DIENOGEST 2 mg Coated Tablet

Содержание инструкции

1. Dienogest Aristo 2 mg tablets
   1. What is Dienogest Aristo and what is it used for
   2. What you need to know before you take Dienogest Aristo
   3. How to take Dienogest Aristo
   4. Possible side effects
   5. How to store Dienogest Aristo
   6. Contents of the pack and other information

Dienogest Aristo 2 mg tablets

Dienogest

Generic medicine

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

1. What is Dienogest Aristo and what is it used for

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

2. What you need to know before you take Dienogest Aristo

Do not take Dienogest Aristo

• if you are allergicto dienogest or any of the other ingredients of this medicine (listed in section 6).
• 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 “Dienogest Aristo and venous thrombosis” below;
• if you have or have ever had a serious arterial disease, including cardiovascular disease such as a heart attackor a strokeor heart diseasethat causes a reduction in blood supply (angina pectoris). See “Dienogest Aristo and arterial thrombosis” below;
• if you have diabeteswith vascular damage;
• if you have or have ever had a serious 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;
• if you have or have ever had a benign or malignant liver tumor;
• if 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;
• if you have unexplained vaginal bleeding.

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

Warnings and precautions
You should not use hormonal contraceptives in any form (pill, patch, intrauterine system) while taking Dienogest Aristo.
Dienogest Aristo 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 Dienogest Aristo 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 Dienogest Aristo;
• you develop a liver diseaseduring the use of Dienogest Aristo. Symptoms may include yellowing of the skin or eyes or itching all over the body. Tell your doctor even 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), in which case, avoid excessive exposure to the sun or ultraviolet rays;
• you suffer from lower abdominal painduring the use of Dienogest Aristo.

During treatment with Dienogest Aristo, your chance of becoming pregnant is reduced as Dienogest Aristo may affect ovulation.
If pregnancy occurs during the taking of Dienogest Aristo, you have a slightly higher risk of having an ectopic pregnancy (the embryo develops outside the uterus). Tell your doctor before taking Dienogest Aristo if you have had an ectopic pregnancy in the past or if you have reduced function of the fallopian tubes.

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

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

Dienogest Aristo 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-only preparations, such as Dienogest Aristo. 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 going to have surgery, a prolonged stay in bed, or if you have had a serious accident. It is important that you inform your doctor in advance that you are taking Dienogest Aristo, as it may be necessary to stop treatment. Your doctor will tell you when to restart taking Dienogest Aristo. Generally this will be possible about two weeks after you have fully regained your mobility.

Dienogest Aristo and arterial blood clots
There is little evidence of an association between the use of progestin-only preparations, such as Dienogest Aristo, and an increased risk of a blood clot, for example in the 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 the use of progestin-only preparations.
The risk of having an arterial blood clotincreases:

• if you smoke. It is strongly recommended that you stop smoking while using Dienogest Aristo, 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 Dienogest Aristo.

Stop taking Dienogest Aristo 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 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.

Dienogest Aristo and cancer
From the data currently available, it is not clear whether Dienogest Aristo 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 you should contact your doctor if you feel any lump.
In women taking hormones, rare cases of benign liver tumors and, even more rarely, malignant liver tumors have been observed. Contact your doctor if you experience particularly severe abdominal pain.

Dienogest Aristo and osteoporosis
Changes in bone mineral density (BMD)
The use of Dienogest Aristo may affect the robustness of bones in adolescents (12 years 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 Dienogest Aristo for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).
If you use Dienogest Aristo, adequate intake of calcium and vitamin D through food 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 Dienogest Aristo, because the medicine has a moderate suppressive effect on the production of estrogens (another type of female hormone) by the body.

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

The use of Dienogest Aristo may affect the robustness of bones in adolescents (12 years 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 Dienogest Aristo for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).

Other medicines and Dienogest Aristo
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 Dienogest Aristo.
Some medicines can affect the levels of Dienogest Aristo 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 infections(known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• other fungal infections(griseofulvin, ketoconazole).
• St John's Wort preparations. Ask your doctor or pharmacist before taking any medicine.

Dienogest Aristo with food and drink
During treatment with Dienogest Aristo, you should avoid drinking grapefruit juice as it may increase the levels of Dienogest Aristo 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 Dienogest Aristo, as Dienogest Aristo may affect the results of some tests.

Pregnancy and breastfeeding
Do not take Dienogest Aristo 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 dienogest.

3. How to take Dienogest Aristo

Take this medicine always exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is 1 tablet daily.
The following instructions apply to Dienogest Aristo unless otherwise prescribed by your doctor.
Follow these instructions, otherwise you may not benefit adequately from treatment with
Dienogest Aristo.
You can start treatment with Dienogest Aristo 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, start the next one without interruption. Continue to
take the tablets even during your menstrual period.
There is no experience in the treatment with Dienogest Aristo of patients with endometriosis for periods
longer than 15 months.

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

If you forget to take Dienogest Aristo or suffer from vomiting or diarrhoea
The effectiveness of Dienogest Aristo 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 Dienogest Aristo, or in case of severe diarrhoea, 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 diarrhoea within 3-4 hours of taking Dienogest Aristo, 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 Dienogest Aristo
If you stop taking Dienogest Aristo, the symptoms of endometriosis may recur.

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
Dienogest Aristo and usually disappear with continued use. Changes in bleeding patterns may also occur,
such as spotting, irregular bleeding or cessation of the cycle.

Common: may affect up to 1 in 10 users

• weight increase
• depressed mood, sleep disorders, nervousness, loss of interest in sex, 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 flushes
• uterine/vaginal bleeding, including spotting
• weakness, irritability

Uncommon: may affect up to 1 in 100 users

• 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 eye
• 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 peritonitis (atrophic vulvovaginitis) or nodule or nodules in the breast
• fluid retention swelling

Additional side effects in adolescents (12 years and under 18 years):

• loss of bone density

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at
http://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 Dienogest Aristo

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date which is reported on the blister and on the box after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater. Ask your pharmacist how to eliminate the medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dienogest Aristo contains

• The active ingredient is dienogest. Each tablet contains 2 mg of dienogest.
• The other ingredients are magnesium stearate, corn starch, microcrystalline cellulose, povidone, pregelatinized corn starch.

Description of the appearance of Dienogest Aristo and contents of the pack
Dienogest Aristo tablets are white or off-white in colour, and round.
Dienogest Aristo 2 mg tablets are packaged in blister packs made of white and opaque PVC/PVdC-aluminium
containing 28, 84, 100 and 168 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany