Sitagliptin Viso Farmaceutica 50 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Sitagliptin Viso Farmacéutica 50 mg Film-Coated Tablets EFG

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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Sitagliptin Viso Farmacéutica is and what it is used for
2. What you need to know before taking Sitagliptin Viso Farmacéutica
3. How to take Sitagliptin Viso Farmacéutica
4. Possible adverse effects
5. How to store Sitagliptin Viso Farmacéutica
6. Contents of the pack and other information

1. What is Sitagliptina Viso Farmacéutica and what is it used for?

Sitagliptina contains the active substance sitagliptin, which belongs to a class of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lower blood sugar levels in adult patients with type 2 diabetes mellitus.

This medicine helps increase insulin levels produced after a meal and reduces 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 may be used alone or in combination with other blood sugar-lowering medicines (insulin, metformin, sulfonylureas, or glitazones) that 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 condition in which the body does not produce enough insulin and the insulin it does produce does not work as well as it should. The body may also 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.

2. What you need to know before taking Sitagliptina Viso Farmacéutica

Do not take Sitagliptina Viso Farmacéutica:

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

Warnings and precautions

Cases of inflammation of the pancreas (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 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 your blood.

These conditions may increase your risk of developing pancreatitis (see section 4).

• type 1 diabetes mellitus
• diabetic ketoacidosis (a diabetes complication 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 (hypoglycemia), as it does not act when blood sugar levels are low. However, when this medicine is used in combination with a sulfonylurea or with insulin, low blood sugar may occur. Your doctor may reduce the dose of your sulfonylurea or insulin.

Children and adolescents

This medicine should not be used in children or adolescents under 18 years of age. It is not effective in children and adolescents between 10 and 17 years of age. It is unknown whether this medicine is safe and effective in children under 10 years of age.

Other medicines and Sitagliptina Viso Farmacéutica

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 digoxin levels in your blood when taken with sitagliptin.

Pregnancy and breastfeeding

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

You should not take this medicine during pregnancy.

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

Driving and using machines

The influence of this medicine on the ability to drive and use machines is none or 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 hypoglycemia, which can affect your ability to drive and use machines or work without a secure support point.

Sitagliptina Viso Farmacéutica contains sodium

Sodium:

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

3. How to take Sitagliptina Viso Farmacéutica

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• one 100 mg film-coated tablet
• once daily
• taken orally

If you have kidney problems, your doctor may prescribe a lower dose (such as 25 mg or 50 mg). You may take this medicine with or without food or drink.

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

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

If you take more Sitagliptina 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 at telephone number 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Sitagliptina Viso Farmacéutica

If you forget to take a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and return to your regular schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Sitagliptina Viso Farmacéutica

Keep taking this medicine for as long as your doctor prescribes it, so it can continue helping you control your blood sugar level. Do not stop taking this medicine without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

• Severe and persistent pain in the abdomen (stomach area) which may extend to the back, with or without nausea and vomiting, as these could be signs of inflammation of the pancreas (pancreatitis).

If you experience a severe allergic reaction (frequency not known), including skin rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another 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, nausea, flatulence, vomiting.

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

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

Some patients have experienced the following side effects when taking sitagliptin in combination with a sulphonylurea 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 hands or legs.

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

Common: swelling of the hands or legs.

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

Common: influenza-like illness.

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 runny nose, sore throat, osteoarthritis, pain in arms or legs.

Uncommon: dizziness, constipation, itching.

Rare: reduction in the number of platelets.

Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the blister, on the label of the bottle, and on the carton, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptina Viso Farmacéutica

• The active substance is sitagliptin.

Sitagliptin 50 mg:

Each film-coated tablet contains sitagliptin monohydrochloride monohydrate equivalent to 50 mg of sitagliptin.

• The other components are:

Tablet core: Calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, sodium stearyl fumarate, magnesium stearate.

Coating of the tablet (50 mg): Polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol, talc, yellow iron oxide, red iron oxide.

Appearance of the product and contents of the pack

Sitagliptina Viso Farmacéutica 50 mg film-coated tablets EFG: Orange-colored, round, biconvex film-coated tablets, approximately 8 mm in diameter, marked with "C" on one side and smooth on the other.

Sitagliptina Viso Farmacéutica 50 mg film-coated tablets EFG are packed in:

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

Only certain 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

Further information on this medicinal product can be obtained from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Date of the last review of this leaflet: August 2021

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