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21 norethisterone 1 mg and mestranol 0.05 mg tablets and 7 inert lactose tablets.

Uses

Actions
Like other combination type pills, ORTHO-NOVUM produces a contraceptive effect primarily by suppressing the hypothalamic pituitary system resulting in prevention of ovulation. The oestrogenic compound, mestranol, acts by suppressing secretion of follicle stimulating hormone (FSH), resulting in prevention of follicle development and the rise of plasma oestradiol which is thought to be the stimulus for releasing luteinising hormone (LH). The progestogenic compound, norethisterone, primarily acts by inhibiting the preovulatory rise of LH.

Long-term administration of combination type oral contraceptives may also produce a direct effect on ovarian steroidogenesis or the response of the ovary to gonadotrophins. Although the primary mechanism of action is inhibition of ovulation, alterations in the genital tract including changes in the cervical mucus (which increases the difficulty of sperm penetration) and the endometrium (which reduce the likelihood of implantation) may also contribute to contraceptive effectiveness.

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Indications
Oral contraception. ORTHO-NOVUM is primarily designed as an agent for conception control, however, it is also useful in the treatment of certain menstrual disorders. If menstrual periods are heavy , irregular or painful, treatment with ORTHO-NOVUM may prove beneficial.

Dosage and Administration
28 Day Pack
Ortho-Novum 28 Day Pack
To achieve maximum contraceptive effectiveness, Ortho-Novum 28 day must be taken as directed and at daily intervals not exceeding 24 hours. Women should be instructed to take the tablets at the same time every day, preferably at bedtime.

First Cycle
On the first day of the menstrual cycle, i.e. the first day of bleeding, the woman is instructed to take a white active tablet corresponding to the day of the week from the green area of the Ortho-Novum 28 day pack. Thereafter one white active tablet is taken daily, following the arrows on the pack, until all 21 white tablets have been taken. The woman should then be instructed to take one orange inactive tablet daily for the next seven days. Withdrawal bleeding should usually occur within two to four days after the last white tablet has been taken. The woman should be advised that her first cycle after taking all Ortho-Novum 28 day tablets is likely to be shorter than usual, i.e. approximately 23 to 24 days. Thereafter, her cycles should return to normal, approximately 28 days.

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The next and all subsequent courses of Ortho-Novum 28 day will begin on the day after the last package was completed, even if withdrawal bleeding is still in progress. Each course of Ortho-Novum 28 day is begun on the same day of the week as the first course, always beginning with a white active tablet from the green area.
Ortho-Novum 28 day is effective from the first day if taken as described above.

Ortho-Novum 21 and 28 Day Packs

Missed Tablets
If the woman is less than 12 hours late in taking one of her white active tablets, she should take this tablet at once and then take the next one at her usual time. If the woman is more than 12 hours late in taking one of her white active tablets, she should continue to take her tablets daily as usual, ignoring the missed tablet or tablets, but also take extra contraceptive precautions (other than the rhythm or temperature method) for the next seven days. If these seven days extend into the inactive orange tablet section (if using a 28 day pack) or the 7 tablet free days (if using a 21 day pack), she should start a new pack on the next day after having taken the last white active table from the green section of the current pack (i.e. skip the orange inactive tablets or the tablet free days). This will mean that the woman may not have a period until the end of two packs.

However, if the woman misses one or more orange inactive tablets, she will be protected against pregnancy provided she begins the active tablets on the appropriate day.

If the woman has not adhered to the prescribed regimen (missed one or more active tablets or started taking them on a day later than recommended), the probability of pregnancy should be considered at the time of the first missed period before Ortho-Novum 21 or 28 day is resumed. In the case of the continuous intake of active tablets from two packs of Ortho-Novum 21 or 28 day (see before), a period should occur at the end of the second pack. If it does not, pregnancy should be ruled out before Ortho-Novum 21 or 28 day is resumed.

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Interactions
Oral contraceptives may be rendered less effective by virtue of interaction with phenylbutazone, analgesics, antihistamines, antimigraine preparations, tranquillizers, anticonvulsants (barbiturates, primidone, phenytoin), and antibiotics (ampicillin, chloramphenicol, griseofulvin, isoniazid, neomycin, nitrofurantoin, penicillin V, rifampicin, sulfonamides and tetracyclines).

Oral contraceptives may alter the effectiveness of other types of medicines, such as anticonvulsants, antihypertensive agents (for example, guanethidine), beta-blockers, hypnotics, hypoglycaemic agents, oral anticoagulants, theophylline, tranquillizers, tricyclic antidepressants and vitamins.

Oral contraceptives may cause alterations in certain laboratory estimations. A medicine free period of two months may be required before some of these parameters return to normal.

Overdosage

Symptoms
Overdosage may be manifested by nausea, vomiting, breast enlargement and vaginal bleeding.
Serious ill effects have not been reported following acute ingestions of large doses of oral contraceptives by young children.

Treatment
There is no specific antidote and treatment should by symptomatic. If a patient is seen within three hours of swallowing a significant number of tablets, emesis may be induced with syrup of ipecacuanha (15mL for a child one year and older, followed by a large glass of fluid; this may be repeated once only if vomiting does not occur).

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Pharmaceutical Precautions
Store below 25?C.

Medicine Classification
Prescription medicine.