Rosen Gold 0.02 mg+3 mg (Tablet)

Indications

• Oral contraceptive
• Treatment of moderate acne vulgaris
• Treatment of premenstrual dysphoric disorder (PMDD)

Pharmacology

• Contains Ethinylestradiol and Drospirenone
• Synthetic version of estrogen and progesterone
• Inhibit ovulation
• Change in cervical mucus
• Changes in endometrium
• Display favorable lipid profile

Dosage

• Tablets must be taken in order directed on package
• Tablet-taking must be started with the first pink tablet and continue daily for 24 consecutive days
• Withdrawal bleeding usually starts on days 2-3 after starting the white tablets
• Different instructions for preceding hormonal contraceptive use, changing from another combined hormonal pill or vaginal ring, changing from a progestogen-only-method, following first-trimester abortion, following delivery or second-trimester abortion

Administration

• Management of Missed Tablets
• How to Delay a Period
• Advice in case of Vomiting

Interaction

• Interactions with other drugs may lead to decreased or increased ethinylestradiol concentrations
• Certain antibiotics may reduce efficacy of oral contraceptives
• Non hormonal back-up method of contraception is recommended in case of ethinylestradiol serum concentrations changes

Contraindications

• Known or suspected pregnancy
• Heart disease or clotting of blood in the vein
• Liver disease or jaundice
• High blood pressure, migraine, diabetes with vascular involvement
• Presence or history of thromboembolic events
• History of migraine with focal neurological symptoms
• Pancreatitis or severe hypertriglyceridaemia
• Severe renal insufficiency or acute renal failure
• Presence or history of liver tumors
• Undiagnosed vaginal bleeding
• Hypersensitivity to any of the components of this preparation

Side Effects

• Dizziness
• Headache
• Breast pain
• Nausea
• Unscheduled uterine bleeding
• Migraine
• Changes in eyesight or speech
• Unusual pain or swelling in legs
• Chest pains or shortness of breath
• Rash or yellow skin
• Rise in blood pressure

Pregnancy & Lactation

• Contraindicated during pregnancy
• Pregnancy must be excluded before starting
• Non-hormonal method of contraception is recommended before attempting to conceive
• Lactation may be influenced by combined pill
• Use not recommended until complete weaning

Precautions & Warnings

• Benefits of COC use should be weighed against possible risks for each individual woman
• Physician should decide on discontinuation if conditions worsen
• Considerations for circulatory disorders and risk factors

Use in Special Populations

• Pediatric Use after menarche
• No dosage adjustment needed
• Not indicated after menopause

Overdose Effects

• Nausea
• Vomiting
• Breast tenderness
• Dizziness
• Abdominal pain
• Drowsiness/fatigue
• Withdrawal bleeding may occur

Therapeutic Class

• Oral Contraceptive preparations

Storage Conditions

• Do not store above 30°C
• Keep away from light and out of the reach of children

Related Brands

• Novelon Lite 0.02 mg+3 mg (Tablet) - renata-limited
• Elisa 0.02 mg+3 mg (Tablet) - nuvista-pharma-ltd
• Valentino 0.02 mg+3 mg (Tablet) - healthcare-pharmaceuticals-ltd