AIACET 75 micrograms FILM-COATED TABLETS

Introduction

Leaflet: Information for the user

aiacet 75 micrograms film-coated tablets EFG

desogestrel

Read 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 further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is aiacet and what is it used for
2. What you need to know before you start taking aiacet
3. How to take aiacet
4. Possible side effects
5. Storing aiacet
6. Contents of the pack and other information

1. What is aiacet and what is it used for

aiacet is used to prevent pregnancy.

There are two main types of hormonal contraceptives:

• The combined pill, "The Pill", which contains two types of female sex hormone, oestrogen and progestogen.
• The progestogen-only pill, or mini-pill, which does not contain oestrogen hormones.

aiacet is a progestogen-only pill.

aiacet contains a small dose of a type of female hormone, the progestogen desogestrel.

Most progestogen-only pills 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 pills.

aiacet is different from other progestogen-only pills because it has a dose that is high enough to prevent the egg from ripening in most cases. Therefore, aiacet provides high contraceptive efficacy.

Unlike the combined pill, aiacet can be taken by women who cannot tolerate oestrogens and by women who are breastfeeding.

A disadvantage is that you may have irregular vaginal bleeding during the use of aiacet. You may also not bleed at all.

2. What you need to know before you start taking aiacet

aiacet, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take aiacet:

• 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 clotin a blood vessel [for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism)].
• if you have or have ever had jaundice(yellowing of the skin) or severe liver disease and your liver is still not working normally.
• if you have or are suspected to have a cancerrelated to sex steroids, such as certain types of breast cancer.
• if you have any unexplained vaginal bleeding.

Tell your doctor before using aiacet if any of these conditions apply to you. Your doctor may recommend that you use a non-hormonal method of birth control.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take aiacet if:

• you have ever had breast cancer;
• you have liver cancer, as it cannot be ruled out that aiacet may have an effect;
• you have ever had a thrombosis;
• you have diabetes;
• you suffer from epilepsy (see section "Taking aiacet with other medicines");
• you suffer from tuberculosis (see section "Taking aiacet with other medicines");
• you have high blood pressure;
• you have or have had chloasma (yellowish-brown patches on the skin, particularly on the face); in this case, you should avoid intense exposure to the sun or ultraviolet radiation.

If you use aiacet in any of the situations described, you should remain under medical supervision. Your doctor can explain what you should do.

Breast cancer

Examine your breasts regularly and contact your doctor as soon as possible if you notice any lump in your breasts.

It has been observed that breast cancer occurs slightly more frequently in women who take the pill than in women of the same age who do not take it. If the woman stops taking the pill, the risk decreases gradually, so that 10 years after stopping it, the risk is the same as that of women who have never taken it. Breast cancer is rare before the age of 40, but the risk increases as the woman gets older. Therefore, the additional number of breast cancers diagnosed is higher the older the age at which the pill is stopped. The duration of pill use is not as important.

Out of 10,000 women who have taken the pill for up to 5 years and stop taking it around the age of 20, there will be less than one additional case of breast cancer diagnosed up to 10 years after stopping the pill, which will be added to the 4 cases normally diagnosed in this age group. Similarly, out of 10,000 women who have taken the pill for up to 5 years and stop taking it around the age of 30, there will be 5 additional cases to the 44 cases normally diagnosed. In 10,000 women who have taken the pill for up to 5 years and stop taking it around the age of 40, there will be 20 additional cases to the 160 cases normally diagnosed.

It is believed that the risk of breast cancer in users of progestogen-only pills like aiacet is similar to that of women who take the pill, although the data do not allow for clear conclusions to be drawn.

It seems that breast cancers found in women who take the pill are less advanced than breast cancers found in women who do not take it. It is not known if the difference in breast cancer risk is due to the pill. It could be that women are monitored more closely, so breast cancer is detected earlier.

Thrombosis

Contact your doctor immediately if you notice any possible signs of thrombosis (see also "Regular check-ups").

Thrombosis is the formation of a blood clot that can block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis). If the clot breaks loose from the veins where it has formed, it can reach and block the arteries of the lungs, causing what is known as a "pulmonary embolism", which can be fatal. Pulmonary embolism can cause chest pain, difficulty breathing, collapse, and even death.

Deep vein thrombosis is rare. It can develop whether or not you are taking the pill. It can also occur if you become pregnant.

The risk of thrombosis is higher in pill users than in non-users. It is believed that the risk in users of progestogen-only pills like aiacet is lower than in users of pills that also contain oestrogens (combined pills).

Psychiatric disorders

Some women who use hormonal contraceptives like aiacet 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 data available on the safety and efficacy in adolescents under 18 years of age.

Taking aiacet with other medicines

Tell 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 prescribes you another medicine (or your pharmacist) that you are taking aiacet. They can inform you if you need to take any additional contraceptive measures (for example, using condoms) and if so, for how long, or if you should modify the use of the other medicine.

Some medicines:

• may influence aiacet levels in the blood
• may make aiacet less effective in preventing pregnancy
• may cause unexpected bleeding.

These include medicines used for the treatment of:

• epilepsy (for example primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate, and phenobarbital),
• tuberculosis (for example rifampicin, rifabutin),
• HIV infection (for example ritonavir, nelfinavir, nevirapine, efavirenz),
• Hepatitis C virus infection (for example boceprevir, telaprevir),
• other infectious diseases (for example griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• depressive mood (products containing the herbal remedy St. John's Wort),
• certain bacterial infections (for example clarithromycin, erythromycin),
• fungal infections (for example ketoconazole, itraconazole, fluconazole),
• high blood pressure, angina, or certain heart rhythm disorders (for example diltiazem).

If you are taking medicines or herbal remedies that may make aiacet less effective, you should also use a barrier contraceptive method. Since the effect of another medicine on aiacet can last up to 28 days after stopping the medicine, during this time, you should also use the additional barrier contraceptive method. Your doctor can inform you if you need to take any additional contraceptive measures and if so, for how long.

aiacet may also interfere with the effect of other medicines, causing an increase in the effect (for example medicines containing ciclosporin) or a decrease in the effect (for example lamotrigina).

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 aiacet if you are pregnant or think you may be pregnant.

Breastfeeding

aiacet can be used during breastfeeding. Desogestrel does not seem to affect milk production or the quality of breast milk. However, it has been rarely reported that milk production decreases during the use of aiacet. A small amount of the active ingredient of aiacet passes into breast milk.

The health of breastfed children whose mothers used aiacet has been studied for 7 months, until the children were 2.5 years old. No effects on the growth or development of the children have been observed.

If you are breastfeeding and want to use aiacet, consult your doctor.

Driving and using machines

There is no indication that the use of aiacet has any effect on the ability to drive or operate machinery.

aiacet contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Regular check-ups

During treatment with aiacet, your doctor will require you to have regular check-ups. In general, the frequency and characteristics of these check-ups will depend on your personal situation.

3. How to take aiacet

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

How and when to take the tablets

Each aiacet blister pack contains 28 tablets. Take the first tablet from the blister pack where the correct day of the week appears. Every time you start a new aiacet blister pack, take a tablet from the top row, but not just any tablet. For example, if you start on a Wednesday, you should take the tablet from the top row marked with "WED". Continue taking one tablet a day until the blister pack is empty, always following the direction of the arrows. Looking at the front of the blister pack, you can easily check if you have already taken your tablet on a given day.

Take your tablet approximately at the same time every day, swallowing it whole with water. You may experience some bleeding during the use of aiacet, but you should continue taking the tablets normally. When you finish a blister pack, you should start a new one the next day, therefore without leaving any day of rest and without waiting for bleeding to appear.

Starting the first pack of aiacet

• When you have not used hormonal contraception in the previous month:

Wait until you have your period and on the first day of your period, take the first tablet of aiacet. This way, you do not need to take additional contraceptive precautions.

You can also start on days 2 to 5 of your cycle, but in this case, make sure to use a complementary contraceptive method (barrier method, condom) during the first 7 days of treatment with the tablets.

• When switching from a combined pill, vaginal ring, or transdermal patch:

If you are not in a tablet, ring, or patch rest interval.

You can start taking aiacet the day after taking the last tablet from your current pack or the day of removal of the vaginal ring or transdermal patch (this means you do not have to leave a rest period from the tablets, ring, or patch). If your current pill contains inactive tablets (placebo), you can start taking aiacet the day after taking the last active tablet (if you are not sure, consult your doctor or pharmacist). Following these instructions, you do not need to take additional contraceptive precautions.

If you are in a tablet, ring, or patch rest period.

You can also start the day after the rest period without a tablet, ring, or patch, or with inactive tablets (placebo) from your current contraceptive. If you follow these instructions, make sure to use a complementary contraceptive method (barrier method) during the first 7 days of taking the tablets.

• If you were taking a progestin-only pill:

You can stop your current preparation at any time and start taking aiacet immediately. You will not need to take additional contraceptive precautions.

• If you were using an injectable, implant, or intrauterine progestin release system (IUS):

Start using aiacet at the time you would receive the next injection or the day the implant or IUS is removed. You do not need to take additional contraceptive precautions.

• After childbirth:

You can start taking aiacet between 21 and 28 days after the birth of your baby. If you start later, make sure to use a complementary 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 take aiacet. You can find more information about breastfeeding in section 2 "Pregnancy and breastfeeding". Your doctor can also advise you.

• After an abortion:

Your doctor will advise you.

If you take more aiacet than you should

No serious harmful effects have been described for taking too many aiacet tablets at once. The symptoms that may occur are nausea, vomiting, and in young women, a slight vaginal bleeding.

For more information, consult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take aiacet

• If it has been less than 12 hourssince the usual time of taking the tablet, the effectiveness of aiacet is maintained. Take the forgotten tablet as soon as you remember and the following tablets at the usual time.
• If it has been more than 12 hourssince the usual time of taking the tablet, the effectiveness may have been reduced. The more consecutive tablets you have forgotten, the greater the risk that the contraceptive effectiveness has decreased. Take the last forgotten tablet as soon as you remember and continue with the following tablets at the usual time, also using a complementary contraceptive method (barrier method) during the next 7 days.

If you forget one or more tablets in the first week of startingtreatment and you have had sexual intercourse during the previous week of forgetting the tablets, there is a possibility that you may have become pregnant. Consult your doctor.

If you suffer from gastrointestinal disorders (e.g., vomiting or severe diarrhea)

Follow the instructions for forgetting tablets. If you vomit within 3-4 hours after taking your aiacet tablet or have severe diarrhea, it may be that the active ingredient has not been fully absorbed.

If you interrupt treatment with aiacet

You can stop taking aiacet at any time you want. From the day you stop taking it, you will no longer be protected from 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, this medication can cause side effects, although not all people experience them. Contact your doctor if you suffer from any of the following side effects, especially if they are acute or persistent.

Severe side effects that may be associated with the use of aiacet are explained in the sections "Breast cancer" and "Thrombosis" in section 2 "What you need to know before taking aiacet". Read this point to know the detailed information and consult your doctor immediately if you consider it necessary.

Consult your doctor immediately if 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).

Irregular vaginal bleeding may occur during the use of aiacet. It can be a slight spotting that does not even require the use of a pad or a more intense bleeding, which is similar to a scarce menstruation and may require the use of sanitary protection (tampons or pads). It can also happen that you never have bleeding. Irregular bleeding is not a sign that the contraceptive protection of aiacet has decreased. In general, you do not need to do anything, just continue taking aiacet. However, if the bleeding is intense or prolonged, consult your doctor.

How often do other possible side effects occur?

Frequent(may affect up to 1 in 10 women):

• mood changes, depressed mood, decreased sexual desire (libido)
• headache
• nausea
• acne
• breast pain, irregular menstruation, or no menstruation
• weight gain

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

• vaginal infection
• discomfort with contact lens use
• vomiting
• hair loss
• painful menstruation, ovarian cysts
• fatigue

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

• rash, hives, painful purple bumps on the skin (erythema nodosum) (are skin effects)

Frequency not known(cannot be estimated from the available data):

• allergic reactions

Aside from these side effects, breast secretion may occur.

Reporting side effects

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

5. Storage of aiacet

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

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

This medication does not require special storage conditions.

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

6. Package contents and additional information

Composition of aiacet

• The active ingredient is desogestrel. Each tablet contains 75 micrograms of desogestrel.

• The other components are: tablet core:anhydrous colloidal silica, alpha-tocopherol, lactose monohydrate, cornstarch, povidone, and stearic acid. Coating:hypromellose, macrogol 6000, propylene glycol, talc, and titanium dioxide (E-171).

Appearance of the product and package contents

Film-coated tablet, cylindrical, biconvex, and white in color with a diameter of approximately 6.00 mm.

aiacet is presented in PVC/Aluminum blister packs.

Each individual blister pack is packaged in a sleeve that is inserted into a cardboard box.

Presentation of:

28 film-coated tablets

84 film-coated tablets

168 film-coated tablets

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Cyndea Pharma, S.L.

Polígono Industrial Emiliano Revilla Sanz

Avenida de Ágreda, 31,

Ólvega, 42110 Soria

Spain

Date of the last revision of this leaflet:October 2020

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76226/P_76226.html

QR code to: https://cima.aemps.es/cima/dochtml/p/76226/P_76226.html