Package leaflet: Information for the user

Warning!
Keep this leaflet. Information on the immediate packaging is in a foreign language.
Azalia
75 micrograms, coated tablets
Desogestrel
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

What Azalia is and what it is used for
Important information before taking Azalia
How to take Azalia
Possible side effects
How to store Azalia
Contents of the pack and other information

1. What Azalia is and what it is used for

Azalia is used for contraception (to prevent pregnancy).
How does Azalia work?
Azalia contains a small amount of one type of female sex hormone, a progestogen called desogestrel. Therefore, Azalia is known as a progestogen-only pill or a "mini-pill".
Unlike combined oral contraceptives, progestogen-only pills or mini-pills do not contain oestrogen; they contain only a progestogen.
Most progestogen-only pills or mini-pills primarily work by preventing sperm from entering the uterus, but they do not always prevent the maturation of the egg cells, which is the main mechanism of combined oral contraceptives.
Azalia differs from other mini-pills in that its dose is sufficient in most cases to prevent ovulation (the release of an egg).
As a result, Azalia has a high contraceptive efficacy.
Unlike combined oral contraceptives, Azalia can be used by women who cannot tolerate oestrogens and by breastfeeding women. A disadvantage of using Azalia is the occurrence of irregular vaginal bleeding during tablet intake.
Bleeding may also not occur at all.

2. Important information before using Azalia

The Azalia medication does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
When not to use Azalia
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Do not use Azalia in any of the cases listed below. Before starting Azalia, inform your doctor if any of the following conditions apply.
Your doctor may recommend using a non-hormonal method of birth control.

If the patient is allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
If the patient has thrombosis. Thrombosis is the formation of blood clots in blood vessels. These clots may lead to blockage of blood vessels {e.g. in the legs (deep vein thrombosis), lungs (pulmonary embolism), heart (heart attack), or brain (stroke)}.
If the patient has or has previously had severe liver disease and liver function (determined by blood laboratory tests) has not returned to normal.
If the patient has a tumour dependent on certain sex hormones (progestagens), such as some types of breast cancer.
If the patient has unexplained vaginal bleeding.

If any of the above conditions occur for the first time during treatment with Azalia,
contact your doctor immediately.
Warnings and precautions
Before starting to take Azalia, discuss this with your doctor or pharmacist.
If Azalia is used in any of the cases listed below, close monitoring is recommended.
Your doctor will explain how to proceed. Before starting Azalia, inform your doctor:

if the patient has or has previously had breast cancer,
if the patient has liver cancer,
if the patient has or has previously had venous thrombosis (blood clot),
if the patient has diabetes,
if the patient has epilepsy (see section 2 “Azalia with other medicines”),
if the patient has tuberculosis (see section 2 “Azalia with other medicines”),
if the patient has high blood pressure,
if the patient has or has previously had chloasma (yellowish-brown pigmentation patches on the skin, especially on the face); in such a case, avoid excessive exposure to sunlight or ultraviolet radiation,
if the patient has depression or mood changes.

Breast cancer
Regularly examine your breasts and contact your doctor immediately if you notice any lump.
Breast cancer occurs slightly more frequently in women using oral contraceptives than in women of the same age who do not use them.
After stopping oral contraceptives, the risk gradually decreases.
Ten years after stopping the pill, the risk is the same as in women who have never used oral contraceptives. Breast cancer rarely occurs in women under 40 years of age, but the risk increases with the patient's age. Therefore, the number of diagnosed breast cancer cases increases with the patient's age at which contraceptive pills are still taken.
The duration of oral contraceptive use has less significance.
Among 10,000 women who used oral contraceptives for 5 years and stopped taking the pill before age 20, fewer than 1 additional case of breast cancer will be diagnosed within 10 years after stopping, compared to 4 cases normally diagnosed in this age group. Similarly, among 10,000 women who used oral contraceptives for 5 years and stopped before age 30, there are 5 additional cases above the 44 cases normally diagnosed. Among 10,000 women who used oral contraceptives for 5 years and stopped before age 40, there are 20 additional cases above the 160 cases normally diagnosed.
It is believed that the risk of breast cancer in women using progestagen-only pills, such as Azalia, is similar to that in women using combined pills (containing estrogens as well), but data are not conclusive.
It appears that breast cancer detected in women using oral contraceptives is usually less advanced than in women who did not use oral contraceptives.
It is unknown whether this difference is caused by oral contraceptive use. The reason for earlier detection may be that women using contraceptives are examined more frequently.
Thrombosis
Contact your doctor immediately if potential symptoms of thrombosis are observed (see also “Contact your doctor immediately”).
Thrombosis is the formation of blood clots that may block a blood vessel.
Thrombosis sometimes occurs in the deep veins of the lower limbs (deep vein thrombosis). If a clot detaches from the vein where it formed, it may travel to the lungs and block arteries.
This condition is called “pulmonary embolism.” As a result, a life-threatening condition may occur, which can lead to death. Deep vein thrombosis is rare and may occur regardless of whether oral contraceptives are used or not. It may also occur during pregnancy.
The risk is higher in women using oral contraceptives than in women who do not use them. The risk with progestagen-only pills, such as Azalia, is likely lower than with combined oral contraceptives (containing estrogens).
Psychiatric disorders:
Some women using hormonal contraceptives, including Azalia, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.
Children and adolescents
The safety and efficacy of desogestrel in adolescents under 18 years of age have not been established. Data are not available.
Azalia with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
The patient should also inform other doctors or dentists (or pharmacist) who prescribe other medicines that she is using Azalia.
Your doctor will inform you whether additional contraceptive methods (e.g. condoms) are needed, and if so, for how long, and whether dosage adjustments of other medicines are required.
Some medicines:

may affect the blood concentration of Azalia,
may reduce effectiveness in preventing pregnancy,
may cause unexpected bleeding.

These include medicines used to treat:

epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate, and phenobarbital);

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tuberculosis (e.g. rifampicin, rifabutin);
HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz);
hepatitis C virus infection (e.g. boceprevir, telaprevir);
or other infectious diseases (e.g. griseofulvin);
high blood pressure in the pulmonary blood vessels (bosentan);
depressive disorders (herbal medicine - St. John's wort);
certain bacterial infections (e.g. clarithromycin, erythromycin);
fungal infections (e.g. ketoconazole, itraconazole, fluconazole);
high blood pressure (hypertension), angina pectoris, or certain heart rhythm disorders (e.g. diltiazem).

If the patient uses medicines or herbal products that may reduce the effectiveness of Azalia, an additional barrier method of contraception should also be used. Since the effect of another medicine on Azalia may last up to 28 days after discontinuation, prolonged use of an additional barrier method of contraception is necessary. Your doctor may inform you whether additional contraceptive measures are needed and, if so, for how long.
Azalia may also affect the action of other medicines, increasing their effect (e.g. medicines containing cyclosporine) or reducing their effect (e.g. lamotrigine).
Before taking any medicine, consult your doctor or pharmacist.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use Azalia if the patient is pregnant or suspects she may be pregnant.
Azalia can be used during breastfeeding. It does not appear to affect the production or quality of breast milk. However, a decrease in milk production has occasionally occurred during use of Azalia. Small amounts of the active substance in Azalia pass into breast milk. The health effects in children breastfed for 7 months by mothers using desogestrel were evaluated up to 2.5 years of age. No effects on growth and development were observed.
Contact your doctor if a woman is breastfeeding and wishes to use Azalia.
Driving and operating machinery
Azalia has no effect on the ability to drive or operate machinery.
Azalia contains monohydrate lactose
Patients with lactose intolerance should be aware that Azalia tablets contain 52.34 mg of lactose (in the form of monohydrate lactose).
If intolerance to certain sugars has previously been diagnosed, the patient should contact their doctor before taking this medicine.
Regular check-ups
While using Azalia, your doctor will ask you to attend regular check-ups. The frequency and type of check-ups will depend on your health status.
Contact your doctor immediately:

if the patient experiences severe pain or swelling in either lower limb, unexplained chest pain, shortness of breath, or unusual cough, especially coughing up blood (indicating possible thrombosis);
if the patient experiences sudden, severe stomach pain or yellowing of the skin (indicating possible liver disorders);
if the patient detects a lump in the breast (indicating possible breast cancer);

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if the patient experiences sudden or severe pain in the lower abdomen or stomach area (indicating possible ectopic pregnancy, a pregnancy developing outside the uterus);
if the patient is to be immobilized or undergo surgery (consult your doctor at least four weeks in advance);
if the patient experiences unusual, heavy vaginal bleeding,
if the patient suspects she is pregnant.

3. How to use Azalia

This medicine should always be taken exactly as prescribed by your doctor.
If in doubt, consult your doctor or pharmacist.
Each Azalia blister pack contains 28 tablets. Arrows and days of the week are printed on the front of the
blister to help ensure correct use of the medicine.
It is recommended to take the tablet at the same time every day. Swallow the tablet whole with water.
Each time a new Azalia blister pack is started, take the tablet from the top row. For example, if treatment
begins on a Wednesday, take the tablet from the top row marked "Qua" (Qua – Wednesday; see "Translation
of abbreviations for days of the week appearing next to each tablet on the immediate packaging" at the
end of this leaflet).
Continue taking one tablet daily until the blister is finished, always following the direction indicated by
the arrows. If treatment starts on a Monday, the end of the arrow on the blister will be empty. However,
in all other cases, before starting a new blister, take the tablets located in the upper left corner of that
blister.
This makes it easy to check whether a tablet has been taken on any given day. Bleeding may occur during
treatment with Azalia (see "Possible side effects"), but continue taking the tablets as usual.
After finishing one blister, start the next pack the following day – without interruption and without
waiting for bleeding to occur.

Starting the first pack of Azalia
If you are not currently using (or have not used in the last month) hormonal contraceptives
Wait for the onset of menstrual bleeding.
Take the first tablet of Azalia on the first day of your menstrual period.
There is no need to use additional contraceptive methods.
You may also start taking the tablet between day 2 and day 5 of the cycle. In such cases, however,
you must use additional contraceptive methods (barrier methods) for the first 7 days of tablet intake.

Switching from a combined oral contraceptive pill, vaginal ring, or transdermal patch
You may start taking Azalia the day after taking the last active tablet of your current contraceptive
package, or on the day of removal of the vaginal ring or transdermal patch (meaning no gap in use of
the pill, vaginal ring, or patch).
If your current contraceptive package includes placebo tablets, you may start Azalia the day after
taking the last active tablet (if in doubt about which tablet this refers to, consult your doctor or
pharmacist). If the above guidelines are followed, additional contraceptive methods are not required.
At the latest, you may start Azalia on the day following the break from tablets, vaginal ring, patch, or
after taking the last placebo tablet of your current contraceptive. In this case, use additional
contraceptive methods (barrier methods) for the first 7 days of tablet intake.

Switching from a progestogen-only pill (mini-pill)
You may start Azalia on any day, immediately after stopping the previous progestogen-only pill.
There is no need to use additional contraceptive methods.

Switching from an injection, implant, or intrauterine device (IUD) releasing progestogen
Start taking Azalia on the day when the next injection is due, or on the day of removal of the implant
or intrauterine system. There is no need to use additional contraceptive methods.

After childbirth
You may start taking Azalia between day 21 and day 28 after delivery. If you start later, use an
additional contraceptive method (barrier methods) for the first 7 days of tablet intake during the first
cycle.
However, if you have had sexual intercourse, pregnancy must be ruled out before starting Azalia.
Additional information for breastfeeding women is available under the subsection "Pregnancy and
breastfeeding" in section 2. Consult your doctor for advice.

After premature delivery or miscarriage
Consult your doctor.

Missed dose of Azalia
If the tablet is taken less than 12 hours late
Take the missed tablet as soon as you remember, and take the next tablet at the usual time. The
contraceptive effect of Azalia remains intact.

If the tablet is taken more than 12 hours late
Take the missed tablet as soon as you remember, and take the next tablet at the usual time. This may
mean taking two tablets on the same day. This is not harmful. (If more than one tablet has been
missed, there is no need to make up for the earlier missed tablets.) In this case, there is a possibility
of becoming pregnant.
Continue taking the tablets as usual and use an additional contraceptive method, such as a
condom, for the next 7 days.
The more consecutive tablets missed, the greater the risk of reduced contraceptive effectiveness.

If one or more tablets were missed during the first week of use and sexual intercourse occurred in
the week before the missed tablets, there is a possibility of pregnancy. Consult your doctor for
advice.

In case of vomiting, diarrhoea, or use of medicinal charcoal
If vomiting or acute diarrhoea occurs, or medicinal charcoal is taken within 3–4 hours after taking
the tablet, there is a risk that the active substance has not been fully absorbed. Follow the advice for
missed tablets.

Taking more than the recommended dose of Azalia
No severe harmful effects have been observed after taking multiple tablets of Azalia at the same
time. Symptoms such as nausea, vomiting, and, in young girls, slight vaginal bleeding may occur.
For further information, consult your doctor.

Stopping use of Azalia
You may stop taking Azalia at any time.
From the day you stop taking it, you are no longer protected against pregnancy.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Serious adverse effects associated with the use of Azalia are described in section 2, "Important information before taking Azalia". Please read these sections for additional information and consult your doctor if necessary.
You should immediately contact your doctor if allergic reactions (hypersensitivity) occur, including swelling of the face, lips, tongue and (or) throat causing difficulty in breathing or swallowing (angioedema and (or) anaphylaxis) (the frequency of this adverse effect cannot be determined from available data).

Irregular vaginal bleeding may occur during treatment with Azalia. This may range from slight spotting, not requiring the use of sanitary protection, to heavier bleeding resembling a light menstrual period, requiring the use of sanitary protection. Bleeding may also not occur at all. These are common adverse effects (may occur in up to 1 in 10 users). Irregular bleeding does not mean that the contraceptive effect of Azalia is reduced. Usually, no action is required and continued use of Azalia is sufficient. However, if bleeding is heavy or prolonged, medical advice should be sought.

The following other adverse effects have been reported by users of desogestrel:

Common (may occur in up to 1 in 10 users):

mood changes,
decreased libido (loss of sexual drive),
depression,
headache,
nausea,
acne,
breast pain,
weight gain.

Uncommon (may occur in up to 1 in 100 users):

vaginal infections,
difficulty wearing contact lenses,
vomiting,
hair loss,
painful menstruation,
ovarian cyst,
fatigue.

Rare (may occur in up to 1 in 1000 users):

rash,
urticaria (hives),
painful red or purple skin nodules (erythema nodosum) (these are skin disorders).

In addition to the above, milk secretion or discharge from the breasts may occur.
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Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Azalia

Keep in the original packaging to protect from light and moisture.
No special storage temperature requirements.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Azalia contains
The active substance is desogestrel. Each tablet contains 75 micrograms of desogestrel.
The other ingredients are:
Tablet core:
Monohydrate lactose,
Potato starch,
Povidone K 30,
Colloidal anhydrous silica,
Stearic acid,
α-Tocopherol.
Tablet coating:
Polyvinyl alcohol,
Titanium dioxide (E 171),
Macrogol 3000,
Talc.

What Azalia looks like and contents of the pack
White or almost white, round, biconvex coated tablets with a diameter of approximately 5.5 mm,
marked with the letter “D” on one side and “75” on the other.
Azalia 75 micrograms, coated tablets, are packed in an aluminium-PVC/PVDC foil blister.
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Each blister is placed in an aluminium laminate sachet.
Sachets containing blisters are packed into a cardboard box with a patient leaflet and a cardboard sachet for storage.
Pack sizes: 28 coated tablets, 84 coated tablets (3 blisters of 28 tablets each).
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Portugal, country of export:
Gedeon Richter Plc., Gyömroi út 19-21., 1103, Budapest, Hungary
Manufacturer:
Gedeon Richter Plc., Gyömroi út 19-21., 1103, Budapest, Hungary
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Portugal, country of export: 5317474
Parallel import authorisation number: 132/23
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Azalia 75 microgram filmtabletta, Hungary
Azalia 75 microgram potahovaná tableta, Czech Republic
Azalia 75 mikrogram filmom obalené tablety, Slovakia
Azalia, Poland
Azalia 75 microgram plėvele dengtos tabletės, Lithuania
Azalia 75 mikrogram apvalkotā tablete, Latvia
Tangolita, Denmark
Азалия 75 мигрограма филмирани таблетки, Bulgaria
Azalia 75 micrograme comprimate filmate, Romania

Translation of abbreviations for days of the week printed on each tablet in the immediate packaging:
Seg - Monday
Ter - Tuesday
Qua - Wednesday
Qui - Thursday
Sex - Friday
Sab - Saturday
Dom - Sunday
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