Melkart Duo

Leaflet included in the packaging: patient information

Melkart Duo, 50 mg + 850 mg, film-coated tablets

Melkart Duo, 50 mg + 1000 mg, film-coated tablets

Vildagliptin+ Metformin hydrochloride
You should carefully read the contents of this leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Melkart Duo and what is it used for

The active substances of Melkart Duo are vildagliptin and metformin, which belong to the group of
oral antidiabetic medicines.
Melkart Duo is used to treat adult patients with type 2 diabetes. This type of diabetes is also called
non-insulin-dependent diabetes.
Type 2 diabetes is a disease in which the body does not produce enough insulin, or the insulin produced
by the body does not work properly. Type 2 diabetes can also develop when the body produces too much
glucagon.
Both insulin and glucagon are produced in the pancreas. Insulin helps to lower blood sugar levels, especially
after a meal. Glucagon is a substance that stimulates the production of sugar in the liver and causes an increase
in blood sugar levels.

How Melkart Duo works

Both active substances, vildagliptin and metformin, help to maintain normal blood sugar levels.
Vildagliptin works by stimulating the pancreas to produce insulin and reducing the production of glucagon.
Metformin, on the other hand, helps the body to use insulin more effectively.
It has been shown that the medicine lowers blood sugar levels, which can help to prevent complications in
diabetes.

2. Important information before taking Melkart Duo

When not to take Melkart Duo:

Warnings and precautions

Risk of lactic acidosis

Melkart Duo may rarely cause a very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease).
If any of the above conditions apply to you, you should consult your doctor for more detailed instructions.

You should temporarily stop taking Melkart Duo if you have a condition that may lead to dehydration

(significant loss of water from the body), such as severe vomiting, diarrhea, fever, or heat stroke, or if you drink less fluid than usual. You should consult your doctor for more detailed instructions.

You should stop taking Melkart Duo and immediately contact your doctor or the nearest hospital if you experience any symptoms of lactic acidosis

because this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, accompanied by severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
Melkart Duo does not replace insulin. Therefore, you should not take Melkart Duo to treat type 1 diabetes.
Before starting treatment with Melkart Duo, you should discuss it with your doctor, pharmacist, or nurse if you have or have had pancreatic disease.
Before starting treatment with Melkart Duo, you should consult your doctor, pharmacist, or nurse if you are taking a sulfonylurea (a type of antidiabetic medicine).
Your doctor may want to reduce the dose of sulfonylurea taken with Melkart Duo 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.
Diabetic skin changes are a common complication of diabetes. You should follow your doctor's or nurse's advice on skin and foot care. It is also recommended that you pay special attention to the occurrence of new blisters or ulcers while taking Melkart Duo. If they occur, you should quickly discuss them with your doctor.
If you are to undergo major surgery, you should not take Melkart Duo during the surgery and for some time after it. Your doctor will decide when you should stop and restart treatment with Melkart Duo.
Before starting treatment with Melkart Duo and at three-month intervals during the first year of treatment, and then periodically, you should have your liver function tested. This will help to detect any signs of increased liver enzyme activity as soon as possible.
During treatment with Melkart Duo, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have worsening kidney function.
Your doctor will regularly assess your blood sugar levels and urine.

Melkart Duo contains lactose and sodium

If you have been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means that it is considered "sodium-free".

Children and adolescents

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

Melkart Duo and other medicines

If you are to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, you should stop taking Melkart Duo before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart treatment with Melkart Duo.
You should tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood sugar tests and kidney function tests or your doctor may need to adjust your dose of Melkart Duo.
In particular, you should inform your doctor about the following medicines:

• corticosteroids used to treat inflammatory conditions
• beta-2-adrenergic receptor agonists used to treat respiratory disorders;
• other medicines used to treat diabetes;
• diuretics (medicines that increase urine production);
• 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);
• some medicines that affect the thyroid, or
• some medicines that affect the nervous system.

Taking Melkart Duo with alcohol

You should avoid consuming excessive amounts of alcohol while taking Melkart Duo, 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 are planning to have a baby, you should consult your doctor before taking this medicine. Your doctor will discuss with you the possible risks associated with taking Melkart Duo during pregnancy.

• You should not take Melkart Duo during pregnancy or breastfeeding (see also section "When not to take Melkart Duo").

Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

If you experience dizziness while taking Melkart Duo, you should not drive or operate machinery.

3. How to take Melkart Duo

The dose of Melkart Duo varies depending on your condition. Your doctor will determine what dose of Melkart Duo you should take.
You should always take this medicine exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg film-coated tablet taken twice a day.

When and how to take Melkart Duo

• The tablets should be swallowed whole with a glass of water.
• You should take one tablet in the morning and one tablet in the evening, with a meal or just after a meal. Taking the tablet immediately after a meal will help to reduce the risk of gastrointestinal disturbances.

You should continue to follow your doctor's advice on diet while taking Melkart Duo. Diet is particularly important when you are taking a diabetes diet to control your weight.

Taking more than the recommended dose of Melkart Duo

If you have accidentally taken too many Melkart Duo tablets or if someone else has taken them, you should immediately inform your doctor or pharmacist. You may need medical attention. If you need to go to a doctor or hospital, you should take the medicine packaging and this leaflet with you.

Missing a dose of Melkart Duo

If you forget to take a tablet, you should take it during the next meal, unless it is time to take the next tablet. You should not take a double dose (two tablets at once) to make up for the missed tablet.

Stopping treatment with Melkart Duo

To maintain proper blood sugar levels, you should take the medicine for as long as your doctor has prescribed it. You should not stop taking Melkart Duo without your doctor's advice. If you have any questions about how long to take Melkart Duo, you should ask your doctor.

4. Possible side effects

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

You should stop taking Melkart Duo and immediately contact your doctorif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to 1 in 10,000 people): Melkart Duo may very rarely cause a very serious side effect called lactic acidosis (see section "Warnings and precautions"). If you experience it, you should stop taking Melkart Duo and immediately contact your doctor or the nearest hospital, as lactic acidosis can lead to coma.
• 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 appearance of rash or hives. They may indicate a reaction called "angioedema".
• Liver disease (hepatitis)(rare): symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-colored urine. They may indicate liver disease (hepatitis).
• Pancreatitis(frequency not known): symptoms include severe and persistent abdominal pain (in the pancreas area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients taking Melkart Duo have experienced the following side effects:

• Very common(may affect more than 1 in 10 people): nausea, vomiting, diarrhea, abdominal pain or stomach pain.
• Common(may affect up to 1 in 10 people): dizziness, headache, uncontrollable shaking, metallic taste in the mouth, low blood sugar.
• Uncommon(may affect up to 1 in 100 people): joint pain, fatigue, constipation, swelling of the hands, ankles, or feet (edema).
• Very rare(may affect up to 1 in 10,000 people): dryness of the mucous membranes of the throat, common cold, fever; symptoms of high lactic acid levels in the blood (called lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat or deepened, rapid breathing; skin redness, itching;

Some patients taking Melkart Duo and a sulfonylurea have experienced the following side effects:

• Common: dizziness, shaking, weakness, low blood sugar, excessive sweating.

Some patients taking Melkart Duo and insulin have experienced the following side effects:

• Common: headache, chills, nausea (nausea), low blood sugar, heartburn.
• Uncommon: diarrhea, bloating.

After the medicine was placed on the market, the following side effects have also been reported:

• Frequency not known(frequency cannot be estimated from the available data): itching rash, pancreatitis, local skin peeling or blistering, muscle pain.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Adverse Reaction Monitoring 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Melkart Duo

You should 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 packaging after EXP.

The expiry date refers to the last day of the month stated.

There are no special storage precautions for this medicine.

Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Duo contains

• The active substances are vildagliptin and metformin hydrochloride.
• Each Melkart Duo 50 mg + 850 mg film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (which corresponds to 662.88 mg of metformin).
• Each Melkart Duo 50 mg + 1000 mg film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (which corresponds to 779.86 mg of metformin).
• The other ingredients are: hydroxypropylcellulose, lactose (see section 2), microcrystalline cellulose PH 102, sodium carmellose, sodium stearyl fumarate, and coating (hypromellose type 2910, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172)).

What Melkart Duo looks like and contents of the pack

Melkart Duo 50 mg + 850 mg, film-coated tablets

Yellow, elongated, oval film-coated tablets with a dividing line on one side and "VA" marking on the other side. Tablet length: 19.4 ± 0.5 mm

Melkart Duo 50 mg + 1000 mg, film-coated tablets

Dark yellow, elongated, oval film-coated tablets with a dividing line between "V" and "B" markings on one side and a dividing line on the other side. Tablet length: 21.1 ± 0.5 mm

Aluminum/OPA/Aluminum/PVC blister pack containing 60 film-coated tablets in a cardboard box.

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.

Avda. Cornellá 144, 7º-1ª, Edificio Lekla

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 countries, please contact 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: 01.12.2022