Dessette mono

Patient Information Leaflet

Dessette mono, 75 micrograms, coated tablets
Desogestrel
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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Dessette mono is and what it is used for

Dessette mono is used for the prevention of pregnancy. Dessette mono contains a small amount of one type of female sex hormone, a progestagen called desogestrel. For this reason, Dessette mono is known as a progestagen-only pill. Unlike combined oral contraceptives, a progestagen-only pill does not contain oestrogen, only a progestagen.

Most progestagen-only pills work mainly by preventing sperm from entering the womb, but they do not always prevent the release of an egg, which is the main mechanism of combined oral contraceptives. Dessette mono differs from most progestagen-only pills in that its dose is sufficient in most cases to prevent the maturation of the egg cell. As a result, Dessette mono has high contraceptive efficacy.

Unlike combined oral contraceptives, Dessette mono can be used by women who cannot tolerate oestrogens and by breastfeeding women. A disadvantage of using Dessette mono is the possibility of experiencing irregular bleeding. Bleeding may also not occur at all.

2. Important information before using Dessette mono

Dessette mono, like other hormonal contraceptives, does not protect against
HIV infection (AIDS) or other sexually transmitted diseases.
When not to use Dessette mono

• If the patient is allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
• If the patient has thrombosis. Thrombosis is the formation of blood clots in blood vessels (e.g. in the legs – deep vein thrombosis), which may lead to embolism (e.g. in the blood vessels of the lungs – pulmonary embolism).
• If the patient has or has previously had jaundice (yellowing of the skin) or severe liver disease, and liver function parameters have not yet returned to normal.
• If the patient has a hormone-dependent tumour, such as certain types of breast cancer, or if such a tumour is suspected.
• If the patient has vaginal bleeding of unknown cause.

If any of the above conditions occur, the patient should inform the doctor before
starting to use Dessette mono. The doctor may recommend using a non-hormonal
contraceptive method.
If any of the above conditions occur for the first time during treatment with Dessette
mono, the patient should contact the doctor immediately.
Warnings and precautions
Before using Dessette mono, discuss the following with your doctor or pharmacist:

• if the patient has ever had breast cancer;
• if the patient has liver cancer, as the influence of Dessette mono on this type of tumour cannot be excluded;
• if the patient has ever had thrombosis;
• if the patient has diabetes;
• if the patient has epilepsy (see section "Dessette mono and other medicines");
• if the patient has tuberculosis (see section "Dessette mono and other medicines");
• if the patient has high blood pressure;
• if the patient has or has previously had chloasma (yellowish-brown pigmented patches on the skin, particularly on the face); in such a case, excessive exposure to sunlight or ultraviolet radiation should be avoided.

If any of the above disorders occur during treatment with Dessette mono, close monitoring of the patient may be necessary. The doctor will explain what actions should be taken.
Breast cancer
The breasts should be examined regularly, and the patient should contact the doctor immediately if any lump in the breast is detected.
Breast cancer occurs slightly more frequently in women using oral contraceptives than in women of the same age who do not use them. After discontinuation of oral contraceptives, the risk gradually decreases, so that after ten years the risk is the same as in women who have never used oral contraceptives. Breast cancer is rare in women under the age of 40, but the risk increases with age. Therefore, the number of additional diagnosed cases of breast cancer increases the later in life the patient stops using oral contraceptives. The duration of use is of lesser significance.
Among 10,000 women who used oral contraceptives for up to 5 years but stopped at age 20, fewer than one additional case of breast cancer would be diagnosed within 10 years after stopping, in addition to the four cases usually diagnosed in this age group. Similarly, among 10,000 women who used oral contraceptives for up to 5 years but stopped at age 30, there would be 5 additional cases of breast cancer in addition to the 44 cases usually diagnosed. Among 10,000 women who used oral contraceptives for up to 5 years but stopped at age 40, there would be 20 additional cases of breast cancer in addition to the 160 cases usually diagnosed.
The risk of breast cancer in women using progestogen-only oral contraceptives, such as Dessette mono, is considered to be similar to that in women using combined oral contraceptives, although data are not conclusive.
In women using oral contraceptives, diagnosed breast cancer appears to be generally less advanced than in women not using oral contraceptives. It is not known whether this difference is caused by the use of oral contraceptives. It may be due to earlier detection, as women using oral contraceptives are more frequently examined.
Thrombosis
If symptoms suggesting thrombosis occur, contact the doctor immediately (see also "Regular check-ups").
Thrombosis is a condition in which blood clots form and may block blood vessels. Thrombosis sometimes occurs in the deep veins of the lower limbs (deep vein thrombosis). If such a clot detaches from the vein where it formed, it may travel to the lungs and block arteries, causing so-called "pulmonary embolism". This may result in death. Deep vein thrombosis is rare. It may occur regardless of whether oral contraceptives are used or not. It may also occur during pregnancy.
The risk is higher in women using oral contraceptives than in women who do not use them. The risk associated with progestogen-only oral contraceptives, such as Dessette mono, is considered lower than that associated with combined oral contraceptives containing oestrogen.
Psychiatric disorders
Some women using hormonal contraceptives, including Dessette mono, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.
Children and adolescents
There are no clinical data available on the efficacy and safety of use in adolescents under 18 years of age.
Dessette mono and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines or herbal products the patient plans to take. Inform any other doctor, including a dentist or pharmacist, who prescribes another medicine, that the patient is using Dessette mono. They may advise whether additional contraceptive methods (e.g. condoms) should be used, and if so, for how long, and whether the way other medicines are taken should be changed.
Some medicines may:

• affect the blood concentration of Dessette mono
• cause it to be less effective in preventing pregnancy
• 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 infection (e.g. ritonavir, nevirapine, efavirenz);
• hepatitis C virus (HCV) infection (e.g. boceprevir, telaprevir);
• other infections (e.g. griseofulvin);
• pulmonary hypertension (bosentan);
• depressive disorders (medicines containing St John's wort (Hypericum perforatum) );
• certain bacterial infections (e.g. clarithromycin, erythromycin);
• fungal infections (e.g. ketoconazole, itraconazole, fluconazole);
• high blood pressure (hypertension), ischaemic heart disease, cardiac arrhythmias (e.g. diltiazem).

When using medicinal products or herbal remedies that reduce the effectiveness of Dessette mono, additional barrier contraceptive methods should be used.
Other medicines may affect the action of Dessette mono for up to 28 days after stopping their use; therefore, additional barrier contraceptive methods should be used throughout this period. The doctor will inform the patient whether an additional contraceptive method should be used, and if so, for how long.
Dessette mono may also affect the action of other medicines, thereby increasing (e.g. medicines containing cyclosporine) or decreasing (e.g. lamotrigine) their effect.
Consult a doctor or pharmacist before using any medicine.
Pregnancy and breastfeeding
Pregnancy
Do not use Dessette mono if the patient is pregnant or suspects she may be pregnant.
Breastfeeding
Dessette mono may be used during breastfeeding. It does not appear to affect the production or quality of breast milk. However, a slight decrease in milk production has occasionally been observed during use of Dessette mono. A small amount of the active substance in Dessette mono passes into breast milk.
The health of children breastfed for 7 months by mothers using Dessette mono was assessed up to 2.5 years of age. No effect on growth and development of these children was observed.
If a woman is breastfeeding and wishes to take Dessette mono, she should consult her doctor.
Driving and using machines
There is no evidence that use of Dessette mono has any effect on attention or concentration.
Regular check-ups
While using Dessette mono, the doctor will inform the patient about the need for regular check-ups. The frequency and type of check-ups will depend on the patient's health status.
Contact the doctor immediately if:

• severe pain or swelling in either leg, unexplained chest pain, shortness of breath, unusual cough, especially coughing up blood (indicating possible thrombosis);

• sudden, severe abdominal pain or yellowing of the skin (indicating possible liver dysfunction);

• a lump appears in the breast (indicating possible breast cancer);

• sudden or severe pain in the lower abdomen or stomach area (indicating possible ectopic pregnancy, i.e. pregnancy in which the foetus develops outside the uterus);

• surgery or immobilisation is planned (consult the doctor at least four weeks in advance);

• unusual heavy vaginal bleeding occurs;

• pregnancy is suspected.

Dessette mono contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, she should
contact the doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Dessette mono

When and how to use Dessette mono
Each blister pack of Dessette mono contains 28 tablets. The days of the week are printed on the blister with arrows indicating the direction. Each day corresponds to one tablet. Each time you start a new blister pack of Dessette mono, you should take the tablet from the top row. Do not start the blister pack with any random tablet. For example, if you start on Wednesday, take the tablet from the top row marked "Wed". Continue taking one tablet daily until the blister is empty, always following the direction indicated by the arrows. Looking at the blister, you can easily check whether you have taken the tablet for that day.
Tablets should be taken every day at the same time. Swallow the tablet whole with water. While using Dessette mono, bleeding may occur, but you should continue taking the tablets as before. After finishing one blister pack, start the next one the following day—i.e., without a break and without waiting for bleeding to occur.

Starting the first pack of Dessette mono

• If you have not used hormonal contraceptives in the previous month
  Wait for the onset of menstrual bleeding. Take the first tablet of Dessette mono on the first day of menstrual bleeding. There is no need to use additional contraceptive methods. You may also start taking this medicine between days 2 and 5 of your cycle. In this case, you must use an additional contraceptive method (barrier method) for the first 7 days of tablet intake.
• Switching from a combined oral contraceptive, vaginal contraceptive system, or transdermal contraceptive system
  Start taking Dessette mono the day after taking the last active tablet of your current contraceptive, or on the day of removal of the vaginal contraceptive system or transdermal system (this means no break in tablet taking, vaginal system, or transdermal system use). If your current contraceptive pack also contains inactive (placebo) tablets, it is best to start taking Dessette mono the day after taking the last active tablet (if in doubt about which tablet is meant, consult your doctor or pharmacist). If the above instructions are followed, there is no need to use additional contraceptive methods. You may also start taking Dessette mono later, but no later than the day following the tablet-free interval, the removal of the vaginal or transdermal system, or the period of taking placebo tablets (inactive tablets) of your current contraceptive. In this case, you must use an additional contraceptive method (barrier method) for the first 7 days of tablet intake.
• Switching from another progestogen-only contraceptive
  You may start taking Dessette mono on any day, immediately after stopping the previous progestogen-only contraceptive. There is no need to use additional contraceptive methods.
• Switching from an injection, implant, or intrauterine system (IUS) releasing progestogen
  Start taking Dessette mono on the day when the next injection is due, or on the day of removal of the implant or intrauterine system. There is no need to use additional contraceptive methods.
• After childbirth
  You may start taking Dessette mono between days 21 and 28 after childbirth. If you start later, you must use an additional contraceptive method (barrier method) until the end of the first 7 days of tablet intake. However, if you have had sexual intercourse, pregnancy must be ruled out before starting Dessette mono. Additional information for breastfeeding women is provided in section 2, "Pregnancy and breastfeeding". You should also consult your doctor for advice.
• After miscarriage or termination of pregnancy
  Consult your doctor.

Missed dose of Dessette mono

• If the delay in taking the tablet is less than 12 hours, the effectiveness of Dessette mono remains unchanged. Take the missed tablet as soon as possible, and continue taking the following tablets at your usual time.
• If the delay in taking the tablet is more than 12 hours, the effectiveness of Dessette mono may be reduced. The more tablets you miss consecutively, the greater the risk of reduced contraceptive effectiveness. Take the last missed tablet as soon as possible, and continue taking the following tablets at your usual time. You should also use an additional contraceptive method (barrier method) for the next 7 days of tablet intake. If you missed one or more tablets during the first week of starting the medicine and had sexual intercourse in the week before missing the tablet, there is a possibility of pregnancy. Consult your doctor for advice.

Gastrointestinal disturbances (e.g., vomiting, acute diarrhoea)
Follow the recommendations for missed tablets described above. If vomiting or acute diarrhoea occurs within 3–4 hours after taking a tablet of Dessette mono, there is a risk that the active substance has not been completely absorbed.

Overdose of Dessette mono
No severe harmful effects have been observed after taking too many tablets of Dessette mono at the same time. Possible symptoms include nausea, vomiting, and, in young girls, slight vaginal bleeding. For further information, consult your doctor.

Discontinuation of Dessette mono
You may discontinue taking Dessette mono at any time. From the day of discontinuation, you may become pregnant.

If you have any further doubts regarding the use of this product, consult your doctor or pharmacist.

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 Dessette mono are described in the sections “Breast cancer” and “Thrombosis” in section 2 “Important information before taking Dessette mono”. Please read this section for additional information and, if necessary, seek immediate medical advice.
If allergic reactions (hypersensitivity) occur, such as swelling of the face, lips, tongue or throat causing difficulty in breathing or swallowing (angioedema and/or anaphylactic reactions), contact a doctor immediately.
Irregular vaginal bleeding may occur during treatment with Dessette mono. This may be slight spotting, not requiring sanitary protection, or heavier bleeding, similar to a light menstrual period, which does require sanitary protection. Bleeding may also not occur at all. Irregular bleeding does not indicate reduced contraceptive effectiveness of Dessette mono. Usually, no action is required and treatment with Dessette mono should be continued. However, if bleeding is heavy or prolonged, consult a doctor.
The following side effects have been reported in women using desogestrel-only contraceptive tablets such as Dessette mono:
Common (may affect up to 1 in 10 women)

• mood changes, depressed mood, decreased sex drive (libido)
• headache
• nausea
• acne
• breast pain, irregular menstrual bleeding or absence of periods
• weight gain

Uncommon (may affect up to 1 in 100 women)

• vaginal infection
• contact lens intolerance
• vomiting
• hair loss
• painful periods, ovarian cysts
• feeling of fatigue

Rare (may affect up to 1 in 1000 women)

• rash, urticaria, painful red nodules of the skin (erythema nodosum) (these are skin disorders)

Frequency not known (frequency cannot be estimated from the available data)

• allergic reactions

In addition to the side effects listed above, galactorrhea may occur.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Dessette mono

Keep the 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. The expiry date refers to the last day of the stated month.
PVC/Aluminium blister: Do not store above 30 °C.
PVC/Aluminium blister in sachet: No special requirements.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What the medicine contains

• The active substance in the medicine is desogestrel (75 micrograms).
• The other ingredients are:

Tablet core:
monohydrate lactose, corn starch, maltodextrin, sodium carboxymethyl starch (type A), hypromellose, stearic acid, microcrystalline cellulose, all-rac-α-tocopherol.

Tablet coating:
hypromellose, monohydrate lactose, titanium dioxide (E 171), stearic acid, macrogol 4000, microcrystalline cellulose, sodium citrate.

What the medicine looks like and contents of the pack

One blister of Dessette mono contains 28 white, round, film-coated tablets with embossing.

Dessette mono is available in the following pack sizes:
1, 3 or 6 blisters in a cardboard box.
1, 3 or 6 blisters, each individually packed in a sachet, in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki