ENDOVELLE 2 mg Tablet

Зміст інструкції

1. ENDOVELLE 2 mg tablets
   1. What is ENDOVELLE and what is it used for
   2. What you need to know before you take ENDOVELLE
2. ENDOVELLE is not a contraceptive. If you want to avoid pregnancy, you must use the
   1. How to take ENDOVELLE
   2. Possible side effects
   3. How to store ENDOVELLE
   4. Contents of the pack and other information

ENDOVELLE 2 mg tablets

Dienogest
Generic medicine

Read 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 pass it on to others even if they have the same
symptoms as you, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell 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 you take ENDOVELLE
• 3. How to take ENDOVELLE
• 4. Possible side effects
• 5. How to store ENDOVELLE Contents of the pack and other information

1. What is ENDOVELLE and what is it used for

ENDOVELLE is a preparation for the treatment of endometriosis (painful symptoms due to dislocation of the internal uterine lining tissue). ENDOVELLE contains a hormone, the progestin dienogest.

2. What you need to know before you take ENDOVELLE

Do not takeENDOVELLE if

• you have a blood clotin the veins (thromboembolic disorder). This can occur, for example, in a blood vessel in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism). See also “ ENDOVELLE and venous blood clots” below;
• you have or have ever had a severe arterial disease, including cardiovascular disease such as a heart attackor a strokeor a heart conditionthat causes a reduction in blood supply (angina pectoris). See “ ENDOVELLE and arterial and venous arterial thrombosis” below;
• you have diabetes with vascular damage;
• you have or have ever had a severe liver disease(and liver function values have not returned to normal). Symptoms of liver disease may be yellowing of the skin and/or itching all over the body;
• you have or have ever had a benign or malignant liver tumor;
• you have or have ever had, or suspect you have, a malignant tumordependent on sex hormones, such as breast cancer or cancer of the genital organs;
• you experience unexplained vaginal bleeding;
• you are allergic (hypersensitive)to dienogest or any of the other ingredients of this medicine ( see paragraph 6, and the end of paragraph 2). If any of these conditions occur for the first time during the use of ENDOVELLE, stop treatment immediately and consult your doctor

Warnings and precautions
You should not use hormonal contraceptives in any form (tablets, patches, intrauterine system) while taking ENDOVELLE.

ENDOVELLE is not a contraceptive. If you want to avoid pregnancy, you must use the

condom or other non-hormonal contraceptive precautions.
In some situations you must pay particular attention while using ENDOVELLE and it may be
necessary for your doctor to visit you regularly. Tell your doctor if any of the conditions
listed below apply to you:
if:

• - you have ever had a blood clot(venous thromboembolism) or if one of your close relatives has had a blood clot at a relatively young age
• - you have a close relative who has had breast cancer
• - you have ever suffered from depression
• - you have high blood pressureor this condition occurs during the use of ENDOVELLE
• - you develop a liver diseaseduring the use of ENDOVELLE. Symptoms may include yellowing of the skin or eyes or itching all over the body. Also tell your doctor if these symptoms have occurred during a previous pregnancy
• - you have diabetesor had it during a previous pregnancy
• - you have ever had chloasma(patchy brown pigmentation of the skin, especially on the face). If so, avoid excessive exposure to the sun or ultraviolet rays
• - you suffer from lower abdominal painduring the use of ENDOVELLE

During treatment with ENDOVELLE the possibility of pregnancy is reduced as
ENDOVELLE may have an effect on ovulation.
In the event of a pregnancy occurring during the intake of ENDOVELLE there is a slight

increased riskof ectopic pregnancy (the embryo develops outside the uterus).
Tell your doctor before taking ENDOVELLE if you have had an ectopic pregnancy in the
past or if you have a
reduced function of the fallopian tubes.

ENDOVELLE and severe uterine bleeding
Uterine bleeding, for example in women with a disease characterized by the growth of the mucous
membrane of the uterus (endometrium) inside the muscular layer of the uterus, called internal endometriosis, or
benign tumors of the uterus, also called uterine fibroids (uterine leiomyomas), may worsen with
use of ENDOVELLE. If the bleeding is heavy and continuous, this can lead to a
lowering of red blood cell levels (anemia), which may in some cases be severe. In case of anemia,
you should discuss with your doctor whether to discontinue treatment with ENDOVELLE.

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 that there may be a slight, but not statistically significant,
increased risk of a blood clot in the legs(venous thromboembolism) associated
with the use of progestin-based preparations, such as ENDOVELLE. Very rarely, blood clots can cause serious permanent damage or can even be fatal.
The risk of having a venous blood clotincreases:

• - with increasing age;
• - if you are overweight;
• - if you or one of your close relatives has had a blood clot in the leg (thrombosis), in the lung (pulmonary embolism), or in other organs at a young age;
• - if you are to undergo surgery, prolonged bed rest, or if you have had a serious accident. It is important that you inform your doctor in advance that you are taking ENDOVELLE, as it may be necessary to suspend treatment. Your doctor will tell you when to resume taking ENDOVELLE. Generally this will be possible about 2 weeks after you have fully regained your mobility.

ENDOVELLE and arterial blood clots
There is little evidence of an association between the use of progestin-based preparations, such as
ENDOVELLE, and an increased risk of a blood clot, for example in the blood vessels
of the heart (heart attack) or brain (stroke). In hypertensive women, the risk of stroke may be
slightly increased by the use of progestin-based preparations.
The risk of having an arterial blood clotincreases:

• - if you smoke. It is strongly recommended to stop smoking during the use of ENDOVELLE,especially if you are over 35 years old;
• - if you are overweight;
• - if one of your close relatives 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 consult your doctor immediately if you notice any
possible sign of a blood clot, such as:

• - severe pain and/or swelling in a leg;
• - sudden and severe chest pain, which may radiate to the left arm;
• - sudden shortness of breath;
• - sudden cough without an apparent cause;
• - unusual, severe or prolonged headache or worsening of migraine;
• - partial or total 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
From the currently available data, it is unclear whether ENDOVELLE increases or decreases the risk of
breast cancer. Breast cancer has been observed with a slightly higher frequency in women who use hormonal preparations compared to those who do not use them, but it is not known if this is due to the treatment. For example, it is possible that, in women
who use hormonal preparations, more tumors are diagnosed, and earlier, because they
undergo more frequent medical check-ups. The occurrence of breast cancer decreases
gradually after discontinuation of hormonal treatment. It is important that you regularly check
your breasts andyou should contact your doctor if you feel any lump.
In women taking hormones, benign liver tumors and, even more
rarely, malignant liver tumors have been observed. Contact your doctor if you experience particularly severe abdominal pain.

ENDOVELLE and osteoporosis
Changes in bone mineral density (BMD)
The use of ENDOVELLE may affect the robustness of bones in adolescents (aged 12 or under
18 years). If you are under 18 years of age, your doctor will need to carefully assess the benefits and risks
associated with the use of ENDOVELLE for you as a patient, taking into account possible
risk factors for bone mass reduction (osteoporosis).
If you are using ENDOVELLE, adequate intake of calcium and vitamin D will be helpful for your bones
through diet and supplements.
If you have an increased risk of osteoporosis (fragile bones 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 production of estrogens (another type of
female hormone) by the body.

Other medicines and ENDOVELLE
Always tell your doctor about any medicine or herbal product you are taking. Also,
tell any doctor or dentist who prescribes you other medicines (or the pharmacist) that you are
taking ENDOVELLE.
Some medicines can affect the levels of ENDOVELLE in the blood and can make it
less effective or can cause unwanted effects.
These include:

• medicines used for the treatment of: o epilepsy(e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate); o tuberculosis(e.g. rifampicin); o HIV and Hepatitis C virus infection(known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) or fungal infections(griseofulvin, ketoconazole).
• preparations based on St. John's Wort.

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 as it may
increase the levels of ENDOVELLE in the blood. This may increase the risk of side effects.

Laboratory tests
If you are going to have a blood test, tell your doctor or laboratory staff that you are
taking ENDOVELLE, as ENDOVELLE may affect the results of some tests.

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

Driving and using machines
No effects on the ability to drive or operate machinery have been observed in women using
ENDOVELLE.

ENDOVELLEcontains lactose
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking
this medicine.

Children and adolescents
ENDOVELLE should not be used in girls before menarche (first menstrual bleeding).
The use of ENDOVELLE may affect the robustness of bones in adolescents (aged 12 or under
18 years). If you are under 18 years of age, your doctor will need to carefully assess the benefits and risks
associated with the use of ENDOVELLE for you as a patient, taking into account possible
risk factors for bone mass reduction (osteoporosis).

3. How to take ENDOVELLE

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist. For adults, the usual dose is 1 tablet a day.
Unless otherwise prescribed by your doctor, follow these instructions, otherwise you may not
benefit adequately from treatment with ENDOVELLE.
You can start treatment with ENDOVELLE on any day of your cycle.
Adults: take one tablet preferably at the same time each day, with the amount of
liquid necessary. When you finish one pack, you should start the next without interruption.
Continue to take the tablets even during your menstrual period.
There is no experience with ENDOVELLE treatment in patients with endometriosis for periods
longer than 15 months.

If you use more ENDOVELLEthan you should
There are no reports of serious harmful effects following the intake of an excessive number
of ENDOVELLE tablets at the same time. However, if you are worried, contact your
doctor.

If you forget to take ENDOVELLEor suffer from vomiting or diarrhea
The effectiveness of ENDOVELLE is reduced if you skip a tablet. If you forget to take one or more
tablets, take one tablet as soon as you remember and then continue the next day
to take the tablet at the usual time.
In case of vomiting within 3-4 hours of taking ENDOVELLE, or in case of severe diarrhea, it is
possible that the active ingredient of the tablet is not completely absorbed by your
body. The situation is comparable to what happens when you forget to take a
tablet. After vomiting or diarrhea within 3-4 hours of taking ENDOVELLE, you should take
another tablet as soon as possible.
Do not take a double dose to compensate for forgetting the tablet.

If you stop taking ENDOVELLE
If you stop taking ENDOVELLE, the symptoms of endometriosis may recur.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. These effects are most common during the first few 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 the menstrual cycle.

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

• weight increase
• 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 discomfort, ovarian cyst, or hot flashes
• uterine/vaginal bleeding, including spotting
• weakness, irritability

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

• anemia
• weight loss or increased appetite;
• anxiety, depression, or mood swings;
• imbalance of the autonomic nervous system (which controls 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;
• 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, appearance of visible hair in typically male areas (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, hypersensitivity to light, or skin pigmentation problems;
• bone pain, muscle spasms, pain and/or feeling of heaviness in the arms, hands
• or legs and feet;
• - urinary tract infection;
• vaginal candidiasis, dryness of the genital area, vaginal discharge, pelvic pain, atrophic inflammation of the genitals with discharge (atrophic vulvovaginitis), or nodule(s) in the breast;
• - fluid retention edema.

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store ENDOVELLE

Store 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 in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ENDOVELLE contains
The active ingredient is dienogest. Each tablet contains 2 mg of dienogest.
The other ingredients are: lactose monohydrate, corn starch, povidone K30, vegetable magnesium stearate.

Description of the appearance of ENDOVELLE and contents of the pack
ENDOVELLE tablets are round, white in colour with a diameter of 5 mm..
ENDOVELLE is available in blisters containing 28 tablets.
Boxes containing are available
1 x 28 tablets (calendar pack)
3 x 28 tablets (calendar pack)
6 x 28 tablets (calendar pack)

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Exeltis Healthcare S.L.
Av. Miralcampo 7 - Poligono Ind. Miralcampo
19200 Azuqueca de Henares – Guadalajara
Spain

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

• 24008 - Villaquilambre, León. Spain

This medicinal product is authorised in the Member States of the European Economic Area with thefollowing
names:
SwedenAustria, Czech Republic, Germany, Hungary,
Poland, Slovakia, Italy:
Endovelle