MAPOLI 25mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Mapoli 25 mg/ml Oral Solution EFG

sitagliptin

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

1. What is Mapoli and what is it used for

This medicine contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lower 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 lower your blood sugar level, which is 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 lower blood sugar levels, which you may already 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 the body does not produce enough insulin, and the insulin it produces does not work as well as it should. The body also makes 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 Mapoli

Do not takeMapoli

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

Warnings and precautions

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

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

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

Children and adolescents

Children and adolescents under 18 years of age should not take this medicine. It is not effective in children and adolescents between 10 and 17 years of age. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Mapoli

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 heartbeat and other heart problems). It may be necessary to monitor your digoxin blood levels if you take it with this medicine.

Mapoli with food and drinks

This medicine can be taken with or without food.

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.

You should not take this medicine 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.

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

Mapoli contains sodium benzoate:

It may cause allergic reactions (which may be delayed).

Mapoli contains benzyl alcohol:

Benzyl alcohol (E1519): 0.02 mg per 1 ml. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you have liver or kidney disease, or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may build up in your body and may cause side effects (called "metabolic acidosis").

Mapoli contains sodium:

This medicine contains less than 1 mmol of sodium (23 mg) per ml; i.e., it is essentially "sodium-free".

3. How to take Mapoli

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

• 100 mg (4 ml of oral solution)
• once a day
• by mouth

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

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

Diet and exercise can help your body use blood sugar better. It is important that you follow the diet and exercise recommended by your doctor while taking this medicine.

Method of administration

Please use the supplied oral syringe to administer your specific dose - see the instructions below. The syringe can be used to measure your dose by drawing the liquid up to the correct mark on the syringe.

How to use the oral syringe:

If you take more Mapoli than you should

If you take more than the prescribed dose of this medicine, contact your doctor immediately, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Mapoli

If you have forgotten to take a dose, take it as soon as you remember. If you do not remember until the time of your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Mapoli

Keep taking this medicine while your doctor prescribes it for you to continue helping you control your blood sugar level. Do not stop taking this medicine without consulting your doctor first.

If you have any other 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 this medicine 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 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/exfoliative skin, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and call your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another for 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, nausea, flatulence, vomiting.

Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.

Some patients have experienced different types of stomach upset when starting the combination of sitagliptin and metformin (classified as common).

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

Common: flatulence, swelling of 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 trials, or during its use after approval alone and/or with other diabetes medicines:

Common: low blood sugar, 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 (sometimes requiring 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 through the Spanish Medicines Surveillance 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. Storage of Mapoli

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 blister, on the label of the bottle, and on the carton after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

After opening, store in a refrigerator (between 2°C and 8°C).

After opening the bottle, the solution can be stored for 90 days.

Discard any remaining medicine 90 days after opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mapoli

The active substance is sitagliptin. Each ml of oral solution contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg of sitagliptin.

The other ingredients are:

Sodium benzoate (E219), hydroxyethylcellulose (E1525), citric acid (E330), disodium edetate (E385), polysorbate 80 (E433), butylhydroxyanisole (E320), sodium citrate (E331), Polysorb 7477 (which contains sucralose (E955) acesulfame), forest fruit flavor (composed of maltodextrin (E1400), modified starch (E1400-E1500) (derived from potato), lactic acid (E270), benzyl alcohol (E1519), ethanol (E1510), ethyl butyrate, raspberry flavor, propylene glycol (E1520)), purified water.

Appearance and packaging

Mapoli is a turbid and whitish oral solution with a forest fruit flavor. It comes in a type III amber glass bottle with a child-resistant cap and a tamper-evident closure.

The folded cardboard box contains a glass bottle with a cap and a 5 ml oral dosing syringe (with CE marking, CE 0459) graduated with 0.5 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Labomed Pharmaceutical Company SA

Metaxa Ioanni 84

19441 Kropia

Greece

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Date of the last revision of this leaflet: July 2023

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