DUFASTON 10 mg Tabletki Powlekane

Treść ulotki

1. DUFASTON 10 mg film-coated tablets
   1. WHAT IS DUFASTON AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING DUFASTON
   3. HOW TO TAKE DUFASTON
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE DUFASTON
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

DUFASTON 10 mg film-coated tablets

didrogesterone
READ THIS LEAFLET CAREFULLY BEFORE USING THIS MEDICINE

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Never give it to others, even if theirsymptoms are the same as yours, as it could be harmful.
• If any of the side effects gets worse, or if you notice any side effectnot listed in this leaflet, tell your doctor or pharmacist.

The full name of the medicine is Dufaston 10 mg film-coated tablets. In this leaflet
the abbreviated name “Dufaston” is used.
Contents of this leaflet:

• 1. What DUFASTON is and what it is used for
• 2. What you need to know before you take DUFASTON
• 3. How to use DUFASTON
• 4. Possible side effects
• 5. How to store DUFASTON
• 6. Contents of the pack and other information.

1. WHAT IS DUFASTON AND WHAT IT IS USED FOR

What is Dufaston
DUFASTON contains a medicine called didrogesterone.

• Didrogesterone is a synthetic hormone.
• It is very similar to the progesterone hormone produced by the body.
• Medicines like Dufaston are called progestins.

What is Dufaston used for
Dufaston can be taken alone or with estrogens. You may also take an estrogen,
depending on the reason why you are taking Dufaston.
Dufaston is used:

• To treat the symptoms of menopause (this treatment is called hormone replacementtherapy or HRT)
• These symptoms vary from woman to woman.
• They can include hot flushes, night sweats, sleep disturbances, vaginal dryness and urinary symptoms.
• For problems that occur when the body does not produce enough progesterone:
• Threatened miscarriage and recurrent miscarriage
• Infertility due to low progesterone levels
• Dysmenorrhea (painful periods)
• Endometriosis (when tissue from the uterine lining grows outside the uterus)
• Irregular menstrual cycles
• Secondary amenorrhea (absence of menstruation before menopause)
• Functional metrorrhagia (excessive blood loss during menstruation or bleeding outside of cycles).

How Dufaston works
The body normally balances the amount of the natural hormone progesterone with estrogen (the other
main female hormone). If the body does not produce enough progesterone, Dufaston supplements it and
restores the balance.
The doctor may ask you to take estrogens together with Dufaston. This depends on the reason why
you are taking Dufaston.
For some women using HRT, taking only estrogens can cause abnormal thickening
of the uterine lining. This can happen even if you do not have a uterus and have a history of endometriosis.
Taking didrogesterone for part of the menstrual cycle helps to prevent thickening of the uterine
lining.

2. WHAT YOU NEED TO KNOW BEFORE USING DUFASTON

Do not use DUFASTON:
if you are allergic to the active substance or any of the excipients of Dufaston (listed in
section 6)
if you have had vaginal bleeding of unknown cause
if you have or suspect you have a progestin-dependent tumor (whose growth is sensitive
to progestins) such as a brain tumor called meningioma
if you have or have had breast canceror suspect you have it
if you have excessive thickening of the uterine wall(endometrial hyperplasia) that is not
being treated
if you have or have ever had a blood clot in a vein(thrombosis) in the legs (deep vein
thrombosis) or in the lungs (pulmonary embolism)
if you suffer from a blood coagulation disorder(such as protein C, protein
S, or antithrombin deficiency)
if you have or have recently had a disease caused by blood clots in the arteries, such as a

heart attack, strokeor angina
if you have or have ever had liver diseaseand liver function tests have not returned
to normal
if you have a rare blood disease called "porphyria", which is hereditary (runs in families)
Do not take Dufaston if you are in any of the above conditions. If you are not sure, consult your doctor
or pharmacist before taking Dufaston. If any of the conditions described above
appear for the first time during the use of Dufaston, stop taking it immediately and consult
your doctor immediately.
If you are taking Dufaston together with an estrogen, for example as part of HRT, please

Warnings and precautions
Tell your doctor if you have or have ever had any of the following problems, before starting treatment
as these may reappear or worsen during treatment with Dufaston. If this happens, you should see your doctor more often for a check-up:

• fibroids inside the uterus
• growth of the uterine wall outside the uterus (endometriosis) or a history of excessive growth of the uterine wall (endometrial hyperplasia)
• increased risk of developing blood clots (see “Blood clots in a vein [thrombosis]”)
• increased risk of having an estrogen-sensitive cancer (resulting from having mother, sister or grandmother with breast cancer)
• high blood pressure
• liver disorder, such as a benign liver tumor
• diabetes
• gallstones
• migraine or severe headaches
• a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• a very high level of fats in the blood (triglycerides)
• fluid retention due to heart or kidney problems

Stop taking Dufaston and see your doctor immediately
if you notice any of the following effects during HRT:

• one of the conditions listed in the section "Do not use Dufaston"
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of a liver disease
• a significant increase in blood pressure (symptoms may include headache, fatigue, dizziness)
• headache similar to migraine that occurs for the first time
• pregnancy
• if you notice signs of a blood clot, such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty breathing. For more information, see "Blood clots in a vein (thrombosis)".

Children and adolescents
The use of Dufaston in girls before their first menstruation is not indicated. The efficacy and tolerability of Dufaston in adolescents between 12 and 18 years of age are not known

Be particularly careful with Dufaston:
If you need to take Dufaston for abnormal bleeding, your doctor will need to investigate the cause of
the bleeding before starting treatment with this medicine.

If you experience unexpected bleeding or spottingit is usually not
a cause for concern. This is more likely to happen during the first few months of therapy with
Dufaston.
However, schedule an appointment with your doctor immediatelyif the bleeding or spotting:

• continues beyond the first few months
• starts after you have been on treatment for a while
• continues even after stopping treatment. This could be a sign that the uterine lining is becoming thicker. Your doctor will need to investigate the cause of the bleeding or spotting and may perform a test to look for cancer of the uterine lining.

Before taking Dufastondiscuss with your doctor or pharmacistif you have any of the following
conditions:

• depression
• liver problems
• a rare hereditary blood disorder called “porphyria”. If you have any of the conditions listed (or are unsure) talk to your doctor or pharmacist before taking Dufaston. It is particularly important to report if the conditions listed have worsened during pregnancy or previous hormone therapy. Your doctor may decide to monitor you more closely during treatment. If you observe a worsening or reappearance of the conditions listed while taking Dufaston, your doctor may interrupt the treatment.

Dufaston and HRT
Along with the benefits, HRT has some risks that you and your doctor need to consider when deciding
to start this treatment. If you are taking Dufaston with an estrogen as part of HRT, the risks and
benefits are similar to those of estrogen alone.

Early menopause
There is limited evidence on the risks of HRT used to treat early menopause. In
younger women there is a low level of risk. This means that the benefit-risk ratio for young women on HRT for early menopause may be better than in older women.

Medical check-ups
Before starting or restarting HRT, your doctor will ask about your personal and family medical
history and may decide to examine your breasts or pelvis (lower abdomen).
Before and during treatment, your doctor may perform screening tests such as a mammogram (an
X-ray of the breast). They will tell you how often you should have these tests. Once you have started
taking Dufaston, you should see your doctor for regular check-ups (at least once a year).

Endometrial cancer and endometrial hyperplasia
Women who have a uterus and take HRT with estrogen alone for a long time have a
higher risk of:

• endometrial cancer (cancer of the uterine lining)
• endometrial hyperplasia (altered thickening of the uterine lining) Taking Dufaston together with estrogen (for at least 12 days in a 28-day cycle) or as continuous combined estrogen-progestin therapy can prevent this additional risk.

Breast cancer
Women who take combined estrogen-progestin HRT or estrogen-only HRT have a
higher risk of breast cancer. The risk depends on how long you take HRT. The additional risk of breast cancer becomes apparent after about 3 (1-4) years. After stopping
HRT, the additional risk will decrease over time, but this risk may persist for 10 years or more
if HRT has been used for over 5 years.
Make sure to:

• have regular breast checks (your doctor will tell you how often)
• check your breasts regularly for changes such as:
• skin depressions
• changes in the nipple
• any visible or palpable lump. If you notice any changes, see your doctor immediately.

Ovarian cancer
Ovarian cancer is rare - much rarer than breast cancer. The use of estrogen-only or estrogen-progestin therapy has been associated with a slight increase in the risk of ovarian
cancer.
The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who do not use HRT, about 2 women out of 2,000 will be diagnosed with
ovarian cancer within 5 years. For women who have been using HRT for 5 years, there will be about 3 cases per 2,000 women treated (i.e., about 1 additional case).

Blood clots in a vein (thrombosis)
HRT increases the risk of venous thrombosis. The risk increases up to three times compared to
the population that does not use HRT. The risk is higher in the first year of treatment.
You are more likely to develop thrombosis if:

• you are older
• you have cancer
• you are very overweight
• you are taking an estrogen
• you are pregnant or have recently had a baby
• you (or your close relatives) have previously had thrombosis that may have affected your legs or lungs
• you are immobilized for a long period due to surgery, trauma or illness (see also Surgery)
• you have a disease called “Systemic Lupus Erythematosus” (SLE) - a disease that causes joint pain, skin rashes and fever. If you are in any of the conditions listed above (or are unsure) ask your doctor if you can take HRT.

If you experience swelling with pain in the legs, sudden chest pain or difficulty breathing:

• go to your doctor immediately
• do not take HRT until your doctor authorizes you to continue. These may be symptoms of venous thrombosis.

Also tell your doctor or pharmacist if you are taking medications to prevent thrombosis
(anticoagulants) such as warfarin. Your doctor will need to pay particular attention to the benefits and
risks of taking HRT.

Surgery
If you have scheduled surgery, tell your doctor before the surgery that you are
taking HRT. Do this well before the surgery. You may need to stop
HRT several weeks before the operation. In some cases, you may need some
other treatments before and after the operation. Your doctor will tell you when to start
taking HRT again.

Heart disease
HRT does not help prevent heart disease. Women who take combined estrogen-progestin HRT have a slight increase in risk of developing heart disease compared to
those who do not take it. The risk of heart disease also increases with age. The number of
additional cases of heart disease due to combined estrogen-progestin HRT is very low in healthy women recently postmenopausal. The number of additional cases increases as age progresses.
If you experience chest pain that radiates to your arm or neck:

• go to your doctor immediately
• do not take HRT until your doctor authorizes you to continue. The pain may be a symptom of a heart attack.

Stroke
Taking combined estrogen-progestin HRT or estrogen-only HRT increases the risk of having a stroke.
The risk increases up to one and a half times compared to the population that does not use HRT. The
comparative risk between users and non-users does not change with age or time since
menopause. The risk of stroke increases with age. This means that the overall risk of stroke in
women taking HRT increases with age.
If you experience unexplained and severe headache or migraine (with or without visual disturbances):

• go to your doctor immediately
• do not take HRT until your doctor authorizes you to continue. This may be an early symptom of a stroke.

Other conditions
HRT does not prevent memory loss. There is some evidence of a greater risk of memory loss in women who start HRT after the age of 65. Talk to your doctor for advice.

Other medicines and Dufaston
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including over-the-counter medicines and herbal remedies.
In particular, tell your doctor or pharmacist if you are taking the following medicines. These medicines may reduce the effect of Dufaston and cause bleeding or spotting:

• herbal preparations containing St. John's wort, sage or ginkgo biloba
• medicines for epilepsy such as phenobarbital, phenytoin, carbamazepine
• medicines for infections such as rifampicin, rifabutin, nevirapine, efavirenz
• medicines for AIDS such as ritonavir, nelfinavir. If you are taking any of these medicines (or are unsure) talk to your doctor or pharmacist before taking Dufaston.

Dufaston with food and drink
DUFASTON can be taken independently of food intake.

Pregnancy, breastfeeding and fertility,
Pregnancy
There may be an increased risk of hypospadias (a birth defect of the penis involving
the urinary opening) in babies whose mothers have taken certain progestins. However, this
increased risk has not yet been confirmed. So far, there is no evidence that taking
dihydrogesterone during pregnancy is dangerous. Over 10 million pregnant women have
taken Dufaston.

• Talk to your doctor before taking Dufaston if you are pregnant.
• If you become pregnant or think you might be, consult your doctor. They will discuss with you the benefits and risks of taking Dufaston during pregnancy.

Breastfeeding
If you are breastfeeding, do not take Dufaston. It is not known whether Dufaston passes into breast milk and has effects
on the baby. Studies with other progestins show that a small amount of them passes into breast
milk.

Fertility
There is no evidence that didrogesterone reduces fertility, when taken as recommended
by the doctor
Driving and using machines
You may experience drowsiness or dizziness after taking Dufaston. This is more frequent in the first
hours after taking it. If this happens, do not drive or use machines. Wait to see what effect
Dufaston has on you, before driving or using machines.

Important information about some excipients of Dufaston
Dufaston contains milk sugar (lactose). If you know you cannot tolerate or digest some sugars (to
have an intolerance to some sugars), talk to your doctor before taking the medicine. This
may concern rare inherited conditions that affect how the body uses lactose, such as
"total lactase deficiency" or "glucose-galactose malabsorption".

3. HOW TO TAKE DUFASTON

Dufaston should always be taken exactly as your doctor has prescribed. If you are unsure, ask your doctor or pharmacist. The doctor will adjust the dose based on what is right for you.

Taking the medication

• Swallow each tablet with water.
• You can take the tablets with or without food.
• If you need to take more than one tablet, spread the doses throughout the day. For example, take one tablet in the morning and one in the evening.
• Try to take the tablets at the same time each day. This ensures a constant amount of medication in the body. This will also help you remember to take the tablets.
• The fracture line on the tablets is only to make them easier to break to aid swallowing. It cannot be used to take half a tablet.

How many tablets to take
The number of tablets to take and for how long depends on the reason for your treatment. If you still have natural cycles, the first day of your cycle is when bleeding begins. If you no longer have natural cycles, your doctor will decide when the first day of your cycle begins and when you should start taking the tablets.

For treating menopause symptoms

• If you are being treated with a ‘sequential’ HRT (you take an estrogen tablet or use a patch every day of the cycle):
• Take 1 tablet daily
• Take the tablet in the last 14 days of a 28-day cycle.
• If you are being treated with a ‘cyclic’ HRT (you take an estrogen tablet or use a patch generally for 21 days followed by a 7-day treatment-free interval):
• Take 1 tablet daily
• Take the tablet in the last 12-14 days of estrogen therapy.
• If necessary, your doctor may increase the dose to 2 tablets daily.

Threatened miscarriage:

• If you have never had a miscarriage before:
• Take a dose of up to 4 tablets.
• Then take 2 or 3 tablets daily until you no longer have symptoms.

Habitual abortion:

• If you have already had miscarriages:
• Take 2 tablets daily.
• Take the medication until the twelfth week of pregnancy .

Infertility due to low progesterone levels:

• Take 1 or 2 tablets daily.
• Take them from the second half of the cycle until the first day of the next cycle.
• The day to start therapy and the number of days to take the tablets will depend on the length of your cycle.
• Continue therapy for at least 3 consecutive cycles.

Dysmenorrhea (painful periods):

• Take 1 or 2 tablets daily.
• Take them only from the 5th to the 25th day of the cycle.

Endometriosis:

• Take 1 to 3 tablets daily.
• You may need to take the tablets:
• Every day of the cycle.
• Only from the 5th to the 25th day of the cycle.

Irregular menstrual cycles:

• Take 1 or 2 tablets daily.
• Take them from the second half of the cycle until the first day of the next cycle.
• The day to start therapy and the number of days to take the tablets will depend on the length of your cycle.

Secondary amenorrhea (absence of menstruation before menopause):

• Take 1 or 2 tablets daily.
• Continue for 14 days during the second half of the theoretical cycle.

Functional metrorrhagia (excessive bleeding during menstruation or bleeding outside of cycles)

• If the treatment is to stop the bleeding:
• Take 2 or 3 tablets daily.
• Continue for at least 10 days.
• For continuous treatment:
• Take 1 or 2 tablets daily.
• Continue for the second half of the cycle.
• The day to start therapy and the number of days to take the tablets will depend on the length of your cycle.

If you use more DUFASTON than you should
If you (or anyone else) have swallowed an excessive dose of DUFASTON, it is unlikely to harm you. No treatment is necessary. If you are worried, contact your doctor.

If you forget to take Dufaston

• Take the forgotten tablet as soon as you remember. However, if more than 12 hours have passed since you were supposed to take it, skip the forgotten dose and take the next one at the usual time.
• Do not take a double dose to make up for the forgotten dose.
• You may notice some bleeding or light spotting if you have forgotten a dose.

If you stop taking Dufaston
Do not stop taking Dufaston without your doctor's advice.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dufaston can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:

Side effects when Dufaston is taken alone
Stop taking Dufaston and see your doctor immediately if you experience any of the
following side effects:

• liver problems - signs may include yellowing of the skin and the whites of the eyes (jaundice), feeling tired, general feeling of unwellness or stomach pain (affects less than 1 in 100 treated patients)
• allergic reactions - signs may include difficulty breathing or reactions involving the whole body such as feeling unwell, nausea, diarrhoea or low blood pressure (affects less than 1 in 1000 treated patients)
• swelling of the skin of the face and neck that can cause difficulty breathing (affects less than 1 in 1000 treated patients) Stop taking Dufaston and see your doctor immediately if you notice any of the above side effects

Other side effects of Dufaston taken alone:
Common(affects less than 1 in 10 treated patients)

• headache, migraine
• nausea
• tension or pain in the breasts
• irregular, heavy or painful periods
• absence of menstruation or less frequent menstruation than normal

Uncommon(affects less than 1 in 100 treated patients)

• weight gain
• dizziness
• depressed mood
• vomiting
• allergic reactions such as skin rashes, severe itching or hives;
• abnormal liver function, such as jaundice, unwellness, abdominal pain

Rare(affects less than 1 in 1000 treated patients)

• drowsiness
• breast swelling
• a type of anaemia caused by the destruction of red blood cells
• swelling due to fluid retention, often in the lower legs or ankles
• increase in the size of tumours that are sensitive to progestogens (such as meningioma).

Side effects in younger patients are expected to be similar to those appearing in the
adult population.

Side effects when Dufaston is taken with an oestrogen (combined oestrogen-progestogen therapy)
the medicine containing oestrogen. See also section “Before using Dufaston” for more
information on the side effects reported below.

Stop taking Dufaston and see your doctor immediately if you experience any of the
following side effects:

• Swelling with pain in the legs, sudden chest pain or difficulty breathing. These may be signs of thrombosis.
• Chest pain that spreads to the arm and neck. This could be a sign of a heart attack.
• Severe or unexplained headaches or migraines (with or without vision problems). These could be signs of a stroke. Stop taking the medicine and see your doctor immediately if you experience any of the above side effects.

Schedule a visit to your doctor immediately if you notice:

• Skin depressions of the breast, nipple changes or any visible or palpable hardening. These could be signs of breast cancer.

Other side effects due to taking Dufaston with an oestrogen include abnormal thickening or cancer of the uterine lining or ovarian cancer.
If any of these side effects get worse, or if you notice any other effect

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting
side effects you can help provide more information on the safety of this
medicine.

5. HOW TO STORE DUFASTON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dufaston contains
The active ingredient is dihydrogesterone

• each film-coated tablet contains 10 mg of dihydrogesterone The excipients of the core are: lactose, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate. The excipient of the film coating is: Opadry white Y-1-7000 [hypromellose, Macrogol 400, titanium dioxide (E171)].

Description of the appearance of Dufaston and contents of the pack
The tablets are round, biconvex, with a fracture line, white in colour, with a diameter of 7 mm,
with ‘155’ imprinted on one side on both sides of the fracture line.

• The tablets are packaged in blisters consisting of an aluminum foil and a PVC film.
• The pack contains 14 or 42 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane,
Spencer Dock
Dublin 1,
D01 YE64
Ireland

Manufacturer
Abbott Biologicals B.V., Olst - Netherlands.