Package leaflet: Information for the patient

Aridya, 2 mg, tablets
Dienogest
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Aridya is and what it is used for
Important information before taking Aridya
How to take Aridya
Possible side effects
How to store Aridya
Contents of the pack and other information

1. What Aridya is and what it is used for

Aridya is used in the treatment of endometriosis (painful symptoms caused by abnormally located endometrial tissue). Aridya contains a hormone, a progestagen called dienogest.

2. Important information before taking Aridya

When not to take Aridya

if the patient is allergic to dienogest or any of the other ingredients of this medicine (listed in section 6);
if the patient currently has blood clots (venous thromboembolic disease). This may occur, for example, in blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also “Aridya and venous blood clots” below;
if the patient currently has or has previously had severe arterial disease, including cardiovascular disease such as: heart attack, stroke, or heart disease causing reduced blood flow (angina pectoris). See also “Aridya and arterial blood clots” below;
if the patient currently has diabetes with blood vessel damage;
if the patient currently has or has previously 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 of the whole body;
if the patient currently has or has previously had a benign or malignant liver tumour;
if the patient currently has, has previously had, or is suspected of having a malignant hormone-dependent tumour, such as: breast cancer or genital organ tumour;
if the patient has unexplained vaginal bleeding.

If any of these conditions occur for the first time during treatment with Aridya, the patient must
immediately stop taking the medicine and consult a doctor.
Warnings and precautions
While taking Aridya, hormonal contraceptives in any form (tablet, patch, vaginal ring) must not be used.
Aridya is NOT a contraceptive. To prevent pregnancy, condoms or other non-hormonal contraceptive methods should be used.
In certain situations, special caution is required when using Aridya. Regular medical examinations may be necessary. Inform the doctor if any of the following conditions are present or have occurred in the past in the patient.
If:

the patient has previously had blood clots (venous thromboembolic disease) or a close family member has had blood clots at a relatively young age;
a close relative of the patient has breast cancer;
the patient has ever had depression;
the patient has high blood pressure or develops high blood pressure during treatment with Aridya;
the patient develops liver disease while taking Aridya. Symptoms may include yellowing of the skin, eyes, or itching all over the body. Inform the doctor if such symptoms occurred during a previous pregnancy;
the patient has diabetes or had gestational diabetes during a previous pregnancy;
the patient has ever had chloasma (brownish-yellow patches on the skin, especially on the face). In such cases, avoid prolonged exposure to sunlight or ultraviolet radiation;
the patient experiences lower abdominal pain while taking Aridya.

While taking Aridya, the chance of becoming pregnant is reduced because Aridya may affect ovulation.
If pregnancy occurs during treatment with Aridya, there is a slightly increased risk of ectopic pregnancy (the embryo develops outside the uterus). Before starting Aridya, inform the doctor if the patient has previously had an ectopic pregnancy or has any tubal disorders.
Aridya and severe uterine bleeding
Uterine bleeding, for example in women with a condition where the endometrium (uterine lining) grows into the muscular layer of the uterus, known as adenomyosis, or benign uterine tumours, sometimes called uterine fibroids, may worsen during treatment with Aridya. If bleeding is heavy and persists for a long time, it may lead to a reduced number of red blood cells (anaemia), which in some cases may be severe. In case of anaemia, discuss with the doctor whether discontinuation of Aridya is necessary.
Aridya and changes in bleeding pattern
Most women treated with Aridya experience changes in menstrual bleeding patterns (see section 4 “Possible side effects”).
Aridya and venous blood clots
Some studies suggest a slight, statistically non-significant increased risk of blood clots in the legs (venous thromboembolic disease) associated with the use of progestogen-containing medicines such as Aridya. Very rarely, blood clots may cause severe, permanent disability or even lead to death.
The risk of venous blood clots increases:

with age;
if the patient is overweight;
if the patient or a close relative has had blood clots in the leg (thrombosis), lungs (pulmonary embolism), or another organ at a young age;
if the patient is scheduled for surgery, has had a serious accident, or will be immobile for a prolonged period. It is important to inform the doctor in advance about the use of Aridya, as treatment may need to be discontinued. The doctor will advise when to restart Aridya. Usually, this is two weeks after recovery.

Aridya and arterial blood clots
There is limited evidence of an association between progestogen-containing medicines such as Aridya and an increased risk of arterial blood clots, for example in blood vessels of the heart (heart attack) or brain (stroke). In women with high blood pressure, the risk of stroke may be slightly increased with the use of medicines like Aridya.
The risk of arterial blood clots increases:

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

Before starting Aridya, discuss this with the doctor or pharmacist.
The patient must stop taking Aridya and contact the doctor immediately if any possible symptoms of blood
clots are observed, such as:

severe pain and/or swelling in one leg;
sudden severe chest pain, which may 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 blindness or double vision;
difficulty speaking or inability to speak;
dizziness or fainting;
weakness, unusual sensations, or numbness in any part of the body.

Aridya and cancer
Current data do not clearly indicate whether Aridya increases the risk of breast cancer or not.
Breast cancer has been observed slightly more often 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 tumours are detected and detected earlier in women taking hormones because they are examined more frequently by a doctor. The incidence of breast cancer gradually decreases after stopping hormonal treatment. Regular breast examinations are important, and the patient should contact the doctor if a lump is detected.
In rare cases, benign liver tumours have been reported in women taking hormones, and even more rarely, malignant liver tumours. Contact the doctor in case of extremely severe abdominal pain.
Aridya and osteoporosis
Changes in bone mineral density (BMD)
The use of Aridya may affect bone strength in adolescents (aged 12 to less than 18 years). Therefore, if the patient is under 18 years of age, the doctor will individually assess the benefits and risks of using Aridya, taking into account possible risk factors for bone loss (osteoporosis).
If the patient is taking Aridya, she should ensure adequate intake of calcium and vitamin D through diet or supplements for bone health.
If the patient has an increased risk of developing osteoporosis (weakening of bones due to loss of bone minerals), the doctor will carefully consider the benefits and risks of treatment with Aridya, as Aridya has a moderate suppressive effect on the body's production of estrogen (another type of female hormone).
Children and adolescents
Aridya must not be used in girls before the onset of the first menstrual period.
The use of Aridya may affect bone strength in adolescents (aged 12 to less than 18 years). Therefore, if the patient is under 18 years of age, the doctor will individually assess the benefits and risks of using Aridya, taking into account possible risk factors for bone loss (osteoporosis).
Other medicines and Aridya
Always inform the doctor about all medicines or herbal products the patient is currently or recently taking, or may take in the future. Also inform any other doctor, dentist, or pharmacist prescribing another medicine that the patient is taking Aridya.
Some medicines may affect the blood concentration of Aridya and reduce its effectiveness or cause adverse effects.
These include:

medicines used to treat: o epilepsy (e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate); o tuberculosis (e.g. rifampicin); o HIV infection and hepatitis C (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz); o fungal infections (griseofulvin, ketoconazole).
St. John’s wort ( Hypericum perforatum).

Before taking any medicine, 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 blood concentration of Aridya and consequently increase the risk of adverse effects.
Laboratory tests
If the patient needs to have a blood test, she should inform the doctor or laboratory staff that she is taking Aridya, as Aridya may affect the results of certain tests.
Pregnancy and breastfeeding
Aridya must not be used during pregnancy or while breastfeeding.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed in patients taking dienogest.

3. How to take Aridya

This medicine should always be taken as directed by the physician or pharmacist. In case of doubt,
consult the physician or pharmacist.
The recommended dose is 1 tablet per day.
The following information applies to Aridya unless otherwise advised by the physician. The instructions
below should be followed carefully; otherwise, the patient may not obtain the full benefit of treatment with Aridya.
Treatment with Aridya may be started on any day of the natural cycle.
Adult women: one tablet should be taken daily, preferably at the same time each day, with a small amount of liquid if necessary. After finishing a pack, the next pack should be started immediately without a break. Continue taking tablets also during menstrual bleeding days.
Taking more Aridya than recommended
There have been no reports of serious harmful effects following a single intake of an excessive number
of Aridya tablets. However, in case of doubt, consult the physician.
Missing a dose or experiencing vomiting or diarrhoea
The effectiveness of Aridya will be reduced if a tablet is missed. If one or more tablets are missed, take one tablet as soon as possible and continue taking one tablet at the usual time the next day.
If vomiting occurs within 3–4 hours after taking Aridya, or if severe diarrhoea occurs, there is a risk that the active substance of the tablet will not be absorbed. This situation is similar to missing a tablet. If vomiting or severe diarrhoea occurs within 3–4 hours after taking Aridya, take another tablet as soon as possible.
Do not take a double dose to make up for a missed tablet.
Stopping treatment with Aridya
If the patient stops taking Aridya, previous symptoms of endometriosis may return.
If there are any further doubts regarding the use of this medicine, consult the physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
These reactions occur more frequently during the first months after starting Aridya treatment and usually subside with continued use. Changes in bleeding pattern may also occur, such as: spotting, irregular bleeding, or complete absence of menstruation.

Common (affects no more than 1 in 10 women)

weight gain
low mood, sleep problems, nervousness, loss of interest in sex, or mood changes
headache or migraine
nausea, abdominal pain, flatulence, bloating, or vomiting
acne or hair loss
back pain
breast discomfort, ovarian cyst, or hot flushes
uterine and (or) vaginal bleeding, including spotting
weakness or irritability

Uncommon (affects no more than 1 in 100 women)

anaemia
weight loss or increased appetite
anxiety, depression, or sudden mood changes
autonomic nervous system imbalance (controls unconscious bodily functions such as sweating) or attention disturbances
dry eye
tinnitus
non-specific circulatory problems or palpitations
low blood pressure
shortness of breath
diarrhoea, constipation, abdominal discomfort, gastritis, gingivitis
dry skin, excessive sweating, generalized pruritus, development of male-pattern hair growth (hirsutism), brittle nails, dandruff, skin inflammation, abnormal hair growth, photosensitivity, or pigmentation disorders
bone pain, muscle cramps, pain and (or) heaviness in arms and hands or legs and feet
urinary tract infection
vaginal candidiasis (thrush), genital dryness, vaginal discharge, pelvic pain, atrophic vaginitis with discharge (atrophic vulvovaginitis), or breast lump(s)
fluid retention leading to oedema

Additional adverse reactions in adolescents (aged 12 to less than 18 years):

loss of bone density

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions contributes to further information on the safety of this medicine.

5. How to store Aridya

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging after "EXP".
The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine.
Store the medicine in its original packaging to protect it from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.
Other ingredients are: magnesium stearate, maize starch, microcrystalline cellulose, povidone (K25), pregelatinized starch, maize.

What Aridya looks like and contents of the pack
Aridya tablets, 2 mg, are white or almost white, round tablets.
Aridya tablets are packed in white, opaque PVC/PVDC/Aluminium blisters and are available in packs containing: 28, 84, 100 and 168 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw
Manufacturer:
Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 Berlin
Germany
This medicinal product is authorised 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 2 mg Tablets
Poland Aridya
Italy Dienogest Aristo 2 mg tablets