Visanne

Package leaflet: Information for the patient

Visanne, 2 mg, tablets
Dienogest
Please read all of this leaflet carefully before taking this medicine, because it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Visanne is and what it is used for
2. What you should 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 used in the treatment of endometriosis (painful symptoms caused by abnormally located endometrial tissue). Visanne contains a hormone, a progestagen called dienogest.

2. IMPORTANT INFORMATION BEFORE TAKING VISANNE

When not to take Visanne
Do not take Visanne if:

• you are allergic (hypersensitive) to dienogest or any of the other ingredients of this medicine (see section 6 and the end of section 2).
• you have or have had blood clots (venous thromboembolic disease) in your veins. This may occur, for example, in blood vessels in the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also “Visanne and venous blood clots” below;
• you have or have had severe arterial disease, including cardiovascular disease such as heart attack, stroke, or heart disease causing reduced blood flow (angina pectoris). See also “Visanne and arterial blood clots” below;
• you have diabetes with blood vessel damage;
• you have or have had severe liver disease (and liver function parameters have not returned to normal). Symptoms of liver disease may include yellowing of the skin and/or itching of the whole body;
• you have or have had a benign or malignant liver tumour;
• you have or have had, or are suspected of having, a malignant hormone-dependent tumour, such as breast cancer or genital organ tumour;
• you have unexplained vaginal bleeding.

If any of these conditions occur for the first time while taking Visanne, you must
immediately stop taking the medicine and consult your doctor.

Warnings and precautions
While taking Visanne, you must not use hormonal contraceptives in any form (tablet, patch, vaginal ring).
Visanne is not a contraceptive. To prevent pregnancy, you should use condoms or other non-hormonal contraceptive methods.

In certain situations, special caution is required when using Visanne. Regular medical check-ups may be necessary. Inform your doctor if any of the following conditions are present or have occurred in the past in the patient.

If:

• you or a family member had blood clots (venous thromboembolism) in the past, or a close relative had blood clots at a relatively young age;
• a close relative has breast cancer;
• you have ever had depression;
• you have high blood pressure, or high blood pressure develops during treatment with Visanne;
• you develop liver disease while taking Visanne. Symptoms may include yellowing of the skin, eyes, or itching of the whole body. Inform your doctor if such symptoms occurred during a previous pregnancy;
• you have diabetes or had gestational diabetes during a previous pregnancy;
• you have ever had chloasma (brownish patches on the skin, especially on the face). In such cases, avoid prolonged exposure to sunlight or ultraviolet radiation;
• you experience lower abdominal pain while taking Visanne.

While taking Visanne, the chance of becoming pregnant is reduced because Visanne may affect ovulation.
If pregnancy occurs while taking Visanne, there is a slightly increased risk of ectopic pregnancy (the embryo develops outside the uterus). Before starting Visanne, inform your doctor if you have had an ectopic pregnancy in the past or have any tubal disorders.

Visanne and severe uterine bleeding
Uterine bleeding, for example in women with a condition where the lining of the uterus (endometrium) grows into the muscular layer of the uterus (adenomyosis), or benign uterine tumours, sometimes called uterine fibroids, may worsen during treatment with Visanne. If bleeding is heavy and persists for a long time, it may lead to a decrease in red blood cells (anaemia), which may be severe in some cases. If anaemia occurs, discuss with your doctor whether treatment with Visanne should be discontinued.

Visanne and changes in bleeding pattern
Most women taking Visanne experience changes in menstrual bleeding patterns (see section 4 “Possible side effects”).

Visanne and venous blood clots
Some studies suggest a slight, statistically non-significant increase in the risk of blood clots in the legs (venous thromboembolic disease) associated with the use of progestogen-containing medicines such as Visanne. Very rarely, blood clots may cause serious, permanent disability or even death.

The risk of venous blood clots increases:

• with age;
• if you are overweight;
• if you or a close relative had a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or another organ at a young age;
• if you are scheduled for surgery, have had a serious accident, or will be immobile for a prolonged period. It is important to inform your doctor in advance about taking Visanne, as treatment may need to be interrupted. Your doctor will advise when to restart Visanne. Usually, this is two weeks after recovery.

Visanne and arterial blood clots
There is limited evidence of an association between progestogen-containing medicines such as Visanne 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 high blood pressure, the risk of stroke may be slightly increased with the use of medicines such as Visanne.

The risk of arterial blood clots increases:

• in women who smoke – quitting smoking is strongly advised when taking Visanne, especially in women over 35 years of age;
• if you are overweight;
• if a close relative had a heart attack or stroke at a young age;
• if you have high blood pressure.

Consult your doctor before taking Visanne.
You must stop taking Visanne and contact your doctor immediately if you notice any possible symptoms of blood clots, 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 an obvious cause;
• any unusual, severe, or prolonged headache or worsening of migraine;
• partial or complete blindness or double vision;
• difficulty speaking or inability to speak;
• dizziness or fainting;
• weakness, unusual sensation, or numbness in any part of the body.

Visanne and cancer
Current data do not clearly indicate whether Visanne increases the risk of breast cancer or not.
Breast cancer has been observed slightly more frequently in women taking hormones compared to women not taking hormones, but it is unknown whether this is caused by the treatment. For example, it may be due to the fact that more tumours are detected and detected earlier in women taking hormones because they are examined more frequently by a doctor. The incidence of breast tumours gradually decreases after stopping hormonal treatment. Regular breast examinations are important, and you should contact your doctor if you feel a lump.

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

Visanne and osteoporosis
Changes in bone mineral density (BMD)
The use of Visanne may affect bone strength in adolescents (12 to less than 18 years).
Therefore, if the patient is under 18 years of age, the doctor will individually assess the benefits and risks of using Visanne, taking into account possible risk factors for bone loss (osteopor游戏副本).
If the patient is taking Visanne, adequate intake of calcium and vitamin D through diet or supplements is recommended for bone health.
If the patient has an increased risk of developing osteoporosis (weakening of bones due to loss of bone minerals), the doctor will carefully consider the benefits and risks of treatment with Visanne, as Visanne has a moderate suppressive effect on the body's production of estrogen (another type of female hormone).

Visanne and other medicines
Always inform your doctor about any medicines or herbal products you are currently taking.
You should also inform any doctor, dentist, or pharmacist prescribing another medicine that you are taking Visanne.
Some medicines may affect the blood concentration of Visanne and 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 infection and hepatitis C (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz); fungal infections (griseofulvin, ketoconazole).
• the herbal remedy St John’s wort ( Hypericum perforatum ).

Before taking any medicine, consult your doctor or pharmacist.

Visanne with food and drink
While taking Visanne, you should avoid drinking grapefruit juice, as it may increase the blood concentration of Visanne. 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 Visanne, as Visanne may affect the results of certain tests.

Pregnancy, breastfeeding and fertility
Do not take Visanne during pregnancy or while breastfeeding.

Driving and using machines
No effect on the ability to drive or operate machinery has been observed in people taking Visanne.

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

Children and adolescents
Visanne should not be used in girls before their first menstrual period.
The use of Visanne may affect bone strength in adolescents (12 to less than 18 years).
Therefore, if the patient is under 18 years of age, the doctor will individually assess the benefits and risks of using Visanne, taking into account possible risk factors for bone loss (osteoporosis).

3. HOW TO TAKE VISANNE

Visanne should always be taken exactly as directed by the doctor. If in doubt, consult the doctor or pharmacist again. The usual dose for adults is 1 tablet per day.
The following information applies to Visanne unless otherwise instructed by the doctor. Follow these instructions carefully; otherwise, the patient may not achieve the full benefit of treatment with Visanne.
Treatment with Visanne may be started on any day of the natural cycle.
Adults: Take 1 tablet daily, preferably at the same time each day, with a small amount of liquid if necessary. After finishing a pack, start the next pack immediately without a break. Continue taking tablets also during menstrual bleeding.
Taking more Visanne than prescribed
There have been no reports of serious harmful effects following a single intake of an excessive number of Visanne tablets. However, if in doubt, contact the doctor.
Missing a dose of Visanne or experiencing vomiting or diarrhoea
The effectiveness of Visanne may be reduced if a tablet is missed. If one or more tablets are missed, take one tablet as soon as possible and continue taking one tablet daily at the usual time.
If vomiting occurs within 3–4 hours after taking Visanne, or if severe diarrhoea develops, there is a risk that the active substance may not be fully absorbed. These situations are similar to missing a tablet. After vomiting or diarrhoea occurring within 3–4 hours of taking Visanne, take another tablet as soon as possible.
Do not take a double dose to make up for a missed tablet.
Stopping treatment with Visanne
If the patient stops taking Visanne, previous symptoms of endometriosis may return.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
Such reactions are more common during the first months after starting treatment with Visanne
and usually subside with continued use. Changes in bleeding pattern may also occur,
such as spotting, irregular bleeding, or absence of menstruation.

Common (occurring in 1 to 10 out of 100 patients)

• Weight gain
• Low mood, sleep problems, nervousness, loss of interest in sex, or mood changes
• Headache or migraine
• Nausea, abdominal pain, bloating, distended abdomen, or vomiting
• Acne or hair loss
• Back pain
• Breast discomfort, ovarian cyst, or hot flushes
• Uterine and (or) vaginal bleeding, including spotting
• Weakness or irritability

Uncommon (occurring in 1 to 10 out of 1,000 patients)

• Anaemia
• Weight loss or increased appetite
• Anxiety, depression, or sudden mood changes
• Autonomic nervous system imbalance (controls unconscious body functions, e.g. sweating) or attention disorders
• Dry eye
• Tinnitus
• Non-specific circulatory problems or palpitations
• Low blood pressure
• Shortness of breath
• Diarrhoea, constipation, abdominal discomfort, gastritis, gingivitis
• Dry skin, excessive sweating, severe itching of the whole body, development of male-pattern hair growth (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, photosensitivity reaction, or pigmentation disorders
• Bone pain, muscle cramps, pain and (or) heaviness in arms and hands or legs and feet
• Urinary tract infection
• Vaginal candidiasis, genital dryness, vaginal discharge, pelvic pain, atrophic genital inflammation with discharge (atrophic vaginitis and vulvitis), or breast lump(s)
• Fluid retention causing oedema

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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. HOW TO STORE VISANNE

Keep in the original packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Do not use after" or "EXP".
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Visanne contains
The active substance is dienogest. Each tablet contains 2 mg of dienogest.
Other components are: monohydrate lactose, potato starch, microcrystalline cellulose, povidone
K 25, talc, crospovidone (type A), magnesium stearate.

What Visanne looks like and contents of the pack
Visanne tablets are white or almost white, round, flat on both sides with bevelled edges,
with the letter "B" embossed on one side, and 7 mm in diameter.
The tablets are supplied in blister packs containing 14 tablets.
Cartons contain blisters with 28, 86 or 168 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Manufacturer:
Bayer Weimar GmbH & Co. KG
Döbereinerstrasse 20
99427 Weimar
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Visanne: Austria, Czech Republic, Croatia, Denmark, Finland, France, Netherlands, Iceland, Malta, Germany, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, Hungary, Italy
Visannette: Belgium, Cyprus, Estonia, Greece, Spain, Lithuania, Luxembourg, Latvia

For further information, please contact the local representative of the Marketing Authorisation Holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
Phone: (22) 572 35 00