Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2018 Publisher: Pfizer New Zealand Limited, P O Box 3998, Auckland, New Zealand, 1140, Toll Free Number: 0800 736 363
LOETTE is indicated for the prevention of pregnancy.
To achieve maximum contraceptive effectiveness, LOETTE must be administered as directed and at the same time every day, at intervals not exceeding 24 hours.
Each package of LOETTE contains 21 active pink tablets and 7 white inactive tablets.
On the first day of the menstrual cycle, i.e. the first day of bleeding, the woman is instructed to take a pink active tablet corresponding to that day of the week from the pink shaded section of the LOETTE pack. Thereafter, one pink active tablet is taken daily, following the arrows marked on the package, until all 21 pink active tablets have been taken. The woman is then instructed to take one white inactive tablet daily for the next seven days following the arrows marked on the LOETTE pack. Withdrawal bleeding should usually occur within 2 to 4 days after the last pink active tablet is taken.
LOETTE is effective from the first day of therapy if the tablets are begun on Day 1 as described. Starting on Days 2-7 is allowed, but during the first cycle a back-up method of contraception is recommended for the first 7 days of tablet taking.
The back-up method of contraception must be an additional non-hormonal barrier method such as condoms or a diaphragm with a spermicide. Back-up contraception does not include the rhythm or temperature methods.
The next and all subsequent courses of LOETTE will begin on the day after the last package was completed, even if withdrawal bleeding is still in progress. Each course of LOETTE is thus begun on the same day of the week as the first course.
Any time a new cycle of LOETTE is started later than the eighth day after discontinuance of the pink active tablet, the woman should use a back-up non-hormonal method of contraception (other than the rhythm or temperature methods), until an active pink tablet has been taken for 7 consecutive days.
If withdrawal bleeding does not occur and LOETTE has been taken according to directions, and conditions possibly impairing contraceptive effectiveness (refer to Advice in Case of Vomiting or Diarrhoea and section 4.5) can be ruled out, it is unlikely that the woman has conceived. She should be instructed to begin a second course of LOETTE on the usual day. If bleeding does not occur at the end of this second cycle, LOETTE should not be taken until diagnostic procedures to exclude the possibility of pregnancy have been performed.
If the woman has not adhered to the prescribed regimen (missed one or more 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 LOETTE is resumed.
The woman is advised to take the first pink LOETTE tablet from the pink shaded section, which corresponds to the day of the week on the day after the last active tablet of her previous oral contraceptive. However the woman can also begin LOETTE on any day during the tablet-free or inactive tablet interval of her previous oral contraceptive.
During the first LOETTE cycle, a non-hormonal back-up method of contraception (other than the rhythm or temperature methods) should be used until one active tablet has been taken for 7 consecutive days.
If transient spotting or breakthrough bleeding occurs, the woman is instructed to continue the regimen since such bleeding is usually without significance. If the bleeding is persistent or prolonged, the woman is advised to consult her physician.
The woman may switch any day from progestogen-only tablets and should begin LOETTE the next day. She should start LOETTE on the day of an implant removal or, if using an injection, on the day the next injection would be due. In all of these situations, the woman should be advised to use a non-hormonal back-up method of contraception (other than the rhythm or temperature methods) until one active tablet has been taken daily for 7 consecutive days.
To delay a withdrawal bleed the woman should discard the inactive white pills from the current pack and start the next pack on the day following the intake of the last pink tablet from the current pack. The extension can be carried on for as long as wished until the end of the second pack, when the white pills are taken. During the extension the woman may experience breakthrough bleeding or spotting. Regular intake of LOETTE is then resumed with the next pack.
The woman may start immediately. Additional contraceptive measures are not needed.
Since the immediate post-partum period is associated with an increased risk of thromboembolism, LOETTE should be started no earlier than day 28 after delivery in the nonlactating mother or after second-trimester abortion. The woman should be advised to additionally use a back-up method of contraception (other than the rhythm or temperature methods) until one active tablet has been taken daily for the 7 consecutive days. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of LOETTE use or the woman has to wait for her first menstrual period (see section 4.4, Venous Thrombosis and Thromboembolism, and section 4.6).
Contraceptive efficacy may be reduced if tablets are missed and particularly if the missed tablets extend the inactive tablet interval. If tablets were missed in the first week of the cycle and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered.
If one active pink tablet is missed, but is less than 12 hours late, it should be taken as soon as it is remembered. Subsequent tablets should be taken at the usual time.
If one active pink tablet is missed and is more than 12 hours late or if more than one active tablet is missed, contraceptive protection may be reduced.
The last missed pink tablet should be taken as soon as it is remembered, even if this means taking two active pink tablets in one day. Any earlier missed tablets should be discarded. The woman should then continue to take tablets at her usual time. In addition, a non-hormonal back-up method of contraception (other than the rhythm or temperature methods) should be used until one active tablet has been taken daily for 7 consecutive days.
If the 7 days where back-up is required run beyond the last active pink tablet in the current pack, the next pack must be started on the day following the intake of the last pink tablet in the current pack. All inactive (white) tablets should be discarded. This prevents an extended break in the active tablet taking that may increase the risk of escape ovulation. The woman is unlikely to have a withdrawal bleed until the inactive tablet interval of the second pack, but she may experience spotting or breakthrough bleeding on active tablet taking days.
If the user does not have a withdrawal bleed at the end of the second pack, the possibility of pregnancy must be ruled out before resuming tablet taking.
If the woman misses one or more white inactive tablets, she will still be protected against pregnancy provided she begins the pink active tablets on the appropriate day.
If vomiting or diarrhoea occurs during or shortly after the intake of LOETTE, contraceptive reliability may be jeopardised. If vomiting or diarrhoea occurs within 4 hours after tablet taking, absorption may not be complete. In such an event, the advice concerning Management of Missed Tablets is applicable. The woman must take the extra active tablet(s) needed from a back-up pack.
Safety and efficacy of combined oral contraceptives have been established in women of reproductive age. Use of these products before menarche is not indicated.
Combined oral contraceptives are not indicated for use in postmenopausal women.
Symptoms of oral contraceptive overdose in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. In children, serious ill effects have not been reported following large doses of oral contraceptives.
Treatment of overdose, if necessary, is directed to the symptoms.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764 766).
24 months.
Store below 25ºC.
One-month pack containing one blister tray or a three-month pack containing 3 blister trays. Each blister tray contains 21 pink active tablets, each containing levonorgestrel 100 µg and ethinylestradiol 20 µg, and 7 white inactive tablets.
None stated.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
