Visanne

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Visanne 2 mg tablets

dienogest
Please read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. (See Section 4)

Contents of this leaflet:

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

1. WHAT VISANNE IS AND WHAT IT IS USED FOR

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING VISANNE

Do not take Visanne if:

• you have a blood clot in your veins (venous thromboembolic disorder). This may occur, for example, in a blood vessel of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also “Visanne and venous thrombosis” below;
• you have or have ever had a serious arterial disease, including a cardiovascular disease such as heart attack or stroke, or a heart disease causing reduced blood supply (angina pectoris). See “Visanne 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 generalized itching;
• you have or have ever had a benign or malignant liver tumor;
• you have or have ever had, or suspect you may have, a malignant hormone-dependent tumor, such as breast or genital organ cancer;
• you experience unexplained vaginal bleeding;
• you are allergic (hypersensitive) to dienogest or to 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 Visanne, 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 Visanne.
Visanne 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 be particularly cautious while using Visanne, and your doctor may need to monitor 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 a close family member has had a blood clot at a relatively young age;
• if a close relative has had breast cancer;
• if you have ever suffered from depression;
• if you have high blood pressure or if this develops during treatment with Visanne;
• if you develop a liver disease while taking Visanne. Symptoms may include yellowing of the skin or eyes or generalized itching. Inform your doctor even if these symptoms occurred during a previous pregnancy;
• if you have diabetes or had gestational diabetes during a previous pregnancy;
• if you have ever had chloasma (patchy brown skin pigmentation, especially on the face). In this case, avoid excessive exposure to sunlight or ultraviolet radiation;
• if you experience lower abdominal pain while taking Visanne.

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

Visanne and severe uterine bleeding

Uterine bleeding, for example in women with a condition characterized by the growth of the uterine lining (endometrium) into the muscular layer of the uterus, called adenomyosis, or benign uterine tumors, also known as uterine fibroids (uterine leiomyomas), may worsen with the use of Visanne. If bleeding is heavy and continuous, it may lead to a decrease in red blood cell levels (anemia), which can in some cases be severe. If you develop anemia, you and your doctor should consider whether to discontinue treatment with Visanne.

Visanne and changes in bleeding pattern

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

Visanne 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 Visanne. 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 family member has had a blood clot in the leg (thrombosis), lung (pulmonary embolism), or other organ at a young age;
• if you are scheduled for surgery, prolonged bed rest, or have had a serious accident. It is important to inform your doctor in advance that you are taking Visanne, as treatment may need to be suspended. Your doctor will advise you when to restart Visanne. This is usually possible about 2 weeks after you have regained full mobility.

Visanne and arterial blood clots

There is limited evidence of an association between the use of progestogen-only preparations such as Visanne and an increased risk of arterial blood clots, for example in 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 progestogen-only preparations.

The risk of arterial blood clot increases:

• if you smoke. It is strongly recommended that you stop smoking while taking Visanne, especially if you are over 35 years of age;
• if you are overweight;
• if a close family member has had a heart attack or stroke at a young age;
• if you have high blood pressure. Talk to your doctor before taking Visanne.
  Stop taking Visanne 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 that 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 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.

Visanne and cancer

Based on currently available data, it is unclear whether Visanne 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, women using hormonal preparations may have more frequent medical check-ups, leading to earlier detection of tumors. 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 detect any lumps.

In rare cases, benign liver tumors and, even more rarely, malignant liver tumors have been observed in women taking hormonal medications. Contact your doctor if you experience particularly severe abdominal pain.

Visanne and osteoporosis

Changes in bone mineral density (BMD)

The use of Visanne may affect bone strength in adolescents (aged 12 to less than 18 years). If you are under 18 years of age, your doctor should carefully evaluate the benefits and risks associated with using Visanne for you as a patient, considering possible risk factors for reduced bone mass (osteoporosis).

While taking Visanne, adequate intake of calcium and vitamin D through diet 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 Visanne, as the medicine has a moderate suppressive effect on the body's production of estrogens (another type of female hormone).

Other medicines and Visanne

Always inform your doctor 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 Visanne.

Some medicines may affect the levels of Visanne in your 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) or tuberculosis (e.g., rifampicin) or HIV and Hepatitis C virus infections (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 (Hypericum perforatum).

Consult your doctor or pharmacist before taking any medicine.

Visanne with food and drink

During treatment with Visanne, you should avoid drinking grapefruit juice because it may increase the levels of Visanne in your blood. This could 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 Visanne, as Visanne may affect the results of certain tests.

Pregnancy, breastfeeding and fertility

Do not take Visanne if you are pregnant or breastfeeding.

Driving and using machines

No effects on the ability to drive or use machines have been observed in women taking Visanne.

Visanne contains lactose

If you have an intolerance to certain sugars, consult your doctor before taking Visanne.

Children and adolescents

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

The use of Visanne may affect bone strength in adolescents (aged 12 to less than 18 years). If you are under 18 years of age, your doctor should carefully evaluate the benefits and risks associated with using Visanne for you as a patient, considering possible risk factors for reduced bone mass (osteoporosis).

3. HOW TO TAKE VISANNE

Always take Visanne exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
For adults, the usual dose is 1 tablet per day.
Unless otherwise prescribed by your doctor, follow these instructions carefully; otherwise, you may not receive adequate benefit from treatment with Visanne.
You may start treatment with Visanne on any day of the cycle.
Adults: take one tablet daily, preferably at the same time each day, with a sufficient amount of liquid.
When you finish a pack, start the next one the following day without interruption. Continue taking the tablets even during menstrual bleeding.

If you take more Visanne than you should
There have been no reports of serious harmful effects following the simultaneous intake of an excessive number of Visanne tablets. However, if you are concerned, contact your doctor.

If you forget to take Visanne or experience vomiting or diarrhoea
The effectiveness of Visanne 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 one tablet at the usual time the next day.
If you vomit within 3–4 hours after taking Visanne, 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 within 3–4 hours of taking Visanne, 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 Visanne
If you stop taking Visanne, symptoms of endometriosis may return.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. These effects occur more commonly during the first months of treatment with Visanne and usually disappear with continued use. Changes in bleeding patterns may also occur, such as spotting, irregular bleeding, or cessation of menstruation.

Common adverse reactions (affecting 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 adverse reactions (affecting 1 to 10 users out of 1,000)

• anaemia;
• weight loss or increased appetite;
• anxiety, depression, or mood swings;
• autonomic nervous system imbalance (controlling 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 disorders;
• bone pain, muscle spasms, pain and/or 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-related swelling.

Additional adverse reactions in adolescents (12 to less than 18 years): loss of bone density.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse reactions directly via

5. HOW TO STORE VISANNE

Keep in the original packaging to protect the medicine from light.
Keep 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.
Do not dispose of medicines 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 Visanne contains
The active substance is dienogest. Each tablet contains 2 mg of dienogest.
The other components are: monohydrate lactose, potato starch, microcrystalline cellulose, povidone
K 25, talc, crospovidone, magnesium stearate.
Description of the appearance of Visanne and contents of the pack
Visanne tablets are white or almost white, round, flat, with bevelled edges, 7 mm in diameter,
imprinted with a "B" on one side.
Visanne is available in blisters containing 14 film-coated tablets.
Boxes containing 28, 84 or 168 tablets are available.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156, Milan (MI), Italy.
Manufacturer:
Bayer Weimar GmbH und Co. KG, Weimar, Germany.
For any information about this medicinal product, please contact the Marketing Authorization Holder.
This medicinal product is approved in the European Economic Area countries with the
following names:
Visanne: Croatia, Denmark, Germany, Finland, France, Hungary, Iceland, Italy, Malta, the
Netherlands, Norway, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, the Czech Republic and Sweden.
Visannette: Belgium, Cyprus, Estonia, Greece, Latvia, Lithuania, Luxembourg and Spain.
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