NACREZ 75 micrograms FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Nacrez 75 micrograms film-coated tablets EFG

Desogestrel

Read this leaflet carefully before you start taking this medicine.

• Keep this 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 pack

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

1. What is Nacrez and what is it used for

Nacrez is used to prevent pregnancy. It contains a small amount of a type of female sex hormone, the progestogen desogestrel. For this reason, Nacrez is called a progestogen-only pill (POP), also known as a minipill. Unlike combined oral contraceptives, the minipill does not contain an estrogen in addition to the progestogen.

Most minipills work mainly by preventing sperm from entering the uterus. They do not always prevent the release of an egg from the ovary, which is the main effect of combined oral contraceptives. Nacrez differs from other minipills because it contains a dose that is high enough to prevent the release of an egg in most cases. Therefore, Nacrez has a high contraceptive effect.

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

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

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

Do not take Nacrez

• if you are allergicto desogestrel or any of the other ingredients of this medicine (listed in section 6).
• if you have a blood clot. A blood clot is a clot that forms in a blood vessel [e.g. in the legs (deep vein thrombosis)] that can travel to the lungs and cause a pulmonary embolism.
• if you have or have had jaundice(yellowing of the skin) or severe liver diseaseand if liver function is still not normal.
• if you have or are suspected to have a cancerthat is sensitive to sex steroids, such as certain types of breast cancer.
• if you have unexplained 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 disorders 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 had breast cancer.
• if you have liver cancer, because it cannot be ruled out that Nacrez may have an effect on this type of cancer.
• if you have ever had a blood clot.
• if you are diabetic.
• if you have epilepsy(see section 2: "Using Nacrez with other medicines").
• if you have tuberculosis(see section 2: "Using Nacrez with other medicines").
• if you have high blood pressure.
• if you have or have ever had chloasma(brownish-yellow patches on the skin, especially on the face); in this case, avoid excessive exposure to the sun or ultraviolet radiation.

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

When using Nacrez in any of these situations, you may need to be kept under close observation. Your doctor can explain what you need to do.

Regular check-ups

While taking Nacrez, your doctor will ask you to come back for regular check-ups. In general, the frequency and type of these check-ups will depend on your individual situation.

Contact your doctor as soon as possible

• if you experience severe pain or swelling in one leg, unexplained chest pain, difficulty breathing, an unusual cough, especially if you cough up blood(which could indicate a blood clot or pulmonary embolism, respectively).
• if you suddenly develop severe stomach painor become jaundiced(which could indicate liver problems).
• if you detect a (which could indicate breast cancer).
• if you develop severe pain in the lower abdomen or stomach area or if it occurs suddenly(which could indicate an ectopic pregnancy, i.e. a pregnancy outside the uterus)
• if you need to be immobileor need to undergo surgery(consult your doctor at least 4 weeks in advance)
• if you experience unusual or heavy vaginal bleeding
• if you suspect you are pregnant.

Breast Cancer

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

It has been shown that breast cancer is slightly more common in women who take oral contraceptives compared to 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. The development of breast cancer is rare in women under 40 years old, but the risk increases with age. Therefore, a higher number of breast cancer cases are diagnosed the older the woman is when she stops taking oral contraceptives. The duration of treatment with oral contraceptives is less important.

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

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

It appears to be less likely that breast cancers detected in women who take oral contraceptives will spread, compared to breast cancers detected in women who do not take them. It is not known whether the difference in breast cancer risk is due to the use of oral contraceptives. It is possible that more frequent examinations have been carried out, so that breast cancer may have been detected earlier.

Thrombosis

Contact your doctor immediately if you detect any possible signs of a blood clot. For more information on signs, see "Contact your doctor as soon as possible", first bullet point.

A blood clot is the formation of a clot that can block a blood vessel. In some cases, a blood clot 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 a so-called "pulmonary embolism". As a result, life-threatening situations can occur; that is, they can lead to death. Deep vein thrombosis is not common. It can develop both when you are taking oral contraceptives and when you are not. It can also develop if you become pregnant.

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

Children and adolescents

There are no data available on the safety and efficacy of desogestrel in adolescents under 18 years of age.

Psychiatric disorders

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

Using Nacrez with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines or herbal products. Also, inform any other doctor or dentist who prescribes you another medicine (or pharmacist) that you are using Nacrez. They can tell you if you need to take extra contraceptive precautions (e.g. condoms) and, if so, for how long.

Some medicines

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

These medicines include those used to treat:

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

Nacrez 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 other medicine.

Using Nacrez with food and drink

You can take Nacrez with or without food and drink.

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 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 the quality of breast milk. However, it has been reported that milk production may decrease during the use of Nacrez. A small amount of the active substance of Nacrez passes into breast milk.

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

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

Driving and using machines

Nacrez does not affect your ability to drive or use machines.

Nacrez contains lactose

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

3. How to take Nacrez

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

Method of administration

• The Nacrez package contains 28 tablets;
• take one tablet a day.
• Swallow the whole tabletwith a sufficient amount of water.

The front of the package has arrows printed between the tablets. If you turn the package over and look at the back, you will see the days of the week printed on the aluminum foil. Each day corresponds to a tablet. Every 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 (on the back) with "Wed". Keep taking one tablet a day until the package is empty. Always follow the direction indicated by the arrows. By looking at the back of the package, you can easily check if you have already taken the tablet for a specific day.

Take your daily tablet approximately at the same time. Take the whole tablet with water. It is possible that some bleeding may occur 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, without interruption and without waiting for bleeding to occur.

Starting the first package of Nacrez

If you have not used hormonal contraceptives in the last cycle

Wait for your menstruation to start. On the first day of menstruation, take the first Nacrez tablet. You do not need to take 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 switch from a combined oral contraceptive, vaginal ring, or transdermal patch

You can start taking Nacrez one day after taking the last tablet of the current oral contraceptive package or the day the vaginal ring or patch is removed (this means that you will never be without protection, whether you take tablets, wear a ring, or patch). If the package of the contraceptive you are currently taking also contains inactive tablets, you can start taking Nacrez one day after taking the last active tablet (if you are not sure which one it is, consult your doctor or pharmacist). If you follow these instructions, you do not need to take additional contraceptive measures. At the latest, you can also start treatment one day after the moment you stop being protected by tablets, ring, or patches, 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 switch from another progestin-only oral contraceptive (minipill) to Nacrez

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

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

Start using Nacrez when you are due for the next injection or the day the implant or IUD is removed. You do not need to take additional contraceptive measures.

After having a child

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 (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 rule out 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 harmful effects have been reported due to taking too many desogestrel tablets at once. The symptoms that may appear are nausea, vomiting, and in young girls, a slight vaginal bleeding. For more information, ask your doctor for advice.

If you forget to take Nacrez

If you have delayed less than 12 hoursin taking a tablet, Nacrez still maintains 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 delayed more than 12 hoursin taking a tablet, it is possible that the reliability of Nacrez may decrease. The more tablets you forget to take consecutively, the higher the risk that the contraceptive efficacy will decrease. Take the last tablet 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 an additional contraceptive method (such as condoms)during the 7 days following 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, you may become pregnant. Ask your doctor for advice.

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

Follow the advice 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 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.

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

During the use of Nacrez, vaginal bleeding may occur at irregular intervals. It may be just a slight spotting that does not require the use of pads, or more intense bleeding, which is similar to a light menstruation and requires the use of pads. It may also happen that menstruation is completely interrupted. Irregular bleeding is not a sign that the contraceptive protection of Nacrez has decreased. In general, you do not need to take any action. Simply continue taking Nacrez. However, if the bleeding is intense 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 sexual desire (libido), depressive mood (feeling more sad than usual), headache, nausea, acne, breast pain, irregular or absent menstruation, weight gain

Uncommon: may affect up to 1 in 100 people

Vaginal infection, difficulties in using contact lenses, vomiting, alopecia, 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 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 prospectus. You can also report them through the Spanish Medicines Monitoring System website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Nacrez

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 indicated month.

Storage conditions with outer packaging:

This medication does not require special storage conditions

Storage conditions without outer packaging:

Store below 25°C.

The active substance shows an environmental risk for fish.

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

6. Additional information

Composition of Nacrez

• The active ingredient is: desogestrel. Each film-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, anhydrous colloidal silica, hypromellose, macrogol 400, talc, and titanium dioxide.

Appearance of Nacrez and package contents

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

A Nacrez blister package contains 28 film-coated tablets. Each box contains 1, 3, or 6 blister packages. Each blister package may or may not be individually packaged in a sleeve.

Not all presentations may be marketed.

Marketing authorization holder

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturer

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 medication is authorized in the EEA member states under the following names:

Germany Theranette® 75 Mikrogramm Filmtabletten

Belgium Nacrez

Czech Republic Xynia 0,075 mg potahované tablety

Denmark Nacrez

Hungary Nacrez 0,075 mg filmtabletta

Italy Nacrez 75 microgrammi compresse rivestite con film

Netherlands Desogestrel 0,075 mg Theramex, filmomhulde tabletten

Romania: SOFTINETTE 0,075 mg comprimate filmate

Slovenia Nacrez 75 mikrogramov filmsko obložene tablete

Spain Nacrez 75 microgramos comprimidos recubiertos con película EFG

United Kingdom Nacrez 75 micrograms Film-coated Tablets

This prospectus was revised in September 2020

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