Aridia

Package Leaflet: Information for the Patient

Aridya, 2 mg, tablets

Dienogest

Read the package 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 or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Aridya and what is it used for

Aridya is used to treat endometriosis (painful symptoms caused by abnormally located uterine lining). Aridya contains a hormone, a progestogen called dienogest.

2. Important information before taking Aridya

When not to take Aridya

• if the patient is allergicto dienogest or any of the other ingredients of this medicine (listed in section 6);
• if the patient has blood clots(thromboembolic disorders) in the veins. This may occur, for example, in the blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also "Aridya and blood clots in the veins" below;
• if the patient has or has had severe arterial disease, including cardiovascular disease, such as: heart attack, strokeor heart diseasecausing reduced blood flow (angina pectoris). See also "Aridya and arterial blood clots" below;
• if the patient has diabeteswith blood vessel damage;
• if the patient has or has had severe liver disease(and liver function tests have not returned to normal). Symptoms of liver disease may include yellowing of the skin and (or) itching all over the body;
• if the patient has or has had a benign or malignant liver tumor;
• if the patient has or has had, or is suspected to have, malignant hormone-dependent tumors, such as: breast cancer or genital organ tumors;
• if the patient has unexplained vaginal bleeding.

If any of these conditions occur for the first time while taking Aridya, the patient should stop taking it immediately and consult a doctor.

Warnings and precautions

While taking Aridya, the patient should not use hormonal contraceptives in any form (pill, patch, intrauterine system). Aridya is nota contraceptive. To prevent pregnancy, the patient should use condoms or other non-hormonal contraceptives. In some situations, the patient should be particularly cautious when taking Aridya. Regular medical check-ups may be necessary. The patient should inform their doctor if any of the following conditions occur or have occurred:

• the patient has had blood clots(venous thromboembolic disease) in the past or a close family member has had blood clots at a relatively young age;
• a close family member of the patient has breast cancer;
• the patient has had depressionin the past;
• the patient has high blood pressureor develops high blood pressure while taking Aridya;
• the patient develops liver diseasewhile taking Aridya. Symptoms may include yellowing of the skin, eyes, or itching all over the body. The patient should inform their doctor if such symptoms occurred during a previous pregnancy;
• the patient has diabetesor has had diabetes during a previous pregnancy;
• the patient has had chloasma(brown patches on the skin, especially on the face) in the past. In such cases, the patient should avoid prolonged sun exposure or ultraviolet radiation;
• the patient experiences abdominal painwhile taking Aridya.

While taking Aridya, the chance of becoming pregnant is reduced, as Aridya may affect ovulation. If the patient becomes pregnant while taking Aridya, there is a slightly increased riskof an ectopic pregnancy (the embryo develops outside the uterus). Before starting Aridya, the patient should tell their doctor if they have had an ectopic pregnancy in the past or have tubal dysfunction.

Aridya and severe uterine bleeding

Uterine bleeding, for example in women with a disease in which the uterine lining (endometrium) grows into the uterine muscle layer, called adenomyosis or uterine fibroids, sometimes called myomas, may worsen while taking Aridya. If the bleeding is heavy and prolonged, it may lead to a decrease in red blood cells (anemia), which can be severe in some cases. If anemia occurs, the patient should discuss with their doctor whether to stop taking Aridya.

Aridya and changes in bleeding profile

In most women treated with Aridya, changes in menstrual bleeding profile occur (see section 4 "Possible side effects").

Aridya and blood clots in the veins

Some studies suggest that there may be a slightly increased riskof blood clots in the legs (venous thromboembolic disease)associated with the use of progestogen-only medicines like Aridya. Very rarely, blood clots can cause severe, permanent disability or even be fatal. The risk of venous blood clotsincreases:

• with age;
• if the patient is overweight;
• if the patient or a close family member has had blood clots in the leg (deep vein thrombosis), lung (pulmonary embolism), or other organs at a relatively young age;
• if the patient is scheduled for surgery, has had a serious accident, or is immobilized for a long time. It is essential to inform the doctor about taking Aridya in advance, as it may be necessary to stop treatment. The doctor will advise when to restart Aridya. This is usually two weeks after recovery.

Aridya and arterial blood clots

There is limited evidence of a link between the use of progestogen-only medicines like Aridya and an increased risk of blood clots in the arteries, for example in the blood vessels of the heart (heart attack) or brain (stroke). In women with high blood pressure, the risk of stroke may be slightly increased when taking Aridya. The risk of arterial blood clotsincreases:

• in women who smoke. It is recommended to quit smoking when taking Aridya, especially if the patient is over 35 years old;
• if the patient is overweight;
• if the patient or a close family member has had a heart attack or stroke at a young age;
• if the patient has high blood pressure.

Before starting Aridya, the patient should discuss this with their doctor or pharmacist.

Stop taking Aridya and contact a doctor immediately if the patient notices any of the following symptoms of a blood clot:

• severe pain and (or) swelling in one leg;
• sudden severe chest pain, which may also radiate to the left arm;
• sudden shortness of breath;
• sudden cough without an obvious cause;
• any unusual, severe, or prolonged headache or worsening of migraine;
• partial or complete loss of vision or double vision;
• difficulty speaking or inability to speak;
• dizziness or fainting;
• weakness, strange feeling, or numbness in any part of the body.

Aridya and cancer

Currently available data do not clearly indicate whether Aridya increases the risk of breast cancer or not. Breast cancer has been observed slightly more frequently in women taking hormones compared to women not taking hormones, but it is not known whether this is caused by the treatment. For example, it may be due to the fact that more tumors are detected and detected earlier in women taking hormones because they are more frequently examined by a doctor. The frequency of breast tumors gradually decreases after stopping hormonal treatment. Regular breast examinationis essential, and the patient should consult a doctor if they notice a lump. In rare cases, women taking hormones have reported benign liver tumors, and in even rarer cases, malignant liver tumors. The patient should consult a doctor if they experience severe abdominal pain.

Aridya and osteoporosis

Changes in bone mineral density (BMD) may occur when taking Aridya. The use of Aridya may affect bone strength in young people (aged 12 to less than 18 years). Therefore, if the patient is under 18 years old, the doctor will individually assess the benefits and risks of taking Aridya, considering possible risk factors for bone loss (osteoporosis). If the patient takes Aridya, they should ensure adequate calcium and vitamin D intake from their diet or supplements for bone health. If the patient has an increased risk of osteoporosis (weakened bones due to loss of bone mineral substance), the doctor will carefully assess the benefits and risks of treating with Aridya, as Aridya has a moderate estrogen-suppressing effect.

Children and adolescents

Aridya should not be used in girls before their first menstrual period. The use of Aridya may affect bone strength in young people (aged 12 to less than 18 years). Therefore, if the patient is under 18 years old, the doctor will individually assess the benefits and risks of taking Aridya, considering possible risk factors for bone loss (osteoporosis).

Aridya and other medicines

The patient should always inform their doctor about all medicines or herbal products they are currently taking or have recently taken, or other medicines they may take. The patient should also tell any other doctor or dentist prescribing another medicine or pharmacist about taking Aridya. Some medicines may affect the level of Aridya in the blood and reduce its effectiveness or cause side effects. These include:

• medicines used to treat the following diseases:
  1. epilepsy (e.g., phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
  2. tuberculosis (e.g., rifampicin);
  3. HIV and hepatitis C infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
  4. fungal infections (griseofulvin, ketoconazole).
• St. John's Wort (Hypericum perforatum).

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

Aridya with food and drink

While taking Aridya, the patient should avoid drinking grapefruit juice, as it may increase the level of Aridya in the blood and increase the risk of side effects.

Laboratory tests

If the patient needs to have a blood test, they should tell their doctor or laboratory staff that they are taking Aridya, as Aridya may affect the results of some tests.

Pregnancy and breastfeeding

Aridya should not be used during pregnancy or breastfeeding.

Driving and using machines

No effect on the ability to drive and use machines has been observed in patients taking dienogest.

3. How to take Aridya

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist. The recommended dose is one tablet per day. The following information applies to Aridya, unless the doctor has prescribed otherwise. The patient should follow the instructions below; otherwise, they may not get the full benefit of Aridya. The patient can start taking Aridya on any day of their natural cycle. Adult patients: take one tablet daily, preferably at the same time, with a small amount of liquid if necessary. After finishing one pack, start the next pack without a break. The patient should continue taking tablets even during menstrual bleeding days.

Taking more than the recommended dose of Aridya

There are no reports of serious harmful effects after taking more than the recommended dose of Aridya. However, in case of doubt, the patient should consult a doctor.

Missing a dose of Aridya or experiencing vomiting or diarrhea

The effect of Aridya will be less if the patient misses a dose. If the patient misses one or more tablets, they should take only one tablet as soon as possible and continue with the next tablet at the usual time. If the patient vomits within 3-4 hours of taking Aridya or experiences severe diarrhea, there is a risk that the active substance will not be absorbed by the body. This situation is similar to missing a dose. If the patient vomits or experiences diarrhea within 3-4 hours of taking Aridya, they should take another tablet as soon as possible. The patient should not take a double dose to make up for a missed tablet.

Stopping Aridya

If the patient stops taking Aridya, their previous endometriosis symptoms may return. If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Aridya can cause side effects, although not everybody gets them. These effects are more common during the first few months after starting Aridya and usually disappear with continued treatment. Changes in bleeding profile, such as spotting, irregular bleeding, or complete absence of menstruation, may also occur. Common(affects no more than 1 in 10 patients)

• weight gain
• low mood, sleep problems, nervousness, loss of interest in sex, or mood changes
• headache or migraine
• nausea, abdominal pain, bloating with gas, abdominal distension, or vomiting
• acne or hair loss
• back pain
• breast discomfort, ovarian cyst, or hot flashes
• uterine or vaginal bleeding, including spotting
• weakness or irritability.

Uncommon(affects no more than 1 in 100 patients)

• anemia
• weight loss or increased appetite
• anxiety, depression, or sudden mood changes
• autonomic nervous system imbalance (controls subconscious body functions, such as sweating) or attention disorders
• dry eye
• tinnitus
• non-specific circulation problems or palpitations
• low blood pressure
• shortness of breath
• diarrhea, constipation, abdominal discomfort, gastritis, or gum inflammation
• dry skin, excessive sweating, severe itching all over the body, hirsutism, nail fragility, dandruff, skin inflammation, abnormal hair growth, hypersensitivity to light, or pigmentation problems
• bone pain, muscle cramps, pain and (or) feeling of heaviness in the arms and hands or legs and feet
• urinary tract infection
• vaginal thrush, vaginal dryness, discharge, pelvic pain, or breast lump.

Additional side effects in adolescents (aged 12 to less than 18 years):

• bone density loss.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Aridya

Keep this 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". The expiry date refers to the last day of the month. There are no special storage instructions for this medicine. Store in the original package to protect from light. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aridya contains

• The active substance is dienogest. Each tablet contains 2 mg of dienogest.
• The other ingredients are: magnesium stearate, cornstarch, microcrystalline cellulose, povidone (K25), pregelatinized starch, cornstarch.

What Aridya looks like and contents of the pack

Aridya 2 mg tablets are white or almost white, round tablets. The tablets are packed in white, non-transparent PVC/PVDC/Aluminum blisters and are available in packs of 28, 84, 100, and 168 tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Aristo Pharma Sp. z o.o. ul. Baletowa 30 02-867 Warsaw

Manufacturer:

Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany This medicinal product is authorized in the Member States of the European Economic Area under the following names: Austria Aridya 2 mg Tablets Czech Republic Aridya Spain Dienogest Aristo 2 mg tablets EFG Germany Dienogest Aristo 2mg Tablets Poland Aridya Italy Dienogest Aristo 2 mg tablets Date of last revision of the leaflet:September 2022