Duphaston

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Duphaston

10 mg, coated tablets
Dydrogesterone

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Duphaston and what is it used for

What is Duphaston

Duphaston contains the active substance dydrogesterone.

• Dydrogesterone is a synthetic hormone.
• It is very similar in structure and action to the hormone called progesterone, which is naturally produced in the body.
• Medicines like Duphaston are called progestagens.

What is Duphaston used for

Duphaston can be used alone or in combination with estrogen. The simultaneous use of estrogen depends on the indication for use.
Duphaston is used to treat:

• •Disorders caused by insufficient production of progesterone by the body, such as:
• painful menstruation
• endometriosis - a condition in which the uterine lining occurs outside the uterus
• absence of menstruation in the pre-menopausal period
• irregular menstruation
• menstrual bleeding that is excessively heavy or occurs at an inappropriate time in the cycle (between periods)
• premenstrual syndrome
• infertility caused by low progesterone levels and
• to reduce the risk of miscarriage
• •Menopausal symptoms - this treatment is called Hormone Replacement Therapy (HRT).
• These symptoms vary from woman to woman.
• They may include hot flashes, night sweats, sleep disturbances, vaginal dryness

and urinary tract disorders.

How Duphaston works

Normally, the body produces the right amounts of natural progesterone and natural estrogen (another important female hormone) in the right proportions. If the body does not produce enough progesterone, Duphaston supplements this amount and restores balance.
The doctor may prescribe simultaneous use of estrogen with Duphaston. This depends on the indication for use.
In some women using HRT, taking only estrogen may cause overgrowth of the uterine lining. This can also occur if the patient has had a hysterectomy and has had endometriosis in the past. Taking dydrogesterone for part of the cycle prevents overgrowth of the uterine lining.

2. Important information before taking Duphaston

When not to take Duphaston

• •if the patient is allergic to dydrogesterone or any of the other ingredients of Duphaston (listed in section 6).
• •if there is or is suspected to be a tumor (cancer) whose growth depends on progesterone - such as a brain tumor called meningioma.
• •if there is vaginal bleeding of unknown cause. Do not take Duphaston if any of the above information applies to the patient. In case of doubts, consult a doctor or pharmacist before taking Duphaston.

In the case of taking Duphaston with estrogen, e.g. as HRT, you should also read the patient leaflet attached to the estrogen-containing medicine.

Warnings and precautions

In the case of taking Duphaston due to irregular bleeding, the doctor will determine the cause of the bleeding before starting treatment.
Usually, the occurrence of unexpected bleeding or spottingis not a cause for concern. This happens especially during the first months of taking Duphaston.
However, you should contact your doctor immediatelyif bleeding or spotting:

• •lasts longer than a few months,
• •occurs after some time after starting treatment,
• •occurs even after stopping treatment. These may be symptoms of overgrowth of the uterine lining. The doctor will find the cause of bleeding or spotting and may order a test for uterine lining cancer.

Consult a doctor or pharmacist before taking Duphaston

Duphastonif the patient has any of the following diseases:

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

If any of the above warnings apply to the patient (or in case of doubts), consult a doctor or pharmacist before taking 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 with estrogen as HRT, the following information is important. You should also read the patient leaflet attached to 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 history. 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, regular check-ups with the doctor should be scheduled (at least once a year).

Uterine lining cancer and uterine lining overgrowth

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

• •uterine lining cancer,
• •uterine lining overgrowth. Taking Duphaston 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 HRT in the form of estrogen and progestogen combination, 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 use. 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:

• •have 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, contact your doctor immediately.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking HRT with 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 in about 2 out of 2000 women over a 5-year period. In women who took HRT for 5 years, it will occur in about 3 out of 2000 women 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 use.
Blood clots are more likely to occur in:

• •older age,
• •cancer,
• •overweight,
• •taking estrogen,
• •pregnancy or immediately after childbirth,
• •a history of blood clots in the legs or lungs in the patient or their close family,
• •immobilization due to surgery, injury, or illness (see "Surgery" below),
• •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), consult a doctor to ensure that the patient can start HRT.

In case of painful swelling of the legs, sudden chest pain, or difficulty breathing, you should:

• •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 case of planned surgery, inform your doctor that you are taking HRT. It may be necessary to stop taking HRT a few weeks before surgery. In some cases, other treatment may be necessary 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 higher risk of heart disease than in 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 case of chest pain that radiates to the arm or neck, you should:

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

Stroke

Taking HRT in the form of estrogen and progestogen combination or estrogen alone increases the risk of stroke. This risk is 1.5 times higher than in women not taking HRT. The increased 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 case of severe, unexplained headache or migraine (with or without visual disturbances), you should:

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

Children and adolescents

There is no indication 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

Tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and about medicines you plan to take, including those available without a prescription and herbal medicines.
In particular, inform your doctor or pharmacist if you are taking:

• •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 you are taking any of the above medicines (or in case of doubts), consult your 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, breastfeeding, or if you think you may be pregnant, or if you are planning to become pregnant, 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 on the underside of the penis) in children whose mothers took certain progestogens. However, this increased risk has not been conclusively proven. So far, there is no evidence that taking dydrogesterone during pregnancy is harmful. More than 10 million women have taken Duphaston during pregnancy.

• •If you are pregnant before taking Duphaston, you should consult your doctor.
• •If you become pregnant or think you may be 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 on other progestogens have shown that a small amount of the medicine passes into the breast milk of nursing women.

Fertility

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

Driving and using machines

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, do 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 lactose

If you have been informed by your doctor that you have an intolerance to some sugars, contact 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. If you have any doubts, 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, day 1 of the cycle is the day bleeding starts. 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 taking tablets:
• 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 abnormal uterine bleeding

• •In the case of treatment to stop bleeding:
• Take 2 or 3 tablets per day.
• Use for up to 10 days.
• •Continuous use:
• 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 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

• •If the patient has not had a miscarriage in the past:
• Take a dose containing up to 4 tablets.
• Then take 2 or 3 tablets per day until symptoms subside.
• •If the patient has had a miscarriage in the past:
• Take 2 tablets per day.
• Use until the 12th week 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

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

Taking a higher dose of Duphaston than recommended

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

Missing a dose of Duphaston

• •If you miss a tablet, take the dose as soon as possible. However, if more than 12 hours have passed since the scheduled dose, do not take the missed tablet and take the next tablet at the usual time.
• •Do not take a double dose to make up for the missed dose.
• •If you miss a dose, you may experience bleeding or spotting.

Stopping Duphaston treatment

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 while taking the medicine:

Side effects when taking only Duphaston.

If you experience any of the following side effects, stop taking Duphaston and contact your doctor:

• •liver disorders - symptoms may include yellowing of the skin or whites of the eyes (jaundice), weakness, general feeling of being unwell, or stomach pain (affects less than 1 in 100 people);
• •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 people);
• •skin swelling around the face and throat, which can cause difficulty breathing (affects less than 1 in 1000 people). If you experience any of the above side effects, stop taking Duphaston and contact your doctor.

Other side effects when taking only Duphaston:

Frequent(affects less than 1 in 10 people)

• •migraine, headache;
• •nausea;
• •breast tenderness or pain;
• •irregular, heavy, or painful menstrual bleeding;
• •absence of menstruation or less frequent menstrual bleeding.

Uncommon(affects less than 1 in 100 people)

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

Rare(affects less than 1 in 1000 people)

• •drowsiness;
• •breast swelling;
• •a type of anemia that occurs when red blood cells are broken down;
• •fluid retention, often affecting the legs or ankles;
• •growth of progestogen-sensitive tumors (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)

When taking Duphaston with estrogen, you should also read the patient leaflet attached to the estrogen-containing medicine. For more information on the following side effects, see the "Important information before taking Duphaston" section.

If you experience any of the following side effects, stop taking Duphaston and contact your doctor:

• •painful swelling of the legs, 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 headache or migraine (with or without visual disturbances). This may be a symptom of a stroke. If you experience any of the above side effects, stop taking Duphaston and contact your doctor.

You should contact 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 may occur when taking Duphaston with estrogen include:

• excessive growth of the uterine lining,
• uterine lining 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, Ministry of Health
Jerusalem Avenue 181C
02-222 Warsaw
tel.: +48 (22) 49 21 301
fax: +48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide 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 month.
Medicines should not be disposed of via wastewater or household waste. 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.
• •The 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

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

Marketing authorization holder in Romania, the country of export:

Mylan Healthcare B.V.
Krijgsman 20
1186 DM Amstelveen
Netherlands

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Romania, the country of export:
2078/2009/01
2078/2009/02

Parallel import authorization number: 200/12 Date of approval of the leaflet: 01.04.2022

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