Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, ISANDO, 1609
Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism in women of reproductive age.
This includes patients with polycystic ovary syndrome requiring treatment of these symptoms. For the treatment of acne, DIANE-35 should be used when topical therapy or systemic antibiotic treatments are not considered appropriate.
As DIANE-35 is also a hormonal contraceptive, it must not be used in combination with other hormonal contraceptives (see section 4.3).
DIANE-35 is to be taken regularly in order to achieve the therapeutic efficacy and the required contraceptive protection. Previously used hormonal contraception should be discontinued. The dose regimen of DIANE-35 is similar to the usual regimen of most of the combined oral contraceptives. Thus, the same administration rules must be considered. Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The irregular intake of DIANE-35 can lead to intermenstrual bleedings and could deteriorate the therapeutic and contraceptive reliability. Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet-taking is continuous. One tablet is to be taken daily for 28 consecutive days.
Each subsequent pack is started the day after the last tablet of the previous pack. Withdrawal bleeding usually starts on day 2-3 after starting the hormone-free larger white coated tablets and may not have finished before the next pack is started.
Tablet-taking has to start on day 1 of the women’s natural cycle (i.e. the first day of her menstrual bleeding), but during the first cycle an additional barrier method is recommended for the first 14 days The first tablet should be taken from the starter section of the calendar pack by selecting the appropriate tablet for that day of the week (e.g. “Mon” for Monday).
The woman should start with DIANE-35 on the day after the last hormone-containing tablet of her previous oral contraceptive. In case a vaginal ring or transdermal patch has been used, the woman should start using DIANE-35 on the day of removal of the last ring or patch of a cycle pack.
The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due), but during the first cycle an additional barrier method is recommended for the first 14 days of tablet-taking.
The woman may start immediately, but during the first cycle an additional barrier method is recommended for the first 14 days of tablet-taking.
For breastfeeding women see section 4.6.
Women should be advised to start at day 21 to 28 after delivery or second-trimester abortion, but during the first cycle an additional barrier method is recommended for the first 14 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of DIANE-35 or the woman has to wait for her first menstrual period.
Missed hormone-free larger white coated tablets can be disregarded. However, they should be discarded to avoid unintentionally prolonging the hormone-free larger white tablet phase. The following advice only refers to missed hormone-containing beige coated tablets:
If the user is less than 12 hours late in taking any hormone-containing tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.
If she is more than 12 hours late in taking any hormone-containing tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules:
If a hormone-containing tablet has been missed for more than 12 hours, 7 days of additional barrier methods are required.
If the woman missed tablets and subsequently has no withdrawal bleed in the hormone-free larger white coated tablet phase, the possibility of a pregnancy should be considered.
If an intermenstrual bleeding occurs during the 3 weeks in which the beige tablets are being taken, their use should not be interrupted. A slight bleeding (spotting) will usually stop spontaneously. However, if the bleeding is heavy, similar to a menstrual bleeding, then a thorough examination is indicated to exclude organic factors.
If bleeding fails to occur while the tablets from the starter section are being taken, tablet-taking must provisionally be stopped, and the doctor must be consulted.
In case of severe gastro-intestinal disturbances, absorption may not be complete and additional contraceptive measures should be taken.
If vomiting occurs within 3-4 hours after taking a hormone-containing beige coated tablet, the advice concerning missed tablets, as given in section ‘Management of missed tablets’, is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack.
The length of use depends on the severity of the symptoms of androgenisation and their response to treatment. In general, treatment should be carried out over several months. Time to relief of symptoms is at least 3 months. Acne and seborrhoea usually respond sooner than hirsutism. The need to continue treatment should be evaluated periodically by the treating physician. Should there be a recurrence of symptoms weeks or months after discontinuation of tablet-taking, treatment with DIANE-35 may be resumed. In case of a restart of DIANE-35 (following a 4 week or greater pill-free interval), the increased risk of venous thromboembolism should be considered (see section 4.4).
Oral use.
There have been no reports ofserious deleterious effects from overdose. Symptoms that may occur in case of taking an overdose of hormone-containing beige coated tablets are nausea, vomiting and withdrawal bleeding. The last may even occur in girls before their menarche, if they have accidentally taken the medicinal product.There are no antidotes and further treatment should be symptomatic.
3 years.
Store at or below 30°C.
Protect from light.
PVC/PE.EVOH.PE/PCTFE/aluminium blisters of 28 tablets.
No special requirements.
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