Duphaston

LEAFLET INCLUDED IN THE PACKAGE: PATIENT INFORMATION

WARNING: Keep the leaflet, the information on the immediate packaging is in a foreign language.

Duphaston

10 mg, coated tablets
Dydrogesterone

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• 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 any side effects 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. Package contents 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, 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 uterine cavity,
• 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 too low a level of progesterone and
• to reduce the risk of miscarriage.

Symptoms of menopause - this treatment is called Hormone Replacement Therapy or HRT for short.

• 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 lining of the uterus to grow. This can also occur if the patient has had a hysterectomy and has had endometriosis in the past. Taking dydrogesterone by these patients for part of the cycle prevents the lining of the uterus from growing.

2. Important information before taking Duphaston

When not to take Duphaston

In the case of concomitant administration of Duphaston with estrogen, e.g. as HRT, you should also read section 2 of the patient leaflet included with 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 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 a doctor or pharmacist before starting Duphaston

Duphastonif you have any of the following conditions:

• 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),
you should consult a doctor or pharmacist before starting Duphaston. It is especially important to inform the doctor if the condition worsened during pregnancy or during previous hormone therapy. If the condition worsens or recurs during Duphaston treatment, the doctor may recommend stopping the 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 included with 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-administering 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 a mammogram (breast X-ray). The doctor will inform you how often to perform these tests. After starting Duphaston treatment, 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 estrogens alone for HRT, there is a higher risk of:

• endometrial cancer,
• endometrial hyperplasia. 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 hormone 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 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:

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

You should also inform your doctor or pharmacist about taking anticoagulant medications, 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 about HRT use. It may be necessary to stop 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 as HRT, there is a slightly higher likelihood 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.
If you experience chest pain that radiates to the arm or neck, you should:

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

Stroke

Taking HRT in the form of estrogen with progestogen or estrogen alone increases the risk of stroke. This risk is up to 1.5 times higher than in non-HRT users. 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.
If you experience severe, unexplained headaches or migraines (with or without visual disturbances), you should:

• contact your doctor immediately,
• stop taking HRT until your doctor resumes 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

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 available without a prescription and herbal medicines.
In particular, you should inform your 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 infection - AIDS) - such as ritonavir, nelfinavir. The above-mentioned medicines may reduce the effectiveness of Duphaston and lead to bleeding and spotting. If you are taking any of these medicines (or in case of doubts), you should 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 suspect you are pregnant, or 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 urethral opening is located in an abnormal position) 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 women have taken Duphaston during pregnancy.

• 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 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, 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 monohydrate)

If you have been informed by your doctor that you have an intolerance to some sugars or have difficulty digesting them, 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. If you have any doubts, you should consult 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 per day, you should space out the intake of the medicine 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 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 you are still menstruating, the 1st day of the cycle is the day you start bleeding. If you no longer have natural periods, your 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 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 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.
• In the case of 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 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 an estrogen tablet or patch throughout the 28-day cycle)
• Take 1 Duphaston tablet 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 an estrogen tablet or patch 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, you should consult your doctor.

Missing a dose of Duphaston

• If you miss a dose, you should take it as soon as possible. However, if more than 12 hours have passed since the scheduled dose, you should not take the missed dose and take the next dose at the usual time.
• You should 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 during treatment:

Side effects when taking Duphaston alone

If you experience 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),
• swelling of the skin around the face and throat, which can cause difficulty breathing (affects less than 1 in 1000 patients). If you experience any of these side effects, you should stop taking Duphaston immediately and consult your doctor.

Other side effects when taking Duphaston alone:

Frequently(affects less than 1 in 10 patients)

• migraine, headache,
• nausea,
• breast tenderness or pain,
• irregular, heavy, or painful menstrual bleeding,
• absence of menstruation or less frequent menstrual bleeding than usual. 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 are broken down,
• swelling caused by fluid retention, often affecting the legs or ankles,
• increased size of progesterone-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, you should also read the patient leaflet included with 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, you should stop taking Duphaston immediately and consult 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 headaches or migraines (with or without visual disturbances). This may be a symptom of a stroke. If you experience any of these side effects, you should stop taking Duphaston immediately and consult 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:

• 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 or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
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 stated.
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. Package contents 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 what the package contains

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.
20 tablets in a blister pack, 1 blister pack in a cardboard box.
For more detailed information, please contact the marketing authorization holder or 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:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Romanian marketing authorization number:2078/2009/01
2078/2009/02
Parallel import authorization number:270/12
Date of leaflet approval: 06.05.2022