Sitagliptin Alter 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sitagliptin Alter 25 mg film-coated tablets EFG

Sitagliptin Alter 50 mg film-coated tablets EFG

Sitagliptin Alter 100 mg film-coated tablets EFG

Sitagliptin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents

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

1. What Sitagliptina Alter is and what it is 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 increase insulin levels produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medicine to help you lower your blood sugar, which is too high due to your type 2 diabetes. This medicine may be used alone or in combination with other blood sugar-lowering medicines (such as insulin, metformin, sulfonylureas, or glitazones) 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 condition in which your body does not produce enough insulin, and the insulin your body 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 taking Sitagliptina Alter

Do not take Sitagliptina Alter

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take sitagliptin.

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

If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking this medicine.

Inform your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis)
• gallstones, alcohol addiction, or very high blood levels of triglycerides (a type of fat). These medical conditions may increase your risk of developing pancreatitis (see section 4)
• type 1 diabetes
• diabetic ketoacidosis (a diabetes complication causing high blood sugar levels, rapid weight loss, nausea, or vomiting)
• any kidney problems currently or in the past
• an allergic reaction to sitagliptin (see section 4).

This medicine is unlikely to cause low blood sugar because it does not act when blood sugar levels are low. However, when this medicine is used in combination with a medicine containing a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea-containing medicine or insulin.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not known whether this medicine is safe and effective 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 need to take any other medicines.

In particular, inform your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). Your digoxin blood levels may need to be monitored if you are taking sitagliptin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be taken during pregnancy.

It is unknown whether 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 the ability to drive or operate machinery is negligible or none. However, dizziness and somnolence have been reported, which may affect your ability to drive or operate machinery.

In addition, taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without secure support.

3. How to take Sitagliptina Alter

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• taken orally

If you have kidney problems, your doctor may prescribe you lower doses (such as 25 mg or 50 mg).

You may take this medicine with or without food and beverages.

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

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

If you take more Sitagliptina Alter than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20, or 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 remember only at the time of your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Sitagliptina Alter

Keep taking this medicine for as long as your doctor prescribes it, so it can continue helping control your blood sugar. You should not stop taking this medicine without first consulting your doctor.

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

4. Possible adverse effects

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

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

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

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue, or throat which may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor will prescribe a treatment for the allergic reaction and will switch you to another medicine for the treatment of diabetes.

Some patients experienced the following adverse effects after adding sitagliptin to 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 various types of stomach discomfort when starting sitagliptin and metformin together (frequency classified as common).

Some patients experienced the following adverse 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 adverse effects while taking sitagliptin and pioglitazone:
Common: flatulence, swelling of hands or legs

Some patients experienced the following adverse effects while taking sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or legs

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

Common: influenza-like illness

Uncommon: dry mouth

Some patients experienced the following adverse effects while taking sitagliptin alone during clinical trials, or during post-marketing use alone and/or in combination with other antidiabetic medicines:

Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, osteoarthritis, pain in arm or leg

Uncommon: dizziness, constipation, itching

Rare: reduction in platelet count

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin Alter

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

Do not use this medicine after the expiry date stated on the packaging following "EXP". The expiry date refers to the last day of the indicated month.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE Point located in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused packaging and medicines. This 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 components are: In the tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate and sodium stearyl 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 of the product and contents of the pack

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

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

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

PVC/PVDC-aluminum blisters.

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

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and 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 under the following names:

Spain: Sitagliptina Alter film-coated tablets EFG

France: SITAGLIPTINE ALTER, comprimé pelliculé

Date of the most recent review of this leaflet: November 2018.

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