Melkart

Leaflet included in the packaging: patient information

Melkart, 50 mg, tablets

Vildagliptin
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you for a specific reason. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Melkart and what is it used for
• 2. Important information before taking Melkart
• 3. How to take Melkart
• 4. Possible side effects
• 5. How to store Melkart
• 6. Contents of the pack and other information

1. What is Melkart and what is it used for

Melkart's active substance, vildagliptin, belongs to a group of oral anti-diabetic medicines.
Vildagliptin is used to treat type 2 diabetes in adults when diabetes cannot be controlled by diet and exercise. The medicine helps control blood sugar levels. The doctor will prescribe Melkart to the patient as the only medicine or with other anti-diabetic medicines that the patient is already taking, if they do not control diabetes sufficiently.
Type 2 diabetes develops when the body does not produce enough insulin or when the insulin produced by the body does not work properly. Type 2 diabetes can also develop when the body produces too much glucagon.
Insulin helps lower blood sugar levels, especially after meals. Glucagon stimulates the liver to produce sugar, which increases its level in the blood. Both substances are produced in the pancreas.

How Melkart works

Melkart works by stimulating the pancreas to produce more insulin and less glucagon. This helps control blood sugar levels. It has been shown that the medicine lowers blood sugar levels, which can help prevent diabetes complications.
Even if the patient starts taking an anti-diabetic medicine, it is essential to continue following a suitable diet and/or performing the recommended physical exercises.

2. Important information before taking Melkart

When not to take Melkart:

• if the patient is allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic to vildagliptin or any of the other ingredients of Melkart, they should not take the medicine and consult a doctor.

Warnings and precautions

Before starting Melkart, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has type 1 diabetes (i.e., their body does not produce insulin) or if they have been diagnosed with diabetic ketoacidosis;
• if the patient is taking a sulfonylurea (the doctor may recommend reducing the dose of sulfonylurea taken with Melkart to avoid hypoglycemia);
• if the patient has moderate or severe kidney disease (the patient may need a lower dose of Melkart);
• if the patient is on dialysis;
• if the patient has liver disease;
• if the patient has heart failure;
• if the patient has had or has pancreatitis.

If the patient has previously taken vildagliptin but had to stop treatment due to liver disease, they should not take this medicine.
Diabetic skin changes are a common complication of diabetes. The patient should follow the doctor's or nurse's recommendations regarding skin and foot care. The patient should also pay special attention to the development of new blisters and ulcers while taking Melkart. If they occur, the patient should contact their doctor immediately.
Before starting Melkart, the patient should have liver function tests, and then repeat them every three months in the first year of treatment and periodically during the entire treatment. This is to detect an increase in liver enzyme activity as soon as possible.

Children and adolescents

Melkart should not be used in children and adolescents under 18 years of age.

Melkart and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The doctor may need to change the dose of Melkart if the patient is taking medicines such as:

• thiazides or other diuretics
• corticosteroids (usually used to treat inflammatory conditions)
• medicines used to treat thyroid disorders
• certain medicines that affect the nervous system

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine.
Melkart should not be used during pregnancy. It is not known whether Melkart passes into breast milk. Melkart should not be used if the patient is breastfeeding or plans to breastfeed.

Driving and using machines

If the patient experiences dizziness while taking Melkart, they should not drive or operate machinery.

Melkart contains lactose

Melkart contains lactose (milk sugar). If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially 'sodium-free'.

3. How to take Melkart

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

When and how to take Melkart

The dose of Melkart depends on the patient's condition. The doctor will inform the patient exactly how many tablets of Melkart to take. The maximum daily dose is 100 mg.
Usually, the recommended dose of Melkart is:

• 50 mg once daily in the morning, if the patient is taking Melkart with a sulfonylurea;
• 100 mg once daily, taken in two doses: 50 mg in the morning and 50 mg in the evening, if the patient is taking Melkart alone, in combination with metformin or a glitazone, metformin and a sulfonylurea, or with insulin;
• 50 mg once daily in the morning, if the patient has moderate or severe kidney disease or is on dialysis.

How to take Melkart

The tablets should be swallowed whole with a glass of water.

How long to take Melkart

• Melkart should be taken every day, as long as the doctor recommends. The doctor may decide on long-term treatment.
• The doctor will regularly monitor the patient's condition to check if the treatment is having the desired effect.

Overdose of Melkart

If the patient has taken too many Melkart tablets or if someone else has taken this medicine, they should contact their doctor immediately. Medical attention may be necessary. If it is necessary to visit a doctor or hospital, the patient should take the medicine packaging with them.

Missed dose of Melkart

If the patient forgets to take a dose, they should take it as soon as possible. Then, they should take the next dose at the usual time. However, if it is almost time for the next dose, the patient should not take the missed dose.
The patient should not take a double dose to make up for a missed tablet.

Stopping Melkart treatment

The patient should not stop taking Melkart without consulting their doctor. If the patient has any further doubts about taking this medicine, they should consult their doctor.

4. Possible side effects

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

Some side effects require immediate medical attention:

The patient should stop taking Melkart and contact their doctor immediately if they experience any of the following side effects:

• angioedema (rare: may affect up to 1 in 1,000 people): symptoms include swelling of the face, lips, or throat, difficulty swallowing, breathing difficulties, sudden onset of rash or hives, which may indicate angioedema;
• liver disease (hepatitis) (frequency not known): symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may indicate liver disease;
• pancreatitis (rare: may affect up to 1 in 1,000 patients): symptoms include severe and persistent abdominal pain (around the stomach area) that may radiate to the back, as well as nausea and vomiting.

Other side effects

The following side effects have been reported during treatment with Melkart:

• Very common (may affect more than 1 in 10 patients): sore throat, runny nose, fever.
• Common (may affect up to 1 in 10 patients): itchy rash, itching, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles, or feet (edema), excessive sweating, vomiting, stomach pain, diarrhea, heartburn, nausea, blurred vision.
• Uncommon (may affect up to 1 in 100 patients): weight gain, chills, weakness, sexual dysfunction, low blood sugar, bloating.
• Rare (may affect up to 1 in 1,000 patients): pancreatitis.

After the medicine was marketed, the following side effects have also been reported:

• frequency not known (frequency cannot be estimated from the available data): localized skin peeling or blistering, vasculitis, which can cause skin rash or spiky, flat, red, round patches under the skin surface or bruising.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Melkart

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Do not use Melkart if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Melkart contains

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• Excipients: lactose, sodium stearyl fumarate, microcrystalline cellulose PH 102, croscarmellose sodium.

What Melkart looks like and contents of the pack

White to almost white, round, biconvex tablets with a diameter of 8.0 mm ± 0.5 mm.
Aluminium/OPA/Aluminium/PVC blisters in packs containing 28 or 56 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain
SAG Manufacturing, S.L.U
Ctra. N-I, km 36
28750 San Agustín de Guadalix
Madrid – Spain

For more information and information on the names of the medicinal product in other EEA member states, please contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

Date of last revision of the leaflet: 13.06.2025