DIENOGEST ARISTO 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

Dienogest Aristo 2 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Dienogest Aristo and what is it used for
2. What you need to know before taking Dienogest Aristo
3. How to take Dienogest Aristo
4. Possible side effects
5. Storage of Dienogest Aristo
6. Contents of the pack and further information

1. What is Dienogest Aristo and what is it used for

Dienogest Aristo is a preparation for the treatment of endometriosis (painful symptoms caused by an abnormal location of uterine lining tissue). This medicine contains a hormone, the progestogen dienogest.

2. What you need to know before taking Dienogest Aristo

Do not take dienogest:

• if you are allergic(hypersensitive) to dienogest or any of the other ingredients of this medicine (listed in section 6);
• if you have a blood clot(thromboembolic disorder) in the veins. This can occur, for example, in the blood vessels of the legs (deep vein thrombosis) or the lungs (pulmonary embolism). See later “Dienogest and blood clots in the veins”;
• if you have or have ever had a severe arterial disease, including cardiovascular disease, such as a heart attack, stroke, or heart diseasethat causes a reduction in blood flow (e.g., angina pectoris). See later “Dienogest and blood clots in the arteries”;
• if you have diabeteswith blood vessel damage;
• if you have or have ever had a severe liver disease(and your liver function values have not returned to normal). Symptoms of liver disease can be a yellow color of the skin and/or itching all over the body;
• if you have or have ever had a benign or malignant liver tumor;
• if you have or have ever had, or are suspected to have, a malignant tumor, dependent on sex hormones, such as breast cancer or genital organ cancer;
• if you have unexplained vaginal bleeding;

If any of these disorders occur for the first time while taking dienogest, stop taking it immediately and consult your doctor.

Warnings and precautions

You must not take oral contraceptives in any form (in tablet, patch, intrauterine system) while taking dienogest.

Dienogest is NOT a contraceptive. If you wish to prevent pregnancy, you will need to use condoms or other non-hormonal contraceptive precautions.

In some cases, you will need to be particularly careful while taking dienogest, and it may be necessary for your doctor to examine you periodically. Inform your doctor if you are affected by any of the following conditions:

• if you have ever had a blood clot(venous thromboembolism) or a close relative has had a blood clot at a relatively early age;
• if you have a close relative who has had breast cancer;
• if you have ever had depression;
• if you have high blood pressureor develop hypertension while taking dienogest;
• if you develop liver disease while taking dienogest. Symptoms can include a yellow color of the skin or eyes, or itching all over the body. Inform your doctor if any of these symptoms have occurred in a previous pregnancy;
• if you have diabetesor have had temporary diabetes in a previous pregnancy;
• if you have ever had chloasma(brownish discoloration of the skin, especially on the face); if so, avoid excessive exposure to the sun or ultraviolet radiation;
• if you experience lower abdominal painwhile taking dienogest.

While taking dienogest, the likelihood of becoming pregnant is reduced because dienogest can affect ovulation.

If you become pregnant while taking dienogest, you have a slightly higher riskof having an ectopic pregnancy (the embryo develops outside the uterus). Inform your doctor before starting to take dienogest if you have had an ectopic pregnancy or if you have a disorder of the fallopian tube function.

Dienogest and severe uterine bleeding

Uterine bleeding may worsen with the use of dienogest, for example, in women who have a condition in which the uterine lining (endometrium) grows into the muscular layer of the uterus, known as adenomyosis or benign uterine tumors,sometimes called uterine fibroids (uterine leiomyomas). If the bleeding is heavy and prolonged, it can lead to a decrease in the number of red blood cells (anemia), which in some cases can be severe. In case of anemia, you should consult your doctor about whether you should stop taking dienogest.

Dienogest and changes in bleeding pattern

Most women treated with dienogest experience changes in menstrual bleeding pattern (see section 4, Possible side effects).

Dienogest and blood clots in the veins

Some studies indicate that there may be a slight, although not statistically significant, increase in the risk of blood clots in the legs (venous thromboembolism)associated with the use of preparations containing progestogens like dienogest. Very rarely, blood clots can cause permanent disability and can be life-threatening.

The risk of blood clots in the veinsincreases:

• with age
• if you are overweight
• if you or a close relative have had a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or other organ at a young age.
• if you need to have surgery, have had a serious accident, or if you are to be immobilized for a prolonged period. It is important that you inform your doctor in advance that you are taking dienogest, as treatment may need to be interrupted. Your doctor will tell you when to start taking dienogest again. This usually occurs about two weeks after regaining mobility.

Dienogest and blood clots in the arteries

There is limited evidence of a relationship between progestogen-only preparations like dienogest and an increased risk of blood clots, for example, in the blood vessels of the heart (heart attack) or brain (stroke). In women with hypertension, these preparations may slightly increase the risk of stroke.

The risk of blood clots in the arteriesincreases:

• if you smoke. You are strongly advised to stop smoking while taking Dienogest, especially if you are over 35 years old;
• if you are overweight;
• if a close relative has had a heart attack or stroke at a young age;
• if you have high blood pressure.

Consult your doctor before starting to take Dienogest.

Dienogest and cancer

Based on currently available data, it is not clear whether dienogest increases or does not increase the risk of breast cancer. It has been observed that breast cancer is slightly more common in women taking hormones compared to those not taking them, but it is unknown whether this is caused by the treatment. For example, it is possible that more tumors are detected and detected earlier in women taking hormones because they are examined more frequently by their doctor. The occurrence of breast tumors decreases after stopping hormonal treatment. It is important that you regularly check your breastsand consult your doctor if you feel any lump.

In rare cases, in women taking hormones, benign liver tumorsand in even rarer cases, malignant liver tumorshave been reported. Contact your doctor if you experience unusually severe stomach pain.

Dienogest and osteoporosis

Changes in bone mineral density (BMD)

The use of dienogest may affect bone strength in adolescents (12 to less than 18 years). If you are under 18 years old, your doctor will carefully weigh the benefits and risks of using dienogest for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

If you use dienogest, it will be helpful for your bones to have an adequate intake of calcium and vitamin D, both through food and dietary supplements.

If you are at higher risk of osteoporosis (weakening of bones due to loss of bone minerals), your doctor will carefully weigh the risks and benefits of your treatment with dienogest because dienogest causes moderate suppression of estrogen production by your body.

Children and adolescents

Dienogest is not indicated in girls before menarche (first menstruation).

The use of dienogest may affect bone strength in adolescents (12 to less than 18 years). If you are under 18 years old, your doctor will carefully weigh the benefits and risks of using dienogest for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

Taking dienogest with other medicines

Some medicines may influence the levels of dienogest in the blood and make it less effective or cause unwanted effects.

These include:

• medicines used to treat:

• epilepsy(e.g., phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate)
• tuberculosis(e.g., rifampicin)
• HIV and Hepatitis C infections(protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• fungal infections(griseofulvin, ketoconazole)

• herbal preparations containing St. John's Wort:

Consult your doctor or pharmacist before using any medicine.

Taking dienogest with food and drinks

During treatment with dienogest, you should avoid drinking grapefruit juice, as it can increase the levels of dienogest in your blood. This can increase the risk of experiencing side effects.

Lab tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking dienogest, as dienogest can affect the results of some tests.

Pregnancy, breastfeeding, and fertility

Do not take dienogest if you are pregnant or during the breastfeeding period.

Driving and using machines

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

3. How to take Dienogest Aristo

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day.

The following statements apply to dienogest unless your doctor prescribes otherwise. Follow these instructions; otherwise, you will not benefit fully from treatment with dienogest.

You can start treatment with dienogest on any day of your natural cycle.

Adults: take one tablet every day, preferably at the same time, with some liquid if necessary. When you finish one pack, the next should be started without interruption. Continue taking the tablets even during menstrual bleeding days.

If you take more dienogest than you should

No serious harmful effects have been reported due to taking too many dienogest tablets at once. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take dienogest or if you have vomiting or diarrhea

Dienogest will be less effective if you forget a tablet. If you forget one or more tablets, take a single tablet as soon as you remember; then continue the next day, taking the tablet at the usual time.

If you vomit within 3-4 hours after taking a dienogest tablet or if you have severe diarrhea, there is a risk that the active ingredients of the tablet may not be fully absorbed by your body. This situation is similar to what happens when you forget a tablet. After vomiting or diarrhea within 3-4 hours after taking dienogest, you should take another tablet as soon as possible.

Do not take a double dose to make up for forgotten doses.

If you stop taking dienogest

If you stop taking dienogest, your original symptoms of endometriosis may return.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The effects are more frequent in the first few months after starting to take dienogest and usually disappear with continued use. You may also experience changes in your bleeding pattern, for example, you may have spotting, irregular bleeding, or your menstruation may stop completely.

Common(affect 1 to 10 users in 100)

• weight gain
• depressive mood, sleep disorders, nervousness, loss of interest in sex, or mood swings
• headache or migraine
• nausea, abdominal pain, flatulence, abdominal swelling, or vomiting
• acne or hair loss
• back pain
• breast tenderness, ovarian cyst, or hot flashes
• uterine/vaginal bleeding, including spotting
• weakness or irritability.

Uncommon(affect 1 to 10 users in 1,000)

• anemia
• weight loss or increased appetite
• anxiety, depression, or mood changes
• autonomic nervous system imbalance (which controls unconscious body functions, e.g., sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• non-specific circulatory problems or unusual palpitations
• low blood pressure
• breathing difficulties
• diarrhea, constipation, abdominal discomfort, gastrointestinal inflammation, gingivitis
• dry skin, excessive sweating, intense itching all over the body, male-type hair growth (hirsutism), nail fragility, dandruff, dermatitis, abnormal hair growth, hypersensitive reaction to light, or skin pigmentation problems
• bone pain, muscle spasms, pain and/or heaviness in the arms and hands or legs and feet
• urinary tract infection
• vaginal candida infection, genital dryness, vaginal discharge, pelvic pain, atrophic vulvovaginitis, or breast lump(s)
• swelling due to fluid retention.

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

• loss of bone density.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dienogest Aristo

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after "CAD.". The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE Collection Pointat your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dienogest Aristo

• The active ingredient is dienogest. Each tablet contains 2 mg of dienogest.

• The other components are magnesium stearate, corn starch, microcrystalline cellulose, povidone K25, and pregelatinized corn starch.

Appearance of the Product and Package Contents

Dienogest Aristo tablets are white or off-white, round.

They are presented in a white opaque PVC/PVdC-aluminum blister pack.

The boxes contain blister packs with 28, 84, 100, or 168 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Austria Aridya 2 mg Tabletten

Czech Republic Aridya 2 mg tablety

Germany Dienogest Aristo 2 mg Tabletten

Italy Dienogest Aristo 2 mg compresse

Poland Dienogest Aristo 2 mg tabletki

Spain Dienogest Aristo 2 mg comprimidos EFG

Date of the Last Revision of this Leaflet:September 2022

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/