Melkart duo

Package leaflet: Information for the patient

Melkart Duo, 50 mg + 850 mg, film-coated tablets
Melkart Duo, 50 mg + 1000 mg, film-coated tablets
Vildagliptin + Metformini hydrochloridum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Contents of this leaflet

1. What Melkart Duo is and what it is used for
2. What you need to know 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 Melkart Duo is and what it is used for

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

How Melkart Duo works
Both active substances, vildagliptin and metformin, help maintain normal blood glucose levels.
Vildagliptin works by stimulating the pancreas to produce more insulin and by reducing glucagon production. Metformin, on the other hand, helps the body use insulin more effectively.
The medicine has been shown to reduce blood glucose levels, which may help prevent complications associated with diabetes.

2. Important information before using Melkart Duo

When not to use 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 inform their doctor before taking Melkart Duo;
• if the patient has uncontrolled diabetes, for example severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odour of the breath;
• if the patient has recently had a heart attack or has heart failure or severe circulatory problems or difficulty breathing, which may be symptoms 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 body fluid);
• if the patient is due to undergo a contrast radiological examination (a special type of imaging test requiring injection of a contrast agent). For further information on this, see also the section "Warnings and precautions";
• if the patient has liver disease;
• if the patient drinks alcohol in excess (daily or occasionally);
• if the patient is breastfeeding (see also section "Pregnancy and breastfeeding");
• if the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

Warnings and precautions
Risk of lactic acidosis
Melkart Duo may cause a very rare but serious side effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infection, prolonged fasting, alcohol consumption, dehydration (see further details below), liver dysfunction, and any medical conditions in which a part of the body is inadequately 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 further instructions.
The patient should temporarily stop taking Melkart Duo if they develop a medical condition associated with dehydration (significant loss of body fluid), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult their doctor for further instructions.
The patient should stop taking Melkart Duo and immediately contact their doctor or the nearest hospital if any symptoms of lactic acidosis occur, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise accompanied by severe fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
Melkart Duo does not replace insulin. Therefore, Melkart Duo should not be used in the treatment of type 1 diabetes.
Before starting treatment with Melkart Duo, the patient should discuss this with their doctor, pharmacist, or nurse if they have or have had pancreatic disorders.
Before starting treatment with Melkart Duo, the patient should consult their doctor, pharmacist, or nurse if they are taking an antidiabetic medicine called a sulfonylurea.
The doctor may wish to reduce the dose of the sulfonylurea when used together with Melkart Duo to avoid low blood glucose levels (hypoglycaemia).
If the patient previously took vildagliptin but had to discontinue it 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 advice regarding skin and foot care. The patient should also pay particular attention to the appearance of new blisters or ulcers while taking Melkart Duo. If these occur, the patient should promptly discuss them with their treating doctor.
If the patient is scheduled for major surgery, they must not take Melkart Duo during the procedure and for some time afterwards. The doctor will decide when the patient should stop and resume treatment with Melkart Duo.
Before starting treatment with Melkart Duo and at three-monthly intervals during the first year of treatment, and thereafter periodically, liver function tests should be performed. This allows signs of increased liver enzyme activity to be detected as early as possible.
During treatment with Melkart Duo, the doctor will monitor the patient’s kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.
The doctor will regularly monitor blood and urine glucose levels.
Melkart Duo contains lactose and sodium
If the patient has been diagnosed with intolerance to certain sugars, they should consult their doctor before starting this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dosage unit, meaning the medicine is considered "sodium-free".
Children and adolescents
Melkart Duo is not recommended for use in children and adolescents under 18 years of age.
Melkart Duo and other medicines
If the patient is to receive an iodine-containing contrast agent injected into the bloodstream, for example for an X-ray or CT scan, they must stop taking Melkart Duo before or at the latest at the time of injection. The doctor will decide when the patient should stop and resume treatment with Melkart Duo.
The patient should inform 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 require more frequent monitoring of blood glucose levels and kidney function, or the doctor may need to adjust the dose of Melkart Duo. It is especially important to inform the doctor about the following medicines:

• glucocorticoids, 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 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);
• certain medicines affecting the thyroid gland; or
• certain medicines affecting the nervous system.

Use of 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, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine. The doctor will discuss with the patient the possible risks associated with taking Melkart Duo during pregnancy.

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

Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
If the patient experiences dizziness while taking Melkart Duo, they should not drive or operate machinery.

3. How to take Melkart Duo

The dose of Melkart Duo varies depending on the patient's condition. The doctor will determine the appropriate dose of Melkart Duo to take.
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg coated tablet taken twice daily.
If the patient has impaired kidney function, the doctor may prescribe a lower dose. If the patient is taking a diabetes medicine called a sulfonylurea, the doctor may also prescribe a lower dose.
The doctor may prescribe this medicine to be taken alone (as monotherapy) or together with certain other medicines that lower blood sugar levels.

When and how to take Melkart Duo

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one in the evening, with a meal or immediately after a meal. Taking the tablet right after a meal may help reduce the risk of gastrointestinal disturbances.

Continue to follow all dietary recommendations provided by the doctor. Maintaining a proper diet while taking Melkart Duo is particularly important, especially if the patient is on a diabetes diet aimed at controlling body weight.
The break line on the tablet is not intended for splitting the tablet.

Taking more Melkart Duo than recommended
If too many tablets of Melkart Duo have been accidentally taken, or if someone else has taken the tablets, inform the doctor or pharmacist immediately. Medical attention may be required. If it is necessary to see a doctor or go to the hospital, bring the medicine packaging and leaflet along.

Missed dose of Melkart Duo
If the patient forgets to take a tablet, it should be taken during the next meal, unless it is already almost time for the next dose. Do not take a double dose (two tablets at once) to make up for a missed tablet.

Stopping Melkart Duo
To maintain proper blood sugar levels, the medicine should be taken for as long as the doctor recommends. Do not stop taking Melkart Duo without consulting the doctor. If there are any questions about how long to continue taking Melkart Duo, consult the doctor.

If there are any further doubts regarding the use of this medicine, consult the doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Stop taking Melkart Duo and contact a doctor immediately if any of the following adverse reactions occur:

• Lactic acidosis (very rare: may occur in up to 1 in 10,000 patients): Melkart Duo may very rarely cause a very serious adverse reaction called lactic acidosis (see section "Warnings and precautions"). If lactic acidosis occurs, stop taking Melkart Duo immediately and seek medical advice from a doctor or the nearest hospital, as lactic acidosis may lead to coma.
• Angioedema (rare: may occur in up to 1 in 1,000 patients): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, breathing difficulties, sudden onset of rash or hives. These may indicate a reaction known as "angioedema".
• Liver disease (hepatitis) (rare): Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-coloured urine. These may indicate liver disease (hepatitis).
• Pancreatitis (frequency not known): Symptoms include severe and persistent abdominal pain (around the stomach), which may radiate to the back, as well as nausea and vomiting.

Other adverse reactions
The following adverse reactions have been reported in some patients taking Melkart Duo:

• Very common (may occur in more than 1 in 10 patients): nausea, vomiting, diarrhoea, stomach pain or abdominal discomfort (abdominal pain), loss of appetite.
• Common (may occur in up to 1 in 10 patients): dizziness, headache, uncontrolled tremor, metallic taste in the mouth, low blood glucose levels.
• Uncommon (may occur in up to 1 in 100 patients): joint pain, fatigue, constipation, swelling of the hands, ankles or feet (oedema).
• Very rare (may occur in up to 1 in 10,000 patients): dryness of the throat mucosa, nasal congestion, 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 deep, rapid breathing; skin redness, itching;
decreased vitamin B levels (pallor, fatigue, psychiatric symptoms such as confusion or memory disturbances).

In some patients taking Melkart Duo together with a sulfonylurea, the following adverse reactions have occurred:

• Common: dizziness, tremor, weakness, low blood glucose levels, excessive sweating.

In some patients taking Melkart Duo together with insulin, the following adverse reactions have occurred:

• Common: headache, chills, nausea, low blood glucose levels, heartburn.
• Uncommon: diarrhoea, flatulence.

Since this medicine has been placed on the market, the following adverse reactions have also been reported:

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

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions may also be reported to the responsible entity.
By reporting adverse reactions, you help provide more information on the safety of this medicine.

5. How to store Melkart Duo

The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents 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 (equivalent 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 (equivalent to 779.86 mg of metformin).
• Excipients: hydroxypropylcellulose, lactose (see section 2), microcrystalline cellulose PH 102, sodium croscarmellose, 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 the imprint "VA" 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 the imprints "V" and "B" on one side and a score line on the other side. Tablet length: 21.1 ± 0.5 mm
Aluminium/OPA/Aluminium/PVC blister pack containing 60 film-coated tablets in a cardboard box.

Marketing Authorisation 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 further information and details on the product names in other EEA countries, please contact the local representative of the Marketing Authorisation 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]