Ask a doctor about a prescription for SITAGLIPTIN VISO FARMACEUTICA 25 mg FILM-COATED TABLETS
Package Leaflet: Information for the Patient
Sitagliptin Viso Farmacéutica 25 mg film-coated tablets EFG
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Contents of the pack
Sitagliptin contains the active substance sitagliptin, which belongs to a class 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 decreases the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help reduce 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 reduce 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 may produce 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.
Do not take Sitagliptin Viso Farmacéutica:
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:
These diseases may increase your risk of developing pancreatitis (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.
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:
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.
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:
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.
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.
Composition of Sitagliptin Viso Farmacéutica
Sitagliptin 25 mg:
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.
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:
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:
Country | Medicine name |
Germany: | Sitagliptin Glenmark 25 mg film-coated tablets |
Denmark: | Sitagliptin Glenmark |
Czech Republic: | Sitagliptin Glenmark |
Finland: | Sitagliptin Glenmark 25 mg film-coated tablets |
Norway: | Sitagliptin Glenmark |
Slovakia: | Sitagliptin Glenmark 25 mg |
Spain: | Sitagliptina Viso Farmacéutica 25 mg film-coated tablets EFG |
Sweden: | Sitagliptin Glenmark 25 mg film-coated tablets |
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/
The average price of SITAGLIPTIN VISO FARMACEUTICA 25 mg FILM-COATED TABLETS in October, 2025 is around 6.63 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for SITAGLIPTIN VISO FARMACEUTICA 25 mg FILM-COATED TABLETS – subject to medical assessment and local rules.