Agartha

Leaflet attached to the packaging: patient information

AGARTHA, 50 mg, tablets

Wildagliptin

You should read the contents of the 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 doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is AGARTHA and what is it used for

The active substance of AGARTHA is wildagliptin, which belongs to a group of medicines called "oral anti-diabetic medicines".
AGARTHA is a medicine used to treat adult patients with type 2 diabetes, who cannot control their blood sugar levels by diet and exercise alone. AGARTHA helps control blood sugar levels. The doctor may prescribe AGARTHA as the only anti-diabetic medicine or in combination with other anti-diabetic medicines that the patient may be taking, if they have not been effective enough in controlling blood sugar levels.
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. Diabetes can also develop when the body produces too much glucagon.
Insulin is a substance that helps 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. Both of these substances are produced in the pancreas.

How AGARTHA works

AGARTHA works by stimulating the pancreas to produce insulin and reducing the production of glucagon. Therefore, AGARTHA helps control blood sugar levels.
It has been shown that the medicine lowers blood sugar levels, which can help prevent complications of diabetes. Despite starting pharmacological treatment for diabetes, it is essential for the patient to continue following a suitable diet and (or) performing recommended physical exercises.

2. Important information before taking AGARTHA

When not to take AGARTHA:

• if the patient is allergic to wildagliptin or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic to wildagliptin or any of the other ingredients of AGARTHA, they should not take this medicine and should tell their doctor.

Warnings and precautions

Before starting to take AGARTHA, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has type 1 diabetes (i.e., their body does not produce insulin) or if they have a condition called diabetic ketoacidosis,
• if the patient is taking a anti-diabetic medicine called a sulfonylurea derivative (the doctor may want to reduce the dose of the sulfonylurea derivative taken with AGARTHA to avoid low blood sugar levels [hypoglycemia]),
• if the patient has moderate or severe kidney disease (a lower dose of AGARTHA should be used),
• if the patient is undergoing dialysis,
• if the patient has liver disease,
• if the patient has heart failure,
• if the patient has or has had pancreatitis.

If the patient has previously taken wildagliptin but had to stop taking it due to liver disease, they should not take this medicine.
Skin conditions are a common complication of diabetes. The patient should follow the doctor's or nurse's advice regarding skin and foot care. While taking AGARTHA, the patient should pay particular attention to the development of new blisters or ulcers. If they occur, the patient should contact their doctor immediately.
Before starting treatment with AGARTHA and at three-month intervals during the first year of treatment, and then periodically, the patient should undergo tests to assess liver function. This will help detect signs of increased liver enzyme activity as soon as possible.

Children and adolescents

AGARTHA is not recommended for children and adolescents under 18 years of age.

AGARTHA and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The doctor may change the dose of AGARTHA if the patient is taking other medicines such as:

• thiazides or other diuretics (also known as water pills)
• corticosteroids (usually used to treat inflammatory conditions)
• medicines used to treat thyroid disorders
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
AGARTHA should not be taken during pregnancy. It is not known whether wildagliptin (the active substance of AGARTHA) passes into breast milk. AGARTHA should not be taken while breastfeeding or planning to breastfeed.

Driving and using machines

If the patient experiences dizziness while taking AGARTHA, they should not drive or operate machinery.

AGARTHA contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicinal product.

3. How to take AGARTHA

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

What dose to take and when

The recommended dose of AGARTHA varies depending on the patient's overall condition. The doctor will determine exactly how many AGARTHA tablets to take. The maximum daily dose is 100 mg.
The recommended dose of AGARTHA is:

• a dose of 50 mg per day taken as a single dose in the morning, when AGARTHA is taken with a medicine called a sulfonylurea derivative.
• a dose of 100 mg per day, taken in two doses of 50 mg in the morning and 50 mg in the evening, when AGARTHA is taken alone, with a medicine called metformin, or with a glitazone, in combination with metformin and a sulfonylurea derivative or insulin.
• a dose of 50 mg per day taken in the morning, if the patient has moderate or severe kidney disease or is undergoing dialysis.

How to take AGARTHA

• Tablets should be swallowed whole with water.

How long to take AGARTHA

• AGARTHA should be taken every day, for as long as the doctor has prescribed. The doctor may decide on long-term treatment.
• The doctor will regularly check the patient's health to see if the treatment is working.

Taking a higher dose of AGARTHA than recommended

If the patient has taken too many AGARTHA tablets or if someone else has taken this medicine, they should immediately
talk to their doctor. The patient may need medical attention. If they need to go to the doctor's office or hospital, they should take the packaging of the medicine with them.

Missing a dose of AGARTHA

If the patient forgets to take a dose of this medicine, they should do so as soon as they remember. Then, they should take the next dose at the usual time. However, if it is almost time for the next dose, they should skip the missed dose. They should not take a double dose to make up for the missed tablet.

Stopping treatment with AGARTHA

The patient should not stop taking AGARTHA unless their doctor tells them to. If they have any questions about how long to take this medicine, they should consult their doctor.

4. Possible side effects

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

Some side effects require immediate medical attention:

If the patient experiences any of the following side effects, they should stop taking AGARTHA and consult their doctor:

• Angioedema ( rare: may occur in up to 1 in 1000 patients): Symptoms include swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives. These may indicate a reaction called "angioedema".
• Liver disease (hepatitis) ( rare: may occur in up to 1 in 1000 patients): Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark urine. These may indicate liver disease (hepatitis).
• Pancreatitis ( frequency not known): 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 have experienced the following side effects while taking AGARTHA and metformin:

• Common (may occur in up to 1 in 10 patients):Tremor, headache, dizziness, nausea, low blood sugar
• Uncommon (may occur in up to 1 in 100 patients):Fatigue

AGARTHA and sulfonylurea derivative:

• Common (may occur in up to 1 in 10 patients):Tremor, headache, dizziness, weakness, low blood sugar
• Uncommon (may occur in up to 1 in 100 patients):Constipation
• Very rare (may occur in up to 1 in 10,000 patients):Sore throat, cold

AGARTHA and glitazone:

• Common (may occur in up to 1 in 10 patients):Weight gain, swollen hands, ankles, or feet (edema)
• Uncommon (may occur in up to 1 in 100 patients):Headache, weakness, low blood sugar

AGARTHA alone:

• Common (may occur in up to 1 in 10 patients):Dizziness
• Uncommon (may occur in up to 1 in 100 patients):Headache, constipation, swollen hands, ankles, or feet (edema), joint pain, low blood sugar
• Very rare (may occur in up to 1 in 10,000 patients):Sore throat, cold, fever

Some patients have experienced the following side effects while taking AGARTHA, metformin, and sulfonylurea derivative:

• Common (may occur in up to 1 in 10 patients):Dizziness, tremor, weakness, low blood sugar, excessive sweating

Some patients have experienced the following side effects while taking AGARTHA and insulin (with or without metformin):

• Common (may occur in up to 1 in 10 patients):

Headache, chills, nausea (vomiting), low blood sugar, heartburn

• Uncommon (may occur in up to 1 in 100 patients):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 listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +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 AGARTHA

The medicine should be stored out of sight and reach of children.
Do not take 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 the original packaging to protect from moisture.
There are no special storage temperature requirements for the medicine.
Do not use AGARTHA packaging that is damaged or shows signs of opening.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What AGARTHA contains

The active substance is wildagliptin.
Each tablet contains 50 mg of wildagliptin.
The other ingredients are lactose, microcrystalline cellulose, sodium carboxymethylcellulose (type A), and magnesium stearate.

What AGARTHA looks like and contents of the pack

AGARTHA 50 mg tablets are white to light yellow in color, round, flat with beveled edges. On one side of the tablet, there is the marking "AA3". Diameter: 8 mm.
AGARTHA 50 mg tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters. The blisters are packaged in a cardboard box with a patient leaflet.
Pack sizes: 28, 30, 56, 60, 112, 120, or 180 tablets
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 on the medicine and its names in other EU member states, the patient 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
[email protected]

Date of last revision of the leaflet: January 2022