SITAGLIPTIN VISO FARMACEUTICA 25 mg FILM-COATED TABLETS

2. What you need to know before you take Sitagliptin Viso Farmacéutica

Do not take Sitagliptin Viso Farmacéutica:

• 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 sitagliptin.

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 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 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 Sitagliptin Viso Farmacéutica

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 sitagliptin.

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.

Do not take this medicine during pregnancy.

It is not known if this medicine passes into breast milk. Do 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 or minimal. 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 hypoglycemia, which may affect your ability to drive or use machines or work without a safe support point.

Sitagliptin Viso Farmacéutica contains sodium and lactose

Sodium:

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

Lactose:

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Sitagliptin Viso Farmacéutica

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:

• one 100 mg film-coated tablet
• once a day
• orally

If you have kidney problems, your doctor may prescribe lower doses (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 reduce 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 sitagliptin.

If you take more Sitagliptin Viso Farmacéutica than you should

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

If you forget to take Sitagliptin Viso Farmacéutica

If you have forgotten 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 make up for missed doses.

If you stop taking Sitagliptin Viso Farmacéutica

Continue 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 before consulting your doctor.

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 sitagliptin and contact a doctor immediatelyif 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 on the skin/exfoliative skin, 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:

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, somnolence.

Some patients have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin (the frequency is 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 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 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 side effects, consult your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin Viso Farmacéutica

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

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 a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptin Viso Farmacéutica

• The active substance is sitagliptin.

Sitagliptin 25 mg:

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

• The other ingredients are:

Core of the tablet:Calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, sodium stearyl fumarate, magnesium stearate

Coating of the tablet (25 mg):Lactose monohydrate, hypromellose, titanium dioxide, triacetin, iron oxide red.

Appearance of the product and contents of the pack

Sitagliptin Viso Farmacéutica 25 mg film-coated tablets EFG: Film-coated tablets are pink, round, biconvex, approximately 6 mm in diameter, and marked with "LC" on one face and smooth on the other face.

Sitagliptin Viso Farmacéutica 25 mg film-coated tablets EFG are available in:

• PVC/PVDC-aluminum blisters: 10, 14, 28, 30, 56, 98, and 100 tablets.
• White high-density polyethylene (HDPE) bottles with a desiccant silica gel plug in the polypropylene (PP) cap and with a tamper-evident ring: 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Laboratorios Liconsa, S.A

Avda. Miralcampo, nº 7, Pol. Ind.

Azuqueca de Henares

19200 Guadalajara

Spain

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

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

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

Date of last revision of this leaflet: August 2021

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/