Rozy DS 0.50mg+1.00mg Tablet

✔️ Commonly reported adverse effects include:

Breast tenderness or pain

Irregular vaginal bleeding or spotting

Abdominal pain or bloating
Serious but rare side effects may include venous thromboembolism, stroke, or breast cancer.
Bleeding irregularities usually resolve with continued use.

✔️ Dosage & Administration

Recommended Dose: One tablet daily, preferably taken at the same time each day.

How to Start:

Women not currently on HRT or switching from a continuous combined regimen can begin anytime.

Women transitioning from sequential or cyclic HRT should complete their current cycle before starting.

Missed Dose: Take as soon as remembered. If over 24 hours have passed, skip the missed dose—do not double up.

Duration: Each pack provides 28 days of continuous therapy. Start the next pack immediately after finishing the current one.

Tablets should be swallowed whole with water, with or without food.

Use the lowest effective dose for the shortest duration to manage postmenopausal symptoms.

Children and Adolescents: Not recommended.

Elderly: No dosage adjustment needed.

Hepatic Impairment: Contraindicated in severe cases.

Renal Impairment: Avoid in severe renal disease.

✔️ Drug Interactions

Reduced Efficacy:

Hepatic enzyme–inducing drugs such as carbamazepine, phenytoin, barbiturates, rifampicin, primidone, oxcarbazepine, topiramate, and griseofulvin may lower hormone levels and reduce clinical efficacy.

Certain antibiotics (e.g., penicillins, tetracyclines) may slightly decrease estradiol levels.

Increased Effects:

CYP3A4 inhibitors such as ketoconazole or cimetidine may increase estradiol levels.

Alcohol consumption during therapy may raise circulating estrogen levels.

✔️ Rozy DS should not be used in women with:

• Undiagnosed genital bleeding
• Known or suspected breast or estrogen-dependent malignancies
• Severe liver or kidney disease
• Active or past venous or arterial thromboembolism (DVT, pulmonary embolism, stroke, myocardial infarction)
• High risk of thrombosis or hypertriglyceridemia
• Liver tumors (benign or malignant)
• Pregnancy or lactation
• Hypersensitivity to any ingredient in the formulation

✔️ Pregnancy & Lactation

Contraindicated during pregnancy and breastfeeding.

If pregnancy occurs, discontinue treatment immediately.

Small quantities of Drospirenone may pass into breast milk.

✔️ Storage Conditions

Store below 30°C, away from light and moisture.

Keep out of reach of children.