Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Gedeon Richter Plc, Gyömroi út 19-21, H-1103, Budapest, Hungary
Contraception
To achieve contraceptive effectiveness, Azalia must be used as directed (see ‘How to take Azalia’ and ‘How to start Azalia’).
No clinical studies have been performed in patients with renal impairment.
No clinical studies have been performed in patients with hepatic insufficiency. Since the metabolism of steroid hormones might be impaired in patients with severe hepatic disease, the use of Azalia in these women is not indicated as long as liver function values have not returned to normal (see section 4.3).
The safety and efficacy of Azalia in adolescents below 18 years has not been established. No data are available.
Oral use.
Tablets must be taken every day at about the same time so that the interval between two tablets always is 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.
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.
After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method of contraception.
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 Azalia use or the woman has to wait for her first menstrual period.
For additional information for breastfeeding women see section 4.6.
The woman should start Azalia 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.
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).
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 after initiation of Azalia and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered.
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. In such an event, the advice concerning missed tablets, as given in subsection “Management of missed tablets” is applicable.
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. If the prescribed product may conceivably influence latent or manifest disease (see section 4.4), the control examinations should be timed accordingly.
Despite the fact that Azalia 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 Azalia does not protect against HIV (AIDS) and other sexually transmitted diseases.
There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and further treatment should be symptomatic.
24 months.
Store in the original package in order to protect from light and moisture.
This medicinal product does not require any special temperature storage conditions.
Azalia film-coated tablets are packaged in a blister made of transparent, hard PVC/PVDC-Aluminium foil. Each blister is placed in a laminated aluminium sachet. The blisters in the sachets are packed into a folded carton box with a patient leaflet and etui storing bag.
Pack sizes: 1x28, 3x28, 6x28, 13x28 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
