Azalia

Leaflet accompanying the packaging: information for the user

Azalia, 75 micrograms, coated tablets

Desogestrel

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 Azalia 75 micrograms coated tablets are and what they are 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 to prevent pregnancy.

How the medicine works

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 mini-pill. Unlike the combined contraceptive pill, the progestogen-only pill or mini-pill does not contain estrogen, only progestogen. Most progestogen-only pills or mini-pills 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 mini-pills 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 taking. 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 the following conditions occur. The doctor may recommend the use of a non-hormonal birth control method.

• 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 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 cases listed below, 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;
• 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
Regular breast self-examination 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 contraceptive pills than in women of the same age who do not take them. After stopping the contraceptive pill, the risk gradually decreases. Ten years after stopping the pill, the risk is the same as in women who have never taken the pill. Breast cancer rarely occurs in women under 40, 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 taking the pill. The duration of pill use is of lesser importance.
Thrombosis
The doctor should be consulted immediately if potential symptoms of thrombosis are observed (see also "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 legs (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 or not contraceptive pills are taken. It can also occur during pregnancy.
The risk of occurrence is higher in women taking contraceptive pills 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 pills that also contain estrogen (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 are 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 planned to be taken.
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 level of Azalia,
• may reduce the efficacy 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, a barrier method of contraception should also be used. Since the effect of another medicine on Azalia may last up to 28 days after its discontinuation, prolonged use of a barrier method of contraception is necessary. The doctor may inform the patient whether there is a need to use additional contraceptive methods 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, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
Azalia should not be taken if the patient is pregnant or thinks she 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 been reported 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 the children was observed.
The doctor should be consulted if the woman is breastfeeding and wants to take Azalia.

Driving and using machines

Azalia has no effect on the ability to drive and use machines.

Azalia contains lactose

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 doctor should be consulted before taking the medicine.

Regular check-ups

While taking Azalia, 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.
Consult a doctor immediately:

• if the patient experiences severe pain or swelling in any of the legs, 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 stomach 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 4 weeks in advance);
• if the patient experiences unusual or heavy vaginal bleeding;
• if the patient suspects she is pregnant.

3. How to take Azalia

This medicine should always be taken as directed by the doctor. In case of doubts, 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 water.
Each time a new Azalia blister pack is started, a tablet should be taken from the top row. For example, if tablet taking starts on a Wednesday, the tablet from the top row marked Wednesday should be taken.
Tablet taking 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 taking should be continued as usual.
After finishing the 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 hormonal contraceptives are not being taken (or have not been taken in the last month)

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 taking can also be started between the 2nd and 5th day of the cycle, but in such cases, additional contraceptive methods (mechanical methods) should be used for the first 7 days of tablet taking.
Changing from a combined oral contraceptive, vaginal ring, or transdermal patch
Azalia use can be started the 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 taking the tablet, vaginal ring, or transdermal patch). If the pack of the currently used contraceptive contains tablets without active substances, Azalia use can be started the day after taking the last tablet containing active substances (if in doubt, the doctor or pharmacist should be consulted). If the above instructions are followed, there is no need to use additional contraceptive methods.
The latest Azalia use can be started on the day after the break in taking tablets, vaginal ring, or transdermal patch, or after taking the last placebo tablet of the currently used contraceptive. In this case, additional contraceptive methods (mechanical methods) should be used for the first 7 days of tablet taking.
Changing from another progestogen-only pill (mini-pill)
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.
Changing from an injection, implant, or intrauterine system releasing progestogen
Azalia use should be started on the day the next injection is 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 21 and 28 days after childbirth. If Azalia use is started later, during the first cycle, additional contraceptive methods (mechanical methods) should be used for the first 7 days of tablet taking. 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" subsection in section 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 taking them 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 there are vomiting, diarrhea, or activated charcoal is used
In case of vomiting or severe diarrhea 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 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, 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.
In case of any further doubts about taking 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.
Consult a doctor immediatelyif allergic reactions occur, including hypersensitivity, such as swelling of the face, lips, tongue, and/or throat causing difficulty in 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 even the use of a panty liner, or more severe bleeding, similar to a light menstrual period, requiring the use of a panty liner. 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 as usual. However, if the bleeding is heavy or prolonged, the doctor should be consulted.
Patients taking desogestrel have reported the following other side effects:

• change in mood,
• decreased sexual desire (libido),
• depression,
• headache,
• nausea,
• acne,
• breast pain,
• weight gain.

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

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

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

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

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

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 pack and other information

What Azalia contains

The active substance of Azalia is desogestrel. One tablet contains 75 micrograms of desogestrel.
The other ingredients are:
Core:
Lactose monohydrate,
Potato starch,
Povidone K-30,
Colloidal anhydrous silica,
Stearic acid,
All-rac-α-tocopherol.
Coating:
Polyvinyl alcohol,
Titanium dioxide, E171,
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 letter "D" on one side and "75" on the other side.
Azalia, 75 micrograms, film-coated tablets are packaged in a blister pack of hard, transparent PVC/PVDC-Aluminum foil.
Each blister pack is placed in a laminated aluminum sachet.
The sachets with blister packs are packaged in a cardboard box with a patient information leaflet and a case for storage.
Pack sizes: 28 film-coated tablets, 84 film-coated tablets (3 blister packs of 28 tablets). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

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
For more information, the representative of the marketing authorization holder should be contacted:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
lekalert@grodzisk.rgnet.org
Date of last revision of the leaflet:October 2021