ENDODIEN 2 mg Tabletki Powlekane

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1. Endodien 2 mg tablets
   1. WHAT IS ENDODIEN AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENDODIEN
   3. HOW TO TAKE ENDODIEN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ENDODIEN
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

Endodien 2 mg tablets

dienogest

Read this leaflet carefully before you start taking this medicine as 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. Do not pass it on to others even if their
• symptoms are the same as yours because 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 Endodien is and what it is used for
• 2. What you need to know before you take Endodien
• 3. How to take Endodien
• 4. Possible side effects
• 5. How to store Endodien
• 6. Contents of the pack and other information

1. WHAT IS ENDODIEN AND WHAT IT IS USED FOR

Endodien is a preparation for the treatment of endometriosis (painful symptoms due to displacement of the tissue lining the inside of the uterus). Endodien contains a hormone, the progestin dienogest.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENDODIEN

Do not take Endodien 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 “ Endodien and venous thrombosis” below;
• you have or have ever had a serious arterial disease, including a diseaseof the cardiovascular system such as a heart attackor a strokeor a heart conditionthat causes a reduction in blood supply (angina pectoris). See “ Endodien and arterial thrombosis” below;
• you have diabeteswith vascular damage;
• you have or have ever had a serious 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 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 section 6, and the end of section 2).

If any of these conditions occur for the first time during the use of Endodien, stop the treatment immediately and consult your doctor.

Warnings and precautions
Talk to your doctor before taking Endodien
You should not use hormonal contraceptives in any form (tablets, patches, intrauterine system) while taking Endodien.
Endodien is NOT a contraceptive. If you want to avoid pregnancy, you must use a condom or other non-hormonal contraceptive precautions.
In some situations you need to be particularly careful while using Endodien and you may need to be visited regularly by your doctor. 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 a close relative 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 Endodien;
• you develop a liver diseaseduring the use of Endodien. Symptoms may include yellowing of the skin or eyes or itching all over the body. Also tell your doctor if these symptoms 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 Endodien.

During treatment with Endodien, the possibility of pregnancy is reduced as Endodien may have an effect on ovulation.
If a pregnancy occurs during the use of Endodien, there is a slight increase in the riskof ectopic pregnancy (the embryo develops outside the uterus). Tell your doctor before taking Endodien if you have had an ectopic pregnancy in the past or if you have reduced function of the fallopian tubes.

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

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

Endodien and venous blood clots
Some studies suggest that 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 progestin-only preparations, such as Endodien. 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 a close relative 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 going to have surgery, a prolonged stay in bed, or if you have had a serious accident. It is important that you tell your doctor in advance that you are taking Endodien, as it may be necessary to stop the treatment. Your doctor will tell you when to start taking Endodien again. Generally this will be possible about 2 weeks after you have fully regained your mobility.

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

• if you smoke. It is strongly recommended that you quit smoking during the use of Endodien, especially if you are over 35 years of age;
• if you are overweight;
• if a close relative has had a heart attack or stroke at a young age;
• if you have high blood pressure.
• Stop taking Endodien and consult your doctor immediately if you notice any possible sign of thrombosis, 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.

Endodien and cancer
From the currently available data, it is not clear whether Endodien 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 whether 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 check your breasts regularlyand contact your doctor if you feel any lumps.
In women taking hormones, benign liver tumors and, even more rarely, malignant liver tumors have been observed in rare cases. Contact your doctor if you experience particularly severe abdominal pain.

Endodien and osteoporosis
Changes in bone mineral density (BMD)
The use of Endodien may affect the strength of bones in adolescents (aged 12 and 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 Endodien for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).
If you use Endodien, adequate intake of calcium and vitamin D through diet and supplements will be helpful for your bones.
If you have an increased risk of osteoporosis (fragile bones due to loss of minerals), your doctor will carefully assess the risks and benefits of treatment with Endodien, because the medicine has a moderate suppressive effect on the production of estrogen (another type of female hormone) by the body.

Children and adolescents
Endodien should not be used in girls before menarche (first menstrual bleeding).

The use of Endodien may affect the strength of bones in adolescents (aged 12 and 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 Endodien for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).

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

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

Endodien and beverages
During treatment with Endodien, you should avoid drinking grapefruit juice as it may increase the levels of Endodien 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 Endodien, as Endodien may affect the results of some tests.

Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding or planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Endodien if you are pregnant or breastfeeding

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

Endodien contains lactose
If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking Endodien.
Endodien contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. HOW TO TAKE ENDODIEN

Always take Endodien exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist. For adults, the usual dose is 1 tablet per day.
The following instructions apply to Endodien unless otherwise prescribed by your doctor. Follow these
instructions, otherwise you will not benefit adequately from treatment with Endodien.
You can start treatment with Endodien 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 in the treatment of patients with endometriosis with Endodien for periods longer than 15
months.

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

If you forget to take Endodien or suffer from vomiting or diarrhea
The effectiveness of Endodien 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 Endodien, 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 that which occurs when you forget to take a tablet.
After vomiting or diarrhea within 3-4 hours of taking Endodien, you should take another tablet as
soon as possible.
Do not take a double dose to make up for a missed tablet.

If you stop taking Endodien
If you stop taking Endodien, the symptoms of endometriosis may recur.
If you have any further questions or doubts, contact your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Common (affecting 1 to 10 users out of 100)

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

Uncommon (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, vulvovaginal dryness, vaginal discharge, pelvic pain, atrophic inflammation of the genitals with discharge (atrophic vulvovaginitis) or nodule or nodules in the breast;
• swelling from fluid retention.

Additional side effects in adolescents:
loss of bone density.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through sospetta-reazione-avversa
Reporting side effects can help to increase information about the medicine.

5. HOW TO STORE ENDODIEN

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP”.
The expiry date refers to the last day of the 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 Endodien contains

• The active ingredient is dienogest. Each tablet contains 2 mg of dienogest.
• The other ingredients are: lactose monohydrate, corn starch, povidone, sodium glycolate starch, magnesium stearate, hypromellose (E464), hydroxypropylcellulose (E463), talc (E553b), hydrogenated cottonseed oil, titanium dioxide (E171)

Description of the appearance of Endodien and contents of the pack
Endodien tablets are white, film-coated, round and biconvex with imprinted "2"
on one side and an approximate diameter and thickness of 6.1 mm and 2.7 mm, respectively.
They are available in blisters containing 14 film-coated tablets.
They are available in boxes containing 28, 84 or 168 tablets.

Marketing Authorisation Holder
Farmitalia S.R.L.
Viale Alcide De Gasperi, 165/B
95127, Catania - Italy

Manufacturer:
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159MünsterGermany

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