ADIENOCARE 2 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Adienocare 2 mg EFG tablets

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

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

Contents of the Package Leaflet

1. What is Adienocare and what is it used for
2. What you need to know before taking Adienocare
3. How to take Adienocare
4. Possible side effects
5. Storage of Adienocare
6. Package contents and additional information

1. What is Adienocare and what is it used for

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

2. What you need to know before taking Adienocare

Do not take Adienocare:

• 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 lungs (pulmonary embolism). See later “Adienocare 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 decrease in blood flow (e.g., angina pectoris). See later “Adienocare 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 yellowing 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 or genital cancer
• if you have vaginal bleedingof unknown cause
• if you are allergic (hypersensitive)to dienogest or any of the other components of this medication (including those listed in section 6 and the end of section 2).

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

Warnings and precautions

You should not take oral contraceptives in any form (in tablets, patches, intrauterine systems) while taking Adienocare.

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

In some cases, you should be particularly careful while taking this medication, 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 young age
• if you have a close relative who has had breast cancer
• if you have ever had depression
• if you have high blood pressure or develop hypertension while taking this medication
• if you develop liver disease while taking this medication. Symptoms can include yellowing 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 have diabetes or 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 sun exposure or ultraviolet radiation
• if you experience lower abdominal pain while taking this medication.

While taking Adienocare, the likelihood of becoming pregnant is reduced, as this medication can affect ovulation.

If you become pregnant while taking this medication, you have a slightly higher riskof having an ectopic pregnancy (the embryo develops outside the uterus). Inform your doctor before starting Adienocare if you have had an ectopic pregnancy or have a dysfunction of the fallopian tubes.

Adienocare and severe uterine bleeding

Uterine bleeding may worsen with the use of this medication, 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 (leiomyomas). If the bleeding is heavy and prolonged, it can lead to a decrease in the number of red blood cells (anemia), which can be severe in some cases. In case of anemia, you should consult your doctor about whether you should stop taking this medication.

Adienocare and changes in bleeding patterns

Most women treated with this medication experience changes in menstrual bleeding patterns (see section 4, Possible side effects).

Adienocare 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 progestogen-containing preparations like Adienocare. Very rarely, blood clots can cause permanent and severe disability or even be fatal.

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 surgery, have had a serious accident, or need to be immobilized for a prolonged period. It is essential that you inform your doctor in advance that you are taking Adienocare, as treatment may need to be interrupted. Your doctor will tell you when to start Adienocare again. This usually occurs about two weeks after regaining mobility.

Adienocare and blood clots in the arteries

There is limited evidence of a relationship between progestogen-containing preparations like Adienocare 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 Adienocare, 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 this medication

Stop taking Adienocare and contact your doctor immediately if you notice possible signs of a blood clot, such as:

• severe pain and/or swelling in one of your legs
• severe and sudden chest pain that may radiate to the left arm
• sudden difficulty breathing
• sudden cough without an obvious cause
• unusual, severe, or prolonged headache or worsening of migraine
• partial or complete loss of vision or double vision
• difficulty or inability to speak
• dizziness or fainting
• weakness, unusual sensation, or numbness in any part of the body.

Adienocare and cancer

Based on currently available data, it is not clear whether Adienocare 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, tumors may be detected more frequently and 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 essential that you regularly check your breastsand consult your doctor if you feel any lump.

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

Adienocare and osteoporosis

Changes in bone mineral density (BMD)

The use of this medication 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 Adienocare for you as a patient on an individual basis, considering possible risk factors for bone loss (osteoporosis).

If you use this medication, 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 this medication because it causes moderate suppression of estrogen production (another type of female hormone) by your body.

Other medications and Adienocare

Always inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, including herbal preparations that you are taking. Also, inform any other doctor or dentist who prescribes you another medication (or pharmacist) that you are taking Adienocare.

Some medications may influence Adienocare blood levels and make it less effective or cause unwanted effects.

These include:

• medications 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 medication.

Taking Adienocare with food and drinks

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

Laboratory tests

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

Pregnancy, breastfeeding, and fertility

Do not take this medication 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 Adienocare users.

Adienocare contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Children and adolescents

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

The use of this medication 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 Adienocare for you as a patient on an individual basis, considering possible risk factors for bone loss (osteoporosis).

3. How to take Adienocare

Follow your doctor's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again. The usual dose for adults is one tablet per day.

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

You can start treatment with this medication 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 on days of menstrual bleeding.

If you take more Adienocare than you should

No serious harmful effects have been reported from taking too many Adienocare 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 medication and the amount ingested.

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

Adienocare 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 have vomiting within 3-4 hours after taking a tablet of this medication 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 this medication, 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 Adienocare

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. The effects are more frequent in the first few months after starting to take this medication and usually disappear with continued use. You may also experience changes in your bleeding pattern, such as spotting, irregular bleeding, or your menstruation may cease 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, such as sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• non-specific circulatory problems or rare 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 side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Adienocare

Keep the blister pack in the original packaging to protect it from light.

Keep this medicine out of the sight and reach of children.

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

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

6. Package Contents and Additional Information

Composition of Adienocare

• The active ingredient is dienogest. Each tablet contains 2 mg of dienogest.
• The other ingredients are lactose monohydrate, povidone K30, pregelatinized corn starch, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Package Contents

Adienocare tablets are white or slightly yellowish, round, marked with "D2" on one side and unmarked on the other side, with an approximate diameter of 7 mm.

They are presented in a blister pack containing 28 tablets.

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Procare Health Iberia, S.L.

Avda. Miguel Hernández, 21 Bajo

46450 Benifaió (Valencia)

Spain

Manufacturer

Cyndea Pharma, S.L.

Polígono Industrial Emiliano Revilla Sanz

Av. de Ágreda 31

42110 Ólvega (Soria)

Spain

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

Netherlands: Dimetrum 2 mg tablets

France: Dimetrum 2 mg, tablet

Belgium: Dimetrum 2 mg, tablet

Greece: EFILDA

Denmark: Dienogest Besins

Finland: Dienogest Besins 2 mg, tablet

Iceland: Dienogest Besins 2 mg, tablet

Luxembourg: Dimetrum 2 mg, tablet

Sweden: Dienogest Besins 2 mg, tablet

Spain: Adienocare 2 mg tablets EFG

Cyprus: Dienogest Besins 2 mg δισκία

Norway: Dienogest Besins

Date of Last Revision of this Leaflet: August 2022

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