DESIRETT 75 MICROGRAMS Film-coated tablets

Зміст інструкції

1. Desirett 75 micrograms film-coated tablets
   1. What is Desirett and what is it used for?
   2. What you need to know before taking Desirett
   3. How to take Desirett
   4. Possible side effects
   5. How to store Desirett
   6. Contents of the pack and other information

Desirett 75 micrograms film-coated tablets

Desogestrel
Generic medicine

Read this leaflet carefully before you start using this medicine because it containsimportant
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 pass it on to others, even if they have the same
symptoms, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Desirett is and what it is used for
• 2. What you need to know before you take Desirett
• 3. How to take Desirett
• 4. Possible side effects
• 5. 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 pregnancy prevention.
Desirett contains a small amount of a type of female sex hormone, the progestin desogestrel.
For this reason Desirett is called a progestin-only pill (POP), or minipill.
Unlike the combined pill, the POP or minipill does not contain an estrogenic hormone in addition to the progestin.
Most POPs or minipills work mainly by preventing sperm from entering the uterus, but do not always prevent the maturation of egg cells, which is the primary action of combined-type pills. Desirett differs from most minipills in that it has a dosage that in most cases is high enough to prevent the maturation of egg cells. As a consequence, Desirett provides high contraceptive efficacy. Unlike combined-type pills, Desirett can be used by women intolerant to estrogens and by breastfeeding women.
One disadvantage during the use of Desirett is that vaginal bleeding may occur at irregular intervals. You may also have no bleeding at all.

2. What you need to 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 takeDesirett

• if you are allergic to desogestrel and any of the other ingredients of this medicine (listed in section 6).
• if you have a 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), present or previous, or severe liver disease and liver function is not yet 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.

Tell your doctor before taking Desirett if you have any of these conditions. Your doctor may
advise you to use a non-hormonal contraceptive method.
See your doctor immediately if any of these conditions occur for the first time while you are taking Desirett.

Warnings and precautions
Tell your doctor before starting to use Desirett, if

• you have or have had breast cancer.
• you have liver cancer, as a possible effect of Desirett cannot be excluded.
• you have ever had a 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 (brownish-yellow patches on the skin, especially of the face); in this case, avoid excessive exposure to the sun or ultraviolet radiation.

When Desirett is used in the presence of any of the above 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 feel any lump in your
breast. Breast cancer has been found slightly more often in women who take the pill
compared to those 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 age. Therefore, the extra number of cases of breast cancer
diagnosed is the higher the age until which the woman continues to take the
pill. Less important, however, is the duration of use of the pill.
For every 10,000 women who take the pill for periods of up to 5 years, but who stop doing so within 20
years of age, there would be less than 1 additional case of breast cancer detected 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 of up to 5 years, but stop within 30
years of age, there would be 5 additional cases in addition to the 44 normally diagnosed. In 10,000 women who take the
pill for periods of up to 5 years but stop within 40 years of age, there would be 20 additional cases
in addition to the 160 normally diagnosed.
The risk of breast cancer in users of progestin-only pills like Desirett is
believed to be similar to that of women who use the pill, but the evidence is less conclusive.
Breast cancer found in women who take the pill appears to be less advanced than that
found in women who do not use the pill. It is not known whether the difference in the risk of breast
cancer is due to the pill. Perhaps women who use the pill are examined more often, and therefore the
breast cancer can 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. A
thrombosis can sometimes manifest in the deep veins of the legs (deep vein thrombosis). If this
clot detaches from the vein where it formed, it can reach and block the pulmonary artery causing the
so-called “pulmonary embolism”. Consequently, life-threatening situations can occur. Deep vein
thrombosis is a rare event. It can develop independently of taking the pill and can
occur even during pregnancy. The risk is higher in users of the pill compared to non-
users. The risk with progestin-only pills, such as Desirett, is believed to be lower
than that found in women who use pills that also contain estrogens (combined pills).

Psychiatric disorders
Some women who use hormonal contraceptives including Desirett have reported depression or depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you experience
changes in mood and depressive symptoms, see your doctor as soon as possible for further medical advice.

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

Other medicines and Desirett
Tell your doctor if you are taking, have recently taken or might take any other medicines
or herbal products, including medicines available without a prescription.
Also tell all other doctors or dentists who prescribe other medicines (or the pharmacist) that
you are taking Desirett. They may tell you whether you need to use additional contraceptive methods (for
example, a condom) and, if so, for how long, or whether you need to change the use of another medicine you are taking.
Some medicines:

• can affect the blood levels of Desirett
• can lead to a decrease in contraceptive efficacy
• can cause unexpected bleeding. These include medicines used for the treatment of:
• 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 infectious diseases (e.g. griseofulvin)
• high blood pressure in the blood vessels of the lungs (bosentan)
• depressed mood (St. John's wort herbal remedy)
• some bacterial infections (e.g. clarithromycin, erythromycin)
• fungal infections (e.g. ketoconazole, itraconazole, fluconazole)
• high blood pressure (hypertension), angina or some 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. Because the effect of another medicine on Desirett can
last up to 28 days after stopping the medicine, you need to use an additional barrier contraceptive method for that period. Your doctor can tell you if you need to take additional contraceptive
precautions and for how long.
Desirett can also interfere with the functioning of other medicines causing or an increase (e.g.
medicines containing cyclosporine) or a decrease in the 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 production
or quality of breast milk. However, cases of decreased breast milk production have been reported infrequently during the use of Desirett. A small amount of the active ingredient of Desirett passes into
breast milk.
The health of breastfed babies up to 7 months of age whose mothers were using Desirett has been
studied up to 2 and a half years of age. No effect on growth and development of
babies was observed.
If you are breastfeeding and want to use Desirett, contact your doctor.

Driving and operating machinery
There is no evidence of any effect of Desirett use on alertness and concentration.

Desirett contains lactose (milk sugar) and soybean oil.
If your doctor has diagnosed you with 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 use Desirett, your doctor will tell you to come back for regular check-ups. In general, the frequency and
nature of these checks will depend on your personal situation.

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 a thrombosis).
• you have sudden severe abdominal pain or jaundice (which may indicate liver problems);
• you feel a lump in your breast (which may indicate breast cancer);
• you have sudden or severe abdominal pain or stomach pain (which may indicate an ectopic pregnancy, i.e. a pregnancy outside the uterus);
• in case of immobilization or surgery (consult your doctor at least 4 weeks before);
• you have unusual, heavy vaginal bleeding;
• you think you are 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, as well as the 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 one tablet from the top row. Do not start with any tablet. For example, if you start taking the tablets on Wednesday, you must take the tablet marked with ‘WED’ (Wednesday) from the top row.
Continue to take one tablet a day until the pack is finished, always following the direction of the arrows. By looking at the blister, you can easily check if your tablet for a particular day has already been taken. Take the tablet every day at about the same time.
The tablet must be swallowed whole, with a little water. During use of Desirett, you may experience bleeding, but continue to take the tablets as normal. After finishing one pack, start the new pack of Desirett the next day – without observing any interruption and without waiting for any bleeding.

Starting your first pack ofDesirett

When you have not used any hormonal contraception in the previous month
Wait for your menstrual period before starting. Take the first Desirett tablet on the first day of your period. You do not need to adopt additional contraceptive precautions.
You can also start between the second and fifth day of your cycle, but in this case, you must also use an additional contraceptive method (barrier method) for the first seven days of taking the tablets.

When switching from a combined pill, vaginal ring or transdermal patch
You can start taking Desirett the day after the last tablet of the previous pill pack, or the day the vaginal ring or patch is removed (this means that you do not observe any pill-free, ring-free or patch-free interval). If your previous contraceptive also contains inactive tablets, you can start Desirett the day after taking the last active tablet (if in doubt, ask your doctor or pharmacist). If you follow these instructions, no additional contraceptive precautions are necessary.
You can also start, at the latest, on the day following the pill-free, ring-free, patch-free or inactive tablet-free interval of your current contraceptive. If you follow these instructions, you must use an additional contraceptive method (barrier method) for the first 7 days of taking the tablets.

When switching from a progestin-only pill (minipill)
You can stop taking the minipill at any time and start taking Desirett directly. You do not need to adopt additional contraceptive precautions.

When switching from an injectable contraceptive, an implant or an intrauterine device releasing

progestin(IUD)
Start using Desirett on the day your injection is due or the day the implant or IUD is removed. You do not need to adopt additional contraceptive precautions.

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

After an abortion, spontaneous or induced
Your doctor will advise you.

If you forget to takeDesirett
If less than 12 hourshave passed since the usual time to take the tablet, the reliability of Desirett remains. Take the forgotten tablet as soon as you remember and take the subsequent tablets as usual.
If more than 12 hourshave passed, the reliability of Desirett may be reduced. The more consecutive tablets you forget, the higher the risk that the contraceptive effectiveness is decreased.
Take the last forgotten tablet as soon as you remember and take the subsequent tablets as usual. For the next 7 days of taking the tablets, you must also use an additional contraceptive method (barrier method). If one or more tablets have been forgotten in the first week of starting to take the tablets and you have had sexual intercourse during the previous week, there is a possibility that you may be pregnant. Ask your doctor for advice.

If you suffer from gastrointestinal disorders (e.g. vomiting or severe diarrhea)
Follow the instructions for forgotten tablets in the previous paragraph. In case of vomiting within 3-4 hours of taking a Desirett tablet, or in case of severe diarrhea, the active ingredient may not have been completely absorbed.

If you take more Desirett than you should
There are no reports of serious adverse effects resulting from taking more Desirett tablets in one go. The symptoms that may occur are nausea, vomiting and, in young girls, mild vaginal bleeding. For more information, contact your doctor for advice.

If you stop takingDesirett
You can 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Desirett can cause side effects, although not everybody gets them.
Serious side effects associated with the use of Desirett are described in the paragraphs "Breast cancer" and
"Thrombosis" in section 2 “What you need to know before you take Desirett”. Read the paragraph
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 breathing or swallowing (angioedema and/or
anaphylaxis).
During the use of Desirett, vaginal bleeding may occur at irregular intervals. This may only be
mild spotting that does not require the use of a sanitary pad or heavier bleeding, more
similar to a light period and requiring the use of a sanitary pad. It is also possible to have no
bleeding at all. Irregular bleeding is not a sign that the contraceptive protection of
Desirett has decreased. Usually no intervention is necessary; continue to take Desirett. However, if the
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: altered mood, depressed mood, decreased sexual desire (libido), headache, nausea, acne, breast pain, irregular or absent periods, increased body weight.
• Uncommon: may affect up to 1 in 100 women: vaginal infection, difficulty wearing contact lenses, vomiting, hair loss, painful periods, ovarian cyst, fatigue.
• Rare: may affect up to 1 in 1,000 women: skin rash, hives, painful bluish-reddish subcutaneous nodules (erythema nodosum). These are skin conditions.
• Not known (frequency cannot be estimated from available data): allergic reaction.

Apart from these side effects, breast secretion may occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 particular storage conditions.
Do not use Desirett after the expiry date stated on the pack after “EXP”. The expiry date refers to the last day of that month.
This active substance presents an environmental risk for fish.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Desirett contains
The active ingredient is: desogestrel (75 micrograms)
The other ingredients are: lactose monohydrate, corn starch, povidone, d-α-tocopherol, soybean oil, anhydrous colloidal silica, hydrated colloidal silica, stearic acid, hypromellose, macrogol, titanium dioxide
(E 171) (see also "Important information on some components of Desirett" in paragraph 2).

Description of the appearance of Desirett and contents of the pack
A 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

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 Member States of the European Economic Area 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 micrograms
Slovakia: Desirett 75 micrograms
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