Visanne

Package Leaflet: Information for the Patient

Visanne, 2 mg, tablets

Dienogest

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Visanne and what is it used for
• 2. Important information 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 IS VISANNE AND WHAT IS IT USED FOR

Visanne is used to treat endometriosis (painful symptoms caused by abnormally located uterine lining). Visanne contains a hormone, a progestogen called dienogest.

2. IMPORTANT INFORMATION BEFORE TAKING VISANNE

When not to take Visanne

If:

• you have been diagnosed with hypersensitivity (allergy)to dienogest or any other component of this medicine (see section 6 and the end of section 2).
• you have blood clots(thromboembolic disease) in your veins. This can occur, for example, in the blood vessels of your legs (deep vein thrombosis) or lungs (pulmonary embolism). See also “Visanne and blood clots in the veins”below;
• you have or have had severe arterial disease, including cardiovascular disease, such as heart attack, stroke, or heart diseasecausing reduced blood flow (angina pectoris). See also “Visanne and blood clots in the arteries”below;
• you have diabeteswith blood vessel damage;
• you have or have had severe liver disease(and liver function tests have not returned to normal). Symptoms of liver disease may include yellowing of the skin and (or) itching all over the body;
• you have or have had benign or malignant liver tumors;
• you have or have had or suspect malignant hormone-dependent tumors, such as breast cancer or genital organ tumors;
• you have unexplained vaginal bleeding;

If any of these conditions occur for the first time while taking Visanne, stop taking it immediately and consult a doctor.

Warnings and precautions

While taking Visanne, do not use hormonal contraceptives in any form (pill, patch, intrauterine system). Visanne is NOT a contraceptive. To prevent pregnancy, use condoms or other non-hormonal contraceptives. In some situations, you should be particularly careful when taking Visanne. Regular medical check-ups may be necessary. Tell your doctor if any of the following conditions occur or have occurred:

If:

• you have had blood clots(venous thromboembolic disease) or a close family member has had blood clots at a relatively young age;
• a close relative has breast cancer;
• you have had depression;
• you have high blood pressureor develop high blood pressure while taking Visanne;
• you develop liver diseasewhile taking Visanne. Symptoms may include yellowing of the skin, eyes, or itching all over the body. Tell your doctor if you have had such symptoms during a previous pregnancy;
• you have diabetesor have had diabetesduring a previous pregnancy;
• you have had chloasma (melasma)(yellow-brown spots on the skin, especially on the face). In this case, avoid prolonged sun exposure or ultraviolet radiation;
• you experience abdominal painwhile taking Visanne.

While taking Visanne, the chance of becoming pregnant is reduced, as Visanne may affect ovulation. If you become pregnant while taking Visanne, there is a slightly increased riskof ectopic pregnancy (the embryo develops outside the uterus). Before starting Visanne, tell your doctor if you have had an ectopic pregnancy or have tubal dysfunction.

Visanne and heavy vaginal bleeding

Vaginal bleeding, for example in women with a disease in which the uterine lining (endometrium) grows into the uterine muscle layer, called adenomyosis, or benign uterine tumors, also called uterine fibroids, may worsen while taking Visanne. If the bleeding is heavy and prolonged, it may lead to a decrease in red blood cells (anemia), which can be severe in some cases. If you have anemia, discuss with your doctor whether to stop taking Visanne.

Visanne and changes in bleeding pattern

In most women treated with Visanne, changes in menstrual bleeding pattern occur (see section 4 “Possible side effects”).

Visanne and blood clots in the veins

Some studies suggest that there may be a slightly increased risk of blood clots in the legs (venous thromboembolic disease)associated with the use of progestogen-only medicines like Visanne. Very rarely, blood clots can cause severe, permanent disability or even death. The risk of venous blood clotsincreases:

• with age;
• if you are overweight;
• if you have had blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs (also in a close family member);
• if you are planning to have surgery, have had a serious accident, or are immobilized for a long time. It is important to inform your doctor in advance that you are taking Visanne, as it may be necessary to stop treatment. Your doctor will tell you when to restart Visanne. This is usually 2 weeks after recovery.

Visanne and blood clots in the arteries

There is limited evidence of a link between the use of progestogen-only medicines like Visanne and an increased risk of 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 when taking Visanne. The risk of arterial blood clotsincreases:

• in women who smoke - it is recommended to quit smoking when taking Visanne, especially if you are over 35 years old;
• 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.

Consult your doctor before taking Visanne.

Stop taking Visanne and consult your doctor immediately if you notice any of the following symptoms of a blood clot:

• severe pain and (or) swelling in one leg;
• sudden severe chest pain that may also radiate to the left arm;
• sudden shortness of breath;
• sudden unexplained cough;
• any unusual, severe, or prolonged headache or worsening of migraine;
• partial or complete loss of vision or double vision;
• difficulty speaking or inability to speak;
• dizziness or fainting;
• weakness, strange feeling, or numbness in any part of the body.

Visanne and cancer

Currently available 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 not known whether this is caused by the treatment. For example, it may be due to the fact that more tumors are detected and detected earlier in women taking hormones, as they are more frequently examined by a doctor. The frequency of breast tumors decreases gradually after stopping hormonal treatment. Regular breast examinationis important, and you should consult your doctor if you feel a lump. In rare cases, women taking hormones have reported benign liver tumors, and in even rarer cases, malignant liver tumors. Consult your doctor if you experience severe abdominal pain.

Visanne and osteoporosis Bone Mineral Density (BMD) changes

Taking Visanne may affect bone strength in young women (12 to less than 18 years old). Therefore, if you are under 18 years old, your doctor will individually weigh the benefits and risks of taking Visanne, considering possible risk factors for bone loss (osteoporosis). If you are taking Visanne, you should ensure adequate calcium and vitamin D intake from your diet or supplements for bone health. If you have an increased risk of osteoporosis (bone weakness due to loss of bone mineral substance), your doctor will carefully weigh the benefits and risks of treating you with Visanne, as Visanne has a moderate estrogen-suppressing effect.

Visanne and other medicines

Always inform your doctor about any medicines or herbal products you are currently taking. You should also tell any doctor, dentist, or pharmacist prescribing another medicine that you are taking Visanne. Some medicines may affect the level of Visanne in your blood 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 and hepatitis C infections(protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz); fungal infections(griseofulvin, ketoconazole).
• 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 level of Visanne in your blood. This may increase the risk of side effects.

Lab tests

If you need to have a blood test, tell your doctor or laboratory staff that you are taking Visanne, as Visanne may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

Do not take Visanne during pregnancy or breastfeeding.

Driving and using machines

No effect on the ability to drive and use machines has been observed in people taking Visanne.

Visanne contains lactose.

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

Children and adolescents

Visanne should not be used in girls before their first menstrual period. Taking Visanne may affect bone strength in young women (12 to less than 18 years old). Therefore, if you are under 18 years old, your doctor will individually weigh the benefits and risks of taking Visanne, considering possible risk factors for bone loss (osteoporosis).

3. HOW TO TAKE VISANNE

Always take Visanne exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist. The following information is for Visanne, if your doctor has not prescribed otherwise. You must follow the instructions below, otherwise, you will not get the full benefit of Visanne. You can start taking Visanne on any day of your natural cycle. Adults: Take one tablet every day, preferably at the same time, with a small amount of liquid if needed. After finishing one pack, start the next one without a break. Continue taking tablets even during menstrual bleeding days.

If you take more Visanne than you should

There are no reports of serious harmful effects after accidentally taking too many Visanne tablets. However, if you are concerned, consult your doctor.

If you forget to take Visanne or have vomiting or diarrhea

Visanne will be less effective if you miss a tablet. If you miss one or more tablets, take only one tablet as soon as possible and continue with the next tablet at the usual time the next day. If you vomit within 3-4 hours of taking Visanne or have severe diarrhea, there is a risk that the active substance will not be absorbed by your body. These situations are similar to missing a tablet. After vomiting or diarrhea within 3-4 hours of taking Visanne, take the next tablet as soon as possible. Do not take a double dose to make up for a missed tablet.

Stopping Visanne

If you stop taking Visanne, your previous endometriosis symptoms may return.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Visanne can cause side effects, although not everybody gets them. These effects are more common during the first few months after starting Visanne and usually disappear with continued treatment. Changes in bleeding pattern, such as spotting, irregular bleeding, or absence of menstruation, may also occur.

Common (affects 1 to 10 users in 100)

• weight gain
• low mood, sleep problems, nervousness, loss of interest in sex, or mood changes
• headache or migraine
• nausea, abdominal pain, bloating, abdominal distension, or vomiting
• acne or hair loss
• back pain
• breast discomfort, ovarian cyst, or hot flashes
• vaginal or uterine bleeding, including spotting
• weakness or irritability

Uncommon (affects 1 to 10 users in 1,000)

• anemia
• 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 circulation problems or palpitations
• low blood pressure
• shortness of breath
• diarrhea, constipation, abdominal discomfort, gastroenteritis, or gingivitis
• dry skin, excessive sweating, severe itching all over the body, hirsutism, nail fragility, dandruff, skin inflammation, abnormal hair growth, hypersensitivity to light, or pigmentation problems
• bone pain, muscle cramps, pain and (or) feeling of heaviness in the arms and hands or legs and feet
• urinary tract infection
• vaginal thrush, vaginal dryness, discharge, pelvic pain, or breast lump
• fluid retention

Additional side effects in adolescents (12 to less than 18 years old): bone density loss.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VISANNE

Keep the blister pack in the outer carton in order to protect from light. Do not use this medicine after the expiry date which is stated on the carton after “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. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Visanne contains

The active substance is dienogest. Each tablet contains 2 mg of dienogest. The other ingredients are lactose monohydrate, 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 with beveled edges, with the letter “B” embossed on one side, and have a diameter of 7 mm. The tablets are provided in a blister pack containing 14 tablets. The packs contain blisters with 28, 86, or 168 tablets.

Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the Member States of the European Economic Area 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 Marketing Authorization Holder: Bayer Sp. z o.o., Al. Jerozolimskie 158, 02-326 Warsaw, tel.: (22) 572 35 00.

Date of last revision of the leaflet: January 2021