VILDAGLIPTINA STADA 50 mg TABLETS

2. What you need to know before you take Vildagliptina Stada

Do not take vildagliptina:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking vildagliptina if you:

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

If you have previously taken vildagliptina but had to stop taking it due to liver disease, you should not take this medicine.

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 vildagliptina. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with vildagliptina, at intervals of three months during the first year, and periodically thereafter. This is done to detect any signs of increased liver enzymes (transaminases) as soon as possible.

Children and adolescents

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

Other medicines and Vildagliptina Stada

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Your doctor may change your dose of vildagliptina if you are taking other medicines such as:

• thiazides or other diuretics (also known as water pills)
• corticosteroids (generally used to treat inflammation)
• thyroid medicines
• certain medicines that affect the nervous system.

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 use vildagliptina during pregnancy. It is not known if vildagliptina passes into breast milk. Do not take vildagliptina if you are breastfeeding or plan to breastfeed.

Driving and using machines

If you feel dizzy while taking vildagliptina, do not drive or use tools or machines.

Vildagliptina Stada contains lactose and sodium

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

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

3. How to take Vildagliptina Stada

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Dose

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

The recommended dose of vildagliptina is:

• 50 mg once a day in the morning if you are taking vildagliptina with another medicine known as a sulfonylurea.

• 100 mg per day in two doses of 50 mg in the morning and evening if you are taking vildagliptina alone, with another medicine known as metformin, or with a glitazone, with a combination of metformin and a sulfonylurea, or with insulin (with or without metformin).

• 50 mg per day in the morning if you have moderate or severe kidney disease or if you are undergoing dialysis.

How to take Vildagliptina Stada

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina Stada

Take vildagliptina every day while your doctor tells you to. You may need to continue this treatment for a long time.

Your doctor will perform periodic checks to ensure that the treatment has the desired effect.

If you take more Vildagliptina Stada than you should

If you have taken too many tablets of vildagliptina, or if someone else has taken your medicine, consult your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

You may need medical attention. If you have to visit a doctor or go to the nearest hospital, take the package with you.

If you forget to take Vildagliptina Stada

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

If you stop taking Vildagliptina Stada

Do not stop taking this medicine unless your doctor tells you to.

If you have any further questions on 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.

Some symptoms require immediate medical attention

You should stop taking vildagliptina 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 include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives.
• liver disease (hepatitis) (rare). Symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine.
• pancreatitis (frequency not known). Symptoms include severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients experienced the following side effects while taking vildagliptina and metformin:

Common (may affect up to 1 in 10 people)

• tremor, headache, dizziness, nausea, low blood sugar.

Uncommon (may affect up to 1 in 100 people)

• fatigue.

Some patients experienced the following side effects while taking vildagliptina and a sulfonylurea:

Common

• tremor, headache, dizziness, weakness, low blood sugar.

Uncommon

• constipation.

Very rare (may affect up to 1 in 10,000 people)

• sore throat, nasal congestion.

Some patients experienced the following side effects while taking vildagliptina and a glitazone:

Common

• weight gain, swollen hands, ankles, or feet (edema).

Uncommon

• headache, weakness, low blood sugar.

Some patients experienced the following side effects while taking vildagliptina alone:

Common

• dizziness.

Uncommon

• headache, constipation, swollen hands, ankles, or feet (edema), joint pain, low blood sugar.

Very rare

• sore throat, nasal congestion, fever.

Some patients experienced the following side effects while taking vildagliptina, metformin, and a sulfonylurea:

Common

• dizziness, tremor, weakness, low blood sugar, excessive sweating.

Some patients experienced the following side effects while taking vildagliptina and insulin (with or without metformin):

Common

• headache, chills, nausea (discomfort), low blood sugar, heartburn.

Uncommon

• diarrhea, flatulence.

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

Frequency not known (cannot be estimated from the available data)

• itchy rash, pancreatitis, localized skin peeling or blisters, muscle pain.
• liver disease (hepatitis): usually disappears when treatment is discontinued. Symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine.
• abnormal liver function tests, usually reversible when treatment is discontinued.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptina Stada

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 and on the carton after "EXP". The expiry date is the last day of the month stated.

Store in the original package to protect from moisture.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packages and medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptina Stada 50 mg tablets EFG

• The active substance is vildagliptina. Each tablet contains 50 mg of vildagliptina.
• The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), sodium starch glycolate (type A) (from potato), and magnesium stearate (E470b).

Appearance of the product and contents of the pack

Vildagliptina Stada 50 mg tablets EFG are round, white to pale yellow, flat, beveled-edge tablets with a diameter of 8.0 ± 0.2 mm.

Vildagliptina Stada 50 mg tablets EFG are available in cardboard boxes containing normal or unit-dose blisters of 14, 28, 30, 56, 60, 90, 105, 112, or 180 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

Date of last revision of this leaflet:April 2021

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