Package leaflet: Information for the user

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

Table of contents

What Dydrogesterone Polpharma is and what it is used for
Important information before taking Dydrogesterone Polpharma
How to take Dydrogesterone Polpharma
Possible side effects
How to store Dydrogesterone Polpharma
Contents of the pack and other information

1. What Dydrogesterone Polpharma is and what it is used for

What Dydrogesterone Polpharma is
Dydrogesterone Polpharma contains the active substance called "dydrogesterone".

Dydrogesterone is a synthetic hormone.
Dydrogesterone is very similar to the natural hormone progesterone produced in the body.
Medicines such as Dydrogesterone Polpharma are known as progestogens.

What Dydrogesterone Polpharma is used for
Dydrogesterone Polpharma may be used alone or in combination with oestrogen. Whether oestrogen is taken at the same time depends on the reason why the patient is taking the medicine.
Dydrogesterone Polpharma is used:
For symptoms caused by insufficient production of progesterone by the body, such as:

menstrual cycle disorders.

In the treatment of menopausal symptoms – this treatment is known as Hormone Replacement Therapy (HRT).
This medicine may be used in combination with oestrogen to treat menopausal symptoms in women who still have their uterus. Menopausal symptoms vary among women.
How Dydrogesterone Polpharma works
Normally, the body produces balanced amounts of natural progesterone and natural oestrogen (another important female hormone) in appropriate proportions. If the body does not produce sufficient progesterone on its own, Dydrogesterone Polpharma is used to treat the resulting disorders.
Your doctor may also prescribe concomitant oestrogen therapy with Dydrogesterone Polpharma to achieve appropriate hormonal balance. In some women receiving HRT, taking oestrogen alone may lead to endometrial hyperplasia (thickening of the lining of the uterus). This may also occur in women who have had a hysterectomy or who have a history of endometriosis (presence of endometrial tissue outside the uterus). Taking dydrogesterone for part of the cycle prevents endometrial hyperplasia in these women.

2. Important information before using Dydrogesterone Polpharma

When not to use Dydrogesterone Polpharma

If the patient is allergic to dydrogesterone or any of the other ingredients of Dydrogesterone Polpharma (listed in section 6).
If the patient has or there is a justified suspicion of a tumour dependent on progesterone, called meningioma.
If the patient has vaginal bleeding of unknown cause.
If Dydrogesterone Polpharma is used in combination with oestrogen, please also read the section "When not to take" in the package leaflet of the oestrogen-containing medicine.
In case of severe liver function disorders or disorders of bile pigment excretion (Dubin-Johnson syndrome, Rotor syndrome) or if these diseases occurred in the past.
In case of previous or existing liver tumours.
If the patient has thrombophlebitis or thromboembolic disease (pathological formation of blood clots in blood vessels).

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

lasts longer than several months,
occurs after some time since starting treatment,
occurs even after stopping treatment. These may be symptoms of endometrial hyperplasia (overgrowth of the lining of the uterus). The doctor will investigate the cause of bleeding or spotting and may recommend testing for endometrial cancer.

Note: Dydrogesterone Polpharma is not a contraceptive medicine and does not prevent pregnancy.
You must stop taking Dydrogesterone Polpharma and contact your doctor immediately
if you experience any of the following symptoms:

occurrence of a condition listed in the section "When not to use Dydrogesterone Polpharma";
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, together with breathing difficulties, suggesting angioedema;
significant increase in blood pressure (symptoms may include headache, fatigue, dizziness);
migraine-like headache or unusually severe headache occurring for the first time;
acute visual disturbances;
if you notice symptoms of blood clots, such as:
- painful swelling and redness of the legs;
- sudden chest pain;
- difficulty breathing;

For more information, see "Blood clots in veins (venous thrombosis)".
When to exercise special caution when using Dydrogesterone Polpharma
Before starting treatment, inform your doctor if you have ever had any of the following conditions, as they may recur or worsen during treatment with Dydrogesterone Polpharma. In such cases, more frequent check-ups with your doctor may be necessary:

porphyria (hereditary metabolic disorder affecting the production of haem, the red pigment in blood);
depression;
abnormal liver function tests due to acute or chronic liver disease;
jaundice and (or) itching.

Inform your doctor if you have:

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

Dydrogesterone Polpharma and Hormone Replacement Therapy (HRT)
HRT use involves risks that should be considered when deciding whether to start or continue taking the medicine. If you are taking Dydrogesterone Polpharma with oestrogen as part of HRT, the following information is important. Please also read the package leaflet of the oestrogen-containing medicine.

Early menopause
Experience in treating women with premature menopause (due to ovarian failure or surgical intervention) is limited. If you have premature menopause, the risks associated with HRT may differ. Please discuss this with your doctor.

Medical examinations/Check-ups
Before starting (or restarting) HRT, your doctor will take a medical and family history. The doctor may decide to perform a physical examination, which may include breast examination and (or) pelvic examination if necessary. After starting HRT, your doctor may recommend regular check-ups (at least once a year). During these visits, your doctor will discuss the benefits and risks of continuing HRT. You should have regular breast examinations as recommended by your doctor.

Endometrial hyperplasia (excessive thickening of the lining of the uterus) and endometrial cancer:
Taking HRT with oestrogen alone increases the risk of endometrial hyperplasia and endometrial cancer. Taking Dydrogesterone Polpharma together with oestrogen (for at least 12 days per month in a 28-day cycle) or as continuous combined oestrogen-progestagen therapy can prevent this additional risk.

Breast cancer
There is evidence that combined oestrogen-progestagen HRT or oestrogen-only HRT increases the risk of breast cancer. This risk depends on how long HRT is used. The additional risk becomes apparent after about 3 years of HRT use. After stopping HRT, the risk decreases over time but may persist for 10 years or longer if HRT was used for more than 5 years.

Comparison:
Among women aged 50–54 who do not use HRT, an average of 13–17 cases of breast cancer per 1000 women are diagnosed within 5 years.
Among women aged 50 who start oestrogen-only HRT for 5 years, there are 16–17 cases per 1000 users (i.e. 0 to 3 additional cases).
Among women aged 50 who start combined HRT for 5 years, breast cancer is detected in 21 per 1000 women (i.e. 4–8 additional cases of breast cancer).
Among women aged 50–59 who do not use HRT, an average of 27 per 1000 women are diagnosed with breast cancer within 10 years.
Among women aged 50 who start oestrogen-only HRT for 10 years, there are 34 cases of breast cancer per 1000 users (i.e. 7 additional cases).
Among women aged 50 who start combined HRT for 10 years, breast cancer occurs in 48 per 1000 users (i.e. 21 additional cases of breast cancer).
Regularly examine your breasts. Contact your doctor if you notice any changes such as:

skin lumps,
changes in the nipple,
any visible or palpable lumps.

If you have the opportunity to participate in a breast cancer screening programme (mammography screening), it is advisable to take advantage of this offer. Inform the person performing the mammogram that you are taking a medicine used in HRT. Medicines used in HRT may cause increased breast density, which can affect mammography results. If breast tissue density is increased, it may not be possible to detect all abnormalities.

Ovarian cancer
Ovarian cancer is rare – significantly rarer than breast cancer. Using oestrogen-only or combined oestrogen-progestagen HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, among women aged 50–54 who do not use HRT, about 2 cases of ovarian cancer per 2000 women are diagnosed within 5 years. Among women using HRT for 5 years, about 3 cases per 2000 users (i.e. about 1 additional case).

Effect of HRT on the heart and circulation
Blood clots in veins (venous thrombosis):
The risk of venous blood clots is about 1.3 to 3 times higher in HRT users than in non-users, especially during the first year of use.
Venous blood clots can be serious; if they reach the lungs, they may cause chest pain, breathlessness, fainting, or even death.
The likelihood of venous blood clots increases with age and if any of the following apply, inform your doctor:

you cannot walk for a long time due to major surgery, injury or illness;
you are significantly overweight (BMI >30 kg/m²);
you have any blood clotting disorders requiring long-term treatment with anticoagulant medicines;
if any close relative has ever had a blood clot in the leg, lungs or another organ;
you have systemic lupus erythematosus (SLE);
you have cancer.

Comparison:
Among women aged 50 who do not use HRT, an average of 4 to 7 per 1000 would be expected to develop a venous blood clot over more than 5 years.
Among women aged 50 who use oestrogen-progestagen HRT for more than 5 years, this would be 9 to 12 cases per 1000 users (i.e. 5 additional cases).

Heart disease (heart attack):
There is no evidence that HRT prevents heart attacks. Women over 60 who use oestrogen-progestagen HRT are slightly more likely to develop heart disease than those who do not use HRT.

Stroke:
The risk of stroke is about 1.5 times higher in women using HRT than in those who do not use HRT. The number of additional stroke cases caused by HRT use will increase with age.

Comparison:
Among women aged 50 who do not use HRT, an average of 8 per 1000 can be expected to have a stroke within 5 years.
Among women aged 50 using HRT, there are 11 cases per 1000 users within 5 years (i.e. 3 additional cases).
You should contact your doctor immediately if you experience first signs of adverse reactions, become pregnant or have abnormal bleeding.

Children and adolescents under 18 years of age
Dydrogesterone Polpharma is not intended for use in children before the first menstrual bleeding. Dydrogesterone Polpharma is not recommended for adolescents aged 12 to 18 due to insufficient data on safety and efficacy.

Dydrogesterone Polpharma and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those you plan to take, even if they are available without a prescription.
Some medicines may affect the action of Dydrogesterone Polpharma, 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 preparations containing St John's wort (Hypericum perforatum), licorice root, sage or Japanese knotweed.

Conversely, progesterone may reduce the effect of blood sugar-lowering medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.

Pregnancy
In children whose mothers used certain progestagens, the risk of hypospadias (a congenital malformation of the penis involving the urethral opening) may be increased. However, this increased risk has not yet been confirmed. Dydrogesterone has been used by an estimated over 10 million pregnant women. To date, there is no evidence that taking dydrogesterone during pregnancy is harmful.

Breastfeeding
Breastfeeding is not recommended during treatment with Dydrogesterone Polpharma. It is not known whether Dydrogesterone Polpharma passes into breast milk or affects the infant. Studies with other progestagens show that small amounts of these medicines pass into breast milk.

Fertility
There is no evidence that dydrogesterone, when taken as prescribed by a doctor, reduces fertility.

Driving and operating machinery
After taking Dydrogesterone Polpharma, mild drowsiness or dizziness may occur. This is more likely during the first few hours after taking the medicine than later. If this occurs, do not drive or operate tools or machinery. Wait a while to see how Dydrogesterone Polpharma affects your ability to drive, use tools or operate machinery.

Dydrogesterone Polpharma contains lactose
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to use Dydrogesterone Polpharma

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist. The doctor will adjust the dose according to the patient's needs.
Taking this medicine
Swallow the tablet with water.
The tablet may be taken with or without food.
If the patient needs to take more than one tablet, they should be taken at evenly spaced intervals throughout the day.
For example, take one tablet in the morning and one in the evening.
Try to take the tablet at the same time each day. This helps maintain a constant level of medicine in the body
and also helps remember to take the tablets.
How many tablets to take
The number of tablets taken and the days on which they are taken depend on the reason for treatment.
The doctor will decide when it is best to take Dydrogesterone Polpharma.
If the patient still has natural menstrual periods, day 1 of the cycle is the first day of bleeding.
If the patient does not have natural periods, the doctor will decide with the patient when to start day 1 of the cycle and when to begin taking the tablets.
In case of irregular menstrual cycles
1 to 2 coated tablets of Dydrogesterone Polpharma per day.
Start taking the medicine in the second half of the cycle and continue until the first day of the next menstrual cycle.
The day to start taking the tablets and the number of days for taking them depend on the length of the individual cycle.
In case of hormone replacement therapy (HRT)
For hormone replacement therapy in combination with an oestrogen preparation:
If the patient is using "continuous sequential" HRT (taking an oestrogen tablet or using a patch or gel throughout the entire 28-day cycle):

take 1 tablet per day during the last 14 days of each 28-day cycle.

If the patient is using "cyclical" HRT (taking an oestrogen tablet or using a patch or gel usually for 21 days, followed by a 7-day treatment-free interval):

take 1 tablet per day during the last 12 to 14 days of oestrogen therapy. If necessary, the doctor may increase the dose to 2 coated tablets per day.

After taking the last coated tablet of Dydrogesterone Polpharma, a withdrawal bleed resembling a period occurs.
The doctor will aim to prescribe the lowest effective dose for the shortest duration necessary to treat symptoms.
Talk to the doctor if the patient feels the dose is too strong or not strong enough.
Children and adolescents under 18 years of age
Dydrogesterone Polpharma is not intended for use in children before the onset of first menstruation.
Dydrogesterone Polpharma is not recommended for use in adolescents aged 12 to 18 years due to insufficient data on safety and efficacy.
If more than the recommended dose of Dydrogesterone Polpharma has been taken
If the patient (or someone else, including a child) has taken too many Dydrogesterone Polpharma tablets, it is unlikely to cause harm.
If concerned, consult a doctor.
If a dose of Dydrogesterone Polpharma is missed

If the patient forgot to take a tablet and less than 12 hours have passed, take the tablet as soon as remembered. Take the next tablet at the usual time the following day.
If more than 12 hours have passed since the tablet should have been taken, skip that dose. Take the next tablet at the usual time the following day and continue as usual.
Do not take a double dose to make up for a missed dose.
If a tablet is missed, there is an increased chance of irregular bleeding or spotting.

Stopping treatment with Dydrogesterone Polpharma
Do not stop taking Dydrogesterone Polpharma without consulting a doctor.
If surgery is required
If the patient is scheduled for surgery, inform the surgeon that she is taking Dydrogesterone Polpharma.
It may be necessary to stop taking Dydrogesterone Polpharma approximately 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2, "Venous thromboembolism"). Ask the doctor when it is safe to restart Dydrogesterone Polpharma.
For any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects may occur during treatment with this medicine.
Adverse effects during treatment with Dydrogesterone Polpharma alone
Immediately stop taking Dydrogesterone Polpharma and contact your doctor
if any of the following adverse effects occur:

liver function disorders – symptoms may include yellowing of the skin and whites of the eyes (jaundice), weakness, general malaise or abdominal pain (may occur in up to 1 in 100 treated individuals);
allergic reactions – symptoms may include breathing difficulties or systemic symptoms such as nausea, vomiting, diarrhoea or low blood pressure (may occur in up to 1 in 1,000 treated individuals);
swelling of the skin around the face and throat, which may cause breathing difficulties (may occur in up to 1 in 1,000 treated individuals). If any of the above adverse effects are observed, immediately stop taking Dydrogesterone Polpharma and consult a doctor.

Other adverse effects during treatment with Dydrogesterone Polpharma alone
Common (may occur in up to 1 in 10 people)
Migraine, headache, nausea, tender and/or painful breasts, menstrual bleeding problems: irregular, heavy or painful periods, absence of periods, periods longer or less frequent than usual.
Uncommon (may occur in up to 1 in 100 people)
Weight gain, dizziness, low mood, vomiting, allergic skin reactions such as rash, severe itching or urticaria.
Rare (may occur in up to 1 in 1,000 people)
Fatigue, breast swelling, anaemia due to increased breakdown of red blood cells (haemolytic anaemia), fluid retention causing swelling, often in the lower legs or joints (oedema), increase in size of progestagen-dependent tumours (e.g. meningioma).
Younger patients are expected to experience similar adverse effects as those observed in adult women.
Adverse effects of Dydrogesterone Polpharma when taken in combination
with oestrogen (combined oestrogen-progestagen hormone replacement therapy)
If the patient is taking Dydrogesterone Polpharma with oestrogen, please refer to the patient information leaflet of the oestrogen-containing medicine. See also section 2 "Important information before taking Dydrogesterone Polpharma" for further information on the adverse effects listed below.
If any of the following adverse effects occur, immediately stop taking
Dydrogesterone Polpharma and seek medical help:

painful swelling of the legs, sudden chest pain or difficulty breathing. These may be symptoms of a blood clot.
chest pain radiating to the arms or neck. These may be symptoms of a heart attack.
severe unexplained headache or migraine (with or without visual disturbances). These may be symptoms of a stroke. If any of the above adverse effects occur, immediately stop taking Dydrogesterone Polpharma and seek medical help.

Immediately seek medical help if the patient notices any of the following symptoms:

skin dimpling of the breast, changes in the nipples or visible or palpable lumps. These may be symptoms of breast cancer. Other adverse effects of Dydrogesterone Polpharma when taken in combination with oestrogen include excessive build-up of the endometrial lining, endometrial cancer and ovarian cancer.

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

5. How to store Dydrogesterone Polpharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot" indicates the batch number.
No special storage instructions apply 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. This will help protect the environment.

6. Contents of the pack and other information

What Dydrogesterone Polpharma contains

The active substance is dydrogesterone. Each film-coated tablet contains 10 mg of dydrogesterone.
- The other ingredients are: monohydrate lactose, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate. Other ingredients in the coating: hypromellose, macrogol 400, titanium dioxide (E 171).

What Dydrogesterone Polpharma looks like and contents of the pack
The film-coated tablets are white, round, biconvex, with the marking “L1” on one side of the tablet and no marking on the other side.
The tablets are packed in blisters in a cardboard box, containing: 10, 20, 28, 56 and 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Cyndea Pharma, S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda 31
42110, Ólvega (Soria)
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Dydrogesteron Polpharma 10 mg Filmtabletten
Poland: Dydrogesterone Polpharma

Dydrogesterone polpharma