Prospect: Information for the patient

Adienocare 2 mg tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Adienocare and what it is used for

2.What you need to know before starting to take Adienocare

3.How to take Adienocare

4.Possible adverse effects

5.Storage of Adienocare

6.Contents of the package and additional information

This medication 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 Adienocare:

• 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 later“Adienocare and blood clots in the veins”
• if you suffer or have ever suffered from aserious arterial disease, even a cardiovascular disease, such as aheart attack,strokeorheart diseasethat causes a decrease in blood flow (for example, angina pectoris). See later“Adienocare and blood clots in the arteries”
• if you havediabeteswith vascular damage
• if you suffer or have ever suffered from aserious liver disease(and your liver function values have not returned to normal). The symptoms of liver disease can be yellow skin and/or itching all over the body
• if you suffer or have ever suffered from abenign or malignant liver tumor
• if you suffer or have ever suffered from, or are suspected of having amalignant tumor, hormone-dependent, such as breast cancer or genital organs cancer
• if you haveunexplained vaginal bleeding
• if you areallergic (hypersensitive)to dienogest or to any of the other components of this medication (including in section 6 and end of section 2).

If any of these conditions 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 tablet, patch, intrauterine system) while taking Adienocare.

Adienocare is not a 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 this medication and may need to be examined by your doctor periodically. Inform your doctor if you are affected by any of the following conditions:

-if you have ever had ablood clot(thromboembolism) or 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 develop hypertension while taking this medication

-if you have aliver diseasewhile taking this medication. The symptoms can include yellow 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 have had temporary diabetes in a previous pregnancy

-if you have ever hadmelasma(brownish-yellow skin spots, especially on the face); if so, avoid excessive exposure to the sun or ultraviolet rays

-if you havelower abdominal painwhile taking this medication.

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

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

Adienocare and severe uterine bleeding

Severe uterine bleeding may worsen with the use of this medication, for example, in women with a condition in which the uterine lining (endometrium) grows into the muscle layer of the uterus, known as adenomyosis uterine orbenign uterine tumors, sometimes called uterine fibroids (leiomyomas uterine). 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 this medication.

Adienocare and changes in menstrual bleeding pattern

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

Adienocare 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 progestogens like Adienocare. 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 Adienocare, as treatment may need to be interrupted. Your doctor will tell you when to start taking Adienocare again. This usually happens about two weeks after regaining mobility.

Adienocare and blood clots in the arteries

There is little evidence of a relationship between progestogen-containing preparations like Adienocare and an increased risk of having a blood clot, 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 ablood clot in the arteriesincreases:

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

Consult your doctor before starting to takethis medication

Adienocare and cancer

Based on the available data, it is not clear whether Adienocare increases or decreases the risk of breast cancer. Breast cancer has been observed to be slightly more frequent 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 breast 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.

Adienocare and osteoporosis

Bone mineral density (BMD) changes

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, taking into account 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 have a higher risk of developing osteoporosis (bone weakening due to loss of bone minerals), your doctor will carefully weigh the risks and benefits of your treatment with this medication because it causes a 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 over-the-counter medications, herbal preparations you are taking. Also, inform any other doctor or dentist who prescribes another medication (or pharmacist) that you are taking Adienocare.

Some medications may affect the levels of Adienocare 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(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.

Adienocare with food and drinks

During treatment with this medication, you should avoid drinking grapefruit juice, as it may increase the levels of Adienocare 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 Adienocare, as this medication may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

Do not take this medication if you are pregnant or breastfeeding.

Driving and operating machinery

No adverse effects on the ability to drive and operate machinery have 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 takingthis 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, taking into account possible risk factors for bone loss (osteoporosis).

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of 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 the 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. Once you have finished a package, the next one should be started without interruption. Continue taking the tablets on days with menstrual bleeding.

If you take more Adienocare than you should

No serious adverse 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeAdienocare or if you experience vomiting or diarrhea

Adienocare 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 experience vomiting within 3-4 hours after taking a tablet of this medication or if you 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 occurs 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 compensate for missed doses.

If you interrupt treatment withAdienocare

If you interrupt treatment with this medication, your original symptoms of endometriosis may return.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Side effects are more common in the first few months after starting to take this medicine and usually disappear with continued use. You may also experience changes in your bleeding pattern, for example, you may present with bruising, irregular bleeding, or your menstruation may completely cease.

Frequent (affect between 1 and 10 in 100 users)

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

• skin dryness, excessive sweating, intense itching all over the body, male-type hair growth (hirsutism), nail fragility, 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 infection, vaginal dryness, vaginal discharge, pelvic pain, atrophic vulvovaginitis, or a lump or multiple lumps in the breasts
• 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 or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for 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 medicine.

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

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.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Adienocare

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

Appearance of the product and contents of the packaging

Adienocare tablets are white or slightly yellowish, round, marked with “D2” on one face and without a mark on the other face, 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 sizes of packaging may be commercially available.

Marketing authorization holder

Procare Health Iberia, S.L.

Avenida Miguel Hernández, 21 Bajo

46450 Benifaió (Valencia)

Spain

Responsible for manufacturing

Cyndea Pharma, S.L.

Emiliano Revilla Sanz Industrial Estate

Avenida de Ágreda 31

42110 Ólvega (Soria)

Spain

This medicine is authorized in the member states of the European Economic Area with 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, tablets

Iceland: Dienogest Besins 2 mg, tablets

Luxembourg: Dimetrum 2 mg, tablet

Sweden: Dienogest Besins 2 mg, tablet

Spain: Adienocare 2 mg tablets EFG

Cyprus: Dienogest Besins 2 mg δισκ?α

Norway: Dienogest Besins

Last review date of this leaflet: August 2022

More detailed and up-to-date information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/