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1

OPERATING INSTRUCTIONS

CYCLO-PROGYNOVA® dragee

is taken by mouth.

2 mg of estradiol valerate and 0.5 mg of norgestrel.

· Ingredients: White dragees: Lactose, corn starch, povidone 25000, talc,

magnesium stearate, sucrose, polyvidone 700000, polyethylene 6000, calcium carbonate, wax light brown dragees: Lactose, corn starch, povidone 25000, talc, magnesium stearate , sucrose, povidone 700000, polyethylene glycol 6000, calcium carbonate, wax E,glycerin, titanium dioxide, yellow iron oxide pigment, red iron oxide pigment.

Please this INSTRUCTIONS carefully before using this medicine

read, as it contains important information for you.

· Keep these operating instructions. You can need to read again.

· If you have other questions, please talk your doctor or pharmacist.

· This medicine has been prescribed to you personally, please do not give it to others.

· When This medicine you are taking this medicine you go to a doctor or hospital

using, tell your doctor that when.

· Follow the instructions in this manual. Do Other than the recommended dose for the

not use high or low dose drug.

In these Instructions for Use:

1. What is CYCLO-PROGYNOVA and what is it used for?

2. Cautions before using

CYCLO-PROGYNOVA 3. How to use CYCLO-PROGYNOVA?

4. What are the possible side effects?

5. Storage of CYCLO-PROGYNOVA

Headings are included.

1. What is CYCLO-PROGYNOVA and what is it used for?

· 11 whitecontaining 2 mg of estradiol valerate each in the package CYCLO-PROGYNOVA

colored dragees; andeach containing 2 mg of estradiol valerate and 10 lightcontaining 0.5 mg of norgestrel

a total of 21 drageesbrown dragee.

· CYCLO-PROGYNOVA contains estrogen and progesterone hormones. Estrogen and

progesterone effect on the uterus and the menstrual cycle.

· CYCLO-PROGYNOVA providesnatural menopause and hormoneunvaccinated women

of estrogendue todeficiency, removal of reproductive organs or ovarian failure in

hormone replacement therapy (HRT;femalesigns and symptomsdeficiency

a treatment for the reduction ofhormones in the premenopausal period) for.

2

It is alsoeffects of other medicinal products approved

usedinwith high risk of fracture, with or without resistance to the

to prevent post-menopausal bone resorptionwomenfor the prevention of bone resorption. CYCLOPROGYNOVA is used for

irregular menstruation and in case of menstruation.

2. Cautions before using CYCLO-PROGYNOVA

Your doctor willgynecological, breast, blood pressure and other examinations appropriately

perform. If you are known to have any liver disease, your doctor

will regularly check your liver function.

If you are likely to become pregnant, CYCLO-PROGYNOVA canchange it

not.oral (or other hormonal)when you start CYCLO-PROGYNOVA,

If you are taking birth control measures other thancontraceptiondoctor

these birthuntil yourtells you that you no longer need the contraceptive method of protection

continue applyingcontrol methods. If you are taking an oral (or other hormonal) contraceptive

pill,an alternative (hormonalbefore you start CYCLO-PROGYNOVA

you must switch tonon-) contraception. On the other hand, if your doctor has indicated that you no longer

need to use a contraceptive method, you do not need to use anCYCLOPROGYNOVA

additional contraceptive pill while taking.

DO NOT use CYCLO-PROGYNOVA in the following cases:not use CYCLO-PROGYNOVA

Doif any of the following conditions apply.

If any of them fit you,before using CYCLO-PROGYNOVA

consult your doctor.

If;

· If you are pregnant or if you are breast-feeding

· If you have undiagnosed vaginal bleeding

· Known or if you suspect breast cancer

· could proceed with the effects of sex hormones, known orsuspected malignant

aretumors (malignancy), if any (or if it was in the past)

· Do not Good or malignant liver tumors If you have a

severe liver disease

(acute arterial thromboembolism) (orhaspast

if ithappened in the)

· In your legs (deep vein thrombosis), in your lungs (pulmonary embolism) or in

other parts of your body if there is a clot story (pre-formed)If you have a

·high risk of venous or arterial clots (high risk of venous or arterial

thrombosis)

· If you have severe triglycerides (a special type of fat in the blood)If you

·are allergic to one of the substances in the drug

• Known or suspected estrogen t huylutümör your (endometrial cancer)

If

· Untreated intrauterine membrane thickening (endometrial hyperplasia)

If any of these conditions happen to you when you use drugs use immediately

first,discontinueand consult your doctor.

3

USE CYCLO-PROGYNOVA CAREFULLY:

Your doctor will discuss the benefits and risks of CYCLO-PROGYNOVA with you.

Your doctor, for example due to a combination of risk factors or a very strong risk factor

will check whether your risk of developing thrombosis is higher. The riskfactors

may be higher than the sum of two separate risks in the case of combination of. If the risk is too

high, your doctor will not prescribe you HRT.

The risk of side effects associated with circulatory disorders is particularlyover the age of 35 and

high in womensmokers.

Studies indicate that HRTvenous thromboembolism (VTE), formation of blood clots in veins, clot formation in the

may causelegs and lungs (deep vein thrombosis or pulmonary embolism)

a risk increase in the development of. Yourvenous thromboembolism

doctor willthe benefit / risk ratio before HRT treatment in women at risk for

carefully assess.

Two major clinical trials with hormones used in the treatment of HRT suggestheart attack

that the risk of(myocardial infarction) may increase slightly in the first year of use

. In two large clinical trials with these hormones, the risk of stroke increased by 30-40%

.

If the patient has an adenoma (benign tumor) in the anterior portion of the pituitary gland, close medical control

(including periodic measurement of prolactin levels) is required.

If HRT is used in the presence of any of the conditions listed below, you

may need to be kept under close observation. Your doctor may explain these to you.

Therefore,if any of these situations apply to you,the

tell your doctor before you start usingCYCLONE-PROGYNOV:

· higher your veins thrombosis (formation of blood clots) if there is risk. The risk increases with age

and may be higher if:

You haveof the legs (deep vein thrombosis)one of your close relatives

thrombosis (bloodblood vesselsor lungs (pulmonary embolism) in

clot) in the;

· If you are overweight;

If you have varicose veins.

· If you are already using CYCLO-PROGYNOVA, tell your doctor about any

expected hospitalization or surgery. The reason for this is

that the risk of deep vein thrombosis may besurgery, serious injury or immobility

temporarily increased as a result of.

· If you have uterine fibroids (benign womb)If your

·endometriosisduring the course of treatment (uterine wallshould not be present in the body

becomes active againpresence oftissues in tissues that)

• Your liver disease (such as Dubin-Johnson syndrome or Rotor syndrome) or

if you have gallbladder disease

· During pregnancy or if you have already had jaundice during the use of sex hormones.If you have

·diabetes (diabetes)

4

. In this case,

HRT treatment may cause an increased risk of acute pancreatitis.

· If you have high blood pressure (if your blood pressure is high)

• There are yellow-brown spots (chloasma) that may occur due to pregnancy

(Do not be exposed to direct sun or ultraviolet light in this case)

· If you have epilepsy (sara)

· Lump or pain in your breasts (benign breast If youIf you

have asthma ·haveIf you have

migraine ·If

hereditary disease called porphyria •there is

hereditary hearing loss (otosclerosis)If you

·havewith a chronic inflammatory disease that causes joint pain and skin rash

systemic lupus erythematosus

· Korean minor disease with abnormal movements or ifpreviously

it has been

· hereditary (hereditary) If you anjiyoödem (Body of the hands, feet, face,the airway

swelling seen in parts ofpassages,a genetic disease). EstradiolCYCLO-PROGYNOVA

valerate hormone inmay trigger orhereditary angioedema symptoms

worsen.

· If you are 65 years or older when HRT is started. This is because,from clinical trials

according to the limited evidence, hormonal therapyto asuch as memory capacity

can increase the risk of dementia (dementia)great extent,.

HRT and cancer

· Endometrial cancer (uterine wall cancer) When

estrogens are used alone for a long time, the risk of endometrial cancer

increases. Progesterone in CYCLO-PROGYNOVA reduces the risk.

During the first months of CYCLO-PROGYNOVA treatmentintense bleedings and spotting

may occur. If intensive bleedings and spotting start after a period ofor

treatmentpersist after discontinuation of treatmentendometrial biopsyexclude endometrial cancer

, the cause should be investigated, including, to. Therefore, contact your doctor.

· Breast cancer

In some studies, women diagnosed with breast cancer for several years have been diagnosed with breast cancer a little more

frequently.

the Women's Health Initiative Study (WHI) and thea randomized, placebo-controlled study, have

Epidemiological studies such asMillion Women's Study (MWS),shown that HRTfor many years

breast cancer in women using estrogen, estrogen-progesterone, or tibolone

increases the risk of. (see. 4. What are the possible side effects?)

Some clinical trials, several years of HRT female hormone name after menopause

(toreplace the estrogen thewith the aim of treatments performed)breastin women undergoing

5

diagnosed withcancerbeen reported to have an increased risk. Risk increases during treatment.HRT treatment. The

This increased risk disappears within a few years (up to five years) after the end ofrisk of

breast cancer relative to PPE or estradiol (E2) in the MWS Study

is greater when sequential or sustained progesterone is added, regardless of the type of progesterone. Theredifferent

is no evidence of a risk difference betweenroutes of administration.

The hormone therapy used in the WHI Study compared with the placebo; Inhormone

patients receivingtherapy, there iswhich is slightly larger in size and more frequently local lymph node metastasis