Prospect: information for the user

Glypvilo 50 mg EFG tablets

vildagliptin

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section4.

1.What is Glypvilo and for what it is used

2.What you need to know before starting to takeGlypvilo

3.How to takeGlypvilo

4.Possible adverse effects

5.Storage ofGlypvilo

6.Contents of the package and additional information

The active ingredient of Glypvilo, vildagliptina, belongs to a group of medications called «oral antidiabetics».

Glypvilo is used to treat adult patients with type 2 diabetes when diabetes cannot be controlled solely by diet and exercise. It helps control blood sugar levels. Your doctor will prescribe Glypvilo alone or in combination with other antidiabetic medications you are already taking if these are not effective enough to control diabetes.

Type 2 diabetes appears if the body does not produce enough insulin or if the insulin produced does not function properly. It can also appear if the body produces too much glucagon.

Insulin is a substance that helps reduce blood sugar levels, especially after meals. Glucagon is a substance that promotes sugar production by the liver and increases blood sugar levels. Both substances are produced in the pancreas.

How Glypvilo works

Glypvilo stimulates the pancreas to produce more insulin and less glucagon. This helps control blood sugar levels. This medication has been shown to reduce blood sugar, which will help prevent complications of your diabetes.

Although you start taking this medication for your diabetes, it is essential that you continue with the diet and/or exercise that have been recommended.

Do not take Glypvilo

• If you are allergic to vildagliptin or any of the other components of this medication (listed in section 6). If you think you may be allergic to vildagliptin or any other component of Glypvilo, do not take this medication and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Glypvilo

• If you have type 1 diabetes (i.e., your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
• If you are taking a diabetes medication known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taken together with Glypvilo to avoid low blood glucose [hypoglycemia]).
• If you have moderate or severe kidney disease (you will need to take a lower dose of Glypvilo).
• If you are undergoing dialysis.
• If you have liver disease.
• If you have heart failure.
• If you have or have had pancreatitis.

If you have previously taken vildagliptin but had to stop due to liver disease, do not take this medication.

Skin lesions are common complications of diabetes. Follow your doctor's or nurse's recommendations for skin and foot care, paying special attention to the appearance of blisters or ulcers while taking Glypvilo. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with Glypvilo, at three-month intervals during the first year, and periodically thereafter. This is done to detect as soon as possible any signs indicating an increase in liver enzymes (transaminases).

Children and adolescents

The administration of Glypvilo is not recommended in children and adolescents under 18 years.

Other medications and Glypvilo

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

Your doctor may change your Glypvilo dose if you are taking other medications such as:

• Thiazides or other diuretics (also known as urine medications)
• Corticosteroids (usually used to treat inflammation)
• Thyroid medications
• Certain medications that affect the nervous system.

Pregnancy and breastfeeding

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

You should not use Glypvilo during pregnancy. It is unknown whether Glypvilo passes into breast milk. Do not take Glypvilo if you are breastfeeding or plan to breastfeed.

Driving and operating machines

If you feel dizzy while taking Glypvilo, do not drive or operate tools or machines.

Glypvilo contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take and when

The dose of Glypvilo that you should take varies depending on your condition. Your doctor will tell you exactly how many Glypvilo tablets you should take. The maximum daily dose is 100 mg.

The recommended dose of Glypvilo is:

• 50 mg once a day in the morning, if you are taking Glypvilo along with another medication known as a sulfonylurea.
• 100 mg per day in two doses of 50 mg in the morning and evening if you are taking Glypvilo alone, with another medication known as metformin or a glitazone, or with a combination of metformin and a sulfonylurea.
• 50 mg per day in the morning if you have moderate or severe kidney disease or if you are undergoing dialysis.

How to take Glypvilo

• Swallow the tablet whole with a little water.

Duration of treatment with Glypvilo

• Take Glypvilo every day as your doctor tells you to. You may have to follow this treatment for a long time.
• Your doctor will perform regular checks to ensure that the treatment is having the desired effect.

If you take more Glypvilo than you should

If you have taken too many Glypvilo tablets, or if someone else has taken your medication,consult your doctor immediately.You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging with you.

If you forget to take Glypvilo

If you forget to take a dose of this medication, take it as soon as you remember. Then take the next dose at your usual time. If it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Glypvilo

Do not stop taking Glypvilo unless your doctor tells you to. If you have doubts about the duration of treatment with Glypvilo, consult your doctor.

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

Some symptoms require immediate medical attention

You should stop taking Glypvilo and see your doctor immediately if you experience any of the following side effects:

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms that include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of hives or urticaria, which may be indicative of a reaction called “angioedema”.
• Liver disease (hepatitis) (unknown frequency): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (inflammation of the pancreas) (rare: may affect up to 1 in 1,000 people): symptoms that include intense and persistent abdominal pain (stomach area), which can reach your back, as well as nausea and vomiting.

Other side effects

Some patients experienced the following side effects while taking Glypvilo:

• Very common (may affect more than 1 in 10 people): sore throat, nasal congestion, fever.
• Common (may affect up to 1 in 10 people): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles, or feet (edema), excessive sweating, vomiting, stomach pain and abdominal area (abdominal pain), diarrhea, heartburn, nausea (discomfort), blurred vision.
• Uncommon (may affect up to 1 in 100 people): weight gain, chills, weakness, sexual dysfunction, low blood glucose levels, flatulence
• Rare (may affect up to 1 in 1,000 people): pancreatitis (inflammation of the pancreas).

Since the marketing of this product, the following side effects have also been reported:

• Unknown frequency (cannot be estimated from available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that may cause skin eruptions or pinpoint, flat, red, and rounded spots under the skin's surface or hematomas.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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 medicationafter the expiration date that appears on the packaging/blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Glypvilo

• The active ingredient is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

• The other components (excipients) are mannitol (E421), hydroxypropylcellulose (type EF, 300-600 mPas), hydroxypropylcellulose of low substitution, microcrystalline cellulose (type 112), potato starch type A carboxymethylcellulose sodium , anhydrous colloidal silica and stearate sodium fumarate . See section 2 “Glypvilo” contains sodium.

Appearance of the product and contents of the package

White to almost white, round tablets with beveled edges, 8 mm in diameter, 3.2-5.0 mm in thickness.

Glypvilo is available in packages containing 28, 30, 56, 60, 90, 112 and 180 tablets in blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

or

Tad Pharma GmbH,

Heinz-Lohmann-Straße 5,

27472 Cuxhaven, Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L.,

C/ Anabel Segura 10, Pta . Baja, Office 1

28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet: October 2023

The detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/