Package leaflet: Information for the patient

Diemono, 2 mg, coated tablets
Dienogestum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Diemono is and what it is used for
What you need to know before taking Diemono
How to take Diemono
Possible side effects
How to store Diemono
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 endometrial tissue). Diemono contains a hormone, a progestagen called dienogest.

2. Important information before taking Diemono

When not to use 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 venous thromboembolism (blood clot in the veins). This may occur, 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 disease 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 a benign or malignant liver tumour;
if the patient has or has had in the past, or there is suspicion of, a 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,
treatment should be stopped immediately and medical advice should be sought.
Warnings and precautions
While taking Diemono, hormonal contraceptives in any form (tablet, patch, vaginal ring) 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 in certain situations when using Diemono. Regular medical examinations may be necessary. Inform your doctor if any of the following apply:

if the patient has ever had a blood clot (venous thromboembolism) in the past or if a close relative had a blood clot at a relatively young age;
if a close relative 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 a previous pregnancy;
if the patient has diabetes or had gestational diabetes during a previous pregnancy;
if the patient has ever had chloasma (brownish patches on the skin, especially on the face). In such cases, avoid prolonged exposure to sunlight 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 while taking Diemono, there is a slightly increased risk of ectopic pregnancy (where the embryo develops outside the uterus).
Before starting Diemono, the patient should inform the doctor if she has previously had an ectopic pregnancy or has tubal disorders.
Diemono and severe uterine bleeding
Uterine bleeding, for example in women with a condition where the lining of the uterus (endometrium) 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.
If anaemia occurs, 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 patterns (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 thromboembolism) associated with the use of progestogen-containing medicines such as Diemono. Very rarely, blood clots may cause serious, permanent disability or even death.
The risk of venous blood clots increases:

with age;
if the patient is overweight;
if the patient or a close relative has had a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or another organ at a young age;
if surgery is planned, a serious accident has occurred, or prolonged immobilisation is expected. 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 the use of 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 due to taking these medicines.
The risk of arterial blood clots 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 relative of the patient had a myocardial infarction or stroke at a young age;
if the patient has high blood pressure.

Consult your doctor before taking Diemono.
Stop taking Diemono and contact your doctor immediately
if any possible symptoms of blood clots are observed, such as:

severe pain and/or swelling in one leg;
sudden severe chest pain, possibly radiating to the left arm;
sudden shortness of breath;
sudden cough without an obvious cause;
any unusual, severe, or persistent headache or worsening of migraines;
partial or complete blindness or double vision;
difficulty speaking or inability to speak;
dizziness or fainting;
weakness, unusual sensations, or numbness in any part of the body.

Diemono and cancer
Current 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 result from the fact that more tumours are detected and detected earlier in women taking hormones because they are examined more frequently by doctors. After stopping hormonal treatment, the incidence of breast cancer gradually decreases. Regular breast examinations are important, and you should contact your doctor if you feel a lump.
In rare cases, benign liver tumours have been reported in women using hormones, and even more rarely, malignant liver tumours. Contact your doctor if you experience extremely severe abdominal pain.
Diemono and osteoporosis
Changes in bone mineral density (BMD)
The 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 the patient is currently taking, has recently taken, or may take in the future. You should also inform any other doctor, dentist, or pharmacist prescribing another medicine that Diemono is being used.
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 (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, grapefruit juice should be avoided, 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 or operate machinery has been observed in patients taking Diemono.
Children and adolescents
Diemono must not be used in girls before their first menstrual period.
The 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 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 must always be taken as directed by the physician. In case of 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 should follow
these instructions carefully; otherwise, the patient may 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 fluid.
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 following 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 diarrhea
The effectiveness of Diemono may 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 daily at the usual time.
If vomiting occurs within 3–4 hours after taking Diemono or if severe diarrhea develops, there is a risk that the active substance may not be fully absorbed. This situation is similar to missing a tablet. If vomiting or severe diarrhea occurs within 3–4 hours after 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 recur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
These effects are more common during the first few 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 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 release, bloated abdomen, 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 effects (may affect up to 1 in 100 women):

anaemia
weight loss or increased appetite
anxiety, depression, or sudden mood changes
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, gingivitis
dry skin, excessive sweating, severe generalized itching, development of male-pattern 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 effects in adolescents (aged 12 to less than 18 years): loss of bone density.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects 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.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps 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: Monohydrate lactose, corn starch, maltodextrin, magnesium stearate.

Tablet coating:
Hypromellose 15 cP, monohydrate lactose, 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 packed in PVC/PE/PVDC/Aluminium blisters.
The pack contains 28 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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