AIZEA

Posology To achieve contraceptive effectiveness, AIZEA must be used as directed (see “How to take AIZEA” and “How to start AIZEA”). Special populations Renal impairment No clinical studies have been performed in patients with renal impairment.

Hepatic impairment No clinical studies have been performed in patients with hepatic impairment. ). Paediatric population The safety and efficacy of AIZEA in adolescents below 18 years has not yet been established. No data are available.

Method of administration Oral use. How to take AIZEA Tablets must be taken every day at about the same time so that the interval between two tablets is always 24 hours. The first tablet should be taken on the first day of menstrual bleeding.

Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one. How to start AIZEA No preceding hormonal contraceptive use [in the past month] Tablet-taking has to start on day 1 of the woman's natural cycle (day 1 is the first day of her menstrual bleeding).

Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet-taking. Following first-trimester abortion After first-trimester abortion it is recommended to start immediately.

In that case there is no need to use an additional method of contraception. Following delivery or second-trimester abortion The woman should be advised to start any day between day 21 to 28 after delivery or second- trimester abortion.

When starting later, she should be advised to additionally use a barrier method until completion of the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of AIZEA use or the woman has to wait for her first menstrual period.

6. How to start AIZEA when changing from other contraceptive methods Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch). The woman should start AIZEA preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC or on the day of removal of her vaginal ring or transdermal patch.

In these cases, the use of an additional contraceptive is not necessary. Not all contraceptive methods may be available in all EU countries. The woman may also start at the latest on the day following the usual tablet-free, patch-free, ring-free, or placebo tablet interval of her previous combined hormonal contraceptive, but during the first 7 days of tablet-taking an additional barrier method is recommended.

Changing from a progestogen-only-method (minipill, injection, implant or from a progestogen-releasing intrauterine system [IUS]). 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).

Management of missed tablets Contraceptive protection may be reduced if more than 36 hours have elapsed between two tablets. If the user is less than 12 hours late in taking any tablet, the missed tablet should be taken as soon as it is remembered and the next tablet should be taken at the usual time.

If she is more than 12 hours late, she should use an additional method of contraception for the next 7 days. If tablets were missed in the first week and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered.

Advice in case of gastrointestinal disturbances In case of severe gastro-intestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet-taking, absorption may not be complete.

2 is applicable. Treatment surveillance Before prescription, a thorough case history should be taken and a thorough gynaecological examination is recommended to exclude pregnancy. Bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated before prescription.

The interval between check-ups depends on the circumstances in each individual case. 4), the control examinations should be timed accordingly. Despite the fact that AIZEA is taken regularly, bleeding disturbances may occur. If bleeding is very frequent and irregular, another contraceptive method should be considered.

If the symptoms persist, an organic cause should be ruled out. Management of amenorrhoea during treatment depends on whether or not the tablets have been taken in accordance with the instructions and may include a pregnancy test. The treatment should be stopped if a pregnancy occurs.

Women should be advised that AIZEA does not protect against HIV (AIDS) and other sexually transmitted diseases.

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using desogestrel. Since desogestrel causes ovulation inhibition close to 100%, in contrast to other progestogen-only pills, irregular bleeding is more common than with other progestogen-only pills.

In 20 - 30% of the women, bleeding may become more frequent, whereas in another 20% bleeding may become less frequent or totally absent. Vaginal bleeding may also be of longer duration. After a couple of months of treatment, bleedings tend to become less frequent.

Information, counselling, and a bleeding diary can improve the woman's acceptance of the bleeding pattern. 5%) reported other undesirable effects in the clinical trials with using desogestrel were acne, mood changes, breast pain, nausea and weight increase.

The undesirable effects are listed in the table below. All undesirable effects are listed by system organ class frequency; common (≥1/100), uncommon (1/1,000 to 1/100), rare (<1/1,000) and not known (cannot be estimated from the available data).

0 Breast discharge may occur during use of using AIZEA. On rare occasions, ectopic pregnancies have been reported . 4). In women using (combined) oral contraceptives a number of (serious) undesirable effects have been reported. g. 4. 5).

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

United Kingdom:

Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

If any of the conditions/risk factors mentioned below is present, the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start with AIZEA.

In the event of aggravation, exacerbation, or first appearance of any of these conditions, the woman should contact her physician. The physician should then decide on whether the use of AIZEA should be discontinued. The risk for breast cancer increases in general with increasing age.

During use of combined oral contraceptives (COCs) the risk of having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of COC use and is not related to the duration of use, but to the age of the woman when using the COC.

The expected number of cases diagnosed per 10 000 women who use COCs (up to 10 years after stopping) relative to never users over the same period has been calculated for the respective age groups and is presented in the table below.

7 44 30-34 years 110 100 35-39 years 180 160 40-44 years 260 230 The risk in users of progestogen-only contraceptives (POCs), such as AIZEA, is possibly of similar magnitude as that associated with COCs. However, for POCs the evidence is less conclusive.

Compared to the risk of getting breast cancer ever in life, the increased risk associated with COCs is low. The cases of breast cancer diagnosed in COC users tend to be less advanced than in those who have not used COCs. The increased risk in COC users may be due to an earlier diagnosis, biological effects of the pill or a combination of both.

Since a biological effect of progestogens on liver cancer cannot be excluded an individual benefit/risk assessment should be made in women with liver cancer. When acute or chronic disturbances of liver function occur the woman should be referred to a specialist for examination and advice.

Epidemiological investigations have associated the use of COCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for desogestrel used as a contraceptive in the absence of an oestrogenic component is unknown, AIZEA should be discontinued in the event of a thrombosis.

Discontinuation of AIZEA should also be considered in case of long- term immobilisation due to surgery or illness. Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence. Although progestogens may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using progestogen-only pills.

However, diabetic patients should be carefully observed during the first months of use. If a sustained hypertension develops during the use of AIZEA, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the discontinuation of AIZEA should be considered.

Treatment with AIZEA leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase. It is as yet unknown whether the decrease has any clinically relevant effect on bone mineral density. The protection with traditional progestogen-only pills against ectopic pregnancies is not as good as with combined oral contraceptives, which has been associated with the frequent occurrence of ovulations during the use of progestogen-only pills.

Despite the fact that AIZEA consistently inhibits ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum.

Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking AIZEA. The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of progestogens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; (hereditary) angioedema.

8). Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating treatment.

5). Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency, or glucose-galactose malabsorption should not taken this medicine. g. corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis.

The changes generally remain within the normal range. To what extent this also applies to progestogen-only contraceptives is not known.

• Active venous thromboembolic disorder. • Presence or history of severe hepatic disease as long as liver function values have not returned to normal. • Known or suspected sex-steroid sensitive malignancies. Undiagnosed vaginal bleeding.

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