Velenta

Package leaflet: Information for the user

Velenta, 10 mg, coated tablets
Dydrogesteronum
Please read the entire leaflet carefully before taking this 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 pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Velenta is and what it is used for

What Velenta is
Velenta contains an active substance called dydrogesterone.

• Dydrogesterone is a synthetic hormone.
• It is very similar to the hormone progesterone, naturally produced in the body.
• Medicines such as Velenta are known as progestagens.

What Velenta is used for
Velenta may be used alone or in combination with oestrogen. Concomitant use of oestrogen depends on the indication for treatment.
Velenta is used in the treatment of:

• Disorders caused by insufficient production of progesterone in the body, such as:
  • irregular menstruation
  • painful menstruation
  • endometriosis – a condition in which the uterine lining occurs outside the uterine cavity
  • secondary amenorrhoea
  • menstrual bleeding that is excessively heavy or occurs at irregular times (intermenstrual bleeding)
  • premenstrual syndrome
  • infertility due to low progesterone levels and for reducing the risk of miscarriage (treatment of habitual and threatened miscarriage).
• Symptoms of menopause as part of a treatment known as "hormone replacement therapy" or "HRT". Velenta may be used in combination with oestrogen to treat menopausal symptoms in women who still have their uterus. These symptoms vary among women.

How Velenta works
Normally, the body produces progesterone and another major female hormone, oestrogen, in appropriate proportions. Velenta is used to treat disorders that may occur when the body does not produce enough progesterone.
Your doctor may prescribe concomitant oestrogen with Velenta to restore hormonal balance.
In some women receiving HRT, taking oestrogen alone may cause endometrial hyperplasia. Endometrial hyperplasia may also affect endometriotic lesions previously diagnosed outside the uterus in women who have had their uterus removed. Taking dydrogesterone for part of the cycle prevents endometrial hyperplasia in these patients.

2. Important information before taking Velenta

When not to take Velenta:

• if the patient is allergic to dydrogesterone or any of the other ingredients of this medicine (listed in section 6)
• if the patient has or is suspected to have a tumour (growth) dependent on progesterone, such as meningioma
• if the patient has vaginal bleeding of unknown cause
• if Velenta is taken in combination with oestrogen, please also read the "When not to take" section in the patient information leaflet of the oestrogen-containing medicine
• in case of severe acute liver disease or disorders of bile pigment excretion (Dubin-Johnson syndrome, Rotor syndrome) or if these conditions occurred in the past
• if the patient has had or currently has liver tumours
• if the patient has thrombophlebitis or thromboembolic disorders (abnormal blood clot formation in blood vessels)
• meningioma or history of meningioma.

Warnings and precautions
If Velenta must be taken due to abnormal bleeding,
the doctor will determine the cause of the bleeding before starting treatment with this medicine.
Usually, unexpected vaginal bleeding or spotting is not a reason for concern.
This commonly occurs especially during the first few months of taking Velenta.
However, you should contact your doctor immediately if bleeding or spotting:

• lasts longer than a few months
• occurs after some time from the start of treatment
• occurs even after stopping treatment. These may be symptoms of endometrial hyperplasia (overgrowth of the uterine lining). Your doctor will investigate the cause of bleeding or spotting and may recommend tests to rule out endometrial cancer.

Note: Velenta is not a contraceptive and does not prevent pregnancy.
You should stop taking Velenta and contact your doctor immediately if you notice any of the following symptoms:

• occurrence of any condition listed under "When not to take Velenta"
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver disease
• swelling of the face, tongue and (or) throat and (or) difficulty swallowing or hives accompanied by breathing difficulties, which may indicate angioedema
• significant increase in blood pressure (symptoms may include headache, fatigue, dizziness)
• migraine-like headache or unusually severe headache occurring for the first time
• sudden visual disturbances
• if you notice symptoms of venous thrombosis, such as:
  • painful swelling and redness of the legs;
  • sudden chest pain;
  • difficulty breathing. For more information, see section "Blood clots in veins (thrombosis)".

When to exercise particular caution when taking Velenta
Inform your doctor before starting treatment if you have ever had any of the following health problems, as they may recur or worsen during treatment with Velenta. If any of these apply to you, you should have more frequent check-ups:

• porphyria (inherited metabolic disorder with impaired formation of haem, the red blood pigment)
• depression
• abnormal liver function test results due to acute or chronic liver disease
• cholestatic jaundice and (or) itching.

Inform your doctor if you have:

• stroke (including in the past)
• high blood pressure.

Velenta and HRT
HRT carries certain risks in addition to its benefits, which you and your doctor must consider before starting treatment. If you are taking Velenta together with oestrogen as part of HRT, the following information is important. You should also read the patient leaflet included with the oestrogen-containing medicine.
Early menopause
Limited data are available on the risks of HRT use in women with premature menopause (due to ovarian failure or surgical intervention). The risk is lower in younger women. This means that the benefit-risk ratio of HRT may be more favourable in younger women than in older women.
Medical examinations
Before starting (or restarting) HRT, your doctor will take a medical and family history. Your doctor may decide to perform a physical examination, which may include breast and (or) pelvic examination if necessary. After starting HRT, your doctor may recommend regular check-ups (at least once a year). During these check-ups, your doctor will discuss the benefits and risks of continuing HRT. You should have regular breast examinations as recommended by your doctor.
Endometrial hyperplasia and endometrial cancer:
Taking oestrogen-only HRT increases the risk of endometrial hyperplasia (overgrowth of the uterine lining) and endometrial cancer in women with an intact uterus.
Taking Velenta together with oestrogen (for at least 12 days per month in a 28-day cycle) or as continuous combined oestrogen-progestogen therapy can prevent this additional risk.
Breast cancer
Evidence confirms that taking hormone replacement therapy (HRT) containing oestrogen and progestogen, or oestrogen alone, increases the risk of breast cancer. The additional risk depends on the duration of HRT use. This additional risk becomes apparent after about 3 years (1–4 years) of HRT use. After stopping HRT, the additional risk gradually decreases over time, but the risk may persist for 10 years or longer if HRT lasted more than 5 years.
Comparison
Among women aged 50 to 54 years who do not use HRT, breast cancer will be diagnosed over a 5-year period in an average of 13 to 17 women per 1000.
Among women aged 50 who start oestrogen-only HRT for 5 years, there will be 16–17 cases per 1000 users (i.e. 0 to 3 additional cases).
Among women aged 50 who start oestrogen-progestogen HRT for 5 years, there will be 21 cases per 1000 users (i.e. 4 to 8 additional cases).
Among women aged 50 to 59 who do not use HRT, breast cancer will be diagnosed over a 10-year period in an average of 27 women per 1000.
Among women aged 50 who start oestrogen-only HRT for 10 years, there will be 34 cases per 1000 users (i.e. 7 additional cases).
Among women aged 50 who start oestrogen-progestogen HRT for 10 years, there will be 48 cases per 1000 users (i.e. 21 additional cases).
You should have regular breast examinations. Consult your doctor if you notice any changes such as:

• skin indentation;
• changes in the nipple;
• any visible or palpable lumps. In addition, participation in mammographic screening programmes is recommended if available. For mammography, it is important to inform the staff performing the X-ray that you are taking HRT, as this medicine may increase breast density, which may affect mammography results. With increased breast density, mammography may not detect all lumps.

Ovarian cancer
Ovarian cancer is rare – significantly rarer than breast cancer. Use of oestrogen-only HRT or combined oestrogen-progestogen HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, among women aged 50 to 54 who do not use HRT, ovarian cancer will be diagnosed over a 5-year period in about 2 women per 2000.
Among women who used HRT for 5 years, it will occur in about 3 women per 2000 users (i.e. about one additional case).
Meningioma
Use of Velenta is associated with the development of usually benign tumours of the tissue layer between the brain and the skull (meningioma). If a meningioma is diagnosed in the patient, the doctor will discontinue treatment with Velenta (see section "When not to take Velenta"). If the patient notices any symptoms such as visual disturbances (e.g. double or blurred vision), hearing loss or tinnitus, loss of smell, progressively worsening headaches, memory loss, seizures, or weakness of hands or legs, she should inform her doctor immediately.
Blood clots in veins (thrombosis)
HRT increases the risk of venous blood clots. This risk is 3 times higher than in women not using HRT. The risk is highest during the first year of HRT use.
Blood clots can be life-threatening; if a clot travels to the lungs, it may cause chest pain, shortness of breath, fainting, or even death.
The likelihood of developing a venous blood clot increases with age and if any of the following situations apply. Inform your doctor if any of the following apply to you:

• if you are immobile for a long time due to major surgery, injury or illness;
• if you are significantly overweight (BMI > 30 kg/m²);
• if you have any blood clotting disorders requiring long-term anticoagulant treatment;
• a close relative has ever had a blood clot in the leg, lungs or another organ;
• if you have systemic lupus erythematosus (SLE);
• if you have cancer;
• use of oestrogens;
• if you are elderly;
• pregnancy or the period shortly after childbirth.

Comparison
Among women aged 50 who do not use HRT, about 4 to 7 per 1000 can be expected to develop a venous blood clot over a 5-year period.
Among women aged 50 who use oestrogen-progestogen HRT for more than 5 years, there will be 9 to 12 cases per 1000 users (i.e. 5 additional cases).
If you experience painful leg swelling, sudden chest pain or difficulty breathing, you should:

• contact your doctor immediately
• stop taking HRT until your doctor decides whether to resume treatment. These may be symptoms of blood clots.

You should also inform your doctor or pharmacist if you are taking anticoagulant (blood-thinning) medicines such as warfarin. Your doctor will pay special attention to the benefits and risks of HRT use.
Planned surgery
If you are scheduled for surgery, inform the surgeon that you are taking Velenta. It may be necessary to stop taking Velenta about 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2, "Blood clots in veins (thrombosis)"). Your doctor will inform you when you can restart taking Velenta.
Heart disease
HRT does not prevent heart disease. Women taking oestrogen and progestogen as part of HRT have a slightly higher likelihood of heart disease than women not using HRT. The risk of heart disease increases with age. The number of additional cases of heart disease due to oestrogen-progestogen HRT is very small in healthy women with early signs of perimenopause but before menopause. The number of additional cases increases with age.
If you experience chest pain radiating to the arm or neck, you should:

• contact your doctor immediately
• stop taking HRT until your doctor resumes treatment.

This pain may be a symptom of myocardial infarction.
Stroke
Use of HRT as oestrogen-progestogen therapy or oestrogen-only therapy increases the risk of stroke. This risk is up to 1.5 times higher than in women not using HRT. The increased risk in HRT users compared to non-users does not change with age or time since menopause. However, since the risk of stroke is strongly age-dependent, the overall risk of stroke in women using HRT increases with age.
Comparison
Among women over 50 who do not use HRT, an average of 8 per 1000 can be expected to have a stroke over a 5-year period.
Among women over 50 who use HRT, there will be 11 cases per 1000 users over a 5-year period (i.e. 3 additional cases).
You should inform your doctor immediately if you notice any first signs of adverse reactions, become pregnant, or experience abnormal bleeding.
Use in children and adolescents under 18 years of age
Velenta is not intended for use in children before the onset of first menstrual bleeding. Velenta is not recommended for adolescents aged 12 to 18 years due to insufficient data on safety and efficacy.
Velenta and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription and herbal medicines.
Some medicines may affect the action of Velenta, potentially reducing its effectiveness. These include:

• antiepileptic medicines used to treat epilepsy (e.g. phenobarbital, carbamazepine, phenytoin)
• medicines used to treat infections (e.g. rifampicin, rifabutin, nevirapine, efavirenz)
• medicines used to treat HIV infection [AIDS] (e.g. ritonavir, nelfinavir)
• herbal medicines containing St John's wort (Hypericum perforatum), sage or ginkgo.

Progesterone, on the other hand, may reduce the effect of medicines that lower blood sugar levels.
Velenta with food and drink
Velenta can be taken with or without food.
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before taking this medicine.
Pregnancy
There is currently no evidence that use of Velenta during pregnancy is harmful.

• If you are pregnant, you should consult your doctor before taking Velenta.
• If you become pregnant or suspect you are pregnant, contact your doctor. Your doctor will discuss the benefits and risks of taking Velenta during pregnancy.

There may be an increased risk of hypospadias (a congenital malformation of the penis where the urethral opening is in an abnormal location) in children whose mothers took certain progestogens. However, this increased risk has not yet been confirmed. It is estimated that over 10 million pregnant women have taken dydrogesterone.
Breastfeeding
Do not take Velenta during breastfeeding. It is not known whether Velenta passes into breast milk or affects the infant. Studies with other progestogens have shown that they pass into human milk in small amounts.
Fertility
There is no evidence that dydrogesterone reduces fertility when taken as directed by a doctor.
Driving and operating machinery
After taking Velenta, mild drowsiness or dizziness may occur. This is more likely during the first few hours after taking the medicine. If you experience these symptoms, do not drive or operate tools or machinery. You should wait and observe how the medicine affects you before deciding to drive or operate tools or machinery.
Velenta contains lactose
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to take Velenta

This medicine should always be taken as directed by the doctor. If in doubt,
consult the doctor. The doctor will adjust the dose according to individual needs.
Taking this medicine
Swallow the tablet with water.
The tablet may be taken with or without food.
If the patient is taking more than one tablet per day, the doses should be
taken at evenly spaced intervals throughout the day; for example, one tablet in the morning and one in the evening.
Try to take the tablets at the same time each day. This helps maintain a constant level of
medicine in the body. It also helps to remember to take the tablets.
How much medicine to take
The number of tablets taken and the days on which Velenta is taken depend on the indication. The doctor
will decide when it is best to take Velenta. If the patient still has menstrual periods, day 1
of the cycle is the first day of bleeding. If the patient no longer has natural periods,
the doctor will decide when day 1 of the cycle falls and when to start taking the tablets.
Use in the treatment of painful menstruation

• Take 1 or 2 tablets per day.
• Use only from day 5 to day 25 of the cycle.

Use in the treatment of endometriosis

• Take 1 to 3 tablets per day.
• The doctor will instruct to take the tablets:
  • Every day of the cycle or
  • Only from day 5 to day 25 of the cycle.

Use in the treatment of secondary amenorrhoea

• Take 1 or 2 tablets per day.
• Use for 14 days during the second half of the expected cycle.

Use in the treatment of irregular menstruation

• Take 1 or 2 tablets of Velenta per day.
• The medicine should be taken from the second half of the cycle until the first day of the next menstruation.
• The day treatment is started and the number of days the medicine is taken depend on the length of the cycle.

Use in the treatment of abnormal uterine bleeding

• For treatment aimed at stopping bleeding:
  • Take 2 or 3 tablets per day.
  • Use for up to 10 days.
• For continuous treatment:
  • Take 1 or 2 tablets per day.
  • Use during the second half of the cycle.
• The day treatment is started and the number of days the medicine is taken depend on the length of the cycle.

Use in the treatment of premenstrual syndrome

• Take 2 tablets per day.
• Use from the second half of the cycle until the first day of the next cycle.
• The day treatment is started and the number of days the medicine is taken depend on the length of the cycle.

Use to reduce the risk of miscarriage (treatment of habitual and threatened miscarriages)

• In patients who have not previously miscarried:
  • Take one dose containing up to 4 tablets.
  • Then take 2 or 3 tablets per day until symptoms subside.
• In patients who have previously miscarried:
  • Take 2 tablets per day.
  • Use until the 12th week of pregnancy.

Use in infertility due to low progesterone levels

• Take 1 or 2 tablets per day.
• Use from the second half of the cycle until the first day of the next cycle.
• The day treatment is started and the number of days the medicine is taken depend on the length of the cycle.
• Treatment should continue for at least 3 consecutive cycles.

Use in the treatment of menopausal symptoms (HRT)
In hormone replacement therapy combined with an oestrogen-containing medicine:

• If the patient is using HRT in a "continuous sequential" regimen (taking an oestrogen tablet or applying an oestrogen patch or gel throughout a 28-day cycle):
  • 1 tablet of Velenta should be taken once daily during the last 14 days of each 28-day cycle.
• If the patient is using HRT in a "cyclical" regimen (taking an oestrogen tablet or applying an oestrogen patch or gel usually for 21 days, followed by a 7-day treatment-free interval):
  • 1 tablet of Velenta per day should be taken during the last 12 to 14 days of oestrogen use.
  • If necessary, the doctor may increase the dose to 2 coated tablets per day.

After taking the last coated tablet of Velenta, a withdrawal bleed resembling a menstrual period occurs.
The doctor will prescribe the lowest possible dose, and treatment of symptoms should be as short as
possible. Contact the doctor if the patient feels the dose is too strong or
too weak.
Use in children and adolescents under 18 years of age
Velenta is not intended for use in children before the onset of first menstrual bleeding.
Velenta is not recommended for adolescents aged 12 to 18 years due to insufficient data on safety and efficacy.
Taking more than the recommended dose of Velenta
It is unlikely that taking too many tablets of Velenta by the patient (or another person) would be harmful. If in doubt, contact the doctor.
Missing a dose of Velenta

• If the patient forgets to take a tablet on a given day and less than 12 hours have passed since it should have been taken, the tablet should be taken as soon as remembered. The next tablet should be taken the following day at the usual time.
• If the patient forgets to take a tablet on a given day and more than 12 hours have passed since it should have been taken, the missed tablet should be skipped. The next tablet should be taken the following day at the usual time, and treatment should continue as usual.
• Do not take a double dose to make up for a missed dose.
• If a dose is missed, there is an increased likelihood of irregular bleeding or spotting.

Stopping treatment with Velenta
Do not stop taking Velenta without consulting the doctor.
If there are any further questions about the use of this medicine, consult
the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with Velenta alone.
Adverse reactions occurring during treatment with Velenta alone
If any of the adverse reactions listed below occur, treatment with Velenta must be stopped immediately and medical advice must be sought:

• Liver disorders – symptoms may include yellowing of the skin or whites of the eyes (jaundice), weakness, general feeling of nausea or abdominal pain (may occur in fewer than 1 in 100 patients)
• Hypersensitivity reactions – symptoms may include difficulty breathing or systemic symptoms such as nausea, vomiting, diarrhoea or low blood pressure (may occur in fewer than 1 in 1000 patients)
• Skin swelling of the face and throat area, which may cause difficulty breathing (may occur in fewer than 1 in 1000 patients). If any of the above adverse reactions occur, treatment with Velenta must be stopped immediately and medical advice must be sought.

Other adverse reactions occurring during treatment with Velenta alone
Common (may occur in fewer than 1 in 10 patients)
Migraine, headache, nausea, breast tenderness or pain, menstrual bleeding disorders:
irregular, heavy or painful menstrual bleeding, absence of menstruation, or menstruation occurring less frequently than usual.
Uncommon (may occur in fewer than 1 in 100 patients)
Weight gain, dizziness, depressed mood, vomiting, skin hypersensitivity reactions such as rash, severe itching or urticaria.
Rare (may occur in fewer than 1 in 1000 patients)
Somnolence, breast swelling, anaemia due to increased breakdown of red blood cells (haemolytic anaemia), fluid retention causing oedema, frequently affecting the lower legs or ankles, increase in size of progestagen-dependent tumours (e.g. meningioma).
In younger patients, adverse reactions are expected to be similar to those observed in adult women.

Adverse reactions occurring during treatment with Velenta combined with oestrogen
(HTZ – oestrogen with progestagen)
When taking Velenta with oestrogen, the patient leaflet included with the oestrogen-containing medicine should also be consulted. For further information on the adverse reactions listed, see section “Important information before taking Velenta”.

If any of the adverse reactions listed below occur, treatment with Velenta must be stopped immediately and medical advice must be sought:

• Painful swelling of the legs, sudden chest pain or difficulty breathing. These may be symptoms of blood clots;
• Chest pain radiating to the arm or neck. These may be symptoms of myocardial infarction;
• Severe, unexplained headache or migraine (possibly accompanied by visual disturbances). These may be symptoms of stroke. If any of the listed adverse reactions occur, treatment with Velenta must be stopped immediately and medical advice must be sought.

Medical advice must be sought immediately if the patient notices:

• Skin indentation of the breast(s), changes in the nipple, or visible or palpable lumps. These may be symptoms of breast cancer.

Other adverse reactions occurring during treatment with Velenta combined with oestrogen include:

• Excessive growth of the endometrial lining
• Endometrial cancer
• Ovarian cancer

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 .
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Velenta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Velenta contains

• The active substance is dydrogesterone.
• Each coated tablet contains 10 mg of dydrogesterone.
• Other ingredients are:
  Tablet core: monohydrate lactose, hypromellose, corn starch, colloidal anhydrous silica, magnesium stearate.
  Tablet coating: hypromellose, macrogol 400, titanium dioxide (E 171).

What Velenta looks like and contents of the pack
White, round (diameter approximately 7 mm), biconvex coated tablet, marked with
“L1” on one side and unmarked on the other side.
The tablets are packed in PVC/PVDC/Aluminium blisters, in a cardboard box. The pack contains
10, 20, 28, 56 or 84 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
e-mail: [email protected]

Manufacturer
Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida Agreda 31, Ólvega
42110 Soria
Spain

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Document signed by
Agnieszka Tenerowicz-Możdżyńska
Date: 2026.01.20 11:04:24 CET