Package Insert: Information for the User

Azalia75 microgram tablets coated with EFG film

desogestrel

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 not listed in this package insert.See section 4.

Azalia is used to prevent pregnancy.

How does it work?

Azalia contains a small amount of a type of female sex hormone, the progestin desogestrel. For this reason, Azalia is called a progestin-only pill (POP) or mini-pill. Unlike combined contraceptives, POPs or mini-pills do not contain estrogenic hormones, and only contain a progestin.

Most POPs primarily prevent 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 it has a dose that is high enough in most cases to prevent the egg from maturing. As a result, Azalia offers a high level of contraceptive efficacy.

Unlike combined contraceptives, Azalia can be used by women who do not tolerate estrogens and by breastfeeding women. A drawback is that during the use of Azalia, irregular vaginal bleeding may occur at irregular intervals. It is also possible that there will be no bleeding.

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

Do not take Azalia

• If you are allergic to desogestrel or any of the other components of this medication (listed in section 6).
• If you have a blood clot. A blood clot is the formation of a blood clot in a blood vessel, for example, in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you have or have had jaundice (the skin turns yellow) or a severe liver disease and your liver function (according to blood tests) has not returned to normal or is not yet normal.
• If you have or suspect you have a cancer that is sensitive to sex steroids, such as some types of breast cancer.
• If you experience any 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 birth control method.

Consult your doctor immediately if any of these situations occur for the first time while using Azalia.

Warnings and precautions

Consult 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 it cannot be ruled out that Azalia may have an effect;
• You have or have had a blood clot;
• You have diabetes;
• You have epilepsy (see "Use of Azalia with other medications");
• You have tuberculosis (see "Use of Azalia with other medications");
• You have high blood pressure;
• You have or have had melasma (brown-yellow patches 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 using Azalia in the presence of any of these situations, it may be necessary to have a strict control. Your doctor may explain what you should do.

Breast cancer

Have your breasts regularly examined and contact your doctor as soon as possible if you feel any lumps in them.

Breast cancer has been found more frequently in women taking oral contraceptives than in women of the same age who are not taking them. If women stop taking oral contraceptives, the risk decreases gradually, so that 10 years after stopping the oral contraceptives, the risk is the same as that of women who have never taken oral contraceptives. Breast cancer is rare under 40 years of age, but the risk increases with the age of the woman. Therefore, the number of extra breast cancers is higher if the woman continues to take the contraceptive for a longer period. The time taken by the contraceptive is less important.

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

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

The breast cancers found in women taking oral contraceptives seem to have a lower probability of having spread than the breast cancers found in women not taking oral contraceptives. It is not clear if this difference in breast cancer risk is due to the contraceptive. Women may be examined more frequently, so that breast cancer is detected earlier.

Thrombosis

If you detect 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 appears in the deep veins of the legs (deep vein thrombosis). If this clot breaks away from the veins where it formed, it can reach and block the arteries of the lungs, causing a condition called "pulmonary embolism." As a result of this, fatal situations can occur. Deep vein thrombosis is rare. It can occur whether or not you take the contraceptive. It can also occur if you become pregnant.

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

Mental health disorders

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

Children and adolescents

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

Use of Azalia with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

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

Some medications may:

-Affect the levels of Azalia in the blood,

-Make it less effective in preventing pregnancy,

-Produce unexpected bleeding.

This includes medications 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),

-Mood disorders (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 medications or herbal remedies that may make Azalia less effective, you should also use a barrier contraceptive method. Since the effect of other medications on Azalia can last up to 28 days after stopping that medication, you need to use the additional barrier contraceptive method during that period. Your doctor may advise you if you need to take additional contraceptive precautions and, if so, for how long.

Azalia may also interfere with the functioning of other medications, producing an increase in their effect (e.g., medications containing cyclosporine) or a decrease in their effect (e.g., lamotrigine).

Consult your doctor or pharmacist before taking any medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant, or if you intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

Azalia can be used during breastfeeding. Azalia does not appear to affect milk production or milk quality. However, with rare frequency, a decrease in milk production has been reported during the use of Azalia. A small amount of the active ingredient in Azalia passes into breast milk. A study has been conducted on the health of children up to 2.5 years of age who were fed breast milk for 7 months by mothers taking desogestrel. 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 operating machinery

There is no indication that the use of Azalia may have any effect on attention and concentration.

Azalia contains lactose

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

Regular check-ups

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

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

Each blister of Azalia contains 28 tablets. On the front of the blister, 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.

Each time you start a new blister of Azalia, 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 "MIE".

You must continue taking one tablet a day, until the blister is empty, always following the direction indicated by the arrows. If you start on a Monday, the blister will be empty at the end of the arrows, but in any other case, before starting a new blister, you should take the remaining tablets from the top corner of this blister. In 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 is empty, the next day you should start a new pack of Azalia – without interruption and without waiting for bleeding to appear.

How to start the first pack of Azalia

When you have not used a hormonal contraceptive the previous month

Wait for your period to start. Take the first tablet of Azalia on the first day of your period. 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 that 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 taking the last tablet of the current contraceptive pack, or the day of removal of your vaginal ring or transdermal patch (this means that there will be no break without tablets, ring, or patch). If the current pack also contains inactive tablets, you can start taking Azalia the day after taking the last active tablet (if you are not sure which one 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 the usual period without tablets, ring, or patch, or the day after the placebo tablets of the 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 on any day and start taking Azalia immediately. You will not need to take additional contraceptive precautions.

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

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

After giving birth

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 that you take the tablets. However, if you have already had sex, 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 can also advise you.

After an abortion

Your doctor will advise you.

If you forget to take Azalia

If you delayless than 12 hoursin taking the tablet, the reliability of Azalia is maintained. Take the missed tablet as soon as you remember and take the next tablets at the usual time.

If you delaymore than 12 hoursin taking the tablet, the reliability of Azalia may be reduced.

The more consecutive tablets you have forgotten, the greater the risk of reduced contraceptive efficacy.

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

If you have forgotten one or more tablets in the first week of taking the tablets and had sex the week before forgetting the tablets, there is a possibility of becoming pregnant. Ask your doctor for advice.

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

Follow the same advice as when you forget a tablet, described above. If you vomit or use activated charcoal within 3-4 hours of 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 adverse effects have been reported after taking too many tablets of Azalia at once. The symptoms that may appear are nausea, vomiting, and, in young women, light 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 bring the packaging and the medication leaflet to the healthcare professional.

If you interrupt treatment with 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 questions about the use of this medication, ask your doctor or pharmacist.

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

Severe side effects associated with the use of Azalia are described in Section 2 “What you need to know before starting to take Azalia”.For more information, read this section and consult your doctor immediately when necessary.

Consult your doctor immediatelyif you experienceallergic 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).

Irregular vaginal bleeding may occur during the use of Azalia. This may be a light spotting that may not require a pad or a more intense bleeding that resembles a light period that requires sanitary protection. It may also occur that you do not experience any bleeding. These side effects are common(can affect up to 1 in 10 users). Irregular bleeding is not a sign that the contraceptive protection of Azalia is reduced. In general, you do not need to do anything, just continue taking Azalia. However, if the bleeding is heavy or prolonged, consult your doctor.

Users of desogestrel have reported the following side effects:

Common (can affect up to 1 in 10 users);

• Mood changes
• Depression
• Decreased libido (sex drive)
• Headache
• Nausea
• Acne
• Breast tenderness
• Weight gain

Uncommon (can affect up to 1 in 100 users)

• Vaginal infection
• Difficulty wearing contact lenses
• Vomiting
• Hair loss
• Dysmenorrhea (painful menstruation)
• Ovarian cyst
• Fatigue

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

• Rash
• Urticaria
• Painful, blue-red nodules (erythema nodosum) (skin diseases)

In addition to these side effects, you may experience nipple secretion or milk leakage.

Reporting side effectssif you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require any special temperature for conservation.

Keep this medication out of sight and reach of children.

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

Medications should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Azalia

The active principle is desogestrel. A coated tablet contains 75 micrograms of desogestrel.

The other components are:

Tablet core:

Lactose monohydrate

Carboxymethylcellulose sodium (type A) (from potato starch)

Povidone K-30

Anhydrous colloidal silica

Stearic acid

all-rac-?-tocopherol

Tablet coating:

Polyvinyl alcohol

Titanium dioxide, E171

Macrogol 3000

Talc

Appearance of the product and packaging contents

Azalia is a white or almost white, round, biconvex, coated tablet of approximately 5.5 mm in diameter, with a “D” engraved on one face and a “75” on the other.

Azalia is packaged in ahard and transparent PVC/PVDC-Aluminiumblister. Each blister is inserted into an aluminium laminated pouch. The pouches with the blisters are included in a cardboard box containing a leaflet and a storage bag.

Packaging sizes: 1x28, 3x28, 6x28, 13x28 coated tablets

Not all packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Gedeon Richter Plc.

Gyömroi út 19-21

1103, Budapest Hungary

For further information about this medicinal product, 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 medicinal product is authorized in the Member States of the European Economic Area with the following names:

DESOCEANE in Belgium

AZALIA in Denmark

AZALIA 75 micrograms 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

Last review date of this leaflet:09/2021

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es