Package leaflet: Information for the user

Desirett 75 micrograms film-coated tablets

Desogestrel
Equivalent medicine
Please read all of this leaflet carefully before you start using 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. It is not suitable for all women; therefore, do not give it to others, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What is Desirett and what is it used for

Desirett is used for the prevention of pregnancy.
Desirett contains a small amount of a type of female sex hormone, the progestin desogestrel.
For this reason, Desirett is known as a progestogen-only pill (POP), or mini-pill.
Unlike the combined oral contraceptive pill, the POP or mini-pill does not contain an oestrogenic hormone in addition to the progestogen.
Most POPs or mini-pills primarily work by preventing sperm from entering the uterus, but do not always prevent the maturation of egg cells, which is the main action of combined-type pills. Desirett differs from most mini-pills in that its dosage is in most cases high enough to prevent the maturation of egg cells. As a result, Desirett provides high contraceptive efficacy. Unlike combined-type pills, Desirett can be used by women who are intolerant to oestrogens and by women who are breastfeeding.
A disadvantage of using Desirett is that vaginal bleeding may occur at irregular intervals. You may also experience no bleeding at all.

2. What you should know before taking Desirett

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

if you are allergic to desogestrel or to any of the other ingredients of this medicine (listed in section 6).
if you have thrombosis. Thrombosis is the formation of a blood clot in a blood vessel [e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)].
if you have jaundice (yellowing of the skin), current or past, or severe liver disease and liver function has not 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.
if you are allergic to peanuts or soy.

Inform your doctor before taking Desirett if you have any of these conditions. Your doctor may
recommend that you use a non-hormonal contraceptive method.
Contact your doctor immediately if any of these conditions occur for the first time while you are taking Desirett.
Warnings and precautions
Inform your doctor before starting to use Desirett if:

you have or have had breast cancer.
you have liver cancer, since a possible effect of Desirett cannot be excluded.
you have ever had thrombosis.
you suffer from diabetes.
you suffer from epilepsy (see section “Other medicines and Desirett”).
you suffer from tuberculosis (see section “Other medicines and Desirett”).
you have high blood pressure.
you have or have had chloasma (yellow-brown patches on the skin, especially on the face); in this case avoid excessive exposure to sunlight or ultraviolet radiation.

When Desirett is used in the presence of any of the above-mentioned conditions, close medical supervision may be necessary. Your doctor will explain what to do.
Breast cancer
Check your breasts regularly and contact your doctor as soon as possible if you notice any lump in your
breast. Breast cancer has been found slightly more often in women taking the pill than in women of the same age who do not take it. If a woman stops taking the pill, the risk gradually decreases, so that 10 years after stopping the pill, the risk is the same as that observed in women who have never taken it. Breast cancer is rare under the age of 40, but the risk increases with advancing age. Therefore, the number of additional cases of breast cancer diagnosed is higher the older the woman is when she stops taking the pill. The duration of pill use is less important.
For every 10,000 women who take the pill for periods up to 5 years but stop before age 20, there would be less than 1 additional case of breast cancer diagnosed up to 10 years after stopping treatment, in addition to the 4 cases normally diagnosed in women of this age.
Similarly, in 10,000 women who take the pill for periods up to 5 years but stop before age 30, there would be 5 additional cases beyond the 44 normally diagnosed. In 10,000 women who take the pill for periods up to 5 years but stop before age 40, there would be 20 additional cases beyond the 160 normally diagnosed.
The risk of breast cancer in users of progestogen-only pills such as Desirett is considered to be similar to that in women using combined oral contraceptives, but the evidence is less conclusive.
The breast cancer found in women taking the pill appears to be less advanced than that found in women not using the pill. It is not known whether the difference in breast cancer risk is due to the pill. Perhaps women who use the pill are examined more frequently, and thus breast cancer may be diagnosed earlier.
Thrombosis
Contact your doctor immediately if you notice possible signs of thrombosis (see also “Regular medical checks”). Thrombosis is the formation of a blood clot that can block a blood vessel. Thrombosis may sometimes occur in the deep veins of the legs (deep vein thrombosis). If this clot detaches from the vein where it formed, it can travel to and block the pulmonary artery, causing so-called “pulmonary embolism”. As a result, life-threatening situations may occur. Deep vein thrombosis is a rare event. It can develop independently of taking the pill and 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 Desirett is considered to be lower than that in women using combined pills (containing both progestogen and estrogen).
Psychiatric disorders
Some women using hormonal contraceptives, including Desirett, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice.
Use in adolescents
There are no data available on efficacy and safety in adolescents under 18 years of age.
Other medicines and Desirett
Inform your doctor if you are taking, have recently taken, or might take any other medicines or herbal products, including those obtained without a prescription.
Also inform any other doctors or dentists who prescribe other medicines (or your pharmacist) that you are taking Desirett. They can advise you whether you need to use additional contraceptive methods (for example, a condom), and if so, for how long, or whether you need to adjust the use of another medicine you are taking.
Some medicines:

may affect blood levels of Desirett
may lead to reduced contraceptive effectiveness
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 infections (e.g. ritonavir, nelfinavir, nevirapine, efavirenz)
hepatitis C virus infection (e.g. boceprevir, telaprevir)
other infections (e.g. griseofulvin)
high blood pressure in the blood vessels of the lungs (pulmonary hypertension) (bosentan)
depression (St. John’s wort herbal remedy)
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 could make Desirett less effective, you must also use a barrier contraceptive method. Since the effect of another medicine on Desirett may last up to 28 days after stopping the medicine, you must use an additional barrier contraceptive method during this period. Your doctor can advise you whether you need to take additional contraceptive precautions and for how long.
Desirett may also interfere with the action of other medicines, causing either an increase (e.g. medicines containing cyclosporine) or a decrease in effect (e.g. lamotrigine).
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy and breastfeeding
Pregnancy
Do not use Desirett if you are pregnant or think you might be.
Breastfeeding
Desirett can be used while breastfeeding. Desirett does not appear to affect the quantity or quality of breast milk. However, rare cases of decreased breast milk production have been reported during use of Desirett. A small amount of the active ingredient of Desirett passes into breast milk.
The health of children breastfed up to 7 months of age, whose mothers were using Desirett, 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 Desirett, contact your doctor.
Driving and using machines
There are no indications of any effect of Desirett on alertness or concentration.
Desirett contains lactose (milk sugar) and soybean seed oil.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
If you are allergic to peanuts or soy, do not use this medicine.
Regular medical checks
When you are using Desirett, your doctor will advise you to return for regular check-ups. In general, the frequency and nature of these checks will depend on your individual circumstances.
Contact your doctor as soon as possible if:

you have severe pain or swelling in one of your legs, unexplained chest pain, shortness of breath, unusual cough, especially if accompanied by coughing up blood (possible signs of thrombosis).
you have sudden severe stomach pain or jaundice (which may indicate possible liver problems).
you feel a lump in your breast (which may indicate breast cancer).
you have sudden or severe pain in the lower abdomen or stomach area (which may indicate an ectopic pregnancy, i.e. a pregnancy outside the uterus).
you are facing immobilization or surgery (consult your doctor at least 4 weeks beforehand).
you have unusual, heavy vaginal bleeding.
you think you may be pregnant.

3. How to take Desirett

When and how to take the tablets?
The Desirett pack contains 28 tablets. The days of the week are printed on the blister, along with arrows indicating the order in which to take the tablets. Each day corresponds to one tablet. Each time you start a new pack of Desirett, take the first tablet from the top row. Do not start with a random tablet. For example, if you begin taking the tablets on Wednesday, take the tablet marked 'WED' (Wednesday) from the top row. Continue taking one tablet daily until the pack is finished, always following the direction of the arrows. By looking at the blister, you can easily check whether you have already taken your tablet for a particular day. Take the tablet at approximately the same time each day.
The tablet must be swallowed whole with a little water. While using Desirett, you may experience bleeding; however, continue taking the tablets as usual. After finishing one pack, start the next pack of Desirett the following day—without any break and without waiting for any bleeding.

Starting your first pack of Desirett
When you have not used any hormonal contraceptive in the previous month
Wait for your menstrual period before starting. Take the first tablet of Desirett on the first day of your period. No additional contraceptive precautions are necessary.
You may also start between the second and fifth day of your cycle; however, in this case, you must also use an additional contraceptive method (barrier method) during the first seven days of tablet intake.

When switching from a combined oral contraceptive pill, vaginal ring, or transdermal patch
You may start taking Desirett the day after taking the last active tablet of your previous pill pack, or the day after removing the vaginal ring or transdermal patch (meaning you do not take any pill-free, ring-free, or patch-free interval). If your previous contraceptive also contains inactive tablets, you may start Desirett the day after taking the last active tablet (in case of doubt, consult your doctor or pharmacist). If you follow these instructions, no additional contraceptive precautions are necessary.
Alternatively, you may start at the latest on the day after the pill-free, ring-free, patch-free, or inactive tablet interval of your current contraceptive. If you follow this approach, you must use an additional contraceptive method (barrier method) for the first 7 days of tablet intake.

When switching from a progestin-only pill (minipill)
You may stop taking the minipill at any time and start taking Desirett immediately. No additional contraceptive precautions are necessary.

When switching from a progestin-releasing injectable contraceptive, implant, or intrauterine device (IUD)
Start using Desirett on the day your injection is due or on the day your implant or IUD is removed. No additional contraceptive precautions are necessary.

After childbirth
You may start Desirett between day 21 and day 28 after the birth of your baby. If you start later, you must use an additional contraceptive method (barrier method) until you have completed the first 7 days of tablet intake.
However, if you have already had sexual intercourse, pregnancy must be ruled out before starting Desirett. Further information for breastfeeding women is provided in section 2 “Pregnancy and breastfeeding”. Your doctor can also advise you.

After a spontaneous or induced abortion
Your doctor will provide you with advice.

If you forget to take Desirett
If less than 12 hours have passed since the usual time of taking the tablet, the effectiveness of Desirett remains unchanged. Take the missed tablet as soon as you remember, and take the following tablets as usual.

If more than 12 hours have passed, the effectiveness of Desirett may be reduced. The greater the number of consecutive tablets missed, the higher the risk that contraceptive protection may be compromised. Take the last missed tablet as soon as you remember, and continue taking the tablets as usual. For the next 7 days of tablet intake, you must also use an additional contraceptive method (barrier method). If one or more tablets were missed during the first week of starting the tablets and you had sexual intercourse in the preceding week, pregnancy may have occurred. Consult your doctor.

If you experience gastrointestinal disturbances (e.g., vomiting or severe diarrhoea)
Follow the instructions given for missed tablets in the previous section. If vomiting occurs within 3–4 hours after taking a Desirett tablet, or if you experience severe diarrhoea, the active ingredient may not have been completely absorbed.

If you take more Desirett than you should
There are no reports of serious harmful effects following the intake of more than the recommended number of Desirett tablets at one time. Symptoms that may occur include nausea, vomiting, and, in younger girls, slight vaginal bleeding. For further information, contact your doctor for advice.

If you stop taking Desirett
You may stop taking Desirett at any time. From the day you stop taking the pill, you are no longer protected against pregnancy.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Desirett can cause side effects, although not everyone experiences them.
Serious side effects associated with the use of Desirett are described in the sections "Breast cancer" and
"Thrombosis" in section 2, "What you should know before taking Desirett". Please read this section carefully
for further information and consult your doctor promptly when necessary.
Seek immediate medical attention if you experience allergic reactions (hypersensitivity), including swelling
of the face, lips, tongue and/or throat causing difficulty in breathing or swallowing (angioedema and/or
anaphylaxis).
Irregular vaginal bleeding may occur during use of Desirett. This may be only slight spotting that does not
require the use of sanitary protection, or it may be heavier bleeding, more similar to a light menstruation
requiring sanitary protection. It is also possible to have no bleeding at all. Irregular bleeding is not a sign that
the contraceptive protection provided by Desirett is reduced. Normally, no intervention is necessary; continue
taking Desirett. However, if bleeding is heavy or prolonged, consult your doctor.
Women using Desirett have reported the following side effects:

Common: may affect up to 1 in 10 women: mood changes, depressed mood, decreased sexual desire (libido), headache, nausea, acne, breast pain, irregular or absent menstruation, weight gain.
Uncommon: may affect up to 1 in 100 women: vaginal infection, difficulty wearing contact lenses, vomiting, hair loss, painful menstruation, ovarian cyst, fatigue.
Rare: may affect up to 1 in 1,000 women: skin rash, urticaria, painful, bluish-red subcutaneous nodules (erythema nodosum). These are skin conditions.
Not known (frequency cannot be estimated from the available data): allergic reaction.

In addition to these side effects, breast discharge may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Desirett

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Desirett after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
This 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 Desirett contains
The active substance is: desogestrel (75 micrograms)
The other components are: monohydrate lactose, maize starch, povidone, d-α-tocopherol, soybean seed oil, anhydrous colloidal silicon dioxide, hydrated colloidal silicon dioxide, stearic acid, hypromellose, macrogol, titanium dioxide (E 171) (see also "Important information on some components of Desirett" in section 2).

Description of the appearance of Desirett and package contents
One Desirett blister contains 28 white, round, film-coated tablets.
Each pack contains 1, 3, 6 or 13 blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Rome
Italy

Manufacturer
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera
C/ La Vallina s/n
24008 - Navatejera, León
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
United Kingdom: Desogestrel 75 microgram film-coated tablets
Bulgaria: Desirett 75 mcg
Czech Republic: Velavel 0.075 mg
Estonia: Desirett 75 mcg
Germany: Desirett 75 mcg
Hungary: Desirett 75 mcg
Lithuania: Desirett 75 mikrogramai plėvele dengtos tabletės
Latvia: Desirett 75 mikrogramí apvalkotās tabletes
Poland: Desirett
Romania: Desirett 75 micrograme
Slovakia: Desirett 75 microgramov
Slovenia: Desirett 75 mikrogramov filmsko obložene tablete
Belgium: Desirett 75 microgrammes comprimé pelliculé
Luxembourg: Desirett 75 microgrammes comprimé pelliculé
Italy: Desirett
Sweden: Yadina 75 mcg filmdragerade tabletter
Norway: Desirett 75 mcg
Finland: Yadina 75 mcg
Iceland: Desirett 75 mcg
Denmark: Desirett 75 mcg