Package Leaflet: Information for the User

Visannette2mg tablets

dienogest

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for youonlyand should not be given to others even if they have similar symptomsto yours, as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1.What isVisannetteand what it is used for

2.What you need to know before you start takingVisannette

3.How to takeVisannette

4.Possible side effects

1. Storage ofVisannette

6.Contents of the pack and additional information

Visannetteis apreparationfor the treatment of endometriosis (painful symptoms caused by anaatypicallocalization of uterine lining tissue).Visannettecontains a hormone, the progestogen dienogest.

Do not take Visannette:

• if you have ablood 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 had aserious arterial disease, even a cardiovascular disease, such as aheart attack, astrokeor aheart diseasethat causes a decrease in blood flow (for example, angina pectoris). Seelater“Visannette and blood clots in the arteries”

• if you havediabeteswith vascular damage
• if you have or have had aserious liver disease(and your liver function values have not returned to normal). The symptoms of liver disease can be a yellow color of the skin and/or itching all over the body
• if you have or have had abenign or malignant liver tumor

• if you have or have had, or are suspected of having amalignant tumor, hormone-dependent, such as breast cancer or genital organs cancer

• if you have avaginal bleedingof unknown cause
• if you areallergic (hypersensitive)to dienogest or to any of the other components of this medication (including in section6 and end of section2).

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

Warnings and precautions

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

Visannette is not an oral contraceptive. If you want to prevent pregnancy, you should use condoms or other non-hormonal contraceptive precautions.

In some cases, you should 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 disorders:

• if you have ever had ablood clot(thromboembolism) or if a close relative has had a blood clot at a relatively early age
• if you have a close relative who has hadbreast cancer
• if you have ever haddepression
• if you havehigh blood pressureor if you have hypertension while taking Visannette
• if you have aliver diseasewhile taking Visannette. The symptoms can include a yellow color of the skin or eyes, or itching all over the body. Inform your doctor if any of these symptoms have appeared in a previous pregnancy
• if you havediabetesor have had temporary diabetes in a previous pregnancy
• if you have ever hadmelasma(brownish-yellow patches on the skin, especially on the face); if so, avoid excessive exposure to the sun or ultraviolet rays
• if you havelower abdominal painwhile taking Visannette.

While taking Visannette, the probability of becoming pregnant decreases because Visannette can 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 to take Visannette, if you have already had an ectopic pregnancy or if you have a fallopian tube dysfunction.

Visannette and severe uterine bleeding

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

Visannette and changes in menstrual bleeding pattern

Most women treated with Visannette experience changes in menstrual bleeding pattern (see section4, Possible side effects).

Visannette and blood clots in the veins

Some studies suggest that there may be a slight, but not statistically significant, increase in therisk of blood clots in the legs (thromboembolism), in relation to the use of preparations containing progestogens such as Visannette. Very rarely, blood clots can cause permanent and severe disabilities or even be fatal.

The risk ofblood clots in the veinsincreases:

• with age
• if you are overweight
• if you or a close relative has had a blood clot in the leg (thrombosis), lungs (pulmonary embolism) or in another organ, at a relatively early age.
• if you need surgery, if you have had a serious accident or if you have been immobilized for a prolonged period. It is essential to inform your doctor in advance that you are taking Visannette, as the 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 little evidence of a relationship between progestogen-containing 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 hypertension, these preparations may slightly increase the risk of stroke.

The risk of having ablood clot in the arteriesincreases:

• if you smoke. You are strongly advised to quit smoking while taking Visannette, especially if you are over 35years old
• if you are overweight
• if a close relative has had a heart attack or stroke at a relatively early 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, for example:

• intense and/or swelling in one of your legs
• intense and sudden chest pain, which may reach the left arm
• sudden difficulty breathing
• unexplained cough
• unusual headache, intense or prolonged, or worsening of a 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

From the available data, it is not clear whether Visannette increases or decreases the risk of breast cancer. It has been observed that breast cancer is slightly more frequent in women taking hormones, compared to those not taking them, but it is unknown whether this is caused by the treatment. For example, tumors may be detected more frequently and earlier in women taking hormones because they are examined more frequently by their doctor. The appearance of breast tumors decreases after interrupting hormone treatment.It is essential to regularly check your breastsand consult your doctor if you feel any lump.

In rare cases, in women taking hormones, benign liver tumors have been reported and, in exceptional cases, malignant liver tumors. Contact your doctor if you have unusual stomach pain.

Visannette and osteoporosis

Bone mineral density (BMD) changes

The use of Visannette may affect the bone strength of adolescents (12 to less than 18 years old). If you are under 18 years old, your doctor will carefully weigh the benefits and risks of using Visannette for you as a 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 have a higher risk of developing osteoporosis (bone weakening due to mineral loss), your doctor will carefully weigh the risks and benefits of your treatment with Visannette because Visannette causes a moderate suppression of estrogen production (another type of female hormone) by your body.

Visannette and other medications

Inform your doctor or pharmacist if you are using or have used recently othermedications, including over-the-counter medications, even those acquired without a prescription, including herbal preparations you are taking. Also, inform any other doctor or dentist who prescribes another medication (or pharmacist) that you are taking Visannette.

Some medications may affect the levels of Visannette in the blood and make it less effective, or may cause unwanted effects.

These include:

• medications used to treat:

• epilepsy
• for example, phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate
• tuberculosis
• for example, rifampicin
• infections with HIV
• and hepatitis C virus (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• fungal infections
• griseofulvin, ketoconazole
• herbal preparation ofSt. John's Wort.

Consult your doctor or pharmacist before using any medication.

Visannette and food and drinks

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 unwanted effects.

Lab tests

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

Pregnancy, breastfeeding, and fertility

Do not take Visannette if you are pregnant or breastfeeding.

Driving and operating machinery

No adverse effects have been observed on the ability to drive and operate machinery in Visannette users.

Visannette contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Children and adolescents

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

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

Follow exactly the administration instructions for this medication 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 the 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. After finishing one package, the next one should be started without interruption. Continue taking the tablets on menstrual bleeding days as well.

If you take more Visannette than you should

No serious adverse effects have been reported from taking too many Visannette tablets at once. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Visannette or experience vomiting or diarrhea

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

If you have vomiting within 3-4 hours after taking a Visannette tablet or if you have intense diarrhea, there is a risk that the active principles of the tablet will not be fully absorbed by your body. This situation is similar to what happens 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 compensate for missed doses.

If you interrupt treatment with Visannette Visannette

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Side effects are more common 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 experience spotting, irregular bleeding, or your menstruation may stop completely.

Frequent (may affect up to 1 in 10 patients)

• weight gain
• depressive mood, sleep disorders, nervousness, loss of interest in sex or unstable mood
• 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 or vaginal bleeding, including spotting
• weakness or irritability.

Less frequent (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 bodily functions, for example, sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• unspecified circulatory problems or irregular heartbeats
• low blood pressure
• difficulty breathing
• diarrhea, constipation, abdominal discomfort, gastrointestinal inflammation, gingivitis
• dry skin, excessive sweating, intense itching all over the body, male-type hair growth (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, light hypersensitivity, or skin pigmentation problems
• bone pain, muscle spasms, pain and/or heaviness in the arms and hands, or the legs and feet
• urinary tract infection
• vaginal candidiasis infection, vaginal dryness, vaginal discharge, pelvic pain, atrophic vaginal inflammation, or a lump or multiple lumps in the breasts
• swelling due to fluid retention.

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

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store in the original packaging to protect it from light.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD:”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. Please ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Visannette

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

The other components are lactose monohydrate, potato starch, microcrystalline cellulose, povidone K25, talc, crospovidone, and magnesium stearate.

Appearance of the product and contents of the packaging

Visannette tablets are white or off-white, round, with flat faces, beveled edges, with a “B” embossed on one face and a diameter of7mm.

They are presented in a blister pack containing 14tablets.

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for Manufacturing

Bayer WeimarGmbHandCo.KG

Weimar, Germany

For more information about this medication, please contact the local representative of the marketing authorization holder.

This medication is authorized in the European Economic Area member states with 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.

Last reviewed date of this leaflet: May 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/