Endovelle

Package leaflet: Information for the patient

Endovelle, 2 mg, tablets
dienogest
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Endovelle is and what it is 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 Endovelle is and what it is used for

Endovelle is used in the treatment of endometriosis (painful symptoms caused by abnormally located endometrial tissue). Endovelle contains a hormone, a progestagen called dienogest.

2. Important information before taking Endovelle

When not to take Endovelle:

If:

• you have blood clot (venous thromboembolic disease) in the veins. This may occur, for example, in blood vessels in the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also "Endovelle and venous blood clots" below;
• you have or have previously had severe arterial disease, including cardiovascular disease such as heart attack, stroke, or heart disease causing reduced blood flow (angina pectoris). See also "Endovelle and arterial blood clots" below;
• you have diabetes with blood vessel damage;
• you have or have previously had severe liver disease (and liver function tests have not returned to normal). Symptoms of liver disease may include yellowing of the skin and/or itching of the whole body;
• you have or have previously had, or are suspected of having, a benign or malignant liver tumour;
• you have or have previously had, or there is suspicion of, a malignant hormone-dependent tumour, such as breast cancer or genital organ tumour;
• 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, you must stop taking it immediately and consult your doctor.

Warnings and precautions

While taking Endovelle, you must not use hormonal contraceptives in any form (tablet, patch, vaginal ring).
Endovelle is not a contraceptive. To prevent pregnancy, you should use condoms or other non-hormonal contraceptive methods.

In certain situations, special caution is required when taking Endovelle. Regular medical examinations may be necessary. Inform your doctor if any of the following conditions are present or have occurred in the past in the patient:

If:

• you have previously had a 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;
• you have ever 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 of the whole body. Inform your doctor if such symptoms occurred during a previous pregnancy;
• you have diabetes or had gestational diabetes during a previous pregnancy;
• you have ever had chloasma (dark brown patches on the skin, especially on the face). In such cases, avoid prolonged sun exposure or ultraviolet radiation;
• you experience lower abdominal pain while taking Endovelle.

While taking Endovelle, the chance of becoming pregnant is reduced because Endovelle may affect ovulation.
If pregnancy occurs while taking Endovelle, there is a slightly increased risk of ectopic pregnancy (the embryo develops outside the uterus). Before starting Endovelle, inform your doctor if you have previously had an ectopic pregnancy or have tubal disorders.

Endovelle and severe uterine bleeding

Uterine bleeding, for example in women with a condition where the lining of the uterus (endometrium) grows into the muscular layer of the uterus, known as adenomyosis, or benign uterine tumours, sometimes called uterine fibroids, may worsen during treatment with Endovelle.
If bleeding is heavy and persists for a long time, it may lead to a decrease in red blood cells (anaemia), which may be severe in some cases.
If anaemia occurs, discuss with your doctor whether discontinuation of Endovelle is necessary.

Endovelle and changes in bleeding pattern

Most women treated with Endovelle experience changes in menstrual bleeding pattern (see section 4 "Possible side effects").

Endovelle and venous blood clots

Some studies suggest a slight, statistically non-significant increased risk of blood clots in the legs (venous thromboembolism) associated with the use of progestogen-containing medicines such as Endovelle. Very rarely, blood clots may cause serious, permanent disability or even death.
The risk of venous blood clot increases:

• with age;
• if you are overweight;
• if you or a close relative had a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or another organ at a young age;
• if surgery is planned, you have had a serious accident, or prolonged immobilisation. It is important to inform your doctor in advance about taking Endovelle, as treatment may need to be interrupted. Your doctor will advise when to restart Endovelle. Usually, this is two weeks after recovery.

Endovelle and arterial blood clots

There is little evidence of an association between progestogen-containing medicines such as Endovelle and an increased risk of arterial 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 with the use of medicines such as Endovelle.
The risk of arterial blood clot increases:

• in women who smoke – quitting smoking is recommended when taking Endovelle, especially if aged over 35 years;
• if you are overweight;
• if a close relative had a heart attack or stroke at a young age;
• if you have high blood pressure.

Consult your doctor before taking Endovelle.
You must stop taking Endovelle and contact your doctor immediately
if you notice possible symptoms of a blood clot, such as:

• severe pain and/or swelling in one leg;
• sudden severe chest pain, which may 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, unusual sensation, or numbness in any part of the body.

Endovelle and cancer

Current 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 caused by treatment. For example, it may result from the fact that more tumours are detected and detected earlier in women taking hormones because they are examined more frequently by a doctor. The incidence of breast cancer gradually decreases after stopping hormone therapy. Regular breast examinations are important, and you should contact your doctor if you feel a lump.

In rare cases, benign liver tumours have been reported in women taking hormones, and in even rarer cases, malignant liver tumours. Contact your doctor if you experience extremely severe abdominal pain.

Endovelle and osteoporosis

Changes in bone mineral density (BMD)

The use of Endovelle may affect bone strength in adolescents (12 to less than 18 years). Therefore, if the patient is under 18 years of age, the doctor will individually assess the benefits and risks of using Endovelle, taking into account possible risk factors for bone loss (osteoporosis).

If the patient is taking Endovelle, for bone health, adequate intake of calcium and vitamin D through diet or supplements is recommended.

If the patient has an increased risk of developing osteoporosis (weakening of bones due to loss of bone minerals), the doctor will carefully consider the benefits and risks of treatment with Endovelle, as this medicine has a moderate suppressive effect (suppression) on the body's production of estrogen (another type of female hormone).

Endovelle and other medicines

Always inform your doctor about any medicines or herbal products you are currently taking. You should also inform any doctor, dentist, or pharmacist prescribing another medicine that you are taking Endovelle.

Some medicines may affect the blood levels of Endovelle and reduce its effectiveness or cause side effects. These include:

• medicines used for the following conditions:
  o epilepsy (e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
  o tuberculosis (e.g. rifampicin);
  o HIV infection and hepatitis C (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
  o 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, the patient should avoid drinking grapefruit juice, as it may increase the blood levels of Endovelle. This may increase the risk of side effects.

Laboratory tests

If the patient needs to have a blood test, she should inform the doctor or laboratory staff that she is taking Endovelle, as Endovelle may affect the results of certain tests.

Pregnancy, breastfeeding and effect on fertility

Endovelle must not be used during pregnancy or breastfeeding.

Driving and operating machinery

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

Endovelle contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Children and adolescents

Endovelle should not be used in girls before their first menstrual period.
The use of Endovelle may affect bone strength in adolescents (12 to less than 18 years). Therefore, if the patient is under 18 years of age, the doctor will individually assess the benefits and risks of using Endovelle, taking into account possible risk factors for bone loss (osteoporosis).

3. How to take Endovelle

Endovelle should always be taken as directed by the physician. If in doubt,
contact the physician or pharmacist again. The usual dose for adults is 1 tablet per day.
The following information applies to the medicinal product Endovelle unless otherwise advised by the physician.
The instructions below should be followed; otherwise, the patient may not obtain the full benefits of treatment with Endovelle.

Treatment with Endovelle may be started on any day of the natural cycle.

Adults: One tablet should be taken daily, preferably at the same time each day, with a small amount of liquid if necessary. After finishing a pack, the next pack should be started immediately without a break. Continue taking tablets also during menstrual bleeding days.

Taking more Endovelle than recommended
There have been no reports of serious harmful effects following a single intake of an excessive number of Endovelle tablets. However, if in doubt, contact a physician.

Missing a dose of Endovelle
The effectiveness of Endovelle may be reduced if a tablet is missed.
If one or more tablets have been missed, take one tablet as soon as possible and continue taking one tablet daily at the usual time.

If vomiting occurs within 3–4 hours after taking Endovelle, or if severe diarrhoea develops, 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 tablet. If vomiting or severe diarrhoea occurs within 3–4 hours after taking Endovelle, take another tablet as soon as possible.

Do not take a double dose to make up for a missed tablet.

Stopping treatment with Endovelle
If a patient stops taking Endovelle, previous symptoms of endometriosis may recur.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
These effects are more common during the first few months after starting treatment with
Endovelle and usually subside with continued use. Changes in bleeding patterns may also occur,
such as spotting, irregular bleeding, or absence of menstruation.

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

• weight gain;
• low mood, sleep problems, nervousness, loss of interest in sex, or mood changes;
• headache or migraine;
• nausea, abdominal pain, bloating, distended abdomen, or vomiting;
• acne or hair loss;
• back pain;
• breast discomfort, ovarian cyst, or hot flushes;
• uterine and (or) vaginal bleeding, including spotting;
• weakness or irritability.

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

• anaemia;
• weight loss or increased appetite;
• anxiety, depression, or sudden mood changes;
• autonomic nervous system imbalance (controls unconscious bodily functions, e.g. sweating) or attention disorders;
• dry eye;
• tinnitus;
• non-specific circulatory problems or palpitations;
• low blood pressure;
• shortness of breath;
• diarrhoea, constipation, abdominal discomfort, gastritis, enteritis, gingivitis;
• dry skin, excessive sweating, severe itching of the whole body, development of male-type hair growth (hirsutism), brittle nails, dandruff, skin inflammation, abnormal hair growth, photosensitivity reaction, or pigmentation problems;
• bone pain, muscle cramps, pain and (or) heaviness in arms and hands or legs and feet;
• urinary tract infection;
• vaginal candidiasis, genital dryness, vaginal discharge, pelvic pain, atrophic genital inflammation with discharge (atrophic vulvovaginitis), or breast lump(s);
• fluid retention causing swelling.

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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 .
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Endovelle

Keep in the original packaging 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 pack following the word:
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated after the abbreviation "Lot" on the carton and on the blister pack.
Medicines must 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 is dienogest. Each tablet contains 2 mg of dienogest.
• The other ingredients are: monohydrate lactose, corn starch, povidone (K30), magnesium stearate.

What Endovelle looks like and contents of the pack
Endovelle tablets are round, white, with a diameter of 5 mm.
The tablets are packed in blisters of 28 tablets.
The cardboard box contains:
1 x 28 tablets (calendar pack)
3 x 28 tablets (calendar pack)

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

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

This medicinal product is authorised in 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