Posology : מינונים

4.2.   Posology and Method of Administration
4.2.1.                Effectiveness of Oral Contraceptive
When used perfectly, without missing any pills, the chance of becoming pregnant is less than 1% (i.e. <1 pregnancy per 100 women in their first year of use). Typical failure rates are actually 5% in the first year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.

4.2.2.Adults
To achieve the maximum contraceptive effectiveness ORTHO-CYCLEN tablets must be taken exactly as directed and in the correct order at the same time each day, e.g., at bedtime. Tablets are taken without interruption as follows:

One blue active tablet administered daily with water at the same time of the day for 21 days. After the last tablet has been taken, a period of 7 days follows, during which no tablets should be taken. During this period of no medication, bleeding can be expected, usually beginning 2 to 4 days after the last active tablet. After this break of 7 days, the next cycle of ORTHO- CYCLEN should be started, even if there is no bleeding or if bleeding has not yet ended.

For the initial cycle of therapy, treatment should commence on the first day of the menstrual cycle: one tablet daily (in the order described above) with water at the same time of the day for 21 days. If this procedure is correctly followed, TRADENAME helps to prevent pregnancy starting from the first day of intake and including the 7 days during which no tablets are taken.

Sunday Start: Take the first active tablet on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day. If Sunday is not the first day of your period, use another method of birth control as a back-up method if you have coital exposure anytime from the Sunday you start your first pack until the next Sunday (7 days).

4.2.3. Children
Safety and efficacy of ORTHO-CYCLEN tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years of age and older. Use of this product before menarche is not indicated.

4.2.4.         Elderly
Use of this product is not indicated in post-menopausal women.



4.2.5. Switching from Another Hormonal Contraceptive
For a switch-over from a different combination oral contraceptive, treatment with ORTHO-CYCLEN should begin between 1 - 7 days following the last active tablet from the previous oral contraceptive cycle. In no case should more than 7 pill-free days elapse before initiating treatment with ORTHO- CYCLEN. If more than 7 days elapse between the last active pill of the previous cycle and the first active pill of the new cycle, a reliable supplementary non-hormonal contraceptive method should be used until 7 active pills have been taken without interruption. If coital exposure has occurred during such an extended pill-free interval, the possibility of fertilization should be considered.

When switching from an oral progestogen only pill, treatment with ORTHO- CYCLEN should be initiated on the first day following the last active pill. It is not necessary to use an additional non-hormonal method of contraception for the initial 7 days.

Physicians are advised to refer to prescribing information for recommendations regarding switching from another form of hormonal contraception (e.g., transdermal contraceptive system, injectables, etc.).

4.2.6. Use after Childbirth
Women who elect not to breast-feed should start oral contraceptive therapy no sooner than 3 weeks after childbirth. (See Sections 4.4.2.
Thromboembolic and Other Vascular Disorders and 4.6. Pregnancy and
Lactation.)

4.2.7. Use after Abortion or Miscarriage
After an abortion or miscarriage that occurs prior to 20 weeks gestation, oral contraceptives can be started immediately. An additional method of contraception is not needed. Be advised that ovulation may occur within 10 days of an abortion or miscarriage.

After an induced or spontaneous abortion that occurs at or after 20 weeks gestation, hormonal contraceptives may be started either on Day 21 post- abortion or on the first day of the first spontaneous menstruation, whichever comes first. A non-hormonal contraceptive must be used concurrently for the first 7 days of the first cycle. In exceptional cases where there are medical reasons for immediate reliable contraception, treatment with ORTHO-CYCLEN may be started within 1 week post-abortum, taking into consideration the increased risk of thromboembolic disease in the immediate post-abortum period.     (See Section 4.4.2. Thromboembolic and Other Vascular Disorders).

4.2.8.       Advice in the Case of Missed Tablets
If one active tablet has been missed (no more than 24 hours should elapse between tablets), take the missed tablet as soon as it is remembered. Take the next tablet at the regular time. This means two tablets may be taken in one day.

If two active tablets are missed in week one or week two, take two tablets on the day it is remembered and two tablets the next day. Then take one tablet per day as directed until the pack is finished. In addition, a reliable supplementary non-hormonal contraceptive method should be used until active pills have been taken for 7 days without interruption.

If two active tablets are missed in week three, throw out the rest of the pill pack and start a new pack that same day. In addition, a reliable supplementary non-hormonal contraceptive method should be used until active pills have been taken for 7 days without interruption.

If three active tablets are missed anytime during the first three weeks, throw out the rest of the pack and start a new pack that same day. In addition, a reliable supplementary non-hormonal contraceptive method should be used until active pills have been taken for 7 days without interruption.

4.2.9.       Breakthrough Bleeding or Spotting
In the event of breakthrough bleeding or spotting, treatment should be continued. This type of bleeding usually disappears after the third cycle, but may vary between individuals. If breakthrough bleeding persists, a healthcare professional should be consulted.

In the event of no withdrawal bleeding, treatment should be continued. If the pills have been taken correctly, the absence of such bleeding is not necessarily an indication of pregnancy. Nevertheless, the possibility of pregnancy should be ruled out.

4.2.10.      In Case of Vomiting/Diarrhea
If vomiting occurs within 3 hours of pill intake, or if severe diarrhea lasting for greater than 24 hours occurs, the effectiveness of the contraception may not be adequate, and an additional non-hormonal method of contraception should be used until 7 active tablets have been taken for 7 days without 
interruption. If vomiting and/or diarrhea persist, a healthcare professional should be consulted because the effectiveness of the oral contraceptive may be compromised.