doctor immediately. Your doctor will prescribe a medication to treat the allergic reaction and change your medication for diabetes treatment.

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

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

Infrequent (may 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 in combination with a sulfonylurea and metformin:

Very frequent (may 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 in combination with pioglitazone and metformin:

Frequent: swelling of hands or feet

Some patients experienced the following side effects while taking sitagliptin in combination 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 medications for diabetes:

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity and sore throat, arthritis, pain in the arm or leg

Infrequent: dizziness, constipation, itching

Rare: reduction in platelet count

Unknown frequency: kidney problems (which may 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 Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging 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 trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sitagliptin Alter

• The active ingredient is sitagliptin.

Sitagliptin Alter 25 mg: Each film-coated tablet contains 28.3423 mg of sitagliptin hydrochloride equivalent to 25 mg of sitagliptin.

Sitagliptin Alter 50 mg: Each film-coated tablet contains 56.685 mg of sitagliptin hydrochloride equivalent to 50 mg of sitagliptin.

Sitagliptin Alter 100 mg: Each film-coated tablet contains 113.370 mg of sitagliptin hydrochloride equivalent to 100 mg of sitagliptin.

• The other components are: In the tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate, and stearic acid and sodium salt. The tablet coating contains: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), red iron oxide (E172) (25 mg and 100 mg) and yellow iron oxide (E172) (50 mg and 100 mg).

Appearance of the product and contents of the package

Sitagliptin Alter 25 mg: Film-coated tablet, round, biconvex, pink.

Sitagliptin Alter 50 mg: Film-coated tablet, round, biconvex, light yellow.

Sitagliptin Alter 100 mg: Film-coated tablet, round, biconvex, beige.

PVC/PVDC-aluminum blisters.

Sitagliptin Alter 25 mg: Packages of 28 film-coated tablets.

Sitagliptin Alter 50 mg: Packages of 14, 28, 30, 56, 84, 90, and 98 film-coated tablets.

Sitagliptin Alter 100 mg: Packages of 14, 28, 30, 56, 84, 90, and 98 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

SpainSitagliptin Alter film-coated tablets EFG

FranceSITAGLIPTINE ALTER, coated tablet

Last review date of this leaflet:November 2018.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.