VILDAGLIPTIN/METFORMIN KERN PHARMA 50 mg/850 mg FILM-COATED TABLETS

2. What you need to know before you take Vildagliptin/Metformin Kern Pharma

Do not take vildagliptin/metformin

• if you are allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of these ingredients, consult your doctor before taking vildagliptin/metformin.
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below), or ketoacidosis. Ketoacidosis is a disorder in which substances called “ketone bodies” accumulate in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor of the breath.
• if you have recently had a heart attack or if you have heart failure or severe circulatory problems or breathing difficulties that may be a sign of heart problems.
• if you have severe kidney function impairment.
• if you have a severe infection or severe dehydration (massive water loss from the body).
• if you are going to have a contrast radiography (a specific type of diagnostic test with X-rays and an injectable contrast medium). For more information, see the section “Warnings and precautions”.
• if you have liver problems.
• if you drink excessive alcohol (daily or only occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

Risk of lactic acidosis

Vildagliptin/metformin may cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys do not work properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any medical disorder in which a part of the body has a reduced oxygen supply (such as acute and severe heart diseases).

If any of the above applies to you, consult your doctor for further instructions.

Stop taking vildagliptin/metformin for a short period if you have a disorder that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. Consult your doctor for further instructions.

Stop taking vildagliptin/metformin and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis, as this disorder can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense fatigue
• breathing difficulties
• reduction of body temperature and heart rate

Lactic acidosis is a medical emergency and should be treated in a hospital.

Vildagliptin/metformin is not a substitute for insulin. Therefore, you should not take vildagliptin/metformin for the treatment of type 1 diabetes.

Consult your doctor, pharmacist, or nurse before starting to take vildagliptin/metformin if you have or have had a pancreatic disease.

Consult your doctor, pharmacist, or nurse before starting to take vildagliptin/metformin if you are taking a diabetes medicine known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taken together with vildagliptin/metformin to avoid low blood sugar (hypoglycemia).

If you have previously taken vildagliptin 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. Pay special attention to the appearance of blisters or ulcers while taking vildagliptin/metformin. If this occurs, you should consult your doctor immediately.

If you need to undergo major surgery, you should stop taking vildagliptin/metformin during the procedure and for a period after it. Your doctor will decide when you should stop taking vildagliptin/metformin and when you can restart it.

Liver function tests should be performed before starting treatment with vildagliptin/metformin, 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.

During treatment with vildagliptin/metformin, your doctor will check your kidney function at least once a year or more frequently if you are an elderly person and/or if your kidney function is worsening.

Your doctor will periodically check your blood and urine sugar levels.

Children and adolescents

The administration of vildagliptin/metformin is not recommended in children and adolescents under 18 years of age.

Other medicines and vildagliptin/metformin

If you need to be given an injection of a contrast medium containing iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking vildagliptin/metformin before the injection or at the time of the injection. Your doctor will decide when you should stop taking vildagliptin/metformin and when you can restart it.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. You may need more frequent blood sugar and kidney function tests, or your doctor may need to adjust your vildagliptin/metformin dose. It is especially important to mention the following:

• corticosteroids, usually used to treat inflammation;
• beta-2 agonists, usually used to treat respiratory disorders;
• other active substances used to treat diabetes;
• medicines that increase urine production (diuretics);
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib);
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists);
• specific active substances that affect the thyroid;
• specific active substances that affect the nervous system;
• specific active substances used to treat angina (e.g., ranolazine);
• specific active substances used to treat HIV infection (e.g., dolutegravir);
• specific active substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib);
• specific active substances used to treat stomach acid and peptic ulcers (e.g., cimetidine);

Taking vildagliptin/metformin with alcohol

Avoid excessive alcohol consumption while taking vildagliptin/metformin, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will inform you about the potential risks of taking vildagliptin/metformin during pregnancy.
• Do not take vildagliptin/metformin if you are pregnant or breastfeeding (see also “Do not take vildagliptin/metformin”).

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

If you feel dizzy while taking vildagliptin/metformin, do not drive or operate tools or machines.

Vildagliptin/Metformin Kern Pharma contains lactose and sodium

This medicine contains lactose. 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, i.e., it is essentially “sodium-free”.

3. How to take Vildagliptin/Metformin Kern Pharma

The dose of vildagliptin/metformin that you should take varies depending on your condition. Your doctor will tell you exactly what dose of vildagliptin/metformin you should take.

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one 50 mg/850 mg or 50 mg/1000 mg film-coated tablet twice a day.

If you have reduced kidney function, your doctor may prescribe a lower dose. Your doctor may also prescribe a lower dose if you are taking a diabetes medicine known as a sulfonylurea.

Your doctor may prescribe this medicine alone or with certain medicines that lower your blood sugar levels.

How to take vildagliptin/metformin

• Swallow the tablets whole with a glass of water
• Take one tablet in the morning and the other in the evening with meals or after meals.

Taking the tablet after meals will reduce the risk of digestive discomfort.

Follow your doctor's dietary advice. In particular, if you follow a weight control diet for diabetics, continue with the diet while taking vildagliptin/metformin.

The score line is not intended for breaking the tablet.

If you take more vildagliptin/metformin than you should

If you have taken too many tablets of this medicine or if someone else has taken your tablets, consult your doctor or pharmacist immediately.You may need medical attention. If you have to visit a doctor or go to the nearest hospital, take the pack and this leaflet with you.

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.

If you forget to take vildagliptin/metformin

If you forget to take a tablet, take it with your next meal, unless it is already time for your usual dose. Do not take a double dose (two tablets at the same time) to make up for forgotten doses.

If you stop taking vildagliptin/metformin

Continue taking this medicine while your doctor prescribes it to continue controlling your blood sugar. Do not stop taking vildagliptin/metformin unless your doctor tells you to. If you have any doubts about the duration of treatment, consult your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking vildagliptin/metformin and contact your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to 1 in 10,000 people):

Vildagliptin/metformin may cause a very rare but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens to you, you should stop taking vildagliptin/metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to a coma.

• 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 rash or hives, which may be indicative of a reaction called “angioedema”.
• Liver disease (hepatitis) (uncommon: may affect up to 1 in 100 people): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (uncommon: may affect up to 1 in 100 people): symptoms that include severe and persistent stomach pain (abdominal pain), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients have experienced the following side effects while taking vildagliptin/metformin:

• Common (may affect up to 1 in 10 people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable tremor, constipation, nausea (discomfort), vomiting, diarrhea, flatulence, acidity, stomach pain, and abdominal pain.
• Uncommon (may affect up to 1 in 100 people): fatigue, weakness, metallic taste, low blood sugar, loss of appetite, swollen hands, ankles, or feet (edema), chills, pancreatitis, muscle pain.

• Very rare (may affect up to 1 in 10,000 people): signs of having high levels of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea and vomiting, abdominal pain, irregular heartbeat or deep and rapid breathing, skin redness, itching; decreased levels of vitamin B12 (pallor, fatigue, mental symptoms such as confusion or memory changes).

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 pinpoint red and round spots under the skin surface or bruises.

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

5. Storage of Vildagliptina/Metformina Kern Pharma

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 indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the cartons and any remaining medicines in the SIGRE collection point at your usual pharmacy. If you are unsure, ask your pharmacist how to dispose of the cartons and any remaining medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Vildagliptina/Metformina Kern Pharma

• The active substances are vildagliptina and metformina hydrochloride:
• Each film-coated tablet of Vildagliptina/Metformina Kern Pharma50 mg/850 mgcontains 50 mg of vildagliptina and 850 mg of metformina hydrochloride (corresponding to 660 mg of metformina).
• Each film-coated tablet of Vildagliptina/Metformina Kern Pharma50 mg/1,000 mgcontains 50 mg of vildagliptina and 1,000 mg of metformina hydrochloride (corresponding to 780 mg of metformina).

• The other ingredients are: In the core of the tablet: hydroxypropylcellulose, lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, magnesium stearate and sodium. Additionally, the film coating contains: hypromellose, titanium dioxide, macrogol, talc (E553b), yellow iron oxide (E172).

Appearance and package contents of the product

Vildagliptina/Metformina Kern Pharma 50 mg/850 mg film-coated tablets EFG

Film-coated tablets, oval and oblong, yellow in color, with a score line on one face and the engraving "VA" on the other face. Tablet diameter: 19.4 ± 0.5 mm.

Vildagliptina/Metformina Kern Pharma 50 mg/1,000 mg film-coated tablets EFG

Film-coated tablets, dark yellow in color, oval and oblong, with a score line between the "V" and the "B" on one face and another score line on the other face. Tablet diameter: 21.1 ± 0.5 mm.

They are presented in ALU/OPA-ALU-PVC blister packs, in packs of 10, 30, 60, 120, 180 and 360 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

SAG MANUFACTURING S.L.U.

National Highway I, Km 36

San Agustin de Guadalix 28750

Spain

Or

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50, Esplugues de Llobregat

08950 Barcelona,

Spain

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

Spain: Vildagliptina/Metformina Kern Pharma 50 mg/850 mg film-coated tablets EFG

Vildagliptina/Metformina Kern Pharma 50 mg/1,000 mg film-coated tablets EFG

Malta: Vildagliptin/Metformin Kern Pharma 50 mg/850 mg film-coated tablets

Vildagliptin/Metformin Kern Pharma 50 mg/1,000 film-coated tablets

Portugal: Metformina + Vildagliptina Pharmakern

Date of the 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/.