Endovelle

Package leaflet: Information for the user

Endovelle 2 mg tablets

dienogest
Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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 side effects
5. How to store Endovelle
   Contents of the pack and other information

1. What Endovelle is and what it is used for

Endovelle is a preparation for the treatment of endometriosis (painful symptoms caused by displacement of the uterine lining tissue). Endovelle contains a hormone, the progestin dienogest.

2. What you should know before taking Endovelle

DO NOT TAKE Endovelle if:

• you have a blood clot in the veins (thromboembolic disorder). This may occur, for example, in a blood vessel of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also “Endovelle and venous blood clots” below;
• you have or have ever had a severe arterial disease, including a cardiovascular disease such as a heart attack or stroke, or heart disease causing reduced blood supply (angina pectoris). See “Endovelle and arterial blood clots and venous thrombosis” below;
• you have diabetes with vascular complications;
• you have or have ever had a severe liver disease (and liver function values 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 ever had a benign or malignant liver tumour;
• you have or have ever had, or suspect you may have, a hormone-dependent malignant tumour, such as breast 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 treatment immediately and consult your doctor.

Warnings and precautions
You must not use hormonal contraceptives in any form (tablet, patch, intrauterine system) while taking Endovelle.
Endovelle is NOT a contraceptive. If you wish to avoid pregnancy, you must use a condom or other non-hormonal contraceptive methods.
In certain situations, you should exercise particular caution while using Endovelle, and your doctor may need to monitor you regularly. Inform your doctor if any of the following conditions apply to you:

• 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;
• a close female relative has had breast cancer;
• you have ever suffered from depression;
• you have high blood pressure, or this develops during treatment with Endovelle;
• you develop liver disease while taking Endovelle. Symptoms may include yellowing of the skin or eyes, or itching all over the body. Inform your doctor also if these symptoms occurred during a previous pregnancy;
• you have diabetes or had gestational diabetes during a previous pregnancy;
• you have ever had chloasma (patchy brown skin pigmentation, especially on the face). In this case, avoid excessive exposure to sunlight or ultraviolet radiation;
• you experience lower abdominal pain while taking Endovelle.

During treatment with Endovelle, the likelihood of pregnancy is reduced because Endovelle may affect ovulation.
If pregnancy occurs while taking Endovelle, there is a slight increase in the risk of ectopic pregnancy (the embryo develops outside the uterus).
Inform your doctor before taking Endovelle if you have previously had an ectopic pregnancy or if you have impaired function of the Fallopian tubes.

Endovelle and severe uterine bleeding
Uterine bleeding, for example in women with a condition characterised by growth of the uterine lining (endometrium) into the muscular layer of the uterus, known as adenomyosis, or benign uterine tumours, also called uterine fibroids (uterine leiomyomas), may worsen with the use of Endovelle. If bleeding is heavy and persistent, this may lead to a decrease in red blood cell levels (anaemia), which may in some cases be severe. If you develop anaemia, discuss with your doctor whether treatment with Endovelle should be discontinued.

Endovelle and changes in bleeding pattern
Most women treated with Endovelle experience changes in their menstrual bleeding pattern (see section 4, “Possible side effects”).

Endovelle and venous blood clots
Some studies suggest there may be a slight, but not statistically significant, increase in the risk of a blood clot in the legs (venous thromboembolism) associated with the use of progestogen-only preparations such as Endovelle. Very rarely, blood clots can cause serious permanent damage or may even be fatal.
The risk of venous blood clots increases:

• with increasing age;
• if you are overweight;
• if you or a close family member has had a blood clot in the leg (thrombosis), lung (pulmonary embolism), or other organ at a young age;
• if you are undergoing surgery, prolonged bed rest, or have had a serious accident. It is important to inform your doctor in advance that you are taking Endovelle, as treatment may need to be suspended. Your doctor will advise you when to restart taking Endovelle. Generally, this can be done approximately 2 weeks after you have regained full mobility.

Endovelle and arterial blood clots
There is limited evidence of an association between the use of progestogen-only preparations such as Endovelle and an increased risk of arterial blood clots, for example in blood vessels of the heart (heart attack) or brain (stroke). In women with hypertension, the risk of stroke may be slightly increased by the use of progestogen-only preparations.
The risk of arterial blood clots increases:

• if you smoke. It is strongly recommended that you stop smoking while taking Endovelle, especially if you are over 35 years of age;
• 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.

Talk to 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 radiate to the left arm;
• sudden shortness of breath;
• sudden cough without apparent 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 sensations or numbness in any part of the body.

Endovelle and cancer
Based on currently available data, it is unclear whether Endovelle increases or decreases the risk of breast cancer. Breast cancer has been observed slightly more frequently in women using hormonal preparations compared to those who do not, but it is not known whether this is due to the treatment. For example, it is possible that women using hormonal preparations are diagnosed with more tumours, and earlier, because they undergo more frequent medical check-ups. The occurrence of breast cancer gradually decreases after stopping hormonal treatment. It is important that you regularly examine your breasts and contact your doctor if you feel any lumps.
In rare cases, benign liver tumours and, even more rarely, malignant liver tumours have been observed in women taking hormones. Contact your doctor if you experience severe abdominal pain.

Endovelle and osteoporosis
Changes in bone mineral density (BMD)
The use of Endovelle may affect bone strength in adolescents (aged 12 to under 18 years). If you are under 18 years of age, your doctor must carefully evaluate the benefits and risks associated with using Endovelle for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).
If you are taking Endovelle, adequate intake of calcium and vitamin D through diet and/or supplements will be beneficial for your bones.
If you have an increased risk of osteoporosis (bone fragility due to mineral loss), your doctor will carefully assess the risks and benefits of treatment with Endovelle, because Endovelle has a moderate suppressive effect on the body's production of oestrogens (another type of female hormone).

Other medicines and Endovelle
Always inform your doctor about any medicines or herbal products you are taking. Also, inform any doctor or dentist who prescribes other medicines (or the pharmacist) that you are taking Endovelle.
Some medicines may affect the levels of Endovelle in the blood and may make it less effective or may cause side effects.
These include:

• medicines used to treat:
  o epilepsy (e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
  o tuberculosis (e.g. rifampicin);
  o HIV virus and Hepatitis C virus infection (known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) or
  o fungal infections (griseofulvin, ketoconazole).
• preparations containing St. John’s Wort (Hypericum perforatum).

Ask your doctor or pharmacist for advice before taking any medicine.

Endovelle with food and drink
During treatment with Endovelle, you should avoid drinking grapefruit juice because it may increase the levels of Endovelle in the blood. This may increase the risk of side effects.

Laboratory tests
If you are having a blood test, inform your doctor or laboratory staff that you are taking Endovelle, as Endovelle may affect the results of certain tests.

Pregnancy and breastfeeding
Do not take Endovelle if you are pregnant or breastfeeding.

Driving and using machines
No effects on the ability to drive or use machines have been observed in users of Endovelle.

Endovelle contains lactose
If your doctor has informed you that you are intolerant to certain sugars, contact your doctor before taking this medicine.

Children and adolescents
Endovelle must not be used in girls before menarche (first menstrual bleeding).
The use of Endovelle may affect bone strength in adolescents (aged 12 to under 18 years). If you are under 18 years of age, your doctor must carefully evaluate the benefits and risks associated with using Endovelle for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).

3. How to take Endovelle

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. For adults, the usual dose is 1 tablet per day.
Unless otherwise prescribed by your doctor, follow the instructions below carefully; otherwise, you may not obtain adequate benefit from treatment with Endovelle.
You may start treatment with Endovelle on any day of your cycle.
Adults: take one tablet daily, preferably at the same time each day, with a sufficient amount of liquid. When you finish a pack, start the next one the following day without interruption.
Continue taking the tablets even during menstrual bleeding.

If you take more Endovelle than you should
There have been no reports of serious harmful effects following the ingestion of an excessive number of Endovelle tablets taken at the same time. However, if you are concerned, contact your doctor.

If you forget to take Endovelle or experience vomiting or diarrhoea
The effectiveness of Endovelle is reduced if you miss a tablet. If you forget to take one or more tablets, take one tablet as soon as you remember, and then continue taking one tablet per day at your usual time.
If you vomit within 3–4 hours after taking Endovelle, or if you have severe diarrhoea, the active substance in the tablet may not be completely absorbed by your body. This situation is similar to that which occurs when you forget to take a tablet.
After vomiting or severe diarrhoea occurring within 3–4 hours of taking Endovelle, you should take another tablet as soon as possible.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Endovelle
If you stop taking Endovelle, symptoms of endometriosis may return.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects most commonly occur during the first months of treatment with Endovelle and usually disappear with continued use. Changes in bleeding patterns may also occur, such as spotting, irregular bleeding, or cessation of menstruation.

Common side effects (affecting 1 to 10 users out of 100)

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

Uncommon side effects (affecting 1 to 10 users out of 1,000)

• anaemia
• weight loss or increased appetite
• anxiety, depression, or mood swings
• autonomic nervous system imbalance (controlling unconscious bodily functions such as sweating) or attention disorders
• dry eyes
• tinnitus
• non-specific circulatory problems or uncommon palpitations
• low blood pressure
• shortness of breath
• diarrhoea, constipation, abdominal discomfort, inflammation of the stomach and intestine (gastrointestinal inflammation), inflammation of the gums (gingivitis)
• dry skin, excessive sweating, intense itching all over the body, appearance of visible hair in typically male areas (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, photosensitivity, or skin pigmentation problems
• bone pain, muscle spasms, pain and/or heaviness in arms, hands, legs, or feet
• urinary tract infection
• vaginal candidiasis, genital dryness, vaginal discharge, pelvic pain, atrophic inflammation of the genitals with discharge (atrophic vulvovaginitis), or breast lump(s)
• fluid retention (oedema)

Additional side effects in adolescents (aged 12 to under 18 years): loss of bone density.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Endovelle

Keep in the original packaging to protect the medicine 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 pack after "EXP". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Endovelle contains
The active substance is dienogest. Each tablet contains 2 mg of dienogest.
The other components are: monohydrate lactose, maize starch, povidone K30, vegetable magnesium stearate.

Description of the appearance of Endovelle and contents of the pack
Endovelle tablets are round, white, with a diameter of 5 mm.
Endovelle is available in blisters containing 28 tablets.
Packages available are:
1 x 28 tablets (calendar pack)
3 x 28 tablets (calendar pack)
6 x 28 tablets (calendar pack)
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Exeltis Italia S.r.l.
Via San Bovio 3
20054 Segrate (MI)
Italy

Manufacturer
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera.
C/ La Vallina s/n
24193 - Villaquilambre, León.
Spain

This medicinal product is authorized in the European Economic Area Member States under the following names:
Endovelle
Sweden, Austria, Czech Republic, Germany, Hungary, Poland, Slovakia, Italy: