(and dosage form):
Each tablet contains 0,750 mg levonorgestrel.
A21.8.2 Progesterones with or without oestrogens.
Norlevo® acts as a contraceptive by preventing the nidation of a fertilised ovum in the uterine mucosa.
Norlevo® is indicated for the prevention of pregnancy within 72 hours of unprotected sexual intercourse or the recognizable failure of mechanical methods.
Norlevo® is intended for emergencies only and is completely unsuitable for regular contraception. Its reliability is not as high as that of the familiar pill which is taken for at least 21 days of the menstrual cycle.
Hypersensitivity to any of the ingredients.
Norlevo® should not be used if there is a possibility that pregnancy already exists, eg, if unprotected sexual intercourse has already taken place in the same cycle or if the last menstrual period failed to occur.
Norlevo® should not be given to patients with undiagnosed vaginal bleeding, nor to those with a history of or current high risk of arterial disease.
Severe hepatic impairment:
The repeated use of Norlevo® within a monthly cycle is to be avoided, since it constitutes undesirable hormonal stress and may result in severe cycle disturbances.
Patients who become pregnant despite emergency contraception should be carefully evaluated for ectopic pregnancy. The effect of Norlevo® on the conceptus in the event of a failure to prevent conception is not definitely known. Therefore, a pregnancy test must be performed if there is any doubt.
DOSAGE AND DIRECTIONS FOR USE:
The first tablet is to be taken as soon as possible after sexual intercourse, up to 72 hours later at the most. The other tablet is to be taken 12 hours later.
The earlier Norlevo® is used, the more effective it is. Even extremely high doses of hormone can no longer prevent pregnancy once a fertilized ovum has become implanted in the uterine mucosa.
All further unprotected sexual intercourse must be avoided until the next menstrual period; until then, only mechanical and/or chemical methods (condom, foam, pessary) of contraception may be used.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side effects of Norlevo® may include gastro-intestinal disturbances, changes in appetite or weight, fluid retention, oedema, acne, melasma or chloasma, allergic skin reactions, urticaria, mental depression, breast changes including discomfort or less frequently gynaecomastia, changes in libido, hair loss or hirsutism, fatigue, drowsiness or insomnia, fever, headache, premenstrual syndrome like symptoms, and altered menstrual cycles or irregular menstrual bleeding. Anaphylaxis or Anaphylactoid reactions may occur less frequently. Alterations in liver function tests have been reported and jaundice has been reported less frequently, during prolonged levonorgestrel administration.
Pregestogens given during pregnancy may cause virilisation of the female fetus. Certain progestogens may have an adverse effect on serum lipids.
The next menstrual period may occur earlier or later than usual. At all events you should visit your doctor 3 weeks after taking Norlevo® regardless of whether bleeding has occurred or not.
Norlevo® should be used with caution in patients with a history of mental depression. Norlevo® should not be used diagnostically for pregnancy testing and should not be given in missed or incomplete abortion.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-effects and Special Precautions.
Treatment is symptomatic and supportive.
White, round, biconvex tablet.
2 Tablets in orange PVC/PE/PVDC plastic foil sealed on aluminium foil blister strips.
1 blister strip packed in a printed cardboard box.
Store in a cool place below 25°C.
Protect from moisture and light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Barvic House North
1st floor, 4 Burke Street
Kensington B, Randburg 2125
Hexal Pharma (SA) (PTY) Ltd
46 Mahogany Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19 October 2000.
New addition to this site: April 2005
Source: Pharmaceutical Industry
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