VILDAGLIPTINA COMBIX 50 mg TABLETS

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

Do not take Vildagliptina Combix

• if you are allergic to vildagliptina or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptina or any other ingredient of this medicine, do not take this medicine and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nurse before you start taking Vildagliptina Combix

• 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 an antidiabetic 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]),
• if you have moderate or severe kidney disease (you will need to take a lower dose of vildagliptina),
• 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 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 happens, 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 use of this medicine is not recommended in children and adolescents under 18 years of age.

Using Vildagliptina Combix with other medicines

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 called 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.

You should not use vildagliptina during pregnancy. It is not known if this medicine passes into breast milk. You should not take vildagliptina if you are breastfeeding or planning to breastfeed.

Driving and using machines

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

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycemia or hyperglycemia, such as blurred vision. This can be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is advisable to drive or use machines.

Vildagliptina Combix contains lactose and sodium

This medicine contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult 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/use Vildagliptina Combix

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

How much to take and when

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

The recommended dose of vildagliptina is:

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

• 100 mg daily in two doses (50 mg in the morning and 50 mg in the evening) if you are taking vildagliptina alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.

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

How to take Vildagliptina

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina

• Take vildagliptina every day for as long as your doctor recommends. You may need to continue 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 Vildagliptina than you should

If you have taken too many vildagliptina tablets, or if someone else has taken your medicine, consult your doctor immediately, or call the Toxicology Information Service, phone 91 562 04 20. 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

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 forgotten doses.

If you stop taking Vildagliptina

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

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 including swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may be indicative of a reaction called “angioedema”,
• liver disease (hepatitis) (frequency not known): symptoms including yellowing of the skin and eyes, nausea, loss of appetite or dark urine, which may be indicative of liver disease (hepatitis).
• pancreatitis (rare: may affect up to 1 in 1,000 people): symptoms including 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:

• 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, 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 sugar levels, flatulence.
• Rare (may affect up to 1 in 1,000 people): pancreatitis

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

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that can cause skin rashes or red, flat, round spots under the skin surface or bruising.

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 Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Vildagliptina Combix

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 shown.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

• Composition of Vildagliptina Combix

• The active substance is vildagliptina. Each tablet contains 50 mg of vildagliptina.
• The other ingredients (excipients) are:

Lactose anhydrous, sodium stearyl fumarate and sodium, microcrystalline cellulose and sodium croscarmellose.

Appearance of the product and contents of the pack

Vildagliptina Combix 50 mg are round, biconvex tablets, white to off-white in color, approximately 8.0 mm in diameter, available in aluminum/aluminum blisters containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multiple packs consisting of 3 packs, each containing 112 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 – Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50,

Esplugues de Llobregat, 08950 Barcelona,

Spain

or

SAG MANUFACTURING, S.L.U.

Ctra. N-I, km 36

28750 San Agustín de Guadalix

Madrid – Spain

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

BG – Bulgaria ???????????? ????????? 50 mg ???????

ES – Spain Vildagliptina Galenicum 50 mg tablets

MT – Malta Vildagliptin Galenicum 50 mg tablets

LV - Latvia Vildagliptin Galenicum 50 mg tablets

HR – Croatia Vildagliptin Galenicum 50 mg tablets

EE – Estonia Vildagliptin Galenicum 50 mg tablets

DE – Germany Vildagliptin Galenicum 50 mg tablets

Date of last revision of this leaflet:April 2023

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