Package leaflet: Information for the patient

NACREZ 75 micrograms film-coated tablets

Desogestrel
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What NACREZ is and what it is used for
What you need to know before taking NACREZ
How to take NACREZ
Possible side effects
How to store NACREZ
Contents of the pack and other information

1. What NACREZ is and what it is used for

NACREZ is used to prevent pregnancy. It contains a small amount of a type of female sex hormone, the progestin desogestrel. For this reason, NACREZ is known as a progestin-only pill (POP) or mini-pill. Unlike combined oral contraceptives, the POP or mini-pill does not contain an oestrogen hormone in addition to the progestin.
Most POPs or mini-pills primarily work by preventing sperm from reaching the uterus; they do not always prevent the maturation of the egg cell, which is the main mechanism of action of combined oral contraceptives. NACREZ differs from other mini-pills in that its dose is high enough in most cases to prevent the maturation of the egg cell. As a result, NACREZ provides high contraceptive efficacy.
Unlike the combined pill, NACREZ can be used by women who are intolerant to oestrogens and by those who are breastfeeding. A disadvantage is the possibility of irregular vaginal bleeding during use of NACREZ. It is also possible to have no bleeding at all.

2. What you need to know before taking NACREZ

NACREZ, like other hormonal contraceptives, does not protect against HIV infection
(AIDS) or other sexually transmitted diseases.
Do not take NACREZ

if you are allergic to the active substance desogestrel or to any of the other ingredients of this medicine (listed in section 6).
if you have or have had thrombosis. Thrombosis is the formation of a blood clot in a blood vessel (e.g. in the legs (deep vein thrombosis), which may, among other things, travel to the lungs and cause a pulmonary embolism).
if you have or have had jaundice (yellowing of the skin) or a severe liver disease and your liver function has not yet returned to normal.
if you have or suspect you have a cancer sensitive to sex steroids, such as certain types of breast cancer.
if you have unexplained vaginal bleeding.

Consult your doctor before taking NACREZ if you are in any of these conditions. The doctor
may advise you to use a non-hormonal contraceptive method. Contact your doctor immediately if any of these conditions occurs for the first time during use of NACREZ.
Warnings and precautions
Talk to your doctor or pharmacist before taking NACREZ

if you have had breast cancer.
if you have liver cancer, as a possible effect of NACREZ on liver cancer cannot be excluded.
if you have had thrombosis.
if you have diabetes.
if you suffer from epilepsy (see section 2 “Other medicines and NACREZ”).
if you suffer from tuberculosis (see section 2 “Other medicines and NACREZ”).
if you suffer from high blood pressure.
if you have or have had chloasma (brownish-yellow pigmented spots on the skin, especially on the face); if so, avoid excessive exposure to sunlight or ultraviolet radiation.

Contact your doctor if you are in any of these conditions.
If NACREZ is taken while any of these conditions are present, you may need to be closely monitored. Your doctor can advise you what to do.
Regular check-ups
While taking NACREZ, your doctor may recommend regular check-up visits.
Typically, the frequency and nature of these visits will depend on your individual circumstances.
Contact your doctor as soon as possible

if you have sudden or severe pain or swelling in one leg, unexplained chest pain, shortness of breath, unusual cough, especially if the cough is accompanied by blood (these may indicate thrombosis or embolism, respectively);
if you experience sudden and severe stomach pain or develop a yellowish skin color (jaundice) (this may indicate liver problems);
if you feel a lump in your breast (this may indicate breast cancer);
if you experience sudden or severe pain in the lower abdomen or stomach area (this may indicate an ectopic pregnancy, i.e. a pregnancy outside the uterus);
if you are going to remain immobile or undergo surgery (consult your doctor at least four weeks in advance);
if you have unusual and heavy vaginal bleeding;
if you suspect you are pregnant.

Breast cancer
Regularly examine your breasts and contact your doctor as soon as possible if you feel a lump.
Breast cancer has been observed slightly more frequently in women taking the pill compared to women of the same age not taking the pill. If you stop taking the pill, the risk gradually decreases. Ten years after stopping, the risk is the same as in women who have never taken the pill. Breast cancer is rare under the age of 40, but the risk increases with age. Therefore, the number of excess breast cancer diagnoses is higher the older the age at which a woman stops taking the pill. The duration of pill use is a less important factor.
For every 10,000 women who take the pill for a maximum of 5 years but stop before age 20, there will be less than 1 additional case of breast cancer diagnosed up to 10 years after stopping, in addition to the 4 cases normally diagnosed in this age group.
Similarly, for every 10,000 women who take the pill for a maximum of 5 years but stop before age 30, there will be 5 additional cases beyond the 44 normally diagnosed. For every 10,000 women who take the pill for a maximum of 5 years but stop before age 40, there will be 20 additional cases beyond the 160 normally diagnosed.
The risk of breast cancer in users of progestogen-only pills such as NACREZ is believed to be similar to that in women using combined pills (containing estrogens), but the evidence is less conclusive.
It appears that breast cancer observed in women taking the pill is less advanced than breast cancer in women not taking the pill. It is not known whether the difference in breast cancer risk is caused by the pill. It is possible that the cancer was detected earlier because women underwent more frequent examinations.
Thrombosis
Contact your doctor immediately if you notice possible signs of thrombosis. For information on these possible signs, see the section “Contact your doctor as soon as possible”, first point.
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 detaches from the veins where it formed, it can travel to the pulmonary arteries and block them. This causes what is known as a "pulmonary embolism". As a result, life-threatening conditions may occur, which can lead to death. Deep vein thrombosis is a rare event. It can develop independently of whether or not you take the pill. It can also occur during pregnancy.
The risk is higher in users of the pill compared to non-users. The risk with progestogen-only pills such as NACREZ is believed to be lower than in users of pills containing estrogens (combined pills).
Psychiatric disorders
Some women using hormonal contraceptives, including NACREZ, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice.
Children and adolescents
There are no clinical data available on efficacy and safety in adolescents under 18 years of age.
Other medicines and NACREZ
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines or herbal products. Also inform any other doctor or dentist who may prescribe you another medicine (or the pharmacist) that you are taking NACREZ. They can tell you whether you need to use additional contraceptive measures (e.g. condoms) and for how long, and whether the use of other medicines you need should be adjusted.
Some medicines

may affect blood levels of NACREZ
may reduce effectiveness in preventing pregnancy
may cause unexpected bleeding. These include medicines 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, nevirapine, efavirenz),
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),
depressed mood (the herbal preparation 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 reduce the effectiveness of NACREZ, a barrier contraceptive method should also be used. Since the effect of another medicine on NACREZ may last up to 28 days after stopping the medicine, an additional barrier contraceptive method must be used for this duration. Your doctor can advise you whether you need to take additional contraceptive measures and, if so, for how long.
NACREZ may also affect the action of certain medicines, causing either an increase in effect (e.g. for medicines containing cyclosporine) or a reduction in effect (e.g. lamotrigine).
Ask your doctor or pharmacist for advice before taking any medicine.
NACREZ with food and drink
NACREZ can be taken with or without food and drink.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use NACREZ if you are pregnant or think you might be.
Breastfeeding
NACREZ can be used during breastfeeding. NACREZ does not affect the production or quality of breast milk. However, small amounts of the active substance in NACREZ pass into breast milk.
The health of infants breastfed for 7 months by mothers using NACREZ has been studied up to the age of 2.5 years. No effects on growth and development of the children were observed.
If you are breastfeeding and wish to use NACREZ, consult your doctor.
Driving and using machines
NACREZ does not affect the ability to drive or use machines.
NACREZ contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take NACREZ

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Method of administration

The NACREZ pack contains 28 tablets.
Take one tablet daily.
Swallow the tablet whole with a sufficient amount of water.

On the front side of the pack, arrows are printed between the tablets. By turning the pack over and
looking at the back side, you will see the days of the week printed on the foil. Each day corresponds to
one tablet. Each time you start a new pack of NACREZ, take a tablet from the top row. Do not start
with any random tablet. For example, if you start on Wednesday, you must take the tablet in the top row
marked on the back with “Wed”. Continue taking one tablet daily until the pack is finished. Always
follow the direction of the arrows. By looking at the back of the pack, you can easily check whether
you have already taken the tablet for a particular day.
Take the tablet at approximately the same time each day. Swallow the tablet whole with water.
Bleeding may occur while using NACREZ, but you must continue taking the tablets regularly. When
you have finished one pack, start the next pack of NACREZ the following day, without interruption and
without waiting for bleeding to occur.
Starting the first pack of NACREZ

If you have not used a hormonal contraceptive in the previous month Wait for the onset of menstruation. On the first day of your period, take the first tablet of NACREZ. You do not need to use any additional contraceptive measures. You may also start between day 2 and day 5 of your cycle, but in this case you must also use an additional contraceptive method (barrier method, e.g. condom) for the first 7 days of tablet intake.
Switching from a combined oral contraceptive pill, vaginal ring, or transdermal patch You may start taking NACREZ the day after taking the last active tablet of your current pill pack, or the day after removing the vaginal ring or transdermal patch (meaning no pill-free, ring-free, or patch-free interval). If your current pill pack also contains inactive tablets, you may start NACREZ the day after taking the last active tablet (if you are unsure which one this is, consult your doctor or pharmacist). If you follow these instructions, you do not need to use any additional contraceptive measures. You may also start no later than the day after the pill-free, ring-free, or patch-free interval, or after taking the inactive tablets of your current contraceptive. If you follow these instructions, you must use an additional contraceptive method (barrier method, e.g. condom) for the first 7 days of tablet intake.
Switching from a progestogen-only pill (mini-pill) to NACREZ You may stop taking your current pill at any time and immediately start taking NACREZ. You do not need to use any additional contraceptive measures.
Switching from a progestogen-only injectable, implant, or intrauterine system (IUS) to NACREZ Start using NACREZ on the day your next injection is due, or on the day of removal of the implant or IUS. You do not need to use any additional contraceptive measures.
After childbirth You may start taking NACREZ between 21 and 28 days after the birth of your baby. If you start later, you must use an additional contraceptive method (barrier method, e.g. condom) for the first 7 days of tablet intake. However, if you have had sexual intercourse in the meantime, you must ensure that you are not pregnant before starting NACREZ. Additional information for breastfeeding women is provided in section 2 “Pregnancy and breastfeeding”. Also follow your doctor’s advice.
After a spontaneous or induced abortion Follow your doctor’s advice.

If you take more NACREZ than you should
There have been no reports of serious harmful effects from taking too many tablets containing desogestrel. Symptoms that may occur include nausea, vomiting, and, in younger women, slight vaginal bleeding. For further information, consult your doctor.
If you forget to take NACREZ
If you take a tablet less than 12 hours late, the contraceptive protection of NACREZ remains effective. Take the missed tablet as soon as you remember, then take the next tablet at your usual time. If you take a tablet more than 12 hours late, the contraceptive protection of NACREZ may be reduced. The more tablets you miss, the greater the risk that contraceptive effectiveness will be reduced. Take the most recently missed tablet as soon as you remember, then continue taking the following tablets at your usual time. This may mean taking two tablets on the same day. Also use an additional contraceptive method (such as a condom) for the next 7 days of tablet intake. If you have missed one or more tablets during the first week of intake and have had sexual intercourse in the previous week, there is a possibility you could become pregnant. Consult your doctor.
If you experience gastrointestinal disturbances (e.g. vomiting or severe diarrhoea)
Follow the advice for missed tablets given in the previous section. If you vomit within 3–4 hours after taking a NACREZ tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed.
If you stop taking NACREZ
You may stop taking NACREZ at any time. From the day you stop taking it, you are no longer protected
against pregnancy.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, NACREZ can cause side effects, although not everyone experiences them.
Serious side effects associated with the use of NACREZ are described in the sub-sections “Breast cancer” and “Thrombosis” in section 2, "What you should know before taking NACREZ". Please read this section carefully for further information and contact your doctor immediately if necessary.
Irregular vaginal bleeding may occur during the use of NACREZ. This may consist of light spotting that does not require the use of sanitary protection, or heavier bleeding similar to a light menstruation, which does require sanitary protection. It is also possible not to have any bleeding at all. These irregular bleedings do not indicate a reduction in the contraceptive protection provided by NACREZ. Generally, no action is required. Continue taking NACREZ as directed. However, if bleeding is heavy or prolonged, consult your doctor.
Users of desogestrel have reported the following side effects:
Common: may affect up to 1 in 10 people
Mood changes, reduced sex drive (libido), depressed mood (unusual feelings of sadness), headache, nausea, acne, breast pain, irregular or absent menstrual periods, weight gain.
Uncommon: may affect up to 1 in 100 people
Vaginal infections, difficulty wearing contact lenses, vomiting, hair loss, painful menstruation, ovarian cysts, fatigue.
Rare: may affect up to 1 in 1,000 people
Skin disorders such as: skin rash, urticaria, painful red/blue nodules (erythema nodosum).
In addition to these side effects, breast milk secretion may also occur.
You must contact 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 breathing difficulties.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NACREZ

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Storage conditions with the sachet:
This medicine does not require any special storage conditions.
Storage conditions without the sachet:
Do not store above 30°C.
The active substance poses an environmental risk to fish.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NACREZ contains

The active substance is desogestrel. Each film-coated tablet contains 75 micrograms of desogestrel.
The other ingredients are monohydrate lactose (see also “NACREZ contains lactose” in section 2), maize starch, povidone K30, stearic acid, all-rac-alpha-tocopherol, anhydrous colloidal silica, hypromellose, macrogol 400, talc, titanium dioxide.

Description of the appearance of NACREZ and contents of the pack
NACREZ tablets are white to off-white, circular, biconvex, with a diameter of 5.4–5.8 mm, without any engraving.
A NACREZ blister pack contains 28 film-coated tablets. Each carton contains 1, 3 or 6 blisters, which may be individually packaged in a pouch.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Theramex Ireland Limited
Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland

Manufacturer responsible for batch release
Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Theranette 75 Microgram Film Tablets
Belgium Nacrez
Czech Republic Xynia 0.075 mg coated tablets
Denmark Nacrez
Hungary Nacrez 0.075 mg filmtabletta
Italy Nacrez 75 micrograms film-coated tablets
Netherlands Desogestrel 0.075 mg Theramex, filmomhulde tabletten
Romania SOFTINETTE 0.075 mg film-coated tablets
Slovenia Nacrez 75 micrograms film-coated tablets
Spain Nacrez 75 micrograms film-coated tablets EFG
United Kingdom Nacrez 75 micrograms Film-coated Tablets