MELKART 50 mg/1000 mg Tablets

Contents of the leaflet

1. Leaflet included in the packaging: patient information
2. Melkart Duo, 50 mg + 850 mg, film-coated tablets
3. Melkart Duo, 50 mg + 1000 mg, film-coated tablets
   1. Table of contents of the leaflet
4. What is Melkart Duo and what is it used for
   1. How Melkart Duo works
5. Important information before taking Melkart Duo
   1. When not to take Melkart Duo:
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. The patient should temporarily stop taking Melkart Duo if they experience a condition that may lead to dehydration
   5. The patient should stop taking Melkart Duo and immediately consult their doctor or the nearest hospital if they experience any symptoms of lactic acidosis
   6. Melkart Duo contains lactose and sodium
   7. Children and adolescents
   8. Melkart Duo and other medicines
   9. Taking Melkart Duo with alcohol
   10. Pregnancy and breastfeeding
   11. Driving and using machines
6. How to take Melkart Duo
   1. When and how to take Melkart Duo
   2. Taking a higher dose of Melkart Duo than recommended
   3. Missing a dose of Melkart Duo
   4. Stopping treatment with Melkart Duo
7. Possible side effects
   1. Other side effects
   2. Reporting side effects
8. How to store Melkart Duo
9. Contents of the packaging and other information
   1. What Melkart Duo contains
   2. What Melkart Duo looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: 01.12.2022

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
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 by a doctor for a specific person. 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 undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their 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 packaging 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 mellitus. 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 increases blood sugar levels.

How Melkart Duo works

Both active substances, vildagliptin and metformin, help to maintain a normal blood sugar level.
Vildagliptin works by stimulating the pancreas to produce insulin and reducing the production of glucagon. Metformin helps the body to use insulin better.
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:

• if the patient is allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic to any of these ingredients, they should consult their doctor before taking Melkart Duo;

if the patient has uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a disease in which substances called ketone bodies accumulate in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity breath odor;

• if the patient has recently had a heart attack or has heart failure or severe circulatory disorders or breathing difficulties, which may be a sign of heart failure;
• if the patient has significantly reduced kidney function;
• if the patient has a severe infection or is severely dehydrated (has lost a lot of water from the body);
• if the patient is to undergo a contrast radiological examination (a special type of examination that requires the injection of a contrast agent). For more information, see also section "Warnings and precautions";
• if the patient has liver disease;
• if the patient drinks excessive amounts of alcohol (every day or from time to time);
• if the patient is breastfeeding (see also section "Pregnancy and breastfeeding");
• if the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking the medicine.

Warnings and precautions

Risk of lactic acidosis

Melkart Duo may rarely cause a very serious side effect called lactic acidosis, especially if the patient has 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 the patient, they should consult their doctor for more detailed instructions.

The patient should temporarily stop taking Melkart Duo if they experience 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 the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

The patient should stop taking Melkart Duo and immediately consult their doctor or the nearest hospital if they experience any symptoms of lactic acidosis

, as 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, the patient should not take Melkart Duo to treat type 1 diabetes.
Before starting treatment with Melkart Duo, the patient should discuss it with their doctor, pharmacist, or nurse if they have or have had pancreatitis.
Before starting treatment with Melkart Duo, the patient should consult their doctor, pharmacist, or nurse if they are taking a sulfonylurea, a type of antidiabetic medicine.
The doctor may want to reduce the dose of sulfonylurea taken with Melkart Duo to avoid low blood sugar (hypoglycemia).
If the patient has taken vildagliptin before but had to stop taking it due to liver disease, they should not take this medicine.
Diabetic skin changes are a common complication of diabetes. The patient should follow their doctor's or nurse's advice on skin and foot care. It is also recommended that the patient pay special attention to the occurrence of new blisters or ulcers while taking Melkart Duo. If they occur, the patient should consult their doctor promptly.
If the patient is to undergo major surgery, they should not take Melkart Duo during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Melkart Duo.
Before starting treatment with Melkart Duo and at three-month intervals during the first year of treatment, and then periodically, the patient should have liver function tests. This will help to detect any signs of increased liver enzyme activity as soon as possible.
During treatment with Melkart Duo, the doctor will check the patient's kidney function at least once a year or more often if the patient is elderly and/or has worsening kidney function.
The doctor will regularly assess the patient's blood and urine sugar levels.

Melkart Duo contains lactose and sodium

If the patient has been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means 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 the patient is to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Melkart Duo before or at the latest at the time of the injection. The doctor will decide when the patient should stop and resume treatment with Melkart Duo.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent blood sugar checks and kidney function tests or dose adjustments of Melkart Duo by their doctor. It is especially important to inform about the following medicines:

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

Taking Melkart Duo with alcohol

The patient 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 the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine. The doctor will discuss with the patient the possible risks associated with taking Melkart Duo during pregnancy.

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

Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

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

3. How to take Melkart Duo

The dose of Melkart Duo varies depending on the patient's condition. The doctor will determine what dose of Melkart Duo the patient should take.
This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg film-coated tablet taken twice a day.
If the patient has kidney problems, the doctor may prescribe a lower dose. If the patient is taking a sulfonylurea, a type of antidiabetic medicine, the doctor may also prescribe a lower dose.
The doctor may prescribe this medicine to be taken alone (monotherapy) or with certain other medicines that lower blood sugar levels.

When and how to take Melkart Duo

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

The patient should continue to follow their doctor's advice on diet. Diet is especially important when taking Melkart Duo, especially when the patient is on a diabetic diet to control their weight.
The score line is not intended for breaking the tablet.

Taking a higher dose of Melkart Duo than recommended

If the patient has accidentally taken too many Melkart Duo tablets or someone else has taken them, they should immediately inform their doctor or pharmacist. The patient may need medical attention. If it is necessary to visit a doctor or hospital, the patient should take the packaging and leaflet with them.

Missing a dose of Melkart Duo

If the patient forgets to take a tablet, they should take it during the next meal, unless it is already time to take the next tablet. The patient 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 control, the patient should take the medicine for as long as their doctor has prescribed it. The patient should not stop taking Melkart Duo without their doctor's advice. If the patient has any further questions about taking Melkart Duo, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Melkart Duo can cause side effects, although not everybody gets them.
The patient should stop taking Melkart Duo and immediately consult their doctorif they experience any of the following side effects:

• Lactic acidosis(very rare: may occur in up to 1 in 10,000 patients): Melkart Duo may very rarely cause a very serious side effect called lactic acidosis (see section "Warnings and precautions"). If it occurs, the patient shouldstop taking Melkart Duo and immediately consult their doctor or the nearest hospital, as lactic acidosis can lead to coma.
• Anaphylactic reaction(rare: may occur in up to 1 in 1,000 patients): Symptoms include swelling of the face, lips, or throat, difficulty swallowing, breathing difficulties, sudden appearance of rash or hives. These may indicate an allergic reaction called "anaphylactic reaction".
• Liver disease (hepatitis)(rare): Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-colored urine. These 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 occur in more than 1 in 10 patients): nausea, vomiting, diarrhea, abdominal pain or stomach pain.
• Common(may occur in up to 1 in 10 patients): dizziness, headache, uncontrollable shaking, metallic taste in the mouth, low blood sugar.
• Uncommon(may occur in up to 1 in 100 patients): joint pain, fatigue, constipation, swelling of hands, feet, or ankles (edema).
• Very rare(may occur in up to 1 in 10,000 patients): dryness of the mucous membranes of the throat, runny nose, 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;
decreased vitamin B levels (pallor, fatigue, psychological symptoms, such as confusion or memory disorders).
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): itchy rash, pancreatitis, local skin peeling or blistering, muscle pain.

Reporting side effects

If the patient experiences any side effects, including any side effects not mentioned in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 to gather more information on the safety of the medicine.

5. How to store Melkart Duo

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.
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 to protect the environment.

6. Contents of the packaging 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).
• Excipients: 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 score 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 score line between "V" and "B" markings on one side and a score 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