Patient Information Leaflet

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

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, 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

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 it work?
Azalia contains a small amount of a female sex hormone called a progestogen, known as desogestrel. For this reason, Azalia is referred to 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 womb, but they do not always prevent the maturation of egg cells, which is the main mechanism of action of combined oral contraceptives.
Azalia differs from other mini-pills in that its dose is sufficient in most cases to prevent the maturation of eggs.
As a result, Azalia has a high contraceptive efficacy.
Unlike combined oral contraceptives, Azalia can be used by women who do not tolerate oestrogens and by women who are breastfeeding. 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 the medicine Azalia

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

If you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
If you currently have 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 you currently have or have previously had a serious liver disease and liver function (as determined by blood laboratory tests) has not returned to normal.
If you currently have a cancer dependent on certain sex hormones (progestagens), such as some types of breast cancer.
If you currently have unexplained vaginal bleeding.

If any of the above conditions occur for the first time while taking Azalia, contact your doctor immediately.

Warnings and precautions
Before starting to take Azalia, discuss this with your doctor or pharmacist.
If you are taking Azalia and any of the conditions listed below apply to you, close monitoring is recommended.
Your doctor will explain how to proceed. Before starting Azalia, inform your doctor:

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

Breast cancer
You should regularly examine your breasts and contact your doctor immediately if you feel 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 use of oral contraceptives, the risk is the same as in women who have never used them. Breast cancer is rare in women under 40 years of age, but the risk increases with age. Therefore, the number of diagnosed cases of breast cancer increases the older the woman is when she continues taking oral contraceptives.
The duration of oral contraceptive use is of lesser importance.

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Among 10,000 women who used oral contraceptives for 5 years and stopped taking the medicine before age 20, fewer than 1 additional case of breast cancer was diagnosed within 10 years after stopping, compared to 4 cases diagnosed in this age group. Similarly, among 10,000 women who used oral contraceptives for 5 years and stopped before age 30, there were 5 additional cases of breast cancer compared to over 44 cases normally diagnosed. Among 10,000 women who used oral contraceptives for 5 years and stopped before age 40, there were 20 additional cases compared to over 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 the risk in women using combined oral contraceptives (containing estrogens), but the data are not conclusive.
In women using oral contraceptives, detected breast cancer appears to be generally less advanced than in women who did not use oral contraceptives.
It is not known whether this difference is caused by oral contraceptive use. The earlier diagnosis may be due to the fact that women using hormonal contraception undergo more frequent medical examinations.

Thrombosis
Contact your doctor immediately if you notice any potential symptoms of thrombosis (see also "Contact your doctor immediately").
Thrombosis is the formation of blood clots that may block blood vessels.
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." It may result in a life-threatening condition that can lead to death. Deep vein thrombosis is rare and may occur regardless of whether you are taking oral contraceptives or not. It may also occur during pregnancy.
The risk is higher in women taking oral contraceptives than in women who do not take 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
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
You should also inform other doctors, dentists, or pharmacists who prescribe medicines for you that you are taking Azalia.
Your doctor will inform you whether you need to use an additional method of contraception (e.g. condom) and, if so, for how long, and whether dosage adjustments of other medicines are needed.

Some medicines:

may affect the blood concentration of Azalia,
may reduce its 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);
tuberculosis (e.g. rifampicin, rifabutin);
HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz);
hepatitis C virus infection (e.g. boceprevir, telaprevir);
other infectious diseases (e.g. griseofulvin);
high blood pressure in the pulmonary arteries (bosentan);
depressive mood 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 you are taking medicines or herbal products that may reduce the effectiveness of Azalia, you should also use an additional barrier method of contraception. 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 advise 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 you are pregnant or breastfeeding, suspect you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Do not use Azalia if you are pregnant or suspect you may be pregnant.
Azalia may be used during breastfeeding. It does not appear to affect the amount or quality of breast milk produced. However, a decrease in milk production has occasionally been reported during use of Azalia. Small amounts of the active substance in Azalia pass into breast milk. The health effects in infants breastfed for 7 months by mothers taking desogestrel were evaluated until the children reached 2.5 years of age. No effects on growth and development were observed.
Contact your doctor if you are breastfeeding and wish to use Azalia.

Driving and using machines
Azalia has no effect on the ability to drive or operate machinery.

Azalia contains lactose
Patients with lactose intolerance should be aware that Azalia tablets contain 52.34 mg of lactose (as monohydrate lactose).
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

Regular check-ups
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While using Azalia, your doctor will ask you to attend regular check-up examinations. The frequency and type of check-ups will depend on your health status.

Contact your doctor immediately if:

you experience severe pain or swelling in one of your legs, chest pain, shortness of breath, or unusual cough, especially coughing up blood (indicating possible thrombosis);
you experience sudden, severe stomach pain or yellowing of the skin (indicating possible liver disorders);
you notice a lump in your breast (indicating possible breast cancer);
you experience sudden or severe pain in the lower abdomen or stomach area (indicating possible ectopic pregnancy, a pregnancy developing outside the uterus);
you are going to be immobilized or undergo surgery (consult your doctor at least four weeks in advance);
you experience unusual, heavy vaginal bleeding;
you suspect you are pregnant.

3. How to use Azalia

This medicine should always be taken exactly as directed 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 tablet
intake begins on Wednesday, take the tablet from the top row marked "Mie" (Mie – Wednesday; see
"Translation of abbreviations for days of the week appearing next to each tablet on the immediate
packaging" at the end of the leaflet).
Continue taking one tablet daily until the blister is finished, always following the direction of the arrows.
If a patient starts taking tablets on 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 method 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 a 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; however, in such cases,
additional contraceptive methods (mechanical methods) must be used for the first 7 days of tablet
intake.

Switching from a combined oral contraceptive, vaginal ring, or transdermal patch
You may start taking Azalia the day after taking the last active tablet of your current contraceptive
pack, or on the day of removal of the vaginal ring or transdermal patch (this means no break between
the use of the tablet, vaginal ring, or patch and starting Azalia).
If your current contraceptive pack also contains inactive (placebo) tablets, you may start Azalia the day
after taking the last active tablet (if in doubt about which tablet is meant, consult your doctor or
pharmacist). If the above instructions are followed, additional contraceptive methods are not required.
At the latest, Azalia may be started the day after the break from tablets, vaginal ring, patch, or after
taking the last placebo tablet of your current contraceptive. In this case, additional contraceptive methods
(mechanical methods) must be used for the first 7 days of tablet intake.

Switching from a progestogen-only pill (mini-pill)
You may start taking Azalia on any day, immediately after stopping the previous progestogen-only
pill. No additional contraceptive methods are required.

Switching from an injection, implant, or intrauterine system releasing progestogen (IUD)
Start taking Azalia on the day when the next injection is due, or on the day of removal of the implant or
intrauterine system. No additional contraceptive methods are required.

After childbirth
Azalia may be started between 21 and 28 days after childbirth. If treatment is started later, an additional
contraceptive method (mechanical method) must be used during the first cycle for the first 7 days of
tablet intake.
However, if sexual intercourse has occurred, pregnancy must be ruled out before starting Azalia.
Additional information for breastfeeding women can be found under the section "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 delay in taking the tablet is less than 12 hours
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 delay in taking the tablet is more than 12 hours
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 take previously missed tablets). In this case, there is a possibility of
pregnancy.
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 preceding the missed tablets, pregnancy may have occurred. Consult your doctor for advice.

If vomiting, diarrhoea, or activated charcoal occurs
If vomiting or acute diarrhoea occurs, or activated charcoal is taken within 3–4 hours after taking the
tablet, there is a risk that the active ingredient has not been fully absorbed. Follow the instructions for
missed tablets.

Overdose of Azalia
No serious harmful effects have been observed after taking multiple Azalia tablets 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 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicinal product, this medicine may cause adverse effects, although not everyone will experience 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.
Seek immediate medical attention 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 pads. 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 effectiveness of Azalia is reduced. Usually, no action is required and you should continue taking Azalia as directed. However, if bleeding is heavy or prolonged, consult your doctor.

Patients using desogestrel have reported the following other adverse effects:

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

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

Uncommon (may occur in up to 1 in 100 users):
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vaginal infections,
difficulty wearing contact lenses,
vomiting,
hair loss,
painful menstruation,
ovarian cysts,
fatigue.

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

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

In addition to the adverse effects listed above, breast discharge may occur.

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 of the 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 this medicine.

5. How to store the medicine Azalia

Store in the original packaging to protect from light and moisture.
There are no special requirements regarding the storage temperature of the medicinal product.
Keep the medicine out of 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Azalia contains
The active substance is desogestrel. Each tablet contains 75 micrograms of desogestrel.
Other components are:
Tablet core:
Monohydrate lactose,
Potato starch,
Povidone K 30,
Colloidal anhydrous silica,
Stearic acid,
All-rac-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 film-coated tablets with a diameter of approximately 5.5 mm,
marked with the letter "D" on one side and "75" on the other side.
Azalia 75 micrograms, film-coated tablets are packed in PVC/PVDC/Aluminium blisters.
Each blister is placed in an aluminium laminate sachet.
Sachets with blisters are packed into a cardboard box containing the patient leaflet and a cardboard sachet
for storage.
Pack sizes: 28 film-coated tablets, 84 film-coated tablets (3 blisters containing 28 tablets each).

This medicinal product is authorised for sale in the following European Economic Area member states 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

For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Spain, 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 Spain, country of export: 675152.7
675158.9

Parallel import authorisation number: 447/22

Translation of weekday abbreviations printed on each tablet in the immediate packaging:
Lun - Monday
Mar - Tuesday
Mie - Wednesday
Jue - Thursday
Vie - Friday
Sab - Saturday
Dom - Sunday