Novenyl

Novenyl

Manufacturer:

Novell Pharma

Marketer:

Novell Pharma
Concise Prescribing Info
Contents
Nomegestrol acetate
Indications/Uses
In premenopausal women w/ progesterone deficiency & disorders of cycle duration (eg, oligomenorrhoea, polymenorrhoea, spaniomenorrhoea, amenorrhoea); functional uterine bleedings (eg, metrorrhagia, menorrhagia); functional signs & symptoms preceding or accompanying periods (eg, essential dysmenorrhea, premenstrual syndrome, cyclical mastodynia). In postmenopausal women w/ artificial cycle in combination w/ an estrogen.
Dosage/Direction for Use
1 tab daily. Premenopausal women 10 days/cycle (from the 15th to 24th). Postmenopausal women Depend on the estrogen replacement therapy given.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active or past history of arterial thrombo-embolism (eg, MI, cerebrovascular stroke); venous thrombo-embolism (eg, phlebitis, pulmonary embolism). Serious disturbances of liver functions. Undiagnosed genital bleeding. Pregnancy.
Special Precautions
Discontinue if ocular disorder, clinical sign of arterial or venous thrombo-embolism, severe & unexplained headaches occurs. Clinical exam, & if appropriate additional test should be done to confirm absence of breast or uterine cancer (eg, cervix or endometrium). Medical follow-up is advised for patients w/ or w/ history of CV disease, unstable HTN, diabetes or porphyria.
Adverse Reactions
Disturbances of menstruation periods, amenorrhoea & breaktrough bleeding; worsening of venous insufficiency in lower limbs.
Drug Interactions
Reduced efficacy w/ enzyme inducers [eg, anticonvulsants (carbamazepine, phenobarb, phenytoin, pirimidone), barbiturates, griseofulvin, rifabutin, rifampicin].
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DB04 - nomegestrol ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.
Presentation/Packing
Form
Novenyl FC tab 5 mg
Packing/Price
3 × 10's (Rp285,000/boks)
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