Sitagliptin Viso Farmaceutica 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

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.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects 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 side effects
5. How to store Sitagliptin Viso Farmacéutica
6. Contents of the pack and other information

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

Sitagliptina 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 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 disease of the pancreas (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, as it does not act 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

This medicine must not be taken by 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 when used 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 the level of digoxin 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 must not take this medicine during pregnancy.

It is unknown whether this medicine passes into breast milk. You must 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 negligible or none. 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 hypoglycemia, which can affect your ability to drive and use machines or work without secure support.

Sitagliptina Viso Farmacéutica contains sodium and lactose

Sodium:

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

Lactose:

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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 you lower doses (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 ingested.

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 usual schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Sitagliptina Viso Farmacéutica

Keep taking this medicine for as long as your doctor prescribes it so that it can continue helping you control your blood sugar levels. 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 have a severe allergic reaction (frequency not known), including skin rash, hives, skin blistering or peeling, swelling of the face, lips, tongue and throat which 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 when sitagliptin was added 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 sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar level.

Common: constipation.

Some patients have experienced the following side effects when taking sitagliptin with 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 post-approval use alone and/or with other antidiabetic medicines:

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

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 side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, including any side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 monohydrochloride monohydrate equivalent to 25 mg of sitagliptin.

• The other components are:

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

Film coating (25 mg): Lactose monohydrate, hypromellose, titanium dioxide, triacetin, red iron oxide.

Nature of the product and contents of the container

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

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

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

Only some 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

For further information about this medicinal product, please contact 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 revision of this leaflet: August 2021

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