Diemono

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! 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 drug.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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 patient should stop taking it immediately and consult a doctor.

Warnings and precautions

While taking Diemono, the patient should not use hormonal contraceptives in any form (pill, patch, intrauterine system). Diemono is NOT a contraceptive. To prevent pregnancy, the patient should use condoms or other non-hormonal contraceptives. In some situations, the patient should be particularly careful when taking Diemono. Regular medical examinations may be necessary. The patient should inform their doctor if they have any of the following conditions:

While taking Diemono, the chance of getting pregnant is reduced, as Diemono may affect ovulation. If the patient becomes pregnant 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 their 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 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. If the patient has anemia, they should discuss with their doctor whether it is necessary to stop taking Diemono.

Diemono and changes in bleeding profile

Most women treated with Diemono experience changes in menstrual bleeding profile (see section 4 "Possible side effects").

Diemono and venous blood clots

Some studies suggest that there may be a slightly increased 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 patient should consult their doctor before taking Diemono.

The patient should stop taking Diemono and immediately consult their doctor if they notice any possible symptoms of a blood clot, 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 whether this is due to treatment. For example, it 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 patient should consult their doctor if they notice a lump. In rare cases, women taking hormones have reported benign liver tumors, and in even rarer cases, malignant liver tumors. The patient should consult their doctor if they experience severe abdominal pain.

Diemono and osteoporosis

Changes in bone mineral density (BMD) 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 takes 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 weakness due to loss of bone mineral substances), the doctor will carefully assess the benefits and risks of treating with Diemono, as Diemono has a moderate estrogen-suppressing effect.

Diemono and other medicines

The patient should always inform their doctor about all medicines or herbal products they are currently taking or have recently taken, or any other medicines they may take. The patient should also tell any other doctor or dentist prescribing another medicine or pharmacist 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 patient should consult their doctor or pharmacist.

Diemono with food and drink

While taking Diemono, the patient should avoid drinking grapefruit juice, 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 their 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. Taking 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 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 the medicine is considered "sodium-free".

3. How to take Diemono

Diemono should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The usual dose for adults is one tablet per day. The following information applies to Diemono, unless the doctor has prescribed otherwise. The patient should follow the instructions below; otherwise, they will not get the full benefits of taking Diemono. Treatment with Diemono can be started on any day of the natural cycle. Adults: The patient should take one tablet daily, preferably at the same time, with a small amount of liquid if necessary. After finishing the packaging, the patient should start the next one without interruption. The patient should continue taking the tablets 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 patient should consult their doctor.

Missing a dose of Diemono or experiencing vomiting or diarrhea

The effect of Diemono will be less effective if the patient misses a dose. If the patient misses one or more tablets, they should take only one tablet as soon as possible and continue taking the next tablet at the same time the next day. If the patient vomits within 3-4 hours of taking Diemono or experiences severe diarrhea, 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 dose. After vomiting or diarrhea within 3-4 hours of taking Diemono, the patient should take the next tablet as soon as possible. The patient should not take a double dose to make up for the missed tablet.

Stopping Diemono

If the patient stops taking Diemono, their previous endometriosis symptoms may return. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

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, abdominal distension, or vomiting
• acne or hair loss
• back pain
• breast discomfort, ovarian cyst, or hot flashes
• uterine 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 heart palpitations
• low blood pressure
• shortness of breath
• diarrhea, constipation, abdominal discomfort, gastritis, or gum inflammation
• 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, or feeling of heaviness in the arms or legs
• urinary tract infection
• vaginal thrush, vaginal dryness, discharge, pelvic pain, or breast lump
• edema due to fluid retention.

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered 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. The patient should not use this medicine 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 patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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: lactose monohydrate, corn starch, 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 a PVC/PE/PVDC/Aluminum blister pack in a cardboard box. The packaging contains 28 coated tablets. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number:138899

Parallel import authorization number: 23/22

Translation of day-of-the-week symbols on the packaging:
Mo –Monday
Di –Tuesday
Mi– Wednesday
Do– Thursday
Fr– Friday
Sa– Saturday
So –Sunday.
Leaflet approval date: 05.01.2022
[Information about the trademark]