Endovelle

Package Leaflet: Information for the Patient

Endovelle, 2 mg, tablets

dienogest

Read the package 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. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Endovelle and what is it used for

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

2. Important information before taking Endovelle

When not to take Endovelle:

If:

• you have 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 "Endovelle and blood clots" below;
• you have or have had severe arterial disease, including cardiovascular disease, such as a heart attack or stroke, or heart disease causing reduced blood flow (angina pectoris). See also "Endovelle and arterial clots" below;
• you have diabetes with blood vessel damage;
• you have or have had 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;
• you have or have had a benign or malignant liver tumor;
• you have or have had, or there is a suspicion of, a hormone-dependent malignant tumor, such as breast cancer or genital organ cancer;
• you have unexplained vaginal bleeding;
• you are allergic (hypersensitive) 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 Endovelle, stop taking it and consult a doctor.

Warnings and precautions

While taking Endovelle, do not use hormonal contraceptives in any form (pill, patch, intrauterine system). Endovelle is NOT a contraceptive. To prevent pregnancy, use condoms or other non-hormonal contraceptives. In some situations, you should be particularly careful when taking Endovelle. Regular medical check-ups may be necessary. Tell your doctor if any of the following conditions occur or have occurred:

• you have had a blood clot (venous thromboembolic disease) or a close family member has had a blood clot at a relatively young age;
• a close family member has breast cancer;
• you have had depression;
• you have high blood pressure or develop high blood pressure while taking Endovelle;
• you develop liver disease while taking Endovelle. Symptoms may include yellowing of the skin, eyes, or itching all over the body. Tell your doctor if you have had such symptoms during a previous pregnancy;
• you have diabetes or have had diabetes during a previous pregnancy;
• you have had chloasma (yellow-brown spots on the skin, especially on the face). In this case, avoid prolonged sun exposure or ultraviolet radiation;
• you experience abdominal pain while taking Endovelle.

While taking Endovelle, the chance of getting pregnant is reduced, as Endovelle may affect ovulation. If you become pregnant while taking Endovelle, there is a slightly increased risk of ectopic pregnancy (the embryo develops outside the uterus). Before starting Endovelle, tell your doctor if you have had an ectopic pregnancy or have tubal dysfunction.

Endovelle 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 uterine fibroids, may worsen while taking Endovelle. If the bleeding is heavy and prolonged, it may lead to a decrease in red blood cell count (anemia), which can be severe in some cases. If you have anemia, discuss with your doctor whether it is necessary to stop taking Endovelle.

Endovelle and changes in bleeding profile

In most women treated with Endovelle, changes in menstrual bleeding profile occur (see section 4 "Possible side effects").

Endovelle and venous blood clots

Some studies suggest that there may be a slightly increased risk of blood clots in the legs (venous thromboembolic disease) associated with the use of progestogen-containing medications, such as Endovelle. Very rarely, blood clots can cause severe, lasting disability or even death. The risk of venous blood clots increases:

• with age;
• if you are overweight;
• if you have had a blood clot in your leg (deep vein thrombosis), lung (pulmonary embolism), or other organ (also in a close family member);
• if you are scheduled for surgery, have had a serious accident, or are immobilized for a long time. It is essential to inform your doctor in advance that you are taking Endovelle, as it may be necessary to stop treatment. Your doctor will tell you when to resume taking Endovelle. This is usually two weeks after recovery.

Endovelle and arterial blood clots

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

• in women who smoke - it is recommended to quit smoking when taking Endovelle, especially if you are over 35 years old;
• 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 taking Endovelle.

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

• severe pain and (or) swelling in one leg;
• sudden severe chest pain that 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.

Endovelle and cancer

Currently available data do not clearly indicate whether Endovelle 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 because 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 examination is essential, and you should consult your doctor if you feel a lump. In rare cases, women taking hormones have reported benign liver tumors, and in even rarer cases, malignant liver tumors. You should consult your doctor if you experience severe abdominal pain.

Endovelle and osteoporosis Bone Mineral Density (BMD)

Taking Endovelle may affect bone strength in young people (12 to less than 18 years old). Therefore, if the patient is under 18 years old, the doctor will individually weigh the benefits and risks of taking Endovelle, considering possible risk factors for bone loss (osteoporosis). If you are taking Endovelle, for the health of your bones, you should ensure adequate intake of calcium and vitamin D with your diet or supplements. If you have an increased risk of osteoporosis (bone weakness due to loss of bone mineral substances), your doctor will carefully weigh the benefits and risks of treating you with Endovelle, as this medicine has a moderate suppressive effect on estrogen production (another type of female hormone) by the body.

Endovelle and other medicines

Always inform your doctor about the medicines or herbal products you are currently taking. You should also tell any doctor, dentist, or pharmacist prescribing another medicine about taking Endovelle. Some medicines may affect the level of Endovelle in your blood and reduce its effectiveness or cause side effects. These include:

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

Before taking any medicine, consult your doctor or pharmacist.

Endovelle with food or drink

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

Lab tests

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

Pregnancy, breastfeeding, and fertility

Do not take Endovelle during pregnancy or breastfeeding.

Driving and using machines

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

Endovelle contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking Endovelle.

Children and adolescents

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

3. How to take Endovelle

Always take Endovelle exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist. The following information is about Endovelle, if your doctor has not prescribed otherwise. You must follow the instructions below; otherwise, you will not get the full benefit of taking Endovelle. Treatment with Endovelle can be started on any day of the natural cycle. Adults: Take one tablet daily, preferably at the same time, with a small amount of liquid if necessary. After finishing the pack, start the next one without a break. Continue taking the tablets even during menstrual bleeding days.

Taking more than the prescribed dose of Endovelle

There are no reports of serious harmful effects after taking too many Endovelle tablets at once. However, if you have any doubts, consult your doctor.

Missing a dose of Endovelle

The effect of Endovelle will be less if you miss a tablet. If you miss one or more tablets, take only one tablet as soon as possible and continue with the next tablet at the usual time the next day. If you vomit within 3-4 hours of taking Endovelle or have 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 of taking Endovelle, take the next tablet as soon as possible. Do not take a double dose to make up for a missed tablet.

Stopping Endovelle

If you stop taking Endovelle, your previous endometriosis symptoms may return.

4. Possible side effects

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

Common (affecting 1 to 10 in 100 patients)

• weight gain;
• low mood, sleep problems, 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 (affecting 1 to 10 in 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 disorders;
• dry eye;
• tinnitus;
• non-specific circulatory problems or palpitations;
• low blood pressure;
• shortness of breath;
• diarrhea, constipation, abdominal discomfort, gastroenteritis, gingivitis;
• dry skin, excessive sweating, severe itching all over the body, hirsutism, nail fragility, dandruff, skin inflammation, abnormal hair growth, hypersensitivity reaction to light, or pigmentation problems;
• 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 old): bone density loss.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. You can report side effects directly to the Department of Drug Safety Monitoring of the 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Endovelle

Store in the original package to protect from light. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month. After "Lot" on the carton and blister, the batch number is stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Endovelle contains

• The active substance of Endovelle is dienogest. Each tablet contains 2 mg of dienogest.
• The other ingredients are: lactose monohydrate, cornstarch, povidone (K30), magnesium stearate.

What Endovelle looks like and contents of the pack

Endovelle tablets are round, white, and 5 mm in diameter. The tablets are packaged in blisters of 28 tablets. The carton contains: 1 x 28 tablets (calendar pack) or 3 x 28 tablets (calendar pack)

Marketing authorization holder and manufacturer

Marketing authorization holder

Exeltis Poland Sp. z o.o. ul. Szamocka 8 01-748 Warsaw

Manufacturer

Laboratorios León Farma, S.A. C/La Vallina s/n, Polígono Industrial Navatejera 24193 Villaquilambre, León Spain

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

Sweden Endovelle 2 mg tablet Austria Endovelle 2 mg Tabletten Germany Endovelle 2 mg tabletten Czech Republic Endovelle Hungary Endovelle 2 mg tablet Italy Endovelle Poland Endovelle Slovakia Endovelle 2 mg tablet Date of last revision of the leaflet:03.05.2024