Endovelle 2 mg comprimidos efg

Package Insert: Information for the User

Endovelle 2 mg Tablets EFG

dienogest

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others 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 package insert. See section 4.

1. What is Endovelle and for what it is used

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

3. How to take Endovelle

4. Possible adverse effects

5. Storage of Endovelle

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 takeEndovelle:

• 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 “Endovelle 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, astrokeor aheart diseasethat causes a decrease in blood flow (for example, angina pectoris). Consultlater “Endovelle and blood clots in the arteries”
• if you have diabetes with 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
• if you have aunexplained vaginal bleeding
• if you areallergic (hypersensitive)to dienogest or any of the other components of this medication (including in section 6 and end of section 2).

If any of these disorders appear for the first time while takingthis 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 takingthis medication.

This medicationIS 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 especially careful while takingthis medication, 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 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 present hypertension while taking Endovelle
• 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 have diabetes or have had temporarydiabetesin a previous pregnancy
• if you have ever hadmelasma(brownish-yellow patches on the skin, especially on the face); if so, avoid excessive exposure to the sun or ultraviolet rays
• if you sufferlower abdominal painwhile taking this medication.

While takingthis medication, the likelihood of becoming pregnant is reduced becausethis medicationcan affect ovulation.

If you become pregnant while takingthis medication, you have aslightly higher riskof having an ectopic pregnancy (the embryo develops outside the uterus). Inform your doctor before starting to takethis medication, if you have already had an ectopic pregnancy or if you have a fallopian tube dysfunction.

Endovelle and severe uterine bleeding

Severe uterine bleeding may worsen with the use ofthis medication, for example, in women with a condition in which the uterine mucosa (endometrium) grows towards the muscular layer of the uterus, known as adenomyosis uterina orbenign uterine tumors, sometimes called uterine fibroids (leiomyomas uterini). 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 takingthis medication.

Endovelle and changes in menstrual bleeding pattern

Most women treated withthis medicationexperience changes in menstrual bleeding pattern (see section 4, Possible side effects).

Endovelle and blood clots in the veins

Some studies suggest that there may be a slight, but not statistically significant, increase in the risk ofblood clots in the legs(thromboembolism)with the use of preparations containing progestogens likethis medication. Blood clots can cause permanent and severe disabilities or even be fatal.

The risk ofblood clots in the veinsincreases:

Endovelle and blood clots in the arteries

There is little evidence of a relationship between progestogen-containing preparations likethis medicationand 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:

Consult your doctor before starting to takethis medication.

Stop taking Endovelle and contact your doctor immediately if you notice possible signs of a blood clot, for example:

Endovelle and cancer

Currently available data do not clearly show whether this medication increases or decreases the risk of breast cancer. 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 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.

Endovelle 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 old). If you are under 18 years old, your doctor will carefully weigh the benefits and risks of using this medication 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 mineral loss), your doctor will carefully weigh the risks and benefits of your treatment with this medication because this medication causes a moderate suppression of estrogen production (another type of female hormone) by your body.

Endovelle and other medications

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

Some medications may affect the levels of this medication in the blood and make it less effective, or may cause unwanted effects.

These include:

Consult your doctor or pharmacist before using any medication.

Endovelle and food and drinks

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

Lab tests

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

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, inform your doctor or pharmacist before using this medication.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been observed in users of this medication.

Endovelle contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this 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 old). If you are under 18 years old, your doctor will carefully weigh the benefits and risks of using this medication 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 this medication unless your doctor prescribes otherwise. Follow these instructions; otherwise, you will not benefit fully from the treatment with this medication.

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. After finishing one package, the next one should be started without interruption. Continue taking the tablets on days of menstrual bleeding as well.

If you take more Endovelle than you should

No serious adverse effects have been reported from taking too many tablets of this medication at the same time. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Do not forget to bring the medication package.

If you forgot to take Endovelle or if you experience vomiting or diarrhea

This medication will be less effective if you forget a tablet. In case 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 have 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 the missed doses.

If you interrupt treatment with Endovelle

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

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

Frequent (affects between 1 and 10 in 100 users)

• weight gain
• depressed mood, sleep disorders, nervousness, loss of interest in sex, or unstable mood
• headache or migraine
• nausea, abdominal pain, flatulence, abdominal swelling, or vomiting
• acne or hair loss
• back pain
• breast tenderness, ovarian cyst, or hot flashes
• uterine/vaginal bleeding, including spotting
• weakness or irritability.

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

• anemia
• weight loss or increased appetite
• anxiety, depression, or mood change
• autonomic nervous system imbalance (which controls unconscious bodily functions, for example, sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• unspecified circulatory problems or irregular heartbeats
• low blood pressure
• difficulty breathing
• 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, light hypersensitivity, or skin pigmentation problems
• bone pain, muscle spasms, pain, or feeling of heaviness in the arms and hands, or legs and feet
• urinary tract infection
• vaginal candidiasis, vaginal dryness, vaginal discharge, pelvic pain, atrophic vulvovaginitis, or breast lump(s)
• fluid retention swelling.

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep in the 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 or blister after “CAD:”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unusedmedicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of endovelle

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

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

Appearance of the product and contents of the packaging

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

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

1x28 tablets (calendarized pack)

3x28 tablets (calendarized pack)

6x28 tablets (calendarized pack)

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Exeltis Healthcare, S.L.

Avenida de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares. Guadalajara. Spain

Responsible for manufacturing

Laboratorios León Farma, S.A.

C/ Vallina, s/n

Navatejera Industrial Estate

24193 - León.

Spain

Last reviewed date of this leaflet: September 2022

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/