Azalia

Package leaflet: Information for the user

Azalia 75 micrograms film-coated tablets

Desogestrel
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others; it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Azalia 75 micrograms film-coated tablets (hereinafter 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 to prevent pregnancy. Azalia contains a small amount of a type of female sex hormone, the progestin desogestrel. For this reason, Azalia is known as a progestin-only pill or mini-pill. Unlike combined-type pills, the mini-pill does not contain oestrogen hormones, but only a progestin.
Most progestin-only pills work primarily by preventing sperm from reaching the uterus, but they do not always inhibit maturation of the egg cell, which is the main mechanism of action of combined-type pills. Azalia differs from other progestin-only pills because its dosage is sufficiently high to prevent, in most cases, maturation of the egg cell and thus ensures high contraceptive efficacy.
Unlike combined-type pills, Azalia can be used by women who do not tolerate oestrogens and by women who are breastfeeding. A disadvantage is irregular vaginal bleeding, which may occur during use of Azalia. It is also possible that no bleeding occurs at all.

2. What you should know before taking Azalia

Like other hormonal contraceptives, Azalia does not protect against HIV (AIDS) infection or other
sexually transmitted diseases.
Do not take Azalia

• If you are allergic to desogestrel or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have had thrombosis. Thrombosis is the formation of a blood clot in a blood vessel (e.g. in the legs (deep vein thrombosis), or in the lungs (pulmonary embolism)).

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• If you have or have had jaundice (yellowing of the skin) or severe liver disease and your liver function (as determined by blood laboratory tests) has not yet returned to normal.
• If you have or suspect you have a tumour sensitive to sex steroids, such as certain types of breast cancer.
• If you have any unexplained vaginal bleeding.

Inform your doctor before starting to use Azalia if any of these conditions apply to you. Your doctor may
advise you to use a non-hormonal method of birth control.
Contact your doctor immediately if any of these conditions occur for the first time
while taking Azalia.
Warnings and precautions
Talk to your doctor or pharmacist before taking Azalia.
Inform your doctor before starting to take Azalia:

• if you have or have ever had breast cancer;
• if you have liver tumour, as a possible effect of Azalia cannot be ruled out;
• if you have or have ever had thrombosis;
• if you have diabetes;
• if you suffer from epilepsy (see "Other medicines and Azalia");
• if you suffer from tuberculosis (see “Other medicines and Azalia”);
• if you have high blood pressure;
• if you have or have had chloasma (patchy yellow-brown skin pigmentation, especially on the face); in this case avoid excessive exposure to sunlight or ultraviolet radiation;
• if you suffer from depression or mood changes.

When Azalia is used in the presence of any of these conditions, you may need
to be closely monitored. Your doctor will explain what to do.
Breast cancer
Perform regular breast examinations and contact your doctor promptly if you notice any breast lumps.
Breast cancer has been diagnosed slightly more often in women taking the pill
than in women of the same age who do not use it. If you stop taking the pill, the
risk gradually decreases until, 10 years after stopping treatment, the risk returns to the
same level as in women who have never used the pill. Breast cancer is rare in women under
40 years of age, but the risk increases with age. Therefore, the number of additional cases of diagnosed breast cancer is greater the older the age at which a woman continues taking the pill. The duration of pill use is less relevant.
Among 10,000 women who take the pill for up to 5 years and stop before age 20, fewer than 1 additional case of breast cancer is expected to be diagnosed in the 10 years following discontinuation, in addition to the 4 cases normally diagnosed in this age group. Similarly, among 10,000 women who take the pill for up to 5 years and stop before age 30, 5 additional cases are expected in addition to the 44 normally diagnosed. Among 10,000 women who take the pill for up to 5 years and stop before age 40, 20 additional cases are expected in addition to the 160 normally diagnosed.
It is believed that the risk of breast cancer in women using progestogen-only pills such as Azalia is similar to that in women using combined oral contraceptives, but the evidence is less conclusive.
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Breast cancers diagnosed in women taking the pill appear to be less advanced,
compared to breast cancers diagnosed in women not taking the pill. It is not known whether
the difference in breast cancer risk is caused by the pill. It is possible that women who take
the pill undergo more frequent check-ups, leading to earlier diagnosis of breast cancer.
Thrombosis
Contact your doctor immediately if you notice possible signs of thrombosis (see also
section “Regular periodic checks”).
Thrombosis is the formation of a blood clot that may block a blood vessel. Sometimes thrombosis occurs in the deep veins of the legs (deep vein thrombosis). If the clot detaches from the vein where it formed, it may travel to and block the pulmonary arteries, causing what is known as “pulmonary embolism”. This may lead to fatal outcomes. Deep vein thrombosis is rare and may occur whether or not you take the pill. It may also occur if you become pregnant.
The risk is higher in women taking the pill compared to women who do not use it. The risk of thrombosis with progestogen-only pills such as Azalia is considered to be lower than with pills containing oestrogen (combined pills).
Psychiatric disorders
Some women using hormonal contraceptives, including Azalia, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice.
Children and adolescents
There are no clinical safety and efficacy data available for adolescents under 18 years of age.
Other medicines and Azalia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Also, inform any other doctor or dentist who is prescribing another medicine (or the pharmacist) that you are taking Azalia.
They will advise you whether you need to use additional contraceptive measures (e.g. condom), and if so, for how long, or whether it is necessary to adjust the use of another medicine you require.
Some medicines:

• may interfere with blood levels of Azalia.
• may reduce the effectiveness of pregnancy prevention.
• 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);
• other infections (e.g.: griseofulvin);
• high blood pressure in the lung arteries (pulmonary hypertension) (bosentan);
• depressive mood disorders (St. John’s wort herbal remedy);
• certain bacterial infections (e.g.: clarithromycin, erythromycin);
• fungal infections (e.g.: ketoconazole, itraconazole, fluconazole);
• high blood pressure (hypertension), angina or certain heart rhythm disorders (e.g.: diltiazem).

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If you are taking medicines or herbal products that may reduce the effectiveness of Azalia, you must also use a barrier contraceptive method. Since the effect of another medicine on Azalia may last up to 28 days after stopping the medicine, you must continue using the additional barrier contraceptive method for the same period. Your doctor can advise you whether you need to take additional contraceptive precautions and, if so, for how long.
Azalia may also interfere with the action of certain medicines, causing an increase (e.g. medicines containing cyclosporine) or a decrease in their effect (e.g. lamotrigine).
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use Azalia if you are pregnant or think you may be pregnant.
Breastfeeding
Azalia may be used during breastfeeding. Azalia does not appear to affect the quantity or quality of breast milk. However, rare cases of decreased breast milk production have been reported during use of Azalia. A small amount of the active ingredient in Azalia passes into breast milk.
Studies have been conducted on the health of children breastfed for 7 months up to 2.5 years of age whose mothers were taking desogestrel. No effects on children's growth and development were observed.
If you are breastfeeding and wish to take Azalia, contact your doctor.
Driving and using machines
There are no indications of any effect of Azalia on alertness or concentration.
Azalia contains lactose
Patients with lactose intolerance should be informed that Azalia tablets contain
52.34 mg of lactose (as monohydrate lactose).
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
Regular periodic checks
While taking Azalia, your doctor will advise you to return for regular periodic check-ups. In general, the frequency and nature of these checks will depend on your individual health status.
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Contact your doctor as soon as possible if:

• you experience severe pain or swelling in one of your legs, unexplained chest pain, shortness of breath, or unusual cough, especially with blood (indicating possible thrombosis);
• you experience sudden, severe stomach pain or have a yellowish skin tone (indicating possible liver problems);
• you notice a lump in your breast (indicating possible breast cancer);
• you experience sudden or severe lower abdominal or stomach pain (indicating possible ectopic pregnancy);
• you need to be immobilized or undergo surgery (contact your doctor at least four weeks in advance);
• you have unusual and heavy vaginal bleeding;
• you suspect pregnancy.

3. How to take Azalia

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Each Azalia blister pack contains 28 tablets. On the front of the blister, arrows and the days of the week are printed to help you take the pill correctly. Take one tablet daily at about the same time each day. Swallow the tablet whole with water.
Each time you start a new Azalia blister pack, begin with the top row. For example, if you start on Wednesday, take the tablet from the top row marked WED.
Continue taking one tablet every day until the pack is empty, always following the direction of the arrows. If you start on Monday, the pack will be empty by the end of the arrows, but before starting a new pack, you must use the tablets remaining in the top corner of this pack. This way, you can easily check whether you have taken your daily tablet.
Bleeding may occur while using Azalia (see section “Possible side effects”), but you must continue taking the tablet as usual.
Once you have finished the blister pack, start a new pack of Azalia the next day—without interruption and without waiting for bleeding to begin.

Starting the first pack of Azalia

If you have not used any hormonal contraceptive in the previous month
Wait for the onset of your menstrual period. Take the first tablet of Azalia on the first day of your cycle. No additional contraceptive measures are necessary.
You may also start between the second and fifth day of your cycle; however, in this case, make sure to use additional contraceptive methods (barrier method) during the first seven days of tablet intake.

Switching from a combined oral contraceptive pill, vaginal ring, or transdermal patch
You may start taking Azalia the day after taking the last active tablet of your previous pill, or the day you remove the vaginal ring or transdermal patch (meaning no pill-free, ring-free, or patch-free interval). If your previous contraceptive pack contains inactive tablets, you may start Azalia the day after taking the last active tablet (if you are unsure which tablet this is, consult your doctor or pharmacist). If you follow these instructions, no additional contraceptive measures are necessary.
Alternatively, you may start at the latest the day after the treatment-free interval of your previous pill, ring, or patch, or the day after taking the last placebo tablet of your previous contraceptive. If you follow this approach, ensure you use additional contraceptive methods (barrier method) for the first 7 days of tablet intake.

Switching from a progestogen-only pill
You may stop taking the previous contraceptive at any time and start taking Azalia immediately. No additional contraceptive measures are necessary.

Switching from a progestogen-releasing injectable contraceptive, implant, or intrauterine device (IUD)
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. No additional contraceptive measures are necessary.

After childbirth
You may start taking Azalia between day 21 and day 28 after the birth of your baby. If you start later, ensure you use additional contraceptive methods (barrier method) during the first cycle of treatment, for the first 7 days of tablet intake. However, if you have already had sexual intercourse, pregnancy must be ruled out before starting Azalia.
For breastfeeding women, further information is provided in section 2, “Pregnancy and breastfeeding”. Your doctor can also advise you on this.

After a pregnancy termination or spontaneous abortion
Your doctor will advise you accordingly.

If you forget to take Azalia

If the delay in taking the tablet is less than 12 hours, the effectiveness of Azalia remains unchanged. Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.

If the delay in taking any tablet is more than 12 hours, the effectiveness of Azalia may be reduced.
The greater the number of consecutive missed tablets, the higher the risk that contraceptive protection decreases.
Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time. Also use an additional contraceptive method (barrier method) for the next 7 days of tablet intake.

If you have missed one or more tablets during the first week of intake and had sexual intercourse in the week before the missed tablets, there is a possibility you may have become pregnant. Consult your doctor.

If you experience gastrointestinal disturbances (e.g., vomiting, severe diarrhoea)
Follow the advice regarding missed tablets in the section above. If vomiting or severe diarrhoea occurs within 3–4 hours after taking the tablet, absorption of the active substance may not be complete.

If you take more Azalia than you should
There is no evidence of serious harmful effects from taking an excessive number of Azalia tablets at once. In such cases, symptoms such as nausea, vomiting, and slight vaginal bleeding in young women may occur. For further information, consult your doctor.

If you stop taking Azalia
You may stop taking Azalia at any time. From the day you stop, you are no longer protected against pregnancy.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects associated with the use of Azalia are described in section 2, "What you need to know before taking Azalia". Please read this section for further information and, if necessary, consult your doctor immediately.
You must contact your doctor immediately if you experience allergic reactions (hypersensitivity), 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 while taking Azalia. This may consist of light spotting without the need for sanitary protection, or heavier bleeding comparable to a light menstrual period, requiring the use of sanitary pads. Bleeding may also not occur at all. These are common side effects (may affect up to 1 in 10 people). The presence of irregular bleeding does not indicate a reduction in contraceptive protection with Azalia. Generally, no action is required and you should continue taking Azalia as usual. However, if the bleeding is heavy or persists, inform your doctor.
The following other side effects have been reported in women taking desogestrel:
Common (may affect up to 1 in 10 people):

• mood changes,
• depression,
• decreased libido,
• headache,
• nausea,
• acne,
• breast pain,
• weight gain.

Uncommon (may affect up to 1 in 100 people):

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

Rare (may affect up to 1 in 1,000 people):

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

In addition to the side effects listed above, breast discharge or leakage may occur.
Reporting of side effects
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If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Azalia

Keep in the original packaging to protect the medicine from light and moisture.
This medicine does not require any special storage temperature.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Azalia contains
The active substance is desogestrel. One film-coated tablet contains 75 micrograms of
desogestrel.
The other components are:
Tablet core:
Monohydrate lactose
Potato starch
Povidone K-30
Anhydrous colloidal silicon dioxide
Stearic acid
\α-Tocopherol, all-racemic
Coating:
Polyvinyl alcohol
Titanium dioxide E171
Macrogol 3000
Talc

Description of the appearance of Azalia and package contents
Azalia is a white or almost white, round, biconvex, film-coated tablet of approximately 5.5 mm in diameter, marked with the letter “D” on one side and “75” on the other.
Azalia film-coated tablets are packaged in a blister made of transparent rigid PVC/PVDC – aluminium foil. Each blister is placed in a laminated aluminium pouch. The blisters in the pouches are packed in a folding cardboard box together with the leaflet and a small case for storing the blister.
Pack sizes: 1x28, 3x28, 6x28, 13x28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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Gedeon Richter Plc.
Gyömrői út 19-21
1103, Budapest
Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: AZALIA
Belgium: DESOCEANE
Ireland: AZALIA 75 microgram film-coated tablets
Italy: AZALIA
Luxembourg: DESOCEANE
Spain: AZALIA
Portugal: AZALIA
Finland: AZALIA
Norway: AZALIA
Sweden: AZALIA
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