AZALIA

Package leaflet: Information for the user

Warning!
Keep this leaflet. The information on the immediate packaging is in a foreign language.
Azalia (Solgest)
75 micrograms, coated tablets
Desogestrel
Azalia and Solgest are different brand names for the same medicine.
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Azalia is and what it is used for
2. What you need to know 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 it 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 "mini-pill".
Unlike combined oral contraceptives, progestogen-only pills or mini-pills do not contain oestrogen; they contain only a progestogen.
Most progestogen-only pills or mini-pills primarily work by preventing sperm from entering the womb, but they do not always prevent the release of an egg (ovulation), 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.
As a result, Azalia has a 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 vaginal bleeding during tablet intake.
Bleeding may also not occur at all.

2. Important information before using the medicine Azalia

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The medicine Azalia does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
When not to use medicine Azalia
Do not use the medicine Azalia in any of the cases listed below. Before starting to use Azalia, inform your doctor if any of the following conditions 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 (heart attack) 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 some types of breast cancer.
• If the patient has unexplained vaginal bleeding.

If any of the above conditions occurs 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 are using Azalia in any of the cases listed below, close monitoring is recommended.
Your doctor will explain how to proceed. Before starting to use 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 pigmentation 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 the 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 use of oral contraceptives, the risk is the same as in women who have never used them. Breast cancer rarely occurs in women before the age of 40. However, the risk increases with the patient's age. Therefore, the number of diagnosed cases of breast cancer is higher the older the patient is when she continues taking oral contraceptives.
The duration of oral contraceptive use is of lesser importance.
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Among every 10,000 women who used oral contraceptives for 5 years and stopped taking the medicine before the age of 20, fewer than 1 additional case of breast cancer will be diagnosed within 10 years after stopping the pill, 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 pills (containing estrogens as well), 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 hormonal 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 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 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 or have recently taken, as well as any medicines you plan to take.
The patient should also inform other doctors or dentists (or pharmacists) who prescribe other medicines (or a pharmacist) that she is using Azalia.
Your doctor will inform you whether additional contraceptive methods (e.g. condom) are needed, and if so, for how long, and whether the dosage of other medicines needs to be changed.
Some medicines:

• may affect the blood concentration of Azalia,
• may reduce the effectiveness in preventing pregnancy,

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• 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);
• 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 the patient uses medicines or herbal products that may make Azalia less effective, an additional barrier method of contraception should also be used. 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 needed and, if so, for how long.
Azalia may also affect the action of other medicines, causing increased effects (e.g. medicines containing cyclosporine) or reduced effects (e.g. lamotrigine).
Before taking any medicine, consult your doctor or pharmacist.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use Azalia if the patient is pregnant or suspects she may be pregnant.
Azalia can be used during breastfeeding. It does not appear to affect the production or quality of breast milk. However, a decrease in milk production has occurred infrequently during use of Azalia. Small amounts of the active substance of Azalia pass into breast milk. The health impact on children who were breastfed for 7 months by mothers using desogestrel was assessed up to the age of 2.5 years. No effect on growth and development of the children was observed.
Contact your doctor if a woman is breastfeeding and wishes to use Azalia.
Driving and operating machinery
Azalia has no influence on the ability to drive and 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 the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the 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 the patient's health status.
Contact your doctor immediately:

• if the patient experiences severe pain or swelling in either of the lower limbs,

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unexplained chest pain, shortness of breath, unusual cough, especially coughing up blood (indicating possible thrombosis);

• if the patient experiences sudden, severe stomach pain or yellowing of the skin (indicating possible liver disorders);
• if the patient detects a lump in the breast (indicating possible breast cancer);
• if the patient experiences sudden or severe pain in the lower abdomen or stomach area (indicating possible ectopic pregnancy, a pregnancy developing outside the uterus);
• if the patient is to be immobilized or undergo surgery (consult your doctor at least four weeks in advance);
• if the patient experiences unusual, heavy vaginal bleeding,
• if the patient suspects she is pregnant.

3. How to use Azalia

This medicine should always be taken exactly as your doctor has advised.
If in doubt, consult your doctor or pharmacist.
Each Azalia blister pack contains 28 tablets. Arrows and abbreviations of the days of the week are printed on the front of the blister to help ensure correct use.
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 you start taking tablets on Wednesday, take the tablet from the top row marked "Mi" (Mi – Wednesday; see "Abbreviations of the days of the week appearing next to each tablet on the immediate packaging" at the end of this leaflet).
Continue taking one tablet daily until the blister pack 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 any other case, before starting a new blister pack, take the tablets located in the upper left corner of the blister.
This way, it is 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 the following day – without any break and without waiting for bleeding.

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 menstrual 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. In such cases, however, you must use additional contraceptive methods (mechanical methods) for the first 7 days of tablet intake.

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 taking 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 necessary.
At the latest, you may start taking Azalia on the day after the break period for tablets, vaginal ring, patch, or after taking the last placebo tablet of your current contraceptive. In this case, you must use additional contraceptive methods (mechanical methods) for the first 7 days of tablet intake.

Switching from a progestogen-only pill (mini-pill)
You may start taking Azalia 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 device (IUD) releasing progestogen
Start taking Azalia on the day when the next injection would have been due, or on the day of removal of the implant or IUD. There is no need to use additional contraceptive methods.

After childbirth
You may start taking Azalia between 21 and 28 days after delivery. If you start later, you must use an additional contraceptive method (mechanical methods) during the first cycle for the first 7 days of tablet intake.
However, if you have had sexual intercourse, pregnancy must be ruled out before starting Azalia. Additional information for breastfeeding women can be found under the section "Pregnancy and breastfeeding" in section 2. You should also consult your doctor.

After premature delivery or miscarriage
Consult your doctor.

Missed dose of Azalia
If you are less than 12 hours late taking your tablet
Take the missed tablet as soon as you remember, and take the next tablet at your usual time. The contraceptive effect of Azalia remains effective.

If you are more than 12 hours late taking your tablet
Take the missed tablet as soon as you remember, and take the next tablet at your 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 earlier missed tablets.) In this case, there is a possibility of becoming pregnant.
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 you miss, the greater the risk of reduced contraceptive effectiveness.
If you missed one or more tablets during the first week of use and had sexual intercourse in the week before the missed tablets, there is a possibility of pregnancy. Consult your doctor for advice.

If you vomit, have diarrhoea, or take activated charcoal
If you vomit or have severe diarrhoea, or take activated charcoal 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
No serious 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.

Stopping treatment with Azalia
You may stop taking Azalia at any time.
From the day you stop taking the tablets, you are no longer protected against pregnancy.
If you have any further doubts about using 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 have been described in section 2,
"Important information before taking Azalia". Please read these sections to obtain 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 reaction cannot be determined from the available data).
Irregular vaginal bleeding may occur during treatment with Azalia. This may be light spotting, not even requiring the use of sanitary pads, or heavier 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 no more than 1 in 10 women). Irregular bleeding does not mean that the contraceptive effect of Azalia is reduced. Usually, no action is necessary and continued use of Azalia is sufficient. 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 no more than 1 in 10 women):

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

Uncommon (may occur in no more than 1 in 100 women):

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

Rare (may occur in no more than 1 in 1000 women):

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

In addition to the adverse effects listed above, leakage or discharge from the breasts may occur.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 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

Store in the original packaging to protect from light and moisture.
No special temperature storage requirements.
Keep the medicine 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 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. Contents of the pack and other information

What Azalia contains
The active substance in Azalia 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 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 individually packed in an aluminium laminate sachet, inside a cardboard box.
Sachets containing blisters are packed into a cardboard box together with a patient leaflet and a cardboard pouch
for storage.
An additional cardboard pouch is included in the package, intended for storing the blister after removing it from
the aluminium laminate sachet.
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 Germany, the country of export:
Chemical Works of Gedeon Richter Plc., Gyömroi út 19-21, 1103 Budapest, Hungary

Manufacturer:
Chemical Works of 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, Poland

Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in Germany, the country of export: 81269.00.00
Parallel Import Licence Number: 191/24

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 abbreviations for days of the week printed on each tablet in the primary packaging:
Mo - Monday
Di - Tuesday
Mi - Wednesday
Do - Thursday
Fr - Friday
Sa - Saturday
So - Sunday
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