AZALIA 75 micrograms FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Azalia75 micrograms film-coated tablets EFG

desogestrel

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Azalia 75 micrograms film-coated tablets (hereafter referred to as Azalia) and what is it used for
2. What you need to know before you start taking Azalia
3. How to take Azalia
4. Possible side effects
5. Storage of Azalia
6. Contents of the pack and other information

1. What is Azalia and what is it 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 called a progestogen-only pill (POP) or mini-pill. Unlike combined contraceptives, POPs or mini-pills do not contain an estrogenic hormone and only contain a progestogen.

Most POPs work mainly by preventing sperm from entering the uterus, but they do not always prevent the egg from ripening, which is the main action of combined contraceptives. Azalia differs from most POPs in that it has a dose that is usually high enough to prevent the egg from ripening. As a result, Azalia offers high contraceptive efficacy.

Unlike combined contraceptives, Azalia can be used by women who do not tolerate estrogens and by women who are breastfeeding. A drawback is that during the use of Azalia, vaginal bleeding may occur at irregular intervals. It is also possible that you may not have any bleeding.

2. What you need to know before you start taking 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 any of the other ingredients 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 your liver function (as determined by blood tests) has not returned to normal or is still not normal.
• If you have or are suspected to have a cancer that is sensitive to sex steroids, such as some types of breast cancer.
• If you have unexplained vaginal bleeding.

Tell your doctor before you start taking Azalia if any of these conditions apply to you. Your doctor may advise you to use a non-hormonal method of birth control.

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

Warnings and precautions

Consult your doctor or pharmacist before you start taking Azalia.

Tell your doctor before you start using Azalia if:

• you have or have had breast cancer;
• you have liver cancer, as it cannot be excluded that Azalia may have an effect;
• you have or have had a thrombosis;
• you have diabetes;
• you suffer from epilepsy (see "Using Azalia with other medicines");
• you suffer from tuberculosis (see "Using 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, you should avoid excessive exposure to the sun or ultraviolet radiation.
• you have depression or mood changes.

When Azalia is used in the presence of any of these conditions, strict monitoring may be necessary. Your doctor can explain what you need to do.

Breast cancer

Regularly examine your breasts and contact your doctor as soon as possible if you feel any lump in them.

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

In every 10,000 women who take oral contraceptives for 5 years but stop taking them at the age of 20, there will be less than 1 extra case of breast cancer until 10 years after stopping the contraceptives, in addition to the 4 cases that are normally diagnosed in this age group. Similarly, in every 10,000 women who take oral contraceptives for 5 years but stop taking them at the age of 30, there will be 5 extra cases in addition to the 44 cases that are normally diagnosed. In every 10,000 women who take oral contraceptives for 5 years but stop taking them at the age of 40, there will be 20 extra cases in addition to the 160 cases that are normally diagnosed.

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

The breast cancers that are discovered in women who take oral contraceptives seem to have a lower probability of having spread than the breast cancers that are discovered in women who do not take oral contraceptives. It is not clear whether this difference in breast cancer risk is due to the contraceptive. It may be that women are examined more frequently, so that breast cancer is detected earlier.

Thrombosis

If you notice signs of a possible thrombosis, go to your doctor immediately (see also "Regular check-ups").

Thrombosis is the formation of a blood clot that can block a blood vessel. It often occurs in the deep veins of the legs (deep vein thrombosis). If this clot breaks loose from the veins where it has formed, it can reach and block the arteries of the lungs, causing a so-called "pulmonary embolism". As a result, life-threatening situations can occur. Deep vein thrombosis is rare. It can occur whether or not you are taking the contraceptive. It can also occur if you are pregnant.

The risk is higher in users of oral contraceptives than in non-users. It is believed that the risk in users of progestogen-only contraceptives like Azalia is lower than in users of oral contraceptives that also contain estrogens (combined oral contraceptives).

Psychiatric disorders

Some women who use hormonal contraceptives like Azalia have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and symptoms of depression, contact your doctor for additional medical advice as soon as possible.

Children and adolescents

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

Using Azalia with other medicines

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

Also, inform any other doctor or dentist that you are taking Azalia. They may tell you if you need to take additional contraceptive precautions (e.g. use a condom) and if so, for how long, or if you need to change the use of any other medicine that you need.

Some medicines may:

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

This includes medicines used for the treatment of:

• 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),
• depressive states (the herbal remedy St. John's Wort),
• certain bacterial infections (e.g. clarithromycin, erythromycin),

fungal infections (e.g. ketoconazol, itraconazol, fluconazol),

• high blood pressure, angina, or certain heart rhythm disorders) (e.g. diltiazem),

If you are taking medicines or herbal remedies that may make Azalia less effective, you should also use a barrier contraceptive method. Since the effect of other medicines on Azalia can last up to 28 days after stopping that medicine, it is necessary to use the additional barrier contraceptive method during that 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 other medicines, resulting in an increased effect (e.g. medicines containing ciclosporin) or a decreased effect (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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

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

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

Driving and using machines

There are no indications that the use of Azalia may affect attention or concentration.

Azalia contains lactose

Patients with lactose intolerance should know that Azalia film-coated tablets contain 52.34 mg of lactose (as lactose monohydrate). If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

Regular check-ups

When you are taking Azalia, your doctor will ask you to have regular check-ups. In general, the frequency and nature of these check-ups will depend on your personal situation.

3. How to take Azalia

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Each Azalia blister pack contains 28 tablets. On the front of the blister pack, there are printed arrows and the day of the week, which will help you take the medication correctly. Take the daily tablet approximately at the same time every day. Swallow each tablet whole with water.

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

You should continue taking one tablet a day until the blister pack is empty, always following the direction indicated by the arrows. If you start on a Monday, at the end of the arrows the blister pack will be empty, but in any other case, before starting a new blister pack, you should take the tablets that remain in the top corner of this blister pack. This way, you can easily check if you have taken the daily tablet. You may experience some bleeding during the use of Azalia (see "Possible side effects"), but you should continue taking the tablets normally.

When a blister pack is empty, the next day you should start a new Azalia pack - without interruption and without waiting for bleeding to appear.

How to start the first Azalia pack

When you have not used a hormonal contraceptive the previous month

Wait for your menstruation to begin. On the first day of your period, take the first Azalia tablet. You do not need to take additional contraceptive precautions.

You can also start on days 2-5 of your cycle, but in that case, make sure to use an additional contraceptive method (barrier method) during the first 7 days you take the tablets.

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

You can start taking Azalia the day after you take the last tablet of your current contraceptive pack, or the day you remove your vaginal ring or transdermal patch (this means there will be no break without tablets, ring, or patch). If your current pack also contains inactive tablets, you can start taking Azalia the day after you take the last active tablet (if you are not sure which one it is, ask your doctor or pharmacist). If you follow these instructions, you do not need to take additional contraceptive precautions.

You can also start at the latest the day after your usual period without tablets, ring, or patch, or placebo tablets of your current contraceptive. If you follow these instructions, make sure to use an additional contraceptive method (barrier method) during the first 7 days of taking the tablets.

When switching from another progestin-only contraceptive

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

When switching from an injection or an implant or an intrauterine device (IUD) that releases progestin

Start taking Azalia the day you are due for your next injection or the day your implant or IUD is removed. You do not need to take additional contraceptive precautions.

After having a baby.

You can start taking Azalia between 21-28 days after the birth of your baby. If you start later, in the first cycle, make sure to use an additional contraceptive method (barrier method) during the first 7 days you take the tablets. However, if you have already had sexual intercourse, you should rule out pregnancy before starting to use Azalia. You can find additional information for breastfeeding women in "Pregnancy and breastfeeding" in section 2. Your doctor may also advise you.

After an abortion.

Your doctor will advise you.

If you forget to take Azalia

If you are less than 12 hourslate in taking the tablet, the reliability of Azalia is maintained. Take the forgotten tablet as soon as you remember and take the following tablets at the usual time.

If you are more than 12 hourslate in taking the tablet, the reliability of Azalia may be reduced.

The more consecutive tablets you have forgotten, the higher the risk that the contraceptive efficacy will decrease.

Take the last forgotten tablet as soon as you remember and take the following tablets at the usual time. Use an additional contraceptive method (barrier method) also during the next 7 days you take the tablets.

If you have forgotten one or more tablets during the first week of taking tablets and have had sexual intercourse the week before you forgot the tablets, there is a possibility that you may become pregnant. Ask your doctor for advice.

If you have a gastrointestinal disorder (e.g., vomiting, severe diarrhea)

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

If you take more Azalia than you should

No serious harmful effects have been reported after taking too many Azalia tablets at once. The symptoms that may appear are nausea, vomiting, and in young women, mild vaginal bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount used. It is recommended to take the medication package and leaflet to the healthcare professional.

If you stop taking Azalia

You can stop taking Azalia whenever you want. From the day you stop taking it, you will no longer be protected against pregnancy.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Azalia can cause side effects, although not everyone will experience them.

Serious side effects associated with the use of Azalia are described in section 2 "What you need to know before taking Azalia". For more information, read this section and consult your doctor immediately when necessary.

Consult your doctor immediatelyif you experience allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat that cause difficulty breathing or swallowing (angioedema and/or anaphylaxis) (The frequency of this side effect cannot be estimated from the available data).

Vaginal bleeding at irregular intervals may occur during the use of Azalia. This may be only a slight spotting that may not require a pad or a more intense bleeding that resembles a scarce menstruation that requires hygiene protection. You may also not experience any bleeding. These side effects are common (may affect up to 1 in 10 users). Irregular bleeding is not a sign that the contraceptive protection of Azalia decreases. In general, you do not need to do anything, just continue taking Azalia. However, if the bleeding is intense or prolonged, consult your doctor.

Users of desogestrel have reported the following side effects:

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

• mood changes
• depression
• decreased sexual desire (libido)
• headache
• nausea
• acne
• breast tenderness
• weight gain

Uncommon (may affect up to 1 in 100 users)

• vaginal infection
• difficulty wearing contact lenses
• vomiting
• hair loss
• painful menstruation
• ovarian cyst
• fatigue

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

• rash
• hives
• painful blue-red bumps (erythema nodosum) (these are skin diseases)

Aside from these side effects, breast secretion or milk loss may occur.

Reporting side effectsif you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Azalia

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

This medication does not require any special storage temperature.

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

Do not use this medication after the expiration date shown on the package (EXP). The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Azalia composition

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

The other ingredients are:

Core of the tablet:

Lactose monohydrate

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

Povidone K-30

Colloidal anhydrous silica

Stearic acid

all-rac-α-tocopherol

Tablet coating:

Polyvinyl alcohol

Titanium dioxide, E171

Macrogol 3000

Talc

Product appearance and package contents

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

Azalia is packaged in a PVC/PVDC-aluminum hard and transparent blister pack. Each blister pack is inserted into a laminated aluminum pouch. The pouches with the blister packs are included in a cardboard box that contains a leaflet and a storage bag.

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Gedeon Richter Plc.

Gyömroi út 19-21

1103, Budapest, Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Gedeon Richter Ibérica S.A.

Sabino Arana, 28 4º 2º

08028 Barcelona

+34 93 2034300

This medication is authorized in the Member States of the European Economic Area under the following names:

DESOCEANE in Belgium

AZALIA in Denmark

AZALIA 75 micrograms 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 last revision of this leaflet:09/2021

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