DESANTREL 75 MICROGRAMS Film-coated tablets

Зміст інструкції

1. Desantrel 75 microgram tablets film-coated
   1. What is Desantrel and what is it used for
   2. Cosa deve sapere prima di prendere Desantrel
2. Desantrel can be used while breastfeeding. Desantrel does not influence the
   1. How to take Desantrel
   2. Possible side effects
   3. How to store Desantrel
   4. Contents of the pack and other information
3. Desantrel is a film-coated tablet, white in color, round in shape, with a diameter of

Desantrel 75 microgram tablets film-coated

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

1. What is Desantrel and what is it used for

Desantrel is used for pregnancy prevention.

• There are two main types of hormonal contraception
• The combined pill “The Pill” which contains 2 types of female sex hormones, an estrogen and a progestin
• The progestin-only pill, POP, which does not contain estrogen
• Desantrel is a progestin-only pill (POP)
• Desantrel contains a small amount of a type of female sex hormone, the progestin desogestrel.
• Most POPs work mainly by preventing sperm from entering the uterus, but do not always prevent the maturation of egg cells, which is the main way combined-type pills work. Desantrel is different from most POPs having a dosage that in most cases prevents the maturation of the egg cell. As a consequence, Desantrel is a highly effective contraceptive.
• Unlike combined-type pills, Desantrel can be used by women intolerant to estrogens and by breastfeeding women.
• One disadvantage is that, during the use of Desantrel, vaginal bleeding may occur at irregular intervals. You may also have no bleeding at all.

2. Cosa deve sapere prima di prendere Desantrel

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

• if you are allergic to desogestrel, peanuts or soy, or to 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 [for example 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 the liver is not yet functioning normally.
• if you have or suspect you have a cancer that grows under the influence of sex hormones such as certain types of breast cancer.
• if you have unexplained vaginal bleeding.

If you have any of these conditions, tell your doctor before starting to use
Desantrel. The doctor may advise you to use a non-hormonal contraceptive method.
If any of these conditions should occur for the first time while you are
taking Desantrel, consult your doctor immediately.

Warnings and precautions
Consult your doctor, pharmacist or family planning nurse before
taking Desantrel if:

• you have ever had breast cancer
• you have liver cancer, as a possible effect of Desantrel cannot be excluded
• you have ever had a thrombosis
• you suffer from diabetes
• you suffer from epilepsy(see section “Other medicines and Desantrel”)
• you suffer from tuberculosis(see section “Other medicines and Desantrel”)
• 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 the sun or ultraviolet radiation.

When using Desantrel in the presence of any of these conditions, close medical supervision may be necessary. The doctor will explain what to do.

Breast cancer
It is important to check your breasts regularly and you should 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, this 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 the pill.
Breast cancer is rare under the age of 40 but the risk increases with the woman’s age.
Therefore, the extra number of cases of breast cancer diagnosed is higher if
the woman continues to take the pill when she is older. Less important, however, is the
duration of pill use.

• For every 10,000 women who take the pill for periods up to 5 years, but who stop doing so within the age of 20, 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.
• In 10,000 women who take the pill for periods up to 5 years, but stop within the age of 30, there would be 5 additional cases in addition to the 44 normally diagnosed.
• In 10,000 women who take the pill for periods up to 5 years but stop within the age of 40, 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
Desantrel 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 certain whether the pill causes an increased risk of breast cancer. It may be that
women who use the pill are examined more frequently, and therefore breast cancer
can 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.
A thrombosis can sometimes occur 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 arteries in the lungs causing, the so-called “pulmonary embolism”. Pulmonary
embolism can cause chest pain, shortness of breath, collapse or even death. 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 women who use the pill compared to those who do not. It is
believed that the risk with progestin-only pills, such as Desantrel, is lower
than that found in women who use pills that also contain
estrogens (combined pills).

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

Children and adolescents
There are no data available on the efficacy and safety in adolescents under 18 years
of age.

Other medicines and Desantrel
Tell your doctor or pharmacist or family planning nurse if you are taking,
have recently taken or might take any other medicines.
Also tell any other doctor or dentist who prescribes you other medicines that
you are taking Desantrel. They may tell you whether you need to take additional
contraceptive precautions (for example, a condom), and if so, for how long and whether the use of
another medicine for you needs to be changed.
Some medicines

• may have an influence on the levels of Desantrel in the blood
• may reduce effectiveness in preventing pregnancy
• may cause unexpected bleeding

These include medicines used in the treatment of:

• epilepsy (for example primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital)
• tuberculosis (for example rifampicin, rifabutin)
• HIV infections (for example ritonavir, nelfinavir, nevirapine, efavirenz)
• hepatitis C virus infections (for example boceprevir, telaprevir)
• or other infectious diseases (for example griseofulvin)
• high blood pressure in the blood vessels of the lungs (bosentan)
• depressed mood (herbal products based on St. John's wort)
• bacterial infections (for example clarithromycin, erythromycin)
• fungal infections (for example ketoconazole, itraconazole, fluconazole)
• high blood pressure, angina, some types of heart rhythm disorders (for example diltiazem)

If you are taking medicines or herbal products that may reduce the effectiveness of
Desantrel, a barrier method of contraception must be used. Because the effect of a
other medicine on Desantrel can last up to 28 days after stopping the medicine, it is
necessary to use a barrier contraceptive method for a long period.
The doctor can tell you whether you need to take additional contraceptive precautions and if so for
how long.
Desantrel can also interfere with the functioning of other medicines causing either an
increase in effect (for example medicines containing cyclosporine) or a decrease
in effect (lamotrigine).

Ask your doctor or pharmacist for advice before taking other medicines.

Pregnancy and breastfeeding
Pregnancy
Do not use Desantrel if you are pregnant or think you might be.

Breastfeeding

Desantrel can be used while breastfeeding. Desantrel does not influence the

production or the quality of breast milk. However, a small amount of the active ingredient
of Desantrel passes into breast milk.
The health of breastfed babies up to 7 months of age, whose mothers used
desogestrel, has been studied up to the age of 2 and a half years. No effect on
growth and development of the babies has been observed.
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.

Driving and using machines
Desantrel has no effect on the ability to drive or use machines.

Desantrel contains lactose (a sugar from milk) and soybean oil
If your doctor has diagnosed you with intolerance to certain sugars, contact them before
taking this medicine.
If you are allergic to peanuts or soybeans, do not use this medicine.

Regular medical check-ups
While using Desantrel, your doctor will tell you to return for regular medical check-ups.
The frequency and type of these check-ups usually depend on your personal situation.

Contact your doctor as soon as possible if:

• you notice any signs of a blood clot: 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 a sudden severe stomach pain or jaundice (you may notice yellowing of the skin, whites of the eyes or dark urine, probably signs of liver problems);
• you feel a lump in your breast (probably signs of breast cancer);
• you have sudden or severe pain in the lower abdomen or stomach area (probably a sign of 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 experience unusual, heavy vaginal bleeding;
• you think you are pregnant.

3. How to take Desantrel

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

When and how to take the tablets?
The Desantrel pack contains 28 tablets.

• Take one tablet every day at approximately the same time. Swallow the tablet whole, with water.

The days of the week are printed on the blister. On both sides of the blister, arrows are printed indicating the direction and order in which to take the tablets. Each day corresponds to one tablet.

• Each time you start a new strip of Desantrel, take one tablet from the top row. Do not start with any tablet. For example, if you start taking the tablets on Wednesday, take the tablet marked (on the back) with WED from the top row.
• Continue to take one tablet a day until you finish the pack, always following the direction indicated by the arrows. Looking at the back of the blister, you can easily check if you have already taken the tablet for a specific day.

During the use of Desantrel you may experience bleeding (see section 4 Undesirable Effects) but you must continue to take the tablets as usual. After finishing a strip, you must start a new strip of Desantrel the next day, without any interruption and without waiting for any bleeding.

When to start the first pack of Desantrel

• If you are not currently using hormonal contraception (or in the last month)Wait for your menstrual period before starting. Take the first Desantrel tablet on the first day of your menstruation. No further contraceptive precautions are necessary. If you take the first tablet between the second and fifth day of your cycle, use an additional barrier method of contraception for the first 7 days of taking the tablets.
• If you are switching from a combined pill (COC), vaginal ring, or transdermal patch:
• If you have no pill-free interval, ring-free interval or patch-free interval
• Start taking Desantrel the day after taking the last pill from your previous pack, or the day the vaginal ring or patch is removed (this means you do not observe any pill-free, ring-free or patch-free interval).
• If the pill you are taking also contains inactive tablets (placebo), you can start Desantrel 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.

If you have a pill-free interval, ring-free interval or patch-free interval.
You can also start the day after the pill-free, ring-free or patch-free interval or after you have taken all the inactive tablets of your current contraceptive.

If you follow these instructions, make sure to use an additional barrier method of contraception for the first 7 days of taking the tablets.

• Switching from a progestin-only pill:You can switch to another mini pill on any day. No additional contraceptive precautions are necessary.
• Switching from a contraceptive injection, implant, or hormonal intrauterine system (IUS):Start using Desantrel on the day your next injection is due or the day the implant or system is removed. You do not need to take any further contraceptive precautions.
• After childbirth:You can start Desantrel between 21 and 28 days after giving birth. If you start later, make sure to use an additional barrier method of contraception until you have completed the first 7 days of taking the tablets. However, if you have already had sexual intercourse, check that you are not pregnant before starting to take Desantrel. Information for breastfeeding women is available in section 2 ‘Pregnancy and breastfeeding’. Your doctor can give you further information.
• After a spontaneous or induced abortion:Your doctor will provide you with the necessary instructions.

If you forget to take Desantrel

• If less than 12 hourshave passed:
• Take the forgotten tablet as soon as you remember it and take the subsequent tablets at the usual time. Desantrel will still protect you from pregnancy
• If more than 12 hourshave passed:
• If more than 12 hours have passed since taking the tablet, you may not be fully protected from pregnancy. The more consecutive tablets you forget, the higher the risk of pregnancy.
• Take the forgotten tablet as soon as you remember it and take the subsequent tablets at the usual time. For the next 7 days of taking the tablets, also use an additional barrier method of contraception. If you have forgotten one or more tablets in the first week of taking them and have had sexual intercourse during the previous week, it is possible that you are pregnant. Ask your doctor for advice.

If you suffer from gastrointestinal disorders (e.g. vomiting or severe diarrhoea)
If you vomit within 3-4 hours of taking a Desantrel tablet, or if you have severe diarrhoea, the active ingredient may not have been fully absorbed.
Follow the advice for forgotten tablets in the previous section.

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

If you stop taking Desantrel
You can stop taking Desantrel at any time. From the day you stop taking the pill, you are no longer protected from pregnancy.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Inform your doctor if you notice any side effect, especially if it is severe or persistent.

Serious side effectsassociated with the use of Desantrel are described in paragraph 2 “What
you need to know before you take Desantrel”. Read this paragraph carefully for
further information on ‘Breast cancer and thrombosis’ and consult your doctor promptly,
when necessary.

Vaginal bleeding may occur at irregular intervals while you are using Desantrel.
This may be only mild spotting that does not require the use of a sanitary pad or a
heavier bleeding, which resembles a light period. You may need to
use a tampon or a sanitary pad. It is also possible that you will have no
bleeding. Irregular bleeding is not a sign that Desantrel is not
working. Usually no intervention is necessary and you can continue to take
Desantrel. If the bleeding is heavy or prolonged, you should consult your doctor.
How often do other possible side effects occur?
Common:may affect up to 1 in 10 people

• Altered mood
• Depressed mood
• Decreased sexual desire (libido)
• Headache
• Nausea
• Acne
• Breast pain
• Irregular or absent periods
• Weight gain

Uncommon:may affect up to 1 in 100 people

• Vaginal infection
• Difficulty wearing contact lenses
• Vomiting
• Hair loss
• Painful periods
• Ovarian cysts
• Fatigue

Rare:may affect up to 1 in 1000
Skin diseases such as:

• rash
• urticaria
• painful, bluish-reddish subcutaneous nodules (erythema nodosum)

In addition to these side effects, breast discharge may occur.
You should consult your doctor immediately if you experience symptoms of angioedema, such as (i)
swelling of the face, tongue or pharynx, (ii) difficulty swallowing or (iii) urticaria and
difficulty breathing.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist or family planning nurse. You can also
report side effects directly through the national reporting system
at 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 Desantrel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and blister
after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C. Store in the original packaging to
protect the medicine from light.
Do not use this medicine if you notice visible signs of deterioration.
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.
Environmental Risk Assessment (ERA)
The active substance etonogestrel shows an environmental risk to fish.

6. Contents of the pack and other information

What Desantrel contains
The active ingredient is desogestrel.
Each film-coated tablet contains 75 micrograms of desogestrel.
The other ingredients are: lactose monohydrate, corn starch, povidone K30, colloidal hydrated silica,
anhydrous colloidal silica, RRR-α-tocopherol, stearic acid, hypromellose 2910, macrogol
400, titanium dioxide (E171), refined soybean oil.

Description of the appearance of Desantrel and contents of the pack

Desantrel is a film-coated tablet, white in color, round in shape, with a diameter of

approximately 5 mm and a thickness of approximately 2.9 mm, packaged in PVC-PVDC/Al blisters in packs
of 1x28, 3x28, 6x28 and 13x28.
It is possible that not all packs are marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben, Germany
Laboratorios León Farma, S.A
C/ La Vallina s/n, Pol. Ind. Navatejera, 24008 Navatejera, Villaquilambre, León, Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark Delamonie
Austria Desogestrel Sandoz 75 Microgram – Film-coated Tablets
Belgium Saphirena 75 microgram film-coated tablets
Czech Republic Daisenette Neo 0.075 micrograms
Germany Chalant® HEXAL® 75 Microgram Film-coated Tablets
Greece Delamonie
Finland Delamonie 75 mcg tablets, film-coated
France DESOGESTREL SANDOZ 0.075 mg, film-coated tablet
Italy Desantrel
Ireland Desogestrel Rowex 75 microgram Film-coated tablets
Lithuania Delamonie 75 micrograms film-coated tablets
Latvia Delamonie 75 micrograms film-coated tablets
Luxembourg Saphirena 75 microgrammes film-coated tablets
Netherlands Delamonie 75 microgram, film-coated tablets
Norway Delamonie 75 microgram film-coated tablets
Portugal Delamonie
Romania Desogestrel Sandoz 75 micrograms film-coated tablets
Sweden Delamonie 75 microgram film-coated tablets
Slovenia Delamonie 75 micrograms film-coated tablets