Duphaston

Leaflet accompanying 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

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this patient. 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 called "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 administration 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 lining of the uterus occurs outside the uterus
• absence of menstruation during 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 too low a level of progesterone and
• to reduce the risk of miscarriage
• •Symptoms of menopause – 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 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 administration of estrogen with Duphaston. This depends on the indication for which the medicine is taken.
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 been diagnosed with 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 a suspicion of a tumor (cancer) whose growth depends on progesterone - such as a brain tumor called "meningioma".
• •if there are 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 simultaneously with estrogen, e.g. as HRT, the patient should also read section 2 of the patient leaflet accompanying 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.
The occurrence of unexpected bleeding or spottingis usually not a cause for concern. This happens especially during the first months of taking Duphaston.
However, the patient should contact their doctor immediatelyif the 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 overgrowth of the uterine lining. The doctor will find the cause of the bleeding or spotting and may order a test for uterine lining cancer.

The patient should consult their doctor or pharmacist before starting Duphaston

Duphastonif they have 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), they should consult their doctor or pharmacist before starting Duphaston. It is especially important to inform the doctor if the disease worsened during pregnancy or during previous hormone 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 in HRT, the following information is important. The patient 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 may order a breast and pelvic exam.
Before and during treatment, the doctor may order screening tests, such as a mammogram (breast X-ray). The doctor will inform how often these tests should be performed. After starting treatment with Duphaston, the patient should regularly schedule follow-up appointments with their doctor (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 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 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. 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.
The patient should:

• •undergo regular check-ups - the doctor will inform how often they should be performed;
• •regularly self-examine their breasts for the following changes:
• skin dimpling,
• nipple changes,
• visible or palpable lumps. If the patient notices any changes, they should contact their 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 (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
• •taking estrogen
• •pregnancy or immediately after childbirth
• •a history of blood clots in the legs or lungs in the patient or their close relatives
• •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 the patient has any of the above risk factors (or in case of doubts), they should consult their doctor to ensure they can start HRT.

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

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

The patient should also inform their doctor or pharmacist about 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, the patient should inform their doctor about 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 when it is possible to start taking HRT again.

Heart disease

HRT does not prevent heart disease. In women taking estrogen and progestogen in 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, the patient should:

• •contact their 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 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 dependent on age, 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), the patient should:

• •contact their 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking, have recently taken, or plan to take, including those available without a prescription and herbal medicines.
In particular, the patient should inform their doctor or pharmacist about taking 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), they should consult their 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 the patient is pregnant or plans to become pregnant, they should consult their 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 confirmed. There is no evidence that taking dydrogesterone during pregnancy is harmful. More than 10 million women have taken Duphaston during pregnancy.

• •If the patient is pregnant before taking Duphaston, they should consult their doctor.
• •If the patient becomes pregnant or suspects they are pregnant, they should contact their doctor. The doctor will discuss the benefits and risks of taking Duphaston during pregnancy with the patient.

Breastfeeding

Duphaston should not be taken 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 breast milk.

Fertility

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

Driving and using machines

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

Duphaston contains sugar (lactose)

If the patient has been informed by their doctor that they have an intolerance to some sugars, they should consult their doctor before taking Duphaston. 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 the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The doctor will adjust the dose according to the patient's needs.

Taking the medicine

• •Swallow the tablet with water.
• •The tablet can be taken with or without food.
• •If the patient is taking more than one tablet per day, they should space out the doses evenly throughout the day, e.g. take one tablet in the morning and one in the evening.
• •The patient should try to take the tablets at the same time every day. This will ensure that the medicine is always present in the body in a constant amount. It will also help the patient 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 in half.

How much to take

The number of tablets taken and the days on which the medicine is taken depend on the indication. If the patient is still menstruating, day 1 of the cycle is the day of the start of bleeding. If the patient no longer has 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 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 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 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 of 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" regimen (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.
• •If the patient is taking HRT in a "cyclic" regimen (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.
• •If necessary, 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 any worrying symptoms occur, the patient should consult their doctor.

Missing a dose of Duphaston

• •If the patient misses a dose, they should take it as soon as possible. However, if more than 12 hours have passed since the scheduled dose, they should not take the missed dose and take the next dose at the usual time.
• •The patient should not take a double dose to make up for the missed dose.
• •If the patient misses a dose, they may experience bleeding or spotting.

Stopping Duphaston

The patient should not stop taking Duphaston without consulting their 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 Duphaston:

Side effects when taking only Duphaston.

If the patient experiences any of the following side effects, they should stop taking Duphaston and contact their 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 in the face and throat area, which can cause difficulty breathing (affects less than 1 in 1000 people). If the patient experiences any of the above side effects, they should stop taking Duphaston and contact their 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 menstrual bleeding that occurs less often than usual.

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;
• •swelling caused by fluid retention, often affecting the legs or ankles;
• •increased size of progestogen-dependent 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, the patient should also read the patient leaflet accompanying the estrogen-containing medicine. For further information on the following side effects, see the "Important information before taking Duphaston" section.

If the patient experiences any of the following side effects, they should stop taking Duphaston and contact their 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 headache or migraine (with or without visual disturbances). This may be a symptom of a stroke. If the patient experiences any of the above side effects, they should stop taking Duphaston and contact their doctor.

The patient should contact their doctor immediately if they notice:

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

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

• excessive growth of the uterine lining,
• uterine lining cancer
• ovarian cancer.

Reporting side effects

If the patient experiences any side effects, including any side effects 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, 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, more information can be collected on the safety of the 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 stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 silicon dioxide, 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, divisible coated tablets, white in color, with the inscription "155" on both sides of the score line, on one side of the tablet.
28 coated tablets in PVC/Al blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer:

Marketing authorization holder in Portugal, the country of export:

BGP Products, Unipessoal Lda.
Avenida D. João II, Edifício Atlantis, N.º 44C - 7.3 e 7.4
1990-095 Lisbon
Portugal

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
Portuguese marketing authorization number: 5782198

Parallel import authorization number: 41/20

Date of approval of the leaflet: 27.01.2025

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