Package leaflet: Information for the patient

Endofemine, 2 mg, tablets
Dienogestum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Endofemine is and what it is used for
Important information before taking Endofemine
How to take Endofemine
Possible side effects
How to store Endofemine
Contents of the pack and other information

1. What Endofemine is and what it is used for

Endofemine is used in the treatment of endometriosis (painful symptoms caused by abnormally located uterine mucous membrane). Endofemine contains a hormone, a progestagen called dienogest.

2. Important information before taking Endofemine

When NOT to take Endofemine
If:

you have blood clots (venous thromboembolic disease) in your veins. This may occur, for example, in blood vessels in the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also “Endofemine and venous blood clots” below;
you have or have had in the past severe arterial disease, including cardiovascular disease, such as heart attack, stroke, or heart disease causing reduced blood flow (angina pectoris). See also “Endofemine and arterial blood clots” below;
you have diabetes with blood vessel damage;
you have or have had in the past severe liver disease (and liver function parameters have not returned to normal). Symptoms of liver disease may include yellowing of the skin and (or) whole-body itching;
you have or have had in the past, or there is suspicion of benign or malignant liver tumour;
you have or have had in the past, 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 Endofemine,
you must stop taking the medicine immediately and consult your doctor.
Warnings and precautions
While taking Endofemine, you must not use hormonal contraceptives in any form (tablet, patch, vaginal ring).
Endofemine 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 Endofemine. Regular medical examinations may be necessary. You should inform your doctor if any of the following conditions are present or have occurred in the past.

If:
you have had blood clots (venous thromboembolic disease) in the past or a close family member had blood clots 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 Endofemine;
you develop liver disease while taking Endofemine. Symptoms may include yellowing of the skin, eyes, or whole-body itching. 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 (brownish 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 Endofemine.
While taking Endofemine, the chance of becoming pregnant is reduced because Endofemine may affect ovulation.
If pregnancy occurs while taking Endofemine, there is a slightly increased risk of ectopic pregnancy (the embryo develops outside the uterus). Before starting Endofemine, inform your doctor if you have previously had an ectopic pregnancy or have tubal function disorders.
Endofemine and severe uterine bleeding
Uterine bleeding, for example in women with a condition where the endometrial lining grows into the muscular layer of the uterus (adenomyosis), or benign uterine tumours, sometimes called uterine fibroids, may worsen during treatment with Endofemine. 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 Endofemine is necessary.
Endofemine and changes in bleeding pattern
Most women treated with Endofemine experience changes in menstrual bleeding patterns (see section 4, “Possible side effects”).
Endofemine and venous blood clots
Some studies suggest a slight, statistically non-significant increased risk of blood clots in the legs (venous thromboembolic disease) associated with the use of progestogen-containing medicines such as Endofemine. Very rarely, blood clots may cause serious, permanent disability or even lead to death.
The risk of venous blood clot increases:

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

Endofemine and arterial blood clots
There is limited evidence of an association between the use of progestogen-containing medicines such as Endofemine and an increased risk of arterial blood clots, for example in blood vessels of the heart (heart attack) or brain (stroke). In women with high blood pressure, the risk of stroke may be slightly increased by taking medicines such as Endofemine.
The risk of arterial blood clot increases:

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

You should consult your doctor before taking Endofemine.
You must stop taking Endofemine 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 persistent 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.

Endofemine and cancer
Current data do not clearly indicate whether Endofemine increases or does not increase the risk of breast cancer. 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 be due to 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 tumours gradually decreases after stopping hormonal treatment. 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 using hormones, and even more rarely, malignant liver tumours. Contact your doctor if you experience extremely severe abdominal pain.
Endofemine and osteoporosis
Changes in bone mineral density (BMD)
Taking Endofemine 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 Endofemine, taking into account possible risk factors for bone loss (osteoporosis).
If you are taking Endofemine, you should ensure adequate intake of calcium and vitamin D through diet or supplements for bone health.
If you have an increased risk of developing osteoporosis (weakening of bones due to loss of bone minerals), your doctor will carefully consider the benefits and risks of treatment with Endofemine, as Endofemine has a moderate suppressive effect (suppression) on the body's production of oestrogen (another type of female hormone).
Endofemine and other medicines
You should 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 Endofemine.
Some medicines may affect the blood concentration of Endofemine and reduce its effectiveness or cause adverse effects.
These include:

medicines used for the following conditions: epilepsy (e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate); tuberculosis (e.g. 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).
St John’s wort ( Hypericum perforatum ).

Before taking any medicine, consult your doctor or pharmacist.
Endofemine with food and drink
While taking Endofemine, you should avoid drinking grapefruit juice, as it may increase the blood concentration of Endofemine. This may increase the risk of adverse effects.
Laboratory tests
If you need to have a blood test, you should tell your doctor or laboratory staff that you are taking Endofemine, as Endofemine may affect the results of certain tests.
Pregnancy, breastfeeding and fertility
Do not take Endofemine during pregnancy or breastfeeding.
Driving and using machines
No effect on the ability to drive and use machines has been observed in people taking Endofemine.
Endofemine contains lactose
If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.
Children and adolescents
Endofemine should not be used in girls before their first menstrual period.
Taking Endofemine 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 Endofemine, taking into account possible risk factors for bone loss (osteoporosis).

3. How to take Endofemine

Endofemine 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 Endofemine unless otherwise instructed by the physician. The instructions below should be followed; otherwise, the patient may not obtain the full benefits of treatment with Endofemine.
Treatment with Endofemine may be started on any day of the natural cycle.
Adults: One tablet should be taken daily, preferably at the same time each day, if necessary with a small amount of liquid. After finishing a pack, the next pack should be started immediately without a break. Tablets should be continued to be taken also during menstrual bleeding days.

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

Missing a dose of Endofemine or occurrence of vomiting or diarrhea
The effectiveness of Endofemine may be reduced if a tablet is missed.
If one or more tablets are missed, take one tablet as soon as possible and continue taking one tablet at the usual time the next day.
If vomiting occurs within 3–4 hours after taking Endofemine, or if severe diarrhea develops, there is a risk that the active substance of the tablet may not be absorbed by the body. These situations are similar to missing a tablet. After vomiting or diarrhea occurring within 3–4 hours of taking Endofemine, take the next tablet as soon as possible.
Do not take a double dose to make up for a missed tablet.

Stopping treatment with Endofemine
If the patient stops taking Endofemine, previous symptoms of endometriosis may recur.

4. Possible adverse effects

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

Common (affects 1 to 10 users in 100)

weight gain
low mood, sleep disturbances, 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
fatigue or irritability

Uncommon (affects 1 to 10 users in 1,000)

anaemia
weight loss or increased appetite
anxiety, depression, or sudden mood changes
autonomic nervous system imbalance (controls subconscious body functions, e.g. sweating) or attention disturbances
dry eye
tinnitus
non-specific circulatory disorders or palpitations
low blood pressure
shortness of breath
diarrhoea, constipation, abdominal discomfort, gastritis, stomatitis
dry skin, excessive sweating, generalized pruritus, development of male-type hair growth (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, photosensitivity reaction, or pigment disorders
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 inflammation of genital organs with discharge (atrophic vulvovaginitis), or breast lump(s)
fluid retention causing oedema

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 those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 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 Endofemine

Keep the blister in the outer 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 blister and carton after “EXP”.
The expiry date refers to the last day of the stated month.
The batch number is indicated on the blister and carton after “Lot”.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Endofemine contains
The active substance is dienogest. Each tablet contains 2 mg of dienogest.
Other ingredients are: monohydrate lactose, corn starch, povidone (K 30), magnesium stearate of plant origin.

What Endofemine looks like and contents of the pack
Endofemine tablets are round, white tablets with a diameter of 5 mm.
The tablets are supplied in blisters containing 28 tablets.
Cartons contain blisters packed as follows:
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:
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer:
Laboratorios Leon Farma, S.A.
Calle La Vallina s/n, Poligono Industrial Navatejera
24193 Villaquilambre
Spain

For further information about this medicinal product and its names in the Member States of the European Economic Area, please contact the representative of the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 546 64 00