Duphaston

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Duphaston
10 mg, film-coated tablets
Dydrogesterone
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 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

1. What Duphaston is and what it is used for
2. What you need to know before taking Duphaston
3. How to take Duphaston
4. Possible side effects
5. How to store Duphaston
6. 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 called “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.
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 excessive or occurs at an abnormal time in the cycle (intermenstrual bleeding)
  • premenstrual tension 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 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 lead to endometrial hyperplasia (thickening of the lining of the uterus). This may also occur in women who have undergone 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 is vaginal bleeding of unknown cause. Do not take Duphaston if any of the above information applies to the patient. In case of doubt, contact a doctor or pharmacist before taking Duphaston.

In case of concomitant use of Duphaston 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 required due to abnormal bleeding, the doctor
will determine the cause of bleeding before starting treatment.
Usually, unexpected vaginal bleeding or spotting does not
cause concern. This commonly occurs especially during the first few months of
taking Duphaston.
However, contact your doctor immediately if bleeding or spotting:

• persists for longer than several months,
• appears 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 bleeding or spotting and may recommend tests to rule out endometrial cancer.

Consult your doctor or pharmacist before starting to take
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 in case of doubt),
contact your doctor or pharmacist before starting to take
Duphaston. It is especially important to inform the doctor if there was a worsening of the above-mentioned conditions during pregnancy or previous hormonal therapy. If symptoms worsen or recur during treatment with Duphaston,
the doctor may recommend discontinuing treatment.
Duphaston and HRT
HRT carries certain risks in addition to benefits, which the patient and doctor must consider before starting treatment. When taking Duphaston together with oestrogen in
HRT, the following information is important. Also refer to the patient leaflet included with
the oestrogen-containing medicine.
Early menopause
Limited data are available regarding the risk of using HRT during the onset of early menopausal symptoms. The risk is lower in younger women.
This means that in younger women using HRT, the benefit-risk ratio is more favourable than in 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 examination of the breast). The doctor will advise how often these tests should be performed. After starting treatment with Duphaston, schedule regular check-ups with your doctor (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 continuous combined therapy can prevent this additional risk.

Breast cancer
Evidence confirms that taking 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 will gradually decrease over time, but the risk may persist for 10 years or longer if HRT lasted more than 5 years.
You should:

• undergo regular check-ups – your doctor will advise how often these should be performed;
• 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 – significantly rarer than breast cancer. HRT containing only oestrogens or a combination of oestrogens and 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 women per 2000 over a 5-year period. In women who used HRT for 5 years, it will occur in about 3 women per 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 highest during the first year of HRT use.
The occurrence of blood clots is more likely in cases of:

• advanced age
• presence of cancer
• overweight
• use of oestrogens
• pregnancy or immediately after childbirth
• history of blood clots in legs or lungs in the patient (or close family)
• 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 to the patient (or in case of doubt), contact your doctor to confirm whether HRT can be started.

If painful leg swelling, sudden chest pain, or difficulty breathing occurs, 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 medications to prevent blood clots (anticoagulants), 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 about HRT use. 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. In women taking oestrogen and progestogen as HRT, there is a slightly higher likelihood of heart disease than in women not using HRT. The risk of heart disease increases with age. The number of additional cases of heart disease due to oestrogen-progestagen HRT is very small 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 treatment is resumed by the doctor. This pain may be a symptom 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 increase in risk for HRT users compared to non-users does not change with age or time since menopause.
However, since 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, you should:

• contact your doctor immediately,
• stop using HRT until treatment is resumed by the doctor. This may be an early sign of stroke.

Children and adolescents
There is no indication for using Duphaston in children before the first menstrual period. It is not known whether Duphaston is safe and effective in adolescents aged 12-18 years.
Duphaston and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, including over-the-counter medicines and herbal remedies.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• herbal remedies containing St John's wort ( Hypericum perforatum ), sage, or melissa;
• anticonvulsants (used to treat epilepsy) – such as phenobarbital, carbamazepine, phenytoin;
• antibacterial agents (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 the above medicines (or in case of 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 fertility
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, 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 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 about intolerance or inability to digest certain sugars, contact the doctor before taking the medicine. This applies to rare inherited disorders affecting lactose utilization, 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,
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, doses should be evenly spaced throughout the day; for example, 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 not for dividing the dose into halves.

How much medicine to take
The number of tablets and the days on which they are taken depend on the indication. 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 (dysmenorrhoea)

• 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 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 secondary amenorrhoea (absence of 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 to start taking the medicine and the number of days it 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 10 days.
• For continuous treatment:
  • Take 1 or 2 tablets per day.
  • Use during the second half of the cycle.
• The day to start taking the medicine and the number of days it is taken depend on the length of the cycle.

Use in the treatment of premenstrual syndrome (PMS)

• Take 2 tablets per day.
• Use from the second half of the cycle until the first day of the next cycle.
• The day to start taking the medicine and the number of days it is taken depend on the length of the cycle.

Use to reduce the risk of miscarriage

• In patients who have not previously experienced 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 experienced miscarriage:
  • Take 2 tablets per day.
  • Continue 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 to start taking the medicine and the number of days it is taken depend on the length of the cycle.
• Treatment should be continued for at least 3 consecutive cycles.

Use in the treatment of menopausal symptoms – Hormone Replacement Therapy (HRT)

• In patients using sequential HRT (taking an oestrogen tablet or using an oestrogen patch throughout a 28-day cycle):
  • Take 1 Duphaston tablet once daily.
  • Use during the last 14 days of each 28-day cycle.
• In patients using cyclic HRT (taking an oestrogen tablet or using an oestrogen patch for usually 21 days, followed by a 7-day oestrogen-free interval):
  • Take 1 Duphaston tablet per day.
  • Use during the last 12 to 14 days of oestrogen therapy.
• If necessary, your doctor may increase the dose to 2 tablets per day.

Taking more Duphaston than recommended
It is unlikely that taking too many Duphaston tablets by a patient (or another person) would be harmful. Specific treatment is not usually required. If you are concerned or experience any worrying symptoms, contact your doctor.

If you forget to take 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 tablet at the usual time.
• Do not take a double dose to make up for a missed dose.
• Bleeding or spotting may occur if a dose is missed.

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

4. Possible adverse reactions

Like all medicines, Duphaston may cause adverse reactions, although not everyone will experience 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 1,000 patients);
• Swelling of the skin around the face and throat, which may cause breathing difficulties (affects less than 1 in 1,000 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;
• Depressed mood;
• Vomiting;
• Skin allergic reactions – such as rash, severe itching, or urticaria.

Rare (affects less than 1 in 1,000 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 tumours under the influence of progestagens (such as meningioma).

Younger patients may 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 refer to the patient leaflet included 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
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 are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified 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 packaging and other information

What Duphaston contains

• The active substance is dydrogesterone. Each coated tablet contains 10 mg of dydrogesterone.
• Other ingredients: monohydrate lactose, hypromellose, corn 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, film-coated tablets, divisible, marked with "155" on both sides of the break line on one side of the tablet.
28 film-coated tablets in PVC/Al blisters packed in a cardboard box.

For further information, please contact the responsible party or parallel importer:
Responsible party 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, 8121 AA Olst, The Netherlands
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Portugal, country of export, marketing authorization number: 5782198
Parallel import authorization number: 41/20