Duphaston

• depression
• liver disease
• a rare, inherited blood disease called porphyria

If any of the above warnings apply to the patient (or in case of doubts), you should consult a doctor or pharmacist before starting Duphaston.
It is especially important to inform the doctor if the disease worsened during pregnancy or during previous hormonal therapy. If the disease worsens or recurs while taking Duphaston, the doctor may recommend stopping treatment.

Duphaston and HRT

HRT, in addition to its benefits, carries certain risks that the patient and doctor must consider before starting treatment. When taking Duphaston simultaneously with estrogen as HRT, the following information is important. You should also read the patient leaflet accompanying the estrogen-containing medicine.

Early menopause

There is limited data on the risk of HRT during the onset of menopausal symptoms. The risk is lower in younger women. This means that in younger women taking HRT, the relationship between benefits and risks is better than in older women.

Medical examinations

Before starting or re-applying HRT, the doctor will conduct a medical history and family interview. The doctor may also order a breast and pelvic exam.
Before and during treatment, the doctor may order screening tests, such as mammography (breast X-ray). The doctor will inform how often these tests should be performed. After starting treatment with Duphaston, you should regularly schedule follow-up appointments with your doctor (at least once a year).

Endometrial cancer and endometrial hyperplasia

In women with an intact uterus taking estrogen-only HRT for a long time, there is an increased risk of:

• endometrial cancer
• endometrial hyperplasia Taking Duphaston simultaneously with estrogen (for at least 12 days in a 28-day cycle) or as continuous combined therapy may prevent this additional risk.

Breast cancer

Data confirm that taking hormonal replacement therapy (HRT) in the form of estrogen and progestogen, or estrogen alone, increases the risk of breast cancer. The additional risk depends on how long the patient takes HRT. This additional risk becomes apparent after about 3 years (1-4) of HRT. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or longer if HRT lasted more than 5 years.
You should:

• perform regular check-ups - the doctor will inform how often they should be performed
• regularly self-examine your breasts for the following changes:
• skin dimpling
• nipple changes
• visible or palpable lumps. If you notice any changes, you should contact your doctor immediately.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking HRT that includes only estrogen or a combination of estrogen and progestogen is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, in women aged 50-54 who do not take HRT, ovarian cancer will be diagnosed within 5 years in about 2 women out of 2000. In women who took HRT for 5 years, it will occur in about 3 women out of 2000 taking it (i.e. about 1 additional case).

Blood clots

HRT increases the risk of blood clots in the veins. This risk is 3 times higher than in women not taking HRT. The risk is highest in the first year of HRT.
Blood clots are more likely to occur in:

• older age
• cancer
• overweight
• estrogen intake
• pregnancy or immediately after childbirth
• a history of blood clots in the legs or lungs (see "Surgery" below)
• immobility due to surgery, injury, or illness
• a disease called systemic lupus erythematosus - a disease that causes joint pain, rash, and fever. If any of the above risk factors apply to the patient (or in case of doubts), you should consult a doctor to ensure that the patient can start HRT.

In the case of painful leg swelling, sudden chest pain, or difficulty breathing:

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

You should also inform your doctor or pharmacist if you are taking medicines that prevent blood clots (anticoagulants), such as warfarin. The doctor will pay special attention to the benefits and risks of HRT.

Surgery

In the case of planned surgery, you should inform your doctor that you are taking HRT. It may be necessary to stop taking HRT a few weeks before surgery. In some cases, it may be necessary to use other treatment before and after surgery. The doctor will inform you when you can start taking HRT again.

Heart disease

HRT does not prevent heart disease. In women taking estrogen and progestogen as HRT, there is a slightly increased risk of heart disease compared to women not taking HRT. The risk of heart disease increases with age. The number of additional cases of heart disease due to HRT with estrogen and progestogen is very small in healthy women with early menopausal symptoms, but before menopause. The number of additional cases increases with age.
In the case of chest pain that radiates to the arm or neck:

• contact your doctor immediately
• stop taking HRT until the doctor resumes treatment. This pain may be a symptom of a heart attack.

Stroke

Taking HRT in the form of estrogen and progestogen or estrogen alone increases the risk of stroke. This risk is up to 1.5 times higher than in people not taking HRT. The increase in risk in HRT users compared to non-users does not change with age and time since menopause. However, since the risk of stroke is strongly age-dependent, the overall risk of stroke in women taking HRT increases with age.
In the case of severe, unexplained headaches or migraines (with or without visual disturbances):

• contact your doctor immediately
• stop taking HRT until the doctor resumes treatment. This may be an early symptom of a stroke.

Children and adolescents

There are no indications for the use of Duphaston in children before their first menstruation. It is not known whether Duphaston is safe and effective in adolescents aged 12-18.

Duphaston and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription and herbal medicines.
In particular, you should inform your doctor or pharmacist if you are taking any of the following medicines:

• herbal medicines containing St. John's wort (Hypericum perforatum), sage, and yew
• antiepileptic drugs (e.g. used to treat epilepsy) - such as phenobarbital, carbamazepine, phenytoin
• antibacterial drugs (used to treat infections) - such as rifampicin, rifabutin, nevirapine, efavirenz
• antiviral drugs (used to treat HIV/AIDS) - such as ritonavir, nelfinavir. The above medicines may reduce the effectiveness of Duphaston and lead to bleeding and spotting. If the patient is taking any of the above medicines (or in case of doubts), you should consult a doctor or pharmacist before starting HRT.

Duphaston with food and drink

Duphaston can be taken with or without food.

Pregnancy, breastfeeding, and fertility

In pregnancy, during breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, you should consult your doctor before taking this medicine.

Pregnancy

There may be an increased risk of hypospadias (a congenital defect of the penis in which the urethra opens in an abnormal location) in children whose mothers took certain progestogens. However, this increased risk has not been conclusively confirmed. So far, there is no evidence that taking dydrogesterone during pregnancy is harmful. More than 10 million pregnant women have taken Duphaston.

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

Breastfeeding

You should not take Duphaston during breastfeeding. It is not known whether Duphaston passes into breast milk or affects the baby. Studies of other progestogens have shown that a small amount of the medicine passes into the breast milk of breastfeeding women.

Fertility

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

Driving and operating machinery

After taking Duphaston, you may experience slight drowsiness or dizziness. This is more likely to occur during the first few hours after taking the medicine. If you experience these symptoms, you should not drive or operate tools or machines. You should wait and observe how the medicine affects you before deciding to drive or operate tools or machines.

Duphaston contains sugar (lactose)

If you have been informed by your doctor that you have an intolerance to some sugars, you should consult your doctor before taking this medicine. This applies to rare hereditary diseases that affect the body's ability to use lactose, such as "lactase deficiency" or "glucose-galactose malabsorption syndrome".

3. How to take Duphaston

Duphaston should always be taken as directed by your doctor. In case of doubts, you should consult your doctor or pharmacist. The doctor will adjust the dose according to your needs.

Taking the medicine

• Swallow the tablet with water.
• The tablet can be taken with or without food.
• If you are taking more than one tablet per day, you should spread the intake evenly throughout the day, e.g. take one tablet in the morning and one in the evening.
• You should try to take the tablets at the same time every day. This will ensure that there is a constant amount of medicine in your body. It will also help you remember to take the medicine.
• The score line on the tablet allows it to be broken in half to make it easier to swallow. It should not be used to divide the dose into halves.

How much to take

The number of tablets taken and the days on which the medicine is taken depend on the indication. If you are still menstruating, the 1st day of the cycle is the day of the start of bleeding. If you no longer have natural periods, the doctor will determine the first day of the cycle and decide when to start taking the tablets.

Use in the treatment of painful menstruation

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

Use in the treatment of endometriosis

• Take 1 to 3 tablets per day.
• The doctor will prescribe the tablets to be taken
• Every day of the cycle or
• Only from the 5th to the 25th day of the cycle.

Use in the treatment of amenorrhea before menopause

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

Use in the treatment of irregular menstruation

• Take 1 or 2 tablets per day.
• Use from the second half of the cycle to the first day of the next cycle.
• The day of starting the medicine and the number of days on which the medicine is taken depend on the length of the cycle.

Use in the treatment of irregular uterine bleeding

• In the case of treatment to stop bleeding
• Take 2 or 3 tablets per day.
• Use for up to 10 days.
• Continuous treatment
• Take 1 or 2 tablets per day.
• Use in the second half of the cycle.
• The day of starting the medicine and the number of days on which the medicine is taken depend on the length of the cycle.

Use in the treatment of premenstrual tension syndrome

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

Use to reduce the risk of miscarriage

• In the case where the patient has not had a miscarriage in the past:
• Take a single dose of up to 4 tablets.
• Then take 2 or 3 tablets per day until the symptoms subside.
• In the case where the patient has had a miscarriage in the past:
• Take 2 tablets per day.
• Use up to 12 weeks of pregnancy.

Use in the treatment of infertility caused by low progesterone levels

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

Use in the treatment of menopausal symptoms - HRT

• In the case where the patient is taking HRT in a "sequential" manner (taking a tablet or using a patch with estrogen for the entire 28-day cycle)
• Take 1 tablet of Duphaston per day.
• Use for the last 14 days of each 28-day cycle.
• In the case where the patient is taking HRT in a "cyclic" manner (taking a tablet or using a patch with estrogen usually for 21 days, followed by a 7-day break without estrogen)
• Take 1 tablet of Duphaston per day.
• Use for the last 12 to 14 days of estrogen therapy.
• In case of need, the doctor may increase the dose to 2 tablets per day.

Taking more than the recommended dose of Duphaston

It is unlikely that taking too many Duphaston tablets will be harmful. There is no need to treat this condition. In case of doubts or if you experience any worrying symptoms, you should consult your doctor.

Missing a dose of Duphaston

• In the case of missing a tablet, you should take the dose as soon as possible. However, if more than 12 hours have passed since the scheduled dose, you should not take the missed tablet and take the next tablet at the usual time.
• You should not take a double dose to make up for the missed dose.
• In the case of missing a dose, bleeding or spotting may occur.

Stopping Duphaston

You should not stop taking Duphaston without consulting your doctor.

4. Possible side effects

Like all medicines, Duphaston can cause side effects, although not everybody gets them.
The following side effects may occur during treatment:

Side effects when taking only Duphaston

In the case of any of the following side effects, you should stop taking Duphaston immediately and consult your doctor:

• liver disorders - symptoms may include yellowing of the skin or whites of the eyes (jaundice), weakness, general malaise, or stomach pain (affects less than 1 in 100 patients)
• allergic reactions - symptoms may include difficulty breathing or symptoms affecting the whole body, such as nausea, vomiting, diarrhea, or low blood pressure (affects less than 1 in 1000 patients)
• skin swelling in the face and throat area, which can cause breathing difficulties (affects less than 1 in 1000 patients) If you experience any of the above side effects, you should stop taking Duphaston immediately and consult your doctor.

Other side effects when taking only Duphaston

Frequently(affects less than 1 in 10 patients)

• migraine, headaches
• nausea
• breast tenderness or pain
• irregular, heavy, or painful menstrual bleeding
• absence of menstruation or less frequent menstrual bleeding than normal

Less frequently(affects less than 1 in 100 patients)

• weight gain
• dizziness
• depression
• vomiting
• skin allergic reactions - such as rash, severe itching, or hives

Rarely(affects less than 1 in 1000 patients)

• drowsiness
• breast swelling
• a type of anemia that occurs when red blood cells break down
• swelling caused by fluid retention, often affecting the legs or ankles
• increase in the size of tumors that are affected by progestogens (such as meningioma)

In younger patients, similar side effects are expected as those that occurred in adults.

Side effects when taking Duphaston with estrogen (HRT - estrogen with progestogen)

In the case of taking Duphaston simultaneously with estrogen, you should also read the patient leaflet accompanying the estrogen-containing medicine. For further information on the following side effects, see the section "Important information before taking Duphaston".

In the case of any of the following side effects, you should stop taking Duphaston immediately and consult your doctor

• painful leg swelling, sudden chest pain, or difficulty breathing. These may be symptoms of blood clots
• chest pain that radiates to the arm or neck. This may be a symptom of a heart attack
• severe, unexplained headaches or migraines (with or without visual disturbances). These may be symptoms of a stroke If you experience any of the above side effects, you should stop taking Duphaston immediately and consult your doctor.

You should consult your doctor immediately if you notice:

• skin dimpling on the breast, nipple changes, visible or palpable lumps. These may be symptoms of breast cancer

Other side effects that occur when taking Duphaston with estrogen include:

• endometrial hyperplasia
• endometrial cancer
• ovarian cancer

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 or parallel importer.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Duphaston

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Duphaston contains

• The active substance of Duphaston is dydrogesterone
• each coated tablet contains 10 mg of dydrogesterone.
• Other ingredients are: lactose monohydrate, hypromellose, cornstarch, colloidal anhydrous silica, magnesium stearate. Coating:Opadry Y-1-7000 (hypromellose, macrogol 400, titanium dioxide (E 171)).

What Duphaston looks like and contents of the pack

Round, biconvex, coated tablets in white, with the inscription "155" on both sides of the score line, on one side of the tablet.
20 coated tablets in a PVC/Al blister pack, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Viatris Healthcare Limited
Damastown Industrial Park, Mulhuddart
Dublin 15, Dublin
Ireland

Manufacturer:

Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
Netherlands

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń

Marketing authorization number in Romania, the country of export:

2078/2009/01
2078/2009/02

Parallel import authorization number: 310/24

Date of leaflet approval: 30.07.2024

[Information about the trademark]