Package Insert: Information for the Patient

Nacrez 75 microgram film-coated tablets

Desogestrel

Read this package insert carefully before starting to take this medication.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms as you, 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.

Nacrez is used forpreventing pregnancy.It contains a small amount of a type of female sex hormone, the progestin desogestrel.For this reason, Nacrez is called a progestin-only oral contraceptive (POC), also known colloquially asmini-pill.Unlike combined oral contraceptives, the POC or mini-pill does not contain estrogen along with the progestin.

Most POCs or mini-pills primarily act by preventing sperm from entering the uterus.They do not always prevent ovulation or fertilization, which is the primary effect of combined oral contraceptives.Nacrez differs from the rest of the mini-pills because it contains a dose that is high enough in most cases to prevent ovulation or fertilization.Therefore, the contraceptive efficacy of Nacrez is high.

Unlike combined oral contraceptives, Nacrez can be used by women who do not tolerate estrogens as well as by those who are breastfeeding.A disadvantage is that during the use of Nacrez, vaginal bleeding may occur at irregular intervals.It may also occur that menstruation is interrupted.

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

Do not take Nacrez

• if you areallergicto desogestrel or any of the other components of this medication (listed in section 6).
• if you have athrombosis.A thrombosis is the formation of a blood clot in a blood vessel [e.g., in the legs (deep vein thrombosis)] that, among other effects, can move to the lungs and cause a pulmonary embolism.
• if you have or have hadjaundice(yellowing of the skin) orsevere liver diseaseand if liver activity is not yet normal.
• if you have or have hadcancerthat responds to sex steroids, such as certain types of breast cancer.
• if you have any type ofunjustified vaginal bleeding.

Consult your doctor before starting to take Nacrez if you are in any of these situations.Your doctor may advise you to use a non-hormonal contraceptive method. Consult your doctor immediately if any of these conditions occur for the first time while taking Nacrez.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nacrez:

• if you have ever hadbreast cancer.
• if you haveliver cancer, as it cannot be ruled out that Nacrez may have an effect on this type of cancer.
• if you have ever had athrombosis.
• if you arediabetic.
• if you haveepilepsy(see section 2: "Use of Nacrez with other medications").
• if you havetuberculosis(see section 2: "Use of Nacrez with other medications").
• if you havehigh blood pressure.
• if you have or have had any timemelasma(brownish-yellow skin patches, particularly on the face); in this case, avoid excessive exposure to the sun or ultraviolet radiation.

Inform your doctor if you are in any of these situations.

When Nacrez is used in any of these situations, you may be kept under constant observation.Your doctor will be able to explain what you should do.

Regular check-ups

Your doctor will have you return to the consultation for regular check-ups while taking Nacrez.The frequency and type of these check-ups will depend on your individual situation.

Get in touch with your doctor as soon as possible

• if you experienceintense pain or swelling in one leg,unjustified chest pain,difficulty breathing, an unusual cough, especially ifyou cough up blood(which would indicate a possible thrombosis or embolism, respectively).
• if you suddenly developintense stomach painorhave a yellowish appearance(which could indicate liver problems).
• if you detect alump in the breasts(which would indicate possible breast cancer).
• if you developintense pain in the lower abdomen or stomach area or it appears suddenly(which could indicate an ectopic pregnancy, i.e., a pregnancy located outside the uterus)
• if you have to remainimmobileor have to undergo anoperation(consult your doctor at least four weeks in advance)
• if you haveintense vaginal bleeding that is not usual
• if you suspect that you arepregnant.

Breast cancer

Regularly check your breasts and contact your doctor as soon as possible if you detect any type of lump in them.

It has been found that breast cancer is slightly more common in women who take oral contraceptives than in women of the same age who do not take them. When women stop taking oral contraceptives, the risk decreases gradually. Ten years after stopping treatment, the risk is the same as in women who never took oral contraceptives. Breast cancer is rare in women under 40 years old, but the risk increases with age. Therefore, a higher number of breast cancers are diagnosed as women get older when they stop taking oral contraceptives.The duration of treatment with oral contraceptives has less importance.

Of every 10,000 women who take oral contraceptives for a maximum of 5 years but stop treatment at 20 years, less than 1 additional case of breast cancer will be detected 10 years after stopping treatment, in addition to the 4 cases that are diagnosed normally in this age group. Similarly, between 10,000 women who take oral contraceptives for a maximum of 5 years but stop treatment at 30 years, 5 additional cases of breast cancer will be detected, in addition to the 44 cases that are diagnosed normally. Between 10,000 women who take oral contraceptives for a maximum of 5 years but stop treatment at 40 years, 20 additional cases of breast cancer will be detected, in addition to the 160 cases that are diagnosed normally.

It is considered that the risk of developing breast cancer in women who take progestin-only contraceptives like Nacrez is similar to that of women who do not take oral contraceptives that contain estrogen in addition to progestin (combined oral contraceptives), although the evidence is less conclusive.

It appears less likely that breast cancers detected in women taking oral contraceptives will spread compared to breast cancers detected in women who do not take them. The cause of the difference in breast cancer risk is unknown. It is possible that more frequent investigations have been made, so that breast cancer could have been detected earlier.

Thrombosis

Consult your doctor immediately if you detect possible signs of a thrombosis.For more information on the signs, see “Get in touch with your doctor as soon as possible”, first bullet point.

A thrombosis is theformation of a blood clot that can block a blood vessel.In some cases, a thrombosis occurs in the deep veins of the legs (deep vein thrombosis).If the clot breaks loose from the veins where it formed, it can travel to the arteries of the lungs and block them.This causes the so-called “pulmonary embolism”.Consequently, situations that pose a risk to life may occur; that is, they may lead to death.Deep vein thrombosis is a rare occurrence.It can develop whether you take oral contraceptives or not. It can also develop if you become pregnant.

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

Children and adolescents

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

Mental health disorders

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

Use of Nacrez with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any othermedication or herbal product.Also inform any other doctor or dentist who prescribes another medication (or pharmacist) that you are using Nacrez. They may tell you if you need to take additional contraceptive precautions (for example, condoms) and, if so, for how long or if you need to change the use of another medication that you need.

Some medications

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

These medications include those used to treat:

• epilepsy(e.g., primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate, and phenobarbital)
• tuberculosis(e.g., rifampicin, rifabutin)
• HIV infection(e.g., ritonavir, nelfinavir)
• Infection with thehepatitis C virus(e.g., boceprevir, telaprevir)
• other infectious diseases(e.g., griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• depressed mood(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 products that may make Nacrez less effective, you should also use a barrier contraceptive method. Since the effect of another medication on Nacrez may last up to 28 days after stopping the medication, you need to use the additional barrier contraceptive method for that time. Your doctor may tell you if you need to take additional contraceptive precautions and, if so, for how long.

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

Consult your doctor or pharmacist before taking any medication.

Use of Nacrez with food and drinks

You can take Nacrez with food and drinks or without them.

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 notuse Nacrez if you are pregnant or think you may be pregnant.

Breastfeeding

Nacrez can be used during breastfeeding. Nacrez does not appear to affect milk production or quality. However, milk production may decrease occasionally during the use of Nacrez. A small amount of the active ingredient in Nacrez passes into breast milk.

The health of children who were breastfed for 7 months while their mothers were using Nacrez has been studied up to 2.5 years of age. No effects were observed on the growth and development of the children.

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

Driving and operating machinery

Nacrez does not affect driving or operating machinery.

Nacrez contains lactose

Nacrez contains lactose.Consult your doctor before taking this medication if you have been told that you have a certain sugar intolerance.

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

Method of administration

• The Nacrez package contains28 tablets;
• takeone tablet a day.
• Swallow the tablet wholewith a sufficient amount of water.

The front of the package has arrows printed between the tablets.If you turn the package over and observe the back, you will see the days of the week printed on the aluminum foil.Each day corresponds to a tablet.Each time you start a new package of Nacrez, take a tablet from the top row.Do not start with any tablet.For example, if you start on a Wednesday, you must take the tablet from the top row marked (from the back) with "Mi".Follow taking one tablet a day until the package is empty.Always follow the direction indicated by the arrows.You can easily check if you have already taken a tablet for a specific day by looking at the back of the package.

Take your daily tablet approximately at the same time.Take the tablet whole with water.You may experience some bleeding during the use of Nacrez, but you must continue taking the tablets in the usual way.When you finish a package of Nacrez, you must start a new one the next day; in this way,withoutinterruption andwithoutwaiting for bleeding to occur.

Starting the first package of Nacrez

If you have not used hormonal contraceptives in the last cycle

Wait for your period to start.The first day of your period, take the first Nacrez tablet.You do not need to take any additional contraceptive measures.You can also start treatment between days 2-5 of the cycle, but in that case, you must ensure that you use an additional contraceptive method (a barrier method, for example, a condom) during the first 7 days of treatment with the tablets.

If you change from a combined oral contraceptive, vaginal ring, or transdermal patch

You can start taking Nacrez one day after taking the last tablet from the package of hormonal contraceptives you are currently using or the day the vaginal ring or patch is removed.If the package of the contraceptive you are currently using also contains inactive tablets, you can start taking Nacrez one day after taking the last active tablet (if you are not sure which one, consult your doctor or pharmacist).If you follow these instructions, you do not need to take any additional contraceptive measures.At the latest, you can also start treatment one day after the moment you are no longer protected by tablets, ring, or patch, or after taking the inactive tablets of the contraceptive you are currently using.If you follow these instructions, you must ensure that you use an additional contraceptive method (a barrier method, for example, a condom) during the first 7 days of treatment with the tablets.

If you change from another progestin-only oral contraceptive (mini-pill) to Nacrez

You can interrupt treatment at any time and start taking Nacrez immediately.You do not need to take any additional contraceptive measures.

If you change from an injectable or implant or an intrauterine device (IUD) that releases progestin to Nacrez

Start using Nacrez when it is time for your next injection or the day the implant or IUD is removed.You do not need to take any additional contraceptive measures.

After giving birth

You can start Nacrez between 21 and 28 days after the birth of your baby.

If you start later, make sure to use an additional contraceptive method (a barrier method, for example, a condom) until you have completed the first 7 days of taking the tablet.However, if you have already had sexual intercourse, you must exclude pregnancy before starting the use of Nacrez.You can find additional information for breastfeeding women in "Pregnancy and lactation" in section 2.Your doctor may also advise you.

After a spontaneous or induced abortion

Your doctor will advise you what to do.

If you take more Nacrez than you should

No serious side effects have been reported for taking too many tablets with desogestrel at the same time.The symptoms that may appear are nausea, vomiting, and, in young girls, a slight vaginal bleeding.For more information, consult your doctor.

If you forget to take Nacrez

If you have delayedless than 12 hoursin taking a tablet, Nacrez still retains its reliability.Take the tablet you forgot to take as soon as you remember, and then take the next tablet at the usual time.If you have delayedmore than 12 hoursin taking a tablet, it is possible that the reliability of Nacrez may decrease.The more consecutive tablets you forget to take, the higher the risk of decreased contraceptive efficacy.Take thelasttablet you forgot to take as soon as you remember, and then take the next tablets at the usual time.This means that you may take two tablets in one day.Use anadditional contraceptive method (such as condoms)for the next 7 days of treatment with the tablets.If you forgot to take one or more tablets in the first week of treatment and had sexual intercourse in the week before you forgot to take the tablets, it is possible that you may become pregnant.Consult your doctor.

If you have digestive disorders (e.g., vomiting, severe diarrhea)

Follow the instructions for forgotten tablets in the previous section.If you vomit within 3-4 hours after taking your Nacrez tablet or have severe diarrhea, it is possible that the active ingredient may not have been fully absorbed.

If you interrupt treatment with Nacrez

You can interrupt treatment with Nacrez at any time.From the day you interrupt treatment,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, this medicine may cause side effects, although not everyone will experience them.

Severe adverse reactions associated with the use of Nacrez are described in the paragraphs "Breast Cancer" and "Thrombosis" of the section 2 "What you need to know before starting to take Nacrez".For more information, read this section and consult your doctor immediately when you consider it necessary.

During the use of Nacrez, irregular vaginal bleeding may occur.This may be just a light spotting that does not require the use of sanitary napkins, or a more intense bleeding, which resembles a light period and requires the use of sanitary napkins.It may also occur that menstruation is completely interrupted. Irregular bleeding does not constitute a sign that the contraceptive protection of Nacrez has decreased.Generally, you do not need to take any action. Simply continue taking Nacrez.However, if the bleeding is heavy or prolonged, you should consult your doctor.

Users of desogestrel have reported the following side effects:

Frequent: may affect up to 1 in 10 people

Mood changes, decreased libido, depressive mood (feeling more sad than normal), headache, nausea, acne, breast pain, irregular or absent menstruation, weight gain

Infrequent: may affect up to 1 in 100 people

Vaginal infection, difficulty using contact lenses, vomiting, hair loss, painful menstruation, ovarian cysts, fatigue

Rare: may affect up to 1 in 1,000 people

Skin rash, hives, painful red-blue skin bumps (erythema nodosum)

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

You should consult your doctor immediately if you experience symptoms of angioedema, such as (i) swelling of the face, tongue, or pharynx; (ii) difficulty swallowing; or (iii) hives and difficulty breathing.

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 leaflet. You can also report them through theSpanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep out of sight and reach of children.

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

Storage conditions with overwrap:

This medication does not require special storage conditions

Storage conditions without overwrap:

Store below 25°C.

The active substance poses an environmental risk to fish.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Nacrez

-The active ingredient is: desogestrel. Each coated tablet contains 75 micrograms of desogestrel.

-The other components are: lactose monohydrate (see also "Nacrez contains lactose" in section 2), cornstarch, povidone K30, stearic acid, all-rac-alpha-tocopherol, colloidal anhydrous silica, hypromellose, macrogol 400, talc, and titanium dioxide.

Appearance of Nacrez and contents of the package

Nacrez coated tablets are white or off-white, round, and biconvex, with a diameter of 5.4 to 5.8 mm and do not have any embossed inscription.

A blister pack of Nacrez contains 28 coated tablets. Each box contains 1, 3, or 6 blister packs. Each blister pack may or may not be individually wrapped in a pouch.

It is possible that not all presentations will be marketed.

Marketing Authorization Holder

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Responsible for Manufacturing

Cenexi -Osny

17 Rue de Pontoise

Osny 95520

France

Local Representative

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.

28027 Madrid

Spain

This medicine is authorized in the Member States of the EEA under the following names:

GermanyTheranette 75 Mikrogramm Filmtabletten

BelgiumNacrez

Czech RepublicXynia 0.075 mg potahované tablety

DenmarkNacrez

HungaryNacrez 0.075 mg filmtabletta

ItalyNacrez 75 microgrammi compresse rivestite con film

NetherlandsDesogestrel 0.075 mg Theramex, filmomhulde tabletten

Romania:SOFTINETTE 0.075 mg comprimate filmate

SloveniaNacrez 75 mikrogramov filmsko obložene tablete

SpainNacrez 75 microgramos comprimidos recubiertos con película EFG

United KingdomNacrez 75 micrograms Film-coated Tablets

This leaflet was revised in September 2020

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