ENDOVELLE 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

Endovelle 2 mg EFG Tablets

dienogest

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Endovelle and what is it used for

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

2. What you need to know before you take Endovelle

Do not takeEndovelle

• 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 the lungs (pulmonary embolism). See later “Endovelle 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, a stroke, or a heart diseasethat causes a decrease in blood flow (e.g., angina pectoris). See later “Endovelle and blood clots in the arteries”
• if you have diabetes with blood vessel damage
• if you have or have ever had a severe liver disease(and your liver function values have not returned to normal). The symptoms of liver disease can be a yellow color 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 of having, a malignant tumor, dependent on sex hormones, such as breast cancer or genital organ cancer
• if you have vaginal bleedingof unknown cause
• if you are allergic (hypersensitive)to dienogest or any of the other components of this medicine (included in section 6 and the end of section 2).

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

Warnings and precautions

You should not take oral contraceptives in any form (in tablets, patches, intrauterine system) while taking this medicine.

This medicine is NOTa 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 medicine, and it may be necessary for your doctor to examine you periodically. Inform your doctor if you are affected by any of the following disorders:

• if you have ever had a blood clot(venous thromboembolism) or a close relative has had a blood clot at a relatively early age
• if you have a close relative who has had breast cancer
• if you have ever had depression
• if you have high blood pressureor develop hypertension while taking Endovelle
• if you have liver diseasewhile taking this medicine. The symptoms can include a yellow color 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 diabetesin a previous pregnancy
• if you have ever had chloasma(brownish discoloration of the skin, especially on the face); if so, avoid excessive exposure to the sun or ultraviolet rays
• if you experience lower abdominal painwhile taking this medicine.

While taking this medicine, the likelihood of becoming pregnant is reduced because this medicine can affect ovulation.

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

Endovelle and severe uterine bleeding

Uterine bleeding may worsen with the use of this medicine, for example, in women who have a condition in which the uterine lining (endometrium) grows into the muscular layer of the uterus, known as uterine adenomyosis or benign uterine tumors, sometimes called uterine fibroids (uterine leiomyomas). If the bleeding is heavy and prolonged, it can 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 you should stop taking this medicine.

Endovelle and changes in bleeding pattern

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

Endovelle 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-only preparations like this medicine. Very rarely, blood clots can cause permanent disability and can be life-threatening.

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

Endovelle and blood clots in the arteries

There is limited evidence of a relationship between progestogen-only preparations like this medicine 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 high blood pressure, 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 this medicine, 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 medicine.

Stop taking Endovelle and contact your doctor immediately if you notice any of the following signs of a blood clot:

• severe pain and/or swelling in one of your legs
• severe and sudden chest pain that may reach your 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 your body.

Endovelle and cancer

Based on currently available data, it is not clear whether this medicine 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, it is possible that more tumors are detected and at an earlier stage 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 important 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 even rarer cases, malignant liver tumors have been reported. Contact your doctor if you experience unusually severe stomach pain.

Endovelle and osteoporosis

Changes in bone mineral density (BMD)

The use of this medicine may affect bone strength in 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 this medicine for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

If you use this medicine, 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 a 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 medicine because this medicine causes moderate suppression of estrogen production by your body.

Taking Endovelle with other medicines

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

Some medicines may influence the levels of this medicine in your blood and make it less effective, or may cause unwanted effects.

These include:

• medicines used to treat:
• • epilepsy(e.g., phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramato, felbamato)
  • 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 medicine.

Taking Endovelle with food and drinks

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

Lab tests

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

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No effect on the ability to drive and use machines has been observed in users of this medicine.

Endovelle contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Children and adolescents

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

The use of this medicine may affect bone strength in 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 this medicine for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

3. How to take Endovelle

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again. The usual dose for adults is one tablet per day.

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

You can start treatment with this medicine 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 one should be started without interruption. Continue taking the tablets even during days of menstrual bleeding.

If you take more Endovelle than you should

No serious harmful effects have been reported when taking too many tablets of this medicine at once. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. Do not forget to take the medicine pack with you.

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

This medicine 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 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 fully absorbed by your body. This situation is similar to when you forget a tablet. After vomiting or diarrhea within 3-4 hours after taking this medicine, 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 Endovelle

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The 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 have spotting, irregular bleeding, or your menstruation may stop completely.

Common (affect 1 to 10 users in 100)

• weight gain
• depressed mood, sleep disorders, nervousness, loss of interest in sex, or mood swings
• headache or migraine
• nausea, abdominal pain, flatulence, abdominal bloating, 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, e.g., sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• non-specific circulatory problems or uncommon 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 the 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.

Adverse Reaction Reporting:

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

5. Storage of Endovelle

Store 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 or blister after "CAD:". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Endovelle

The active ingredient is dienogest. Each tablet contains 2 mg of dienogest.

The other components are lactose monohydrate, corn starch, povidone K 30, and vegetable magnesium stearate.

Appearance of the Product and Package Contents

Endovelle tablets are round, white, and have a diameter of 5 mm.

They are presented in a blister pack containing 28 tablets. The boxes contain blister packs with:

1x28 tablets (calendarized packaging)

3x28 tablets (calendarized packaging)

6x28 tablets (calendarized packaging)

Only some package sizes may be marketed.

Marketing Authorization Holder

Exeltis Healthcare, S.L.

Miralcampo Avenue, 7.

Miralcampo Industrial Estate.

19200 Azuqueca de Henares. Guadalajara. Spain

Manufacturer

Laboratorios León Farma, S.A.

Vallina Street, s/n

Navatejera Industrial Estate

24193 - León.

Spain

Date of last revision of this leaflet: September 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/