Diemono

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Diemono (Metrissa)
2 mg, coated tablets
Dienogest
Diemono and Metrissa are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Diemono is and what it is 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 Diemono is and what it is used for

Diemono is used in the treatment of endometriosis (painful symptoms caused by abnormally located uterine mucous membrane). Diemono contains a hormone, a progestagen called dienogest.

2. Important information before taking Diemono

When not to use Diemono

• if the patient has hypersensitivity to dienogest or any of the other ingredients of this medicine (listed in section 6);
• if the patient has blood clot (venous thromboembolic disorder), for example in blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also “Diemono and venous blood clots” below;
• if the patient has or has had in the past severe arterial disease, including cardiovascular disorders such as myocardial infarction, stroke, or heart disease causing reduced blood flow (angina pectoris). See also “Diemono and arterial blood clots” below;
• if the patient has diabetes with blood vessel damage;
• if the patient has or has had in the past severe liver disease (and liver function parameters have not returned to normal). Symptoms of liver disease may include yellowing of the skin and (or) itching of the whole body;
• if the patient has or has had in the past benign or malignant liver tumour;
• if the patient has or has had in the past, or there is suspicion of malignant hormone-dependent tumour, such as breast cancer or genital organ tumour;
• if the patient has unexplained vaginal bleeding.

If any of these conditions occurs for the first time during treatment with Diemono,
the medicine must be discontinued immediately and a doctor should be consulted.
Warnings and precautions
While taking Diemono, hormonal contraceptives in any form (tablet, patch, vaginal system) must not be used.
Diemono is NOT a contraceptive. To prevent pregnancy, condoms or other non-hormonal contraceptive methods should be used.
Particular caution is required when using Diemono in certain situations. Regular medical examinations may be necessary. Inform your doctor if any of the following conditions apply to the patient:

• if the patient has ever had blood clot (venous thromboembolic disorder) in the past or if a close family member had a blood clot at a relatively young age;
• if a close family member of the patient has breast cancer;
• if the patient has ever had depression;
• if the patient has high blood pressure or develops high blood pressure during treatment with Diemono;
• if the patient develops liver disease while taking Diemono. Symptoms may include yellowing of the skin, eyes or itching of the whole body. Inform your doctor if such symptoms occurred during previous pregnancy;
• if the patient has diabetes or had gestational diabetes during previous pregnancy;
• if the patient has ever had chloasma (brownish-yellow patches on the skin, especially on the face). In such cases, avoid prolonged sun exposure or ultraviolet radiation;
• if the patient experiences lower abdominal pain while taking Diemono.

While taking Diemono, the chance of becoming pregnant is reduced because Diemono may affect ovulation.
If pregnancy occurs during treatment with Diemono, there is a slightly increased risk of ectopic pregnancy (the embryo develops outside the uterus).
Before starting Diemono, the patient should inform the doctor if she has had an ectopic pregnancy in the past or has tubal disorders.

Diemono and severe uterine bleeding
Uterine bleeding, for example in women with a condition where the endometrium (uterine lining) grows into the muscular layer of the uterus, known as adenomyosis, or benign uterine tumours, sometimes called uterine fibroids, may worsen during treatment with Diemono.
If bleeding is heavy and persists for a long time, it may lead to a reduced number of red blood cells (anaemia), which may be severe in some cases. In case of anaemia, discuss with your doctor whether discontinuation of Diemono is necessary.

Diemono and changes in bleeding pattern
Most women treated with Diemono experience changes in menstrual bleeding pattern (see section 4 “Possible side effects”).

Diemono and venous blood clots
Some studies suggest a slight, statistically non-significant increased risk of blood clots in the legs (venous thromboembolic disorder) associated with the use of progestogen-containing medicines such as Diemono. Very rarely, blood clots may lead to serious, permanent disability or even death.
The risk of venous blood clot increases:

• with age;
• if the patient is overweight;
• if the patient or a close family member had a blood clot in the leg (thrombophlebitis), lungs (pulmonary embolism), or another organ at a young age;
• if surgery is planned, a serious accident has occurred, or prolonged immobilisation is present. It is important to inform the doctor in advance about taking Diemono, as treatment may need to be discontinued. The doctor will advise when to restart Diemono. Usually, this is two weeks after recovery.

Diemono and arterial blood clots
There is limited evidence of an association between progestogen-containing medicines such as Diemono and an increased risk of arterial blood clots, for example in blood vessels of the heart (myocardial infarction) or brain (stroke). In women with hypertension, the risk of stroke may be slightly increased with the use of these medicines.
The risk of arterial blood clot increases:

• in women who smoke – quitting smoking is strongly recommended when taking Diemono, especially in women over 35 years of age;
• if the patient is overweight;
• if a close family member of the patient had myocardial infarction or stroke at a young age;
• if the patient has high blood pressure.

Consult your doctor before taking Diemono.
Discontinue taking Diemono and contact your doctor immediately if any possible symptoms of blood clot occur, such as:

• severe pain and (or) swelling in one leg;
• sudden severe chest pain, which may radiate to the left arm;
• sudden shortness of breath;
• sudden cough without obvious cause;
• any unusual, severe or persistent headache or worsening of migraine;
• partial or complete blindness or double vision;
• difficulty speaking or inability to speak;
• dizziness or fainting;
• weakness, unusual sensation or numbness in any part of the body.

Diemono and cancer
Current data do not clearly indicate whether Diemono increases or does not increase the risk of breast cancer. 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 caused by the treatment. For example, it may be due to the fact that more tumours are detected and detected earlier in women taking hormones because they are examined more frequently by a doctor. After stopping hormonal treatment, the incidence of breast cancer gradually decreases. Regular breast examinations are important, and the patient should contact the doctor if a lump is detected.
In rare cases, benign liver tumours have been reported in women using hormones, and even more rarely, malignant liver tumours. Contact your doctor if there is extremely severe abdominal pain.

Diemono and osteoporosis
Changes in bone mineral density (BMD)
Use of Diemono may affect bone strength in adolescents (aged 12 to less than 18 years). Therefore, if the patient is under 18 years of age, the doctor will individually assess the benefits and risks of using Diemono, taking into account possible risk factors for bone loss (osteoporosis).
If the patient is taking Diemono, she should ensure adequate intake of calcium and vitamin D through diet or supplements for bone health.
If the patient has an increased risk of developing osteoporosis (weakening of bones due to loss of bone minerals), the doctor will carefully consider the benefits and risks of treatment with Diemono, as Diemono has a moderate suppressive effect on the body's production of oestrogen (another type of female hormone).

Diemono and other medicines
Always inform your doctor about all medicines or herbal products currently or recently taken by the patient, or any other medicines the patient may take. Also inform any other doctor or dentist prescribing another medicine or a pharmacist about the use of Diemono.
Some medicines may affect the blood concentration of Diemono and reduce its effectiveness or cause adverse effects.
These include:

• medicines used to treat the following conditions:
• 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);
• St John's wort (Hypericum perforatum).

Consult your doctor or pharmacist before taking any medicine.

Diemono with food and drink
While taking Diemono, avoid drinking grapefruit juice, as it may increase the blood concentration of Diemono. This may increase the risk of adverse effects.

Laboratory tests
If the patient needs to have a blood test, she should inform the doctor or laboratory staff that she is taking Diemono, as Diemono may affect the results of certain tests.

Pregnancy, breastfeeding and fertility
Diemono must not be used during pregnancy or breastfeeding.

Driving and operating machinery
No effect on the ability to drive and operate machinery has been observed in patients taking Diemono.

Children and adolescents
Diemono must not be used in girls before their first menstrual period.
Use of Diemono may affect bone strength in adolescents (aged 12 to less than 18 years).
Therefore, if the patient is under 18 years of age, the doctor will individually assess the benefits and risks of using Diemono, taking into account possible risk factors for bone loss (osteoporosis).

Diemono contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. the medicine is considered “sodium-free”.

3. How to take Diemono

Diemono should always be taken as directed by your doctor. If in doubt,
contact your doctor or pharmacist.
The usual dose for adults is 1 tablet per day.
The following information applies to Diemono unless otherwise instructed by your doctor. You must follow
the instructions below, otherwise the patient will not obtain the full benefit of treatment with
Diemono.
Treatment with Diemono may be started on any day of the natural cycle.
Adults: Take one tablet daily, preferably at the same time each day, and if necessary, with a small amount of liquid. After finishing a pack, start the next pack immediately without a break. Continue taking tablets during menstrual bleeding days.
Taking more Diemono than recommended
There have been no reports of serious harmful effects after a single intake of an excessive number of Diemono tablets. However, if in doubt, contact your doctor.
Missing a dose of Diemono or experiencing vomiting or diarrhoea
The effectiveness of Diemono will be reduced if a tablet is missed. If one or more tablets are missed, take one tablet as soon as possible and continue taking one tablet at the usual time the next day.
If vomiting occurs within 3–4 hours after taking Diemono, or if severe diarrhoea occurs, there is a risk that the active substance in the tablet will not be absorbed by the body.
This situation is similar to that of a missed tablet. After vomiting or diarrhoea occurring within 3–4 hours of taking Diemono, take another tablet as soon as possible.
Do not take a double dose to make up for a missed tablet.
Stopping treatment with Diemono
If the patient stops taking Diemono, previous symptoms of endometriosis may return.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
These reactions are more common during the first months after starting Diemono and usually subside with continued use. Changes in bleeding pattern may also occur, such as spotting, irregular bleeding, or absence of menstruation.

Common adverse reactions (may affect up to 1 in 10 women):

• weight gain
• low mood, sleep disturbances, nervousness, loss of interest in sex, or mood changes
• headache or migraine
• nausea, abdominal pain, flatulence, bloating, or vomiting
• acne or hair loss
• back pain
• breast discomfort, ovarian cyst, or hot flushes
• uterine and (or) vaginal bleeding, including spotting
• weakness or irritability

Uncommon adverse reactions (may affect up to 1 in 100 women):

• anaemia
• weight loss or increased appetite
• anxiety, depression, or sudden mood swings
• autonomic nervous system imbalance (controls unconscious body functions, e.g. sweating) or attention disturbances
• dry eye
• tinnitus
• non-specific circulatory problems or palpitations
• low blood pressure
• shortness of breath
• diarrhoea, constipation, abdominal discomfort, gastritis, or gingivitis
• dry skin, excessive sweating, severe generalized itching, development of male-type hair growth (hirsutism), brittle nails, dandruff, skin inflammation, abnormal hair growth, photosensitivity reaction, or pigmentation disorders
• bone pain, muscle cramps, pain and (or) heaviness in arms and hands or legs and feet
• urinary tract infection
• vaginal fungal infection, genital dryness, discharge, pelvic pain, atrophic genital inflammation with discharge (atrophic vulvovaginitis), or breast lump(s)
• swelling due to fluid retention

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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Diemono

Keep this medicine out of the sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your 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: Monohydrate lactose, corn starch, maltodextrin, magnesium stearate.
  Tablet coating: Hypromellose, monohydrate lactose, titanium dioxide (E 171), macrogol 4000, sodium citrate.

What Diemono looks like and contents of the pack
Diemono tablets are white, with an "m" embossed on one side.
The tablets are packed in PVC/PE/PVDC/Aluminium blisters.
The pack contains 28 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Austria, 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, Poland

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

Austrian marketing authorisation number, country of export: 138899
Parallel import authorisation number: 263/22

Translation of the weekday symbols printed next to each tablet on the immediate packaging:
Mo – Monday
Di – Tuesday
Mi – Wednesday
Do – Thursday
Fr – Friday
Sa – Saturday
So – Sunday