Visanne 2 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Visannette 2 mg tablets

dienogest

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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.

Contents of the leaflet

1. What Visannette is and what it is used for

2. What you need to know before taking Visannette

3. How to take Visannette

4. Possible side effects

   1. How to store Visannette

5. Contents of the pack and other information

1. What Visannette is and what it is used for

Visannette is a preparation used for the treatment of endometriosis (painful symptoms caused by atypical localization of uterine lining tissue). Visannette contains a hormone, the progestogen dienogest.

2. What you need to know before starting to take Visannette

Do not take Visannette:

• if you have a blood clot (thromboembolic disorder) in the veins. This may occur, for example, in blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See further below “Visannette 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 further below “Visannette 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 tumor

• if you have or have ever had, or are suspected of having a malignant, sex hormone-dependent tumor, such as breast cancer or genital organ cancer

• if you have vaginal bleeding of unknown cause

• if you are allergic (hypersensitive) to dienogest or to any of the other components of this medicine (listed in section 6 and at the end of section 2).

If any of these conditions develops for the first time while you are taking Visannette, 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 Visannette.

Visannette 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 Visannette, 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 relative has had a blood clot at a relatively young age
• if a close relative has had breast cancer
• if you have ever had depression
• if you have high blood pressure or develop hypertension while taking Visannette
• if you develop liver disease while taking Visannette. 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 radiation
• if you experience lower abdominal pain while taking Visannette.

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

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

Visannette and severe uterine bleeding

Uterine bleeding may worsen with the use of Visannette, 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 tumors, sometimes called uterine fibroids (uterine leiomyomas). If bleeding is heavy and prolonged, this may lead to a decrease in red blood cells (anemia), which in some cases may be severe. In case of anemia, consult your doctor about whether you should stop taking Visannette.

Visannette and changes in bleeding pattern

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

Visannette and blood clots in the veins

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

The risk of blood clots in the veins increases:

• with age
• if you are overweight
• if you or one of your closest relatives 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 Visannette, as treatment may need to be interrupted. Your doctor will advise you when to restart Visannette. This is usually about two weeks after regaining mobility.

Visannette and blood clots in the arteries

There is limited evidence of an association between progestogen-containing preparations such as Visannette 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, 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 Visannette, especially if you are over 35 years of age
• if you are overweight
• if one of your closest relatives has had a heart attack or stroke at a young age
• if you have high blood pressure.

Consult your doctor before starting to take Visannette.

Stop taking Visannette and contact your doctor immediately if you notice possible signs of a blood clot, such as:

• severe pain and/or swelling in one of your legs
• sudden, severe chest pain, possibly radiating to the left arm
• sudden difficulty breathing
• sudden cough without an obvious 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, abnormal sensation, or numbness in any part of the body.

Visannette and cancer

Based on currently available data, it is unclear whether Visannette increases or decreases the risk of breast cancer. Breast cancer has been observed to be slightly more frequent in women taking 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 hormone users because they are examined more often by doctors. The incidence of breast tumors decreases after stopping hormone 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 in even rarer cases, malignant liver tumors. Contact your doctor if you experience unusually severe stomach pain.

Visannette and osteoporosis

Changes in bone mineral density (BMD)

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

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

If you are at higher risk of developing osteoporosis (weakening of bones due to loss of bone minerals), your doctor will carefully weigh the risks and benefits of your treatment with Visannette, because Visannette causes a moderate suppression of your body’s production of estrogen (another type of female hormone).

Taking Visannette with other medicines

Always inform your doctor or pharmacist if you are using or have recently used any other medicines, even those obtained without a prescription, including herbal preparations you are taking. Likewise, inform any other doctor or dentist who prescribes you another medicine (or the pharmacist) that you are taking Visannette.

Some medicines may influence the levels of Visannette 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 (so-called 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 Visannette with food and drink

During treatment with Visannette, you should avoid drinking grapefruit juice, as it may increase the levels of Visannette 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 Visannette, because Visannette may affect the results of certain tests.

Pregnancy, breastfeeding and fertility

Do not take Visannette if you are pregnant or during the breastfeeding period.

Driving and using machines

No effects on the ability to drive and use machines have been observed in users of Visannette.

Visannette contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Children and adolescents

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

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

3. How to take Visannette

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. The usual dose for adults is one tablet per day.

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

You may start treatment with Visannette 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 one the following day without interruption. Continue taking the tablets even during menstrual bleeding.

If you take more Visannette than you should

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

If you forget to take Visannette or if you vomit or have diarrhoea

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

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

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

If you stop taking Visannette

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. These effects are more common during the first few months after starting Visannette 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 stop completely.

Frequent (may affect up to 1 in 10 people)

• 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 (may affect up to 1 in 100 people)

• anaemia
• weight loss or increased appetite
• anxiety, depression, or mood changes
• autonomic nervous system imbalance (which controls unconscious bodily functions, for example, sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• non-specific circulatory problems or infrequent palpitations
• low blood pressure
• difficulty breathing
• diarrhoea, constipation, abdominal discomfort, inflammation of the stomach and intestines (gastroenteritis), 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 the arms and hands, or legs and feet
• urinary tract infection
• vaginal candidiasis, genital dryness, vaginal discharge, pelvic pain, atrophic inflammation of the genital organs with discharge (atrophic vulvovaginitis), or lump(s) in the breast
• swelling due to fluid retention

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

Reporting of adverse effects:

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

5. Storage of Visannette

Keep in the original packaging to protect from light.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Visannette

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

The other components are lactose monohydrate, potato starch, microcrystalline cellulose, povidone K 25, talc, crospovidone and magnesium stearate.

Appearance of the product and contents of the pack

Visannette tablets are white or almost white, round, flat-faced, with bevelled edges, embossed with a "B" in relief on one side and a diameter of 7 mm.

They are presented in a blister pack containing 14 tablets.

Cartons contain blister packs with 28, 84 or 168 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Bayer Weimar GmbH und Co. KG

Weimar, Germany

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder.

This medicinal product is authorized in the European Economic Area member states under 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.

Date of latest review of this leaflet: May 2023

Detailed 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/