Endodien

PACKAGE LEAFLET: INFORMATION FOR THE USER

Endodien 2 mg tablets

Dienogest
Generic 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 taking 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 ENDODIEN IS 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 SHOULD KNOW BEFORE TAKING ENDODIEN

Do not take Endodien if:

• you have a blood clot in your veins (thromboembolic disorder). This may occur, for example, in a blood vessel of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also “Endodien and venous thrombosis” below;
• you have or have ever had a serious arterial disease, including cardiovascular disease such as heart attack or stroke, or heart disease causing reduced blood flow (angina pectoris). See “Endodien and arterial 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 occurs for the first time while you are taking Endodien, stop treatment immediately and consult your doctor.

Warnings and precautions

Talk to your doctor before taking Endodien.

You must not use hormonal contraceptives in any form (tablet, patch, intrauterine system) while taking Endodien.
Endodien 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 Endodien, 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 relative has had a blood clot at a relatively young age;
• a close relative has had breast cancer;
• you have ever suffered from depression;
• you have high blood pressure or develop it while taking Endodien;
• you develop liver disease while taking Endodien. Symptoms may include yellowing of the skin or eyes or itching all over the body. Inform your doctor even if these symptoms occurred during a previous pregnancy;
• you have diabetes or had it during a previous pregnancy;
• you have ever had melasma (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 Endodien.

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

Endodien 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 or uterine leiomyomas), may worsen with the use of Endodien. If bleeding is heavy and persistent, this may lead to reduced red blood cell levels (anaemia), which may in some cases be severe. In case of anaemia, you should discuss with your doctor whether treatment with Endodien should be discontinued.

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 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 Endodien. Very rarely, blood clots can cause serious permanent damage or may even be fatal.

The risk of venous blood clot increases:

• with increasing age;
• if you are overweight;
• if you or a close relative have 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 that you inform your doctor in advance that you are taking Endodien, as treatment may need to be suspended. Your doctor will advise you when to restart Endodien. Generally, this will be possible about 2 weeks after you regain full mobility.

Endodien and arterial blood clots

There is limited evidence of an association between the use of progestogen-only preparations such as Endodien 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 clot increases:

• if you smoke. It is strongly recommended that you stop smoking while taking 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 signs of thrombosis, such as:

• severe pain and/or swelling in one leg;

• sudden, severe chest pain, possibly radiating 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.

Endodien and cancer

Based on currently available data, it is unclear whether Endodien 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 tumours are detected more frequently and at an earlier stage in women using hormonal preparations because they undergo more frequent medical check-ups. The incidence 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.

Endodien and osteoporosis

Changes in bone mineral density (BMD)

The use of Endodien 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 Endodien for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).

If you are taking Endodien, 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 Endodien, because the medicine has a moderate suppressive effect on the body's production of oestrogens (another type of female hormone).

Children and adolescents

Endodien must not be used in girls before menarche (first menstrual bleeding).

The use of Endodien 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 Endodien for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).

Other medicines and Endodien

Always inform your doctor or pharmacist 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 Endodien.

Some medicines may affect the levels of Endodien in the blood and may make it less effective or may cause side effects.

These include:

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

Endodien and beverages

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

Laboratory tests

If you need to have a blood test, inform your doctor or laboratory staff that you are taking Endodien, as Endodien may affect the results of certain tests.

Pregnancy, breastfeeding and fertility

If you are pregnant, breastfeeding, or planning to have a baby, 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 use machines have been observed in users of Endodien.

Endodien contains lactose

If your doctor has informed you 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 instructed by your doctor. 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 carefully; otherwise, you may not achieve the intended benefit from treatment with Endodien.
You may start treatment with Endodien on any day of the menstrual cycle.
Adults: Take one tablet daily, preferably at the same time each day, with sufficient liquid. When you finish one pack, start the next pack immediately without interruption. Continue taking the tablets even during menstrual bleeding.
There is no experience with the use of Endodien for the treatment of patients with endometriosis for periods longer than 15 months.

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

If you forget to take Endodien or experience vomiting or diarrhoea
The effectiveness of Endodien is reduced if you miss a tablet. If you forget to take one or more tablets, take a single tablet as soon as you remember, and then continue taking the tablets at your usual time the next day.
If you vomit within 3–4 hours after taking Endodien, or if you have severe diarrhoea, the active ingredient 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 Endodien, 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 Endodien
If you stop taking Endodien, symptoms of endometriosis may return.
If you have any questions or doubts about how to use this medicine, contact your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. These effects are more commonly observed during the first 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 menstruation.

Common (affects 1 to 10 users out of 100)

• weight gain;
• depressed mood, sleep disturbances, 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 (affects 1 to 10 users out of 1,000)

• anaemia;
• weight loss or increased appetite;
• anxiety, depression, or mood swings;
• autonomic nervous system imbalance (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;
• 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 sensation of heaviness in arms, hands, legs, or feet;
• urinary tract infection;
• vaginal candidiasis, vulvovaginal dryness, vaginal discharge, pelvic pain, atrophic inflammation of the genital organs with discharge (atrophic vulvovaginitis), or breast lump(s);
• fluid retention with swelling.

Additional adverse reactions in adolescents:
loss of bone density.

Reporting of adverse reactions
If you experience any adverse reaction, consult your doctor or pharmacist. This includes adverse reactions not listed in this leaflet. You may also report adverse reactions directly via the national reporting system:
sospetta-reazione-avversa
By reporting adverse reactions, you can help increase information on the safety of this medicine.

5. HOW TO STORE ENDODIEN

This medicinal product does not require any special storage conditions.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month.
Do not dispose of any medicinal product via 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 PACKAGE AND OTHER INFORMATION

What Endodien contains

• The active substance is dienogest. Each tablet contains 2 mg of dienogest.
• The other components are: monohydrate lactose, corn starch, povidone, sodium starch glycolate, 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, marked with "2" on one side, with approximate diameter and thickness of 6.1 mm and 2.7 mm, respectively.
They are available in blisters containing 14 film-coated tablets.
Cartons containing 28, 84 or 168 tablets are also available.

Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome, Italy

Manufacturer:
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster, Germany

This leaflet was last updated on