Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Duphaston
10 mg, film-coated tablets
Dydrogesteronum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What is Duphaston and for what purpose is it used
Important information before taking Duphaston
How to take Duphaston
Possible adverse effects
How to store Duphaston
Contents of the pack and other information

1. What is Duphaston and for what purpose is it used

What is Duphaston
Duphaston contains an active substance called “dydrogesteron”.

Dydrogesteron is a synthetic hormone.
It is very similar in structure and action to the hormone “progesterone”, naturally produced in the body.
Medicines such as Duphaston are called progestagens.

For what purpose is Duphaston used
Duphaston may be used alone or in combination with oestrogen. Concomitant use of oestrogen depends on the indication.
Duphaston is used in the treatment of:

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 low progesterone levels, and
to reduce the risk of miscarriage.
Symptoms of menopause – this treatment is called Hormone Replacement Therapy or HRT.
These symptoms vary among women.
They may include hot flushes, night sweats, sleep disturbances, vaginal dryness, and urinary tract disorders.

How Duphaston works
Normally, the body produces appropriate amounts of natural progesterone and natural oestrogen (another important female hormone) in the correct proportions. If the body does not produce enough progesterone, Duphaston supplements this deficiency and restores hormonal balance.
Your doctor may prescribe concomitant oestrogen therapy with Duphaston, depending on the indication.
In some women receiving HRT, taking oestrogen alone may cause endometrial hyperplasia (overgrowth of the lining of the uterus). This may also occur in women who have had a hysterectomy or who have a history of endometriosis. Taking dydrogesteron for part of the cycle prevents endometrial hyperplasia in these patients.

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 there is a suspected presence of, a tumour (growth) whose development is dependent on progesterone
if the patient has meningioma or has ever been diagnosed with meningioma (usually a benign tumour of the membrane layer between the brain and the skull)
if there is vaginal bleeding of unknown cause

Do not take Duphaston if any of the above apply to the patient. If in doubt, consult a doctor or pharmacist before taking Duphaston.

When taking Duphaston together with oestrogen, e.g. as HRT,
please also refer to section 2 of the patient leaflet included with the oestrogen-containing medicine.

Warnings and precautions

If Duphaston is to be taken due to abnormal bleeding, the doctor will determine the cause of the bleeding before starting treatment.

Usually, unexpected vaginal bleeding or spotting is not a cause for concern. This may occur especially during the first few months of taking Duphaston.

However, contact your doctor immediately if bleeding or spotting:

persists for longer than a few months
occurs after some time from the start of treatment
continues even after stopping treatment.

These may be symptoms of endometrial hyperplasia. The doctor will investigate the cause of the bleeding or spotting and may recommend tests to rule out endometrial cancer.

Consult a doctor or pharmacist before starting Duphaston if any of the following conditions apply:

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

If any of the above warnings apply to the patient (or if in doubt), contact a doctor or pharmacist before starting Duphaston. It is especially important to inform the doctor if any of the above conditions worsened during pregnancy or during previous hormone therapy. If symptoms worsen or recur during treatment with Duphaston, the doctor may recommend discontinuing treatment.

Duphaston and HRT

HRT involves certain risks as well as benefits, which the patient and doctor must consider before starting treatment. When taking Duphaston together with oestrogen as HRT, the following information is important. Also refer to the patient leaflet included with the oestrogen-containing medicine.

Early menopause

There is limited data on the risks of using HRT at the onset of early menopausal symptoms. The risk is lower in younger women. This means that the benefit-risk ratio for younger women using HRT is more favourable than for older women.

Medical examinations

Before starting or restarting HRT, the doctor will take a medical and family history. The doctor may also recommend breast and pelvic examinations.

Before and during treatment, the doctor may recommend screening tests such as mammography (X-ray of the breast). The doctor will advise how often these tests should be performed. After starting Duphaston, regular check-ups with the doctor should be scheduled (at least once a year).

Endometrial cancer and endometrial hyperplasia

Women with an intact uterus who take oestrogen-only HRT for a prolonged period have an increased risk of:

endometrial cancer
endometrial hyperplasia.

Taking Duphaston together with oestrogen (for at least 12 days per month in a 28-day cycle) or as continuous combined therapy can prevent this additional risk.

Breast cancer

Evidence confirms that using hormone replacement therapy (HRT), either as a combination of oestrogen and progestagen or oestrogen alone, increases the risk of breast cancer. The additional risk depends on how long the patient uses HRT. This increased risk becomes apparent after about 3 years (1–4) of HRT use. After stopping HRT, the additional risk gradually decreases, but may persist for 10 years or longer if HRT was used for more than 5 years.

You should:

have regular check-ups – your doctor will advise how often
regularly examine your breasts yourself for the following changes:
- skin dimpling
- changes in the nipple
- visible or palpable lumps.

If any changes are observed, contact your doctor immediately.

Ovarian cancer

Ovarian cancer is rare – significantly rarer than breast cancer. Using HRT containing oestrogen alone or a combination of oestrogen and progestagen is associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer depends on age. For example, in women aged 50 to 54 who do not use HRT, ovarian cancer will be diagnosed in about 2 out of 2000 women over 5 years. In women who have used HRT for 5 years, it will occur in about 3 out of 2000 users (i.e. about 1 additional case).

Meningioma

Using Duphaston is associated with the development of usually benign tumours of the membrane layer between the brain and the skull (meningioma). If a meningioma is diagnosed in the patient, the doctor will discontinue treatment with Duphaston (see section "When not to take..."). If the patient experiences any symptoms such as vision disturbances (e.g. double or blurred vision), hearing loss or tinnitus, loss of smell, progressively worsening headaches, memory loss, seizures, or weakness in the arms or legs, she should inform the doctor immediately.

Blood clots

HRT increases the risk of venous blood clots. This risk is 3 times higher than in women not using HRT. The risk is greatest during the first year of HRT use.

The likelihood of blood clots is higher if:

the patient is older
there is presence of cancer
the patient is overweight
oestrogens are being taken
the patient is pregnant or has recently given birth
the patient has a personal or family history of blood clots in the legs or lungs
the patient is immobilised due to surgery, injury, or illness (see information in the section "Surgery" below)
the patient has systemic lupus erythematosus – a disease causing joint pain, rash, and fever.

If any of the above risk factors apply to the patient (or if in doubt), contact a doctor to confirm whether HRT can be started.

If there is painful swelling of the legs, sudden chest pain, or difficulty breathing:

contact a doctor immediately
stop using HRT until the doctor decides whether treatment should be resumed.

These may be symptoms of blood clots.

Also inform the doctor or pharmacist if you are taking anticoagulant (blood-thinning) medicines such as warfarin. The doctor will pay special attention to the benefits and risks of using HRT.

Surgery

If surgery is planned, inform the doctor that you are using HRT. It may be necessary to stop HRT several weeks before surgery. In some cases, alternative treatment may be required before and after surgery. The doctor will advise when HRT can be restarted.

Heart disease

HRT does not prevent heart disease. Women taking oestrogen and progestogen as HRT have a slightly higher likelihood of heart disease than women not using HRT. The risk of heart disease increases with age. The number of additional cases due to using oestrogen-progestagen HRT is very small in healthy women with early signs of menopause but before menopause. The number of additional cases increases with age.

If chest pain radiating to the arm or neck occurs:

contact a doctor immediately
stop using HRT until the doctor resumes treatment.

This pain may be a sign of myocardial infarction.

Stroke

Using HRT as oestrogen-progestagen therapy or oestrogen-only therapy increases the risk of stroke. This risk is up to 1.5 times higher than in women not using HRT. The increase in risk for HRT users compared to non-users does not change with age or time since menopause. However, because the risk of stroke is strongly age-dependent, the overall risk of stroke in women using HRT increases with age.

If severe, unexplained headache or migraine (with or without visual disturbances) occurs:

contact a doctor immediately
stop using HRT until the doctor resumes treatment.

This may be an early sign of stroke.

Children and adolescents

There is no indication for using Duphaston in children before their first menstrual period. It is not known whether Duphaston is safe and effective in adolescents aged 12–18 years.

Duphaston and other medicines

Inform the doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription, herbal medicines, and dietary supplements.

In particular, inform the doctor or pharmacist if you are taking:

herbal medicines containing St John's wort (Hypericum perforatum), sage, or rosemary
antiepileptic medicines (e.g. used to treat epilepsy) – such as phenobarbital, carbamazepine, phenytoin
antibacterial medicines (used to treat infections) – such as rifampicin, rifabutin, nevirapine, efavirenz
antiviral medicines (used to treat HIV infection – AIDS) – such as ritonavir, nelfinavir.

The above medicines may reduce the effectiveness of Duphaston and lead to bleeding or spotting. If you are taking any of the above medicines (or if in doubt), contact a doctor or pharmacist before starting HRT.

Duphaston with food and drink

Duphaston can be taken with or without food.

Pregnancy, breastfeeding, and effects on fertility

During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult a doctor before using this medicine.

Pregnancy

There may be an increased risk of hypospadias (a congenital abnormality of the penis involving an abnormally positioned urethral opening) in children whose mothers took certain progestagens. However, this increased risk has not been conclusively confirmed. There is currently no evidence that using dydrogesterone during pregnancy is harmful. More than 10 million pregnant women have taken Duphaston.

If the patient is pregnant before taking Duphaston, she should consult a doctor.
If the patient becomes pregnant or suspects she is pregnant, she should contact her doctor. The doctor will discuss the benefits and risks of taking Duphaston during pregnancy.

Breastfeeding

Do not take Duphaston while breastfeeding. It is not known whether Duphaston passes into breast milk or affects the infant. Studies with other progestagens have shown that small amounts of the drug pass into breast milk.

Fertility

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

Driving and operating machinery

After taking Duphaston, mild drowsiness or dizziness may occur. This is more likely during the first few hours after taking the medicine. If these symptoms occur, do not drive or operate tools or machinery. The patient should wait and observe how the medicine affects her before deciding to drive or operate tools or machinery.

Duphaston contains lactose monohydrate.
If the patient has been informed by a doctor that she has an intolerance or difficulty digesting certain sugars, consult a doctor before taking this medicine. This applies to rare inherited conditions affecting the body's ability to process lactose, such as "lactase deficiency" or "glucose-galactose malabsorption syndrome".

3. How to take Duphaston

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

Taking the medicine

Swallow the tablet with water.
The tablet may be taken with or without food.
If more than one tablet per day is prescribed, doses should be evenly spaced throughout the day, e.g. one tablet in the morning and one in the evening.
Try to take the tablets at the same time each day. This helps ensure a constant level of the drug in the body and also helps with remembering to take the medication.
The break line on the tablet is intended only to facilitate swallowing and should not be used to divide the dose in half.

How much to take
The number of tablets and the days on which they are taken depend on the indication. If the patient still menstruates, day 1 of the cycle is the first day 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.

Treatment of painful menstruation (dysmenorrhoea)

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

Treatment of endometriosis

Take 1 to 3 tablets per day.
The doctor will instruct whether to take the tablets:
Every day of the cycle, or
Only from day 5 to day 25 of the cycle.

Treatment of secondary amenorrhoea before menopause

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

Treatment of irregular menstruation

Take 1 or 2 tablets per day.
Take from the second half of the cycle until the first day of the next cycle.
The day treatment starts and the number of days the medicine is taken depend on cycle length.

Treatment of abnormal uterine bleeding

To stop bleeding:
Take 2 or 3 tablets per day.
Take for up to 10 days.
For continuous treatment:
Take 1 or 2 tablets per day.
Take during the second half of the cycle.
The day treatment starts and the number of days the medicine is taken depend on cycle length.

Treatment of premenstrual syndrome (PMS)

Take 2 tablets per day.
Take from the second half of the cycle until the first day of the next cycle.
The day treatment starts and the number of days the medicine is taken depend on cycle length.

Use to reduce the risk of miscarriage

In patients who have not previously miscarried:
Take an initial dose of up to 4 tablets.
Then take 2 or 3 tablets per day until symptoms subside.
In patients who have previously miscarried:
Take 2 tablets per day.
Continue until week 12 of pregnancy.

Treatment of infertility due to low progesterone levels

Take 1 or 2 tablets per day.
Take from the second half of the cycle until the first day of the next cycle.
The day treatment starts and the number of days the medicine is taken depend on cycle length.
Treatment should continue for at least 3 consecutive cycles.

Treatment of menopausal symptoms – Hormone Therapy (HT)

In patients receiving "sequential" HT (taking an oestrogen tablet or using an oestrogen patch throughout a 28-day cycle):
Take 1 tablet of Duphaston daily.
Take during the last 14 days of each 28-day cycle.
In patients receiving "cyclic" HT (taking an oestrogen tablet or using an oestrogen patch usually for 21 days, followed by a 7-day break without oestrogen):
Take 1 tablet of Duphaston per day.
Take during the last 12 to 14 days of oestrogen therapy.
If necessary, the doctor may increase the dose to 2 tablets per day.

Taking more Duphaston than prescribed
It is unlikely that taking too many Duphaston tablets by a patient (or another person) would be harmful. Specific treatment is not required. In case of doubt or if any worrying symptoms occur, contact your doctor.

If you miss a dose of Duphaston

If a dose is missed, take it as soon as possible. However, if more than 12 hours have passed since the scheduled dose, do not take the missed tablet; instead, take the next tablet at the usual time.
Do not take a double dose to make up for a missed dose.
Missing a dose may result in bleeding or spotting.

Stopping Duphaston
Do not stop taking Duphaston without consulting your doctor.

4. Possible adverse effects

Like all medicines, Duphaston may cause adverse effects, although not everyone experiences them. The following adverse effects may occur during treatment:

Adverse effects during treatment with Duphaston alone
If any of the following adverse effects occur,
stop taking Duphaston immediately and contact your doctor:

Liver disorders – symptoms may include yellowing of the skin or whites of the eyes (jaundice), weakness, general malaise, or stomach pain (affects fewer than 1 in 100 patients)
Allergic reactions – symptoms may include difficulty breathing or systemic symptoms such as nausea, vomiting, diarrhoea, or low blood pressure (affects fewer than 1 in 1000 patients)
Swelling of the skin around the face and throat, which may cause difficulty breathing (affects fewer than 1 in 1000 patients). If any of the above adverse symptoms occur, stop taking Duphaston immediately and contact your doctor.

Other adverse effects during treatment with Duphaston alone
Common (affects fewer than 1 in 10 patients)

Migraine, headache
Nausea
Breast tenderness or pain
Irregular, heavy, or painful menstrual bleeding
Absence of menstruation or menstrual periods occurring less frequently than normal.

Uncommon (affects fewer than 1 in 100 patients)

Weight gain
Dizziness
Depression
Vomiting
Skin allergic reactions – such as rash, severe itching, or urticaria.

Rare (affects fewer than 1 in 1000 patients)

Somnolence
Breast swelling
A type of anaemia occurring due to breakdown of red blood cells
Fluid retention causing oedema, commonly affecting the lower legs or ankles
Increase in size of progestagen-dependent tumours (such as meningioma).

In younger patients, similar adverse effects as those observed in adults may be expected.

Adverse effects during treatment with Duphaston combined with oestrogen (HRT –
oestrogen with progestagen)
When taking Duphaston together with oestrogen, please also read the patient leaflet provided with the oestrogen-containing medicine. For further information regarding the adverse effects listed below, see section "Important information before taking Duphaston".

If any of the following adverse effects occur,
stop taking Duphaston immediately and contact your doctor:

Painful swelling of the legs, sudden chest pain, or difficulty breathing. These may be symptoms of blood clots
Chest pain radiating to the arm or neck. These may be symptoms of myocardial infarction
Severe, unexplained headache or migraine (with or without visual disturbances). These may be symptoms of stroke. If any of the above adverse symptoms occur, stop taking Duphaston immediately and contact your doctor.

Seek immediate medical advice if you notice:

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

Other adverse effects occurring during treatment with Duphaston combined with oestrogen include:

Excessive endometrial hyperplasia
Endometrial cancer
Ovarian cancer.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Duphaston

Keep the medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use the medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Duphaston contains

The active substance is dydrogesterone – each coated tablet contains 10 mg of dydrogesterone.
Other ingredients are: monohydrate lactose, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate. Coating: Opadry Y-1-7000 white (hypromellose, polyethylene glycol 400, titanium dioxide (E 171)).

What Duphaston looks like and contents of the pack
White, round, biconvex, scored, coated tablets with the imprint “155” on both sides of the score line on one side of the tablet.
10, 14, 20, or 28 tablets in PVC/Aluminium blisters, packed in a cardboard box.
For further information, please contact the responsible entity or parallel importer.
Marketing Authorisation Holder in Portugal, country of export:
BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, No. 44C – 7.3 and 7.4
1990-095 Lisbon
Portugal
Manufacturer:
Abbott Biologicals B.V.
Veerweg, 12 Olst
8121 AA Olst
The Netherlands
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Portugal, country of export: 8044719
Parallel Import Authorisation Number: 777/15