Azalia

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! 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.

• You should keep this leaflet so that you can read it again if you need to.
• If you have 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 or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Azalia 75 micrograms, coated tablet (hereinafter: Azalia) and what is it 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 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 a combined contraceptive pill, a progestogen-only pill or minipill does not contain estrogen, only progestogen. Most progestogen-only pills or minipills work primarily by preventing sperm from entering the uterus, but they do not always prevent ovulation, which is the main action of combined contraceptives. Azalia differs from other minipills in that its dose is usually sufficient to prevent ovulation. As a result, Azalia has 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 vaginal bleeding during tablet use. Bleeding may also not occur at all.

2. Important information before taking Azalia

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

When not to take Azalia

Azalia should not be taken in any of the following cases. Before starting Azalia, the doctor should be informed if any of these 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 a blockage in 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 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 vaginal bleeding of unknown origin.

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

Warnings and precautions

Before starting Azalia, the doctor or pharmacist should be consulted. If Azalia is used in any of the following cases, close monitoring is recommended. The doctor will explain how to proceed. Before starting 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 the sun or ultraviolet radiation should be avoided,
• if the patient has depression or mood changes.

Breast cancer
Regular breast exams should be performed and the doctor should be consulted immediately if any lump is felt in the breast.
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 oral contraceptives, the risk gradually decreases.
Ten years after stopping 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 older the patient is when they stop taking oral contraceptives.
It is less important how long oral contraceptives were taken.
For every 10,000 women taking oral contraceptives for 5 years who stopped taking 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 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 taking the medicine at the age of up to 30, there will be 5 additional cases of breast cancer out of more than 44 cases diagnosed normally.
For every 10,000 women taking oral contraceptives for 5 years who stopped taking the medicine at the age of up to 40, there will be 20 additional cases out of more than 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 appears 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 contraceptives are more often examined.
Thrombosis
The doctor should be consulted immediately if potential symptoms of thrombosis are observed (see also "You should consult a doctor immediately").
Thrombosis is the formation of blood clots that can block a blood vessel.
Thrombosis sometimes occurs in the deep veins of the lower limbs (deep vein thrombosis). If the clot breaks off from the place in the vein where it 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 that can lead to death. Deep vein thrombosis is rare and can occur regardless of whether oral contraceptives are taken 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 taking progestogen-only pills, such as Azalia, is likely to be lower than when taking 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, the doctor should be consulted 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

The doctor or pharmacist should be told about all medicines currently being taken or recently taken, as well as any medicines that the patient plans to take.
The patient should also inform other doctors or dentists who prescribe other medicines (or pharmacists) that they are taking Azalia. The doctor will inform the patient 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 being taken.
Some medicines:

• may affect the blood levels 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);
• 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 the patient is taking medicines or herbal products that may cause Azalia to be less effective, an additional barrier method of contraception should be used. Since the effect of another medicine on Azalia may last up to 28 days after its discontinuation, long-term use of an additional barrier method of contraception is necessary. The doctor may inform the patient whether there is a need to use additional contraceptive measures and if so, for how long.
Azalia may also affect the action of other medicines, causing an increase in their action (e.g., medicines containing cyclosporin) or a decrease in their action (e.g., lamotrigine).
Before taking any medicine, the doctor or pharmacist should be consulted.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Azalia should not be taken if the patient is pregnant or suspects that they may be pregnant.
Azalia can be used during breastfeeding. It does not appear to affect milk production or the quality of the milk secreted.
However, a decrease in milk production has occasionally occurred during Azalia use.
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.
The doctor should be consulted if a breastfeeding woman wants to take 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 in the patient, the patient should consult a doctor before taking the medicine.

Regular check-ups

During Azalia use, the doctor will ask the patient to come for regular check-ups. The frequency and type of check-ups will depend on the patient's health.
You should consult a doctor immediately:

• if the patient experiences severe pain or swelling of any limb, unexplained chest pain, shortness of breath, unusual cough, especially coughing up blood (indicating a possible thrombosis);
• if the patient experiences sudden, severe abdominal pain or yellowing of the skin (indicating a possible liver disorder);
• if the patient experiences a breast lump (indicating a possible breast cancer);
• if the patient experiences 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 the patient is to be immobilized or have surgery (the doctor should be consulted at least four weeks in advance);
• if the patient experiences unusual, heavy vaginal bleeding,
• if the patient suspects that they are pregnant.

3. How to take Azalia

This medicine should always be taken as directed by the doctor. In case of doubt, the doctor or pharmacist should be consulted.
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 with the symbol "Qua" (meaning Wednesday; see "Translation of day symbols on the packaging" at the end of the leaflet).
Tablet use should be continued, taking one tablet a day, until the blister pack is empty, always in the direction indicated by the arrows. If the patient starts 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, the tablets in the top left corner of the blister pack should be taken.
This way, it is easy to check if a tablet has been taken on a given day. During Azalia use, bleeding may occur (see "Possible side effects"), but tablet use should be continued as usual.
After the blister pack is empty, the next Azalia pack should be started the next day - without a break and without waiting for bleeding.

Starting the first Azalia pack

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

Wait for the menstrual period to start. On the first day of the menstrual period, take the first Azalia tablet.
There is no need to use other contraceptive methods.
Tablet use can also be started between the 2nd and 5th day of the cycle, but in such cases, additional contraceptive methods (barrier method) should be used for the first 7 days of tablet use.
Switching from a combined oral contraceptive, vaginal ring, or transdermal patch
Azalia use can be started the next day after taking the last tablet from the currently used contraceptive pack or on the day the vaginal ring or transdermal patch is removed (this means no break in contraceptive use). If the currently used contraceptive pack contains tablets without active substances, Azalia use can be started the next day after taking the last tablet containing an active substance (if in doubt, consult a doctor or pharmacist). If the above instructions are followed, there is no need to use additional contraceptive methods.
The earliest Azalia use can be started is the day after the break in tablet use, vaginal ring use, patch use, or after taking the last placebo tablet from the currently used contraceptive pack. In this case, additional contraceptive methods (barrier methods) should be used for the first 7 days of tablet use.
Switching from another progestogen-only pill (minipill)
Azalia use can be started 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 system releasing progestogen
Azalia use should be started on the day the next injection was scheduled or on the day the implant or intrauterine system is removed. There is no need to use additional contraceptive methods.
After childbirth
Azalia use can be started between the 21st and 28th day after childbirth. If Azalia use is started later, during the first cycle, an additional barrier method of contraception should be used for the first 7 days of tablet use.
However, if there has been sexual intercourse, pregnancy should be ruled out before starting Azalia. Additional information for breastfeeding women can be found in the "Pregnancy and breastfeeding" section in point 2. The doctor should also be consulted.
After premature birth or miscarriage
The doctor should be consulted.
Missing a dose of Azalia
If the delay in taking a tablet is less than 12 hours
The missed tablet should be taken as soon as remembered, and the next tablet should be taken at the usual time. Azalia's contraceptive effect is maintained.
If the delay in taking a tablet is more than 12 hours
The missed tablet should be taken as soon as remembered, and the next tablet should be taken at the usual time. This may mean taking two tablets on the same day. This is not a risk (if more than one tablet is missed, there is no need to make up for the previously missed tablets). In this case, there is a possibility of becoming pregnant. Azalia use should be continued as usual, and an additional contraceptive method should be used, e.g., a condom, for the next 7 days.
The more consecutive tablets are missed, the higher the risk of reduced contraceptive efficacy.
If one or more tablets are missed in the first week of use and there has been sexual intercourse in the week preceding the missed tablets, there is a possibility of becoming pregnant.
The doctor should be consulted for advice.
If vomiting or diarrhea occurs, or if activated charcoal is used
If vomiting or severe diarrhea occurs, or if activated charcoal is used 3-4 hours after taking a tablet, there is a risk that the active substance may not have been fully absorbed. The instructions for missing a tablet should be followed.

Taking a higher dose of Azalia than recommended

No severe 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, the doctor should be consulted.

Stopping Azalia use

Azalia use can be stopped at any time. From the day Azalia use is stopped, the patient is no longer protected against pregnancy.
If there are any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Azalia can cause side effects, although not everybody gets them.
Serious side effects related to Azalia use have been described in section 2 "Important information before taking Azalia". These sections should be read to obtain additional information and, if necessary, consult a doctor.
The doctor should be consulted immediatelyif allergic reactions occur (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 Azalia use, 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 menstrual 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 Azalia's contraceptive effect is reduced. Usually, no action is necessary, and Azalia use should be continued. However, if the bleeding is heavy or prolonged, the doctor should be consulted.
Patients taking desogestrel have reported the following side effects:

• change in mood,
• 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.

Rarely(may occur in up to 1 in 1,000 patients):

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

Besides the listed side effects, milk leakage or discharge may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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, 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, more information can be collected on the safety of the medicine.

5. How to store Azalia

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light and moisture.
There are no special storage temperature requirements.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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,
all- rac-α-Tocopherol .
Tablet coating:
Polyvinyl alcohol,
Titanium dioxide (E 171),
Macrogol 3000,
Talc.

What Azalia looks like and what the packaging contains

White or almost white, round, biconvex, film-coated tablets with a diameter of about 5.5 mm, marked with the letter "D" on one side and "75" on the other.
Azalia 75 micrograms, film-coated tablets are packaged in PVC/PVDC-Aluminum blisters.
Each blister is placed in a laminated aluminum sachet.
The sachets with blisters are packaged in a cardboard box with a patient leaflet.
A cardboard sachet is attached to the packaging, in which the blister should be placed after being removed from the protective foil.
Packaging sizes: 28 film-coated tablets, 84 film-coated tablets (3 blisters of 28 tablets) in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Portugal, the 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Portuguese marketing authorization number, country of export:5317508
5317474

Parallel import authorization number: 413/22

Translation of day symbols on the packaging:

Seg- Monday
Ter- Tuesday
Qua- Wednesday
Qui- Thursday
Sex- Friday
Sab- Saturday
Dom- Sunday.

This medicinal product is authorized in the Member States of the European Economic Area 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
Date of leaflet approval: 22.11.2022
[Information about the trademark]