Novelon Lite 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
• Inhibits ovulation by suppressing gonadotropin release
• Changes in cervical mucus to increase difficulty of sperm penetration
• Changes in endometrium to reduce likelihood of implantation
• Drospirenone has antimineralocorticoid activity

Dosage

• Tablets must be taken daily at about the same time
• Start with the first pink tablet and continue daily for 24 days
• Withdrawal bleeding usually starts on days 2-3 after starting the white tablets

Administration

• Management of Missed Tablets
• Delaying a period
• Advice in case of Vomiting

Interaction

• Interactions between ethinylestradiol and other drugs may affect concentrations
• Certain antibiotics and substances may reduce efficacy of oral contraceptives

Contraindications

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

Side Effects

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

Pregnancy & Lactation

• Contraindicated during pregnancy
• Pregnancy must be excluded before starting
• Use during lactation may influence breast milk
• Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the milk

Precautions & Warnings

• Benefits should be weighed against possible risks for each individual woman
• Physician should decide on use if aggravation or exacerbation of conditions occur
• Not indicated after menopause

Use in Special Populations

• Indicated after menarche
• No need for dosage adjustment

Overdose Effects

• May include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue
• Withdrawal bleeding may occur in females
• No specific antidote

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

• Rosen Gold 0.02 mg+3 mg (Tablet) - incepta-pharmaceuticals-ltd