Azalia 75 micrograms film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azalia 75 micrograms film-coated tablets EFG

desogestrel

Read the entire leaflet carefully before you start 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Azalia 75 microgram 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 adverse 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 does it work?

Azalia contains a small amount of a type of female sex hormone, the progestogen desogestrel. For this reason, Azalia is known as a progestogen-only pill (POP) or mini-pill. Unlike combined contraceptives, POPs or mini-pills do not contain an oestrogen hormone and contain only a progestogen.

Most POPs work primarily by preventing sperm from entering the uterus, but do not always prevent the egg from maturing—which is the main action of combined contraceptives. Azalia differs from most POPs in that its dose is sufficiently high in most cases to prevent the egg from maturing. As a result, Azalia provides high contraceptive efficacy.

Unlike combined contraceptives, Azalia can be used by women who do not tolerate oestrogens and by women who are breastfeeding. A drawback is that irregular vaginal bleeding may occur while using Azalia. It is also possible to have no bleeding at all.

2. What you need to know before starting to take Azalia

Azalia, like other hormonal contraceptives, will not protect you against HIV infection (AIDS) or other sexually transmitted diseases.

Do not take Azalia

• If you are allergic to desogestrel or to any of the other components of this medicine (listed in section 6).
• If you have a 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).
• If you have or have had jaundice (yellowing of the skin) or severe liver disease and liver function (as shown by blood tests) has not returned to normal or is still not normal.
• If you have or are suspected of having a cancer sensitive to sex steroids, such as certain types of breast cancer.
• If you experience unexplained vaginal bleeding.

Inform your doctor before starting to take Azalia if any of these situations apply to you. Your doctor may advise you to use a non-hormonal method of contraception.

Contact your doctor immediately if any of these conditions occur for the first time while you are using Azalia.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Azalia.

Inform your doctor before starting to use Azalia if:

• you have or have had breast cancer;
• you have liver cancer, as a possible effect of Azalia cannot be excluded;
• you have or have ever had a thrombosis;
• you have diabetes;
• you suffer from epilepsy (see "Use of Azalia with other medicines");
• you suffer from tuberculosis (see "Use of Azalia with other medicines");
• you have high blood pressure;
• you have or have had chloasma (yellowish-brown pigmentation spots on the skin, especially on the face); in this case, avoid excessive exposure to sunlight or ultraviolet radiation.
• you have depression or mood changes.

When using Azalia under any of these conditions, close monitoring may be necessary. Your doctor can explain what you should do.

Breast cancer

Examine your breasts regularly and contact your doctor as soon as possible if you feel a lump.

Breast cancer has been found slightly more frequently in women taking oral contraceptives than in women of the same age who do not take them. If women stop taking oral contraceptives, the risk gradually decreases, so that 10 years after stopping, the risk is the same as in women who have never taken oral contraceptives. Breast cancer is rare under the age of 40, but the risk increases with age. Therefore, the number of extra cases of breast cancer is higher the older a woman is when she stops taking the contraceptive. The duration of contraceptive use is less important.

Among every 10,000 women who take oral contraceptives for 5 years and stop at age 20, there will be fewer than 1 additional case of breast cancer within 10 years after stopping, in addition to the 4 cases normally diagnosed in this age group. Similarly, among every 10,000 women who take oral contraceptives for 5 years and stop at age 30, there will be 5 additional cases in addition to the 44 cases normally diagnosed. Among every 10,000 women who take oral contraceptives for 5 years and stop at age 40, there will be 20 additional cases in addition to the 160 cases normally diagnosed.

It is believed that the risk of breast cancer in users of progestogen-only oral contraceptives like Azalia is similar to that in women using conventional combined oral contraceptives, but the evidence is less conclusive.

Breast cancers detected in women taking oral contraceptives appear to be less likely to have spread than those found in women not taking oral contraceptives. It is unclear whether this difference in breast cancer risk is due to the contraceptive. It may be that women were examined more frequently, so that breast cancer was detected earlier.

Thrombosis

If you notice signs of a possible thrombosis, contact your doctor immediately (see also “Periodic check-ups”).

Thrombosis is the formation of a blood clot that can block a blood vessel. Thrombosis often occurs in the deep veins of the legs (deep vein thrombosis). If this clot breaks loose from the veins where it formed, it can travel to and block the arteries in the lungs, causing a condition known as “pulmonary embolism.” This can lead to fatal outcomes. Deep vein thrombosis is rare. It can occur whether or not you take a contraceptive. It can also occur during pregnancy.

The risk is higher in users of hormonal oral contraceptives than in non-users. The risk in users of progestogen-only contraceptives like Azalia is believed to be lower than in users of combined oral contraceptives (which also contain estrogens).

Psychiatric disorders

Some women using hormonal contraceptives such as Azalia have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor for medical advice as soon as possible.

Children and adolescents

There are no clinical or safety data available in adolescents under 18 years of age.

Use of Azalia with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Also inform any other doctor or dentist who prescribes you medication (or your pharmacist) that you are taking Azalia. They can advise you whether you need to take additional contraceptive precautions (e.g., use condoms), and if so, for how long, or whether you should change the use of any other medication you need.

Some medicines may:

• affect the blood levels of Azalia,
• make it less effective in preventing pregnancy,
• cause unexpected bleeding.

This includes medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital),

• tuberculosis (e.g., rifampicin, rifabutin),

• HIV infections (e.g., ritonavir, nelfinavir, nevirapine, efavirenz),

• hepatitis C virus infections (e.g., boceprevir, telaprevir) or other infectious diseases

(e.g., griseofulvin),

• high blood pressure in the blood vessels of the lungs (bosentan),

• depression (the herbal remedy St. John’s wort),

• 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).

If you are taking medicines or herbal remedies that may reduce the effectiveness of Azalia, you should also use a barrier contraceptive method. Since the effect of other medicines on Azalia may last up to 28 days after stopping the medicine, it is necessary to use an additional barrier contraceptive method during this period. Your doctor can advise you whether additional contraceptive precautions are needed and, if so, for how long.

Azalia may also interfere with the action of other medicines, increasing their effect (e.g., medicines containing cyclosporine) or decreasing it (e.g., lamotrigine).

Consult your doctor or pharmacist before taking any medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not use Azalia if you are pregnant or suspect you may be pregnant.

Breastfeeding

Azalia can be used during breastfeeding. Azalia does not appear to affect the quantity or quality of breast milk. However, a decrease in breast milk production has been reported infrequently during use of Azalia. A small amount of the active ingredient in Azalia passes into breast milk. The health of children up to 2.5 years of age who were breastfed for 7 months by mothers taking desogestrel has been studied. No effects on growth and development of the children were observed.

If you are breastfeeding and wish to use Azalia, contact your doctor.

Driving and use of machines

There is no indication that the use of Azalia may affect attention or concentration.

Azalia contains lactose

Patients with lactose intolerance should be aware that Azalia tablets contain 52.34 mg of lactose (as lactose monohydrate). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Periodic check-ups

When taking Azalia, your doctor will ask you to have periodic check-ups. The frequency and nature of these check-ups will generally depend on your individual circumstances.

Contact your doctor as soon as possible if: you have severe pain or swelling in one of your legs, unexplained chest pain, shortness of breath, or unusual cough, especially if accompanied by blood-stained sputum (which may indicate thrombosis); you have sudden and severe stomach pain or jaundice (which may indicate liver problems); you feel a lump in your breast (which may indicate breast cancer); you experience sudden or severe pain in the lower abdomen or stomach area (which may indicate an ectopic pregnancy, a pregnancy outside the uterus); you need to remain immobile or are scheduled for surgery (consult your doctor at least four weeks in advance); you have unusual and heavy vaginal bleeding; you suspect you are pregnant.

3. How to take Azalia

Follow exactly the instructions for taking this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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 medicine correctly. Take the daily tablet at approximately the same time each day. Swallow each tablet whole with water.

Each time you start a new Azalia blister pack, take the tablet from the top row. For example, if you start on Wednesday, you should take the tablet in the top row marked “WED”.

Continue taking one tablet daily until the blister pack is empty, always following the direction indicated by the arrows. If you start on a Monday, the blister pack will be empty by the end of the arrows. However, if you start on any other day, before beginning a new pack you must take the remaining tablets in the upper corner of the current blister pack. This way, you can easily check whether you have taken your daily tablet. You may experience some bleeding while using Azalia (see “Possible side effects”), but you should continue taking the tablets as usual.

When a blister pack is empty, start a new pack of Azalia the next day—without interruption and without waiting for bleeding to occur.

How to start the first pack of Azalia

When no hormonal contraceptive has been used the previous month

Wait for your menstruation to begin. On the first day of your period, take the first tablet of Azalia. It is not necessary to use additional contraceptive precautions.

You may also start on days 2–5 of your cycle, but in this case, ensure you use an additional contraceptive method (barrier method) during the first 7 days of taking the tablets.

When switching from a combined oral contraceptive, vaginal ring, or transdermal patch

You may start taking Azalia the day after taking the last tablet of your current contraceptive pack, or on the day of removal of your vaginal ring or transdermal patch (meaning there will be no break without tablets, ring, or patch). If your current pack also contains inactive tablets, you may start taking Azalia the day after taking the last active tablet (if you are unsure which one this is, ask your doctor or pharmacist). If you follow these instructions, additional contraceptive precautions are not necessary.

You may also start at the latest on the day following the usual tablet-free, ring-free, or patch-free interval, or the placebo tablet interval of your current contraceptive. If you follow this advice, ensure you use an additional contraceptive method (barrier method) during the first 7 days of taking the tablets.

When switching from another progestogen-only contraceptive

You may stop taking it on any day and start taking Azalia immediately. You will not need to take additional contraceptive precautions.

When switching from an injection, implant, or intrauterine device (IUD) releasing progestogen

Start taking Azalia on the day your next injection is due, or on the day your implant or IUD is removed. Additional contraceptive precautions are not necessary.

After giving birth

You may start taking Azalia between 21–28 days after the birth of your baby. If you start later, during the first cycle ensure you use an additional contraceptive method (barrier method) during the first 7 days of taking the tablets. However, if you have already had sexual intercourse, you must rule out pregnancy before starting Azalia. Additional information for breastfeeding women can be found under “Pregnancy and breastfeeding” in section 2. Your doctor can also advise you.

After a miscarriage

Your doctor will advise you.

If you forget to take Azalia

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

If you are more than 12 hours late taking your tablet, the effectiveness of Azalia may be reduced.

The more consecutive tablets you miss, the greater the risk that contraceptive protection will decrease.

Take the most recently missed tablet as soon as you remember and take the following tablets at your usual time. Use an additional contraceptive method (barrier method) for the next 7 days while taking the tablets.

If you have missed one or more tablets during the first week of tablet intake and have had sexual intercourse in the week before missing the tablets, there is a possibility you could become pregnant. Seek advice from your doctor.

If you experience gastrointestinal disturbances (e.g. vomiting, severe diarrhoea)

Follow the same advice as when you miss a tablet, described above. If you vomit or use activated charcoal within 3–4 hours after taking the tablet, or have had severe diarrhoea, the active ingredient may not have been completely absorbed.

If you take more Azalia than you should

No serious harmful effects have been reported after taking too many Azalia tablets at once. Symptoms that may occur include nausea, vomiting, and, in young women, slight vaginal bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 915620420, indicating the medicine and amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you stop taking Azalia

You may stop taking Azalia at any time. From the day you stop taking it, you will no longer be protected against pregnancy.

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

4. Possible adverse effects

Like all medicines, Azalia may cause adverse effects, although not everyone will experience them.

Serious adverse effects associated with the use of Azalia are described in section 2, “What you need to know before starting to take Azalia”. For further information, read this section and consult your doctor immediately when appropriate.

Contact your doctor immediately if you experience allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat causing difficulty breathing or swallowing (angioedema and/or anaphylaxis) (The frequency of this adverse effect cannot be estimated from the available data).

Irregular vaginal bleeding may occur during use of Azalia. This may be only slight spotting, which may not require a sanitary pad, or heavier bleeding resembling a light menstruation that requires hygiene protection. It may also happen that you do not have any bleeding at all. These adverse effects are common (may affect up to 1 in 10 users). Irregular bleeding is not a sign that the contraceptive protection of Azalia is reduced. In general, no action is needed; simply continue taking Azalia. However, if the bleeding is heavy or prolonged, consult your doctor.

Users of desogestrel have reported the following adverse effects:

Common (may affect up to 1 in 10 users):

• Mood alteration
• Depression
• Decreased sexual desire (libido)
• Headache
• Nausea
• Acne
• Breast tenderness
• Increase in body weight

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

• Vaginal infection
• Difficulties in wearing contact lenses
• Vomiting
• Hair loss
• Painful menstruation
• Ovarian cyst
• Fatigue

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

• Rash
• Urticaria
• Painful blue-red lumps (erythema nodosum) (these are skin disorders)

In addition to these adverse effects, breast discharge or milk leakage may occur.

Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azalia

Keep in the original packaging to protect it from light and moisture.

This medicine does not require any special storage temperature conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging (EXP). The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azalia

The active substance is desogestrel. One film-coated tablet contains 75 micrograms of desogestrel.

The other components are:

Tablet core:

Lactose monohydrate

Sodium carboxymethyl starch (type A) (derived from potato starch)

Povidone K-30

Colloidal anhydrous silica

Stearic acid

all-rac-?-tocoferol

Tablet coating:

Polyvinyl alcohol

Titanium dioxide, E171

Macrogol 3000

Talc

Appearance of the product and contents of the pack

Azalia is a white or almost white, round, biconvex, film-coated tablet with a diameter of approximately 5.5 mm, marked with a "D" on one side and "75" on the other.

Azalia is packaged in a hard, transparent PVC/PVDC-Aluminum blister. Each blister is placed into a laminated aluminum pouch. The pouches containing the blisters are included in a cardboard box which also contains a patient leaflet and a storage bag.

Pack sizes: 1x28, 3x28, 6x28, 13x28 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Gedeon Richter Plc.

Gyömroi út 19-21

1103, Budapest, Hungary

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Gedeon Richter Ibérica S.A.

Sabino Arana, 28 4º 2º

08028 Barcelona

+34 93 2034300

This medicine is authorised in the Member States of the European Economic Area under the following names:

DESOCEANE in Belgium

AZALIA in Denmark

AZALIA 75 microgram film-coated tablets EFG in Spain

AZALIA in Finland

AZALIA 75 microgram film-coated tablets in Ireland

AZALIA in Italy

DESOCEANE in Luxembourg

AZALIA in Norway

AZALIA in Portugal

AZALIA in Sweden

Date of the most recent review of this leaflet: 09/2021

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es