Package Insert

PACKAGE INSERT: INFORMATION FOR THE USER

Visanne 2 mg tablets

dienogest

Read all of this insert carefully before you start taking this medicine.

  • Keep this insert. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this insert, please tell your doctor or pharmacist.

1. WHAT VISANNE IS AND WHAT IT IS USED FOR

Visanne is a preparation for the treatment of endometriosis (painful symptoms due to displaced tissue of the lining of the womb). Visanne contains a hormone, the progestogen dienogest.

2. BEFORE YOU TAKE VISANNE

DO NOT take Visanne if you:

  • are suffering from a blood clot (thromboembolic disorder) in your veins. This may 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
  • have or have ever had a severe arterial disease, including cardiovascular disease, such as a heart attack,stroke or heart disease which causes a reduced blood supply (angina pectoris). See also "Visanne and arterial blood clots" below
  • have diabetes with blood vessel damage
  • have or have ever had severe liver disease (and your liver function values have not returned to normal). Symptoms of liver disease may be yellowing of the skin and/or itching of the whole body
  • have or have ever had a benign or malignant liver tumour
  • suffer or have ever suffered, or if it is suspected that you suffer from a malignant sex-hormone dependent tumour such as cancer of the breast or the genital organs
  • have any unexplained vaginal bleeding
  • are allergic (hypersensitive) to dienogest or any of the other ingredients of Visanne (see Section 6, and end of Section 2)

If any of these conditions appear for the first time while using Visanne, stop taking it at once and consult your doctor.

When you need to take special care with Visanne

You must not use hormonal contraceptives of any form (tablet, patch, intrauterine system) while taking Visanne.
Visanne is NOT a contraceptive. If you want to prevent pregnancy, you should use condoms or other non-hormonal contraceptive precautions.
In some situations you need to take special care while using Visanne, and your doctor may need to examine you regularly. Tell your doctor if any of the following conditions applies to you:

If you:

  • have ever had a blood clot (venous thromboembolism) or anyone in your immediate family has had a blood clot at a relatively early age
  • have a close relative who has had breast cancer
  • have ever suffered from depression
  • have high blood pressure or develop high blood pressure while taking Visanne
  • develop a liver disease while taking Visanne. Symptoms may include yellowing of the skin or eyes or itching all over your body. Inform your doctor also if such symptoms occurred during a previous pregnancy
  • have diabetes or had diabetes temporarily during previous pregnancy
  • have ever had chloasma (golden-brown patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation
  • suffer from pain in your lower abdomen while taking Visanne.

While taking Visanne your chance of becoming pregnant is reduced because Visanne may affect ovulation.
If you become pregnant while taking Visanne you are at a slightly increased risk of having an extrauterine pregnancy (the embryo develops outside the womb). Tell your doctor before you start taking Visanne, if you had an extrauterine pregnancy in the past or have an impaired function of the Fallopian tubes.

Visanne and serious uterine bleeding

Uterine bleeding, for example in women with a condition where the mucous membrane of your uterus (endometrium) grows into the muscle layer of your uterus, called adenomyosis uteri or benign tumours of the womb sometimes called uterine fibroids (uterine leiomyomata), may become worse with the use of Visanne. If bleeding is heavy and continuous over time, this may lead to low red blood cell levels (anemia), which may be severe in some cases. In the event of anemia, you should discuss with your doctor if you should stop taking 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 indicate 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 preparations with progestagens like Visanne. Very rarely, blood clots may cause serious permanent disabilities or may even be fatal.

The risk of a venous blood clot increases:

  • with increasing age
  • if you are overweight
  • if you or one of your close relatives had a blood clot in the leg (thrombosis), lung (pulmonary embolism), or other organ at a young age
  • if you must have surgery, if you have had a serious accident or if you are immobilized for a long time. It is important to tell your doctor in advance that you are using Visanne as the treatment may have to be stopped. Your doctor will tell you when to start Visanne again. This is usually about two weeks after you are back on your feet

Visanne and arterial blood clots

There is little evidence for an association between preparations with progestagens like Visanne and an increased risk of a blood clot in, for example, the bloodvessels of the heart (heart attack) or the brain (stroke). In women with hypertension the risk of stroke may be slightly enhanced by these preparations.
The risk of an arterial blood clot increases:

  • if you smoke. You are strongly advised to stop smoking when you use Visanne, especially if you are older than 35 years.
  • if you are overweight
  • if one of your close relatives had a heart attack or stroke at a young age
  • if you have high blood pressure

Stop taking Visanne 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 pain in the chest which may reach the left arm
  • sudden breathlessness
  • sudden cough without an obvious cause
  • any unusual, severe or long-lasting headache or worsening of migraine
  • partial or complete blindness or double vision
  • difficulty in speaking or inability to speak
  • giddiness or fainting
  • weakness, strange feeling, or numbness in any part of the body

Visanne and cancer

It is not clear from the data currently available whether or not Visanne increases the risk of breast cancer. Breast cancer has been observed slightly more often in women taking hormones compared to those not taking hormones, but it is not known whether this is caused by the treatment. For example, it may be that more tumours are detected and detected earlier in women taking hormones because they are examined by their doctor more often. The occurrence of breast tumours becomes gradually less after stopping the hormone treatment. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in women taking hormones. Contact your doctor if you have unusually severe stomach pain.

Visanne and osteoporosis

If you have an increased risk of getting osteoporosis (weakening of bones due to loss of bone minerals), your doctor will carefully weigh the risks and benefits of treatment with Visanne because Visanne has a moderate suppressing effect on the production of oestrogen (another type of female hormone) by your body.

Visanne and using other medicines

Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you are taking Visanne.

The following may reduce the effect of Visanne:

  • medicines used for the treatment of
  • epilepsy (e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbamazepine, topiramate, felbamate)
  • tuberculosis (e.g. rifampicin)
  • HIV infections: non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine)
  • other infections (antibiotics such as griseofulvin)
  • the herbal remedy St. John’s wort

The following may increase the levels of Visanne in your blood, and result in undesirable effects:

  • medicines such as
  • antifungals (e.g. ketoconazole, itraconazole, fluconazole)
  • antibiotics (e.g. erythromycin, clarithromycin and roxithromycin)
  • antidepressants (e.g. nefazodone, fluvoxamine, fluoxetine)
  • antacids (e.g. cimetidine)
  • blood pressure medication (e.g. diltiazem, verapamil)
  • protease inhibitors for HIV infections (e.g. ritonavir, saquinavir, indinavir, or nelfinavir)
  • grapefruit


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

Taking Visanne with food and drink

You can take Visanne with or without food.

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking Visanne, because Visanne can affect the results of some tests.

Pregnancy and breast-feeding

Do not take Visanne if you are pregnant or breast-feeding.

Driving and using machines

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

Important information about some of the ingredients of Visanne:

Visanne contains lactose.
If you cannot tolerate certain sugars, please contact your doctor before you take Visanne.

3. HOW TO TAKE VISANNE

Always take Visanne exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. For adults, the usual dose is 1 tablet per day.
The following statements apply to Visanne unless otherwise prescribed by your doctor. Please follow these instructions, otherwise you will not fully benefit from Visanne.
You can start treatment with Visanne on any day of your natural cycle.
Adults: take one tablet every day, preferably at the same time with some liquid as needed. When a pack is finished the next one should be started without interruption. Continue to take the tablets also on days of menstrual bleeding.
There is no experience with Visanne treatment >15 months in patients with endometriosis.

If you take more Visanne than you should

There have been no reports of serious harmful effects from taking too many Visanne tablets at one time. However, if you are concerned, contact your doctor.

If you forget to take Visanne or suffer from vomiting or diarrhoea

Visanne will be less effective if you miss a tablet. If you miss one or more tablets, take one tablet only as soon as you remember, and then continue next day taking the tablet at your usual time.
If you vomit within 3-4 hours of taking Visanne or you have severe diarrhoea, there is a risk that the active substance in the tablet will not be taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea 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 forgotten tablet.

If you stop taking Visanne

If you stop taking Visanne, your original endometriosis symptoms may return.


4. POSSIBLE SIDE EFFECTS

Like all medicines, Visanne can cause side effects, although not everybody gets them. These effects are more common during the first months after start of intake of Visanne and usually disappear with continued use. You may also experience changes in your bleeding pattern, such as spotting, irregular bleeding or your periods may stop completely.

Common (affecting between 1 and 10 in every 100 users)

  • weight gain
  • depressed mood, problems sleeping, nervousness, loss of interest in sex, or changed mood
  • headache or migraine
  • nausea, abdominal pain, wind, swollen tummy or vomiting
  • acne or hair loss
  • back pain
  • breast discomfort, ovarian cyst or hot flushes
  • uterine/vaginal bleeding including spotting
  • weakness or irritability

Uncommon (affecting between 1 and 10 in every 1,000 users)

  • anemia
  • weight loss or increase in appetite
  • anxiety, depression or mood swings
  • imbalance in the autonomic nervous system (controls unconscious bodily functions, e.g. perspiration) or disturbed attention
  • dry eye
  • tinnitus
  • unspecific circulatory problems or uncommon palpitations
  • low blood pressure
  • shortness of breath
  • diarrhoea, constipation, abdominal discomfort, inflammation of the stomach and intestines (gastrointestinal inflammation), inflammation of the gums (gingivitis)
  • dry skin, excessive sweating, severe itching of the whole body, male pattern hair growth (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, hypersensitive response to light or problems with skin pigmentation
  • pains in your bones, muscle spasms, pains and/or a sensation of heaviness in your arms and hands or legs and feet
  • urinary tract infection
  • vaginal thrush, 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 breast
  • swelling due to fluid retention

If any of the side effects gets serious, or if you notice any side effects not listed in this insert, please tell your doctor or pharmacist.


5. HOW TO STORE VISANNE

Store in the original packaging to protect from light.

Keep out of the reach and sight of children.

Do not use Visanne after the expiry date which is stated on the label and blister. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


6. FURTHER INFORMATION

What Visanne contains

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

What Visanne looks like and contents of the pack

Visanne tablets are white to off-white, round flat-faced bevelled-edged with an embossed “B” on one side and a diameter of 7 mm.
They are supplied in a blister pack containing 14 film-coated tablets.
Boxes contain blister packs with 28, 84 or 168 tablets.

Not all packsizes may be marketed

Marketing Authorisation Holder

<to be completed nationally>

Manufacturer

Schering GmbH & Co Produktions KG
Weimar, Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

This medicinal product is authorised in the Member States of the EEA under the following names: <information not yet available, will be included >

This insert was last approved in {MM/YYYY}.

 

This short animation video will help you understand some important facts about endometriosis and how it can be treated.

Endometriosis Video