SITAGLIPTIN ADAMED 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sitagliptina Adamed25 mg film-coated tablets EFG

Sitagliptina Adamed50 mg film-coated tablets EFG

Sitagliptina Adamed 100 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sitagliptina Adamed and what is it used for
2. What you need to know before taking Sitagliptina Adamed
3. How to take Sitagliptina Adamed
4. Possible side effects
5. Storage of Sitagliptina Adamed
6. Package Contents and Additional Information

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

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

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

Your doctor prescribed this medication to help you reduce blood sugar levels, which are too high due to your type 2 diabetes. This medication can be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or glitazones) that lower blood sugar levels, which you may be taking for diabetes, along with your diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce enough insulin, and the insulin it produces 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 taking Sitagliptina Adamed

Do not take Sitagliptina Adamed

• if you are allergic to sitagliptin or any of the other ingredients of this medication (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 this medication.

Tell your doctor if you have or have had:

• a pancreatic disease (such as pancreatitis)
• gallstones, alcohol addiction, or very high blood triglyceride levels. These diseases 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 Sitagliptina Adamed (see section 4).

It is unlikely that this medication will cause low blood sugar levels because it only works when blood sugar levels are high. However, when this medication is used in combination with a medication that contains a sulfonylurea or insulin, low blood sugar levels (hypoglycemia) may occur. Your doctor may reduce the dose of the medication that contains sulfonylurea or insulin.

Children and Adolescents

Children and adolescents under 18 years of age should not use this medication.

It is not effective in children and adolescents between 10 and 17 years of age. It is unknown whether this medication is safe and effective when used in children under 10 years of age.

Other Medications and Sitagliptina Adamed

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

In particular, tell your doctor if you are taking digoxin (a medication 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, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. You should not take this medication during pregnancy.

It is unknown whether this medication passes into breast milk. You should not take this medication if you are breastfeeding or planning to breastfeed.

Driving and Using Machines

The influence of this medication 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.

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

Sitagliptina Adamed contains sodium

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

3. How to take Sitagliptina Adamed

Follow your doctor's instructions for taking this medication exactly. 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 a lower dose (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 levels.

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 sitagliptina.

If you take more Sitagliptina Adamed than you should

If you take more of this medication than prescribed, contact your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Sitagliptina Adamed

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

If you stop taking Sitagliptina Adamed

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

STOP taking sitagliptin and see a doctor immediately if 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, or peeling of the skin, 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 may prescribe a medication to treat the allergic reaction and a different medication for diabetes.

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 levels, 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 sitagliptina 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 levels.

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 and 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 authorization alone and/or with other diabetes medications:

Common: low blood sugar levels, 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: decreased 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 side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sitagliptina Adamed

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

Do not use this medication after the expiration date shown on the blister pack and carton after "EXP.". 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 via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Sitagliptina Adamed

The active ingredient is sitagliptin.

Each 25 mg film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg of sitagliptin.

Each 50 mg film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin.

Each 100 mg film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 100 mg of sitagliptin.

The other ingredients are:

In the tablet core: anhydrous calcium phosphate, microcrystalline cellulose, sodium croscarmellose, sodium stearyl fumarate, and magnesium stearate.

The film coating of the tablet contains: polyvinyl alcohol, macrogol 4000, titanium dioxide (E171), talc, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the product and package contents

25 mg tablet: orange, round, film-coated tablet, convex, with "25" engraved on one side.

50 mg tablet: orange, round, film-coated tablet, convex, with "50" engraved on one side.

100 mg tablet: orange, round, film-coated tablet, convex, with "100" engraved on one side.

PVC/PVDC/Aluminum blisters included in the outer packaging. Packaging of 28 or 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 – 2ª planta

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

Date of the last revision of this package leaflet: December 2020

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://aemps.gob.es/