Package Insert: Patient Information

Mapoli 25 mg/ml Oral Solution EFG

sitagliptin

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this package insert. See section 4.

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

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

Your doctor has prescribed this medication to help reduce your blood sugar level, which is too high due to your type 2 diabetes. This medication may be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones) that reduce blood sugar levels, and 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 may also produce too much sugar. When this occurs, sugar (glucose) accumulates in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

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

Cases of pancreatitis have been reported in patients taking sitagliptin (see section 4).

If you develop blisters on your skin, it 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:

• pancreatitis (such as pancreatitis)
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in your blood. These conditions may increase your risk of developing pancreatitis (see section 4).
• type 1 diabetes
• 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).

This medicine is unlikely to cause low blood sugar, as it does not work when blood sugar levels are 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 should not take this medicine. It is not effective in children and adolescents between 10 and 17 years. The safety and efficacy of this medicine in children under 10 years are unknown.

Other medicines andMapoli

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Inform your doctor especially if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). Your doctor may need to monitor your digoxin levels if you take it with this medicine.

Use ofMapoliwith food and drinks

This medicine can be taken with or without food.

Pregnancy and breastfeeding

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

You should not take this medicine during pregnancy.

The safety of this medicine for use during breastfeeding is unknown. Do not take this medicine if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

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

The use of this medicine in combination with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work safely without support.

Mapoli contains parahydroxybenzoate sodium:

It may cause allergic reactions (possibly delayed).

Mapoli contains benzyl alcohol:

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

Mapoli contains sodium:

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

Follow exactly the administration instructions of this medication as indicated 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 oral route

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

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

Diet and exercise can help your body use blood sugar more effectively. It is essential that you follow the diet and exercise recommended by your doctor while taking this medication.

Administration Method

Please use the oral syringe provided to administer your specific dose - see the instructions below. The syringe can be used to measure your dose by extracting 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 medication, contact your doctor immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Mapoli

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 return to your regular schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Mapoli

Continue taking this medication as long as your doctor prescribes it for you to continue helping you control your blood sugar levels. Do not stop taking this medication before consulting your doctor.

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

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

STOP taking this medicine and contact a doctor immediately if you notice any of the following serious side effects:

• Severe and persistent abdominal pain (stomach area) that could reach the back with or without nausea and vomiting, as they could be signs of pancreatitis inflammation.

If you have a severe allergic reaction (unknown frequency), including skin rash, urticaria, blisters on the skin/skin peeling and swelling of the face, lips, tongue, and throat that can 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:

Frequent (can affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting.

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

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

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

Very frequent (can affect more than 1 in 10 people): low blood sugar.

Frequent: constipation.

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

Frequent: flatulence, swelling of hands or feet.

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

Frequent: swelling of hands or feet.

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

Frequent: flu.

Rare: dry mouth.

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

Frequent: low blood sugar, headache, upper respiratory tract infection, congestion or nasal secretion and sore throat, osteoarthritis, arm or leg pain.

Rare: constipation, itching.

Rare: reduced platelet count.

Unknown frequency: 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack, on the bottle label, and on the box after CAD. The expiration date is the last day of the month indicated.

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

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

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

Dispose of any remaining medication 90 days after opening the bottle.

Medications should not be thrown away through drains or in the trash. Deposit the containers and unusedmedications at the SIGRE collection pointat the pharmacy. Ask yourpharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition ofMapoli

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

The other components are:

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

Appearance of the product and contents of the package

Mapoliis a turbid and white oral solution with a fruit flavor odor. It is presented in an amber glass bottle (type III) with a tamper-evident closure and a child-resistant cap.

The folded cardboard box contains a glass bottle with a cap containing 100 ml of oral solution, an oral medication dosing syringe of 5 ml (applicator, with CE marking, CE 0459) and graduated with 0.5 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible for manufacturing:

Labomed Pharmaceutical Company SA

Metaxa Ioanni 84

19441 Kropia

Greece

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

Viso Farmacéutica, S.L.U

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: July 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/