Dessette mono

Leaflet accompanying the packaging: information for the user

Dessette mono, 75 micrograms, coated tablets

Desogestrel

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dessette mono and what is it used for
• 2. Important information before using Dessette mono
• 3. How to use Dessette mono
• 4. Possible side effects
• 5. How to store Dessette mono
• 6. Contents of the packaging and other information

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

Dessette mono is used to prevent pregnancy. Dessette mono contains a small amount of one type of female sex hormone, progestogen called desogestrel. For this reason, Dessette mono is called a progestogen-only medicine. Unlike combined hormonal contraceptives, progestogen-only medicines do not contain estrogen, only progestogen.
Most progestogen-only medicines work mainly by preventing sperm from entering the uterus, but they do not always prevent ovulation, which is the main action of combined hormonal contraceptives. Dessette mono differs from most progestogen-only medicines in that its dose is usually sufficient to prevent ovulation. As a result, Dessette mono shows high contraceptive efficacy.
Unlike combined oral contraceptives, Dessette mono can be used by women who do not tolerate estrogens and by breastfeeding women. The disadvantage of using Dessette mono is the possibility of 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 hypersensitive to desogestrel or any of the other ingredients of this medicine (listed in section 6).
• If the patient has a thrombosis. Thrombosis is the formation of blood clots in blood vessels (e.g. in the legs - deep vein thrombosis), which can lead to the formation of an embolus (e.g. in the pulmonary blood vessels - pulmonary embolism).
• If the patient has or has had in the past jaundice (yellowing of the skin) or severe liver disease, and liver function parameters have not yet returned to normal.
• If the patient has or is suspected of having a hormone-dependent tumor, such as certain types of breast cancer.
• If the patient has bleeding from the genital tract of unknown cause.

If any of the above conditions occur, the doctor should be informed before starting to use Dessette mono. The doctor may recommend the use of a non-hormonal contraceptive method.
If any of the above conditions occur for the first time while using Dessette mono, the doctor should be consulted immediately.

Warnings and precautions

Before using Dessette mono, the patient should discuss it with their doctor or pharmacist:

• if the patient has ever had breast cancer;
• if the patient has liver cancer, as the effect of Dessette mono on this type of tumor cannot be ruled out;
• if the patient has ever had a thrombosis;
• if the patient has diabetes;
• if the patient has epilepsy (see "Dessette mono and other medicines");
• if the patient has tuberculosis (see "Dessette mono and other medicines");
• if the patient has high blood pressure;
• if the patient has or has had chloasma (yellow-brown pigmentation spots on the skin, especially on the face); in this case, excessive exposure to the sun or ultraviolet radiation should be avoided.

If any of the above disorders occur during the use of Dessette mono, close monitoring of the patient may be necessary. The doctor will explain how to proceed.
Breast cancer
Regular breast self-examination should be performed and the doctor should be consulted immediately if any lump is felt in the breast.
Breast cancer occurs slightly more often in women using oral contraceptives than in women of the same age who do not use them. After stopping the use of oral contraceptives, the risk gradually decreases, so that after ten years it is the same as the risk of breast cancer in women who have never used oral contraceptives. Breast cancer rarely occurs in women before the age of 40, but the risk of its occurrence increases with age. Therefore, the number of additional diagnosed cases of breast cancer is greater, the older the age of the patient taking oral contraceptives. The duration of oral contraceptive use is of less importance.
For every 10,000 women taking oral contraceptives for up to 5 years, but stopping them at the age of 20, there will be less than one additional case of breast cancer diagnosed within 10 years of stopping the tablets, in addition to the four cases of breast cancer that are usually diagnosed in this age group. Similarly, for every 10,000 women taking oral contraceptives for up to 5 years, but stopping them at the age of 30, there will be 5 additional cases of breast cancer, in addition to the 44 cases usually diagnosed. For every 10,000 women taking oral contraceptives for up to 5 years, but stopping them at the age of 40, there will be 20 additional cases of breast cancer, in addition to the 160 cases usually diagnosed.
It is believed that the risk of breast cancer in women using progestogen-only oral contraceptives, such as Dessette mono, is similar to the risk in women using combined oral contraceptives, but the data are not conclusive.
It appears that in women using oral contraceptives, the detected breast cancer is usually less advanced than in women who do not use oral contraceptives. It is not known whether this difference is caused by the use of oral contraceptives. The reason may be earlier detection of breast cancer, as women using oral contraceptives are more often examined.
Thrombosis
If symptoms occur that may indicate thrombosis, the doctor should be consulted immediately (see also "Regular check-ups").
Thrombosis is a condition in which blood clots form, which can block a blood vessel. Thrombosis sometimes occurs in the deep veins of the lower limbs (deep vein thrombosis). If such a clot comes loose from the vein where it formed, it can reach the lungs and block an artery, causing a so-called "pulmonary embolism". As a result, death may occur. Deep vein thrombosis is rare. It can occur regardless of whether oral contraceptives are used or not. It can also occur during pregnancy.
The risk of occurrence is higher in women using oral contraceptives than in women who do not use them. The risk associated with the use of progestogen-only oral contraceptives, such as Dessette mono, is considered to be lower than with the use of oral contraceptives that also contain estrogen (combined oral contraceptives).
Mental disorders
Some women using hormonal contraceptives, including Dessette mono, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, the doctor should be consulted 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

The doctor should be told about all medicines that the patient is currently taking or has recently taken, as well as about any herbal products that the patient plans to take. The doctor should also be told by any other doctor, including the dentist or pharmacist, who prescribes another medicine, that Dessette mono is being used. They may say whether additional contraceptive measures should be used (e.g. condoms), and if so, for how long, as well as whether the use of other medicines should be changed.
Some medicines may:

• affect the concentration of Dessette mono in the blood
• make it 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 infectious diseases (e.g. griseofulvin);
• pulmonary hypertension (bosentan);
• depressive mood (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), ischemic heart disease, heart rhythm disorders (e.g. diltiazem).

In the case of using medicinal products or herbal products that reduce the effectiveness of Dessette mono, additional barrier methods of contraception should be used.
Other medicines may affect the action of Dessette mono for up to 28 days after stopping their use, so additional barrier methods of contraception should be used during this time. The doctor will inform the patient whether they should use an additional contraceptive method, and if so, for how long.
Dessette mono may also affect the action of other medicines, and as a result, increase (e.g. medicines containing cyclosporin) or decrease their action (e.g. lamotrigine).
Before using any medicine, the doctor or pharmacist should be consulted.

Pregnancy and breastfeeding

Pregnancy
Dessette mono should not be used if the patient is pregnant or suspects that they may be pregnant.
Breastfeeding
Dessette mono can be used during breastfeeding. It does not appear to affect milk production or quality. However, a decrease in milk production has occasionally been reported during the use of Dessette mono. A small amount of the active substance in Dessette mono passes into breast milk.
In children breastfed for 7 months by mothers using Dessette mono, the effect on health was studied up to 2.5 years of age. No effect on growth and development was observed in these children.
If a breastfeeding woman wishes to take Dessette mono, she should consult her doctor.

Driving and using machines

There is no evidence that the use of Dessette mono has any effect on attention and concentration.

Regular check-ups

During the use of 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 state of health.

Consult a doctor immediately:

• if severe pain or swelling of any of the lower limbs occurs, unexplained chest pain, shortness of breath, unusual cough, especially coughing up blood (indicating a possible thrombosis);
• if sudden, severe abdominal pain or yellowing of the skin occurs (indicating a possible liver dysfunction);
• if a lump is found in the breast (indicating a possible breast cancer);
• if sudden or severe pain occurs in the lower abdomen or stomach area (indicating a possible ectopic pregnancy, i.e. a pregnancy in which the fetus develops outside the uterus);
• if immobilization or surgery is planned (the doctor should be consulted at least 4 weeks in advance);

if unusual heavy vaginal bleeding occurs;

• if pregnancy is suspected.

Dessette mono contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that the medicine is considered "sodium-free".

3. How to use Dessette mono

When and how to use Dessette mono

Each blister of Dessette mono contains 28 tablets. The blister shows the days of the week printed and connected by arrows. Each day corresponds to one tablet. When starting a new blister of Dessette mono, the tablet should be taken from the top row. The blister should not be started from any tablet.
For example, if starting on a Wednesday, the tablet should be taken from the top row marked "Wed". One tablet should be taken every day, until the blister is empty, always in the direction indicated by the arrows. Looking at the blister, it is easy to check if the tablet has been taken on a given day.
Tablets should be taken every day at the same time.The tablet should be swallowed whole, with water. During the use of Dessette mono, bleeding may occur, but the tablets should be continued as usual. After the blister is empty, the next one should be started the next day - i.e. without interruption and without waiting for bleeding to occur.

Starting the first packaging of Dessette mono

• If no hormonal contraceptives have been used in the last month, wait for the start of menstrual bleeding. The first tablet of Dessette mono should be taken on the first day of menstrual bleeding. There is no need to use additional contraceptive methods. Dessette mono can also be started between the 2nd and 5th day of the cycle. In this case, an additional contraceptive method (barrier method) should be used for the first 7 days of tablet use.
• Changing from a combined hormonal contraceptive, vaginal ring system, or transdermal system, the use of Dessette mono should be started the next day after taking the last tablet of the previous contraceptive or on the day of removal of the vaginal ring system or transdermal system (this means no break in tablet use, vaginal ring system, or transdermal system). If the packaging of the currently used contraceptive contains tablets without active substances, it is best to start using Dessette mono the next day after taking the last tablet containing active substances (in case of doubt, which tablet it is, the doctor or pharmacist should be asked). If the above instructions are followed, there is no need to use additional contraceptive methods. The use of Dessette mono can also be started later, at the latest on the day following the break in tablet use, vaginal ring system use, transdermal system use, or after the period of taking tablets that do not contain active substances (placebo) of the currently used contraceptive. In this case, an additional contraceptive method (barrier method) should be used for the first 7 days of tablet use.

Changing from another progestogen-only medicine, the use of Dessette mono can be started on any day, directly after stopping the previous progestogen-only medicine. There is no need to use additional contraceptive methods.

• Changing from an injection, implant, or intrauterine system (IUS) that releases progestogen, the use of Dessette mono should be started on the day when the next injection is scheduled or on the day of removal of the implant or intrauterine system. There is no need to use additional contraceptive methods.
• After childbirth, Dessette mono can be started between the 21st and 28th day after childbirth. If started later, an additional contraceptive method (barrier method) should be used until the end of the first 7 days of tablet use. However, if sexual intercourse has occurred, pregnancy should be ruled out before starting to use Dessette mono. Additional information for breastfeeding women is included in section 2 "Pregnancy and breastfeeding". The doctor should also be consulted for advice.
• After miscarriage or abortion, the doctor should be consulted.

Missing a dose of Dessette mono

• If the delay in taking a tablet is less than 12 hours, the effectiveness of Dessette mono is still maintained. The missed tablet should be taken as soon as possible, and subsequent tablets should be taken at the usual time.
• If the delay in taking a tablet is more than 12 hours, the effectiveness of Dessette mono may be reduced. The more consecutive tablets are missed, the higher the risk of reduced contraceptive efficacy of the medicine. The last missed tablet should be taken as soon as possible, and subsequent tablets should be taken at the usual time. An additional contraceptive method (barrier method) should also be used for the next 7 days of tablet use. If one or more tablets are missed in the first week of using Dessette mono and sexual intercourse has occurred in the week preceding the missed tablet, there is a possibility of pregnancy. The doctor should be consulted for advice.

Procedure in case of gastrointestinal disorders (e.g. vomiting, severe diarrhea)

The same instructions as for the case of a missed tablet, described above, should be followed. If vomiting or severe diarrhea occurs within 3-4 hours after taking a tablet of Dessette mono, there is a risk that the active substance may not have been fully absorbed.

Use of a higher than recommended dose of Dessette mono

No serious harmful effects have been observed after taking too many tablets of Dessette mono at the same time. The following symptoms may occur: nausea, vomiting, and in young girls, slight vaginal bleeding. For further information, the doctor should be consulted for advice.

Stopping the use of Dessette mono

The use of Dessette mono can be stopped at any time. From the day of stopping the use of the medicine, the patient may become pregnant.
In case of any further doubts related to the use of this product, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Dessette mono can cause side effects, although not everybody gets them.
Severe side effects associated with the use of Dessette mono have been described in the sections "Breast cancer" and "Thrombosis" in section 2 "Important information before using Dessette mono". These sections should be read to obtain additional information, and if necessary, the doctor should be consulted immediately.
In the case of allergic reactions (hypersensitivity), such as swelling of the face, lips, tongue, or throat, causing difficulty in breathing or swallowing (angioedema and/or anaphylactic reactions), the doctor should be consulted immediately.
During the use of Dessette mono, irregular vaginal bleeding may occur.
This may be slight spotting, not requiring the use of sanitary products, or more severe bleeding, similar to a light menstrual period, requiring their use.
Bleeding may also not occur at all.
Irregular bleeding does not indicate a decrease in the contraceptive efficacy of Dessette mono. Usually, no action is necessary, and the use of Dessette mono should be continued. However, if the bleeding is heavy or prolonged, the doctor should be consulted.
Women using progestogen-only oral contraceptives, such as Dessette mono, have reported the following side effects:
Common(may affect up to 1 in 10 women)

• mood changes, depressive mood, decreased libido
• headaches
• nausea
• acne
• breast pain, irregular menstrual periods, or their absence
• weight gain

Uncommon(may affect up to 1 in 100 women)

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

Rare(may affect up to 1 in 1,000 women)

• rash, hives, painful red skin bumps (erythema nodosum) (these are skin disorders)

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

• allergic reactions

In addition to the above side effects, galactorrhea (milk secretion) may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dessette mono

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the specified month.
PVC/Aluminum blister: Do not store above 30°C.
PVC/Aluminum blister in a sachet: No special precautions.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dessette mono contains

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

Core of the tablet:
lactose monohydrate, corn starch, maltodextrin, sodium carboxymethyl cellulose (type A), hypromellose, stearic acid, microcrystalline cellulose, all-rac-α-tocopherol.
Coating of the tablet:
hypromellose, lactose monohydrate, titanium dioxide (E 171), stearic acid, macrogol 4000, microcrystalline cellulose, sodium citrate.

What Dessette mono looks like and what the packaging contains

One blister of Dessette mono contains 28 white, round, coated tablets with an imprint.
Dessette mono is available in packages:
1, 3, or 6 blisters in a cardboard box.
1, 3, or 6 blisters, each in a separate sachet, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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
Date of last revision of the leaflet:06.2022