Agartha Duo

Package Leaflet: Information for the User

AGARTHA DUO, 50 mg + 850 mg, film-coated tablets

AGARTHA DUO, 50 mg + 1000 mg, film-coated tablets

Wildagliptin + Metformin Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• 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 them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package Leaflet

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

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

The active substances of Agartha Duo are wildagliptin and metformin, which belong to the group of oral antidiabetic medicines.
Agartha Duo is used to treat type 2 diabetes in adults. This type of diabetes is also called non-insulin-dependent diabetes. Agartha Duo is used when diet and exercise alone are not enough to control blood sugar levels, and when other antidiabetic medicines (oral or insulin) are also used.
Type 2 diabetes is a condition where the body does not produce enough insulin, or the insulin produced by the body does not work properly. Type 2 diabetes can also occur when the body produces too much glucagon. Both insulin and glucagon are produced in the pancreas. Insulin helps lower blood sugar levels, especially after meals.
Glucagon is a substance that stimulates the liver to produce sugar and increases blood sugar levels.

How Agartha Duo works

Both active substances, wildagliptin and metformin, help control blood sugar levels.
Wildagliptin works by stimulating the pancreas to produce insulin and reducing the production of glucagon. Metformin helps the body use insulin better.
It has been shown that the medicine lowers blood sugar levels, which can help prevent complications of diabetes.

2. Important information before taking Agartha Duo

When not to take Agartha Duo

• if you are allergic to wildagliptin, 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, tell your doctor before taking Agartha Duo.

if you have uncontrolled diabetes, such as 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 condition where substances called ketones build up in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or a fruity odor from the mouth.

• if you have recently had a heart attack or if you have heart failure or severe circulatory problems or breathing difficulties, which may be a sign of heart failure.
• if you have significantly reduced kidney function.
• if you have a severe infection or are severely dehydrated (lost a lot of water from your body).
• if you are going to have a contrast radiology test (a special type of test that requires the injection of a contrast agent). For more information, see also section "Warnings and precautions".
• if you have liver disease.
• if you drink excessive amounts of alcohol (both regularly and from time to time).
• if you are breastfeeding (see also section "Pregnancy and breastfeeding").

Warnings and precautions

Risk of lactic acidosis

Agartha Duo may cause a very rare but 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 infections, prolonged fasting, or alcohol consumption, dehydration (see more detailed information below), liver disease, or any condition where part of the body is not getting enough oxygen (e.g., severe heart disease).
If any of these situations apply to you, you should consult your doctor for more detailed instructions.

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

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

You should stop taking Agartha Duo and contact your doctor immediately or go to the nearest hospital if you 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 with severe fatigue,
• breathing difficulties,
• low body temperature and slow heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
Agartha Duo does not replace insulin. Therefore, you should not take Agartha Duo to treat type 1 diabetes.
Before starting Agartha Duo, you should discuss it with your doctor, pharmacist, or nurse if you have or have had pancreatic disease.
Before starting Agartha Duo, you should tell your doctor, pharmacist, or nurse if you are taking a sulfonylurea antidiabetic medicine. Your doctor may want to reduce the dose of the sulfonylurea medicine you are taking with Agartha Duo to avoid low blood sugar (hypoglycemia).
If you have taken wildagliptin before 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. You should also pay special attention to the occurrence of new blisters or ulcers while taking Agartha Duo. If they occur, you should talk to your doctor as soon as possible.
If you are going to have major surgery, you should stop taking Agartha Duo during and for some time after the surgery. Your doctor will decide when you should stop and restart Agartha Duo.
Before starting Agartha Duo and at 3-month intervals during the first year of treatment, and periodically thereafter, you should have liver function tests. This will help detect any signs of increased liver enzyme activity as soon as possible.
During treatment with Agartha 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 check your blood and urine sugar levels.

Children and adolescents

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

Agartha Duo with other medicines

If you are going to have a contrast agent injected into your bloodstream, for example, for an X-ray or CT scan, you should stop taking Agartha Duo before or at the time of the injection. Your doctor will decide when you should stop and restart Agartha 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 checks or kidney function tests, or your doctor may need to adjust your Agartha Duo dose. It is especially important to inform your doctor about the following medicines:

• corticosteroids, usually used to treat inflammatory conditions,
• beta-2-adrenergic receptor agonists, usually used to treat respiratory disorders,
• other antidiabetic medicines,
• 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 that affect the thyroid gland,
• certain medicines that affect the nervous system,
• certain medicines used to treat angina (e.g., ranolazine),
• certain medicines used to treat HIV infection (e.g., dolutegravir),
• certain medicines used to treat a specific type of thyroid cancer (medullary thyroid carcinoma) (e.g., vandetanib),
• certain medicines used to treat heartburn and stomach ulcers (e.g., cimetidine).

Agartha Duo with alcohol

You should avoid excessive alcohol consumption while taking Agartha Duo, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

• If you are pregnant or think you may be pregnant, or if you are planning to have a baby, you should consult your doctor before taking this medicine. Your doctor will discuss the possible risks and benefits of taking Agartha Duo during pregnancy.
• You should not take Agartha Duo while breastfeeding (see also section "When not to take Agartha Duo").

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

Driving and using machines

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

3. How to take Agartha Duo

The dose of Agartha Duo varies depending on your condition. Your doctor will determine what dose of Agartha Duo you should take.
You should always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg film-coated tablet twice a day.
If you have kidney problems, your doctor may prescribe a lower dose. If you are taking a sulfonylurea antidiabetic medicine, your doctor may also prescribe a lower dose.
Your doctor may prescribe this medicine alone or with other medicines that lower blood sugar levels.

When and how to take Agartha Duo

• Swallow the tablets whole with a glass of water. If necessary, to make it easier to swallow the tablet, it can be broken in half.
• Take one tablet in the morning and one in the evening with a meal or just after a meal. Taking the tablet immediately after a meal will help reduce the risk of stomach upset.

You should continue to follow your doctor's advice on diet while taking Agartha Duo. Following a diet while taking Agartha Duo is especially important if you are following a weight-control diet.

What to do if you take more Agartha Duo than you should

If you accidentally take too many Agartha Duo tablets or if someone else takes them, you should immediately contact your doctor or pharmacist. You may need medical attention. If you need to go to a doctor or hospital, take the medicine pack and this leaflet with you.

What to do if you forget to take Agartha Duo

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

What to do if you stop taking Agartha Duo

To maintain control of your blood sugar levels, you should keep taking the medicine for as long as your doctor has prescribed it. Do not stop taking Agartha Duo without your doctor's advice. If you have any questions about how long to take Agartha Duo, you should ask your doctor.
If you have any further questions about taking this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Agartha Duo can cause side effects, although not everybody gets them.
You should stop taking Agartha Duo 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): Agartha Duo may very rarely cause a very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens to you, you should stop taking Agartha Duo and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
• Anaphylactic reaction (rare: may affect up to 1 in 1,000 people): Symptoms include swelling of the face, tongue, 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, which may indicate liver disease (hepatitis).
• Pancreatitis (frequency not known: cannot be estimated from the available data): Symptoms include severe and persistent abdominal pain (around the stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

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

• Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhea, stomach pain or discomfort (abdominal pain), loss of appetite.
• Common (may affect up to 1 in 10 people): dizziness, headache, uncontrolled 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, feet, or ankles (edema).
• Rare (may affect up to 1 in 10,000 people): sore throat, runny nose, fever; symptoms of high lactic acid levels in the blood (lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat or deep and rapid breathing; skin rash, itching; low vitamin B12 levels (anemia, fatigue, mental symptoms such as confusion or memory problems).

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

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

Some patients taking Agartha 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 made available, the following side effects have also been reported:

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Agartha Duo

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP"/"Expiry Date (EXP)". The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Store in the original package to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Agartha Duo contains

The active substances are wildagliptin and metformin hydrochloride.
Each Agartha Duo 50 mg + 850 mg film-coated tablet contains 50 mg of wildagliptin and 850 mg of metformin hydrochloride.
Each Agartha Duo 50 mg + 1000 mg film-coated tablet contains 50 mg of wildagliptin and 1000 mg of metformin hydrochloride.
The other ingredients are:
Agartha Duo 50 mg + 850 mg, film-coated tablets: hydroxypropyl cellulose, magnesium stearate, hypromellose 2910, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172).
Agartha Duo 50 mg + 1000 mg, film-coated tablets: hydroxypropyl cellulose, magnesium stearate, hypromellose 2910, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Agartha Duo looks like and contents of the pack

Agartha Duo 50 mg + 850 mg, film-coated tablets are yellow, oval, biconvex, approximately 18.0 mm long and 9.0 mm wide, with a yellow border, white or almost white dividing line surface. On one side of the tablet, there is an embossed marking AB3, and on the other side, a dividing line. The dividing line surface of the tablet is white with yellow edges.
Agartha Duo 50 mg + 1000 mg, film-coated tablets are brown, oval, biconvex, approximately 17.7 mm long and 10.0 mm wide, with a brown border, white or almost white dividing line surface. On one side of the tablet, there is an embossed marking AB4, and on the other side, a dividing line. The dividing line surface of the tablet is white with brown edges.
The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Agartha Duo 50 mg + 850 mg, film-coated tablets are packaged in PA/Aluminum/PVC/Aluminum blisters, in a cardboard box.
Agartha Duo 50 mg + 850 mg, film-coated tablets are available in packs of 60 film-coated tablets and in multipacks containing 120 (2x60), 180 (3x60).
Agartha Duo 50 mg + 1000 mg, film-coated tablets are packaged in PA/Aluminum/PVC/Aluminum blisters, in a cardboard box.
Agartha Duo 50 mg + 1000 mg, film-coated tablets are available in packs of 60 film-coated tablets and in multipacks containing 120 (2x60), 180 (3x60).
Not all pack sizes may be marketed.

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki

Manufacturer

Gedeon Richter Romania S.A.
Strada Cuza Voda 99-105
540306 Targu Mures
Romania
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
To obtain more detailed information about the medicine and its names in other European Economic Area countries, you should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
phone: +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of last revision of the package leaflet: January 2022