VISANNE 2 mg Coated Tablet

Зміст інструкції

1. Visanne 2 mg tablets
   1. WHAT IS VISANNE AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VISANNE
   3. HOW TO TAKE VISANNE
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE VISANNE
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Visanne 2 mg tablets

dienogest

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. (See Section 4)

Contents of this leaflet:

• 1. What Visanne is and what it is used for
• 2. What you need to know before you take 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 a preparation for the treatment of endometriosis (painful symptoms due to displacement of the internal lining tissue of the uterus). Visanne contains a hormone, the progestin dienogest.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VISANNE

Do not take Visanne if:

• you have a blood clotin the veins (thromboembolic disorder). This can occur, for example, in a blood vessel in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism). See also “ Visanne and venous thrombosis” below;
• you have or have ever had a serious arterial disease, including a diseaseof the cardiovascular system such as a heart attackor a strokeor a heart conditionthat causes a reduction in blood supply (angina pectoris). See “ Visanne and arterial thrombosis” below;
• you have diabeteswith vascular damage;
• you have or have ever had a serious liver disease(and liver function values have not returned to normal). Symptoms of liver disease may be yellowing of the skin and/or itching all over the body;
• you have or have ever had a benign or malignant liver tumor;
• you have or have ever had, or suspect you have, a malignant tumordependent on sex hormones, such as breast cancer or cancer of the genital organs;
• you experience vaginal bleedingof unexplained origin;
• you are allergic (hypersensitive)to dienogest or any of the other ingredients of this medicine ( see section 6, and the end of section 2). If any of these conditions occur for the first time during the use of Visanne, stop treatment immediately and consult your doctor.

Warnings and precautions
You should not use hormonal contraceptives in any form (pill, patch, intrauterine system) while taking Visanne.
Visanne is NOT a contraceptive. If you want to avoid pregnancy, you must use a condom or other non-hormonal contraceptive precautions.
In some situations you need to be particularly careful while using Visanne and it may be necessary for your doctor to examine you regularly. Tell your doctor if any of the following conditions apply to you:
if:

• you have ever had a blood clot(venous thromboembolism) or if one of your close relatives has had a blood clot at a relatively young age;
• you have a close relative who has had breast cancer;
• you have ever suffered from depression;
• you have high blood pressureor this condition occurs during the use of Visanne;
• you develop a liver diseaseduring the use of Visanne. Symptoms may include yellowing of the skin or eyes or itching all over the body. Also tell your doctor if these symptoms occurred during a previous pregnancy;
• you have diabetesor had it during a previous pregnancy;
• you have ever had chloasma(patchy brown pigmentation of the skin, especially on the face). If so, avoid excessive exposure to the sun or ultraviolet rays;
• you suffer from lower abdominal painduring the use of Visanne.

During treatment with Visanne, the possibility of pregnancy is reduced as Visanne can have an effect on ovulation.
If a pregnancy occurs during the intake of Visanne there is a slight increased riskof ectopic pregnancy (the embryo develops outside the uterus). Tell your doctor before taking Visanne if you have had an ectopic pregnancy in the past or if you have reduced function of the fallopian tubes.

Visanne and severe uterine bleeding
Uterine bleeding, for example in women with a disease characterized by the growth of the uterine lining (endometrium) within the muscle layer of the uterus, called internal endometriosis, or benign uterine tumors, also called uterine fibroids (uterine leiomyomas), may worsen with the use of Visanne. If the bleeding is heavy and continuous, this can lead to a lowering of red blood cell levels (anemia), which can be severe in some cases. In case of anemia, you should discuss with your doctor whether to discontinue treatment with Visanne.

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

Visanne and venous blood clots
Some studies suggest that there may be a slight, but not statistically significant, increased risk of a blood clot in the legs( venous thromboembolism) associated with the use of progestin-only preparations, such as Visanne. Very rarely, blood clots can cause serious permanent damage or can even be fatal.
The risk of having a venous blood clotincreases:

• with increasing age;
• if you are overweight;
• if you or one of your close relatives has had a blood clot in the leg (thrombosis), in the lung (pulmonary embolism), or in other organs at a young age;
• if you are going to have surgery, a prolonged stay in bed, or if you have had a serious accident. 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 start taking Visanne again. Generally this will be possible about 2 weeks after you have fully regained your mobility.

Visanne and arterial blood clots
There is little evidence of an association between the use of progestin-only preparations, such as Visanne, and an increased risk of a blood clot, 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 by the use of progestin-only preparations.
The risk of having an arterial blood clotincreases:

• if you smoke. It is strongly recommended that you stop smoking during the use of Visanne, especially if you are over 35 years old;
• if you are overweight;
• if one of your close relatives has had a heart attack or stroke at a young age;
• if you have high blood pressure. Talk to your doctor before taking Visanne Stoptaking Visanne and consult your doctor immediately if you notice any possible sign of thrombosis, such as:
• severe pain and/or swelling in a leg;
• sudden and severe chest pain that may radiate to the left arm;
• sudden shortness of breath;
• sudden cough without a known cause;
• unusual, severe or prolonged headache or worsening of migraine;
• partial or total loss of vision or double vision;
• difficulty or inability to speak;
• dizziness or fainting;
• weakness, unusual sensations or numbness in any part of the body.

Visanne and cancer
From the data currently available, it is not clear whether Visanne increases or decreases the risk of breast cancer. Breast cancer has been observed with a slightly higher frequency in women who use hormonal preparations compared to those who do not use them, but it is not known whether this is due to the treatment. For example, it is possible that, in women who use hormonal preparations, more tumors are diagnosed, and earlier, because they undergo more frequent medical check-ups. The occurrence of breast cancer decreases gradually after discontinuation of hormonal treatment. It is important that you check your breasts regularlyand contact your doctor if you feel any lump.
In women taking hormones, benign and, more rarely, malignant liver tumors have been observed in rare cases. Contact your doctor if you experience particularly severe abdominal pain.

Visanne and osteoporosis
Changes in bone mineral density (BMD)
The use of Visanne may affect the strength of bones in adolescents (aged 12 and under 18 years). If you are under 18 years of age, your doctor will need to carefully assess the benefits and risks associated with the use of Visanne for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).
If you are using Visanne, adequate intake of calcium and vitamin D through diet and supplements will be helpful for your bones.
If you have an increased risk of osteoporosis (fragile bones due to loss of minerals), your doctor will carefully assess the risks and benefits of treatment with Visanne, because the medicine has a moderate suppressive effect on the production of estrogens (another type of female hormone) by the body.

Other medicines and Visanne
Always tell your doctor about any medicine or herbal product you are taking. Also, tell any doctor or dentist who prescribes you other medicines (or the pharmacist) that you are taking Visanne.
Some medicines can affect the levels of Visanne in the blood and may make it less effective or may cause unwanted effects.
These include:

• medicines used for the treatment of epilepsy(e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate) or tuberculosis(e.g. rifampicin) or HIV and Hepatitis C virus infection(known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) or other fungal infections(griseofulvin, ketoconazole).
• preparations containing St John's Wort.

Ask your doctor or pharmacist for advice before taking any medicine.

Visanne with food and drink
During treatment with Visanne, you should avoid drinking grapefruit juice as it can increase the levels of Visanne in the blood. This may increase the risk of side effects.

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

Pregnancy, breastfeeding and fertility
Do not take Visanne if you are pregnant or if you are breastfeeding.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed in women using Visanne.

Visanne contains lactose
If you are intolerant to certain sugars, contact your doctor before taking Visanne.

Children and adolescents
Visanne should not be used in girls before menarche (first menstrual bleeding).
The use of Visanne may affect the strength of bones in adolescents (aged 12 and under 18 years). If you are under 18 years of age, your doctor will need to carefully assess the benefits and risks associated with the use of Visanne for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).

3. HOW TO TAKE VISANNE

Always take Visanne exactly as your doctor has instructed. If you have any doubts, ask your
doctor or pharmacist. For adults, the usual dose is 1 tablet a day.
Unless otherwise prescribed by your doctor, follow these instructions, otherwise you may not
benefit adequately from treatment with Visanne.
You can start treatment with Visanne on any day of your cycle.
Adults: take one tablet preferably at the same time each day, with the amount of liquid
needed. When you finish one pack, you should start the next without interruption. Continue to
take the tablets even during your menstrual period.

If you use more Visanne than you should
There are no reports of serious harmful effects following the intake of an excessive number of
Visanne tablets at the same time. However, if you are concerned, contact your doctor.

If you forget to take Visanne or suffer from vomiting or diarrhea
The effectiveness of Visanne is reduced if you miss a tablet. If you forget to take one or more
tablets, take one tablet as soon as you remember and then continue the next day
to take the tablet at the usual time.
In case of vomiting within 3-4 hours of taking Visanne, or in case of severe diarrhea, it is possible
that the active ingredient of the tablet is not completely absorbed by your body. The
situation is comparable to what happens when you forget to take a tablet.
After vomiting or diarrhea within 3-4 hours of taking Visanne, you should take another tablet
as soon as possible.
Do not take a double dose to make up for a missed tablet.

If you stop taking Visanne
If you stop taking Visanne, the symptoms of endometriosis may return.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are most common during the first few months of
treatment with Visanne and usually disappear with continued use. Changes in bleeding patterns may also occur, such as spotting, irregular bleeding or
cessation of the menstrual cycle.

Common side effects (affecting 1 to 10 users out of 100)

• weight increase;
• depressed mood, sleep disorders, nervousness, loss of interest in sex, mood swings;
• headache or migraine;
• nausea, abdominal pain, flatulence, abdominal bloating or vomiting;
• acne or hair loss;
• back pain;
• breast discomfort, ovarian cyst or hot flushes;
• uterine/vaginal bleeding, including spotting;
• weakness, irritability.

Uncommon side effects (affecting 1 to 10 users out of 1,000)

• anemia
• weight loss or increased appetite;
• anxiety, depression or mood swings;
• imbalance of the autonomic nervous system (which controls unconscious bodily functions such as sweating) or attention disorders;
• dry eyes;
• tinnitus;
• non-specific circulatory problems or unusual palpitations;
• low blood pressure;
• shortness of breath;
• diarrhea, constipation, abdominal discomfort, inflammation of the stomach and intestines (gastrointestinal inflammation), inflammation of the gums (gingivitis);
• dry skin, excessive sweating, intense itching all over the body, appearance of visible hair in typically male areas (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, hands or legs and feet;
• urinary tract infection;
• vaginal candidiasis, vulvovaginal dryness, vaginal discharge, pelvic pain, atrophic inflammation of the genitals with discharge (atrophic vulvovaginitis) or nodule or nodules in the breast;
• fluid retention swelling.

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
to adverse.

5. HOW TO STORE VISANNE

Store in the original package to protect the medicine from light.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP”.
The expiry date refers to the last day of the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Visanne contains
The active ingredient is dienogest. Each tablet contains 2 mg of dienogest.
The other ingredients are: lactose monohydrate, potato starch, microcrystalline cellulose, povidone
K 25, talc, crospovidone, magnesium stearate.

Description of the appearance of Visanne and contents of the pack
Visanne tablets are white or off-white, round, flat and with bevelled edges, with a
diameter of 7 mm, with a “B” imprinted on one side.
Visanne is available in blisters containing 14 film-coated tablets.
Packs containing 28, 84 or 168 tablets are available.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156, Milan (MI).

Manufacturer:
Bayer Weimar GmbH und Co. KG Weimar, Germany.
For any information about this medicine, contact the Marketing Authorisation Holder.

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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.

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