Adienocare 2 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Adienocare 2 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Adienocare is and what it is used for
2. What you need to know before taking Adienocare
3. How to take Adienocare
4. Possible adverse effects
5. How to store Adienocare
6. Contents of the pack and other information

1. What Adienocare is and what it is used for

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

2. What you need to know before starting Adienocare

Do not take Adienocare:

• if you have a blood clot (thromboembolic disorder) in the veins. This may occur, for example, in blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See below “Adienocare and blood clots in the veins”
• if you currently suffer or have ever suffered from a serious arterial disease, including cardiovascular disease, such as a heart attack, stroke, or heart disease causing reduced blood flow (e.g., angina pectoris). See below “Adienocare and blood clots in the arteries”
• if you have diabetes with blood vessel damage
• if you currently suffer or have ever suffered from a serious liver disease (and your liver function values have not returned to normal). Symptoms of liver disease may include yellowing of the skin and/or generalized itching
• if you currently suffer or have ever suffered from a benign or malignant liver tumor
• if you currently suffer, have ever suffered, or are suspected of having a malignant tumor dependent on sex hormones, such as breast cancer or genital organ cancer
• if you have vaginal bleeding of unknown cause
• if you are allergic (hypersensitive) to dienogest or any of the other components of this medicine (listed in section 6 and at the end of section 2).

If any of these conditions occurs for the first time while you are taking this medicine, stop taking it immediately and consult your doctor.

Warnings and precautions

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

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

In some cases, you should exercise special caution while taking this medicine, and your doctor may need to examine you periodically. Inform your doctor if any of the following conditions apply to you:

• if you or a close relative have ever had a blood clot (venous thromboembolism)
• if a close family member has had breast cancer
• if you have ever had depression
• if you have high blood pressure or develop hypertension while taking this medicine
• if you develop liver disease while taking this medicine. Symptoms may include yellowing of the skin or eyes, or generalized itching. Inform your doctor if any of these symptoms occurred during a previous pregnancy
• if you have diabetes or had gestational diabetes in a previous pregnancy
• if you have ever had chloasma (golden-brown skin patches, especially on the face); if so, avoid excessive sun exposure or ultraviolet radiation
• if you experience lower abdominal pain while taking this medicine.

While taking Adienocare, your chance of becoming pregnant is reduced because this medicine may affect ovulation.

If you become pregnant while taking this medicine, you have a slightly higher risk of an ectopic pregnancy (the embryo develops outside the uterus). Inform your doctor before starting Adienocare if you have previously had an ectopic pregnancy or have any tubal abnormalities.

Adienocare and severe uterine bleeding

Uterine bleeding may worsen with the use of this medicine, for example in women with a condition where 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 bleeding is heavy and prolonged, it may lead to a decrease in red blood cells (anemia), which in some cases may be severe. If you have anemia, consult your doctor about whether you should stop taking this medicine.

Adienocare and changes in bleeding patterns

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

Adienocare and blood clots in the veins

Some studies suggest 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 such as Adienocare. Very rarely, blood clots may cause permanent and serious disability or even be fatal.

The risk of venous blood clots increases:

• with age
• if you are overweight
• if you or a close family member has had a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or another organ at a young age
• if you require surgery, have suffered a serious injury, or need to remain immobile for a prolonged period. It is important to inform your doctor in advance that you are taking Adienocare, as treatment may need to be interrupted. Your doctor will advise you when to restart Adienocare, usually about two weeks after regaining mobility.

Adienocare and blood clots in the arteries

There is limited evidence of an association between progestogen-containing preparations like Adienocare and an increased risk of arterial blood clots, for example, in 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 arterial blood clots increases:

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

Consult your doctor before starting this medicine.

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 leg
• sudden, severe chest pain, possibly radiating 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 vision loss, or double vision
• difficulty or inability to speak
• dizziness or fainting
• weakness, numbness, or abnormal sensations in any part of the body.

Adienocare and cancer

Based on currently available data, it is unclear whether Adienocare increases or decreases the risk of breast cancer. Breast cancer has been observed to be slightly more common in women taking hormones compared to those who do not, but it is unknown whether this is caused by the treatment. For example, more tumors may be detected earlier in women taking hormones because they are examined more frequently by doctors. The occurrence of breast tumors decreases after stopping hormonal treatment. It is important to regularly examine your breasts and consult your doctor if you feel any lump.

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

Adienocare and osteoporosis

Changes in bone mineral density (BMD)

The use of this medicine may affect bone strength in adolescents (aged 12 to under 18 years). If you are under 18 years of age, your doctor will therefore carefully evaluate the benefits and risks of using Adienocare for you individually, taking into account possible risk factors for bone loss (osteoporosis).

If you use this medicine, adequate intake of calcium and vitamin D—through diet or dietary supplements—will help support your bone health.

If you are at higher risk of developing osteoporosis (weakened bones due to loss of bone minerals), your doctor will carefully weigh the risks and benefits of your treatment with this medicine, as it causes moderate suppression of estrogen production (another type of female hormone) by your body.

Other medicines and Adienocare

Always inform your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription, as well as herbal preparations. Also inform any other doctor or dentist prescribing you a medicine (or your pharmacist) that you are taking Adienocare.

Some medicines may affect the blood levels of Adienocare and reduce its effectiveness, or may 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 virus 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 Adienocare with food and drinks

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

Laboratory tests

If you require a blood test, inform your doctor or laboratory staff that you are taking Adienocare, as this medicine may affect the results of certain tests.

Pregnancy, breastfeeding, and fertility

Do not take this medicine if you are pregnant or during breastfeeding.

Driving and using machines

No effects on the ability to drive or use machines have been observed in users of Adienocare.

Adienocare contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Children and adolescents

This medicine is not indicated for use in girls before menarche (first menstrual period).

The use of this medicine may affect bone strength in adolescents (aged 12 to under 18 years). If you are under 18 years of age, your doctor will therefore carefully evaluate the benefits and risks of using Adienocare for you individually, taking into account possible risk factors for bone loss (osteoporosis).

3. How to take Adienocare

Follow exactly the instructions for use of this medicine as given by your doctor. 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 has prescribed otherwise. Follow these instructions; otherwise, you will not benefit fully from treatment with Adienocare.

You may start treatment with this medicine on any day of your natural cycle.

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

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 at 91 562 04 20, indicating the medicine and the amount ingested.

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

Adienocare will be less effective if you miss 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 your usual time.

If you vomit within 3–4 hours after taking a tablet of this medicine or if you have severe diarrhea, there is a risk that the active ingredients of the tablet may not be completely absorbed by your body. This situation is similar to forgetting a tablet. After vomiting or diarrhea occurring within 3–4 hours of taking this medicine, you should take another tablet as soon as possible.

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

If you stop taking Adienocare

If you stop treatment with this medicine, your original endometriosis symptoms may return.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. These effects are more common during the first few months after starting this medicine 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 (affects between 1 and 10 in every 100 users)

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

Uncommon (affects between 1 and 10 in every 1,000 users)

• anaemia
• weight loss or increased appetite
• anxiety, depression, or mood changes
• autonomic nervous system imbalance (which controls unconscious bodily functions, e.g. sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• nonspecific circulatory problems or infrequent palpitations
• low blood pressure
• difficulty breathing
• diarrhoea, constipation, abdominal discomfort, inflammation of the stomach and intestines (gastrointestinal inflammation), inflammation of the gums (gingivitis)
• dry skin, excessive sweating, severe itching all over the body, growth of male-pattern hair (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, hypersensitivity to light, or skin pigmentation problems
• bone pain, muscle spasms, pain and/or heaviness in the arms and hands, or in the legs and feet
• urinary tract infection
• vaginal candidiasis, genital dryness, vaginal discharge, pelvic pain, atrophic inflammation of the genitals with discharge (atrophic vulvovaginitis), or a lump or lumps in the breasts
• swelling due to fluid retention

Additional adverse effects in adolescents (12 to less than 18 years): loss of bone density.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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 expiry date stated on the packaging after "EXP:". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Adienocare

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

Appearance of the product and contents of the pack

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

They are presented in a blister pack containing 28 tablets.

Boxes contain blister packs with 28, 84 or 168 tablets.

Only certain pack 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Dimetrum 2 mg tabletten

France: Dimetrum 2 mg, comprimé

Belgium: Dimetrum 2 mg, comprimé

Greece: EFILDA®

Denmark: Dienogest Besins

Finland: Dienogest Besins 2 mg, tabletti

Iceland: Dienogest Besins 2 mg, tafla

Luxembourg: Dimetrum 2 mg, comprimé

Sweden: Dienogest Besins 2 mg, tablet

Spain: Adienocare 2 mg comprimidos EFG

Cyprus: Dienogest Besins 2 mg δισκ?α

Norway: Dienogest Besins

Date of latest review of this leaflet: August 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/