Diane-35 inhibits ovulation and thereby has a contraceptive effect. Patients who are using Diane-35 should, therefore, not use an additional hormonal contraceptive, since this leads to an overdose of hormones and is not necessary for effective contraceptive protection. For the same reason, women who desire to become pregnant should not use Diane-35. Diane-35 must be taken regularly in order to develop an adequate therapeutic efficacy and effective contraceptive protection.
Method of administration: Oral use.
Use: Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval, during which withdrawal bleeding usually occurs, which often starts on the 2nd-3rd day after taking the last tablet and can continue until the next pack is started.
Contraceptive protection starts on the first day the tablets are taken and also continues during the 7 tablet-free days. The simultaneous use of hormonal contraceptives must therefore stop.
Medical examination/consultation: Before using, it is advisable to perform a thorough general medical examination (including body weight, blood pressure, heart, legs and skin, urine test for diabetes, and liver diagnostic tests when necessary) as well as gynecological examinations (including the breasts and a cytological smear taken from the vaginal portion of the cervix and the cervix) and to compile a thorough family medical history in order to be able to detect diseases requiring treatment and risks. Pregnancy must be ruled out. It is advisable to have checkups every six months during use.
Coagulation system disorders should be ruled out if thromboembolic events (e.g. deep venous thrombosis, stroke, heart attack) have occurred in blood relatives at an early age.
It should also be pointed out that taking oral contraceptives does not protect against HIV infections (AIDS) and other sexually transmitted diseases.
Starting treatment: No previous hormonal contraception (during the past month): Tablet taking of one tablet daily has to start on day 1 of the woman's natural cycle (the first day of her menstrual bleeding). If the course is started between days 2 and 5, an additional contraceptive precaution (barrier contraceptive) is recommended during the first 7 days of tablet taking.
Only amenorrheic women start treatment immediately as prescribed by their physician; in the case of which, the first day of tablet taking is equivalent to the first day of the menstrual cycle and counting is continued according to the following recommendations.
Having previously taken combined oral contraceptives or having used a vaginal ring or a transdermal patch: Diane-35 should preferably be started on the day after having taken the last hormone-containing tablet of the previous combination product (or after the removal of the ring or of the patch), but at the latest on the day after the usual hormone-free interval, or on the day after having taken the last placebo from the previous combination product. If a ring or patch has previously been used, Diane-35 should preferably be started on the day of its removal, but at the latest on the day when re-administration of the previous contraceptive would be necessary.
Changing from a progestagen-only product (minipill, injection, implant) or from an intrauterine system (IUS): If the minipill has been taken previously, Diane-35 can be started on any day (the change from an implant or intrauterine system must take place on the day of removal, and at the time the next injection would be due, when changing from an injectable contraceptive). However, in all cases, additional contraceptive precautions are required during the first 7 days of tablet use.
After a first-trimester abortion: The tablets can be started immediately. In this case, no additional contraceptive precautions are required.
After delivery or a second-trimester abortion: The tablets should be started on days 21 to 28 after delivery or after an abortion in the second trimester. If they are started later, an additional barrier contraceptive must be used during the first 7 days of tablet taking. If, however, sexual intercourse has already taken place, pregnancy must be ruled out or the first menstrual period must have occurred before starting use.
Duration of administration: The time to symptomatic relief is at least three months. The treating physician should regularly check whether there is still a need for treatment.
The length of use depends on the severity of the symptoms of androgenisation and their response to treatment. Acne and seborrhea usually respond sooner than hirsutism. It is recommended to take Diane 35 for at least another 3 to 4 cycles after the signs have subsided.
If there has been a lack of response or only insufficient response in treating severe acne or seborrhea for at least six months or hirsutism for at least 12 months achieved, combined use of Diane-35 and Androcur 10 mg tablets or Androcur 50 mg tablets has to be considered or rather the treatment approach has to be reconsidered. As soon as the androgenisation signs have subsided but contraception is still desired, maybe a switch should be made to a low-dose oral contraceptive. Should there be a recurrence of androgenic symptoms, treatment with Diane-35 can be resumed. When resuming treatment with Diane-35 (after a tablet-free interval of at least 4 weeks), the increased risk of venous thromboembolism should be considered (see Precautions).
How to proceed when a tablet has been missed: If a user of Diane-35 forgot to take a tablet at the usual time, it has to be taken within 12 hours. All subsequent tablets should then be taken again at the usual time. Contraceptive protection is not impaired. If it has been more than 12 hours, contraception is no longer reliable. When tablets have been forgotten, there are basically two things to bear in mind: 1. Tablet taking must never be interrupted for longer than 7 days.
2. In order to build up adequate contraceptive protection, i.e. to achieve suppression of the hypothalamic-pituitary-ovarian system, it is necessary to take the tablets for 7 days.
Accordingly, the following recommendations can be made for routine practice.
Week 1: The missed tablet should be taken as soon as possible, even if this means taking two tablets at the same time. The remaining tablets are then taken at the usual time. During the next 7 days, however, an additional barrier contraceptive, such as a condom, should be used. If sexual intercourse has taken place in the past 7 days, the possibility of pregnancy should be taken into consideration. The risk of pregnancy is all the higher, the more tablets have been forgotten and the closer this is to the regular tablet-free interval.
Week 2: The missed tablet should be taken as soon as possible, even if this means taking two tablets at the same time. The remaining tablets are then taken at the usual time.
Provided that the tablets have been taken correctly on the 7 days before the first missed tablet, there is no need to use additional protective measures. If this was not the case or if more than 1 tablet was forgotten, the use of additional protective measures for 7 days should be recommended.
Week 3: On account of the approaching 7 tablet-free days, complete contraceptive protection can no longer be guaranteed. On the other hand, reduction of the contraceptive effect can be prevented by adjusting the tablet-taking schedule. By adhering to either of the two following procedures, there is no need for additional contraceptive measures, provided that the tablets were taken correctly on the 7 days preceding the first missed tablet. If this is not the case, the woman should proceed as described in item 1 and also use additional protective measures during the next 7 days.
1. The user should make up for the last missed tablet as soon as possible, even if this means taking two tablets at the same time. The remaining tablets are then taken at the usual time. The next blister pack is started directly after completion of the current blister pack, i.e. there should be no tablet-free interval between the two packs. It is unlikely that the user will have withdrawal bleeding before completing the second pack, however spotting or breakthrough bleeding can occur during use.
2. It can also be recommended to stop taking tablets from the current blister pack, followed by a tablet-free interval of up to 7 days, including the days on which tablets were omitted. The next pack should then be started.
In the event of missed tablets and missed withdrawal bleeding during the next regular tablet-free interval, the possibility of pregnancy should be considered.
Absence of withdrawal bleeding: In the absence of withdrawal bleeding, use should be discontinued until pregnancy has been excluded with certainty.
How to proceed in the case of intermenstrual bleeding: It is imperative to continue taking Diane-35 in the event of intermenstrual bleeding. Spotting usually ceases spontaneously or can be resolved within 4 to 5 days - as can intermenstrual bleeding of menstrual intensity (breakthrough bleeding) - by the additional administration of 25 - 50 μg of ethinyl estradiol (but not extending beyond the last tablet in a pack of Diane-35).
If breakthrough bleeding does not cease or if it recurs, a thorough examination to exclude an organic cause is indicated, including curettage.
This also applies to spotting, which occurs at irregular intervals in several consecutive cycles or which occurs for the first time after long use of Diane-35. In these cases, the bleeding is usually caused by organic changes and not by the product.
How to proceed in the case of vomiting or severe diarrhea: Vomiting or severe diarrhea may lead to incomplete absorption of the active ingredients. Additional non-hormonal methods of contraception (except the rhythm or temperature methods) should be used. If vomiting or severe diarrhea occur within 3 to 4 hours after tablet taking, the procedure quoted with regard to missed tablets as previously mentioned should be followed. If the user concerned does not want to depart from her normal tablet-taking rhythm, she must take the replacement tablet(s) from another blister pack.
Liver: After recovering from viral hepatitis (when the liver parameters have returned to normal), approximately six months should elapse before using a product, such as Diane-35.
Additional information on certain patient groups: Children and adolescents: Diane-35 may only be used after the menarche.
Geriatric patients: Not applicable. Diane-35 is not indicated after the menopause.
Patients with hepatic dysfunction: Diane-35 is contraindicated in women with severe hepatic disease, as long as liver function values have not returned to normal. See also Contraindications.
Patients with renal dysfunction: Diane-35 has not been specifically studied in patients with impaired renal function. The available data do not indicate the need for any treatment adjustment in this patient group.