MELIGLIX 100 mg FILM-COATED TABLETS

Introduction

B.

Patient Information Leaflet: Information for the Patient

Meliglix 25 mg film-coated tablets EFG

Meliglix 50 mg film-coated tablets EFG

Meliglix 100 mg film-coated tablets EFG

sitagliptin

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

• Keep this patient information leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medication has been prescribed to you personally, and you should not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor, pharmacist, or nurse. Even if they are not listed in this patient information leaflet. See section 4.

Patient Information Leaflet Contents

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

1. What is Meliglix and what is it used for

Meliglix contains the active substance sitagliptin, which belongs to a group 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 increase the levels of insulin produced after meals and reduces the amount of sugar produced by the body.

Your doctor has prescribed this medication to help you lower your 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 thiazolidinediones) that lower blood sugar levels, which you may be taking for your diabetes, along with a diet and exercise plan.

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 produce too much sugar.

When this happens, sugar (glucose) builds up in the body. This can lead to serious medical problems such as heart disease or kidney disease, blindness, and amputation.

2. What you need to know before taking Meliglix

Do not take Meliglix

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

Warnings and precautions

Consult your doctor or pharmacist before taking sitagliptin.

There have been reports of pancreatitis (inflammation of the pancreas) in patients taking sitagliptin (see section 4).

The appearance of blisters on the skin may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking sitagliptin.

Tell your doctor if you have or have had:

• a pancreatic disease (such as pancreatitis)
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood.

These health problems may increase the 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)
• current or past kidney problems
• an allergic reaction to sitagliptin (see section 4)

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

Children and adolescents

This medication should not be used in children and adolescents under 18 years of age. It is not effective in children and adolescents between 10 and 17 years of age. The safety and efficacy of the medication in children under 10 years of age are unknown.

Other medications and Meliglix

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

Tell your doctor especially if you are taking digoxin (a medication used to treat irregular heartbeats and other heart problems). You may need to have your digoxin levels checked if you take it with sitagliptin.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

You should not take this medication during pregnancy.

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

Driving and using machines

The effect 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.

Taking this medication in combination with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive or use machines or work without a safe support.

Meliglix contains sodium

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

3. How to take Meliglix

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist.

The recommended dose is:

• one 100 mg film-coated tablet
• once a day
• by mouth

Your doctor may prescribe a lower dose if you have kidney problems (such as 25 mg or 50 mg). You can take this medication with or without food or drinks.

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

Following a diet and exercise plan can help your body use blood sugar better. It is essential to follow the diet and exercise plan recommended by your doctor while taking sitagliptin.

If you take more Meliglix than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Meliglix

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

If you stop taking Meliglix

Continue taking this medication as long as your doctor prescribes it, so it can continue to help control your blood sugar levels. Do 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 contact a doctor immediately if you notice any of the following serious side effects:

• Severe and persistent abdominal pain (stomach area) that may radiate to your back, with or without nausea or vomiting, as these may be symptoms of pancreatitis.

If you have a severe allergic reaction (frequency unknown), including rash, hives, blisters on the skin/exfoliative skin conditions, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking this medication and call your doctor immediately. Your doctor may prescribe a medication to treat your allergy and a different medication for your diabetes.

Some patients have experienced the following side effects after adding sitagliptin to 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 have experienced different types of stomach discomfort when starting to take the combination of sitagliptin and metformin together (common)

Some patients have experienced the following side effects when taking sitagliptin in combination with sulfonylureas and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar levels Common: constipation

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

Common: flatulence, swelling of the hands or feet

Some patients have experienced the following side effects when taking sitagliptin in combination with pioglitazone and metformin:

Common: swelling of the hands or feet

Some patients have experienced the following side effects when taking sitagliptin in combination with insulin (with or without metformin).

Common: flu

Uncommon: dry mouth

Some patients have experienced the following side effects when taking sitagliptin alone in clinical studies or during post-approval use, alone and/or with other diabetes medications:

Common: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or discharge, and sore throat, osteoarthritis, pain in the arms or legs.

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 blisters).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse. Even if they are not listed in this patient information 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. Storing Meliglix

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

Do not use this medication after the expiration date stated on the packaging and blister after "EXP". The expiration date refers to 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. Deposit the packaging and any unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and further information

Composition of Meliglix

• The active substance is sitagliptin.

Meliglix 25 mg: Each film-coated tablet contains sitagliptin hydrochloride equivalent to 25 mg of sitagliptin.

Meliglix 50 mg: Each film-coated tablet contains sitagliptin hydrochloride equivalent to 50 mg of sitagliptin.

Meliglix 100 mg: Each film-coated tablet contains sitagliptin hydrochloride equivalent to 100 mg of sitagliptin.

• The other ingredients are: Tablet core: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate, crospovidone type B (E1202), magnesium stearate (E470b), and sodium stearyl fumarate. Tablet coating: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Appearance of Meliglix and pack contents

Meliglix 25 mg: Film-coated tablets are pink, round, 6.1 mm in size, and engraved with "25" on one side and smooth on the other.

Meliglix 50 mg: Film-coated tablets are light beige, round, 8.1 mm in size, and engraved with "50" on one side and smooth on the other.

Meliglix 100 mg: Film-coated tablets are beige, round, 10.1 mm in size, and engraved with "100" on one side and smooth on the other.

PVC/PE/PVDC/Aluminum blisters. Packs of 14, 28, 30, 56, 84, 90, or 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

PHARMAZAC S.A.

31 Naousis Avenue, 104 47

Athens, Greece

tel.: +30 210 3418889-97

pharmazac@pharmazac.com

Manufacturer

Remedica Ltd.

Aharnon Avenue, Limassol Industrial Estate, 3056 Limassol

Cyprus

tel.: +357 25553000

info@remedica.com.cy

Further information

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

Date of last revision of this patient information leaflet:March 2022

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