SITAGLIPTIN ALTER 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sitagliptina Alter 25 mg film-coated tablets EFG

Sitagliptina Alter 50 mg film-coated tablets EFG

Sitagliptina Alter 100 mg film-coated tablets EFG

Sitagliptina

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

1. What is Sitagliptina Alter and what is it used for

Sitagliptina Alter 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 amounts 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 levels, which are 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, and that 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 condition 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 lead to serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

2. What you need to know before you take Sitagliptina Alter

Do not take Sitagliptina Alter

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take sitagliptin.

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 this medicine.

Tell your doctor if you have or have had:

• a pancreatic disease (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 kidney problem you have now or have had in the past
• 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 known if this medicine is safe and effective when used in children and adolescents under 18 years of age.

Other medicines and Sitagliptina Alter

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 the level of digoxin in your blood 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.

This medicine should not be taken 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. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.

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

3. How to take Sitagliptina Alter

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, ask 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 and drinks.

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

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

If you take more Sitagliptina Alter than you should

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

In case of overdose or accidental ingestion, contact 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 make up for the missed doses.

If you stop taking Sitagliptina Alter

Continue to take this medicine as long as your doctor tells you to, so that you can continue to control your blood sugar levels. You should not stop taking this medicine without first talking to your doctor.

If you have any further questions on 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 a 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, drowsiness.

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 or runny nose, 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 to the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptina Alter

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 carton after “EXP”. The expiry date refers to the last day of the month shown.

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 Sitagliptina Alter

• The active substance is sitagliptin.

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

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

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

• The other ingredients are: In the tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate, and sodium fumarate. 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 and packaging

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

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

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

PVC/PVDC-aluminum blisters.

Sitagliptina Alter 25 mg: Packs of 28 film-coated tablets.

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain Sitagliptina Alter film-coated tablets EFG

France SITAGLIPTINE ALTER, film-coated tablet

Date of last revision of this leaflet:November 2018.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.