Duphaston

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Duphaston

10 mg, coated tablets

Dydrogesterone

It is essential to carefully read the contents of the leaflet before taking the medicine, 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 doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for the person named. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. 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 progesterone, naturally produced in the body.
• Medicines like Duphaston are called progestagens.

What is Duphaston used for

Duphaston may 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 uterine lining occurs outside the uterus;
• absence of menstruation before menopause;
• irregular menstruation;
• menstrual bleeding that is excessively heavy or occurs at an inappropriate time in the cycle (between periods);
• premenstrual tension syndrome;
• infertility caused by low progesterone levels 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 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 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 the uterine lining to grow. 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 the uterine lining from growing.

2. Important information before taking Duphaston

When not to take Duphaston

In the case of taking Duphaston simultaneously with estrogen, e.g. as HRT, you should also read the patient information 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.

Usually, the occurrence of unexpected bleeding or spottingis not a cause for concern. This is especially true during the first few months of taking Duphaston.

However, you should contact your doctor immediatelyif 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 find the cause of the bleeding or spotting and may order a test for endometrial cancer.

You should consult your doctor or pharmacist before starting to take

Duphastonif you have any of the following diseases:

• 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), 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.

In the case of worsening or recurrence 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. You should also read the patient information 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, 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 an extended period, 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 confirms 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 taking HRT. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or more if HRT lasted more than 5 years.

You should:

• perform regular check-ups - the doctor will inform how often to perform them;
• regularly self-examine your breasts for changes such as:
• 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 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 in about 2 out of 2000 women over 5 years. 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 taking 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 (either in the patient or their close family);
• immobility 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 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, 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 progesterone in 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 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 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

Tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and any 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 plan 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, consult your doctor.
• If you become pregnant or think you may be pregnant, contact your doctor. The doctor will discuss the benefits and risks of taking Duphaston during pregnancy with you.

Breastfeeding

Do not take Duphaston while 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 mothers.

Fertility

There is no evidence that dydrogesterone reduces fertility when taken as directed by a 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 machinery. Wait and observe how the medicine affects you before driving or operating machinery.

Duphaston contains sugar (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

Always take Duphaston exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. The doctor will adjust the dose according to your needs.

How to take the medicine

• Swallow the tablet with water.
• The tablet can be taken with or without food.
• If you are taking more than one tablet a day, spread the doses evenly throughout the day, e.g., take one tablet in the morning and one in the evening.
• Try to take the tablets at the same time every day. This will help you remember to take the tablets and ensure a steady amount of medicine in your body.
• The score line on the tablet allows it to be broken in two to make it easier to swallow. Do not use it to divide the dose into two.

How much to take

The number of tablets to take and the days on which they are taken depend on the indication. If you are still menstruating, the 1st day of the cycle is the day you start 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 a day.
• Use only from the 5th to the 25th day of the cycle.

Use in the treatment of endometriosis

• Take 1 to 3 tablets a day.
• The doctor will prescribe taking the 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 a 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 a 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 it 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 a day.
• Use for up to 10 days.
• In the case of continuous treatment:
• Take 1 or 2 tablets a day.
• Use in the second half of the cycle.
• The day of starting the medicine and the number of days it is taken depend on the length of the cycle.

Use in the treatment of premenstrual tension syndrome

• Take 2 tablets a 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 it 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 a day until symptoms subside.
• In the case where the patient has had a miscarriage in the past:
• Take 2 tablets a day.
• Use up to the 12th week of pregnancy.

Use in the treatment of infertility caused by low progesterone levels

• Take 1 or 2 tablets a 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 it 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 an estrogen tablet or patch throughout the 28-day cycle):
• Take 1 Duphaston tablet once a 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 an estrogen tablet or patch for 21 days, followed by a 7-day break without estrogen):
• Take 1 Duphaston tablet a day.
• Use for the last 12 to 14 days of estrogen therapy.
• The dose may be increased to 2 tablets a day if necessary.

Taking more than the recommended dose of Duphaston

It is unlikely that taking more than the recommended dose of Duphaston will be harmful. There is no need to treat this condition. If you have any concerns or experience any worrying symptoms, contact your doctor.

Missing a dose of Duphaston

• If you miss a dose, take it as soon as possible. However, if more than 12 hours have passed since the scheduled dose, do not take the missed dose and take the next dose 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

Do 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 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 around the face and throat, which can cause difficulty breathing (affects less than 1 in 1000 patients). If you experience any of the above side effects, stop taking Duphaston and contact your doctor.

Other side effects when taking only Duphaston

Common(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 usual.

Uncommon(affects less than 1 in 100 patients)

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

Rare(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;
• increased size of tumors that grow under the influence of 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 and progestogen)

When taking Duphaston with estrogen, you should also read the patient information leaflet accompanying 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 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, stop taking Duphaston and contact your doctor.

You should contact your doctor immediately if you notice:

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

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

• endometrial hyperplasia;
• endometrial cancer;
• ovarian cancer.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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

Keep the medicine out of the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Duphaston contains

• The active substance 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 white (hypromellose, macrogol 400, titanium dioxide (E 171)).

What Duphaston looks like and contents of the pack

Round, biconvex, scored, white coated tablets 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:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin, Ireland

Manufacturer:

Abbott Biologicals B.V.

Veerweg 12, 8121 AA Olst

Netherlands

Parallel importer:

InPharm Sp. z o.o.

ul. Strumykowa 28/11

03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.

ul. Chełmżyńska 249

04-458 Warsaw

Marketing authorization number in Romania, the country of export:2078/2009/01

2078/2009/02

Parallel import authorization number:25/11

Date of leaflet approval: 23.10.2023

[Information about the trademark]