Dienosis

The active substance is Dienogest. Each tablet contains 2 mg dienogest.
Excipients/Inactive Ingredients: The other ingredients are lactose monohydrate, cellulose microcrystalline, potato starch, povidone, talc, crospovidone, magnesium stearate.

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

Always take this medicine exactly as the doctor has told the patient. The patient should check with the doctor or pharmacist if she are not sure.
For adults, the usual dose is 1 tablet per day.
The following statements apply to Dienosis unless otherwise prescribed by the doctor. Follow these instructions, otherwise the patient will not fully benefit from Dienosis.
The patient can start the treatment with Dienosis on any day of the 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 Dienosis treatment > 15 months in patients with endometriosis.
If the patient takes more Dienosis than she should: There have been no reports of serious harmful effects from taking too many Dienosis at one time. However, if you the patient is concerned, contact the doctor.
If the patient forgets to take Dienosis or suffer from vomiting or diarrhoea: Dienosis will be less effective if the patient misses a tablet. If the patient misses one or more tablets, take one tablet only as soon as the patient remembers, and then continue next day taking the tablet at the usual time.
If the patient vomits within 3-4 hours of taking Dienosis or have severe diarrhoea, there is a risk that the active substance in the tablet will not be taken up by the body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea within 3-4 hours of taking Dienosis, the patient should take another tablet as soon as possible.
Do not take a double dose to make up for a forgotten tablet.
If the patient stops taking Dienosis: If the patient stops taking Dienogest, the original endometriosis symptoms may return.

There have been no reports of serious harmful effects from taking too many Dienosis at one time.

Do not take Dienosis if the patient: is suffering from a blood clot (thromboembolic disorder) in the veins. This may occur, for example, in the blood vessels of the legs (deep vein thrombosis) or the lungs (pulmonary embolism). See also Dienogest and arterial blood clots under Precautions.
Has or has 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 Dienogest and arterial blood clots under Precautions.
Has diabetes with blood vessel damage.
Has or has ever had severe liver disease (and the 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.
Has or has ever had a benign or malignant liver tumour.
Suffer or has ever suffered, or if it is suspected that the patient suffers from a malignant sex-hormone dependent tumour such as cancer of the breast or the genital organs.
Has any unexplained vaginal bleeding; is allergic to dienogest or any of the other ingredients of this medicine (listed in Description).
If any of these conditions appear for the first time while using Dienosis, stop taking it at once.

Stop taking Dienosis and contact the doctor immediately if the patient notices possible signs of a blood clot, such as: severe pain and/or swelling in one of the patient's 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.
Other medicines and Dienosis: Always tell the doctor which medicines or herbal products the patient is already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that the patient is taking Dienosis.

The patient must not use hormonal contraceptives of any form (tablet, patch, intrauterine system) while taking Dienosis.
Dienosis is NOT a contraceptive. If the patient wants to prevent pregnancy, the patient should use condoms or other non-hormonal contraceptive precautions.
In some situations, the patient needs to take special care while using Dienosis, and the doctor may need to examine the patient regularly. Tell the doctor if any of the following conditions applies to the patient: If the patient: has ever had a blood clot (venous thromboembolism) or anyone in the patient's immediate family has had a blood clot at a relatively early age.
Has a close relative who has had breast cancer.
Has ever suffered from depression.
Has high blood pressure or develop high blood pressure while taking Dienosis.
Develop a liver disease while taking Dienosis. Symptoms may include yellowing of the skin or eyes or itching all over the body. Inform the doctor also if such symptoms occurred during a previous pregnancy.
Has diabetes or had diabetes temporarily during previous pregnancy.
Has 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 the lower abdomen while taking Dienosis.
While taking Dienosis, the chance of becoming pregnant is reduced because Dienogest may affect ovulation.
If the patient becomes pregnant while taking Dienosis, the patient is at a slightly increased risk of having an extrauterine pregnancy (the embryo develops outside the womb). Tell the doctor before the patient starts taking Dienosis, if the patient had an extrauterine pregnancy in the past or have an impaired function of the Fallopian tubes.
Dienosis and serious uterine bleeding: Uterine bleeding, for example in women with a condition where the mucous membrane of the uterus (endometrium) grows into the muscle layer of the uterus, called adenomyosis uteri or benign tumours of the womb sometimes called uterine fibroids (uterine leiomyomata), may become worse with the use of Dienosis. 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, the patient should discuss with the doctor if the patient should stop taking Dienosis.
Dienosis and changes in bleeding pattern: Most women treated with Dienogest experience changes in their menstrual bleeding pattern (see Side Effects).
Dienogest 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 Dienogest. 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 the patient is overweight; if the patient or one of the patient's close relatives had a blood clot in the leg (thrombosis), lung (pulmonary embolism), or other organ at a young age; if the patient must have surgery, if the patient has had a serious accident or if the patient is immobilized for a long time. It is important to tell the doctor in advance that the patient is using Dienosis as the treatment may have to be stopped. The doctor will tell the patient when to start Dienosis again. This is usually about two weeks after the patient is back on the patient's feet.
Dienosis and arterial blood clots: There is little evidence for an association between preparations with progestagens like Dienogest and an increased risk of a blood clot in, for example, the blood vessels 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 the patient smokes. The patient is strongly advised to stop smoking when using Dienosis, especially if the patient is older than 35 years; if the patient is overweight; if one of the patient's close relatives had a heart attack or stroke at a young age; if the patient has high blood pressure.
Talk to the doctor before taking Dienosis.
Dienosis and cancer: It is not clear from the data currently available whether or not Dienosis 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 the doctor more often. The occurrence of breast tumours becomes gradually less after stopping the hormone treatment. It is important to regularly check the breasts and contact the doctor if the patient feels any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in women taking hormones. Contact the doctor if the patient has unusually severe stomach pain.
Dienosis and osteoporosis: Changes in bone mineral density (BMD): The use of Dienosis may affect the strength of the bone of adolescents (12 to under 18 years). If the patient is under 18, the doctor will, therefore, carefully weigh the benefits and risks of using Dienosis for, taking into account possible risk factors for bone loss (osteoporosis).
If the patient uses Dienosis, it will help the patient's bones if the patient has an adequate intake of calcium and vitamin D either via food or via supplements.
If the patient has an increased risk of getting osteoporosis (weakening of bones due to loss of bone minerals), the doctor will carefully weigh the risks and benefits of treatment with Dienosis because Dienosis has a moderate suppressing effect on the production of oestrogen (another type of female hormone) by the body.
Driving and using machines: No effects on the ability to drive and use machines have been observed in users of Dienogest.
Dienosis contains lactose: If the patient has been told by the doctor that the patient intolerance to some sugars, contact the doctor before taking this medicinal product.
Use in Children: Dienosis is not for use in girls before menarche (first menstrual bleeding).
The use of Dienosis may affect the strength of the bone of adolescents (12 to under 18 years). If the patient is under 18, the doctor will, therefore, carefully weigh the benefits and risks of using Dienosis for her as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

Pregnancy and breast-feeding: Do not take Dienosis if the patient is pregnant or breast-feeding.

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are more common during the first months after start of intake of Dienosis and usually disappear with continued use. The patient may also experience changes in the bleeding pattern, such as spotting, irregular bleeding or periods may stop completely.
Common (may affect up to 1 in 10 people): 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 (may affect up to 1 in 100 people): 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 the bones, muscle spasms, pains and/or a sensation of heaviness in the 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; blood clot (venous thromboembolism, arterial thromboembolism).
Additional side effects in adolescents (12 to under 18 years): loss of bone density.

Some medicines can have an influence on the blood levels of Dienosis and can make it less effective, or can cause undesirable 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 Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz); fungal infections (griseofulvin, ketoconazole).
The herbal remedy St. John's wort.
Ask the doctor or pharmacist for advice before taking any medicine.
Dienosis with food and drink: During Dienosis treatment, the patient should avoid drinking grapefruit juice, because this may increase the levels of Dienosis in the blood. This may increase the risk of getting side effects.
Laboratory tests: If the patient needs a blood test, Dienosis can affect the results of some tests.

Store below 30°C. Protect from light.
Do not throw away any medicine via wastewater or household waste. Ask the pharmacist how to throw away medicines the patient no longer uses. These measures will help protect the environment.

Oestrogens, Progesterones & Related Synthetic Drugs

G03DB08 - dienogest ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.

POM