What Visanne is and what it is used for
Dienogest contained in Visanne may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
Visanne is a preparation for the treatment of endometriosis (painful symptoms due to the endometrium occurring outside the uterus). Visanne contains a hormone , the progestogen dienogest.
What you need to know before taking Visanne
Do NOT take Visanne
- if you have a blood clot (thromboembolism) in a vein. This can occur, for example, in the blood vessels of the legs (deep vein thrombosis ) or the lungs ( pulmonary embolism ). See also ” Visanne and venous blood clots ” below
- if you have or have had a serious arterial disease, including cardiovascular diseases such as heart attack, stroke, or heart disease that reduces blood supply to the heart ( angina pectoris ). See also ” Visanne and arterial blood clots ” below
- if you have diabetes with vascular damage
- if you have or have had severe 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 or have had a benign or malignant liver tumor
- if you have or have had or if you are suspected of having a malignant tumor that is dependent on sex hormones, such as breast or genital cancer
- if you have unexplained vaginal bleeding
- if 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 appear for the first time while using Visanne, stop using Visanne immediately and consult a doctor.
Warnings and precautions
You must not use hormonal contraceptives of any kind (tablets, patches, IUD ) while you are taking Visanne.
Visanne is NOT a contraceptive. If you want to avoid pregnancy, use condoms or other non-hormonal contraceptives.
In some situations, you need to be especially careful when using Visanne, and your doctor may need 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 someone in your immediate family has had a blood clot at a relatively young age
- have a close relative who has had breast cancer
- ever had a depression
- have high blood pressure or develop high blood pressure while taking Visanne
- develop the liver disease while taking Visanne. The symptoms can be yellowing of the skin or eyes or itching all over the body. Also, inform your doctor if such symptoms occurred during a previous pregnancy
- have diabetes or had temporary diabetes during a previous pregnancy
- ever had chloasma (yellow-brown spots on the skin, especially on the face). In that case, you should avoid exposing yourself to too much sun or ultraviolet radiation
- get pain in the lower abdomen while taking Visanne
While you are taking Visanne, the chance of you becoming pregnant is reduced, as Visanne can affect ovulation.
If you become pregnant while taking Visanne, the risk of an ectopic pregnancy (the fetus develops outside the womb) is slightly increased. Tell your doctor before you start taking Visanne if you have previously had an ectopic pregnancy or have impaired fallopian tube function.
Visanne and severe bleeding from the uterus
Bleeding from the uterus, for example in women with a disease where the lining of the uterus (endometrium) grows into the muscle tissue of the uterus, called uterine adenomyosis or benign uterine tumor, sometimes also called uterine fibroid (uterine leiomyoma), may worsen when using Visanne. If the bleeding is profuse and prolonged, this can lead to low levels of red blood cells ( anemia ) which can be serious in some cases. If you develop anemia, you should discuss with your doctor whether you should stop using Visanne.
Appearance and changes in the bleeding pattern
Most women treated with Visanne experience changes in the bleeding pattern (see section 4 for possible side effects ).
Visanne and venous blood clots
Some studies show that there may be a slightly, but not statistically significant, increased risk of a blood clot in the leg (venous thromboembolism) in connection with the use of preparations such as Visanne, which contains progestogen. In very rare cases, blood clots can cause serious permanent damage or be life-threatening.
The risk of a venous blood clot increases:
- with increasing age
- if you are overweight
- if you or any of your close relatives have had a blood clot in the leg ( thrombosis ), lung ( pulmonary embolism ), or other organs at a young age
- if you need surgery, have had a serious accident, or become immobile for a long time. You must tell your doctor that you are using Visanne, as treatment may have to be stopped. Your doctor will tell you when to start Visanne again. This usually happens about two weeks after you get back on your feet
Vision and arterial blood clots
There is limited evidence for a connection between preparations containing progestogen, such as Visanne, and an increased risk of blood clots, for example in the blood vessels of the heart (myocardial infarction) or the brain ( stroke ). In women with high blood pressure, the risk of stroke may increase slightly when using these preparations.
The risk of an arterial blood clot increases:
- if you smoke. It is strongly recommended that you stop smoking while using Visanne, especially if you are over 35 years of age
- if you are overweight
- if any of your close relatives have had a heart attack or stroke at a young age
- if you have high blood pressure
Talk to your doctor before taking Visanne.
| Stop taking Visanne and contact your doctor immediately if you notice signs of a blood clot, such as severe pain and/or swelling in one leg sudden severe pain in the chest, possibly radiating into the left arm sudden shortness of breath sudden cough for no apparent reason unusual, severe or prolonged headache or worsening migrainepartial or complete vision loss or double vision difficulty speaking or inability to speakdizziness or fainting weakness, unusual feeling or numbness in any part of the body |
Vision and cancer
Based on the data currently available, it is not clear whether Visanne increases the risk of breast cancer. Breast cancer has been observed slightly more often in women taking hormones than in women not taking hormones, but it is not known whether this is caused by the treatment. For example, it may be that more tumors are detected and that they are detected earlier in women who take hormones because they are examined by doctors more often. The incidence of breast tumors gradually decreases after the hormone treatment has ended. It is important that you regularly examine your breasts and you should contact a doctor if you feel a lump.
In rare cases, benign liver tumors and, in even fewer cases, malignant liver tumors have been reported in women taking hormones. Contact your doctor if you have unusually severe stomach pains.
Vision and osteoporosis
Changes in bone density
The use of Visanne may affect the strength of the skeleton in adolescents (12 up to 18 years). If you are under 18 years of age, the doctor will therefore carefully consider the risk and benefits of using Visanne for you as an individual patient, taking into account possible risk factors for osteoporosis.
If you use Visanne, an adequate intake of calcium and vitamin D, either through your food or supplements, will help your bones.
If you are at increased risk of developing osteoporosis (weakening of the bones due to reduced bone density), your doctor will carefully consider the risk and benefits of treatment with Visanne, as Visanne causes a moderate reduction in the production of estrogen (another type of female hormone ) in your body.
Other medicines and Visanne
| Always tell your doctor what medicines or herbal remedies you are already using. Also, tell other doctors or dentists who prescribe other medicines (or pharmacists) that you are taking Visanne. |
Some medicines can affect the level of Visanne in the blood and can make it less effective, or cause side effects. This applies, among other things:
- drugs used for the treatment of
- epilepsy (eg phenytoin , barbiturates , primidone, carbazepine, oxcarbamazepine, topiramate, felbamate)
- tuberculosis (eg rifampicin)
- HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, and efavirenz)
- fungal infections (griseofulvin, ketoconazole )
- the natural remedy St. John’s wort
Ask your doctor or pharmacist for advice before taking any medicine.
Visanne with food, drink, and alcohol
During treatment with Visanne, you should avoid drinking grapefruit juice, as it may increase the levels of Visanne in the blood. This may increase the risk of side effects.
Laboratory tests
If you need to have a blood test, tell the doctor or laboratory staff that you are taking Visanne, as Visanne can affect the results of some tests.
Pregnancy, breastfeeding, and fertility
Do not take Visanne if you are pregnant or breastfeeding.
Driving ability and use of machinery
There is no information to suggest that the use of Visanne affects the ability to drive or use machines.
Visanne contains excipients
Visanne contains lactose .
If you have an intolerance to certain sugars, you should consult a doctor before starting to take Visanne.
Children and young people
Visanne should not be used by girls before (their first menstrual bleeding).
The use of Visanne may affect the strength of the skeleton in adolescents (12 up to 18 years). If you are under 18 years of age, the doctor will therefore carefully weigh the benefit against the risk when using Visanne for you as an individual patient, taking into account possible risk factors for osteoporosis.
How to take Visanne
Always take Visanne as directed by your doctor. Ask your doctor or pharmacist if you are unsure. For adults, the usual dose is 1 tablet daily.
The following advice applies to Visanne unless your doctor has prescribed otherwise. Follow these instructions, otherwise, you will not get the best effect from Visanne.
You can start treatment with Visanne on any day of the menstrual cycle.
Adults: take one tablet daily, preferably at the same time each day, with a little liquid as needed. When a tablet map is finished, the next one should be started without pause. Continue to take the tablets even on the days when you have menstrual bleeding.
If you have taken too much Visanne
There are no reports of serious adverse effects after taking too many Visanne tablets at the same time.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Visanne or suffer from vomiting or diarrhea
Visanne will have less effect if you forget to take a tablet. If you have forgotten to take one or more tablets, take one tablet as soon as you remember. Then you continue to take a tablet at the usual time the next day.
If you vomit within 3-4 hours after taking Visanne or have severe diarrhea, there is a risk that the active substance in the tablet will not be absorbed by the body. This situation is almost like forgetting to take a tablet. After vomiting or diarrhea within 3-4 hours of taking Visanne, take another tablet as soon as possible.
Do not take a double dose to make up for a missed dose.
If you stop taking Visanne
If you stop taking Visanne, the original symptoms of endometriosis may return.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects are more common in the first few months after you start taking Visanne, and they usually go away with continued use. You may also experience changes in your bleeding pattern, such as spotting, irregular bleeding, or your periods stopping altogether.
Common (affects between 1 and 10 users in 100)
- weight gain
- depressed mood, sleep problems, nervousness, loss of sex drive, or mood changes
- headache or migraine
- nausea, abdominal pain, gas, bloating, or vomiting
- acne or hair loss
- back pain
- breast discomfort, ovarian cysts, or hot flashes
- uterine/vaginal bleeding including spotting
- weakness or irritability
Uncommon (affects between 1 and 10 users in 1,000)
- anemia
- weight loss or increased appetite
- anxiety, depression, or mood swings
- imbalance in the autonomic nervous system (controls unconscious body functions, such as sweating) or impaired attention
- dry eyes
- tinnitus
- non-specific circulation problems or palpitations
- low blood pressure
- shortness of breath
- diarrhea, constipation, stomach upset, inflammation of the stomach and intestines ( gastrointestinal inflammation ), inflammation of the gums ( gingivitis )
- dry skin, profuse sweating, severe itching all over the body, male pattern baldness ( hirsutism ), brittle nails, dandruff, dermatitis (skin inflammation), abnormal hair growth, hypersensitivity to light, or problems with skin pigmentation
- bone pain, muscle cramps, pain and/or heaviness in arms and hands or legs and feet
- urinary tract infection
- yeast infection of the vagina, dry vagina, discharge, pelvic pain, inflammation of the genitals with discharge (atrophic vulvovaginitis), or one or more lumps in the breasts
- swelling due to fluid retention
Additional side effects in adolescents (12 up to 18 years): decreased bone density.
How Visanne should be stored
Store in the original packaging. Light sensitive.
Store out of sight and reach of children.
Use before the expiry date stated on the packaging after “Expiry date” or “EXP”.
The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is dienogest. Each tablet contains 2 mg dienogest.
Other ingredients are lactose monohydrate, potato starch, microcrystalline cellulose, povidone K 25, talc, crospovidone, and magnesium stearate.
Appearance and package sizes of the medicine
Visanne tablets are white to off-white, round, flat tablets with beveled edges and a “B” debossed on one side, 7 mm in diameter.
They are supplied in a blister pack containing 14 tablets.
The cartons contain blister packs of 28, 84, or 168 tablets.
Not all pack sizes may be marketed.
Holder of approved for sale
Bayer AB
Box 606
169 26 Solna
Manufacturer
Bayer Weimar GmbH und Co KG
Weimar, Germany
This medicine is registered in the member countries of the European Economic Area (EEA) under the following names:
Visanne: Croatia, Denmark, Germany, Finland, France, Hungary, Iceland, Italy, Malta, Netherlands, Norway, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, Czech Republic, Sweden, and Malta.
Bissonnette : Belgium, Cyprus, Estonia, Greece, Latvia, Lithuania, Luxembourg, and Spain.