Dienogest Aristo: detailed information

Package leaflet: Information for the patient

Dienogest Aristo 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 only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What is in this leaflet

What Dienogest Aristo is and what it is used for
What you need to know before taking Dienogest Aristo
How to take Dienogest Aristo
Possible side effects
How to store Dienogest Aristo
Contents of the pack and other information

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

Dienogest Aristo is a medication used for the treatment of endometriosis (painful symptoms caused by displacement of the tissue lining the inside of the uterus). Dienogest Aristo contains a hormone, the progestin dienogest.

2. What you should know before taking Dienogest Aristo

Do not take Dienogest Aristo

if you are allergic to dienogest or to any of the other ingredients of this medicine (listed in section 6).
if you have a blood clot in a vein (venous thromboembolic disorder). This may occur, for example, in a blood vessel of the legs (deep vein thrombosis) or of the lungs (pulmonary embolism). See also “Dienogest Aristo and venous thrombosis” below;
if you have or have ever had a severe arterial disease, including a cardiovascular disease such as a heart attack or stroke, or heart disease causing reduced blood supply (angina pectoris). See “Dienogest Aristo and arterial thrombosis” below;
if you have diabetes with vascular complications;
if 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;
if you have or have ever had a benign or malignant liver tumour;
if you have or have ever had, or suspect you may have, a malignant tumour dependent on sex hormones, such as breast or genital organ cancer;
if you have unexplained vaginal bleeding.

If any of these conditions occurs for the first time while you are taking Dienogest Aristo,
stop treatment immediately and consult your doctor.
Warnings and precautions
You must not use hormonal contraceptives in any form (tablet, patch, intrauterine system)
while taking Dienogest Aristo.
Dienogest Aristo is NOT a contraceptive. If you wish to avoid pregnancy, you must use
a condom or other non-hormonal contraceptive precautions.
You should exercise particular caution while using Dienogest Aristo in certain situations,
and it may be necessary for your doctor to examine you regularly. Inform your doctor if any of the
following conditions apply to you:
If:

you have ever had a blood clot (venous thromboembolism) or if any of your close relatives 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 this condition develops during treatment with Dienogest Aristo;
you develop liver disease while taking Dienogest Aristo. 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 rays;
you experience lower abdominal pain while taking Dienogest Aristo.

During treatment with Dienogest Aristo, your chance of becoming pregnant is reduced, as
Dienogest Aristo may affect ovulation.
If you become pregnant while taking Dienogest Aristo, you have a slightly higher risk of an ectopic pregnancy (the embryo develops outside the uterus). Inform 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 condition characterised by the growth of the uterine lining (endometrium) into the muscular layer of the uterus, called adenomyosis, or benign uterine tumours, also known as uterine fibroids (uterine leiomyomas), may worsen with the use of Dienogest Aristo. If bleeding is heavy and persistent, this may lead to reduced levels of red blood cells (anaemia), which in some cases may be severe.
In case of anaemia, you and your doctor should consider whether to discontinue treatment with Dienogest Aristo.
Dienogest Aristo and changes in bleeding pattern
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 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 progestogen-only preparations such as Dienogest Aristo. Very rarely, blood clots can cause serious permanent damage or may even be fatal.
The risk of developing a venous blood clot increases:

with increasing age;
if you are overweight;
if you or one of your close relatives has had a blood clot in the leg (thrombosis), lung (pulmonary embolism), or other organs 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 Dienogest Aristo, as treatment may need to be suspended. Your doctor will advise you when to restart taking Dienogest Aristo. This is generally possible about two weeks after you have regained full mobility.

Dienogest Aristo and arterial blood clots
There is little evidence of an association between the use of progestogen-only preparations such as Dienogest Aristo 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 developing an arterial blood clot increases:

if you smoke. It is strongly recommended that you stop smoking while taking Dienogest Aristo, especially if you are over 35 years of age;
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 contact 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.

Dienogest Aristo and cancer
Based on currently available data, it is unclear whether Dienogest Aristo 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 in women using hormonal preparations, more tumours are detected, and at an earlier stage, because they undergo more frequent medical check-ups. The occurrence 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 women taking hormones, benign liver tumours have been observed rarely and malignant liver tumours very rarely. 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 bone strength in adolescents (from 12 to under 18 years). If you are under 18 years of age, your doctor must carefully evaluate 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 are taking Dienogest Aristo, adequate intake of calcium and vitamin D through diet and supplements will be beneficial for your bones.
If you have an increased risk of osteoporosis (bone fragility due to loss of minerals), your doctor will carefully evaluate the risks and benefits of treatment with Dienogest Aristo, as the medicine has a moderate suppressive effect on the body's production of oestrogens (another type of female hormone).
Children and adolescents
Dienogest Aristo must not be used in girls before menarche (first menstrual bleeding).
The use of Dienogest Aristo may affect bone strength in adolescents (from 12 to under 18 years). If you are under 18 years of age, your doctor must carefully evaluate 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 inform your doctor of 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 Dienogest Aristo.
Some medicines may affect the levels of Dienogest Aristo in the blood and may reduce its effectiveness or cause side effects.
These include:

medicines used to treat:
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).
preparations containing St. John’s wort (Hypericum perforatum). Ask your doctor or pharmacist for advice before taking any medicine.

Dienogest Aristo with food and drink
During treatment with Dienogest Aristo, you should avoid drinking grapefruit juice because it may increase the levels of Dienogest Aristo in the blood. This may increase the risk of side effects.
Laboratory tests
If you are having a blood test, inform your doctor or laboratory staff that you are taking Dienogest Aristo, as it may affect the results of certain tests.
Pregnancy and breastfeeding
Do not take Dienogest Aristo 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 dienogest.

3. How to take Dienogest Aristo

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet per day.
The following instructions apply to Dienogest Aristo unless otherwise prescribed by your doctor.
Follow these instructions carefully; otherwise, you may not obtain adequate benefit from treatment with
Dienogest Aristo.
You may start treatment with Dienogest Aristo on any day of the cycle.
Adults: take one tablet daily, preferably at the same time each day, with sufficient liquid. When you finish a pack, start the next one immediately without interruption. Continue taking the tablets even during menstrual bleeding days.
There is no experience with treatment using Dienogest Aristo in patients with endometriosis for periods
longer than 15 months.
If you take more Dienogest Aristo than you should
There have been no reports of harmful effects following the ingestion 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 experience vomiting or diarrhoea
The effectiveness of Dienogest Aristo is reduced if you miss a tablet. If you forget to take one or more
tablets, take one tablet as soon as you remember, and then continue taking the tablets at your usual time the next day.
If vomiting occurs within 3–4 hours after taking Dienogest Aristo, or if you have severe diarrhoea, the active substance in the tablet may not be completely absorbed by your body. This situation is similar to that which occurs when you miss a tablet. After vomiting or diarrhoea within 3–4 hours of taking Dienogest Aristo, you must take another tablet as soon as possible.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Dienogest Aristo
If you stop taking Dienogest Aristo, symptoms of endometriosis may return.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. These effects occur more commonly during the first 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 menstruation.

Common: affects up to 1 in 10 users

weight gain
depressed mood, sleep disturbances, nervousness, loss of interest in sex, mood changes
headache or migraine
nausea, abdominal pain, flatulence, 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 up to 1 in 100 users

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 (gastroenteritis), 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 heaviness in the arms, hands, legs or feet
urinary tract infection
vaginal candidiasis, vulvovaginal dryness, vaginal discharge, pelvic pain, atrophic inflammation of the genital organs with itching (atrophy vulvovaginitis), or breast lump(s)
fluid retention with swelling

Additional side effects in adolescents (12 to less than 18 years of age):

loss of bone density

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via 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 special storage temperature.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dienogest Aristo contains

The active substance is dienogest. Each tablet contains 2 mg of dienogest.
The other components are magnesium stearate, maize starch, microcrystalline cellulose, povidone, pregelatinized maize starch.

Description of the appearance of Dienogest Aristo and contents of the pack
Dienogest Aristo tablets are white or almost white, round.
Dienogest Aristo 2 mg tablets are packaged in PVC/PVdC-aluminium white opaque blisters containing 28, 84, 100 and 168 tablets.
It is possible that not all pack sizes are marketed.

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