MELIGLIX 25 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 leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 symptoms are the same as yours.
• If you experience 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 Meliglix and what is it used for
2. What you need to know before you take Meliglix
3. How to take Meliglix
4. Possible side effects
5. How to store Meliglix
6. Contents of the pack and other information

1. What is Meliglix and what is it used for

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

Your doctor has prescribed this medicine to help you lower 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 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 like heart disease or kidney disease, blindness, and amputation.

2. What you need to know before you take Meliglix

Do not take Meliglix

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

Warnings and precautions

Talk to 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 medicine will cause low blood sugar (hypoglycemia) because it does not work when your blood sugar level is low. However, when this medicine is used in combination with a medicine like sulfonylurea or insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medicine.

Children and adolescents

This medicine 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 medicine in children under 10 years of age are not known.

Other medicines and Meliglix

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

Tell your doctor especially if you are taking digoxin (a medicine 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 or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

You should not take this medicine during pregnancy.

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

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

Taking this medicine in combination with medicines called sulfonylureas or with insulin may cause low blood sugar (hypoglycemia), which may affect your ability to drive or use machines or work without a safe support.

Meliglix contains sodium

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

3. How to take Meliglix

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is:

• one 100 mg 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 medicine with or without food or drink.

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

Following a diet and exercise plan can help your body use blood sugar better. It is important 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 medicine than you should, 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 medicine and the amount taken.

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 the time of the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose of this medicine.

If you stop taking Meliglix

Continue taking this medicine while your doctor prescribes it so that it can continue to help control your blood sugar levels. Do not stop taking this medicine without consulting your doctor first.

If you have any further questions about 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 (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 not known), 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 medicine and call your doctor immediately. Your doctor may prescribe a medicine to treat your allergy and a different medicine 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 medicines:

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

Uncommon: dizziness, constipation, itching

Rare: reduced platelet count

Frequency not known: kidney problems (which may sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blisters on the skin).

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 Pharmacovigilance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Meliglix

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 and blister after "EXP". The expiry date refers to the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other 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 (E341), 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, 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, 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, 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:March 2022

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/)