Endofemine

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Endofemine, 2 mg, tablets

Dienogest

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Endofemine and what is it used for
• 2. Important information before taking Endofemine
• 3. How to take Endofemine
• 4. Possible side effects
• 5. How to store Endofemine
• 6. Contents of the pack and other information

1. What is Endofemine and what is it used for

Endofemine is used to treat endometriosis (painful symptoms caused by abnormally located uterine lining). Endofemine contains a hormone, a progestogen called dienogest.

2. Important information before taking Endofemine

When NOT to take Endofemine

If:

• there is a blood clot (thromboembolic disease) in the veins. This can occur, for example, in the blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also “Endofemine and venous blood clots”below;
• there is or has been a history of severe arterial disease, including cardiovascular disease, such as heart attack, strokeor heart diseasecausing reduced blood flow (angina pectoris). See also “Endofemine and arterial blood clots”below;
• there is diabetes with vascular damage;
• there is or has been a history of severe liver disease (and liver function parameters have not returned to normal). Symptoms of liver disease may include yellowing of the skin and (or) itching all over the body;
• there is or has been a history of benign or malignant liver tumor;
• there is or has been a history of, or there is a suspicion of, malignanthormone-dependent tumors, such as breast cancer or genital organ tumors;
• there is unexplained vaginal bleeding;
• there is known hypersensitivity (allergy)to dienogest or any of the other ingredients of this medicine (see section 6 and the end of section 2).

If any of these conditions occur for the first time while taking Endofemine, the patient should stop taking it immediately and consult a doctor.

Warnings and precautions

While taking Endofemine, the patient should not use hormonal contraceptives in any form (pill, patch, intrauterine system). Endofemine is NOT a contraceptive. To prevent pregnancy, the patient should use condoms or other non-hormonal contraceptives. In some situations, the patient should exercise special caution when taking Endofemine. Regular medical check-ups may be necessary. The patient should inform their doctor if any of the following conditions occur or have occurred:

If:

• there has been a history of blood clot(venous thromboembolic disease) or a close relative has had a blood clot at a relatively young age;
• a close relative has breast cancer;
• there has been a history of depression;
• there is high blood pressureor high blood pressure develops while taking Endofemine;
• there is liver diseasewhile taking Endofemine. Symptoms may include yellowing of the skin, eyes, or itching all over the body. The patient should inform their doctor if such symptoms occurred during a previous pregnancy as well;
• there is diabetesor diabetes occurred during a previous pregnancy;
• there has been a history of chloasma (melasma)(yellow-brown spots on the skin, especially on the face). In such a case, the patient should avoid prolonged sun exposure or ultraviolet radiation;
• there is abdominal painwhile taking Endofemine.

While taking Endofemine, the chance of becoming pregnant is reduced, as Endofemine may affect ovulation. If the patient becomes pregnant while taking Endofemine, there is a slightly increased riskof ectopic pregnancy (the embryo develops outside the uterus). Before starting Endofemine, the patient should tell their doctor if they have had an ectopic pregnancy or tubal dysfunction in the past.

Endofemine and severe uterine bleeding

Uterine bleeding, for example in women with a disease in which the uterine lining (endometrium) grows into the uterine muscle layer, called adenomyosis, or benign uterine tumors, sometimes called uterine fibroids, may worsen while taking Endofemine. If the bleeding is heavy and prolonged, it may lead to a decrease in red blood cells (anemia), which can be severe in some cases. If the patient has anemia, they should discuss with their doctor whether it is necessary to stop taking Endofemine.

Endofemine and changes in bleeding profile

In most women treated with Endofemine, there are changes in menstrual bleeding profile (see section 4, “Possible side effects”).

Endofemine and venous blood clots

Some studies suggest that there may be a slight, statistically non-significant, increased risk of blood clots in the legs (venous thromboembolic disease)associated with the use of progestogen-containing medicines, such as Endofemine. Very rarely, blood clots can cause severe, permanent disability or even death. The risk of venous blood clotincreases:

• with age;
• if the patient is overweight;
• if the patient or a close relative has had a blood clot in the leg (thrombosis), lung (pulmonary embolism), or other organ at a young age;
• if surgery is planned, a serious accident occurs, or immobilization lasts for a long time. It is essential to inform the doctor in advance about taking Endofemine, as it may be necessary to stop treatment. The doctor will inform when to restart Endofemine. This is usually two weeks after recovery.

Endofemine and arterial blood clots

There is limited evidence of a link between the use of progestogen-containing medicines, such as Endofemine, and an increased risk of blood clots, for example in the heart (heart attack) or brain (stroke). In women with high blood pressure, the risk of stroke may be slightly increased when taking such medicines as Endofemine. The risk of arterial blood clotincreases:

• in women who smoke - it is recommended to quit smoking when taking Endofemine, especially at over 35 years of age;
• if the patient is overweight;
• if a close relative has had a heart attack or stroke at a young age;
• if the patient has high blood pressure.

The patient should consult their doctor before taking Endofemine.

Stop taking Endofemine and contact a doctor immediately if the patient notices any possible signs of a blood clot, such as:

• severe pain and (or) swelling in one leg;
• sudden severe chest pain, which may also radiate to the left arm;
• sudden shortness of breath;
• sudden cough without an obvious cause;
• any unusual, severe, or prolonged headache or worsening of migraine;
• partial or complete blindness or double vision;
• difficulty speaking or inability to speak;
• dizziness or fainting;
• weakness, strange feeling, or numbness in any part of the body.

Endofemine and cancer

Currently available data do not clearly indicate whether Endofemine increases the risk of breast cancer or not. Breast cancer has been observed slightly more frequently in women taking hormones compared to women not taking hormones, but it is not known whether this is due to treatment. For example, it may be due to the fact that more tumors are detected and detected earlier in women taking hormones, as they are more frequently examined by a doctor. The frequency of breast tumors decreases gradually after stopping hormonal treatment. Regular breast examinationis essential, and the patient should consult their doctor if they notice a lump. In rare cases, women taking hormones have reported benign liver tumors, and in even rarer cases, malignant liver tumors. The patient should consult their doctor if they experience severe abdominal pain.

Endofemine and osteoporosis Bone mineral density (BMD) changes

Taking Endofemine may affect bone strength in young people (12 to less than 18 years). Therefore, if the patient is under 18 years old, the doctor will individually weigh the benefits and risks of taking Endofemine, considering possible risk factors for bone loss (osteoporosis). If the patient takes Endofemine, they should ensure adequate calcium and vitamin D intake from their diet or supplements for bone health. If the patient has an increased risk of osteoporosis (bone weakness due to loss of bone minerals), the doctor will carefully weigh the benefits and risks of treating with Endofemine, as Endofemine has a moderate estrogen-suppressing effect.

Endofemine and other medicines

The patient should always inform their doctor about any medicines or herbal products they are currently taking. They should also tell any doctor, dentist, or pharmacist prescribing another medicine about taking Endofemine. Some medicines may affect the level of Endofemine in the blood and reduce its effectiveness or cause side effects. These include:

• medicines used for the following diseases: epilepsy(e.g., phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate); tuberculosis(e.g., rifampicin); HIV and hepatitis C virus infections(so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz); fungal infections(griseofulvin, ketoconazole).
• herbal St. John's Wort (Hypericum perforatum).

Before taking any medicine, the patient should consult their doctor or pharmacist.

Endofemine with food and drink

While taking Endofemine, the patient should avoid drinking grapefruit juice, as it may increase the level of Endofemine in the blood. This may increase the risk of side effects.

Laboratory tests

If the patient needs to have a blood test, they should tell their doctor or laboratory staff that they are taking Endofemine, as Endofemine may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

Endofemine should not be taken during pregnancy or breastfeeding.

Driving and using machines

No effect on the ability to drive and use machines has been observed in people taking Endofemine.

Endofemine contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking Endofemine.

Children and adolescents

Endofemine should not be used in girls before their first menstrual period. Taking Endofemine may affect bone strength in young people (12 to less than 18 years). Therefore, if the patient is under 18 years old, the doctor will individually weigh the benefits and risks of taking Endofemine, considering possible risk factors for bone loss (osteoporosis).

3. How to take Endofemine

Endofemine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The usual dose for adults is 1 tablet per day. The following information applies to Endofemine if the doctor has not prescribed otherwise. The patient should follow the instructions below; otherwise, they will not get the full benefits of taking Endofemine. Treatment with Endofemine can be started on any day of the natural cycle. Adults: The patient should take one tablet daily, preferably at the same time, with a small amount of liquid if necessary. After finishing one pack, the patient should start the next one without a break. The patient should continue taking the tablets during menstrual bleeding days.

Taking more than the recommended dose of Endofemine

There are no reports of serious harmful effects after taking more than the recommended dose of Endofemine. However, in case of doubts, the patient should consult their doctor.

Missing a dose of Endofemine or experiencing vomiting or diarrhea

The effect of Endofemine will be less effective if the patient misses a dose. If the patient misses one or more tablets, they should take only one tablet as soon as possible and continue taking the tablets at the same time the next day. If the patient vomits within 3-4 hours after taking Endofemine or experiences severe diarrhea, there is a risk that the active substance of the tablet will not be absorbed by the body. These situations are similar to missing a dose. After vomiting or diarrhea within 3-4 hours after taking Endofemine, the patient should take the next tablet as soon as possible. The patient should not take a double dose to make up for the missed tablet.

Stopping Endofemine

If the patient stops taking Endofemine, their previous endometriosis symptoms may return.

4. Possible side effects

Like all medicines, Endofemine can cause side effects, although not everybody gets them. Such effects are more common during the first few months after starting Endofemine and usually disappear with continued treatment. Changes in bleeding profile, such as spotting, irregular bleeding, or absence of menstruation, may also occur.

Common (occurring in 1 to 10 out of 100 patients)

• weight gain
• low mood, sleep disturbances, nervousness, loss of interest in sex, or mood changes
• headache or migraine
• nausea, abdominal pain, bloating, abdominal distension, or vomiting
• acne or hair loss
• back pain
• breast discomfort, ovarian cyst, or hot flashes
• uterine or vaginal bleeding, including spotting
• weakness or irritability

Uncommon (occurring in 1 to 10 out of 1,000 patients)

• anemia
• weight loss or increased appetite
• anxiety, depression, or sudden mood changes
• autonomic nervous system imbalance (controls subconscious body functions, e.g., sweating) or attention disturbances
• dry eye
• tinnitus
• non-specific circulatory disorders or palpitations
• low blood pressure
• shortness of breath
• diarrhea, constipation, abdominal discomfort, gastroenteritis, or gum inflammation
• dry skin, excessive sweating, severe itching all over the body, hirsutism, nail brittleness, dandruff, skin inflammation, abnormal hair growth, photosensitivity, or pigmentation disorders
• bone pain, muscle cramps, pain and (or) feeling of heaviness in the arms and hands or legs and feet
• urinary tract infection
• vaginal thrush, vaginal dryness, discharge, pelvic pain, atrophic vaginitis, or breast lump
• edema due to fluid retention

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

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Endofemine

Store the blister pack in the outer packaging to protect it from light. The medicine should be kept out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister pack and carton after “EXP”. The expiry date refers to the last day of the month. The batch number is stated on the blister pack and carton after “Lot”. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Endofemine contains

The active substance is dienogest. Each tablet contains 2 mg of dienogest. The other ingredients are lactose monohydrate, cornstarch, povidone (K 30), and magnesium stearate of vegetable origin.

What Endofemine looks like and contents of the pack

Endofemine tablets are round, white tablets with a diameter of 5 mm. The tablets are provided in a blister pack containing 28 tablets. The packs contain blister packs packaged in the following quantities: 1 x 28 tablets (calendar pack), 3 x 28 tablets (calendar pack), 6 x 28 tablets (calendar pack). Not all pack sizes may be marketed.

Marketing authorization holder:

Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer:

Laboratorios Leon Farma, S.A., Calle La Vallina s/n, Poligono Industrial Navatejera, 24193 Villaquilambre, Spain. For more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel: +48 22 546 64 00. Date of last revision of the leaflet:March 2024