Package Insert: Information for the User

Dienogest Aristo 2 mg Tablets EFG

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Do not take dienogest:

• if you areallergic(hypersensitive) to dienogest or to any of the other components of this medication (listed in section 6);
• if you have ablood clot(thromboembolic disorder) in the veins. This can occur, for example, in the blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See "Dienogest and blood clots in the veins" below;
• if you have or have had aserious arterial disease, even a cardiovascular disease, such as aheart attack, a stroke, or a heart diseasethat causes a decrease in blood flow (for example, angina pectoris). See "Dienogest and blood clots in the arteries" below;
• if you havediabeteswith vascular damage;
• if you have or have had aserious liver disease(and your liver function values have not returned to normal). The symptoms of liver disease can be a yellow color of the skin and/or itching all over the body;
• if you have or have had abenign or malignant liver tumor;
• if you have or have had, or are suspected of having amalignant tumor, dependent on sex hormones, such as breast cancer or genital organ cancer;
• if you have aunexplained vaginal bleeding;

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

Warnings and precautions

Do not take oral contraceptives in any form (in pill, patch, intrauterine system) while taking dienogest.

Dienogest is not an oral contraceptive. If you want to prevent pregnancy, you should use condoms or other non-hormonal contraceptive precautions.

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

• if you have ever had ablood clot(thromboembolism) or if a close relative has had a blood clot at a relatively early age;
• if you have a close relative who has hadbreast cancer;
• if you have ever haddepression;
• if you havehigh blood pressureor if you develop hypertension while taking dienogest;
• if you have a liver disease while taking dienogest. The 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 appeared in a previous pregnancy;
• if you havediabetesor if you had temporary diabetes in a previous pregnancy;
• if you have ever hadmelasma(brownish-yellow patches on the skin, especially on the face); if so, avoid excessive exposure to the sun or ultraviolet rays;
• if you havelower abdominal painwhile taking dienogest.

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

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

Dienogest and severe uterine bleeding

Severe uterine bleeding may worsen with the use of dienogest, for example in women who have a condition in which the uterine mucosa (endometrium) grows into the muscular layer of the uterus, known as adenomyosis uteri orbenign uterine tumors,also called uterine fibroids (leiomyomas uteri). If the bleeding is intense and prolonged, it may 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 to stop taking dienogest.

Dienogest and changes in menstrual 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 suggest that there may be a slight, although not statistically significant, increase in the risk ofblood clots in the legs (thromboembolism)with the use of preparations containing progestagens like dienogest. Very rarely, blood clots can cause permanent and severe disabilities or even be fatal.

The risk ofblood clots in the veinsincreases:

• with age;
• if you are overweight;
• if you or a close relative has had a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or another organ at a relatively early age;
• if you need surgery, if you have had a serious accident, or if you have been immobile for a prolonged period. It is essential to 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 happens about two weeks after regaining mobility.

Dienogest and blood clots in the arteries

There is little evidence of a relationship between progestagen 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 having a blood clot in the arteries increases:

• if you smoke. You are strongly advised to quit 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 relatively early age;
• if you have high blood pressure.

Consult your doctor before starting to take Dienogest.

Dienogest and cancer

Based on the available data, it is not clear whether dienogest increases or decreases the risk of breast cancer. Breast cancer is slightly more common in women taking hormones compared to those not taking hormones, but it is unknown whether this is caused by the treatment. For example, tumors may be detected more frequently and earlier in women taking hormones because they are examined more frequently by their doctor. The appearance of tumors decreases after stopping hormone treatment.It is essential to regularly check your breastsand consult your doctor if you feel any lump.

In rare cases, women taking hormones have been reported to have benign liver tumors and, in exceptional cases, malignant liver tumors. Contact your doctor if you experience unusual stomach pain.

Dienogest and osteoporosis

Bone mineral density (BMD) changes

The use of dienogest may affect the bone strength of 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 a 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 have a higher risk of developing osteoporosis (bone weakening due to mineral loss), your doctor will carefully weigh the risks and benefits of your treatment with dienogest because dienogest causes a moderate suppression of estrogen production (another type of female hormone) by your body.

Children and adolescents

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

The use of dienogest may affect the bone strength of 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 a patient, taking into account possible risk factors for bone loss (osteoporosis).

Combination of dienogest with other medications

Some medications may affect the levels of dienogest in the blood and make it less effective, or may cause unwanted effects.

These include:

• medications used to treat:

• epilepsy(for example, phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate)
• tuberculosis(for example, rifampicin)
• HIV and hepatitis C infections(the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• fungal infections(griseofulvin, ketoconazole)

• herbal preparations ofSt. John's Wort:

Consult your doctor or pharmacist before using any medication.

Combination of dienogest with food and beverages

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

Laboratory tests

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

Pregnancy, lactation, and fertility

Do not take dienogest if you are pregnant or breastfeeding.

Driving and operating machinery

No effects have been observed on the ability to drive and operate machinery in dienogest users.

Follow exactly the administration instructions for this medication as indicated 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 dienogest treatment.

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

Adults: take one tablet each day, preferably at the same time, with some liquid if necessary. Once you finish a package, start the next one without interruption. Continue taking the tablets on menstrual bleeding days as well.

If you take more dienogest than you should

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

If you forget to take dienogest or experience vomiting or diarrhea

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

If you have vomiting within 3-4 hours after taking a dienogest tablet or have intense diarrhea, there is a risk that the active principles of the tablet will 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 compensate for missed doses.

If you interrupt dienogest treatment

If you interrupt dienogest treatment, your original endometriosis symptoms may return.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them. Side effects are more common in the first months after starting dienogest and usually disappear with continued use. You may also experience changes in your bleeding pattern, for example, spotting, irregular bleeding, or your menstrual period may stop completely.

Frequent(affect between 1 and 10 in 100 users)

• weight gain
• depressive mood, sleep disorders, nervousness, loss of interest in sex, or unstable mood
• 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 or vaginal bleeding, including spotting
• weakness or irritability.

Rare(affect between 1 and 10 in 1,000 users)

• anemia
• weight loss or increased appetite
• anxiety, depression, or mood changes
• autonomic nervous system imbalance (which controls unconscious bodily functions, for example, sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• unspecified circulatory problems or irregular heartbeats
• low blood pressure
• difficulty breathing
• diarrhea, constipation, abdominal discomfort, gastrointestinal inflammation, gingivitis
• dry skin, excessive sweating, intense itching all over the body, male-type hair growth (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, light hypersensitivity, or skin pigmentation problems
• bone pain, muscle spasms, pain and/or heaviness in the arms and hands, or the legs and feet
• urinary tract infection
• vaginal candidiasis, vaginal 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):

• bone density loss.

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's possible side effects that don't appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need atthe SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dienogest Aristo

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

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

Appearance of the product and content of the container

The 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 sizes of containers may be commercially available.

Holder of the marketing authorization and Responsible for manufacturing

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 with the following names:

Austria Aridya 2 mg Tabletten

Republic of Czechia 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

Last review date of this leaflet: September 2022

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/