Cyclo-Progynova coated tablets – estradiol valerate and norgestrel for hormone replacement therapy in menopause

Cyclo-Progynova is a hormone replacement therapy (HRT) medicine containing two female sex hormones: the oestrogen estradiol valerate and the progestogen norgestrel. Estradiol valerate is chemically and biologically identical to natural estradiol and replaces missing oestrogen, while the added norgestrel protects the lining of the womb.

The pack contains 21 coated tablets: 11 white (2 mg estradiol valerate) and 10 light brown (2 mg estradiol valerate and 0.5 mg norgestrel), taken cyclically with a 7-day break. It is a prescription-only medicine. Cyclo-Progynova is not a contraceptive.

What is Cyclo-Progynova used for and how should it be taken?

Basic information about the medicine

What is Cyclo-Progynova used for?

According to the Summary of Product Characteristics, Cyclo-Progynova is indicated for:

• hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women, in hypogonadism, castration or primary ovarian insufficiency
• prevention of osteoporosis in postmenopausal women at high risk of fractures who cannot tolerate or must not use other medicines for osteoporosis prevention
• treatment of primary or secondary amenorrhoea (absence of periods)

Experience in women over 65 is limited.

How is it used and dosed?

• Women who still menstruate start on day 5 of the cycle (the first day of bleeding is day 1).
• Women with amenorrhoea, very irregular periods or after menopause may start at any time, provided pregnancy is excluded.
• The tablets are swallowed with a little liquid at about the same time each day, in the order shown by the arrows on the blister.

This is the general dosage from the official documentation – the duration of treatment is set by the doctor.

Special patient groups

• Children and adolescents: not indicated.
• Women aged 65 and over: experience is limited; starting HRT after 65 has been associated with a possible increased risk of dementia.
• Severe liver disease: contraindicated.
• Kidney impairment: available data do not indicate a need for dose adjustment.

Contraindications – when the medicine must not be used

• known or suspected breast cancer, or a history of breast cancer
• known or suspected oestrogen-dependent tumours (e.g. endometrial cancer)
• vaginal bleeding of unknown cause; untreated endometrial hyperplasia
• previous or current venous thromboembolism (deep vein thrombosis, pulmonary embolism) and known thrombophilic disorders (protein C, S or antithrombin deficiency)
• active or recent arterial thromboembolism (angina, myocardial infarction)
• acute or previous liver disease until liver tests return to normal
• porphyria
• hypersensitivity to the active substances or excipients
• pregnancy and breast-feeding

Precautions and warnings

• Medical examinations (including breasts and pelvic organs) are needed before and during HRT, together with regular breast screening.
• Breast cancer: the risk increases with the duration of combined HRT.
• Endometrial and ovarian cancer: the risk is increased in HRT users; unexpected bleeding should be investigated.
• Venous thromboembolism, coronary disease and stroke: the risk is increased, especially with obesity, immobility, surgery and older age.
• Careful monitoring is needed in fibroids, endometriosis, migraine, epilepsy, asthma, diabetes, high blood pressure, gallbladder disease, lupus, otosclerosis, raised triglycerides, fluid retention and chloasma.
• In hereditary or acquired angioedema, estradiol may induce or worsen symptoms.
• The medicine contains lactose and sucrose.

Interactions with other medicines, alcohol and food

• Reduced efficacy and irregular bleeding may be caused by: antiepileptics (barbiturates, phenytoin, primidone, carbamazepine, possibly oxcarbazepine, topiramate, felbamate), tuberculosis medicines (rifampicin, rifabutin), certain HIV medicines (nevirapine, efavirenz, ritonavir, nelfinavir), St John’s wort products, certain antibiotics (penicillins, tetracycline) and paracetamol.
• Hepatitis C medicines (ombitasvir/paritaprevir/ritonavir, glecaprevir/pibrentasvir): ALT increases have been described with ethinylestradiol-containing contraceptives; not known for estradiol – ask your doctor.
• Tell your doctor about all medicines, herbal products and supplements you use.

Pregnancy and breast-feeding

Cyclo-Progynova is contraindicated during pregnancy and breast-feeding. If pregnancy occurs, the medicine is stopped immediately.

Driving and using machines

No effect on the ability to drive or use machines has been observed in users of Cyclo-Progynova.

Possible side effects

• Common (up to 1 in 10): weight gain or loss, headache, abdominal pain, nausea, rash, itching, vaginal bleeding including spotting (usually decreases with continued treatment).
• Uncommon (up to 1 in 100): allergies, depressed mood, dizziness, visual disturbances, palpitations, indigestion, erythema nodosum, hives, chest pain, breast tenderness, oedema.
• Rare (up to 1 in 1,000): anxiety, changes in libido, migraine, contact lens intolerance, bloating, vomiting, excessive hair growth, acne, muscle cramps, painful periods, vaginal discharge, premenstrual syndrome, breast enlargement, exhaustion.
• More frequent in HRT users: breast cancer, endometrial hyperplasia or cancer, ovarian cancer, venous thromboembolism, heart disease, stroke, possible memory loss if HRT is started after 65. With other HRT, gallbladder disorders, chloasma, erythema nodosum and erythema multiforme have also been reported.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: nausea, vomiting and breakthrough bleeding may occur; there is no specific antidote – contact your doctor.
• Missed tablet: take it as soon as possible; if more than 24 hours have passed since the last tablet, do not take an extra one. Missing several tablets may cause bleeding.
• Stopping treatment: decide together with your doctor, with an annual benefit–risk assessment.

Related information

For additional care and support for dry intimate mucosa in menopause, see also the category Products for dry intimate mucosa and burning – care, protection and regeneration – products in this category do not replace the medicine prescribed to you.

Composition, packaging and manufacturer

• White coated tablet: 2 mg estradiol valerate; light brown coated tablet: 2 mg estradiol valerate and 0.5 mg norgestrel.
• Core: lactose monohydrate, maize starch, povidone 25, talc, magnesium stearate; coating: sucrose, povidone 90, macrogol 6000, calcium carbonate, glycerol 85%, titanium dioxide, montan glycol wax, and in the light brown tablets also yellow and red iron oxide.
• Pack: PVC-Al/PVC/PVDC blister with 11 white and 10 light brown tablets (21 tablets), with weekday stickers.
• Manufacturer: BAYER WEIMAR GMBH & CO. KG, Doebereinerstrasse 20, Weimar, Germany. MA holder: BAYER D.O.O. BEOGRAD, Omladinskih brigada 88b, Belgrade.

Storage

• No special storage conditions.
• Keep out of the sight and reach of children; do not use after the expiry date.
• Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Is Cyclo-Progynova a contraceptive pill?

No. The leaflet clearly states that it is not a method of contraception. If you have had a period in the last 12 months or are under 50, continue contraception as advised by your doctor.

Why are the tablets different colours?

The white tablets (first 11 days) contain only estradiol valerate, and the light brown ones (next 10 days) also contain norgestrel, which protects the lining of the womb. After 21 days there is a 7-day break, when bleeding usually occurs.

How long can HRT be taken?

The lowest effective dose for the shortest necessary time is recommended, and the doctor assesses benefits and risks at least once a year. Treatment continues as long as the benefit outweighs the risk.

What if I miss a tablet?

Take it as soon as possible. If more than 24 hours have passed since the last tablet, do not take an extra one but continue as scheduled. Missing several tablets may cause bleeding.

Sources

• ALIMS – Summary of Product Characteristics Cyclo-Progynova® coated tablets (January 2023, Serbian)
• ALIMS – Patient leaflet Cyclo-Progynova® 0.5 mg/2 mg; 2 mg coated tablets (January 2023, Serbian)

Sources checked on: 25.10.2026.