Diemono

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Diemono (Metrissa)

2 mg, coated tablets

Dienogest
Diemono and Metrissa are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Diemono and what is it used for
• 2. Important information before taking Diemono
• 3. How to take Diemono
• 4. Possible side effects
• 5. How to store Diemono
• 6. Contents of the packaging and other information

1. What is Diemono and what is it used for

Diemono is used to treat endometriosis (painful symptoms caused by abnormally located uterine lining). Diemono contains a hormone, a progestogen called dienogest.

2. Important information before taking Diemono

When not to take Diemono

If any of these conditions occur for the first time while taking Diemono, the medicine should be stopped immediately and a doctor consulted.

Warnings and precautions

While taking Diemono, hormonal contraceptives should not be used in any form (pill, patch, intrauterine system). Diemono is NOT a contraceptive. To prevent pregnancy, condoms or other non-hormonal contraceptives should be used. In some situations, special caution is required when taking Diemono. Regular medical examinations may be necessary. The doctor should be informed if the patient has any of the following conditions:

While taking Diemono, the chance of becoming pregnant is reduced, as Diemono may affect ovulation. If pregnancy occurs while taking Diemono, there is a slightly increased risk of ectopic pregnancy (the embryo develops outside the uterus). Before starting Diemono, the patient should tell the doctor if they have had an ectopic pregnancy or have tubal dysfunction.

Diemono and severe uterine bleeding

Uterine bleeding, for example, in women with a disease in which the uterine lining (endometrium) grows into the uterine muscle layer, called adenomyosis, or benign uterine tumors, sometimes called uterine fibroids, may worsen while taking Diemono. If the bleeding is heavy and prolonged, it can lead to a decrease in red blood cells (anemia), which can be severe in some cases. In case of anemia, the doctor should be consulted about whether it is necessary to stop taking Diemono.

Diemono and changes in bleeding profile

In most women treated with Diemono, changes in menstrual bleeding profile occur (see section 4 "Possible side effects").

Diemono and venous blood clots

Some studies suggest that there may be a slight, statistically non-significant increase in the risk of blood clots in the legs (venous thromboembolic disease) associated with the use of progestogen-containing medications, such as Diemono. Very rarely, blood clots can cause severe, permanent disability or even death. The risk of venous blood clots increases:

• with age;

Diemono and arterial blood clots

There is limited evidence of a link between the use of progestogen-containing medications, such as Diemono, and an increased risk of blood clots, 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 when taking these medications. The risk of arterial blood clots increases:

• in women who smoke - it is strongly recommended to quit smoking when taking Diemono, especially at over 35 years of age;

The doctor should be consulted before taking Diemono.

Stop taking Diemono and consult a doctor immediately if possible symptoms of a blood clot occur, such as:

• severe pain and/or swelling of one leg;
• sudden severe chest pain that may also radiate to the left arm;
• sudden shortness of breath;
• sudden cough without an obvious cause;
• any unusual, severe, or prolonged headache or worsening of migraine;
• partial or complete blindness or double vision;
• difficulty speaking or inability to speak;
• dizziness or fainting;
• weakness, strange feeling, or numbness of any part of the body.

Diemono and cancer

Currently available data do not clearly indicate whether Diemono increases the risk of breast cancer or not. Breast cancer has been observed slightly more frequently in women taking hormones compared to women not taking hormones, but it is not known if this is caused by the treatment. For example, this may be due to the fact that more tumors are detected and are detected earlier in women taking hormones, as they are more frequently examined by a doctor. After stopping hormonal treatment, the frequency of breast tumors decreases gradually. Regular breast examination is essential, and the doctor should be consulted if a lump is felt. In rare cases, women taking hormones have reported benign liver tumors, and in even rarer cases, malignant liver tumors. The doctor should be consulted if severe abdominal pain occurs.

Diemono and osteoporosis

Changes in bone mineral density (BMD) may occur when taking Diemono. The use of Diemono may affect bone strength in young people (aged 12 to less than 18 years). Therefore, if the patient is under 18 years old, the doctor will individually assess the benefits and risks of taking Diemono, considering possible risk factors for bone loss (osteoporosis). If the patient is taking Diemono, they should ensure adequate calcium and vitamin D intake in their diet or through supplements. If the patient has an increased risk of osteoporosis (bone weakening due to loss of bone mineral substances), the doctor will carefully assess the benefits and risks of Diemono treatment, as Diemono has a moderate estrogen-suppressing effect.

Diemono and other medicines

The doctor should always be informed about all medicines or herbal products currently being taken or recently taken, or any other medicines that the patient may take. The doctor or dentist prescribing another medicine or pharmacist should also be informed about taking Diemono. Some medicines may affect the level of Diemono in the blood and reduce its effectiveness or cause side effects. These include:

• medicines used to treat the following diseases:
• epilepsy(e.g., phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis(e.g., rifampicin);
• HIV and hepatitis C virus infections(protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• fungal infections(griseofulvin, ketoconazole);
• St. John's wort.

Before taking any medicine, the doctor or pharmacist should be consulted.

Diemono with food and drink

While taking Diemono, grapefruit juice should be avoided, as it may increase the level of Diemono in the blood. This may increase the risk of side effects.

Laboratory tests

If the patient needs to have a blood test, they should tell the doctor or laboratory staff that they are taking Diemono, as Diemono may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

Diemono should not be taken during pregnancy or breastfeeding.

Driving and using machines

No effect on the ability to drive and use machines has been observed in people taking Diemono.

Children and adolescents

Diemono should not be taken by girls before their first menstrual period. The use of Diemono may affect bone strength in young people (aged 12 to less than 18 years). Therefore, if the patient is under 18 years old, the doctor will individually assess the benefits and risks of taking Diemono, considering possible risk factors for bone loss (osteoporosis).

Diemono contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to take Diemono

Diemono should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted. The usual dose for adults is one tablet per day. The following information applies to Diemono, unless the doctor has prescribed otherwise. The instructions below should be followed; otherwise, the patient will not get the full benefits of Diemono. Treatment with Diemono can be started on any day of the natural cycle. Adults: One tablet should be taken daily, preferably at the same time, with a small amount of liquid if necessary. After finishing the packaging, the next one should be started without a break in taking the tablets. The tablets should be continued even during menstrual bleeding days.

Taking more than the recommended dose of Diemono

There are no reports of serious harmful effects after taking too many Diemono tablets at once. However, in case of doubts, the doctor should be consulted.

Missing a dose of Diemono or experiencing vomiting or diarrhea

The effect of Diemono will be less effective if a tablet is missed. If one or more tablets are missed, only one tablet should be taken as soon as possible, and the next tablet should be taken at the usual time the next day. If vomiting occurs within 3-4 hours after taking Diemono or severe diarrhea occurs, there is a risk that the active substance of the tablet will not be absorbed by the body. This situation is similar to missing a tablet. After vomiting or diarrhea within 3-4 hours after taking Diemono, the next tablet should be taken as soon as possible. A double dose should not be taken to make up for a missed tablet.

Stopping Diemono

If the patient stops taking Diemono, their previous endometriosis symptoms may return. If there are any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Diemono can cause side effects, although not everybody gets them. These effects are more common during the first few months after starting Diemono and usually disappear with continued use. Changes in bleeding profile, such as spotting, irregular bleeding, or absence of menstruation, may also occur. Common side effects (may affect up to 1 in 10 women):

• weight gain
• low mood, sleep problems, nervousness, loss of interest in sex, or mood changes
• headache or migraine
• nausea, abdominal pain, bloating with gas, bloated stomach, or vomiting
• acne or hair loss
• back pain
• breast discomfort, ovarian cyst, or hot flashes
• uterine and/or vaginal bleeding, including spotting
• weakness or irritability.

Uncommon side effects (may affect up to 1 in 100 women):

• anemia
• weight loss or increased appetite
• anxiety, depression, or sudden mood changes
• autonomic nervous system imbalance (controls subconscious body functions, e.g., sweating) or attention disorders
• dry eye
• tinnitus
• non-specific circulation problems or palpitations
• low blood pressure
• shortness of breath
• diarrhea, constipation, abdominal discomfort, gastroenteritis, gingivitis
• dry skin, excessive sweating, severe itching all over the body, hirsutism, nail fragility, dandruff, skin inflammation, abnormal hair growth, hypersensitivity to light, or pigmentation problems
• bone pain, muscle cramps, pain and/or feeling of heaviness in the arms and hands or legs and feet
• urinary tract infection
• vaginal yeast infection, vaginal dryness, discharge, pelvic pain, atrophic vaginitis (atrophic vaginitis with discharge) or breast lump or lumps
• edema due to fluid retention.

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

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Diemono

The medicine should be stored out of sight and reach of children. There are no special storage instructions. This medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Diemono contains

• The active substance is dienogest. Each coated tablet contains 2 mg of dienogest.
• Other ingredients are: Tablet core: lactose monohydrate, cornstarch, maltodextrin, magnesium stearate. Tablet coating: hypromellose, lactose monohydrate, titanium dioxide (E 171), macrogol 4000, sodium citrate.

What Diemono looks like and what the packaging contains

Diemono tablets are white with the imprint "m" on one side. The tablets are packaged in PVC/PE/PVDC/Aluminum blisters. The packaging contains 28 coated tablets. For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Austria, the country of export:

Gynial GmbH, Ungargasse 37/4/1, 1030 Vienna, Austria

Manufacturer:

mibe GmbH Arzneimittel, Münchener Straße 15, 06796 Brehna, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Marketing authorization number in Austria, the country of export: 138899

Parallel import authorization number: 263/22

Translation of day symbols on the packaging:

Mo

• Monday Di
• Tuesday Mi
• Wednesday Do
• Thursday Fr
• Friday

Sa

• Saturday So
• Sunday

Date of leaflet approval: 29.06.2022
[Information about the trademark]