VISANNETTE 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

Visannette2mg tablets

dienogest

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Visannette and what is it used for
2. What you need to know before taking Visannette
3. How to take Visannette
4. Possible side effects
   1. Storage of Visannette

1. Contents of the pack and further information

1. What is Visannette and what is it used for

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

2. What you need to know before taking Visannette

Do not take Visannette:

• if you have a blood clot(thromboembolic disorder) in the veins. This can occur, for example, in the blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See later “Visannette and blood clots in the veins”

• if you have or have ever had a severe arterial disease, including cardiovascular disease, such as a heart attack, stroke, or heart diseasethat causes a reduction in blood flow (e.g., angina pectoris). See later “Visannette and blood clots in the arteries”

• if you have diabeteswith blood vessel damage
• if you have or have ever had a severe liver disease(and your liver function values have not returned to normal). Symptoms of liver disease can be 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 tumor, dependent on sex hormones, such as breast cancer or genital organ cancer

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

If any of these disorders occur for the first time while taking Visannette, stop taking it immediately and consult your doctor.

Warnings and precautions

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

Visannette is NOT a contraceptive. If you want to prevent pregnancy, you will need to use condoms or other non-hormonal contraceptive precautions.

In some cases, you will need to be particularly careful while taking Visannette, and it may be necessary for your doctor to examine you periodically. Inform your doctor if you are affected by any of the following conditions:

• if you have ever had a blood clot(venous thromboembolism) or a close relative has had a blood clot at a relatively early age
• if you have a close relative who has had breast cancer
• if you have ever had depression
• if you have high blood pressureor develop high blood pressure while taking Visannette
• if you have liver diseasewhile taking Visannette. Symptoms can include yellowing of the skin or eyes or itching all over the body. Inform your doctor if any of these symptoms have occurred in a previous pregnancy
• if you have diabetesor have had temporary diabetes in a previous pregnancy
• if you have ever had chloasma(brownish discoloration of the skin, especially on the face); if so, avoid excessive exposure to the sun or ultraviolet radiation
• if you experience lower abdominal painwhile taking Visannette.

While taking Visannette, the likelihood of becoming pregnant is reduced because Visannette may affect ovulation.

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

Visannette and severe uterine bleeding

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

Visannette and changes in bleeding pattern

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

Visannette and blood clots in the veins

Some studies indicate that there may be a slight, although not statistically significant, increase in the risk of blood clots in the legs (venous thromboembolism)associated with the use of progestogen-containing preparations like Visannette. Very rarely, blood clots can cause permanent disability and can be life-threatening.

The risk of blood clots in the veinsincreases:

• with age
• if you are overweight
• if you or a close relative have had a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or other organ at a young age.
• if you need to have surgery, have had a serious accident, or need to be immobilized for a prolonged period. It is important that you inform your doctor in advance that you are taking Visannette, as treatment may need to be interrupted. Your doctor will tell you when to start taking Visannette again. This usually happens about two weeks after regaining mobility.

Visannette and blood clots in the arteries

There is limited evidence of a relationship between progestogen-only preparations like Visannette and an increased risk of having a blood clot, for example, in the blood vessels of the heart (heart attack) or brain (stroke). In women with high blood pressure, these preparations may slightly increase the risk of stroke.

The risk of blood clots in the arteriesincreases:

• if you smoke. You are strongly advised to stop smoking while taking Visannette, especially if you are over 35 years old
• if you are overweight
• if a close relative has had a heart attack or stroke at a young age
• if you have high blood pressure.

Consult your doctor before starting Visannette.

Stop taking Visannette and contact your doctor immediately if you notice any of the following signs of a blood clot:

• severe pain and/or swelling in one of your legs
• severe and sudden chest pain that may reach your 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, unusual sensation, or numbness in any part of your body.

Visannette and cancer

Based on currently available data, it is not clear whether Visannette increases or does not increase the risk of breast cancer. It has been observed that breast cancer is slightly more common in women taking hormones compared to those not taking them, but it is unknown whether this is caused by the treatment. For example, it is possible that more tumors are detected and detected earlier in women taking hormones because they are examined more frequently by their doctor. The occurrence of breast tumors decreases after stopping hormonal treatment. It is essential that you regularly check your breastsand consult your doctor if you feel any lump.

In rare cases, in women taking hormones, benign liver tumors and, in even rarer cases, malignant liver tumors have been reported. 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 (12 to less than 18 years). If you are under 18 years old, your doctor will carefully weigh the benefits and risks of using Visannette for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

If you use Visannette, it will be helpful for your bones to have an adequate intake of calcium and vitamin D, both through food and dietary supplements.

If you are at a higher risk of 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 moderate suppression of estrogen production by your body.

Taking Visannette with other medicines

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

Some medicines may influence Visannette levels in the blood and make it less effective or cause unwanted effects.

These include:

• medicines used for the treatment of:

• 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)

• herbal preparations containing St. John's Wort.

Consult your doctor or pharmacist before using any medicine.

Taking Visannette with food and drinks

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

Laboratory tests

If you need a blood test, inform your doctor or laboratory staff that you are taking Visannette, as Visannette can affect the results of some tests.

Pregnancy, breastfeeding, and fertility

Do not take Visannette if you are pregnant or breastfeeding.

Driving and using machines

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

Visannette contains lactose

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

Children and adolescents

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

The use of Visannette may affect bone strength in adolescents (12 to less than 18 years). If you are under 18 years old, your doctor will carefully weigh the benefits and risks of using Visannette for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

3. How to take Visannette

Follow the exact instructions for administration of this medicine as indicated by your doctor. In case of 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 prescribes otherwise. Follow these instructions; otherwise, you will not benefit fully from treatment with Visannette.

You can start treatment with Visannette on any day of your natural cycle.

Adults: take one tablet every day, preferably at the same time, with some liquid if necessary. When you finish a pack, the next one should be started without interruption. Continue taking the tablets even on days of menstrual bleeding.

If you take more Visannette than you should

No serious harmful effects have been reported when taking too many Visannette 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 taken.

If you forget to take Visannette or if you have vomiting or diarrhea

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

If you vomit within 3-4 hours after taking a Visannette tablet or have severe diarrhea, there is a risk that the active ingredients of the tablet may not be fully absorbed by your body. This situation is similar to when you forget a tablet. After vomiting or diarrhea within 3-4 hours after 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 taking Visannette, your original symptoms of endometriosis may return.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The effects are more frequent in the first few months after starting to take 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.

Common (may affect up to 1 in 10 patients)

• weight gain
• depressive mood, sleep disorders, nervousness, loss of interest in sex, or mood swings
• headache or migraine
• nausea, abdominal pain, flatulence, abdominal swelling, or vomiting
• acne or hair loss
• back pain
• breast tenderness, ovarian cyst, or hot flashes
• uterine/vaginal bleeding, including spotting
• weakness or irritability.

Uncommon (may affect up to 1 in 100 patients)

• anemia
• weight loss or increased appetite
• anxiety, depression, or mood changes
• autonomic nervous system imbalance (which controls unconscious body functions, e.g., sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• non-specific circulatory problems or rare palpitations
• low blood pressure
• breathing difficulties
• diarrhea, constipation, abdominal discomfort, gastrointestinal inflammation, gingivitis
• dry skin, excessive sweating, intense itching all over the body, male-type hair growth (hirsutism), nail fragility, dandruff, dermatitis, abnormal hair growth, hypersensitive reaction 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 candida infection, dryness of the genital area, vaginal discharge, pelvic pain, atrophic inflammation of the genitals with discharge (atrophic vulvovaginitis), or a lump or lumps in the breasts
• swelling due to fluid retention.

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

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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 expiration date that appears on the packaging after "CAD:". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packaging and any medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Visannette

The active ingredient 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 package contents

Visannette tablets are white or almost white, round, with flat faces, beveled edges, with a "B" embossed in low relief on one face and a diameter of 7 mm.

They are presented in a blister pack containing 14 tablets.

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

Only some package 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

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

Visanne: Croatia, Denmark, Germany, Finland, France, Hungary, Iceland, Italy, Malta, Netherlands, Norway, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, Czech Republic, and Sweden.

Visannette: Belgium, Cyprus, Estonia, Greece, Latvia, Lithuania, Luxembourg, and Spain.

Date of last revision of this leaflet: May 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/