Package leaflet: Information for the user

Kestrelle 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 they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Kestrelle is and what it is used for

Kestrelle is used to prevent pregnancy.
Kestrelle contains a small amount of a type of female sex hormone, the progestin desogestrel.
For this reason, Kestrelle is called a progestogen-only pill (POP).
Unlike the combined pill, the POP does not contain an oestrogen together with the progestogen.
Most POPs work primarily by preventing sperm from entering the uterus, but they do not always prevent the maturation of egg cells, which is the primary action of combined-type pills.
Kestrelle differs from many POPs in that its dosage is, in most cases, high enough to prevent the maturation of egg cells. As a result, Kestrelle provides high contraceptive efficacy. Unlike combined-type pills, Kestrelle can be used by women who do not tolerate oestrogens and by women who are breastfeeding.
One disadvantage may be that vaginal bleeding can occur at irregular intervals during the use of Kestrelle. On the other hand, bleeding may not occur at all.

2. What you should know before taking Kestrelle

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

If you are allergic to desogestrel or any of the other ingredients of Kestrelle (listed in section 6).
If you have or have ever had 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 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 vaginal bleeding of unknown origin.
If you are allergic to peanuts or soya.

If any of these conditions apply to you, consult your doctor before taking Kestrelle. Your doctor may advise you to use a non-hormonal contraceptive method.
Contact your doctor immediately if any of these conditions occur for the first time during use of Kestrelle.
Warnings and precautions
Talk to your doctor before taking Kestrelle if:

You have ever had breast cancer.
You have liver cancer, as a possible effect of Kestrelle cannot be ruled out.
You have ever had thrombosis.
You have diabetes.
You suffer from epilepsy (see section ‘Other medicines and Kestrelle’).
You have tuberculosis (see section ‘Other medicines and Kestrelle’).
You have high blood pressure.
You have or have had chloasma (brownish-yellow patches on the skin, especially on the face); in this case, avoid excessive exposure to sunlight or ultraviolet radiation.

When Kestrelle is used in the presence of any of these conditions, close medical supervision may be necessary. Your doctor will explain what to do.
Psychiatric disorders:
Some women using hormonal contraceptives, including Kestrelle, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor as soon as possible for further medical advice.
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 compared to women of the same age who do not take it. If a woman stops taking the pill, the risk 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 diagnosed cases of breast cancer increases the older a woman is when she stops taking the pill. The duration of pill use is less important.
Among 10,000 women who take the pill for up to 5 years but stop before age 20, there would be less than one 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, among 10,000 women who take the pill for up to 5 years but stop before age 30, there would be 5 additional cases beyond the 44 normally diagnosed. Among 10,000 women who take the pill for up to 5 years but stop before age 40, there would be 20 additional cases beyond the 160 normally diagnosed.
It is believed that the risk of developing breast cancer in women taking progestogen-only pills, such as Kestrelle, is similar to that in women using combined oral contraceptives, but the evidence is less conclusive.
Breast cancer detected in women taking the pill appears to be less advanced than that found in women not using the pill. It is not certain that the pill causes an increased risk of breast cancer. Women taking the pill are monitored more frequently, so breast cancer may be diagnosed earlier.
Thrombosis
Contact your doctor immediately if you notice possible signs of thrombosis (see also ‘Regular medical check-ups’). 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 breaks loose 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. It may also occur during pregnancy. The risk is higher in women taking the pill compared to those who do not use it. It is believed that with progestogen-only pills, such as Kestrelle, the risk is lower than that in women using pills containing oestrogens (combined pills).
Children and adolescents
There are no clinical data on efficacy and safety in adolescents under 18 years of age.
Other medicines and Kestrelle
Inform your doctor if you are taking, have recently taken, or might take any other medicine or herbal product. Tell any other doctor or dentist who prescribes medicines for you (or your pharmacist) that you are taking Kestrelle. They may advise you whether you need to take additional contraceptive precautions (e.g. condom), and if so, for how long, or whether the use of other medicines needs to be changed.
Some medicines:

may affect blood levels of Kestrelle
may result in reduced 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 infections (e.g., ritonavir, nelfinavir, nevirapine, efavirenz),
hepatitis C virus infections (e.g., boceprevir, telaprevir),
other infections (e.g., griseofulvin),
high blood pressure in the pulmonary vessels (bosentan),
depressed mood (herbal products containing 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 could reduce the effectiveness of Kestrelle, you must also use a barrier contraceptive method. Because the effect of another medicine on Kestrelle may last up to 28 days after stopping the medicine, you must use an additional barrier contraceptive method for this duration. Your doctor can advise you whether you need to take additional contraceptive precautions and, if so, for how long.
Kestrelle may also interfere with the action of certain medicines, causing either an increase (e.g. medicines containing ciclosporin) or a decrease (e.g. lamotrigine) in their effect.
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy and breast-feeding
Pregnancy
Do not use Kestrelle if you are pregnant or think you may be pregnant.
Breast-feeding
Kestrelle may be taken while breast-feeding. Kestrelle does not appear to affect the quantity or quality of breast milk. However, non-frequent cases of decreased breast milk production have been reported during use of Kestrelle. A small amount of the active ingredient of Kestrelle passes into breast milk.
The health of infants breast-fed for 7 months by mothers taking Kestrelle has been studied up to the age of 2.5 years. No effect on growth and development of the children was observed.
If you are breast-feeding and wish to use Kestrelle, consult your doctor.
Driving and using machines
There are no indications regarding the effect of Kestrelle on vigilance and concentration.
Kestrelle 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.
Regular medical check-ups
While using Kestrelle, your doctor will ask you to return for regular check-ups. The frequency and nature of these check-ups normally depend on your individual condition.
Contact your doctor as soon as possible if:

you have severe pain or swelling in one leg, unexplained chest pain, breathing difficulties, unusual cough, especially if accompanied by coughing up blood (possible signs of thrombosis);
you have sudden and severe stomach pain or develop a yellowish appearance (possible signs of liver problems);
you feel a lump in your breast (possible sign of breast cancer);
you have sudden and severe lower abdominal or stomach pain (symptom of a possible ectopic pregnancy, i.e. a pregnancy outside the uterus);
you are immobilized or are scheduled for surgery (consult your doctor at least 4 weeks beforehand);
you have unusual and heavy vaginal bleeding;
you think you may be pregnant.

3. How to take Kestrelle

Route of administration
Kestrelle is for oral use.
When and how to take Kestrelle
The Kestrelle pack contains 28 tablets. The days of the week are printed on the blister, along with arrows indicating the order in which the tablets should be taken. One tablet corresponds to each day. Each time you start a new Kestrelle blister pack, take a tablet from the top row of the blister. Do not start with any random tablet. For example, if you begin taking 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 indicated by the arrows.
Looking at the back of 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 every day.
Swallow the tablet whole with water. Breakthrough bleeding may occur during use of Kestrelle, but continue taking the tablets as usual. After finishing one pack, start the next pack of Kestrelle the following day, without any interruption and without waiting for any bleeding to occur.
Starting the first pack of Kestrelle
When no hormonal contraceptives have been used in the previous month
Wait for your menstrual period before starting. Take the first Kestrelle tablet on the first day of menstruation. No additional contraceptive precautions are necessary.
If you take the first tablet between the second and fifth day of your cycle, use an additional contraceptive method (barrier method) during the first 7 days of tablet intake.
Switching from a combined oral contraceptive pill, vaginal ring, or transdermal patch
You may start taking Kestrelle the day after taking the last active tablet of your previous pill pack, or the day after removing the vaginal ring or transdermal patch (i.e., without any pill-, ring-, or patch-free interval). If your previous contraceptive also contains inactive (placebo) tablets, start Kestrelle on the day you would have taken the last active tablet (if you are unsure which this is, consult your doctor or pharmacist). If you follow these instructions, you do not need to use additional contraceptive precautions.
Alternatively, you may start Kestrelle no later than the day after the pill-, ring-, or patch-free interval, or after taking the inactive tablets of your current contraceptive. If you follow this approach, ensure you use an additional contraceptive method (barrier method, e.g., a condom) for the first 7 days of tablet intake.
Switching from another progestogen-only pill
You may stop taking it at any time and start Kestrelle immediately. No additional contraceptive precautions are needed.
Switching from a progestogen-only injectable, implant, or intrauterine device releasing progestogen (IUD)
Start using Kestrelle on the day your next injection is due, or on the day of removal of your implant or IUD. No additional contraceptive precautions are needed.
After childbirth
You may start taking Kestrelle between day 21 and day 28 after childbirth.
If you start later, ensure you use an additional contraceptive method (barrier method) for the first 7 days of tablet intake.
However, if you have already had sexual intercourse, pregnancy must be ruled out before starting Kestrelle. Further information for breastfeeding women can be found in section 2 “Pregnancy and breastfeeding”. Your doctor will provide you with the necessary instructions.
After an abortion or miscarriage
Your doctor will provide you with the necessary instructions.
If you forget to take Kestrelle
If the delay in taking the tablet is less than 12 hours, the effectiveness of Kestrelle remains unchanged. 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 effectiveness of Kestrelle may be reduced. The more consecutive tablets you miss, the greater the risk that contraceptive protection will be reduced. Take the last missed tablet as soon as you remember and continue taking the following tablets at the usual time. Also use an additional contraceptive method (barrier method) for the next 7 days of tablet intake. If you miss one or more tablets during the first week of starting the pack and have had sexual intercourse in the preceding week, there is a possibility of pregnancy. Consult your doctor.
If you experience gastrointestinal disturbances (e.g., vomiting, severe diarrhoea)
Follow the advice for missed tablets in the section above. If you vomit or take activated charcoal within 3–4 hours after taking a Kestrelle tablet, or if you have severe diarrhoea, the active ingredient may not have been completely absorbed.
If you take more Kestrelle than you should
There have been no reports of serious harmful effects following the ingestion of multiple Kestrelle tablets at once. Symptoms that may occur include nausea, vomiting, and, in young girls, slight vaginal bleeding. For further information, consult your doctor.
If you stop taking Kestrelle
You may stop taking Kestrelle at any time. From the day you stop taking the pill, you are no longer protected against pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects associated with the use of Kestrelle are described in the sections “Breast cancer” and “Thrombosis” and in section 2 “What you need to know before taking Kestrelle”. Please read this section for further information and contact your doctor immediately 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) (frequency not known).
Irregular vaginal bleeding may occur during use of Kestrelle. This may be only slight spotting that does not require the use of sanitary protection, or more pronounced bleeding similar to a light menstrual period. In such cases, tampons or sanitary pads should be used. It may also happen that you do not have any bleeding at all. Irregular bleeding does not indicate that the contraceptive protection provided by Kestrelle is reduced. Usually, no intervention is required and you may continue taking Kestrelle.
However, if bleeding is heavy and prolonged, you should contact your doctor.
The following side effects have been reported:

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

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 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 Kestrelle

Keep this medicine out of the sight and reach of children.
Store below 30  C. Keep in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the carton after Exp. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Kestrelle contains
The active substance is desogestrel (75 micrograms).
The other components are: monohydrate lactose, maize starch, povidone K30, RRR-α-tocopherol, soybean oil,
anhydrous colloidal silica, hydrated colloidal silica, stearic acid, hypromellose, polyethylene glycol, titanium
dioxide (E171) (see also “Kestrelle contains lactose (milk sugar) and soybean oil” in section 2).

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
Italy

Manufacturer
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera.
C/ La Vallina s/n
24193 - Villaquilambre, León
Spain

This medicinal product is authorised in the European Economic Area Member States under the following
names:
Finland: Desogestrel Stragen 75 mikrogrammaa tabletti, kalvopäällysteinen
Italy: Kestrelle
Netherlands: Zarelle 75 microgram filmomhulde tabletten