Dienogest Aristo 2 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dienogest Aristo 2 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Dienogest Aristo is and what it is used for
2. What you need to know before taking 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 Dienogest Aristo is and what it is used for

Dienogest Aristo is a medication used for the treatment of endometriosis (painful symptoms caused by abnormal growth of uterine lining tissue). This medicine contains a hormone, the progestogen dienogest.

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

Do not take dienogest:

• if you are allergic (hypersensitive) to dienogest or to any of the other ingredients of this medicine (listed in section 6);
• if you have a blood clot (thromboembolic disorder) in the veins. This may occur, for example, in the blood vessels of the legs (deep vein thrombosis) or the lungs (pulmonary embolism). See below “Dienogest and blood clots in the veins”;
• if you have or have ever had a serious arterial disease, including cardiovascular disease, such as a heart attack, stroke, or heart disease causing reduced blood flow (e.g. angina pectoris). See below “Dienogest and blood clots in the arteries”;
• if you have diabetes with blood vessel damage;
• if you have or have ever had a serious liver disease (and your 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 are suspected of having, a malignant hormone-dependent tumour, such as breast cancer or genital organ cancer;
• if you have vaginal bleeding of unknown cause;

If any of these conditions occurs for the first time while you are taking dienogest, stop taking it immediately and consult your doctor.

Warnings and precautions

You must not take oral contraceptives in any form (tablet, patch, intrauterine system) while taking dienogest.

Dienogest is NOT a contraceptive. If you wish to prevent pregnancy, you must use condoms or other non-hormonal contraceptive precautions.

In some cases, you should take special care while taking dienogest, and your doctor may need to examine you periodically. Inform your doctor if any of the following conditions apply to you:

• if you have ever had a blood clot (venous thromboembolism) or if a close family member has had a blood clot at a relatively young age;
• if a close family member has had breast cancer;
• if you have ever had depression;
• if you have high blood pressure or develop hypertension while taking dienogest;
• if you develop a liver disease while taking dienogest. Symptoms may include yellowing of the skin or eyes, or itching all over the body. Inform your doctor if any of these symptoms occurred during a previous pregnancy;
• if you have diabetes or had gestational diabetes in a previous pregnancy;
• if you have ever had chloasma (golden-brown skin patches, especially on the face); if so, avoid excessive exposure to sunlight or ultraviolet rays;
• if you experience lower abdominal pain while taking dienogest.

While taking dienogest, your chance of becoming pregnant is reduced because dienogest may affect ovulation.

If you become pregnant while taking dienogest, you have a slightly higher risk of an ectopic pregnancy (the embryo develops outside the uterus). Inform your doctor before starting dienogest if you have previously had an ectopic pregnancy or if you have a fallopian tube dysfunction.

Dienogest and severe uterine bleeding

Uterine bleeding may worsen with the use of dienogest, for example in women who have a condition in which the uterine lining (endometrium) grows into the muscular layer of the uterus, known as uterine adenomyosis or benign uterine tumours, sometimes called uterine fibroids (uterine leiomyomas). If bleeding is heavy and prolonged, this may lead to a reduced number of red blood cells (anaemia), which in some cases may be severe. If you have anaemia, consult your doctor about whether you should stop taking dienogest.

Dienogest and changes in bleeding pattern

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

Dienogest and blood clots in the veins

Some studies suggest a slight, although not statistically significant, increased risk of blood clots in the legs (venous thromboembolism) associated with the use of preparations containing progestogens such as dienogest. Very rarely, blood clots can cause serious and permanent disabilities or may even be fatal.

The risk of venous blood clots increases:

• with age;
• if you are overweight;
• if you or one of your close family members has had a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or another organ at a young age;
• if you require surgery, have suffered a serious accident, or need to be immobilized for a prolonged period. It is important to inform your doctor in advance that you are taking dienogest, as treatment may need to be interrupted. Your doctor will tell you when to restart dienogest. This is usually about two weeks after regaining mobility.

Dienogest and blood clots in the arteries

There is limited evidence of a link between progestogen-containing preparations such as dienogest and an increased risk of arterial blood clots, for example, in the blood vessels of the heart (heart attack) or brain (stroke). In women with hypertension, these preparations may slightly increase the risk of stroke.

The risk of arterial blood clots increases:

• if you smoke. You are strongly advised to stop smoking while taking Dienogest, especially if you are over 35 years of age;
• if you are overweight;
• if one of your close family members has had a heart attack or stroke at a young age;
• if you have high blood pressure.

Consult your doctor before starting to take Dienogest.

Dienogest and cancer

Based on currently available data, it is not clear whether dienogest increases the risk of breast cancer or not. Breast cancer has been observed to be slightly more frequent in women who take hormones compared to those who do not, but it is unknown whether this is caused by the treatment. For example, more tumors may be detected earlier and more frequently in women taking hormones because they are examined more regularly by a physician. The occurrence of breast tumors decreases after discontinuation of hormonal treatment. It is important that you regularly examine your breasts and consult your doctor if you feel any lumps.

In rare cases, benign liver tumors have been reported in women taking hormones, and even more rarely, malignant liver tumors. Contact your doctor if you experience unusually severe stomach pain.

Dienogest and osteoporosis

Changes in bone mineral density (BMD)

The use of dienogest may affect bone strength in adolescents (aged 12 to less than 18 years). If you are under 18 years of age, your doctor will therefore carefully evaluate the benefits and risks of using dienogest for you on an individual basis, taking into account possible risk factors for bone loss (osteoporosis).

If you are using dienogest, it will be helpful for your bones to have an adequate intake of calcium and vitamin D, both through diet and dietary supplements.

If you have an increased risk of developing osteoporosis (weakening of the bones due to loss of bone minerals), your doctor will carefully weigh the risks and benefits of your treatment with dienogest, because dienogest causes a moderate suppression of estrogen production (another type of female hormone) by your body.

Children and adolescents

Dienogest is not indicated in girls before menarche (first menstrual period).

The use of dienogest may affect bone strength in adolescents (aged 12 to less than 18 years). If you are under 18 years of age, your doctor will therefore carefully evaluate the benefits and risks of using dienogest for you on an individual basis, taking into account possible risk factors for bone loss (osteoporosis).

Use of dienogest with other medicines

Some medicines may influence the levels of dienogest in the blood and make it less effective, or may cause unwanted 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 (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)

• fungal infections (griseofulvin, ketoconazole)

• Herbal preparations containing St. John's wort:

Consult your doctor or pharmacist before using any medicine.

Taking dienogest with food and drink

During treatment with dienogest, you should avoid drinking grapefruit juice, as it may increase the levels of dienogest in your blood. This may increase the risk of experiencing adverse effects.

Laboratory tests

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

Pregnancy, breastfeeding, and fertility

Do not take dienogest if you are pregnant or during 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

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day.

The following statements apply to dienogest unless your doctor has prescribed otherwise. Follow these instructions; otherwise, you may not fully benefit from treatment with dienogest.

You may start treatment with dienogest on any day of your natural cycle.

Adults: take one tablet every day, preferably at the same time each day, with some liquid if necessary. When you have finished one pack, start the next pack without interruption. Continue taking the tablets also during menstrual bleeding.

If you take more dienogest than you should

No serious harmful effects have been reported from taking too many dienogest tablets at once. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take dienogest or if you experience vomiting or diarrhoea

Dienogest will be less effective if you miss a tablet. If you forget one or more tablets, take a single tablet as soon as you remember; then continue the following day, taking the tablet at your usual time.

If you vomit within 3–4 hours after taking a dienogest tablet or if you have severe diarrhoea, there is a risk that the active substances in the tablet may not be completely absorbed by your body. This situation is similar to forgetting a tablet. After vomiting or diarrhoea occurring within 3–4 hours of taking dienogest, you should take another tablet as soon as possible.

Do not take a double dose to make up for missed doses.

If you stop taking dienogest

If you stop treatment with dienogest, your original symptoms of endometriosis may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. These effects are more common during the first few months after starting dienogest and usually disappear with continued use. You may also experience changes in your bleeding pattern; for example, you may have spotting, irregular bleeding, or your menstruation may cease completely.

Frequent (affects between 1 and 10 out of every 100 users)

• weight gain
• depressed mood, sleep disorders, nervousness, loss of interest in sex, or mood swings
• 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 or irritability

Uncommon (affects between 1 and 10 out of every 1,000 users)

• anaemia
• weight loss or increased appetite
• anxiety, depression, or mood changes
• autonomic nervous system imbalance (which controls unconscious bodily functions, e.g. sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• non-specific circulatory problems or unusual palpitations
• low blood pressure
• difficulty breathing
• diarrhoea, constipation, abdominal discomfort, inflammation of the stomach and intestines (gastrointestinal inflammation), inflammation of the gums (gingivitis)
• dry skin, excessive sweating, severe itching all over the body, growth of male-pattern hair (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, hypersensitivity to light, or skin pigmentation problems
• bone pain, muscle spasms, 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 the genitals with discharge (atrophic vulvovaginitis), or lump(s) in the breasts
• swelling due to fluid retention

Additional adverse effects in adolescents (aged 12 to under 18 years):

• loss of bone density

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dienogest Aristo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after “EXP.”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Dienogest Aristo

• The active substance is dienogest. Each tablet contains 2 mg of dienogest.

• The other components are magnesium stearate, maize starch, microcrystalline cellulose, povidone K25 and pregelatinized maize starch.

Appearance of the product and contents of the pack

Dienogest Aristo tablets are white or almost white, round tablets.

They are supplied in an opaque white PVC/PVdC-aluminum blister pack.

The cartons contain blister packs with 28, 84, 100 or 168 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria Aridya 2 mg Tabletten

Czech Republic Aridya 2 mg tablety

Germany Dienogest Aristo 2 mg Tabletten

Italy Dienogest Aristo 2 mg compresse

Poland Dienogest Aristo 2 mg tabletki

Spain Dienogest Aristo 2 mg comprimidos EFG

Date of the most recent review of this leaflet: September 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/