Didrogesterone Polpharma

Leaflet attached to the packaging: patient information

Dydrogesterone Polpharma, 10 mg, coated tablets

Dydrogesterone

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

What is Dydrogesterone Polpharma

Dydrogesterone Polpharma contains the active substance dydrogesterone.

• Dydrogesterone is a synthetic hormone.
• Dydrogesterone is very similar to the hormone progesterone, which is produced in the body.
• Medicines like Dydrogesterone Polpharma are called progestagens.

What is Dydrogesterone Polpharma used for

Dydrogesterone Polpharma may be used alone or in combination with estrogen. The simultaneous administration of estrogen with Dydrogesterone Polpharma depends on the reason for the patient's treatment. Dydrogesterone Polpharma is used:

In symptoms caused by insufficient production of progesterone by the body, such as:

• menstrual cycle disorders.

In the treatment of menopausal symptoms - this treatment is called Hormone Replacement Therapy (HRT) or simply HRT.

This medicine may be used in combination with estrogen to treat menopausal symptoms, if the patient has a preserved uterus. Menopausal symptoms vary from woman to woman.

How Dydrogesterone Polpharma works

Normally, the body produces balanced amounts of natural progesterone and natural estrogen (another important female hormone) in the right proportions. If the body does not produce enough progesterone on its own, Dydrogesterone Polpharma is used to treat the disorders that may occur. The doctor may also prescribe simultaneous administration of estrogen with Dydrogesterone Polpharma to achieve the right balance of hormones. In some women using HRT, taking only estrogen can cause the lining of the uterus to grow. This can also occur if the patient has had a hysterectomy and has a history of endometriosis (a buildup of uterine lining outside the uterus). Taking dydrogesterone for part of the cycle prevents the lining of the uterus from growing.

2. Important information before taking Dydrogesterone Polpharma

When not to take 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 is suspected to have a tumor (cancer) that is dependent on progesterone, called meningioma.
• If the patient has vaginal bleeding of unknown cause.
• If Dydrogesterone Polpharma is used in combination with estrogen, the patient should also read the "When not to take" section in the leaflet of the estrogen-containing medicine.
• In cases of severe liver dysfunction or in cases of bile pigment excretion disorder (Dubin-Johnson syndrome, Rotor syndrome) or a history of these diseases.
• In cases of liver tumors.
• If the patient has thrombophlebitis or thromboembolic disease (pathological formation of blood clots in blood vessels).

Warnings and precautions

If it is necessary to take Dydrogesterone Polpharma due to irregular bleeding, the doctor will determine the cause of the bleeding before the patient starts taking this medicine. Usually, the occurrence of unexpected bleeding or spotting is not a cause for concern. This is especially true during the first few months of taking Dydrogesterone Polpharma. However, if the bleeding or spotting:

• lasts longer than a few months,
• appears after some time after starting treatment,
• occurs even after stopping treatment. These may be symptoms of endometrial hyperplasia. The doctor will look for the cause of the bleeding or spotting and may order an examination for endometrial cancer.

Note:Dydrogesterone Polpharma is not a contraceptive and does not prevent pregnancy.

Stop taking Dydrogesterone Polpharma and consult a doctor immediately:

If the patient notices any of the following symptoms:

• the occurrence of a condition listed in the "When not to take Dydrogesterone Polpharma" section;
• jaundice (yellowing of the skin or whites of the eyes). These may be symptoms of liver disease;
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, along with difficulty breathing, which suggest angioedema;
• significant increase in blood pressure (symptoms may include headache, fatigue, dizziness);
• headache resembling migraine or extremely severe headache, occurring for the first time;
• sudden vision disturbances;
• if the patient notices symptoms of a blood clot, such as:
• painful swelling and redness of the legs;
• sudden chest pain;
• difficulty breathing;

To learn more, see "Blood clots in a vein (thrombosis)".

When to be particularly careful when taking Dydrogesterone Polpharma

Before starting treatment, the patient should inform their doctor if they have ever had any of the following disorders, as they may return or worsen during treatment with Dydrogesterone Polpharma. In such cases, the patient should visit their doctor for check-ups more frequently:

• porphyria (a hereditary metabolic disorder with disturbances in the production of red blood cell pigment);
• depression;
• abnormal liver function values due to acute or chronic liver disease;
• jaundice and/or itching.

The patient should inform their doctor if they have:

• had a stroke (also in the past),
• high blood pressure.

Dydrogesterone Polpharma and Hormone Replacement Therapy (HRT)

Taking HRT involves risks that should be considered when deciding whether to start or continue taking the medicine. If the patient is taking Dydrogesterone Polpharma with estrogen as part of HRT, the following information is important. The patient should also read the leaflet of the estrogen-containing medicine.

Early menopause

Experience in treating women with premature menopause (caused by ovarian failure or surgery) is limited. If the patient has premature menopause, the risk of taking HRT may be different. The patient should talk to their doctor.

Medical examinations/Check-ups

Before starting (or re-starting) HRT, the doctor will take the patient's medical history and may decide to perform a physical examination. This may include a breast examination and/or an internal examination if necessary. After starting HRT, the doctor may order check-ups (at least once a year). During these check-ups, the doctor will discuss the benefits and risks of continuing HRT. The patient should regularly examine their breasts, as recommended by their doctor.

Endometrial hyperplasia (excessive thickening of the uterine lining) and endometrial cancer:

Taking HRT with only estrogen increases the risk of endometrial hyperplasia and endometrial cancer. Taking Dydrogesterone Polpharma with estrogen (for at least 12 days in a 28-day cycle) or as continuous combined therapy with estrogen and progestogen may prevent this additional risk.

Breast cancer

There is evidence that taking combined estrogen-progestogen replacement therapy or monohormonal estrogen replacement therapy increases the risk of breast cancer. This depends on how long the patient takes HRT. The additional risk becomes apparent after about 3 years of taking HRT. After stopping HRT, the risk decreases over time, but may persist for 10 years or more if the patient takes HRT for more than 5 years. Comparison: If we consider women aged 50-54 who do not take HRT, on average, 13-17 out of 1000 women will be diagnosed with breast cancer over a period of 5 years. In women aged 50 who start taking HRT with only estrogen for 5 years, there will be 16-17 cases per 1000 users (i.e., 0 to 3 additional cases). In women aged 50 who take combined HRT for 5 years, breast cancer will be diagnosed in 21 out of 1000 women (i.e., 4-8 additional cases of breast cancer). In women aged 50-59 who do not take HRT, on average, 27 out of 1000 women will be diagnosed with breast cancer over a period of 10 years. In women aged 50 who start taking HRT with only estrogen for 10 years, there will be 34 cases of breast cancer per 1000 users (i.e., 7 additional cases). In women aged 50 who start taking combined HRT for 10 years, breast cancer will be diagnosed in 48 out of 1000 users (i.e., 21 additional cases of breast cancer). The patient should regularly examine their breasts. If the patient notices any changes, such as lumps on the skin, changes in the breast, or any visible or palpable nodules, they should consult their doctor. If the patient has the opportunity to participate in a breast cancer screening program (mammography screening program), they should take advantage of it. The patient should inform the person performing the mammography that they are taking HRT. Medicines taken as part of HRT may cause breast tissue to become denser, which can affect mammography results. If breast tissue density increases, it may not be possible to detect all changes.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking single estrogen medicines or combined estrogen-progestogen replacement therapy is associated with a slightly increased risk of ovarian cancer. The risk of ovarian cancer changes with age. For example, in women aged 50-54 who do not take HRT, ovarian cancer will be diagnosed in about 2 cases per 2000 women over 5 years. In women taking HRT for 5 years, there will be about 3 cases per 2000 users (i.e., about 1 additional case).

Effect of HRT on the heart and blood vessels

Blood clots in a vein (thrombosis):

The risk of blood clots in the veins is about 1.3 to 3 times higher in HRT users than in non-users, especially in the first year of taking HRT. Blood clots can be serious and, if they reach the lungs, can cause chest pain, shortness of breath, fainting, or even death. The likelihood of a blood clot in the veins increases with age and if the patient has any of the following conditions, they should inform their doctor:

• the patient is unable to walk for a long time due to a serious operation, injury, or illness;
• the patient is significantly overweight (BMI >30 kg/m2);
• the patient has any blood clotting problems that require long-term treatment with medicines used to prevent blood clots;
• any of the patient's close relatives have ever had a blood clot in their leg, lung, or other organ;
• the patient has systemic lupus erythematosus (SLE);
• the patient has cancer.

Comparison: Considering women aged 50 who do not take HRT, on average, 4 to 7 out of 1000 women can expect to have a blood clot in a vein over a period of 5 years. In women aged 50 who take combined HRT for more than 5 years, there will 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 take combined HRT are slightly more likely to develop heart disease than those who do not take HRT.

Stroke:

The risk of stroke is about 1.5 times higher in women taking HRT than in those not taking HRT. The number of additional stroke cases caused by HRT will increase with age. Comparison: Considering women aged 50 who do not take HRT, on average, 8 out of 1000 women can expect to have a stroke over a period of 5 years. In women aged 50 who take HRT, there will be 11 cases per 1000 users over a period of 5 years (i.e., 3 additional cases). The patient should immediately inform their doctor if they experience any symptoms of side effects, become pregnant, or experience irregular bleeding.

Children and adolescents under 18 years of age

Dydrogesterone Polpharma is not intended for use in children before their first menstrual period. Dydrogesterone Polpharma is not recommended for use in adolescents aged 12 to 18 due to insufficient data on safety and efficacy.

Dydrogesterone Polpharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. Some medicines may affect the action of Dydrogesterone Polpharma. This may lead to a decrease in the effectiveness of Dydrogesterone Polpharma. 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), sage root, or Japanese knotweed.

Progesterone, in turn, may reduce the effectiveness of medicines that lower blood sugar levels.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

In children whose mothers took certain progestogens, the risk of hypospadias (a congenital defect of the penis involving the urethral opening) may be increased. However, this increased risk has not been confirmed. Dydrogesterone has been taken by an estimated 10 million pregnant women. So far, there is no evidence that taking dydrogesterone during pregnancy is harmful.

Breastfeeding

The patient should not breastfeed while taking Dydrogesterone Polpharma. It is not known whether Dydrogesterone Polpharma passes into breast milk or affects the baby. Studies with other progestogens have shown that small amounts of these medicines pass into breast milk.

Fertility

There is no evidence that dydrogesterone taken as directed by the doctor reduces fertility.

Driving and using machines

After taking Dydrogesterone Polpharma, the patient may experience mild drowsiness or dizziness. This is more likely to occur within the first few hours of taking the medicine than later. If this happens, the patient should not drive or operate tools or machines. The patient should wait to see how Dydrogesterone Polpharma affects their ability to drive, use tools, or operate machines.

Dydrogesterone Polpharma contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Dydrogesterone Polpharma

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are not sure, they should ask their doctor or pharmacist. The doctor will adjust the dose to the patient's needs.

How to take this medicine

The patient should swallow the tablet with water. The patient can take the tablet with or without food. If the patient needs to take more than one tablet, they should space them out evenly throughout the day. For example, the patient should take one tablet in the morning and one in the evening. The patient should try to take the tablet at the same time every day. This will help keep a constant amount of medicine in the patient's body. It will also help the patient remember to take the tablets.

How many tablets to take

The number of tablets the patient takes and the days they take them depend on why the patient is being treated. The doctor will decide when to take Dydrogesterone Polpharma. If the patient still has natural periods, the 1st day of the cycle is the day the bleeding starts. If the patient does not have natural periods, the doctor will decide with the patient when to start the 1st day of the cycle and when to start taking the tablets.

In case of irregular menstrual cycles

1 to 2 coated tablets of Dydrogesterone Polpharma per day. The patient should start taking the medicine in the second half of the cycle and continue taking it until the 1st day of the next menstrual cycle. The day of starting the tablets and the number of days of taking the tablets depend on the length of the individual cycle.

In case of hormone replacement therapy (HRT)

In case of hormone replacement therapy in combination with an estrogen preparation: If the patient is taking "continuous sequential" HRT (takes an estrogen tablet or uses a patch or gel for the entire 28-day cycle):

• the patient should take 1 tablet per day for the last 14 days of each 28-day cycle.

If the patient is taking "cyclic" HRT (takes an estrogen tablet or uses a patch or gel usually for 21 days, followed by a 7-day break in treatment):

• the patient should take 1 tablet per day for the last 12 to 14 days of estrogen therapy. If necessary, the doctor may increase the dose to 2 coated tablets per day.

After taking the last coated tablet of Dydrogesterone Polpharma, the patient will experience bleeding similar to a period. The doctor will try to prescribe the lowest dose to treat the symptoms for as short a time as necessary. The patient should talk to their doctor if they think this 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 their first menstrual period. Dydrogesterone Polpharma is not recommended for use in adolescents aged 12 to 18 due to insufficient data on safety and efficacy.

In case of taking more than the recommended dose of Dydrogesterone Polpharma

If the patient (or someone else, including a child) has taken too many Dydrogesterone Polpharma tablets, it is unlikely to cause any harm. If the patient is concerned, they should consult their doctor.

In case of missing a dose of Dydrogesterone Polpharma

• If the patient forgets to take a tablet and it has been less than 12 hours, they should take the tablet as soon as they remember. The next day, they should take the tablet at the usual time.
• If more than 12 hours have passed since the patient should have taken the tablet, they should skip that tablet. The patient should take the next tablet at the usual time and continue taking the tablets as usual.
• The patient should not take a double dose to make up for the missed dose.
• If the patient misses a tablet, there is a greater likelihood of irregular bleeding or spotting.

Stopping Dydrogesterone Polpharma

The patient should not stop taking Dydrogesterone Polpharma without consulting their doctor.

If the patient needs to have surgery

If the patient is scheduled to have surgery, they should tell the surgeon that they are taking Dydrogesterone Polpharma. It may be necessary to stop taking Dydrogesterone Polpharma about 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2, "Blood clots in a vein (thrombosis)"). The patient should ask their doctor when they can start taking Dydrogesterone Polpharma again. If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dydrogesterone Polpharma can cause side effects, although not everybody gets them. The following side effects may occur when taking this medicine.

Side effects when taking only Dydrogesterone Polpharma

The patient should stop taking Dydrogesterone Polpharma and consult their doctor immediately if they experience any of the following side effects:

• 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 people);
• allergic reactions - symptoms may include difficulty breathing or whole-body reactions such as nausea, vomiting, diarrhea, or low blood pressure (may occur in up to 1 in 1000 people);
• skin swelling around the face and throat, which can cause difficulty breathing (may occur in up to 1 in 1000 people). If the patient experiences any of these side effects, they should stop taking Dydrogesterone Polpharma and consult their doctor immediately.

Other side effects when taking only Dydrogesterone Polpharma

Frequently(may occur in up to 1 in 10 people)
Migraine, headache, nausea, breast tenderness and/or pain, bleeding problems: irregular, heavy, or painful periods, absence of periods, longer or less frequent periods than usual.
Less frequently(may occur in up to 1 in 100 people)
Weight gain, dizziness, low mood, vomiting, allergic skin reactions - such as rash, severe itching, or hives.
Rarely(may occur in up to 1 in 1000 people)
Fatigue, breast swelling, hemolytic anemia (anemia caused by increased breakdown of red blood cells), water retention, which can cause swelling, often in the legs or joints (edema), increased size of progestogen-dependent tumors (e.g., meningioma). In younger patients, similar side effects are expected as those that occurred in adult women.

Side effects of Dydrogesterone Polpharma when taken in combination with estrogen (estrogen-progestogen hormone replacement therapy)

If the patient is taking Dydrogesterone Polpharma with estrogen, they should also read the leaflet of the estrogen-containing medicine. See also section 2, "Important information before taking Dydrogesterone Polpharma", for more information on the side effects listed below.

If the patient experiences any of the following side effects, they should stop taking Dydrogesterone Polpharma and seek medical help immediately:

• 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 the patient experiences any of these side effects, they should stop taking Dydrogesterone Polpharma and seek medical help immediately.

The patient should seek medical help immediately if they notice any of the following symptoms:

• indentations on the breast skin, changes in the breasts, or visible or palpable nodules. These may be symptoms of breast cancer. Other side effects of Dydrogesterone Polpharma when taken in combination with estrogen include endometrial hyperplasia, endometrial cancer, and ovarian cancer.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 the medicine.

5. How to store Dydrogesterone Polpharma

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Dydrogesterone Polpharma contains

• The active substance of the medicine is dydrogesterone. Each coated tablet contains 10 mg of dydrogesterone.
• Other ingredients are: lactose monohydrate, hypromellose, cornstarch, 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 coated tablets are white, round, and biconvex with the inscription "L1" on one side of the tablet and no inscription on the other side. The tablets are packaged in blisters in a cardboard box, and the packaging contains: 10, 20, 28, 56, and 84 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Dydrogesteron Polpharma 10 mg Filmtabletten, Poland: Dydrogesterone Polpharma

Date of last revision of the leaflet: