Rozy 0.5/0.25

Indications

• Hormone Replacement Therapy (HRT): Recommended for treating climacteric syndrome in postmenopausal women, which includes vasomotor symptoms (such as hot flushes and sweating attacks), sleep disorders, depressed moods, nervousness, and atrophic urogenital conditions resulting from deficient endogenous estrogen production due to natural menopause, hypogonadism, castration, or primary ovarian failure in women with an intact uterus.
• Prevention of Postmenopausal Osteoporosis.

Pharmacological Composition

This HRT formulation comprises 17β-estradiol, identical chemically and biologically to endogenous human E2, and a synthetic progestogen, DRSP. 17β-estradiol effectively supplements hormone levels during and after the climacteric phase, while the addition of DRSP aids in bleeding control and counteracts endometrial hyperplasia associated with estrogen use.

Effects

• Estradiol’s Impact: Ovarian function decline leads to menopausal syndrome characterized by vasomotor and organic symptoms. HRT aims to alleviate these symptoms. Among physiological estrogens, E2 exhibits the highest potency and binds strongly to estrogen receptors, influencing target organs such as the uterus, hypothalamus, pituitary, vagina, breast, and bones.
• Additional Benefits: Estrogens also contribute to reducing insulin and blood glucose levels and exert local vasoactive effects via receptors, impacting vascular smooth muscle. The oral administration of natural estrogens proves advantageous in certain cases of hypercholesterolemia, maximizing beneficial metabolic liver effects on lipids.

Dosage

• Initiation: Treatment initiation is flexible, allowing women who are not currently on estrogen therapy or those transitioning from a continuous combination product to commence treatment at any time. Women switching from a continuous sequential or cyclic HRT should complete their current cycle before starting the new therapy.
• Daily Dosage: One tablet is taken daily.
• Missed Dose: If a tablet is forgotten, it should be taken as soon as remembered. If more than 24 hours have passed, no additional tablet is necessary. However, missing multiple tablets may result in bleeding.

Administration

• Pack Duration: Each pack covers a 28-day treatment period, with continuous treatment meaning the next pack follows immediately without a break.
• Instructions: Tablets should be swallowed whole with liquid, irrespective of food intake, preferably at the same time daily. For managing postmenopausal symptoms, the lowest effective dose is recommended, and treatment should be initiated and continued with the lowest effective dose for the shortest duration.

Interactions

• Drug Interactions: Certain drugs, such as hydantoins, barbiturates, and rifampicin, may induce hepatic enzymes, potentially reducing the drug’s efficacy and causing irregular bleeding. Maximal enzyme induction usually occurs within 2-3 weeks and may persist for at least 4 weeks after drug cessation. Additionally, some antibiotics may reduce E2 levels.
• Alcohol Interaction: Acute alcohol consumption during HRT usage can lead to elevated risks.

Contraindications

This HRT should not be initiated under the following conditions:

• Undiagnosed abnormal genital bleeding
• Known or suspected breast cancer
• Known or suspected premalignant conditions or malignancies influenced by sex steroids

Side Effects

Common adverse reactions may include breast pain, genital tract bleeding, and gastrointestinal discomfort. However, these side effects typically diminish with continued treatment. Serious adverse reactions include arterial and venous thromboembolic events and breast cancer.

Pregnancy & Lactation

This product should not be used during pregnancy and lactation. Discontinuation is necessary if pregnancy occurs during treatment, as small amounts of DRSP are excreted in breast milk.

Precautions & Warnings

Prior to therapy initiation, consider all relevant conditions and risk factors. Discontinue therapy immediately in case of contraindications or certain symptoms. Reassess the benefit-risk ratio in case of new onset or worsening of specific conditions or risk factors. Special consideration is required for patients with specific medical conditions, such as hepatic or renal impairment.

Overdose Effects

Studies indicate that even inadvertent intake of multiple therapeutic doses poses no acute toxicity risk. Clinical studies support the tolerability of the formulation at higher doses.

Therapeutic Class

This product falls under the category of drugs for menopausal symptoms, specifically hormone replacement therapy.

Storage Conditions

Store below 30°C, away from light and moisture, and out of reach of children.