EndoVelle 2 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Endovelle 2 mg tablets EFG

dienogest

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, and you should not give it to other people, 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Endovelle 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 you start taking Endovelle

Do not take Endovelle:

• if you have a blood clot (thromboembolic disorder) in your veins. This may occur, for example, in the blood vessels of the legs (deep vein thrombosis) or the lungs (pulmonary embolism). See further below “Endovelle and blood clots in the veins”.
• if you have or have ever had a serious arterial disease, including cardiovascular disease, such as heart attack, stroke, or heart disease causing reduced blood flow (e.g. angina pectoris). See further below “Endovelle and blood clots in the arteries”.
• if you have diabetes with blood vessel damage.
• if you have or have ever had 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 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 bleeding of unknown cause.
• if you are allergic (hypersensitive) to dienogest or to any of the other ingredients 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 should not take oral contraceptives in any form (tablet, patch, intrauterine system) while taking this medication.

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

In some cases, you should exercise special caution while taking this medication, and it may be necessary for your doctor to examine you periodically. Inform your doctor if any of the following conditions affect you:

• if you have ever had a blood clot (venous thromboembolism), or if a close family member has had a blood clot at a relatively young age
• 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 Endovelle
• if you have a liver disease while taking this medication. Symptoms may include yellowing of the skin or eyes, or itching all over the body. Inform your doctor if any of these symptoms occurred during a previous pregnancy
• if you have diabetes or previously had temporary diabetes during a prior pregnancy
• if you have ever had chloasma (golden-brown skin patches, especially on the face); if so, avoid excessive exposure to sunlight or ultraviolet rays
• if you experience lower abdominal pain while taking this medication.

While taking this medication, your chance of becoming pregnant is reduced because this medication may 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 this medication if you have previously had an ectopic pregnancy or if you have any impairment in fallopian tube function.

Endovelle and severe uterine bleeding

Uterine bleeding may worsen with the use of this medication, for example in women who have a condition in which 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 the number of red blood cells (anemia), which in some cases can be severe. If you develop anemia, consult your doctor about whether you should stop taking this medication.

Endovelle and changes in bleeding patterns

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

Endovelle and blood clots in veins

Some studies suggest there may be a slight, although not statistically significant, increased risk of blood clots in the legs (venous thromboembolism) associated with the use of preparations containing progestogens such as this medicine. Very rarely, blood clots can cause serious, permanent disabilities or may even be fatal.

The risk of blood clots in veins increases:

• with age
• if you are overweight
• if you or one of your close relatives 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 accident, or need to remain immobile for a prolonged period. It is important to inform your doctor in advance that you are taking this medicine, as treatment may need to be interrupted. Your doctor will advise you when to restart this medication. This is usually about two weeks after you regain mobility.

Endovelle and blood clots in the arteries

There is limited evidence of an association between progestogen-containing preparations such as this medicine and an increased risk of developing a blood clot, for example, in the blood vessels of the heart (heart attack) or brain (stroke). In women with hypertension, such preparations may slightly increase the risk of stroke.

The risk of developing a blood clot in the arteries increases:

• if you smoke. You are strongly advised to stop smoking while taking this medicine, especially if you are over 35 years of age
• if you are overweight
• if one of your close relatives has had a heart attack or stroke at an early 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 possible signs of a blood clot, for example:

• severe and/or swelling in one of your legs
• sudden, severe chest pain, which may extend to your left arm
• sudden difficulty breathing
• sudden cough without an obvious cause
• unusual, severe, or prolonged headache, or worsening of a migraine
• partial or complete loss of vision, or double vision
• difficulty or inability to speak
• dizziness or fainting
• weakness, abnormal sensation, or numbness in any part of the body.

Endovelle and cancer

Based on currently available data, it is not clear whether this medication increases the risk of breast cancer or not. Breast cancer has been observed to be slightly more frequent 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 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 hormone treatment. It is important that you 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 in even more exceptional cases, malignant liver tumors. Contact your doctor if you experience unusually severe stomach pain.

Endovelle and osteoporosis

Changes in bone mineral density (BMD)

The use of this medication may affect bone strength in adolescents (from 12 to less than 18 years of age). If you are under 18 years of age, your doctor will therefore carefully evaluate the benefits and risks of using this medication for you on an individual basis, taking into account possible risk factors for bone loss (osteoporosis).

If you use this medication, it will help support your bones to have an adequate intake of calcium and vitamin D, both through diet and dietary supplements.

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

Taking endovelle with other medicines

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 you are taking. Likewise, inform any other doctor or dentist who prescribes you another medicine (or the pharmacist) that you are taking this medicine.

Some medicines may influence the blood levels of this medicine, making it less effective or causing unwanted effects.

These include:

• medicines used to treat:
  • epilepsy (for example, phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate)
  • tuberculosis (for example, 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)
• 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 may increase the levels of this medicine in your blood. This could 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 this medication, as this medication may affect the results of certain tests.

Pregnancy, breastfeeding, and fertility

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

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

Driving and use of machines

No effect on the ability to drive and use machines has been observed in patients taking this medicinal product.

Endovelle contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Children and adolescents

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

The use of this medicine may affect bone strength in adolescents (from 12 to less than 18 years of age). If you are under 18 years of age, your doctor will therefore carefully assess the benefits and risks of using this medicine for you on an individual basis, taking into account possible risk factors for bone loss (osteoporosis).

3. How to take Endovelle

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again. The usual dose for adults is one tablet daily.

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

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 have finished one pack, start the next pack without interruption. Continue taking the tablets also during menstrual bleeding days.

If you take more endovelle than you should

No serious harmful effects have been reported from taking too many tablets of this medicine at once. In case of overdose or accidental ingestion, consult your doctor or pharmacist or the Poison Information Service immediately, telephone number 91 562 04 20, stating the name of the medicine and the amount ingested. Do not forget to bring the medicine container.

If you forget to take endovelle or if you experience vomiting or diarrhea

This medicine may be less effective if you miss a tablet. If you forget to take one or more tablets, take a single tablet as soon as you remember; then continue taking your next tablet at the usual time the following day.

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 substances in the tablet may not be completely absorbed by your body. This situation is similar to missing a dose. After vomiting or severe 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 interrupt treatment with Endovelle

If you interrupt 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 will experience them. These effects are more frequent during the first months after starting this medicine and usually disappear with continued use. You may also experience changes in your bleeding pattern, for example, spotting, irregular bleeding, or your menstruation may stop completely.

Frequent (affect between 1 and 10 out of 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 (affect between 1 and 10 out of 1,000 users)

• anemia
• weight loss or increased appetite
• anxiety, depression, or mood changes
• autonomic nervous system imbalance (which controls unconscious bodily functions, for example, sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• nonspecific circulatory problems or infrequent palpitations
• low blood pressure
• difficulty breathing
• diarrhea, constipation, abdominal discomfort, inflammation of the stomach and intestines (gastrointestinal inflammation), inflammation of the gums (gingivitis)
• dry skin, excessive sweating, intense itching all over the body, growth of male-pattern body 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 arms and hands, or legs and feet
• urinary tract infection
• vaginal candidiasis, genital dryness, vaginal discharge, pelvic pain, atrophic inflammation of the genital area with discharge (atrophic vulvovaginitis), or lump(s) in the breasts
• swelling due to fluid retention.

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

Reporting of adverse reactions:

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

5. Storage of Endovelle

Keep in the original packaging to protect 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 carton or blister pack after "EXP:". The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of endovelle

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

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

Appearance of the product and contents of the pack

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

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

1x28 tablets (calendar pack)

3x28 tablets (calendar pack)

6x28 tablets (calendar pack)

Only certain package sizes may be marketed.

Marketing Authorization Holder

Exeltis Healthcare, S.L.

Avenida de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares. Guadalajara. Spain

Manufacturer

Laboratorios León Farma, S.A.

C/ Vallina, s/n

Polígono Industrial Navatejera

24193 - León

Spain

Date of latest revision of this leaflet: September 2022

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