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 all of 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 them, even if their signs of illness 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.

Contents of the pack and other information

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

The active substances of Agartha Duo are wildagliptin and metformin, which belong to a group of oral antidiabetic medicines.
Agartha Duo is used to treat adult patients with type 2 diabetes. 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 not sufficient to control blood sugar levels.
Type 2 diabetes is a condition where the body does not produce enough insulin or the insulin produced 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 to lower blood sugar levels, especially after meals. Glucagon is a substance that stimulates the liver to produce sugar, which increases blood sugar levels.

How Agartha Duo works

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

2. What you need to know 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 (have 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 occasionally).
• 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 if you have uncontrolled diabetes, severe infections, prolonged fasting, or excessive alcohol consumption, dehydration (see more 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 talk to 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, high temperature, or if you drink less fluid than usual. You should talk to your doctor for more detailed instructions.

You should stop taking Agartha Duo and contact your doctor or the nearest hospital immediately 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 medical treatment.

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 treatment with Agartha Duo.
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 the dose of Agartha Duo. It is especially important to tell 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 cancer) (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, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Agartha Duo during pregnancy.
• Do not take Agartha Duo if you are breastfeeding (see also section "When not to take Agartha Duo").

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

If you experience dizziness while taking Agartha Duo, do 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 the dose of Agartha Duo you should take.
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 immediately 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. Diet is especially important when you are taking a weight-controlling diet.

If you take more Agartha Duo than you should

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

If you forget to take Agartha Duo

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

If you stop taking Agartha Duo

To keep your blood sugar levels under control, you should keep taking this medicine for as long as your doctor tells you to. Do not stop taking Agartha Duo without talking to your doctor first. If you have any further questions on how long to take Agartha Duo, ask your doctor.
If you have any further questions on the use of this product, 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, stop taking Agartha Duo and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
• Angioedema (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 a condition 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, 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 abdominal pain, loss of appetite.
• Common (may affect up to 1 in 10 people): dizziness, headache, tremor, metallic taste, 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 1,000 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 levels of vitamin B12 (pallor, fatigue, mental symptoms such as confusion or memory problems).

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

• Common: dizziness, tremor, 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 this medicine was marketed, the following side effects have also been reported:

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact details for the reporting of side effects" section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Agartha Duo

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 blister and carton after "EXP"/"Expiry date (EXP)". The expiry date refers to the last day of that 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. These measures 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 of 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 of 120 (2x60), 180 (3x60).
Not all pack sizes may be marketed.

Marketing Authorisation 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 on this medicine and its authorized names in other EU Member States, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel. +48 (22)755 96 48
[email protected]

Date of last revision of the leaflet: January 2022