KESTRELLE 75 MICROGRAMS Film-coated tablets

Зміст інструкції

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

Desogestrel Farmitalia 75 micrograms film-coated tablets
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours because it could 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 Desogestrel Farmitalia is and what it is used for
• 2. What you need to know before you take Desogestrel Farmitalia
• 3. How to take Desogestrel Farmitalia
• 4. Possible side effects
• 5. How to store Desogestrel Farmitalia
• 6. Contents of the pack and other information

1. What is Desogestrel Farmitalia and what is it used for

Desogestrel Farmitalia is used to prevent pregnancy.
Desogestrel Farmitalia contains a small amount of a type of female sex hormone, the progestin
desogestrel. For this reason Desogestrel Farmitalia is called a progestin-only pill (POP).
Unlike the combined pill, the POP does not contain an estrogen together with the progestin.
Most POPs 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 pills.
Desogestrel Farmitalia differs from POPs in having a dosage that in most cases is high enough to prevent the maturation of egg cells. As a consequence, Desogestrel Farmitalia
provides high contraceptive efficacy. Unlike combined pills, Desogestrel
Farmitalia can be used by women who do not tolerate estrogens and by women who are breastfeeding.
A disadvantage may be that vaginal bleeding may occur at irregular intervals during
the use of Desogestrel Farmitalia. On the other hand, bleeding may not occur at all.

2. What you need to know before taking Desogestrel Farmitalia

Desogestrel Farmitalia, like other hormonal contraceptives, does not protect against
infection from HIV (AIDS) or any other sexually transmitted disease.
Do not take Desogestrel Farmitalia:

• If you are allergic to desogestrel or 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 or have had jaundice (yellowing of the skin) or a serious liver disease and your liver function is still not normal.
• If you have or suspect you have a cancer sensitive to sex hormones, such as certain types of breast cancer.
• If you have vaginal bleeding of unknown origin.
• If you are allergic to peanuts or soy.

If any of these conditions apply to you, consult your doctor before taking Desogestrel
Farmitalia. Your doctor may advise you to use a non-hormonal contraceptive method.
Contact your doctor immediately if any of these conditions appear for the first time
while using Desogestrel Farmitalia.

Warnings and precautions
Talk to your doctor or pharmacist before taking Desogestrel Farmitalia if:

• You have ever had breast cancer.
• You have liver cancer, as a possible effect of Desogestrel Farmitalia cannot be excluded.
• You have ever had a thrombosis.
• You have diabetes.
• You suffer from epilepsy (see section ‘Other medicines and Desogestrel Farmitalia’).
• You have tuberculosis (see section ‘Other medicines and Desogestrel Farmitalia’).
• You have high blood pressure.
• You have or have had chloasma (yellowish-brown skin discoloration, especially on the face); if so, avoid excessive exposure to the sun or ultraviolet radiation.

When Desogestrel Farmitalia is used in the presence of any of these conditions, close medical
supervision may be necessary. Your doctor will explain what to do.

Desogestrel Farmitalia and 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 the woman stops taking
the pill, the risk is reduced, 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 40 years of age, but the risk
increases with age. Therefore, the extra number of cases of breast cancer diagnosed is
so much higher the longer the woman continues to take the pill. The duration
of use of the pill is less important.
For every 10,000 women who take the pill for up to 5 years but stop within 20 years, there would be less than one 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 up to 5 years but stop within 30 years, there would be 5
additional cases in addition to the 44 cases normally diagnosed. In 10,000 women who take the pill for periods
up to 5 years but stop within 40 years, there would be 20 additional cases in addition to the 160 cases
normally diagnosed.
It is believed that the risk of developing breast cancer in women who take progestin-only pills, such as Desogestrel Farmitalia, is similar to that found in women who use the combined 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 certain that the pill causes an increase
in the risk of breast cancer. Women who take the pill are checked more often and therefore
it is possible that breast cancer is diagnosed earlier.

Desogestrel Farmitalia and thrombosis
Contact your doctor immediately if you notice possible signs of thrombosis (see also ‘Periodic medical checks’). Thrombosis is the formation of a blood clot that can block a blood vessel. The
thrombosis can sometimes occur in the deep veins of the legs (deep vein thrombosis). If this
clot detaches from the vein in which it formed, it can reach and block the pulmonary artery, causing
the so-called ‘pulmonary embolism’. As a result, life-threatening situations can occur. Deep vein thrombosis is a rare event. It can develop independently of taking the pill. It can also occur
during pregnancy. The risk is higher in women who take the pill compared to those who
do not use it. It is believed that with progestin-only pills, such as Desogestrel Farmitalia, the
risk is lower than that found in women who use pills that also contain
estrogens (combined pills).

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

Other medicines and Desogestrel Farmitalia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. Some medicines can prevent Desogestrel Farmitalia from working correctly.
These include medicines used in the treatment of epilepsy (for example primidone, phenytoin,
carbamazepine, oxcarbazepine, felbamate and phenobarbital), tuberculosis (e.g. rifampicin), HIV
infections (e.g. ritonavir) or other infectious diseases (e.g. griseofulvin), stomach disorders (medicinal charcoal), depression (herbal products based on St. John's wort).
Your doctor can tell you if you need to take additional contraceptive precautions and, if so, for
how long.
Desogestrel Farmitalia can also interfere with the action of some medicines, causing an increase (e.g.
medicines containing cyclosporine) or a decrease in their effect.

Pregnancy and breastfeeding
Pregnancy
Do not use Desogestrel Farmitalia if you are pregnant or think you may be pregnant.
Breastfeeding
Desogestrel Farmitalia can be taken while breastfeeding. Desogestrel Farmitalia does not influence
the production or quality of breast milk. However, small amounts of the active ingredient of Desogestrel
Farmitalia pass into breast milk.
The health of babies breastfed for 7 months by mothers taking Desogestrel Farmitalia has been
studied up to the age of 2 and a half years. No effects on growth and development of
babies were observed.
If you are breastfeeding and want to use Desogestrel Farmitalia, ask your doctor for advice.

Driving and operating machinery
There is no indication of an effect of Desogestrel Farmitalia on alertness and concentration.

Desogestrel Farmitalia contains lactose (milk sugar) and soya oil
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains soya. Do not use it if you are allergic to peanuts or soya.

Periodic medical checks
While using Desogestrel Stragen Nordic, your doctor will ask you to return for periodic
checks. Normally, the frequency and nature of these checks depend on your personal condition.

Contact your doctor as soon as possible if:

• if you have severe pain or swelling in a leg, unexplained chest pain, difficulty breathing, unusual cough, especially if accompanied by coughing up blood (possible indication of a thrombosis)

3. How to take Desogestrel Farmitalia

Route of administration
Desogestrel Farmitalia is for oral use.

When and how to take Desogestrel Farmitalia
The pack of Desogestrel Farmitalia contains 28 tablets. The days of the week are printed on the
blister and also the arrows indicating the order of taking the pills. Each day corresponds to one
tablet. Each time you start a new blister of Desogestrel Farmitalia, take one tablet from the
top row of the blister. Do not start with any tablet. For example, if you start taking
the tablets on Wednesday, you must take the tablet marked with ‘MER’ (Wednesday) from the
top row. Continue to take one tablet a day until you finish the pack, always following the
direction indicated by the arrows. By looking at the back of the blister you can easily check if you have already taken the
tablet on a particular day. Take the tablet every day at approximately the same time.
Swallow the tablet whole, with some water. During the use of Desogestrel Farmitalia, some
bleeding may occur, but continue to take the tablets normally. After finishing a pack, you can start
a new blister of Desogestrel Farmitalia the next day, without any interruption and without
waiting for any bleeding.

When to start the first pack of Desogestrel Farmitalia

When you have not used hormonal contraceptives in the previous month
Wait for your menstrual period before starting to take it. Take the first tablet of Desogestrel
Farmitalia on the first day of your menstruation. You do not need to adopt additional contraceptive precautions.
If you take the first tablet between the second and fifth day of your cycle, adopt an additional contraceptive method (barrier method) for the first 7 days of taking the tablets.

Switching from a combined pill, vaginal ring or transdermal patch
You can start taking Desogestrel Farmitalia the day after taking the last tablet of the
previous pack of pills or on the day the ring or patch is removed (i.e. without any pill-free, ring-free or patch-free interval). If the contraceptive you are coming from also contains
inactive tablets (placebo), you can start Desogestrel Farmitalia on the day you take the last
active tablet (if you are not sure which one it is, ask your doctor or pharmacist). If you follow these instructions, you do not
need to take additional contraceptive precautions.
You can also start at the latest on 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, make sure to
use an additional contraceptive method (barrier method, such as a condom) for the first 7
days of taking the tablet.

Switching from a progestin-only pill
You can stop taking it at any time and immediately take Desogestrel Farmitalia. You do not
need to adopt additional contraceptive precautions.

Switching from an injectable contraceptive, an implant or an intrauterine device releasing

progestin (IUD)
Start using Desogestrel Farmitalia on the day scheduled for your next injection or on the day of
removal of your implant or IUD. You do not need to adopt additional contraceptive precautions.

After childbirth
You can start taking Desogestrel Farmitalia between 21 and 28 days after delivery.
If you start later, make sure to use an additional contraceptive method (barrier method) for the first
7 days of taking the tablet.
However, if you have already had sexual intercourse, pregnancy must be ruled out before starting to use
Desogestrel Farmitalia. Further information for breastfeeding women can be found in
section 2 “Pregnancy and breastfeeding”. Your doctor will give you the necessary instructions.

After an abortion or spontaneous abortion
Your doctor will give you the necessary instructions.

If you forget to take Desogestrel Farmitalia
If the delay in taking the tablet is less than 12 hours, the reliability of Desogestrel Farmitalia
is maintained. Take the tablet as soon as you remember and take the next tablet at the usual
time.
If the delay in taking the tablet is more than 12 hours, the reliability of Desogestrel Farmitalia
may be reduced. The more consecutive tablets you have missed, the greater the risk that the contraceptive effect is reduced. Take the missed tablet as soon as you remember and take the next tablets at the usual
time. Also use an additional contraceptive method (barrier method) for the 7 days
following the intake of the tablet. If you miss one or more tablets in the first week of taking
and, during the previous week, you have had sexual intercourse, there is a possibility that you are pregnant.
Ask your doctor for advice.

If you suffer from gastrointestinal disorders (e.g. vomiting, severe diarrhea)
Follow the advice on forgotten tablets in the section above. If you vomit or use medical charcoal within 3-4
hours of taking the Desogestrel Farmitalia tablet, the active ingredient may not have been completely absorbed.

If you take more Desogestrel Farmitalia than you should
There have been no reports of serious adverse effects resulting from taking more tablets of
Desogestrel Farmitalia at once. If you have taken several pills at the same time, the symptoms
that may occur are nausea, vomiting and mild vaginal bleeding. If you discover that a child has
taken several pills, seek immediate medical advice.

If you stop taking Desogestrel Farmitalia
You can stop taking Desogestrel Farmitalia at any time. From the day you stop
taking the pill, you are no longer protected against possible pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects associated with the use of Desogestrel Farmitalia are described in the sections
“Desogestrel Farmitalia and breast cancer” and “Desogestrel Farmitalia and thrombosis” and in
paragraph 2 “What you need to know before you take Desogestrel Farmitalia”. Read this section for further
information and contact your doctor immediately when necessary.
During the use of Desogestrel Farmitalia, irregular vaginal bleedingmay occur.
This may only be slight spotting that does not require the use of a sanitary pad, or more heavy
bleeding that is quite similar to a light period. In this case, you may need to use tampons or sanitary
napkins. You may also experience no bleeding at all. Irregular bleeding does not indicate that the
contraceptive protection of Desogestrel Farmitalia has decreased. As a rule, no intervention is necessary and
you can continue to take Desogestrel Farmitalia. However, if the bleeding is heavy and prolonged, you should
contact your doctor.
The following side effects have been reported:

• Common (affect less than 1 in 10 women): altered mood, depressed mood, decreased libido (sexual drive), headache, nausea, acne, breast pain, absent or irregular periods, weight gain.
• Uncommon (affect less than 1 in 100 women): vaginal infection, difficulty wearing contact lenses, vomiting, hair loss, painful periods, ovarian cysts, fatigue.
• Rare (affect less than 1 in 1,000 women): skin conditions such as: rash, hives, painful, bluish-reddish subcutaneous nodules (erythema nodosum).

Apart from these side effects, breast secretion may occur.
Contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or throat; difficulty swallowing; hives or difficulty breathing.

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 http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Desogestrel Farmitalia

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
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 Desogestrel Farmitalia contains
The active ingredient is desogestrel (75 micrograms).
The other ingredients are: lactose monohydrate, corn starch, povidone K30, RRR-α-tocopherol, soybean oil, anhydrous colloidal silica, hydrated colloidal silica, stearic acid, hypromellose, polyethylene glycol, titanium
dioxide (E171) (see also “Desogestrel Farmitalia contains lactose (milk sugar) and soybean oil”,
in paragraph 2).

Description of the appearance of Desogestrel Farmitalia and contents of the pack
A blister of Desogestrel Farmitalia contains 28 white, film-coated, round tablets (approximately 5 mm
in diameter). Each pack contains 1, 3 or 6 blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmitalia Srl
Viale Alcide De Gasperi 165/B
95127 Catania
Italy
Manufacturer
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera.
C/ La Vallina s/n

• 24008 - Navatejera, León. Spain