Package Insert:Information for the User

aiacet 75 micrograms Film-Coated Tablets

Desogestrel

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is aiacet and what it is used for

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

3. How to take aiacet

4. Possible side effects

5. Storage of aiacet

6. Contents of the pack and additional information

aiacetis used to prevent pregnancy.

There are two main types of hormonal contraceptives:

aiacet is a pill with progestogen only.

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

Most pills with only progestogen primarily act by preventing sperm from entering the uterus, but do not always prevent the egg from maturing, which is the primary action of combined pills.

aiacetis different from otherpills with only progestogenas it has a dose that is high enough in most cases to prevent the egg from maturing.Therefore,aiacetprovides a high level of contraceptive efficacy.

Unlike the combined pill,aiacetcan be taken by women who do not tolerate estrogens and women who are breastfeeding.

A disadvantage is that it could have irregular vaginal bleeding during the use ofaiacet.It could also not bleed.

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

Do not take aiacet:

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

Inform your doctor before using aiacet if any of these circumstances affect you. Your doctor may recommend that you use a non-hormonal birth control method.

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

Warnings and precautions

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

• you have had breast cancer;
• you have liver cancer, as the effect of aiacet cannot be ruled out;
• you have had a blood clot;
• you have diabetes;
• you have epilepsy (see section “Taking aiacet with other medications”);
• you have tuberculosis (see section “Taking aiacet with other medications”);
• you have high blood pressure;
• you have or have had melasma (yellow-brown skin patches, particularly on the face); in this case, avoid intense exposure to the sun or ultraviolet radiation.

If you use aiacet in any of the described situations, you must remain under medical supervision. 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 notice any lump in your breasts.

Breast cancer has been observed at a slightly higher frequency in women taking the pill than in women of the same age who are not taking it. If the woman stops taking the pill, the risk decreases gradually, so that 10 years after stopping 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 greater the older the age at which the pill was stopped.The duration of use of the pill is not as important.

Of every 10,000 women who have taken the pill for 5 years and who stop taking it around the age of 20, there will be fewer than one additional case of breast cancer observed 10 years after stopping the pill, which will be added to the 4 cases normally diagnosed in this age group.Similarly, of 10,000 women who have taken the pill for 5 years and who stop taking it around the age of 30, there will be 5 additional cases, in addition to the 44 cases normally diagnosed.Of 10,000 women who have taken the pill for 5 years and who stop taking it around the age of 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 pills with only progestogen such as aiacet is similar to that of women taking the pill, although the data do not allow for clear conclusions.

It appears that the breast cancers found in women taking the pill are less widespread than the breast cancers found in women who are not taking the pill. The cause of the difference in breast cancer risk is unknown. It may be that women are more likely to have regular check-ups, so that breast cancer is detected earlier.

Thrombosis

Contact your doctor immediately if you notice possible signs of thrombosis (see also “Regular checks”).

Thrombosis is the formation of ablood clotthat can block a blood vessel. Thrombosis can occur in the deep veins of the legs (deep vein thrombosis). If the clot breaks off from the veins where it formed, it can reach and block the arteries of the lungs, causing what is known as “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 occur while taking or not 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 pills with progestogen only such as aiacet is lower than in users of combined pills.

Mental health disorders

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

Children and adolescents

No clinical data are available on the safety and efficacy in adolescents under 18 years of age.

Taking aiacet with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.Also inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking aiacet. They can inform you if you need to use additional contraceptive measures (for example, the use of condoms) and if necessary, for how long, or if you need to modify the use of the other medication.

Some medications:

• may affect the levels of aiacet in the blood
• may make itless effective in preventing pregnancy
• may cause unexpected bleeding.

These include medications used to treat:

• epilepsy (for example primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate,topiramateand 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),
• depression (products containing the medicinal plant St. John's Wort),
• certain bacterial infections (for example, clarithromycin, erythromycin),
• fungus infections (for example, ketoconazole, itraconazole, fluconazole),
• high blood pressure (hypertension), angina or certain heart rhythm disorders (for example, diltiazem).

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

aiacetcan also interfere with the effect of other medications, causing an increase in effect (for example, medications with cyclosporine) or a decrease in effect (for example lamotrigine).

Consult your doctor or pharmacist before taking any medication.

Pregnancy and breastfeeding

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

Pregnancy

Do not use aiacet ifyou are pregnant or suspect you may be pregnant.

Breastfeeding

aiacet can be used during breastfeeding. Desogestrel does not appear to affect milk production or quality. However, occasionally a decrease in milk production has been reported during the use of aiacet. A small amount of the active ingredient in aiacet passes into breast milk.

A study was conducted on the health of children in breastfeeding for 7 months, whose mothers used aiacet, until the children were 2.5 years old. No effects were observed on the growth or development of the children.

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

Driving and operating machinery

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

aiacetcontains lactose.

This medication contains lactose. Ifyour doctor has told you that you have an intolerance to certain sugars, consult him before taking this medication.

Regular checks

During treatment withaiacet, your doctor will require you to undergo regular checks.Generally, the frequency and characteristics of these checks will depend on your personal situation.

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 blister pack of aiacet contains 28 tablets. Take the first tablet from the blister pack where the correct day of the week appears. Each time you start a new blister pack of aiacet, take a tablet from the top row, but not any tablet. For example, if you start on a Wednesday, you should take the tablet from the top row marked with "MIÉ". 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 particular 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, so without leaving any days of rest and without waiting for bleeding to appear.

Starting the first pack of aiacet

• When not using hormonal contraception in the previous month:

Wait for your period to arrive andon the first day of the period, take the first tablet ofaiacet.This way, you will not need to take additional contraceptive precautions.

You can also start on days2 to5 of your cycle, but in this case, make sure to use an additional 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-free interval.

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

If you are in a tablet-free interval.

You can also start the day after the interval without tablets, ring, or patch, or with tablets without active substance (placebo) from 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 taking another progestin-only pill:

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

• When using an injectable, implant, or intrauterine system (IUS) releasing progestin:

Start usingaiacetat the time you should receive the next injection or the day the implant or IUS is removed.You will not need to take additional contraceptive precautions.

• After childbirth:

You can start withaiacet, between days 21 and 28 after the birth of the baby.If you start later, 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 must rule out pregnancy before starting to takeaiacet.You can find more information about breastfeeding in section 2 "Pregnancy and breastfeeding". Your doctor may also advise you.

• After an abortion:

Your doctor will advise you.

If you take moreaiacetthan you should

No serious adverse effects have been described for taking too manydesogestreltablets 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take aiacet

• Ifless than 12 hourshave passed since the usual time to take the tablet, the efficacy of aiacet is maintained.Take the missed tablet as soon as you remember it and the following tablets at the usual time.
  
• Ifmore than 12 hourshave passed since the usual time to take the tablet, the efficacy may have been reduced.The more consecutive tablets you have forgotten,the greater the risk that the contraceptive efficacy has decreased.Take the last missed tablet as soon as you remember it and continue with the following tablets at your usual time,also using an additional contraceptive method (barrier method) during the next 7 days.

If you forget one or more tablets in thefirst week of startingthe treatment and have had sexual intercourse during the week before forgetting the tablets, there is a possibility that you may be pregnant. Consult your doctor.

If you experience gastrointestinal disorders (e.g. vomiting or intense diarrhea)

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

If you interrupt the 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 against pregnancy.

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

Like all medications, this medication may cause side effects, although not everyone will experience them. Contact your doctor if you experience any of the following side effects, especially if they are acute or persistent.

The following severe side effects may be associated with the use ofaiacetin the sections “Breast Cancer” and “Thrombosis” in section 2 “What You Need to Know Before Starting to Takeaiacet.” Read this section for 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 ofaiacet. This may be a light spotting that does not require the use of a pad or a more intense bleeding that resembles a light period and may require the use of sanitary protection (pads or tampons).It may also occur that you never experience bleeding.Irregular bleeding is not a sign that the contraceptive protection ofaiacethas decreased.In general, you do not need to do anything, just continue takingaiacet. However, if the bleeding is heavy or prolonged, consult your doctor.

How often do other possible side effects occur?

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

• Changes in mood,depressed mood, decreased libido
• Headache
• Nausea
• Acne
• Mammary pain, irregular or absent menstruation
• Weight gain

Poorly frequent(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, urticaria, purple and painful skin lesions (erythema nodosum) (skin effects)

Unknown frequency(cannot be estimated from available data):

• Allergic reactions

In addition to these side effects, breast secretion may occur.

Reporting of side effects

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

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 disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.In case of doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment..

Composition ofaiacet

• 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 content of the container

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

aiacetis presented in PVC/Aluminum blisters.

Each individual blister is conditioned within a carton that is inserted into a cardboard box.

Presentations of:

28 coated tablets

84 coated tablets

168 coated tablets

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Cyndea Pharma, S.L.

Emiliano Revilla Sanz Industrial Estate

Ágreda Avenue, 31,

Ólvega, 42110 Soria

Spain

Date of the last review of this leaflet:October 2020

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (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 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