PROGYNOVA 2 мг Коированная таблетка

Содержание инструкции

1. Progynova 2 mg coated tablets
   1. What is Progynova and what is it used for?
   2. What you need to know before taking Progynova
   3. How to take Progynova
   4. Possible side effects
   5. How to store Progynova
   6. Contents of the pack and other information

Progynova 2 mg coated tablets

estradiol valerate

Read this leaflet carefully before you start to take this medicine because it contains important
information for you.

• 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 only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Progynova and what is it used for?

Progynova is a medicine used in hormone replacement therapy (HRT).
Progynova contains estrogen (valerate estradiol), a female sex hormone that belongs to the group
of medicines for Hormone Replacement Therapy (HRT).
This medicine is used for the treatment of symptoms associated with post-menopause.
During menopause, the amount of estrogen produced by the woman decreases. This can lead to the
appearance of symptoms, such as hot flashes, sweating attacks, insomnia, depressive states, headache,
dizziness.
Progynova relieves these post-menopausal symptoms. In addition, it can reduce the manifestations of atrophy of the
skin and mucous membranes (especially of the urogenital tract).
This medicine will be prescribed to you only if your symptoms severely interfere with your daily
activities.

2. What you need to know before taking Progynova

Medical examination and regular check-ups
The use of HRT involves risks that must be considered when deciding whether to start or continue therapy.
Experience on the treatment of women with premature menopause (due to cessation of ovulation or surgery) is limited. If you have premature menopause, the risks associated with the use of HRT may be different. Consult your doctor.
Before starting (or resuming) HRT, your doctor will ask you some questions about your health history and that of your family. Your doctor may decide to perform some tests. These may include a breast exam and/or a pelvic exam if necessary.
Once you have started treatment with Progynova, you will need to see your doctor for regular check-ups (at least once a year). During these check-ups, discuss with your doctor the benefits and risks associated with continuing treatment with Progynova.
Have regular breast exams as recommended by your doctor.

Do not take Progynova
Do not take Progynova if any of the following conditions apply to you.
If you are unsure about the conditions described below, consult your doctorbefore taking Progynova.

• If you are allergicto valerate estradiolor any of the other ingredients of this medicine (listed in section 6);
• If you are pregnant or breastfeeding;
• If you have, have had, or suspect you have malignant breast tumor;
• If you have had or suspect you have a malignant tumor whose growth is sensitive to estrogens,such as a tumor of the uterine lining (endometrium);
• If you have, or have had in the past, blood clots inside a vein(thrombosis) such as those in the legs (deep vein thrombosis) or those in the lungs (pulmonary embolism);
• If you have or have recently had a disease caused by blood clots in the arteries such as heart attack, strokeor angina(chest pain);
• If you have or have had in the past a liver diseaseand your liver function values have not returned to normal;
• If you have unexplained vaginal bleeding;
• If you suffer from a thickening of the uterine lining(endometrial hyperplasia) that has not been treated;
• If you have a rare blood disease that is inherited (familial) called “porphyria”;
• If you have problems with blood clotting(such as deficiencies of protein C, protein S or antithrombin).

If any of these conditions occur for the first time during the use of Progynova, stop treatment immediately and consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Progynova.
When to be particularly careful with Progynova
Tell your doctor if you have had any of the following conditions in the past, before starting treatment, as these may recur or worsen during treatment with Progynova. If this happens, you should see your doctor more often for check-ups:

• uterine fibroids;
• growth of uterine lining in other locations (endometriosis) or a history of excessive growth of the uterine lining (endometrial hyperplasia);
• increased risk of developing blood clots (see below “Effects of HRT on the heart and circulation - “Blood clots in a vein (thrombosis)”);
• increased risk of tumors sensitive to estrogens (e.g. if you have a mother, sister or grandmother who has had breast cancer);
• high blood pressure;
• liver disease 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 or SLE);
• epilepsy (a condition that causes seizures);
• asthma;
• a disease affecting the eardrum and hearing (otosclerosis);
• very high levels of fats in the blood (triglycerides)
• fluid retention due to heart or kidney problems;
• benign breast disease;
• chorea minor (a disease characterized by involuntary, uncoordinated movements);
• if you suffer from an adenoma (benign tumor) of the anterior lobe of the pituitary gland, you should be carefully monitored by your doctor, who will prescribe periodic measurements of prolactin levels;
• hereditary and acquired angioedema.

Stop taking Progynova and contact your doctor immediately if:

• any condition described in the “Do not take Progynova” section;
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of a liver disease;
• marked increase in blood pressure (symptoms may include headache, fatigue, dizziness);
• migraine-type headache that occurs for the first time;
• if you become pregnant;
• if you notice signs of a blood clot, such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty breathing
• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with difficulty breathing, which are indicative of angioedema.

For more information see below the section “Effects of HRT on the heart and circulation” - “Blood clots in the veins (thrombosis)”.

Note: Progynova is not a contraceptive. If less than 12 months have passed since your last menstrual period or if you are under 50 years of age, you may still need to use additional contraceptive measures to prevent pregnancy. Ask your doctor for advice.

HRT and cancer

Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining

(endometrial carcinoma)
Taking HRT based on estrogen alone increases the risk of excessive thickening of the uterine lining (endometrial hyperplasia) and that of cancer of the uterine lining (endometrial carcinoma).
Adding a progestin to estrogen for at least 12 days of every 28-day cycle protects you from this additional risk. Your doctor will prescribe a progestin separately if you still have a uterus. If you have had a hysterectomy (removal of the uterus), discuss with your doctor whether you can safely use this medicine without a progestin.
In women who still have a uterus and who do not use HRT, on average, 5 out of 1000 will be diagnosed with endometrial carcinoma between the ages of 50 and 65. For women between 50 and 65 years of age who have a uterus and use HRT based on estrogen alone, 10-60 women out of 1000 will be diagnosed with endometrial carcinoma (i.e. an increase of 5 to 55 cases) depending on the dose and duration of treatment.
The appearance of intermenstrual bleeding or spotting (light bleeding between periods), especially during the first cycles of treatment, should not worry you.

Contact your doctorif intermenstrual bleeding or spotting continues to occur after the first few months of treatment, appears after a few months of treatment, or persists after stopping treatment: these symptoms may indicate a thickening of the endometrium.

Breast cancer
If you have or have had breast cancer, you should not take this medicine(see “Do not take Progynova”).
Evidence shows that taking hormone replacement therapy (HRT) based on estrogens and progestins combined or based on estrogen alone increases the risk of breast cancer. The additional risk depends on the duration of HRT use. This additional risk manifests within 3 years of use. After stopping HRT, the additional risk will decrease over time, but this risk may persist for 10 years or more if HRT is used for more than 5 years.
Comparison
In women aged between 50 and 54 who are not taking HRT, breast cancer will be diagnosed in an average of about 13-17 women out of 1000 over a period of 5 years.
In women aged 50 who start taking HRT based on estrogen alone for a period of 5 years, 16-17 cases will occur out of 1000 users (i.e. 0-3 additional cases).
In women aged 50 who start taking HRT based on combined estrogen and progestin for 5 years, there will be 21 cases out of 1000 women treated (i.e. 4 to 8 additional cases).
In women aged between 50 and 59 who are not taking HRT, breast cancer will be diagnosed in an average of 27 women out of 1000 over a period of 10 years.
In women aged 50 who start taking HRT based on estrogen alone for 10 years, 34 cases will occur out of 1000 users (i.e. 7 additional cases).
In women aged 50 who start taking HRT based on combined estrogen and progestin for 10 years, 48 cases will occur out of 1000 users (i.e. 21 additional cases).

Check your breasts regularly. Tell your doctor if you notice any changes such as:

• dimpling of the skin;
• change in the nipples;
• any lump you can see or feel.

In addition, it is recommended to participate in mammography screening programs when they are offered to you. For mammography screening, it is important that you inform the nurse/health professional performing the X-ray that you are using HRT, as this treatment may increase breast density, which may alter the mammography result. When breast density is increased, mammography may not detect all lumps.

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

Liver tumors(of the liver)
Rarely, benign liver tumors and even more rarely malignant liver tumors have been observed after the use of hormonal substances such as those contained in Progynova. In isolated cases, these tumors lead to intra-abdominal bleeding, which can be life-threatening. Although these events are extremely unlikely, you should tell your doctor if you experience any unusual abdominal pain that does not go away quickly.
Effects of HRT on the heart and circulation

Blood clots in a vein (thrombosis)
HRT can increase the risk of blood clots in the veinsin users by 1.3 to 3 times compared to non-users, especially during the first year of use.
Blood clots can be dangerous, and if they reach the lungs, they can cause chest pain, sudden shortness of breath, collapse or even death.
The risk of developing a blood clot in the veins increases with age and if any of the following conditions apply to you. Tell your doctor if any of the following conditions apply to you:

• you are unable to walk for a long period due to major surgery, accident or illness (see also section 3, “If you are going to have surgery”);
• you are severely overweight (BMI> 30 kg/m);
• you have any blood clotting problem that requires long-term treatment with a medicine that prevents blood clots
• if a close relative of yours has had a blood clot in the leg, lung or another organ
• you have Systemic Lupus Erythematosus (SLE)
• you have cancer

For possible signs of a blood clot, see “Stop using Progynova and contact your doctor immediately”.
Comparison
For women around the age of 50 who are not taking HRT, on average, in a period of 5 years, 4-7 cases out of 1000 are expected to have a blood clot in a vein.
For women around the age of 50 who have been taking estro/progestin HRT for more than 5 years, there will be 9-12 cases out of 1000 users (i.e. an increase of 5 cases).
For women around the age of 50 whose uterus has been removed and who are taking estrogen-only HRT for more than 5 years, there will be 5-8 cases out of 1000 (i.e. an increase of 1 case).

Heart disease (heart attack)
There is no evidence that HRT can prevent a heart attack.
Women over the age of 60 who use estro-progestin HRT have a slightly higher probability of developing heart disease compared to women who do not take any HRT.
For women whose uterus has been removed and who are taking estrogen-only HRT, there is no increased risk of developing heart disease.

Stroke
The risk of having a stroke is approximately 1.5 times higher in users of HRT compared to non-users. The number of additional stroke cases due to the use of HRT will increase with age.
Comparison
For women around the age of 50 who are not taking HRT, on average, 8 out of 1000 have the possibility of having a stroke over a 5-year period. For women around the age of 50 who are taking combined oestrogen/progestogen HRT for more than 5 years, there will be 11 cases out of 1000 users (i.e., an increase of 3 cases).

Other conditions

• HRT does not prevent memory loss. The risk of memory loss may be greater in women who start using HRT after the age of 65. Ask your doctor for advice.
• If you have a tendency to develop spots on the face (chloasma), you should minimize exposure to the sun or ultraviolet rays during treatment with Progynova.
• During estrogen therapy, some women are particularly predisposed to the formation of gallstones.
• Abnormal uterine bleeding may occur.

Other medicines and Progynova
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription, herbal medicines or other natural products.
Some medicines can interfere with the effects of Progynova. This can cause irregular bleeding. This applies to the following medicines:

• medicines for epilepsy(e.g. barbiturates, phenytoin, primidone, carbamazepine and possibly oxcarbazepine, topiramate and felbamate);
• Medicines for tuberculosis(e.g. rifampicin, rifabutin);
• Medicines for HIV and hepatitis C virusinfections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors (such as nevirapine, efavirenz, ritonavir and nelfinavir);
• Herbal preparations containing St John's Wort(Hypericum perforatum);
• Medicines for the treatment of fungal infections(such as griseofulvin, fluconazole, itraconazole, ketoconazole and voriconazole);
• Medicines for the treatment of bacterial infections(such as clarithromycin, erythromycin, penicillins and tetracyclines);
• Medicines for the treatment of certain heart diseases, high blood pressure(such as verapamil and diltiazem);
• Grapefruit juice;
• Medicines against the hepatitis C virus (HCV) (such as a combination regimen with ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as a regimen based on glecaprevir/pibrentasvir) can cause increases in blood test results concerning liver function (increased liver enzyme ALT) in women using COCs containing ethinylestradiol. Climen contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT may occur when using Climen with this combination regimen against HCV. Your doctor will give you the necessary instructions.

If you suffer from diabetes, your doctor may adjust your treatment regimen.

Laboratory tests
If you need blood tests, tell your doctor or the laboratory staff that you are taking Progynova, because this medicine can affect the results of some tests.

Pregnancy and breastfeeding
Progynova is to be used only in post-menopausal women. If you are or suspect you are pregnant, do not take this medicine (see “Do not take Progynova”). If you become pregnant, stop taking Progynova and contact your doctor.
Progynova is contraindicated during breastfeeding.

Driving and using machines
No effects on the ability to drive or operate machinery have been observed in users of Progynova.

Progynova contains lactose and sucrose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Progynova

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
any doubts ask your doctor or pharmacist.
Each pack covers 20 days of treatment. Take one Progynova tablet a day.
If you still have your menstrual cycle, start taking Progynova within the 5th day of your menstruation.
In all other cases, your doctor may advise you to start treatment immediately.
If you still have your uterus (if you have not had a hysterectomy) your doctor will prescribe you another hormone
(progestin) and will tell you how to take it. Your doctor will also tell you whether you should take the tablets
continuously (without interruption) or with a break.
It does not matter what time of day you take the tablet but, once you have established a certain
time, you should try to take the tablets at the same time each day. The tablet can be swallowed
with a small amount of liquid.
Follow the instructions for use carefully, otherwise you will not benefit fully from the treatment with
Progynova.
The doctor will prescribe the lowest dose to treat your symptoms and for the shortest necessary period.
Consult your doctor if you think the dose is too high or not high enough.

Use in children and adolescents
Progynova is not indicated for use in children and adolescents

Use in the elderly
There are no data to indicate the need for a dosage adjustment in elderly patients. Tell your
doctor if you are over 65 years old (see “Warnings and precautions”).

Use in patients with impaired liver function(liver)
Formal studies have not been conducted in patients with impaired liver function. Progynova is
contraindicated in women with severe liver disease (see “Do not take Progynova”).

Use in patients with impaired kidney function(kidneys)
Formal studies have not been conducted in patients with impaired kidney function.

If you need surgery
If you are going to have surgery, tell the surgeon that you are using Progynova. It may
be necessary to stop taking it about 4-6 weeks before the operation to reduce the risk of
a blood clot (see “Blood clots in a vein”). Ask your doctor when you can start using
Progynova again.

If you take more Progynova than you should
Overdosage may cause nausea and vomiting and irregular bleeding. No specific treatment is
necessary but consult your doctor if you are concerned

If you forget to take Progynova
If you have forgotten to take a tablet, take it as soon as possible.
Take the next tablet at the usual time. Do not take a double dose to make up for the
forgotten tablet.
If more than 24 hours have passed do not take extra tablets.
Do not take a double dose to make up for the forgotten tablet.
Missing one or more tablets may increase the likelihood of breakthrough bleeding and spotting.

If you stop taking Progynova
If you stop taking Progynova, the symptoms of menopause due to estrogen deficiency may return.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following conditions are reported more often in women using hormone replacement therapy (HRT) that circulate in the
blood than in women who do not use HRT:

• excessive growth or cancer of the uterine lining (hyperplasia or endometrial cancer);
• ovarian cancer;
• blood clots in the veins of the legs or lungs (venous thromboembolism);
• heart disease;
• stroke;
• possible memory loss if HRT is started after the age of 65.

For more information about these side effects, see paragraph 2.
The following side effects have been observed with the use of Progynova. These effects generally
disappear after the first few months of treatment and can be divided as follows:

Common side effects(may affect up to 1 in 100 users):

• weight gain/loss,
• headache,
• abdominal pain (stomach ache),
• nausea,
• skin rash,
• itching,
• uterine/vaginal bleeding, including spotting (light bleeding between periods).

Uncommon side effects(may affect up to 1 in 1000 users):

• hypersensitivity reaction (allergy),
• depressed mood,
• dizziness,
• visual disturbances,
• palpitations,
• dyspepsia (indigestion),
• erythema nodosum (a condition characterized by red nodules under the skin, located on the legs and feet, more rarely on the forearms), urticaria (a skin rash similar to nettle irritation, accompanied by a burning and itching sensation),
• breast pain and breast tenderness,
• edema (swelling).

Rare side effects(may affect up to 1 in 10,000 users):

• anxiety,
• increased/decreased libido (sexual desire),
• migraine (pain localized to one side of the head),
• contact lens intolerance,
• flatulence (presence of gas in the intestines),
• vomiting,
• hirsutism (increased hair growth),
• acne,
• muscle cramps,
• dysmenorrhea (painful periods),
• vaginal discharge,
• symptoms that mimic premenstrual syndrome,
• breast enlargement,
• fatigue.

In women with hereditary angioedema, exogenous estrogens may induce or worsen the symptoms
of angioedema (see “Warnings and precautions”).

The following side effects have been reported with other HRT:

• gallbladder disease
• a number of skin diseases:
• alteration of skin color, especially on the face or neck, known as “chloasma” (pregnancy mask)
• reddish and painful skin nodules (erythema nodosum)
• skin rash with redness or target-shaped lesions (erythema multiforme)
• vascular purpura (pinpoint bleeding of the skin and mucous membranes)

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 at http://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 Progynova

Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date that is stated on the pack after “Exp.”.The expiry
date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water 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 Progynova contains

• The active ingredient is estradiol valerate. Each tablet contains 2.0 mg of estradiol valerate.
• The other ingredients are: lactose monohydrate, corn starch, povidone 25, talc, magnesium stearate, sucrose, povidone 90, macrogol 6.000, calcium carbonate, wax E.

Description of the appearance of Progynova and contents of the pack
Progynova is presented as white film-coated tablets, in packs of 20 tablets.

Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156 Milan

Manufacturer
Bayer Weimar GmbH und Co. KG, Döbereinerstraße 20, 99427 Weimar, Germany