FEMI PILL.pdf - Lomus Pharmaceuticals Pvt. Ltd.

FEMI PILL
Dosage Forms/Composition
Tablet: Each uncoated tablet contains Norethisterone 0.35mg
Pharmacological Index
Hormonal Contraceptive; progestin
INDICATION
Contraception
Pregnancy Risk Factor
X
Contraindications
Hypersensitivity to norethindrone; thromboembolic disorders; severe hepatic disease;
breast cancer; undiagnosed vaginal bleeding.
Warnings/Precautions
Use of any progestin during the first 4 months of pregnancy is not recommended.
Discontinue if sudden partial or complete loss of vision, proptosis, diplopia, or migraine
occur. There is a higher rate of failure with progestin only contraceptives. Progestininduced
withdrawal bleeding occurs within 3-7 days after discontinuation of drug. Use
with caution in patients with asthma, diabetes, seizure disorder, migraine, cardiac or
renal dysfunction, or psychic depression.
Adverse Reactions
>10%:
Cardiovascular: Edema
Endocrine & metabolic: Breakthrough bleeding, spotting, changes in menstrual flow,
amenorrhea
Gastrointestinal: Anorexia
Local: Pain at injection site
Neuromuscular & skeletal: Weakness
1% to 10%:
Cardiovascular: Edema
Central nervous system: Mental depression, fever, insomnia
Dermatologic: Melasma or chloasma, allergic rash with or without pruritus
Endocrine & metabolic: Increased breast tenderness
Gastrointestinal: Weight gain or loss
Genitourinary: Changes in cervical erosion and secretions
Hepatic: Cholestatic jaundice
Drug Interactions
Decreased effect: Aminoglutethimide may decrease effects by increasing hepatic
metabolism. Nelfinavir decreases norethindrone concentrations.

Mechanism of Action
Inhibits secretion of pituitary gonadotropin (LH) which prevents follicular maturation
and ovulation.
Usual Dosage
1 pill everyday. Pills to be take at the same time everyday from the first day of the
menstruation cycle.
If the dose is missed, two pills to be taken in the following day.
Patient Information
Take according to prescribed schedule. Follow instructions for regular self-breast
exam. You may experience dizziness or lightheadedness; use caution when driving or
engaging in tasks that require alertness until response to drug is known. Limit intake of
caffeine. Avoid high-dose vitamin C, folate, or pyridoxine. You may experience
photosensitivity; use sunscreen, wear protective clothing and eyewear, and avoid
direct sunlight. You may experience loss of hair (reversible), weight gain or loss. Report
sudden severe headache or vomiting, disturbances of vision or speech, sudden
blindness, numbness of weakness in an extremity, chest pain, calf pain, respiratory
difficulty, depression or acute fatigue, unusual bleeding, spotting, or changes in
menstrual flow. Pregnancy/breast-feeding precautions: Inform prescriber if pregnant.
Consult prescriber if breast-feeding.
LOMUS Drug Information Center
Lomus Pharmaceuticals Pvt. Ltd.
P.O. Box No 4506, Lomus House (Corporate office),
Kailash Chour, Lazimpat, Kathmandu, Nepal
Ph: 4436396 (Hunting Line). Fx: 977-1-4436395
E-mail: druginfo@lomus.com.np