Dessette Forte

Leaflet accompanying the packaging: information for the user

Dessette forte

30 micrograms + 150 micrograms, film-coated tablets

Ethinylestradiol + Desogestrel

Important information about combined hormonal contraceptives

If used correctly, they are one of the most reliable, reversible methods of contraception.
They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
Caution should be exercised and a doctor should be consulted if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood clots").

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person.
• If the patient experiences any side effects, including any 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 forte and what is it used for
• 2. Important information before taking Dessette forte
• 3. How to take Dessette forte
• 4. Possible side effects
• 5. How to store Dessette forte
• 6. Contents of the pack and other information

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

Composition and type of tablet

Dessette forte is a combined oral contraceptive used for contraception (oral contraceptive pill - "combined pill"). Each tablet contains a small amount of two different female hormones. These are desogestrel (progestogen) and ethinylestradiol (estrogen). Due to the low hormone content, Dessette forte is called a low-dose contraceptive pill.
Dessette forte belongs to monophasic, combined oral contraceptives, as each tablet in the blister pack contains the same hormones in the same doses.

What is Dessette forte used for

Dessette forte is used to prevent pregnancy.
The chance of becoming pregnant while taking contraceptive pills (provided that the patient does not forget to take the pills) is very low.

2. Important information before taking Dessette forte

General notes

Before starting to take Dessette forte, the patient should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before starting to take Dessette forte, the doctor will ask the patient about their medical history and that of their close relatives. The doctor will also measure the patient's blood pressure and, depending on the patient's condition, may also perform other examinations.
The leaflet describes various situations in which the patient should stop taking the medicine or in which its effectiveness may be reduced. In these situations, the patient should abstain from sexual intercourse or use additional non-hormonal methods of contraception, such as a condom or another barrier method. Do notuse the calendar or temperature methods. These methods may be ineffective because taking the oral contraceptive affects the changes in body temperature and cervical mucus that occur during the menstrual cycle.

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

Dessette forte is prescribed by a doctor individually for each patient. This medicine should not be given to others.
Dessette forte should not be used to delay the start of menstrual bleeding.
In exceptional cases, when there is a need to delay the start of menstrual bleeding, the patient should consult a doctor.

When not to take Dessette forte

Dessette forte should not be taken if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable. See also "Warnings and precautions".
Dessette forte should not be taken:

• If the patient is allergic to ethinylestradiol, desogestrel or any of the other ingredients of this medicine (listed in section 6).
• If the patient currently has (or has ever had) a blood clot in the deep veins of the legs (deep vein thrombosis), lungs (pulmonary embolism) or other organs.
• If the patient knows they have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation or antiphospholipid antibodies.
• If the patient needs to have surgery or will be immobilized for a long time (see "Blood clots").
• If the patient has had a heart attack or stroke.
• If the patient has (or has ever had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient stroke symptoms).
• If the patient has any of the following diseases that may increase the risk of a blood clot in an artery: severe diabetes with blood vessel damage, very high blood pressure, very high levels of fats in the blood (cholesterol or triglycerides), a disease called hyperhomocysteinemia.
• If the patient has (or has ever had) a type of migraine called "migraine with aura".
• If the patient has (or has ever had) pancreatitis associated with high levels of fats in the blood.
• If the patient has jaundice (yellowing of the skin) or severe liver disease and liver function has not returned to normal.
• If the patient has (or has ever had) a hormone-dependent tumor (e.g. breast cancer or genital cancer).
• If the patient has (or has ever had) a liver tumor.
• If the patient has had vaginal bleeding of unknown cause.
• If the patient has abnormal growth of the endometrium (endometrial hyperplasia).
• If the patient is pregnant or thinks they may be pregnant.
• If the patient has hepatitis C and is taking antiviral medicines containing ombitasvir, paritaprevir, and ritonavir, and dasabuvir or glecaprevir with pibrentasvir (see "Dessette forte and other medicines").

If any of the above conditions occur for the first time while taking Dessette forte, the medicine should be stopped immediately and a doctor consulted. Until the situation is clarified, a non-hormonal method of contraception should be used (see also "General notes").

Warnings and precautions

Before starting to take Dessette forte, the patient should discuss this with their doctor or pharmacist.
When should the patient contact their doctor?

• If the patient notices any symptoms that may indicate the occurrence of blood clots, which may indicate that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack or stroke (see below "Blood clots").

In order to get a description of the serious side effects mentioned, see "How to recognize the occurrence of blood clots".

The patient should tell their doctor if they have any of the following conditions.

If these symptoms appear or worsen while taking Dessette forte, the patient should also tell their doctor.

• If the patient smokes;
• If the patient has diabetes;
• If the patient is overweight;
• If the patient has high blood pressure;
• If the patient has a heart valve disorder or heart rhythm disorder;
• If the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• If the patient has varicose veins;
• If any of the patient's close relatives have had blood clotting disorders, heart attack or stroke;
• If the patient has migraines;
• If the patient has epilepsy;
• If the patient has been found to have high levels of fats in the blood (hypertriglyceridemia) or a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• If the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• If the patient has recently given birth, as they are at increased risk of blood clots. The patient should consult their doctor for information on how soon they can start taking Dessette forte after giving birth;
• If any of the patient's close relatives have had breast cancer;
• If the patient has liver or gallbladder disease;
• If the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• If the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• If the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• If the patient has sickle cell anemia (a hereditary disease of red blood cells);
• If the patient has had conditions that first appeared or worsened during pregnancy or previous use of hormonal contraception (e.g. loss of hearing, metabolic disease - porphyria, skin disease - pregnancy herpes, Sydenham's chorea);
• If the patient has chloasma (yellow-brown skin patches, especially on the face); in these cases, the patient should avoid sun exposure or ultraviolet radiation;
• If the patient experiences symptoms of angioedema, such as facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing or urticaria with potential breathing difficulties, they should contact their doctor immediately. Estrogen-containing medicines may cause or worsen the symptoms of hereditary or acquired angioedema.

Psychiatric disorders

Some women taking hormonal contraceptives, including Dessette forte, 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 patient should contact their doctor as soon as possible for further medical advice.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Dessette forte, is associated with an increased risk of blood clots, compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur
in veins (called "venous thromboembolism" or "deep vein thrombosis"),
in arteries (called "arterial thromboembolism" or "arterial thrombosis").
Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

It should be remembered that the overall risk of serious blood clots caused by taking Dessette forte is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

The patient should contact their doctor immediately if they notice any of the following symptoms.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be suffering from
these symptoms?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt while standing or walking;
• increased temperature in the affected leg;
• change in skin color in the affected leg, such as pallor, redness, or discoloration. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If the patient is unsure, they should contact their doctor,
as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g. a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which can lead to loss of vision.

The patient should contact their doctor immediately if they notice any of these symptoms.

• chest pain, discomfort, feeling of pressure, heaviness;
• feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the upper body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or fainting;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat.
• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, speech disturbances, or difficulty understanding;
• sudden vision disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance, or coordination;
• sudden severe or prolonged headaches without a known cause;
• loss of consciousness or fainting with or without seizures.

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism), although these side effects are rare. They most often occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg to the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming blood clots in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not taking combined hormonal contraceptives.
If the patient stops taking Dessette forte, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk of blood clots associated with taking Dessette forte is small, but some factors can increase this risk. The risk is higher:

• if the patient is severely overweight (body mass index (BMI) over 30 kg/m2);
• if any of the patient's close relatives have had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years old). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to have surgery, is immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Dessette forte for a few weeks before surgery or immobilization. If the patient needs to stop taking Dessette forte, they should ask their doctor when they can resume taking the medicine;
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Taking a long-haul flight (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of the above factors apply to the patient, even if they are not sure. The doctor may decide to stop the patient taking Dessette forte.
The patient should tell their doctor if any of the above conditions change while taking Dessette forte, e.g. if they start smoking, if any of their close relatives are found to have a blood clot without a known cause, or if they gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of heart attack or stroke associated with taking Dessette forte is very small, but it may increase:

• with age (over approximately 35 years old);
• if the patient smokes.While taking a hormonal contraceptive like Dessette forte, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend a different type of contraception;

The patient should tell their doctor if any of the above conditions change while taking Dessette forte, e.g. if they start smoking, if any of their close relatives are found to have a blood clot without a known cause, or if they gain weight significantly.

DESSette FORTE AND CANCER

In women taking oral contraceptives, breast cancer is diagnosed slightly more often than in women of the same age who do not take them. The slight increase in breast cancer diagnosis gradually decreases over a period of 10 years after stopping oral contraceptives. It is not known whether this difference is caused by taking oral contraceptives. It may be related to the fact that women taking oral contraceptives are more likely to undergo medical examinations, and therefore breast cancer is diagnosed earlier in them.
In rare cases, women taking oral contraceptives have been found to have benign liver tumors, and even more rarely, malignant liver tumors. These tumors can lead to bleeding into the abdominal cavity. If the patient experiences severe abdominal pain, they should contact their doctor immediately.
Cervical cancer may be caused by the presence of human papillomavirus. It has been noted that cervical cancer occurs more frequently in women taking oral contraceptives for an extended period. However, it is not known whether this is due to taking oral contraceptives or may be related to sexual behavior or other factors (e.g. more frequent cervical screening).

Children and adolescents

The efficacy and safety of desogestrel in adolescents under 18 years of age have not been established. There are no available data.

Dessette forte and other medicines

The patient should tell their doctor or pharmacist about all medicines or herbal products they are taking. They should also inform their doctor or pharmacist about taking Dessette forte if they are prescribed other medicines by another doctor or dentist (or pharmacist). They may inform the patient about the need to use additional contraceptive methods and determine the duration of their use or decide whether the use of other medicines should be changed.
Some medicines

• may affect the level of Dessette forte in the blood,
• may make it less effective in preventing pregnancy,
• may cause unexpected vaginal bleeding.

This applies to medicines used to treat:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g. rifampicin);
• HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C virus infection (e.g. boceprevir, telaprevir);
• other infectious diseases (e.g. griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depressive moods (herbal preparations containing St. John's wort [Hypericum perforatum]).

In the case of taking medicines or herbal products that may reduce the effectiveness of Dessette forte, it is recommended to use additional barrier methods of contraception. The effect of other medicines on Dessette forte may last for 28 days, so additional barrier methods should be used during this entire period.
Dessette forte may affect the action of other medicines, such as:

• medicines containing cyclosporin,
• lamotrigine used to treat epilepsy (which may lead to an increased frequency of seizures).

Effect on laboratory tests

If there is a need to perform blood tests, the patient should tell their doctor or laboratory staff that they are taking Dessette forte, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy
Dessette forte should not be taken by women who are pregnant or think they may be pregnant. If the patient suspects they are pregnant while taking Dessette forte, they should contact their doctor immediately.
Breastfeeding
It is not recommended to take Dessette forte while breastfeeding. If the patient wants to take Dessette forte while breastfeeding, they should consult their doctor.

Driving and using machines

No effects on driving or using machines have been reported.

When to consult a doctor

Regular check-ups

A woman taking oral contraceptives should be informed by her doctor about the need for regular medical check-ups. These check-ups are usually performed once a year.

The patient should contact their doctor immediately in the following cases:

• if the patient notices any symptoms that may indicate the occurrence of blood clots, which may indicate that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack or stroke (see above "Blood clots"). To get a description of the serious side effects mentioned, see "How to recognize the occurrence of blood clots";
• if there are any changes in the patient's health, especially the conditions mentioned in this leaflet (see also "When not to take Dessette forte" and "Warnings and precautions"); the patient should not forget about diseases that occur in their close relatives;
• if the patient feels any lumps in their breasts;
• if the patient experiences symptoms of angioedema, such as facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing or urticaria with potential breathing difficulties;
• if the patient wants to take other medicines (see also "Dessette forte and other medicines");
• if the patient is going to have surgery or be immobilized (they should consult their doctor at least 4 weeks in advance);
• if the patient experiences irregular, heavy vaginal bleeding;
• if the patient forgot to take a tablet in the first week of taking the blister pack and had sexual intercourse in the previous 7 days;
• if the patient experiences severe diarrhea;
• if the patient misses two consecutive menstrual periods or suspects they may be pregnant (they should only continue taking the medicine after consulting their doctor).

Dessette forte contains lactose and sodium

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

3. How to take Dessette forte

When and how to take Dessette forte

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
One blister pack of Dessette forte contains 21 tablets.
On the blister pack, each tablet has a symbol of the day of the week on which it should be taken.
The tablets should be taken at the same time every day, with water if necessary. The patient should continue taking the tablets for 21 days, following the direction of the arrows on the blister pack.
Then, the patient should wait for 7 days, during which they will not take any tablets. Menstrual bleeding (withdrawal bleeding) should occur during these 7 days. It usually occurs 2-3 days after taking the last tablet of Dessette forte. The first tablet from the next blister pack should be taken on the 8th day, even if the bleeding is still present. This means that the patient will always start a new blister pack on the same day of the week and that the withdrawal bleeding will occur at approximately the same time every month.

Starting to take Dessette forte for the first time

˗
If the patient did not use any hormonal contraceptive method in the previous month
The patient should start taking Dessette forte on the first day of their menstrual cycle, i.e. the first day of menstrual bleeding. On the packaging, each tablet is marked with the day of the week on which it should be taken. For example, if the patient starts taking the medicine on a Friday, they should take the tablet marked "Fri". Then, they should continue taking the tablets following the direction of the arrows on the blister pack. Dessette forte starts working immediately. There is no need to use an additional contraceptive method.
Taking the tablets can also be started between the 2nd and 5th day of the menstrual cycle, but in this case, the patient should use an additional barrier method of contraception (e.g. a condom) for the first 7 days of taking the tablets in the first menstrual cycle.
˗
In case of changing from another combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or transdermal patch)
The patient can start taking Dessette forte the next day after taking the last active tablet of the previous medicine (without a break in taking the tablets). If the previously taken medicine also contains inactive tablets, the patient can start taking Dessette forte the next day after taking the last active tablet(if in doubt, which tablet is active, the patient should ask their doctor or pharmacist). The patient can also start taking the first tablet of Dessette forte later, but no later than the day following the usual break in taking the tablets of the previously taken medicine (or the day after taking the last inactive tablet of the previously taken medicine). In the case of a vaginal ring or transdermal patch, it is best to start taking Dessette forte on the day the ring or patch is removed. The patient should start taking Dessette forte no later than the day they would have reapplied the vaginal ring or patch.
When taking Dessette forte according to the above instructions, there is no need to use an additional contraceptive method.
˗
In case of changing from a progestogen-only tablet (minipill)
The patient can stop taking the minipill and start taking Dessette forte the next day at the same time. The patient should also use an additional barrier method of contraception (e.g. a condom) for the first 7 days of taking Dessette forte.
˗
In case of changing from a progestogen-only injection, implant, or intrauterine system
The patient should start taking Dessette forte on the day they would have had their next injection or on the day the implant or intrauterine system is removed. The patient should also use an additional barrier method of contraception (e.g. a condom) for the first 7 days of taking Dessette forte.
˗
After childbirth
Immediately after childbirth, the doctor will advise the patient to wait until their first menstrual period before starting to take Dessette forte. The doctor may also advise the patient to start taking the tablets earlier. If the patient is breastfeeding, they should discuss taking Dessette forte with their doctor first.
˗
After miscarriage or abortion
The patient should follow their doctor's advice.

Taking a higher dose of Dessette forte than recommended

No serious side effects have been reported after taking too many Dessette forte tablets at once. After taking several tablets at the same time, the patient may experience nausea, vomiting, or vaginal bleeding.
If a child has taken Dessette forte, the patient should contact their doctor.

Missing a dose of Dessette forte

˗
If the delay in taking a tablet is less than 12 hours,the effectiveness of the tablet is maintained. The patient should take the missed tablet as soon as possible and continue taking the remaining tablets as usual.

• If the delay in taking a tablet is more than 12 hours,the effectiveness of the tablet may be reduced. The more tablets that are missed, the higher the risk of reduced contraceptive effectiveness. The risk of pregnancy is especially high if a tablet is missed at the beginning or end of the blister pack. The patient should follow the instructions below (see also the scheme below).

If more than one tablet is missed from the blister pack

The patient should consult their doctor.

If one tablet is missed in the first week of taking

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time) and continue taking the remaining tablets at the usual time. For the next 7 days, the patient should use an additional barrier method of contraception (e.g. a condom). If the patient had sexual intercourse in the week before missing the tablet, there is a possibility of pregnancy. The patient should tell their doctor immediately.

If one tablet is missed in the second week of taking

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time) and continue taking the remaining tablets at the usual time.
The effectiveness of the tablet is maintained, and there is no need to use additional contraceptive methods.

4. Possible side effects

Like all medicines, Dessette forte can cause side effects, although not everybody gets them. If side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Dessette forte, the patient should consult a doctor. All women using combined hormonal contraceptives have an increased risk of blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thrombosis). For more detailed information on various risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2 "Important information before using Dessette forte". Other serious side effects related to the use of Dessette forte and their symptoms are described in the sections "Blood clots" and "Dessette forte and cancer". Common (may affect up to 1 in 10 women):

• Depressive mood, mood changes,
• Headache,
• Nausea, abdominal pain,
• Breast pain, breast tenderness,
• Weight gain.

Uncommon (may affect up to 1 in 100 women):

• Fluid retention in the body,
• Decreased libido,
• Migraine,
• Vomiting, diarrhea,
• Rash, urticaria,
• Breast enlargement.

Rare (may affect up to 1 in 1000 women):

• Hypersensitivity reactions,
• Increased libido,
• Intolerance to contact lenses,
• Erythema multiforme, erythema nodosum (these are skin diseases),
• Breast discharge,
• Vaginal discharge,
• Weight loss,
• Harmful blood clots in a vein or artery, for example:
• In the leg or foot (e.g., deep vein thrombosis)
• In the lungs (e.g., pulmonary embolism)
• Myocardial infarction
• Stroke
• Mini-stroke or transient stroke symptoms, known as a transient ischemic attack
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of blood clots may be higher if the patient has other risk factors (see section 2 for more information on risk factors and symptoms of blood clots).

Severe side effects

The patient should immediately contact a doctor if any of the following symptoms of angioedema occur: facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing or urticaria with potential breathing difficulties (see also section 2 "Warnings and precautions").

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. By reporting side effects, more information can be gathered on the safety of the medication.

5. How to store Dessette forte

The medication should be stored out of sight and reach of children. Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date refers to the last day of the specified month. PVC/Aluminum blister pack (without sachet): Do not store above 30°C. PVC/Aluminum blister pack in PET/Aluminum/PE sachet: No special precautions. Do not use this medication if, for example, discoloration, crumbling, or other visible signs of tablet damage are observed. Medications should not be disposed of in wastewater or household waste containers. The patient should ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Dessette forte contains

• The active substances of Dessette forte are ethinylestradiol and desogestrel. Each film-coated tablet of Dessette forte contains 30 micrograms of ethinylestradiol and 150 micrograms of desogestrel.
• Other ingredients of the medication are: Core: lactose monohydrate, corn starch, maltodextrin, sodium carboxymethyl cellulose (type A), hypromellose, stearic acid, microcrystalline cellulose, all-rac-α-tocopherol.

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

What Dessette forte looks like and what the pack contains

Dessette forte is a white, biconvex, round film-coated tablet with an embossing. Dessette forte is available in packs of: 1, 3, or 6 blister packs of 21 film-coated tablets in a cardboard box. 1, 3, or 6 blister packs of 21 film-coated tablets, each in a 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:12.2021