Azalia

Leaflet accompanying the packaging: information for the user

Warning!

The leaflet should be kept. Information on the immediate packaging in a foreign language.

Azalia

75 micrograms, coated tablets

Desogestrel

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Azalia and what is it used for
• 2. Important information before using Azalia
• 3. How to use Azalia
• 4. Possible side effects
• 5. How to store Azalia
• 6. Contents of the packaging and other information

1. What is Azalia and what is it used for

Azalia is used to prevent pregnancy.

How does the medicine work?

Azalia contains a small amount of one type of female sex hormone, progestogen, called desogestrel. For this reason, Azalia is called a progestogen-only pill or a minipill. Unlike the combined oral contraceptive pill, the progestogen-only pill or minipill does not contain estrogen, only progestogen. Most progestogen-only pills or minipills work mainly by preventing sperm from entering the uterus, but they do not always prevent egg maturation, which is the main action of combined oral contraceptives. Azalia differs from other minipills in that its dose is usually sufficient to prevent egg maturation. As a result, Azalia has a high contraceptive efficacy. Unlike combined oral contraceptives, Azalia can be used by women who do not tolerate estrogens and by breastfeeding women. The disadvantage of using Azalia is the occurrence of irregular bleeding from the genital tract during tablet use. Bleeding may also not occur at all.

2. Important information before using Azalia

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

When not to use Azalia

Page 1 of 9 Do not use Azalia in any of the following cases. Before starting to use Azalia, the doctor should be informed if any of the following conditions occur. The doctor may recommend the use of 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 a blood clot. A blood clot is the formation of clots in blood vessels. These clots can 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 had a severe liver disease and liver function (determined by blood laboratory tests) has not returned to normal.
• If the patient has a tumor that is dependent on certain sex hormones (progestogens), such as some types of breast cancer.
• If the patient has bleeding from the genital tract of unknown origin.

If any of the above conditions occur for the first time while using Azalia, the doctor should be consulted immediately.

Warnings and precautions

Before starting to use Azalia, the doctor or pharmacist should be consulted. If Azalia is used in any of the cases listed below, close monitoring is recommended. The doctor will explain how to proceed. Before starting to use Azalia, the doctor should be informed:

• if the patient has or has had breast cancer,
• if the patient has liver cancer,
• if the patient has or has had venous thrombosis (thrombosis),
• if the patient has diabetes,
• if the patient has epilepsy (see section 2 "Azalia and other medicines"),
• if the patient has tuberculosis (see section 2 "Azalia and other medicines"),
• if the patient has high blood pressure in the blood vessels of the lungs,
• if the patient has or has had chloasma (yellow-brown pigmented spots on the skin, especially on the face); in this case, excessive exposure to sunlight or ultraviolet radiation should be avoided;
• if the patient has depression or mood changes.

Breast cancer You should regularly check your breasts and immediately contact your doctor if you feel any lump in your breasts. Breast cancer occurs slightly more often in women taking oral contraceptives than in women of the same age who do not take them. After stopping the use of 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 taken oral contraceptives. Breast cancer rarely occurs in women under 40 years of age, but the risk of its occurrence increases with the patient's age. Therefore, the number of diagnosed breast cancer cases is higher, the later the patient's age at which they are still taking oral contraceptives. The duration of oral contraceptive use is of less importance. For every 10,000 women taking oral contraceptives for 5 years who stopped using the medicine at the age of up to 20, there will be less than 1 additional case of breast cancer diagnosed up to 10 years after stopping the use of oral contraceptives, compared to 4 cases diagnosed in this age group. Similarly, for every 10,000 women taking oral contraceptives for 5 years who stopped using the medicine at the age of up to 30, there will be 5 additional cases of breast cancer, in addition to 44 cases diagnosed normally. For every 10,000 women taking oral contraceptives for 5 years who stopped using the medicine at the age of up to 40, there will be 20 additional cases, in addition to over 160 cases diagnosed normally. It is believed that the risk of breast cancer in women taking progestogen-only pills, such as Azalia, is similar to the risk in women taking combined oral contraceptives, but the data is not conclusive. It seems that in women taking oral contraceptives, the detected breast cancer is usually less advanced than in women who do not take oral contraceptives. It is not known whether this difference is caused by the use of oral contraceptives. The reason for the earlier diagnosis of breast cancer may be that women taking oral contraceptives are more often examined. Blood clots You should immediately contact your doctor if you notice any potential symptoms of blood clots (see also "You should immediately contact your doctor"). Blood clots are the formation of blood clots that can block a blood vessel. Blood clots can sometimes occur in the deep veins of the legs (deep vein thrombosis). If a clot breaks loose from the place in the vein where it was formed, it can reach the lungs and block the artery. 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 can occur regardless of whether oral contraceptives are used or not. It can also occur during pregnancy. The risk of occurrence is higher in women taking oral contraceptives than in women who do not take them. The risk of using progestogen-only pills, such as Azalia, is likely to be lower than when using combined oral contraceptives. Mental disorders: Some women taking hormonal contraceptives, including Azalia, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should 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 is not available.

Azalia and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should also inform other doctors or dentists who prescribe other medicines (or pharmacists) that you are taking Azalia. The doctor will inform you whether there is a need to use additional contraceptive methods (e.g., a condom) and if so, for how long, and whether there is a need to change the dosage of other medicines you are taking. Some medicines:

• may affect the blood level of Azalia,
• may reduce the effectiveness of contraception,
• may cause unexpected bleeding.

These are 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);
• other infectious diseases (e.g., griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depressive moods (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 make Azalia less effective, you should also use a barrier method of contraception. Since the effect of another medicine on Azalia may last up to 28 days after its discontinuation, it is necessary to use a barrier method of contraception for a longer period. The doctor may inform you whether it is necessary to use additional contraceptive measures and if so, for how long. Azalia may also affect the action of other medicines, increasing their effect (e.g., medicines containing cyclosporine) or inhibiting their action (e.g., lamotrigine). Before taking any medicine, you should consult your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine. You should not use Azalia if you are pregnant or think you may be pregnant. Azalia can be used during breastfeeding. It does not appear to affect milk production or the quality of the milk produced. However, a decrease in milk production has occasionally occurred during the use of Azalia. Small amounts of the active substance of Azalia pass into breast milk. In children who were breastfed for 7 months by mothers taking desogestrel, the effect on health was investigated up to the age of 2.5 years. No effect on the growth and development of children was observed. You should contact your doctor if you are breastfeeding and want to use Azalia.

Driving and using machines

Azalia does not affect the ability to drive and use machines.

Azalia contains lactose monohydrate

Patients with lactose intolerance should be aware that Azalia tablets contain 52.34 mg of lactose (in the form of lactose monohydrate). If lactose intolerance has been previously diagnosed, the patient should consult their doctor before taking the medicine.

Regular check-ups

While using Azalia, your doctor will ask you to come for regular check-ups. The frequency and type of check-ups will depend on your state of health. You should immediately contact your doctor:

• if you experience severe pain or swelling in any of your legs, unexplained chest pain, shortness of breath, unusual cough, especially coughing up blood (indicating a possible blood clot);
• if you experience sudden, severe abdominal pain or yellowing of the skin (indicating a possible liver disorder);
• if you experience a lump in your breast (indicating a possible breast cancer);

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• if you experience sudden or severe pain in the lower abdomen or pelvic area (indicating a possible ectopic pregnancy, which is a pregnancy developing outside the uterus);
• if you are to be immobilized or have surgery (you should consult your doctor at least four weeks in advance);
• if you experience unusual, heavy vaginal bleeding,
• if you suspect you are pregnant.

3. How to use Azalia

This medicine should always be used as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist. Each Azalia blister pack contains 28 tablets. Arrows and the day of the week are printed on the front of the blister pack, which allows for proper use of the medicine. It is recommended to take the medicine every day at the same time. The tablet should be swallowed whole, with a glass of water. Every time a new Azalia blister pack is started, a tablet should be taken from the top row. For example, if tablet use starts on a Wednesday, a tablet should be taken from the top row marked Qua (Qua - Wednesday, see "Translation of day abbreviations on the packaging" at the end of the leaflet). You should continue taking one tablet a day until the blister pack is empty, always in the direction indicated by the arrows. If you start taking tablets on a Monday, the end of the arrow on the blister pack will be empty, but in any other case, before starting a new blister pack, you should take the tablets located in the top left corner of that blister pack. This way, you can easily check if a tablet has been taken on a given day. During the use of Azalia, bleeding may occur (see "Possible side effects"), but you should continue taking the tablets as usual. After finishing a blister pack, the next Azalia pack should be started the next day - without a break and without waiting for bleeding.

Starting the first pack of Azalia

If you are not using (or have not used in the last month) hormonal contraceptives

You should wait for your period to start. On the first day of your period, you should take the first Azalia tablet. There is no need to use other contraceptive methods. You can also start taking the tablet between the 2nd and 5th day of your cycle, but in such cases, you should use additional contraceptive methods (barrier method) for the first 7 days of tablet use.
Changing from a combined oral contraceptive, vaginal ring, or transdermal patch
You can start using Azalia the next day after taking the last tablet from your current contraceptive pack or on the day you remove the vaginal ring or transdermal patch (this means no break in contraceptive use). If your current contraceptive pack contains tablets without active substances, you can start using Azalia the next day after taking the last active tablet (if in doubt, consult your doctor or pharmacist). If you follow the above instructions, there is no need to use additional contraceptive methods. You can start using Azalia at the latest on the day after the break in tablet use, vaginal ring use, patch use, or after taking the last placebo tablet from your current contraceptive pack. In this case, you should use additional contraceptive methods (barrier methods) for the first 7 days of tablet use.
Changing from another progestogen-only pill (minipill)
You can start using Azalia on any day, immediately after stopping the previous progestogen-only pill. There is no need to use additional contraceptive methods.
Changing from an injection, implant, or intrauterine system releasing progestogen
You should start using Azalia on the day you would have had your next injection or on the day the implant or intrauterine system is removed. There is no need to use additional contraceptive methods.
After childbirth
You can start using Azalia between 21 and 28 days after giving birth. If you start using the medicine later, you should use an additional barrier method of contraception during the first cycle, for the first 7 days of tablet use. However, if you have had sexual intercourse, you should rule out pregnancy before starting to use Azalia. Additional information for breastfeeding women can be found in the "Pregnancy and breastfeeding" subsection in section 2. You should also consult your doctor.
After premature birth or miscarriage
You should consult your doctor.
Missing a dose of Azalia
If the delay in taking a tablet is less than 12 hours You should take the missed tablet as soon as you remember and take the next tablet at the usual time. The contraceptive effect of Azalia is maintained. If the delay in taking a tablet is more than 12 hours You should 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 a risk. (If you miss more than one tablet, there is no need to make up for the previously missed tablets). In this case, there is a possibility of becoming pregnant. You should continue taking the medicine as usual and use an additional contraceptive method, such as a condom, for the next 7 days. The more tablets you miss, the higher the risk of reduced contraceptive effectiveness. If you miss one or more tablets in the first week of use and have had sexual intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. You should consult your doctor for advice.
If you vomit or have diarrhea or take activated charcoal If you vomit or have severe diarrhea or take activated charcoal 3-4 hours after taking a tablet, there is a risk that the active substance may not have been fully absorbed. You should follow the instructions for missing a tablet.

Taking more than the recommended dose of Azalia

No serious harmful effects have been observed after taking many Azalia tablets at the same time. Symptoms such as nausea, vomiting, and, in young girls, slight vaginal bleeding may occur. For further information, you should consult your doctor.

Stopping the use of Azalia

You can stop using Azalia at any time. From the day you stop using the medicine, you are no longer protected against pregnancy. If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Azalia can cause side effects, although not everybody gets them. Serious side effects related to the use of Azalia have been described in section 2 "Important information before using Azalia". You should read these sections for additional information and consult your doctor if necessary. You should immediately contact your doctorif you experience an allergic reaction (hypersensitivity), including swelling of the face, lips, tongue, and/or throat causing difficulty breathing or swallowing (angioedema and/or anaphylaxis) (the frequency of this side effect cannot be determined from the available data). During the use of Azalia, irregular vaginal bleeding may occur. This may be slight spotting, not requiring the use of a sanitary pad, or more severe bleeding, similar to a light period, requiring the use of a sanitary pad. Bleeding may also not occur at all. These are common side effects (may occur in up to 1 in 10 patients). Irregular bleeding does not mean that the contraceptive effect of Azalia is reduced. In general, there is no need to take any action, and you should continue using Azalia. However, if the bleeding is heavy or prolonged, you should consult your doctor. Patients taking desogestrel have reported the following other side effects:

• mood changes,
• decreased sex drive (libido),
• depression,
• headache,
• nausea,
• acne,
• breast pain,
• weight gain.

Frequently(may occur in up to 1 in 10 patients):

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

Uncommonly(may occur in up to 1 in 100 patients):

• rash,
• hives,
• painful red lumps on the skin (erythema nodosum) (these are skin disorders).

Beyond the listed side effects, milk leakage or discharge may occur. Page 7 of 9

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Azalia

Store in the original packaging to protect from light and moisture. There are no special recommendations for storage temperature. The medicine should be stored 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 month stated. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Azalia contains

The active substance of Azalia is desogestrel. One tablet contains 75 micrograms of desogestrel. The other ingredients are: Tablet core: Lactose monohydrate, 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, film-coated tablets with a diameter of about 5.5 mm, marked with the inscription "D" on one side and "75" on the other side. Azalia, 75 micrograms, film-coated tablets are packaged in a blister pack of aluminum-PVC/PVDC. Each blister pack is placed in a laminated aluminum sachet. The sachets with blister packs are packaged in a cardboard box with a patient leaflet and a cardboard sachet for storage. Pack sizes: 28 film-coated tablets, 84 film-coated tablets (3 blister packs of 28 tablets). For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Portugal, the 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź Nr of the authorization in Portugal, the country of export: 5317474 5317508

Parallel import authorization number: 132/23

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Azalia 75 microgram film tablet, Hungary Azalia 75 microgram coated tablet, Czech Republic Azalia 75 micrograms film-coated tablets, Slovakia Azalia, Poland Azalia 75 micrograms film-coated tablets, Lithuania Azalia 75 micrograms film-coated tablets, Latvia Tangolita, Denmark Азалия 75 микрограма филмирани таблетки, Bulgaria Azalia 75 micrograme film-coated tablets, Romania

Translation of day abbreviations on the packaging:

Seg

• Monday Ter
• Tuesday Qua
• Wednesday Qui
• Thursday Sex
• Friday Sab
• Saturday Dom
• Sunday

Date of revision of the leaflet: 07.07.2023

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