Dosage Form: Tablet.
Desogestrel is used to provide contraceptive efficacy in women who want to prevent pregnancy. Desogestrel has proved to be highly efficacious as a contraceptive pill and is an alternative for women who have a weak tolerance levels for the estrogen hormones or who are lactating or breast feeding.
Desogestrel is a progestin structurally related to levonorgestrel, which has been shown to reliably inhibit ovulation.
Advised by physicians.
When used alone: 75 mcg daily when used alone.
For monophasic combined oral contraceptives: usually 150 mcg per day
For triple combined oral contraceptives: 50,150 mcg daily.
One tablet at the same time each day, taken continuously without a break. Tablets should be taken within 3 hours of the same time each day.
When and how to take the tablets: Each strip of Desogestrel contains 28 tablets. Arrows are printed on the front side of the strip, between the tablets. If you turn the strip over, next to each tablet is printed the day of the week each tablet should be taken. Take your tablet at about the same time each day. Swallow each tablet whole with water. Each time you start a new strip of Desogestrel; take a tablet in the top row. For example if you start on Wednesday, you should take the tablet from the top row marked that particular day. You should continue to take one tablet a day until the strip is empty, always follow the direction indicated by the arrows. In this way you can easily check whether you have taken your daily tablet. You may have some bleeding during the use of Desogestrel but you must continue to take your tablets as normal. When a strip is empty, you must start with a new pack of Desogestrel on the next day without interruption and without waiting for a bleed. You can stop taking Desogestrel whenever you want. From the day you stop, you are no longer protected against pregnancy.
Starting first pack of Desogestrel: If you are not using hormonal contraception at present (or in the past month) wait for your period to begin. On the first day of your period take the first Desogestrel tablet. If you take your first tablet on days 2 to 5 of your period use an additional barrier method of contraception for the first 7 days of tablet taking.
When change from a combined pill: Start Desogestrel on the day after the last active tablet of the combined pill; in this case additional contraceptive precautions are not necessary.
When change from a mini-pill, injection, implant or hormonal IUD: Switch on any day from another mini pill. Start Desogestrel the day an implant or IUD is removed or the day your next injection would be due, additional contraceptive precau-tions are not necessary.
If you have a baby or abortion: Start immediately after first trimester abortion, additional contraceptive precautions are not necessary. After delivery or second trimester abortion, start before periods return. If more then 21 days have elapsed, pregnancy must be ruled out and an additional barrier method of contraception should be used for the first 7 days.
If you forget to take one or more tablets
If you are more than 12 hours late: Take a tablet as soon as you remember and take the next one at the usual time. This may mean taking two tablets in one day. This is not harmful. (If you have forgotten more than one tablet you don’t need to take the earlier missed ones). You are not protected against pregnancy. Continue to take your tablets as usual but you must also use an extra method, such as a condom, for the next seven days. If you are more than 12 hours late taking your tablet and have had sex it is safe to use emergency contraception.
If you are less than 12 hours late: Take the tablet as soon as you remember, and take the next tablet at the usual time. The contraceptive action of Desogestrel is maintained. If you missed one or more tablets in the first week of tablet intake and had intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased.
If you vomit or use medical charcoal: If you vomit or use medical charcoal within 3 – 4 hours after taking your Desogestrel tablet, the active ingredient may not have been completely absorbed. Follow the advice for missed tablets.
Route of administration: Orally.
Enzyme-inducing drugs may result in increased clearance and lead to breakthrough bleeding and contraceptive failure. This may be seen with hydantoins, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, rifabutin, felbamate, ritonavir, griseofulvin and products containing St John’s Wort. Reduced absorption of etonogestrel may be seen with medical charcoal.
Known or suspected pregnancy, active venous thromboembolic disorder, presence or history of severe hepatic disease with current abnormal liver function tests, progestogen dependent tumors, undiagnosed vaginal bleeding, hypersensitivity to ingredients.
Common: irregular bleeding, amenorrhoea, headache, weight gain, breast pain, nausea, acne, mood changes, decreased libido. Less common: Vaginitis, dysmenorrhoea, ovarian cysts, vomiting, alopecia, fatigue, difficulty wearing contact lenses. Rare: Rash, urticaria, erythema nodosum.
Pregnancy & Lactation:
Not recommended for use during pregnancy. Desogestrel does not affect the production or quality of breast milk. Small amounts of the metabolite etonogestrel are excreted with the milk. Long term follow-up data are not available, however 7 month data do not indicate a risk to the nursing infant.
Precautions & Warnings:
Epidemiological studies have associated the use of combined OCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). It is unclear whether desogestrel used alone carries the same risk. Discontinue in the event of a thrombosis. Consider stopping prior to long term immobilization due to surgery or illness. Benefit/risk assessment should be made in women with liver cancer. Caution patients with a history of thromboembolic disorders. Patients with diabetes should be carefully monitored. Effects on bone density are unknown.
Oral Contraceptive preparations
Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
Manufactured by: Renata Ltd.