Patient Information Leaflet

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

Keep this leaflet, as you may need to read it again.
If you have any further questions, 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 any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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

1. What Duphaston is and what it is used for

What Duphaston is
Duphaston contains an active substance called “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 such as Duphaston are known as progestogens.

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

Disorders caused by insufficient production of progesterone in the body, such as:
painful menstruation
endometriosis – a condition in which endometrial tissue occurs outside the uterine cavity
absence of menstruation before menopause
irregular menstruation
menstrual bleeding that is excessively heavy or occurs at an abnormal time in the cycle (intermenstrual bleeding)
premenstrual syndrome
infertility due to low progesterone levels, and
to reduce the risk of miscarriage
Symptoms of menopause – this treatment is known as Hormone Replacement Therapy (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 balanced proportions. If the body does not produce sufficient 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 undergoing HRT, taking oestrogen alone may lead to endometrial hyperplasia. This may also occur in women who have had a hysterectomy or who have a history of endometriosis. Taking dydrogesterone 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 justified suspicion of a tumour (cancer) whose growth is dependent on progesterone – such as a brain tumour called "meningioma"
if there are vaginal bleedings 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.

If taking Duphaston together with oestrogen, e.g. as HRT, you should also
read section 2 of the patient leaflet included with the oestrogen-containing medicine.
Warnings and precautions
If Duphaston is 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:

lasts longer than a few months
occurs after a period of time since starting 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 your 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 previous hormonal therapy. If symptoms worsen or recur during treatment with Duphaston, the doctor may recommend stopping treatment.
Duphaston and HRT
HRT carries certain risks in addition to its benefits, which the patient and doctor must consider before starting treatment. When taking Duphaston together with oestrogen as part of HRT, the following information is important. You should also read the patient leaflet included with the oestrogen-containing medicine.
Early menopause
Limited data are available on the risks of using HRT at the onset of early menopausal symptoms. The risk is lower in younger women. This means that for younger women using HRT, the benefit-risk ratio 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 (an X-ray of the breast). The doctor will advise how often these tests should be performed. After starting treatment with Duphaston, regular check-ups with the doctor should be scheduled (at least once a year).
Endometrial cancer and endometrial hyperplasia
In women with an intact uterus who take oestrogen-only HRT for a prolonged period, there is 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 a continuous combined therapy can prevent this additional risk.

Breast cancer
Evidence confirms that using hormone replacement therapy (HRT) in the form of oestrogen-progestagen combination or oestrogen alone increases the risk of breast cancer. The additional risk depends on how long the patient uses HRT. This additional 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 lasted over 5 years.
You should:

have regular check-ups – your doctor will advise how often
regularly self-examine your breasts 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 – much rarer than breast cancer. Using HRT containing oestrogen alone or combined with progestagens 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 a 5-year period. 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).
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.
Blood clots are more likely in cases of:

older age
presence of cancer
obesity
use of oestrogens
pregnancy or immediately after childbirth
personal or family history of blood clots in legs or lungs
immobility due to surgery, injury, or illness (see information in section "Surgery" below)
presence of a disease called "systemic lupus erythematosus" – a condition causing joint pain, rash, and fever. If any of the above risk factors apply (or if in doubt), contact your doctor to ensure it is safe to start HRT.

If painful leg swelling, sudden chest pain, or difficulty breathing occur, you should:

contact your doctor immediately
stop using HRT until the doctor decides whether to resume treatment. These may be symptoms of blood clots.

You should also inform your 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 HRT.
Surgery
If surgery is planned, inform your doctor that you are using HRT. It may be necessary to stop HRT several weeks before surgery. In some cases, alternative treatment may be needed before and after surgery. The doctor will advise when you can restart HRT.
Heart disease
HRT does not prevent heart disease. In women taking oestrogen and progesterone as HRT, the likelihood of heart disease is slightly higher than in women not using HRT. The risk of heart disease increases with age. The number of additional cases of heart disease due to using oestrogen-progestagen HRT is very low in healthy women with early menopausal symptoms but before menopause. The number of additional cases increases with age.
If chest pain radiating to the arm or neck occurs, you should:

contact your 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 non-users of HRT. The increased risk in 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 a severe, unexplained headache or migraine (with or without visual disturbances) occurs, you should:

contact your 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
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those you plan to take, even if they are available without a prescription, as well as herbal medicines.
In particular, inform your doctor or pharmacist if you are taking the following medicines:

herbal remedies containing St. John's wort ( Hypericum perforatum ), sage, or rosemary
antiepileptic drugs (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 medicines may reduce the effectiveness of Duphaston and lead to bleeding and spotting. If you are taking any of the above medicines (or if in doubt), contact your 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 if planning pregnancy, consult your doctor before using this medicine.
Pregnancy
There may be an increased risk of hypospadias (a congenital malformation of the penis involving abnormal positioning of the urethral opening) in children whose mothers took certain progestagens. However, this increased risk has not been definitively confirmed. To date, there is no evidence that using dydrogesterone during pregnancy is harmful. More than 10 million pregnant women have taken Duphaston.

If you are pregnant before taking Duphaston, consult your doctor.
If you become pregnant or suspect you are pregnant, contact your 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 recommended by a doctor.
Driving and using machines
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 (milk sugar)
If you have been informed by your doctor of an intolerance or inability to digest certain sugars, contact your doctor before taking this medicine. This applies to rare inherited disorders affecting lactose metabolism, such as "lactase deficiency" or "glucose-galactose malabsorption syndrome".

3. How to take Duphaston

Duphaston should always be taken exactly as directed by your doctor. If you are unsure, you should
contact your doctor or pharmacist. Your doctor will adjust the dose according to your needs.
Taking the medicine

Swallow the tablet with water.
The tablet may be taken with or without food.
If you are taking more than one tablet per day, divide the doses evenly 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 will help ensure a constant level of medicine in your body and will also help you remember to take it.
The break line on the tablet is intended only to facilitate swallowing and should not be used to divide the dose into halves.

How much medicine to take
The number of tablets and the days on which they are taken depend on the condition being treated. If the patient still has menstrual periods, 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.
Use in the treatment of painful menstruation

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

Use in the treatment of endometriosis

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

Use in the treatment of absent menstruation before menopause

Take 1 or 2 tablets per day.
Use for 14 days during 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 until the first day of the next cycle.
The day treatment starts and the number of days the medicine is taken depend on the length of the cycle.

Use in the treatment of abnormal uterine bleeding

For treatment aimed at stopping bleeding:
Take 2 or 3 tablets per day.
Use for up to 0 days.
For continuous treatment:
Take 1 or 2 tablets per day.
Use during the second half of the cycle.
The day treatment starts and the number of days the medicine is taken depend on the length of the cycle.

Use in the treatment of premenstrual syndrome

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

Use to reduce the risk of miscarriage

In patients who have not previously had a miscarriage:
Take a single dose of up to 4 tablets.
Then take 2 or 3 tablets per day until symptoms subside.
In patients who have previously had a miscarriage:
Take 2 tablets per day.
Use until week 12 of pregnancy.

Use in infertility due to low progesterone levels

Take 1 or 2 tablets per day.
Use 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 the length of the cycle.
Treatment should continue for at least 3 consecutive cycles.

Use in the treatment of menopausal symptoms – HRT

In patients using sequential HRT (taking an estrogen tablet or using an estrogen patch throughout a 28-day cycle):
Take 1 tablet of Duphaston once daily.
Use during the last 14 days of each 28-day cycle.
In patients using cyclic HRT (taking an estrogen tablet or using an estrogen patch for usually 21 days, followed by a 7-day break without estrogen):
Take 1 tablet of Duphaston per day.
Use during the last 12 to 14 days of estrogen therapy.
If necessary, your 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 the patient (or another person) would be harmful.
No specific treatment is required. If you are unsure 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 tablet and take the next one 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 treatment
Do not stop taking Duphaston without consulting your doctor.

4. Possible adverse reactions

Like any medicine, Duphaston may cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with Duphaston:

Adverse reactions during treatment with Duphaston alone
If any of the following adverse reactions 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 less 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 less than 1 in 1000 patients)
Swelling of the skin around the face and throat, which may cause difficulty breathing (affects less than 1 in 1000 patients). If any of the above adverse symptoms occur, stop taking Duphaston immediately and contact your doctor.

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

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

Uncommon (affects less than 1 in 100 patients)

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

Rare (affects less than 1 in 1000 patients)

Drowsiness
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 tumours under the influence of progestagens (such as meningioma)

Younger patients can be expected to experience similar adverse reactions as those observed in adults.

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

If any of the following adverse reactions 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.

Contact your doctor immediately 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 reactions occurring during treatment with Duphaston combined with oestrogen include:

Excessive endometrial hyperplasia
Endometrial cancer
Ovarian cancer

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

5. How to store Duphaston

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
Do not use this 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 required. 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 (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 breakline on one side of the tablet.
20 coated tablets in a PVC/Al blister pack, in a cardboard carton.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Romania, country of export:
Viatris Healthcare Limited
Damastown Industrial Park, Mulhuddart
Dublin 15, Dublin
Ireland
Manufacturer:
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The Netherlands
Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37
02-234 Warsaw 87-100 Toruń
Marketing Authorisation Number in Romania, country of export: 2078/2009/01
2078/2009/02
Parallel Import Licence Number: 310/24