Azalia

Package leaflet: Information for the user

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

• Keep this leaflet so that you can read it again if necessary.
• 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 side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Azalia 75 micrograms coated tablets (hereinafter: 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.
How does the medicine work?
Azalia contains a small amount of one type of female sex hormone, a progestogen called desogestrel. For this reason, Azalia is known as a progestogen-only pill or a mini-pill.
Unlike combined oral contraceptives, progestogen-only pills or mini-pills do not contain oestrogen, only progestogen. Most progestogen-only pills or most mini-pills work mainly by preventing sperm from entering the uterus, but they do not always prevent ovulation, which is the main action of combined oral contraceptives.
Azalia differs from other mini-pills in that its dose in most cases is 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 oestrogens and by breastfeeding women. A disadvantage of using Azalia is the occurrence of irregular bleeding from the genital tract during tablet intake. Bleeding may also not occur at all.

2. Important information before taking Azalia

Azalia does not protect against HIV (AIDS) infection or any other sexually transmitted disease.
When not to take Azalia
Do not take Azalia in any of the cases listed below. Before starting to take Azalia, inform your doctor if any of the following 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 have or have had 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 you have or have had severe liver disease and liver function (as determined by blood laboratory tests) has not returned to normal.
• If you have a tumour dependent on certain sex hormones (progestogens), such as some types of breast cancer.
• If you have unexplained vaginal bleeding.

If any of the above conditions occur for the first time while taking Azalia,
you should contact your doctor immediately.
Warnings and precautions
Before starting to take Azalia, discuss this with your doctor or pharmacist.
If you take Azalia in any of the cases listed below, close monitoring is recommended.
Your doctor will explain how you should proceed. Before starting to take Azalia, inform your doctor:

• if you have or have had breast cancer,
• if you have liver cancer,
• if you have or have had venous thrombosis (blood clot),
• if you have diabetes,
• if you have epilepsy (see section 2. "Azalia and other medicines"),
• if you have tuberculosis (see section 2. "Azalia and other medicines"),
• if you have high blood pressure,
• if you have or have 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 you have depression or mood changes.

Breast cancer
You should regularly examine your breasts 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.
When oral contraceptives are discontinued, the risk gradually decreases.
Ten years after stopping oral contraceptives, the risk is the same as in women who have never used oral contraceptives. Breast cancer rarely occurs in women before the age of 40, but the risk of its occurrence increases with the woman's age. Therefore, the number of diagnosed cases of breast cancer is higher the older the woman is when she continues to take oral contraceptives.
The duration of oral contraceptive use is of lesser importance.
For every 10,000 women who used oral contraceptives for 5 years and stopped taking the medicine before the age of 20, there will be less than 1 additional case of breast cancer diagnosed within 10 years after stopping the medicine, 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 medicine before the age of 30, there are 5 additional cases compared to over 44 cases normally diagnosed.
Among 10,000 women who used oral contraceptives for 5 years and stopped taking the medicine before the age of 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 oral contraceptives (containing oestrogens), but the data are inconclusive.
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 of breast cancer may be the fact that women using contraceptives were examined more frequently.
Thrombosis
Contact your doctor immediately if you observe potential symptoms of thrombosis (see also "Contact your doctor immediately").
Thrombosis is the formation of blood clots that may block a blood vessel.
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 the 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 of using progestogen-only pills, such as Azalia, is likely lower than when using combined oral contraceptives (containing oestrogens).
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 and other medicines
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 (or pharmacists) who prescribe other medicines that you are taking Azalia. Your doctor will inform you whether you need to use an additional method of contraception (e.g. a condom) and, if so, for how long, and whether you need to adjust the dosage of other medicines you are taking.
Some medicines:

• may affect the blood concentration of Azalia,
• may reduce contraceptive efficacy,
• 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. 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 inform you whether additional contraceptive measures are necessary and, if so, for how long.
Azalia may also affect the action of other medicines, causing an increase in their effect (e.g. medicines containing cyclosporine) or inhibition of 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, you should consult your doctor or pharmacist before taking this medicine.
Do not take Azalia if you are pregnant or suspect you may be pregnant.
Azalia can be used during breastfeeding. It does not appear to affect the production or quality of breast milk.
However, a reduction 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 using desogestrel, the impact on health was assessed until the age of 2.5 years. No effect on growth and development of children was observed.
Contact your doctor if you are breastfeeding and wish to take Azalia.
Driving and using machines
Azalia has no effect 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, you should contact your doctor before taking this medicine.
Regular check-ups
While taking 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 you experience severe pain or swelling in either of your lower limbs, unexplained chest pain, shortness of breath, unusual cough, especially coughing up blood (indicating possible thrombosis);
• if you experience sudden, severe stomach pain or yellowing of the skin (indicating possible liver disorders);
• if you detect a lump in your breast (indicating possible breast cancer);
• if you experience sudden or severe pain in the lower abdomen or stomach area (indicating possible ectopic pregnancy, which is a pregnancy developing outside the uterus);
• if you are to be immobilised or are to undergo surgery (consult your doctor at least four weeks in advance);
• if you experience unusual, heavy bleeding from the genital tract,
• if you suspect you are pregnant.

3. How to use Azalia

This medicine should always be taken exactly as prescribed 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-taking begins on Wednesday, take the tablet from the top row marked with the symbol “Qua” (indicating Wednesday; see “Translation of weekday symbols located 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 indicated by the arrows. If a woman 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, the tablets located in the upper left corner of the blister must be taken.

This way, it is easy to check whether a tablet has been taken on a given day. During treatment with Azalia, bleeding may occur (see “Possible side effects”), but continue taking the tablets as usual.

After finishing a blister, start the next pack of Azalia the following day—without interruption and without waiting for bleeding.

Starting the first pack of Azalia

If not currently using (or not having 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 menstruation.
There is no need to use additional contraceptive methods.

Tablet-taking may also begin between day 2 and day 5 of the cycle. In such cases, however, additional contraceptive methods (mechanical methods) must be used during the first 7 days of tablet-taking.

Switching from a combined oral contraceptive, vaginal ring, or transdermal patch
Azalia may be started the day after taking the last active tablet of the current contraceptive pack, 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 the current contraceptive pack also contains inactive (placebo) tablets, Azalia may be started 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, or patch, or after taking the last placebo tablet of the current contraceptive. In this case, additional contraceptive methods (mechanical methods) must be used for the first 7 days of tablet-taking.

Switching from a progestogen-only pill (mini-pill)
Azalia may be started on any day, immediately after discontinuing the previous progestogen-only pill. No additional contraceptive methods are required.

Switching from an injection, implant, or intrauterine device (IUD) releasing progestogen
Azalia should be started on the day the next injection was due, or on the day of removal of the implant or intrauterine device. No additional contraceptive methods are required.

After childbirth
Azalia may be started between 21 and 28 days after delivery. If treatment is started later, an additional contraceptive method (mechanical methods) must be used during the first cycle for the first 7 days of tablet-taking.

However, if sexual intercourse has occurred, pregnancy must be ruled out before starting Azalia. Additional information for breastfeeding women is provided 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 a 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 a 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 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 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 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 recommendations for a missed tablet.

Overdose of Azalia
No severe 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.

Discontinuation of Azalia
Azalia may be discontinued at any time. From the day treatment is stopped, the woman is no longer protected against pregnancy.

If you have any further doubts regarding 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 experiences them.
Serious adverse effects associated with the use of Azalia are described in section 2,
"Important information before using Azalia". Please read these sections for
additional information and consult your doctor if necessary.
You should contact your doctor immediately 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 range from slight spotting, not requiring the use of sanitary pads, 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 women). Irregular bleeding does not mean that the contraceptive effect of Azalia is reduced. Usually, no action is required and you should continue taking Azalia as directed. However, if bleeding is heavy or prolonged, you should consult your doctor.
Women using desogestrel have reported the following adverse effects:
Common (may occur in up to 1 in 10 women):

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

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

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

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

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

In addition to the adverse effects listed above, milk leakage or discharge from the breasts may occur.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should 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.
No special temperature storage requirements.
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 sewage systems 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.
The other ingredients 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 coated tablets with a diameter of approximately 5.5 mm,
marked with the letters "D" on one side and "75" on the other.
Azalia 75 micrograms, coated tablets, are packed in PVC/PVDC-Aluminium blisters.
Each blister is placed in an aluminium laminate sachet.
The sachets with blisters are packed into a cardboard box with a patient leaflet.
A cardboard sachet is included in the package, in which the blister should be stored after removal from the protective foil.
Pack sizes: 28 coated tablets, 84 coated tablets (3 blisters of 28 tablets) in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Portugal, country of export: 5317508
Parallel Import Authorisation Number: 413/22

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

This medicinal product is authorised 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