HANA

Posology To prevent pregnancy, Hana must be used as directed (see ‘How to take Hana’ and ‘How to start Hana’). 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 insufficiency.

3). Paediatric population The safety and efficacy of Hana in adolescents below 18 years has not been established. No data are available. Method of administration Oral use. How to take Hana Tablets must be taken every day at 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 of possible bleeding. When a pack of pills is finished, a new pack should be started directly the day after the previous one.

3 and should be advised to consult with her physician if in doubt. 4) can be managed and followed-up appropriately. No contraceptive use in the past month It is preferable to start tablet-taking on day 1 of the woman’s natural cycle (day 1 is the first day of menstrual bleeding).

However, it can be started on days 2-5, but then a barrier method is recommended for the first 7 days of tablet-taking. Following miscarriage or abortion It is recommended to start tablet-taking immediately or within 5 days after miscarriage or abortion.

In that case there is no need to use an additional method of contraception. Following childbirth The woman should start Hana any day between day 1 and day 21 after childbirth. When starting later, she should use a barrier method for the first 7 days of tablet- taking.

However, if unprotected intercourse has already occurred, the woman should take a pregnancy test or talk to her physician before the actual start of Hana. 6. Starting or resuming Hana after emergency contraception use If a woman wishes to start taking Hana after using emergency hormonal contraception, it is advisable to start tablet-taking on day 1 of the woman’s natural cycle.

If it is considered necessary to start sooner, or if Hana is being resumed after inconsistent use, the following advice should be noted: Levonorgestrel Hana can be started or restarted on the same day as emergency contraception containing levonorgestrel.

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Bleeding irregularity of some kind has been reported in up to 50% of women using desogestrel. Since desogestrel causes ovulation inhibition in close to 100% of cycles, 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, bleeding episodes tend to become less frequent.

Information, counselling, and a bleeding diary can improve the woman’s acceptance of the bleeding pattern. 5%) were acne, mood changes, breast pain, nausea and weight increase. The undesirable effects are listed in the table below by system organ class and frequency.

0 Breast discharge may occur during use of Hana. On rare occasions, ectopic pregnancies have been reported. Hypersensitivity reactions (including angioedema and anaphylaxis) have also 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Excluding pregnancy Excluding pregnancy before starting Hana Women who have recently been pregnantWomen who have not recently been pregnant Following childbirth Following miscarriage, abortion or ectopic pregnancy Pregnancy can reasonably be excluded if the woman • has not had unprotected sex since the start of her last menstrual period or • has been correctly and consistently using a reliable method of contraception (including condoms where those have been used correctly for every episode of sexual intercourse) or • has had unprotected sex but only between day 1 and day 5 of her menstrual cycle.

Pregnancy can reasonably be excluded if the woman • has not had unprotected sex since childbirth or • has had unprotected sex but less than 21 days after childbirth or • is fully breastfeeding, amenorrheic and less than 6 months postpartum.

Pregnancy can reasonably be excluded if the woman • has not had unprotected sex since miscarriage, abortion or ectopic pregnancy or • has had unprotected sex but less than 5 days after miscarriage, abortion or ectopic pregnancy. The woman should use a reliable method of contraception (current contraceptive or a barrier method) until the first day of her next period before starting Hana.

She should be advised that if her menstrual period is already late or does not come when she expects it, she may be pregnant and she should do a pregnancy test (at least 3 weeks after the last episode of unprotected sexual intercourse) or see a physician.

Provided the pregnancy test is negative she can start Hana on the first day of her next period. If, in the meantime, her menstrual period comes, she can start Hana on the first day of her period. Excluding pregnancy before starting a new pack of Hana.

Before starting a new pack of Hana, a woman should be reasonably certain that she is not pregnant. If in doubt, particularly if she has not been using Hana correctly and consistently, she should be advised that there is a chance that she may be pregnant and she should do a pregnancy test at least 3 weeks after the last episode of unprotected intercourse.

Hana must not be used if any of the conditions listed below are present. • Known or suspected sex-steroid sensitive malignancies. • Active venous thromboembolic disorder. • Presence or history of severe hepatic disease as long as liver function values have not returned to normal.

• Undiagnosed vaginal bleeding. 1.