Vivaston

Package leaflet: Information for the patient

VIVASTON, 10 mg, coated tablets
Dydrogesterone
Please read the entire leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
• 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 Vivaston is and what it is used for
2. Important information before taking Vivaston
3. How to take Vivaston
4. Possible side effects
5. How to store Vivaston
6. Contents of the pack and other information

1. What Vivaston is and what it is used for

What is Vivaston
Vivaston contains an active substance called "dydrogesterone".

• Dydrogesterone is a synthetic hormone.
• Dydrogesterone is very similar to the natural hormone progesterone produced in the body.
• Medicines such as Vivaston are known as progestogens.

What Vivaston is used for
Vivaston may be used alone or in combination with oestrogen. Whether oestrogen is taken at the same time depends on the reason why the patient is taking the medicine.
Vivaston is used:

• in disorders caused by insufficient production of progesterone by the body, such as:
  • painful menstruation;
  • endometriosis – a condition in which the tissue lining the uterus grows outside the uterine cavity;
  • absence of menstruation in the premenopausal period;
  • irregular menstruation;
  • menstrual bleeding that is excessively heavy or occurs at an abnormal time in the cycle (between periods);
  • premenstrual syndrome (PMS);
  • infertility caused by low progesterone levels; and
  • to reduce the risk of miscarriage.
• in the treatment of menopausal symptoms – this treatment is called 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 Vivaston 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, Vivaston supplements this deficiency and restores hormonal balance.
Your doctor may prescribe concomitant oestrogen therapy with Vivaston, depending on the indication.
In some women receiving HRT, taking oestrogen alone may lead to overgrowth (hyperplasia) of the endometrium (the lining of the uterus). This risk may also exist in women who have had a hysterectomy or who have a history of endometriosis. Taking dydrogesterone for part of the cycle helps prevent endometrial hyperplasia in these patients.

2. Important information before using Vivaston

When not to use Vivaston

• If the patient is allergic to dydrogesterone or any of the other ingredients of this medicine (listed in section 6).
• If the patient has or there is a justified suspicion of a tumour dependent on progesterone, called meningioma.
• If the patient has vaginal bleeding of unknown cause.

Do not take Vivaston if any of the above situations apply to the patient.
If in doubt, consult a doctor or pharmacist before taking Vivaston.
If taking Vivaston together with oestrogen, e.g. as HRT, also read the “When not to take” section of the patient leaflet included with the oestrogen-containing medicine.

Warnings and precautions

If it is necessary to take Vivaston due to abnormal bleeding, the doctor will determine the cause of the bleeding before the patient starts taking this medicine.
Unexpected vaginal bleeding or spotting usually does not cause concern. This commonly occurs especially during the first few months of taking Vivaston.
However, contact your doctor immediately if bleeding or spotting:

• lasts longer than a few months,
• appears after some time from starting treatment,
• occurs even after stopping treatment. These may be symptoms of endometrial hyperplasia (thickening of the lining of the uterus). 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 to take Vivaston if any of the following apply:

• depression,
• liver disease,
• a rare, inherited (congenital) 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 this medicine. It is especially important to inform the doctor if there was a worsening of any of the above conditions during pregnancy or previous hormone therapy. If symptoms worsen or recur during treatment with Vivaston, the doctor may recommend stopping treatment.

Vivaston and HRT

HRT carries certain risks in addition to its benefits, which the patient and doctor must consider before starting treatment. When taking Vivaston together with oestrogen as HRT, the following information is important. Also refer to 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 perform a breast and pelvic examination.
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 Vivaston, regular follow-up visits with the doctor (at least once a year) are recommended.

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 (cancer of the lining of the uterus),
• endometrial hyperplasia (thickening of the uterine lining).

Taking Vivaston 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

Women taking hormone replacement therapy (HRT) in the form of oestrogen combined with a progestagen, or oestrogen alone, have an increased risk of developing breast cancer. This risk depends on how long the patient takes HRT. The increased risk becomes apparent after about 3 (1–4) years of HRT use. After stopping HRT, the additional risk gradually decreases, but may persist for 10 years or longer if HRT was taken for more than 5 years.
You should:

• have regular check-ups – your doctor will advise how often these should be done;
• regularly examine your breasts yourself for the following changes:
  • skin dimpling,
  • changes in the nipple,
  • visible or palpable lumps. If any changes are noticed, consult a doctor immediately.

Ovarian cancer

Ovarian cancer is rare – significantly rarer than breast cancer. HRT containing oestrogen alone or combined oestrogen-progestagen therapy is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, among women aged 50 to 54 who do not use HRT, ovarian cancer will be diagnosed in about 2 out of 2,000 over a 5-year period. Among women who have taken HRT for 5 years, it will occur in about 3 out of 2,000 (i.e. about 1 additional case).

Blood clots

HRT increases the risk of developing blood clots in the veins. 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 if:

• the patient is older,
• the patient has cancer,
• the patient is overweight,
• the patient is taking oestrogens,
• the patient is pregnant or has recently given birth,
• the patient has previously had blood clots in the legs or lungs (or if there is a family history),
• the patient has been immobilised due to surgery, injury or illness (see “Surgery” section below),
• the patient has systemic lupus erythematosus – a condition causing joint pain, rash and fever.

If any of the above risk factors apply (or if in doubt), contact a doctor to confirm whether it is safe to start HRT.

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

• contact a doctor immediately,
• stop taking HRT until the doctor decides whether to resume treatment. 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 HRT.

Surgery

If surgery is planned, inform the doctor that you are taking HRT. This should be done well in advance of the procedure. 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. Women taking oestrogen and progestogen as HRT have a slightly higher likelihood of developing heart disease than 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 before menopause. The number of additional cases increases with age.

If chest pain radiating to the arm or neck occurs, you should:

• contact a doctor immediately,
• stop taking HRT until the doctor advises resuming treatment. This pain may be a sign of heart attack.

Stroke

Taking 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 increased risk compared to 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 using HRT increases with age.

If a severe, unexplained headache or migraine occurs (which may also involve visual disturbances), you should:

• contact a doctor immediately,
• stop taking HRT until the doctor advises resuming treatment. This may be an early sign of stroke.

Children and adolescents

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

Vivaston and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as herbal medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines. These medicines may reduce the effectiveness of Vivaston and cause bleeding or spotting:

• herbal remedies containing St John’s wort (Hypericum perforatum), sage, or liquorice;
• antiepileptic medicines (used to treat epilepsy) – such as phenobarbital, carbamazepine, phenytoin;
• medicines used to treat infections – such as rifampicin, rifabutin, nevirapine, efavirenz;
• medicines used to treat HIV infection (AIDS) – such as ritonavir, nelfinavir.

If you are taking any of the above medicines (or if in doubt), contact your doctor or pharmacist before starting Vivaston.

Vivaston with food and drink

Vivaston can be taken with or without food.

Pregnancy, breastfeeding and fertility

Pregnancy

There may be an increased risk of hypospadias (a congenital malformation of the penis where the urethral opening is in an abnormal position) 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 dydrogesterone.

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

Breastfeeding

Do not take Vivaston while breastfeeding. It is not known whether Vivaston passes into breast milk or affects the infant. Studies with other progestagens have shown that small amounts of these medicines 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 Vivaston, mild drowsiness or dizziness may occur. This is more likely during the first few hours after taking the medicine than later. If this occurs, do not drive or operate tools or machinery. Wait to see how Vivaston affects your ability to drive, use tools or operate machinery.

Vivaston contains lactose

If the patient has previously been diagnosed with an intolerance to certain sugars, she should consult a doctor before taking this medicine.

3. How to use Vivaston

This medicine should always be used exactly as your doctor has told you. If you are unsure, you should consult your doctor. Your doctor will adjust the dose according to your individual needs.

How to take 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, 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 medicine in your body and also helps you remember to take it.

How much medicine to take
The number of tablets and the days on which they are taken depend on the medical indication.
If you still have menstrual periods: day 1 of the cycle is the first day of bleeding.
If you no longer have natural periods, your doctor will determine the first day of the cycle and decide when to start taking the tablets.

Painful menstruation (dysmenorrhoea)

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

Endometriosis

• Take 1 to 3 tablets per day.
• Your doctor will decide whether to take the tablets:
  • every day of the cycle, or
  • only from day 5 to day 25 of the cycle.

Menstrual suppression before menopause

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

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 on which to start taking the medicine and the number of days it should be taken depend on the length of the cycle.

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 on which to start taking the medicine and the number of days it should be taken depend on the length of the cycle.

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 on which to start taking the medicine and the number of days it should be taken depend on the length of the cycle.

Reducing the risk of miscarriage

• If the patient has 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.
• If the patient has previously had a miscarriage:
  • Take 2 tablets per day.
  • Use until week 12 of pregnancy.

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 on which to start taking the medicine and the number of days it should be taken depend on the length of the cycle.
• Treatment should continue for at least 3 consecutive cycles.

Treatment of menopausal symptoms – Hormone Therapy (HT)

• If the patient is using HT in a "sequential" regimen (taking an estrogen tablet or using an estrogen patch throughout a 28-day cycle):
  • Take 1 tablet of Vivaston once daily.
  • Use during the last 14 days of each 28-day cycle.
• If the patient is using HT in a "cyclical" regimen (taking an estrogen tablet or using an estrogen patch for 21 days, followed by a 7-day break without estrogen):
  • Take 1 tablet of Vivaston 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.

If you take more Vivaston than you should
It is unlikely that taking too many Vivaston tablets (by the patient or another person) would be harmful. Specific treatment is not required. If you are in any doubt, contact your doctor for advice.

If you forget to take Vivaston

• If you miss a dose, take it as soon as possible. However, if more than 12 hours have passed since the scheduled time, do not take the missed tablet. Take the next tablet at the usual time.
• Do not take a double dose to make up for a missed dose.
• If you miss a dose, breakthrough bleeding or spotting may occur.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur during treatment with this medicine.
Adverse effects during treatment with Vivaston alone
If any of the following adverse effects occur,
stop taking Vivaston immediately and contact your doctor:

• Liver function disorders – symptoms may include yellowing of the skin and whites of the eyes (jaundice), weakness, general malaise, or abdominal pain (affects less than 1 in 100 patients);
• Allergic reactions – symptoms may include breathing difficulties 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 Vivaston immediately and contact your doctor.

Other adverse effects during treatment with Vivaston alone
Common (affects less than 1 in 10 patients):

• Migraine, headache,
• Nausea,
• Tenderness or pain in the breasts,
• Irregular, heavy, or painful menstruation,
• Absence of menstruation or periods less frequent than usual.

Uncommon (affects less than 1 in 100 patients):

• Weight gain,
• Dizziness,
• Depressed mood,
• Vomiting,
• Allergic skin 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 the 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).

In younger patients, similar adverse effects are expected as those observed in adult women.
Adverse effects of Vivaston when taken in combination with oestrogen (combined oestrogen-progestagen
hormone replacement therapy)
If the patient is taking Vivaston with oestrogen, please refer to the patient information leaflet of the oestrogen-containing medicine. See also section 2 "Important information before taking Vivaston" for further information on the adverse effects listed below.
If any of the following adverse effects occur, stop taking Vivaston immediately and seek
medical help:

• Painful swelling of the legs, sudden chest pain, or breathing difficulties. These may be symptoms of blood clots.
• Chest pain radiating to arms or neck. This may be a sign of heart attack.
• Severe, unexplained headache or migraine (with visual disturbances). These may be symptoms of stroke. If any of the above adverse effects occur, stop taking Vivaston immediately and seek medical help.

Seek medical help immediately if the patient notices any of the following symptoms:

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

Other adverse effects of Vivaston when taken in combination with oestrogen include excessive buildup of the endometrial lining, endometrial cancer, and ovarian cancer.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Vivaston

Keep the medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of that month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
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 Vivaston contains

• The active substance is dydrogesterone. Each coated tablet contains 10 mg of dydrogesterone.
  • The other ingredients are: monohydrate lactose, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate. Other ingredients present in the coating: hypromellose, macrogol 400, titanium dioxide (E 171).

What Vivaston looks like and contents of the pack
The coated tablets are white, round, biconvex, with the imprint "L1" on one side of the tablet, approximately 7 mm in diameter.
The medicine is packed in PVC/PVDC/Aluminium blisters; the pack contains: 10, 20, 28, 56 or 84 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Cyndea Pharma, S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda 31
42110 Ólvega (Soria)
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic, Poland: VIVASTON