Diemono

Package Leaflet: Information for the Patient

Diemono, 2 mg, coated tablets

Dienogest

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, 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 those not listed in this leaflet, they should inform 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 pack 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 the patient is allergic to dienogest or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a blood clot (thromboembolic disease) in the veins. This may occur, for example, in the blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also "Diemono and blood clots in the veins" below;
• if the patient has or has had a severe arterial disease, including cardiovascular disease, such as a heart attack, stroke, or angina pectoris (a condition that causes reduced blood flow to the heart). See also "Diemono and arterial blood clots" below;
• if the patient has diabetes with blood vessel damage;
• if the patient has or has had severe liver disease (and liver function tests have not returned to normal). Symptoms of liver disease may include yellowing of the skin and/or itching all over the body;
• if the patient has or has had a benign or malignant liver tumor;
• if the patient has or has had, or is suspected to have, a hormone-dependent malignant tumor, such as breast cancer or genital organ cancer;
• if the patient has unexplained vaginal bleeding.

If any of these conditions occur for the first time while taking Diemono, the patient should stop taking the medicine immediately and consult a doctor.

Warnings and precautions

While taking Diemono, the patient should not take 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 cautious when taking Diemono. Regular medical check-ups may be necessary. The patient should inform their doctor if they have any of the following conditions:

• if the patient has ever had a blood clot (venous thromboembolic disease) or a close family member has had a blood clot at a relatively young age;
• if a close family member has breast cancer;
• if the patient has ever had depression;
• if the patient has high blood pressure or develops high blood pressure while taking Diemono;
• if the patient develops liver disease while taking Diemono. Symptoms may include yellowing of the skin, eyes, or itching all over the body. The patient should inform their doctor if they have had such symptoms during a previous pregnancy;
• if the patient has diabetes or has had diabetes during a previous pregnancy;
• if the patient has ever had chloasma (yellow-brown patches on the skin, especially on the face). In such cases, the patient should avoid prolonged sun exposure or ultraviolet radiation;
• if the patient experiences abdominal pain while taking Diemono.

While taking Diemono, the patient's 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 had 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 muscular layer of the uterus, called adenomyosis, or uterine fibroids, may worsen while taking Diemono. If the bleeding is heavy and prolonged, it may lead to a decrease in the number of red blood cells (anemia), which can be severe in some cases. If the patient develops anemia, they should discuss with their doctor whether 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 blood clots in the veins

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-only medicines like Diemono. Very rarely, blood clots can cause severe, permanent disability or even death. The risk of blood clots in the veins increases:

• with age;
• if the patient is overweight;
• if the patient or a close family member has had a blood clot in the leg (deep vein thrombosis), lung (pulmonary embolism), or other organ at a young age;
• if surgery is planned, a serious accident occurs, or immobilization lasts for a long time. It is essential to inform the doctor in advance about taking Diemono, as treatment may need to be stopped. The doctor will advise when to restart Diemono. This is usually two weeks after recovery.

Diemono and arterial blood clots

There is limited evidence of a link between the use of progestogen-only medicines like 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 medicines. The risk of arterial blood clots increases:

• in women who smoke - it is strongly recommended to quit smoking when taking Diemono, especially if over 35 years old;
• if the patient is overweight;
• if a close family member has had a heart attack or stroke at a young age;
• if the patient has high blood pressure.

The patient should consult their doctor before taking Diemono.

Stop taking Diemono and consult a doctor immediately if the patient experiences any of the following symptoms of a blood clot:

• severe pain and/or swelling in 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 loss of vision or double vision;
• difficulty speaking or inability to speak;
• dizziness or fainting;
• weakness, strange feeling, or numbness in 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 slightly more common in women taking hormones compared to women not taking hormones, but it is not known if this is caused by the treatment. For example, it may be due to the fact that more tumors are detected and are detected earlier in women taking hormones because they are more frequently examined by a doctor. After stopping hormonal treatment, the frequency of breast tumors decreases over time. Regular breast checks are 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) may occur when taking Diemono. The use of Diemono may affect bone strength in young women (aged 12 to less than 18 years). Therefore, if the patient is under 18 years old, the doctor will individually weigh 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 minerals), the doctor will carefully weigh the benefits and risks of treating with Diemono, as Diemono has a moderate suppressive effect on estrogen production (another type of female hormone) in the body.

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 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 inform 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 effects on the ability to drive and use machines have been observed in patients 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 women (aged 12 to less than 18 years). Therefore, if the patient is under 18 years old, the doctor will individually weigh the benefits and risks of taking Diemono, considering possible risk factors for bone loss (osteoporosis).

Diemono contains lactose 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 it is essentially "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 if the doctor has not prescribed otherwise. The patient should follow the instructions below; otherwise, they will not get the full benefit of 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 one pack, the patient should start the next pack without a break in tablet intake. The patient should continue taking tablets during menstrual bleeding days.

Take more Diemono than prescribed

There are no reports of serious harmful effects after accidentally taking too many Diemono tablets. However, in case of doubts, the patient should consult their doctor.

Miss a dose of Diemono or experience vomiting or diarrhea

The effectiveness of Diemono will be reduced 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 with the next tablet at the usual 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.

Stop taking 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 treatment. 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, swollen stomach, 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 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 (excessive hair growth), 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 fungal infection, vaginal dryness, discharge, pelvic pain, or breast lump.

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Diemono

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after "EXP". 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 no longer required. This will help protect the environment.

6. Contents of the pack 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, corn starch, maltodextrin, magnesium stearate.

Tablet coating: Hypromellose 15 cP, lactose monohydrate, titanium dioxide (E171), macrogol 4000, sodium citrate.

What Diemono looks like and contents of the pack

Diemono tablets are white with the imprint "m" on one side. The tablets are packaged in PVC/PE/PVDC/Aluminum blisters. The pack contains 28 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o., ul. Dolna 21, 05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel, Münchener Straße 15, 06796 Brehna, Germany, SUN-FARM Sp. z o.o., ul. Dolna 21, 05-092 Łomianki, Date of last revision of the leaflet:02.2021