Azalia 75 microgram film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Desogestrel

Available from:

Gedeon Richter Plc

ATC code:

G03AC; G03AC09

INN (International Name):

Desogestrel

Dosage:

75 microgram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens; desogestrel

Authorization status:

Marketed

Authorization date:

2010-10-08

Patient Information leaflet

UTAS-3
PIL_180x250_180x500
-
2019.07.02.
180 × 500 /180 × 250 mm
/Page1
Azalia
IE
-
2023.02.24.
22940-1.6
-
v_01
-
P 209
P 214
Proc Black
Cronos Pro, (9 pt [9.45 pt])
-
-
WHAT IS IN THIS LEAFLET
1. What Azalia 75 microgram film-coated tablet (hereafter:
Azalia) is and what it is used for
2. What you need to know before you take Azalia
3. How to take Azalia
4. Possible side effects
5. How to store Azalia
6. Contents of the pack and other information
1. WHAT AZALIA IS AND WHAT IT IS USED FOR
Azalia is used to prevent pregnancy. Azalia contains a small
amount of one type of female sex hormone, the progestogen,
desogestrel. For this reason Azalia is called a progestogen-only
pill (POP) or mini-pill. Unlike the combined pill, the POP or
mini-pill does not contain an oestrogen hormone, but only a
progestogen.
Most POPs work primarily by preventing the sperm cells from
entering the womb but do not always prevent the egg cell
from ripening which is the primarily action of combined pills.
Azalia is distinct from most POPs in having a dose that in most
cases is high enough to prevent the egg cell from ripening.
As a result, Azalia provides high contraceptive efficacy.
In contrast to the combined pill, Azalia can be used by women
who do not tolerate oestrogens and by women who are breast
feeding. A disadvantage is that vaginal bleeding may occur at
irregular intervals during the use of Azalia. You also may not
have any bleeding at all.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AZALIA
Azalia like other hormonal contraceptives, does not protect
you against HIV infection (AIDS) and any other sexually
transmitted diseases.
DO NOT TAKE AZALIA
•
If you are allergic to desogestrel or any of the other
ingredients of this medicine (listed in section 6).
•
If you have thrombosis. Thrombosis is the formation of a
blood clot in a blood vessel, (e.g. of the legs (deep venous
thrombosis) or the lungs (pulmonary embolism).
•
If you have or have had jaundice (yellowing of the skin) or
severe liver disease and the function of your li

Summary of Product characteristics

Health Products Regulatory Authority
23 September 2021
CRN00C43V
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azalia 75 microgram film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 microgram desogestrel.
Excipient with known effect: 52.34 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White or almost white, round, biconvex film-coated tablets of about
5,5 mm in diameter, with a sign “D” on one side and “75”
on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Contraception
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To achieve contraceptive effectiveness, Azalia must be used as
directed (see 'How to take Azalia' and 'How to start Azalia').
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. 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).
_ _
_Paediatric population_
The safety and efficacy of Azalia in adolescents below 18 years has
not been established. No data are available.
Method of administration
Oral use.
HOW TO TAKE AZALIA
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.
HOW TO START AZALIA
_No preceding hormonal contraceptive use [in the past month]_
Health Products Regulatory Authority
23 September 2021
CRN00C43V
Page 2 of 9
Tablet-taking has to start on day 1 of