Azalia

Package leaflet: Information for the user

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Azalia is and what it is used for
2. Important information before taking 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 for contraception (to prevent pregnancy).
How does the medicine 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 "mini-pill". Unlike combined oral contraceptives, progestogen-only pills or mini-pills do not contain oestrogen, only 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 ova (eggs), 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 use. Bleeding may also not occur at all.

2. Important information before using Azalia

Azalia does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

When not to use Azalia

Do not use Azalia in any of the following cases. Before starting Azalia, inform your doctor if any of the following 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), in the lungs (pulmonary embolism), in the heart (myocardial infarction), or in the brain (stroke)).
• If the patient has or has had severe liver disease and liver function (as determined by blood laboratory tests) has not returned to normal.
• If the patient has a tumour dependent on certain sex hormones (progestagens), such as certain types of breast cancer.
• If the patient has vaginal bleeding of unknown origin.

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 you use Azalia 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 had breast cancer;
• if the patient has liver cancer;
• if the patient has or has 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 had 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 the patient has depression or mood changes.

Breast cancer

Examine your breasts regularly and contact your doctor immediately if you feel any lump in your breasts.

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 is rare in women under 40 years of age, but the risk increases with the patient's age. Therefore, the number of diagnosed cases of breast cancer increases the older the patient is when continuing to take oral contraceptives. The duration of use of oral contraceptives is of lesser importance.

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 diagnosed in this age group. Similarly, among 10,000 women who used oral contraceptives for 5 years and stopped taking the pill before age 30, there are 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 taking the pill before age 40, there are 20 additional cases compared to over 160 cases normally diagnosed.

It is believed that the risk of breast cancer in women using progestogen-only pills, such as Azalia, is similar to the risk in women using combined pills (containing estrogens), but the 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 not known whether this difference is caused by the use of oral contraceptives. The reason for earlier diagnosis may be that women using contraceptives are examined more frequently.

Thrombosis

Contact your doctor immediately if you notice 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 site 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 may 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 progestogen-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 other medicines that you are using 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 the dosage of other medicines you are taking needs to be adjusted.

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);
• or other infectious diseases (e.g. griseofulvin);
• high blood pressure in the pulmonary blood vessels (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. Because 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 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 production or quality of breast milk. However, a decrease in milk production has been reported infrequently 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 assessed up to the age of 2.5 years. No effects on growth and development were observed.

Contact your doctor if you are breastfeeding and wish to use Azalia.

Driving and operating machinery

Azalia has no influence 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 you have previously been diagnosed with intolerance to certain sugars, consult your 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 leg, unexplained chest pain, shortness of breath, unusual cough, especially coughing up blood (indicating possible thrombosis);
• the patient experiences sudden, severe stomach pain or yellowing of the skin (indicating possible liver disorders);
• the patient feels a lump in the breast (indicating possible breast cancer);
• the patient experiences sudden or severe pain in the lower abdomen or stomach area (indicating possible ectopic pregnancy, a pregnancy developing outside the uterus);
• the patient is to be immobilized or undergo surgery (consult your doctor at least four weeks in advance);
• the patient experiences unusual, heavy vaginal bleeding;
• the patient suspects she is 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 the 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 you start a new Azalia blister pack, take the tablet from the top row. For example, if you start taking tablets on Wednesday, take the tablet from the top row marked "Qua" (Qua = Wednesday; see "Translation of symbols indicating days of the week located 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 you start 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 pack, you must take the tablets located in the upper left corner of that blister.

This makes it easy to check whether a tablet has been taken each day. During treatment with Azalia, bleeding may occur (see "Possible side effects"), but you should continue taking the tablets as usual.

After finishing a blister pack, start the next pack of Azalia 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 past month) hormonal contraceptives
Wait for the onset of menstrual bleeding. Take the first tablet of Azalia on the first day of your period. There is no need to use additional contraceptive methods.

You may also start taking the tablet between days 2 and 5 of your cycle. However, in such cases, you must use additional contraceptive methods (barrier methods) for the first 7 days of tablet use.

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, or on the day of removal of the vaginal ring or transdermal patch (meaning no break in use of the tablet, vaginal ring, or patch). 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, you may start taking Azalia on the day after the tablet-free interval, removal of the vaginal ring or patch, or after taking the last placebo tablet of your current contraceptive. In this case, you must use additional contraceptive methods (barrier methods) for the first 7 days of tablet use.

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

After childbirth
You may start taking Azalia between 21 and 28 days after childbirth. If you start later, you must use an additional contraceptive method (barrier methods) during the first 7 days of tablet use in 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 in section 2 under "Pregnancy and breastfeeding." Consult your doctor for advice.

After a 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 previously missed tablets.) In this case, there is a risk of becoming pregnant. Continue taking the tablets as usual and use an additional contraceptive method (e.g. 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 you had sexual intercourse in the week before the missed tablets, there is a risk of pregnancy. Consult your doctor for advice.

In case of vomiting, diarrhoea, or activated charcoal use
If vomiting or acute diarrhoea occurs, or if activated 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 instructions for a missed tablet.

Taking more than the recommended dose of Azalia
Severe harmful effects have not been observed after taking multiple tablets of Azalia at the same time. Symptoms such as nausea, vomiting, and slight vaginal bleeding in young girls may occur. For further information, consult your doctor.

Stopping treatment with Azalia
You may stop taking Azalia at any time. From the day you stop, you are no longer protected against pregnancy.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can 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.
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 the available data).
Irregular vaginal bleeding may occur during treatment with Azalia. This may be slight spotting, not requiring even the use of sanitary pads, or more pronounced bleeding similar to 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 effect of Azalia is reduced. Usually, no action is necessary and you should continue taking Azalia. However, if bleeding is heavy or prolonged, you should consult your doctor.
Women using desogestrel have reported the following other adverse effects:
Common (may occur in up to 1 in 10 users):

• mood changes,
• decreased sex drive (libido),
• 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,
• painful red or purple skin nodules (erythema nodosum) (these are skin disorders).

In addition to the above, leakage or discharge from the breasts may occur.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
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

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light and moisture.
There are no special requirements regarding storage temperature.
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. Package contents and other information

What Azalia contains
The active substance is desogestrel. One tablet contains 75 micrograms of desogestrel.
Other components are:
Tablet core:
Monohydrate lactose,
Potato starch,
Povidone K 30,
Anhydrous colloidal silicon dioxide,
Stearic acid,
RRR-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.
Azalia 75 microgram film-coated tablets are packed in PVC/PVDC-Aluminium blisters.
Each blister is placed in an aluminium laminate sachet.
Sachets containing blisters are packed in a cardboard box with a patient leaflet and a cardboard pouch
for storage.
An additional cardboard pouch is included in the package, in which the blister should be placed after removal from the protective foil.
Pack sizes: 28 film-coated tablets, 84 film-coated tablets (3 blisters containing 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.
Gyömrői út 19-21
1103 Budapest, Hungary

Manufacturer:
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest, Hungary

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź, Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź, Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów, Poland

Marketing Authorisation Number in Portugal, country of export: 5317474
Parallel Import Authorisation Number: 279/23

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 the weekday symbols printed next to each tablet on the immediate packaging:
Seg – Monday
Ter – Tuesday
Qua – Wednesday
Qui – Thursday
Sex – Friday
Sab – Saturday
Dom – Sunday