Description:

Progynova 2mg tablets (Estradiol Valerate)  is a form of hormone replacement therapy (HRT) containing natural estrogen. It is used to relieve menopausal symptoms (e.g., hot flushes, night sweats, vaginal dryness, mood changes) in postmenopausal women, to treat estrogen deficiency due to hypogonadism or ovarian failure, and as part of transgender feminizing hormone therapy (off-label in many countries). Estradiol valerate is converted to estradiol in the body, supplementing declining ovarian estrogen production.

Prescription: Prescription-only (Rx). Requires a doctor’s prescription (typically from a gynecologist, endocrinologist, or HRT specialist) with assessment of risks (e.g., breast cancer, thrombosis, cardiovascular events) and monitoring (e.g., mammograms, endometrial checks if uterus intact). In Ghana and many markets, it is regulated and available through pharmacies (imported or locally distributed).

Therapeutic Category:

Hormone replacement therapy (HRT) / Estrogen preparation (natural estrogen for menopausal hormone therapy and estrogen deficiency).

Active Ingredients/Composition:

Each sugar-coated tablet contains: Estradiol valerate 2 mg (equivalent to approximately 1.5 mg estradiol after conversion). Excipients: Lactose monohydrate, maize starch, povidone, talc, magnesium stearate, sucrose, calcium carbonate, macrogol 6000, titanium dioxide, copovidone, shellac, purified water, montan glycol wax, red iron oxide (colorant).

Vitamins: None.

Minerals: None.

Variant: 2 mg strength sugar-coated tablets (standard dose for many indications; 1 mg variant exists for lower-dose needs; pack of 28 tablets common for continuous or sequential HRT).

Consume Type:

Oral (tablet; swallow whole with water; can be taken with or without food).

Directions/Usage: Adults (postmenopausal women): 1 tablet (2 mg) once daily continuously (for women without uterus) or sequentially (e.g., 21 days on, 7 days off, with progestogen added if uterus intact to protect endometrium). For estrogen deficiency/hypogonadism: 1-2 mg daily (adjusted to lowest effective dose). In transgender HRT (off-label): Often 2-6 mg daily (divided doses), under specialist guidance. Take at the same time daily. Do not crush/chew. Follow endocrinologist/gynaecologist instructions; regular monitoring required (e.g., breast exams, lipid profile, endometrial ultrasound if uterus present).

Common Side Effects:

• Breast tenderness/enlargement
• Nausea, abdominal pain
• Headache, migraine
• Mood changes (irritability, depression)
• Vaginal spotting/breakthrough bleeding (especially early)
• Weight gain or fluid retention
• Leg cramps Serious/rare: Increased risk of venous thromboembolism (DVT/PE), stroke, breast cancer (long-term use), endometrial hyperplasia/cancer (without progestogen if uterus intact), gallbladder disease. Seek immediate help for chest pain, shortness of breath, severe headache, vision changes, or leg swelling/pain.

Package Type:

Blister packs of 28 tablets (calendar pack with days marked in some markets; sugar-coated, beige/pink tablets in foil-aluminium blisters, in carton box with patient leaflet).

Storage Advice: Store at room temperature (below 25-30°C), in the original packaging to protect from light and moisture. Keep tightly closed. Keep out of reach of children.

Safety Advice:

• Use lowest effective dose for shortest duration (risks increase with duration and dose).
• Contraindicated in known/suspected breast/endometrial cancer, active DVT/PE/stroke, undiagnosed vaginal bleeding, untreated endometrial hyperplasia, severe liver disease, or hypersensitivity.
• Caution in history of VTE, cardiovascular disease, migraine with aura, diabetes, hypertension, gallbladder disease, or systemic lupus.
• If uterus intact: Combine with progestogen (e.g., 10-14 days/month) to prevent endometrial hyperplasia.
• Regular monitoring: Breast exams, mammograms, blood pressure, lipids, glucose.
• Pregnancy/breastfeeding: Contraindicated (Category X—fetal harm).
• Interactions: Enzyme inducers (e.g., rifampin—reduce efficacy), anticoagulants (increased bleeding risk), anticonvulsants, St. John’s Wort.
• Stop immediately if VTE symptoms, jaundice, severe headache, or vision loss occur.
• Not for contraception (use non-hormonal methods if needed).

Product Substitutes: Other estradiol valerate 2 mg tablets in Ghana: Progynova (original Bayer), generic estradiol valerate (various importers), or estradiol hemihydrate (e.g., Estrace generics). Alternatives: Transdermal estradiol patches/gels (lower VTE risk), oral conjugated estrogens (Premarin), or estradiol + progestogen combinations (e.g., Femoston, Kliofem)—consult gynecologist/endocrinologist per indication (e.g., menopause vs. transgender HRT) and risk profile.

Manufacturer/Marketer:

Bayer AG (original innovator and manufacturer of Progynova). In some markets (e.g., exports to Africa), co-marketed or distributed via Zydus Pharma or local partners under Bayer branding. “Zudus pharma” likely refers to Zydus Cadila (Indian generics partner) or a mislabeling for Zydus in some pharmacy listings.

Country of Origin:

Germany.