Desantrel

Package leaflet: Information for the user

Desantrel 75 micrograms film-coated tablets

Desogestrel
Generic medicine
Please read all of this leaflet carefully before you start 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 other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including 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 taking 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 Desantrel is and what it is used for

Desantrel is used for the prevention of pregnancy.

• There are two main types of hormonal contraception:
  • The combined oral contraceptive pill ("The Pill"), which contains two types of female sex hormones, an oestrogen and a progestogen
  • The progestogen-only pill (POP), which does not contain oestrogen
• Desantrel is a progestogen-only pill (POP)
• Desantrel contains a small amount of a type of female sex hormone, the progestogen desogestrel.
• Most POPs work primarily by preventing sperm from entering the uterus, but do not always prevent the maturation of egg cells, which is the main mechanism of action of combined pills. Desantrel differs from most POPs because its dosage usually prevents the maturation of the egg cell. As a result, Desantrel is a highly effective contraceptive.
• Unlike combined pills, Desantrel can be used by women who are intolerant to oestrogens and by women who are breastfeeding.
• One disadvantage is that irregular vaginal bleeding may occur during use of Desantrel. There may also be no bleeding at all.

2. What you need to know before taking 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 or have ever had 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 your liver is not yet functioning normally.
• if you have or suspect you have a cancer that grows under the influence of sex steroids, such as certain types of breast cancer.
• if you have unexplained vaginal bleeding.

If you have any of these conditions, inform your doctor before starting to use
Desantrel. Your doctor may advise you to use a non-hormonal contraceptive method.
If any of these conditions occur for the first time while you are taking
Desantrel, consult your doctor immediately.
Warnings and precautions
Talk to your doctor, pharmacist, or family planning nurse before taking
Desantrel if:

• you have ever had breast cancer
• you have liver cancer, since a possible effect of Desantrel cannot be ruled out
• you have ever had 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 (yellow-brown patches on the skin, especially on the face); in this case, avoid excessive exposure to sunlight or ultraviolet radiation.

When using Desantrel in the presence of any of these conditions, close medical supervision may be necessary. Your doctor will explain what to do.
Breast cancer
It is important to regularly check your breasts and you should contact your doctor as soon as possible if you feel any lumps.
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, this risk decreases, so that 10 years after stopping the pill, the risk is the same as in women who have never taken the pill.
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 if a woman continues taking the pill at an older age. The duration of pill use is less important.

• For every 10,000 women who take the pill for 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.
• In 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.
• In 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.

The risk of breast cancer in users of progestogen-only pills such as
Desantrel is believed to be similar to that in women using combined oral contraceptives, but the evidence is less conclusive.
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 certain whether the pill causes the increased risk of breast cancer. It may be that women who use the pill are examined more frequently, and therefore 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 arteries of the lungs, causing what is known as “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 may also occur during pregnancy.
The risk is higher in women using the pill compared to those who do not. It is believed that the risk with progestogen-only pills such as Desantrel is lower than that observed in women using pills containing estrogen (combined pills).
Psychiatric disorders
Some women using hormonal contraceptives, including Desantrel, 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, consult 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
Inform your doctor, pharmacist, or family planning nurse if you are taking, have recently taken, or might take any other medicines.
Also inform any other doctor or dentist who prescribes medicines for you that you are taking Desantrel. They can advise whether you need to take additional contraceptive precautions (e.g., condom), for how long, and whether the use of another medicine you require should be modified.
Some medicines

• may affect the levels of Desantrel in your blood
• may reduce 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 infectious diseases (e.g., griseofulvin)
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension) (bosentan)
• depression (herbal products containing St. John’s wort)
• bacterial infections (e.g., clarithromycin, erythromycin)
• fungal infections (e.g., ketoconazole, itraconazole, fluconazole)
• high blood pressure (hypertension), angina, certain types of heart rhythm disorders (e.g., diltiazem)

If you are taking medicines or herbal products that may reduce the effectiveness of
Desantrel, a barrier contraceptive method should be used. Since the effect of another medicine on Desantrel may last up to 28 days after stopping the medicine, a barrier contraceptive method may need to be used for a prolonged period.
Your doctor can advise whether you need to take additional contraceptive precautions and, if so, for how long.
Desantrel may also interfere with the action of other medicines, causing either an increase in effect (e.g., medicines containing cyclosporine) or a decrease in effect (lamotrigine).
Ask your doctor or pharmacist for advice before taking any other medicines.
Pregnancy and breastfeeding
Pregnancy
Do not use Desantrel if you are pregnant or think you may be pregnant.
Breastfeeding
Desantrel can be used while breastfeeding. Desantrel does not affect the production or quality of breast milk. However, a small amount of the active ingredient in Desantrel passes into breast milk.
The health of children breastfed up to 7 months of age, whose mothers used desogestrel, has been studied up to 2.5 years of age. No effect on growth and development of the children was observed.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Desantrel has no effect on the ability to drive or use machinery.
Desantrel contains lactose (a milk sugar) and soybean oil
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
If you are allergic to peanuts or soy, do not use this medicine.
Regular medical checks
While using Desantrel, your doctor will advise you to return for regular medical check-ups.
The frequency and type of these checks usually depend on your individual circumstances.
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 sudden severe stomach pain or jaundice (you may notice yellowing of the skin, whites of the eyes, or dark urine, possible signs of liver problems);
• you feel a lump in your breast (possible signs of breast cancer);
• you have sudden or severe lower abdominal or stomach pain (possible sign of ectopic pregnancy, i.e., a pregnancy outside the uterus);
• you are facing immobilization or surgery (consult your doctor at least 4 weeks in advance);
• you have unusual, heavy vaginal bleeding;
• you think you may be pregnant.

3. How to take Desantrel

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult 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. Arrows printed on both sides of the blister indicate 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 a tablet from the top row. Do not start with any random tablet. For example, if you begin taking tablets on Wednesday, take the tablet from the top row marked (on the back) with WED.
• Continue taking one tablet daily until the pack is finished, always following the direction indicated by the arrows. By looking at the back of the blister, you can easily check whether you have already taken the tablet for a specific day.

While using Desantrel, you may experience bleeding (see section 4 Undesirable Effects), but you must continue taking the tablets as usual. When you have finished one strip, you must start a new strip of Desantrel the next day, without any break and without waiting for any bleeding.

When to start the first pack of Desantrel

• If you are currently not using a hormonal contraceptive (or in the last month):
  Wait for your menstrual period before starting. Take the first Desantrel tablet on the first day of your period. No additional contraceptive precautions are necessary.
  If you take the first tablet between the second and fifth day of your cycle, use an additional barrier contraceptive method during the first 7 days of tablet intake.

• Switching from a combined oral contraceptive (COC), vaginal ring, or transdermal patch:

• If there is no pill-, ring-, or patch-free interval:

• Start taking Desantrel 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 no pill-, ring-, or patch-free interval is observed).

• If the pill you are currently taking contains inactive (placebo) tablets as well, you may start Desantrel the day after taking the last active tablet (if in doubt about which one is active, consult your doctor or pharmacist).

• If you follow these instructions, no additional contraceptive precautions are needed.

If there is a pill-, ring-, or patch-free interval:
You may also start the day after the pill-, ring-, or patch-free interval or after taking all the inactive tablets of your current contraceptive.
If you follow these instructions, ensure you use an additional barrier contraceptive method for the first 7 days of tablet intake.

• Switching from a progestogen-only pill (mini-pill):
  You may switch to Desantrel on any day. No additional contraceptive precautions are necessary.

• Switching from a hormonal injection, implant, or intrauterine system (IUS):
  Start using Desantrel on the day the next injection is due, or on the day the implant or hormonal intrauterine system (IUS) is removed. No additional contraceptive precautions are necessary.

• After childbirth:
  You may start Desantrel between day 21 and day 28 after the birth of your baby. If you start later, ensure you use an additional barrier contraceptive method until you have completed the first 7 days of tablet intake. However, if you have already had sexual intercourse, check that you are not pregnant before starting Desantrel. Information for breastfeeding women is available in section 2 ‘Pregnancy and breastfeeding’. Your doctor can provide 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 hours have passed:

• Take the missed tablet as soon as you remember, and take the following tablets at your usual time. Desantrel will still protect you from pregnancy.

• If more than 12 hours have passed:

• If more than 12 hours have passed since the missed tablet, you may not be fully protected against pregnancy. The greater the number of consecutive missed tablets, the higher the risk of pregnancy.

• Take the most recently missed tablet as soon as you remember, and take the following tablets at your usual time. For the next 7 days of tablet intake, use an additional barrier contraceptive method. If you missed one or more tablets during the first week of intake and had sexual intercourse in the previous week, pregnancy may have occurred. Consult your doctor.

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

If you take more Desantrel than you should
There are no reports of serious harmful effects from taking more Desantrel tablets than recommended at one time. Possible symptoms include nausea, vomiting, and, in young girls, slight vaginal bleeding. For further information, consult your doctor.

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

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you experience any side effect, especially if it is severe or persistent.
Serious side effects associated with the use of Desantrel are described in section 2, "What you need to know before taking Desantrel". Please read this section carefully for further information on 'Breast cancer and thrombosis' and consult your doctor promptly when necessary.
You may experience irregular vaginal bleeding while using Desantrel.
This may be only slight spotting that does not require the use of sanitary protection, or it may be heavier bleeding resembling a light menstrual period. You may need to use a tampon or sanitary pad. It is also possible that you do not have any bleeding at all. Irregular bleeding is not a sign that Desantrel is not working. Usually, no intervention is required and you may continue taking Desantrel. If the bleeding is heavy or prolonged, you must consult your doctor.
How often do other possible side effects occur?
Common: may affect up to 1 in 10 people

• Mood changes
• Depressed mood
• Decreased sexual desire (libido)
• Headache
• Nausea
• Acne
• Breast pain
• Irregular or absent menstrual periods
• Increase in body weight

Uncommon: may affect up to 1 in 100 people

• Vaginal infection
• Difficulty wearing contact lenses
• Vomiting
• Hair loss
• Painful menstruation
• Ovarian cysts
• Tiredness

Rare: may affect up to 1 in 1,000 people
Skin disorders such as:

• Rash
• Hives (urticaria)
• Painful bluish-red subcutaneous nodules (erythema nodosum)

In addition to these side effects, breast discharge may occur.
You must contact your doctor immediately if you experience symptoms of angioedema, such as (i) swelling of the face, tongue or throat, (ii) difficulty swallowing, or (iii) hives and difficulty breathing.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or family planning nurse. You can also report side effects directly via 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 stated on the carton and blister pack
after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C. Keep in the original packaging to
protect the medicine from light.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.
Environmental risk (ERA)
The active substance etonogestrel poses an environmental risk for fish.

6. Package contents and other information

What Desantrel contains
The active substance is desogestrel.
Each film-coated tablet contains 75 micrograms of desogestrel.
The other components are: monohydrate lactose, corn starch, povidone K30, hydrated colloidal 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 package contents
Desantrel is a white, round, film-coated tablet with a diameter of approximately 5 mm and a thickness of about 2.9 mm, packaged in PVC-PVDC/Al blisters in pack sizes of 1x28, 3x28, 6x28 and 13x28.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:
Denmark Delamonie
Austria Desogestrel Sandoz 75 Microgram – Film Tablets
Belgium Saphirena 75 microgram film-coated tablets
Czech Republic Daisenette Neo 0.075 micrograms
Germany Chalant® HEXAL® 75 Microgram Film 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 micrograms 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