Cyclo-Progynova 21 Tablets

Cyclo-Progynova 21 Tablets

Description:

Cyclo-Progynova 21 Tablets (biphasic) is a prescription hormone replacement therapy (HRT) medicine containing estradiol valerate and norgestrel, manufactured by Bayer Healthcare. It is designed for perimenopausal and postmenopausal women to relieve symptoms of estrogen deficiency and to help prevent postmenopausal osteoporosis in women at high risk of fractures who cannot use, or are intolerant to, other approved osteoporosis treatments. Each pack contains a cyclical regimen of coated tablets with varying hormone content to mimic the natural menstrual cycle and provide balanced estrogen and progestogen replacement.

Indications:

• Hormone replacement therapy (HRT) for estrogen deficiency symptoms in perimenopausal and postmenopausal women, such as hot flushes, night sweats, mood changes, sleep disturbances, vaginal dryness, and urogenital atrophy.
• Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or have contraindications to, other medicinal products approved for the prevention of osteoporosis.
• Management of climacteric symptoms that negatively affect quality of life due to reduced estrogen levels.

Active Ingredients / Key Components:

• White tablets: estradiol valerate 2 mg.
• Pale brown tablets: estradiol valerate 2 mg + norgestrel 500 micrograms (0.5 mg).
• Each blister contains a total of 21 film-coated (f.c.) tablets in a biphasic regimen (estrogen-only phase followed by combined estrogen-progestogen phase).
• Excipients and inactive ingredients are present but full excipient composition is not available in the provided information.

Dosage & Administration / How to Use:

• Cyclo-Progynova is for oral use only and must be taken exactly as prescribed by a physician experienced in HRT.
• Usual regimen: 1 tablet daily for 21 consecutive days, followed by a 7-day tablet-free interval during which a withdrawal bleed may occur. The sequence of white then pale brown tablets must be followed according to the printed arrows on the blister.
• Swallow the tablet whole with water, preferably at the same time each day, with or without food.
• In women who are not currently on HRT or who are switching from a continuous combined HRT product, treatment can generally be started on any convenient day, as directed by the doctor. When switching from a cyclic HRT regimen, follow medical advice regarding the appropriate start time.
• Do not exceed the prescribed dose or duration. The lowest effective dose should be used for the shortest duration necessary to control symptoms, with regular medical review at least once a year.
• If a dose is missed and less than 24 hours have passed, take it as soon as remembered. If more than 24 hours have passed, skip the missed tablet and continue with the next one at the usual time. Do not take a double dose to make up for a missed tablet.
• Not intended for use as a contraceptive. If contraception is required, use a non-hormonal method unless otherwise advised by your doctor.

Clinical Benefits:

• Provides effective relief from menopausal symptoms such as hot flushes, night sweats, mood swings, irritability, and sleep disturbances by restoring estrogen levels.
• Helps improve vaginal lubrication and elasticity, reducing vaginal dryness, discomfort during intercourse, and urogenital symptoms linked to estrogen deficiency.
• Supports bone health and helps prevent bone loss and fractures in postmenopausal women at high risk of osteoporosis who cannot use other osteoporosis medications.
• Offers a biphasic regimen combining estrogen and progestogen, which helps protect the endometrium (lining of the uterus) in women with an intact uterus and reduces the risk of endometrial hyperplasia associated with unopposed estrogen therapy.

Warnings & Contraindications:

• Cyclo-Progynova is a prescription-only medicine and should only be used under medical supervision after a full personal and family medical history and physical examination, including breast and pelvic examination as appropriate.
• Contraindicated in women with known, past, or suspected breast cancer; known or suspected estrogen-dependent malignant tumors (e.g., endometrial cancer); unexplained vaginal bleeding; untreated endometrial hyperplasia; active or history of venous thromboembolism (deep vein thrombosis, pulmonary embolism); active or recent arterial thromboembolic disease (e.g., myocardial infarction, stroke); acute liver disease or history of liver disease where liver function tests have not returned to normal; known thrombophilic disorders; known hypersensitivity to estradiol valerate, norgestrel, or any excipients; and in pregnancy or breastfeeding.
• Use with caution and only after careful assessment in women with risk factors for thromboembolism, cardiovascular disease, hypertension, diabetes mellitus with or without vascular involvement, obesity, systemic lupus erythematosus, migraine, epilepsy, asthma, or a history of endometrial hyperplasia.
• HRT may be associated with an increased risk of breast cancer, endometrial cancer (if not adequately opposed), ovarian cancer, venous thromboembolism, stroke, and coronary artery disease. Discuss individual risks and benefits with your doctor before starting and during treatment.
• Regular check-ups are required, including breast examinations and mammography according to national screening recommendations and your doctor’s advice.
• Stop treatment and seek immediate medical attention if you experience symptoms such as chest pain, sudden shortness of breath, coughing blood, sudden severe headache, vision changes, speech difficulties, weakness or numbness in one side of the body, severe abdominal pain, or signs of jaundice.
• Consult your doctor before use if you have liver disease, kidney disease, gallbladder disease, high blood pressure, high triglycerides, porphyria, fibroids, endometriosis, or a strong family history of hormone-dependent cancers or thromboembolic events.
• Not intended to diagnose, treat, cure, or prevent any disease without medical supervision. It is specifically indicated for conditions diagnosed by a healthcare professional.
• Keep out of reach of children.

Side Effects:

• Common side effects may include breast tenderness or pain, breast enlargement, spotting or breakthrough bleeding, changes in menstrual-like bleeding pattern, headache, nausea, abdominal discomfort, bloating, mood changes, and weight changes.
• Less common side effects can include fluid retention, leg cramps, changes in libido, skin reactions (rash, itching), and changes in blood pressure or lipid profile.
• Serious but less frequent side effects include venous thromboembolism (deep vein thrombosis, pulmonary embolism), arterial thromboembolic events (stroke, heart attack), gallbladder disease, significant elevation of blood pressure, and liver function disturbances or jaundice.
• Seek immediate medical attention if you notice symptoms of blood clots (pain or swelling in the leg, chest pain, sudden shortness of breath), severe headache, vision changes, speech difficulties, or signs of liver problems (yellowing of skin or eyes, dark urine, severe abdominal pain).
• If you experience any persistent, bothersome, or unusual side effects, contact your doctor or pharmacist promptly.

Storage Instructions:

Store in a cool, dry place away from direct sunlight and moisture. Keep the blister pack in the outer carton to protect from light. Do not store above the temperature stated on the package (usually below 25°c, if specified on the pack). Keep container tightly closed and keep out of reach of children. Do not use after the expiry date printed on the pack.

Specifications:

• Form: film-coated tablets (f.c. tab.).
• Pack size: 21 tablets per pack (biphasic regimen).
• Active ingredients per tablet: white tablets – estradiol valerate 2 mg; pale brown tablets – estradiol valerate 2 mg + norgestrel 500 micrograms.
• Intended use: prescription hormone replacement therapy for perimenopausal and postmenopausal women.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.