Madinette

Leaflet attached to the packaging: information for the user

Madinette

0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Chlormadinone acetate

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they 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 symptoms of blood clots have occurred (see section 2 "Blood clots").

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet to be able to read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• 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 Madinette and what is it used for
• 2. Important information before using Madinette
• 3. How to use Madinette
• 4. Possible side effects
• 5. How to store Madinette
• 6. Contents of the pack and other information

1. What is Madinette and what is it used for

Madinette is a hormonal contraceptive for oral use. If a hormonal contraceptive contains two hormones, like Madinette, it is also called a combined hormonal contraceptive. Because each of the 21 coated tablets in the pack for use in one cycle contains the same amount of both hormones, Madinette is also called a monophasic product.
Hormonal contraceptives, such as Madinette, do not protect against AIDS (HIV infection) or other sexually transmitted diseases. Only condoms can protect against these diseases.

2. Important information before using Madinette

General notes

Before starting to use Madinette, you 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 use Madinette, your doctor will perform a thorough general and gynecological examination, ensure that you are not pregnant, and decide, taking into account contraindications and precautions, whether you can use Madinette. During the use of Madinette, such an examination should be repeated every year.

When not to use Madinette

If you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. The doctor will discuss with you which other contraceptive method will be more suitable for you.

• If you are allergic to ethinylestradiol, chlormadinone acetate, or any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the deep veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
• if you have initial or impending symptoms of blood clots, phlebitis, or embolism, such as transient stabbing, pain, or feeling of pressure in the chest;
• if you know you have disorders that affect blood clotting - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section "Blood clots");
• if you have diabetes and your blood sugar levels are not well controlled;
• if you have high blood pressure that is difficult to control or if your blood pressure has risen significantly (sustained values above 140/90 mmHg);
• if you have had a heart attack or stroke;
• if you have 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 symptoms of a stroke);
• if you have 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 you have (or have ever had) a type of migraine called "migraine with aura";
• if you have (or have had) liver inflammation (e.g., viral) or jaundice and liver function tests have not returned to normal;
• if you have itching all over your body or bile flow disorders, especially if such disorders occurred during a previous pregnancy or during estrogen treatment;
• if you have elevated bilirubin levels in your blood, e.g., due to congenital elimination disorders (Dubin-Johnson syndrome or Rotor syndrome);
• if you have a meningioma or have ever been diagnosed with a meningioma (usually a benign tumor of the tissue layer between the brain and the skull);
• if you have (or have ever had) a liver tumor;
• if you have severe abdominal pain, liver enlargement, or symptoms of bleeding into the abdominal cavity;
• if you have a first-time porphyria attack (a disorder of blood pigment metabolism) or recurring porphyria attacks;
• if you have (or have had) malignant hormone-dependent tumors, such as breast or uterine cancer, or if such tumors are suspected;
• if you have severe lipid metabolism disorders;
• if you have (or have had) pancreatitis with high levels of fats in the blood (triglycerides);
• if you have extremely frequent, persistent, or severe headaches;
• if you experience sudden disturbances in sensation (vision or hearing disturbances);
• if you experience movement disorders (especially paresis);
• if you have worsening epilepsy seizures;
• if you have severe depression;
• if you have a certain type of hearing loss (otosclerosis) that worsened during a previous pregnancy;
• if you have unexplained absence of menstrual bleeding;
• if you have been diagnosed with abnormal growth of the uterine lining (endometrial hyperplasia);
• if you have unexplained vaginal bleeding;
• if you have hepatitis C and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see section "Madinette and other medicines").

If any of the above conditions occur during the use of Madinette, you should stop taking the medicine immediately.
You should not take Madinette or should stop taking it immediately if you have or develop one or more serious risk factors for blood clotting disorders (see section "Warnings and precautions").

Warnings and precautions

You should discuss the use of Madinette with your doctor or pharmacist before starting to use it.
When should you contact your doctor?
You should contact your doctor immediately

• -if you notice possible symptoms of blood clots, which may indicate that you have blood clots in your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolism), a heart attack, or a stroke (see the section below "Blood clots (thrombosis)"). To describe the symptoms of these serious side effects, see "How to recognize blood clots".

You should tell your doctor if you have any of the following conditions.

• If you smoke. Smoking while using hormonal contraceptives like Madinette increases the risk of serious heart and blood vessel disorders. This risk increases with age and the number of cigarettes smoked. This applies especially to women over 35 years old. Women over 35 years old who smoke should use other contraceptive methods.

If these symptoms occur or worsen during the use of Madinette, you should also tell your doctor:

• you should contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with potential breathing difficulties. Estrogen-containing medicines may cause or worsen symptoms of hereditary or acquired angioedema;
• if you have high blood pressure, abnormal lipid levels, overweight, or diabetes (see also section 2 "When not to use Madinette", "Other diseases"). In these cases, the risk of serious side effects (such as heart attack, embolism, stroke, or liver tumor) during the use of combined hormonal contraceptives is higher;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic-uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Madinette after giving birth;
• if you have superficial thrombophlebitis (blood clots in veins under the skin);
• if you have varicose veins.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Madinette, is associated with an increased risk of blood clots compared to not using the therapy.
Blood clots can form
in veins (hereinafter referred to as "venous thromboembolism" or "venous thrombosis"),
in arteries (hereinafter referred to as "arterial thrombosis" or "arterial thromboembolism").
Not all patients who have had a blood clot will recover fully. In rare cases, the consequences of a blood clot can be permanent or, very rarely, fatal.

Remember that the overall risk of harmful blood clots caused by Madinette is small.

HOW TO RECOGNIZE BLOOD CLOTS

You should contact your doctor immediately if you notice any of the following symptoms.

Are you experiencing any of these symptoms? What might be the reason for your condition?

• 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 when standing or walking,
• increased temperature in the affected leg,
• change in the color of the leg skin, e.g., pallor, redness, or cyanosis. 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. Pulmonary embolism

If you are unsure, you should contact your doctor,

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

• The use of 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 using 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 breaks loose from the leg and settles in 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 using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of 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 using combined hormonal contraceptives.
If you stop using Madinette, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Madinette is small.
In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
In a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
Out of 10,000 women using combined hormonal contraceptives containing chlormadinone, such as Madinette, about 6 to 9 will develop blood clots in a year.
The risk of blood clots depends on the individual's medical history (see "Factors that increase the risk of blood clots" below).

You should contact your doctor as soon as possible if you experience more frequent or severe migraine attacks during the use of Madinette (which may indicate cerebral vascular disorders). Your doctor may recommend stopping the use of Madinette.

Factors that increase the risk of blood clots in veins

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

• if you are severely overweight (body mass index (BMI) over 30 kg/m);
• if someone in your immediate family has had blood clots in their legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, you may have hereditary blood clotting disorders;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop using Madinette for a few weeks before surgery or immobilization. If you need to stop using Madinette, you should ask your doctor when you can resume using the medicine;
• with age (especially over 35 years old);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of the above factors apply to you, even if you are not sure. Your doctor may decide to stop the use of Madinette.
You should inform your doctor if any of the above conditions change during the use of Madinette, e.g., if someone in your immediate family is diagnosed with a blood clot without a known cause or if you gain significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

Similarly to blood clots in veins, blood clots in an artery 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 Madinette is very small, but it may increase:

• with age (over approximately 35 years old);
• if you smoke.While using a hormonal contraceptive like Madinette, it is recommended to quit smoking. If you cannot quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if you have diabetes. If you have more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be even higher. You should inform your doctor if any of the above conditions change during the use of Madinette, e.g., if you start smoking, someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain significant weight.

Cancer
In several clinical studies, an increased risk of cervical cancer has been found in women infected with a certain sexually transmitted virus (HPV, human papillomavirus) who have been using contraceptives for a long time. However, it has not been clarified what other additional factors (e.g., different numbers of sexual partners and the use of barrier contraceptive methods) may have influenced these results.
Clinical studies have shown a slightly increased risk of breast cancer in women taking combined hormonal contraceptives. This increased risk decreases within 10 years after stopping the use of combined hormonal contraceptives to the underlying age-related risk. Since breast cancer is rare in women under 40 years old, the increase in the number of diagnosed cases of this disease in women currently or recently using hormonal contraceptives is small compared to the overall risk of breast cancer.
In rare cases, the use of hormonal contraceptives has led to the development of benign or, even more rarely, malignant liver tumors. They can cause life-threatening internal bleeding. If you experience severe, persistent abdominal pain, you should contact your doctor.
The use of chlormadinone acetate has been associated with the development of usually benign brain tumors (meningioma). This risk increases, especially with high doses and prolonged use (several months or years). If a meningioma is diagnosed in you, your doctor will stop the treatment with Madinette (see section "When not to use Madinette"). If you notice any symptoms, such as changes in vision (e.g., double vision or blurred vision), hearing loss or ringing in the ears, loss of smell, headache that worsens over time, memory loss, seizures, weakness in the arms or legs, you should contact your doctor immediately.
Other diseases
Mental disorders
Some women using hormonal contraceptives, including Madinette, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.
Many women taking hormonal contraceptives experience a slight increase in blood pressure. If significant high blood pressure occurs during the use of Madinette, your doctor will recommend stopping the use of Madinette and prescribe a medicine to lower your blood pressure. The use of Madinette can be resumed when your blood pressure returns to normal.
Women who have had impetigo herpetiformis (a skin condition) during a previous pregnancy may experience a recurrence during the use of hormonal contraceptives.
If you have a certain lipid metabolism disorder (hypertriglyceridemia) or have a family history of this disease, you are at increased risk of developing pancreatitis.
If you have acute or chronic liver function disorders, your doctor may recommend stopping the use of Madinette until liver function tests return to normal. If you have had jaundice during a previous pregnancy or during the use of hormonal contraceptives and it recurs, you should stop using Madinette.
If you have diabetes and your blood sugar levels are well controlled, your doctor will carefully assess your condition during the use of Madinette. It may be necessary to change your diabetes treatment.
Not very often, brown spots may appear on the skin (chloasma), especially if such changes occurred during a previous pregnancy. If you know you are prone to chloasma, you should avoid direct exposure to sunlight or ultraviolet radiation (e.g., sunbed) during the use of Madinette.
Negative impact on other disorders
Special medical supervision is also required:

• if you have epilepsy;
• if you have multiple sclerosis;
• if you have very strong muscle spasms (tetany);
• if you have migraines (see also section "When not to use Madinette");
• if you have asthma;
• if you have impaired heart or kidney function (see also section 2 "When not to use Madinette");
• if you have Sydenham's chorea (a disorder of the nervous system);
• if you have diabetes (see also section "When not to use Madinette" and "Other diseases");
• if you have liver disease (see also section "When not to use Madinette");
• if you have lipid metabolism disorders (see also section "When not to use Madinette");
• if you have immune system diseases (including systemic lupus erythematosus);
• if you are severely overweight;
• if you have high blood pressure (see also section "When not to use Madinette");
• if you have endometriosis (when the tissue lining the uterus, called the endometrium, occurs outside the uterus) (see also section "When not to use Madinette");
• if you have varicose veins or phlebitis (see also section "When not to use Madinette");
• if you have blood clotting disorders (see also section "When not to use Madinette");
• if you have had benign uterine tumors (fibroids);
• if you have breast disease (mastopathy);
• if you had a pustular rash (impetigo herpetiformis) during a previous pregnancy;
• if you have depression (see also section "When not to use Madinette");
• if you have chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis). You should tell your doctor if any of the above diseases have occurred in the past, are present, or occur during the use of Madinette.

Efficacy
The contraceptive effect may be affected if the contraceptive is not taken regularly or if vomiting or diarrhea occurs after taking the medicine (see section "What to do if you vomit or have diarrhea while using Madinette"), or if you are taking certain medicines at the same time (see section "Madinette and other medicines"). In very rare cases, metabolic disorders may adversely affect the contraceptive protection.
Even if hormonal contraceptives are taken correctly, it cannot be guaranteed that you will be fully protected against pregnancy.
Irregular bleeding
Especially during the first months of using hormonal contraceptives, irregular vaginal bleeding (intermenstrual bleeding/spotting) may occur. You should consult your doctor if irregular bleeding persists after 3 months of using the tablets or if it occurs after previously regular menstrual cycles.
Spotting may also indicate reduced contraceptive effectiveness.
In some patients, withdrawal bleeding may not occur after 21 days of using Madinette. If Madinette has been taken according to the instructions in section 3 below, pregnancy is unlikely. If Madinette was not taken according to the instructions before the first missed withdrawal bleeding, you should ensure that you are not pregnant before continuing to use the medicine.

Children and adolescents

Madinette is indicated only after the onset of menstruation. The safety and efficacy of Madinette in adolescents under 16 years of age have not been established.

Elderly people

The use of Madinette is not indicated after menopause.

Madinette and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should not use Madinette if you have hepatitis C and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these medicines may cause elevated liver function test results (increased liver enzyme activity).
Your doctor will recommend a different contraceptive method before starting these medicines.
The use of Madinette can be resumed 2 weeks after the end of treatment. See section "When not to use Madinette".
Certain medicines may affect the level of Madinette in your blood and cause reducedcontraceptive effectivenessor unexpected bleeding. These include:

• medicines used to treat:
• epilepsy (such as barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, barbexaclone, primidone),
• tuberculosis (e.g., rifampicin, rifabutin),
• sleep disorders (modafinil),
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• herbal products containing St. John's Wort (Hypericum perforatum). If you want to use herbal products containing St. John's Wort while taking Madinette, you should consult your doctor first.

Medicines that stimulate bowel movements (such as metoclopramide) and activated charcoal may change the absorption of the active substances of Madinette and reduce their effect.
During treatment with these medicines, you should use an additional, barrier method of contraception (e.g., a condom). Additional barrier methods of contraception should be used during the entire time of concurrent drug therapy and for 28 days after the end of treatment. If concurrent drug therapy lasts longer than the tablets in the current pack of the combined hormonal contraceptive, you should start the next pack of the combined hormonal contraceptive without the usual break in tablet-taking. If concurrent drug therapy is required for a long time, you should use non-hormonal contraceptive methods. You should consult your doctor or pharmacist.
Interactions between Madinette and other medicines may increase or enhance the side effects of Madinette. The following medicines may adversely affect the tolerance of Madinette:

• ascorbic acid (a preservative, also known as vitamin C),
• paracetamol (a pain reliever and antipyretic),
• atorvastatin (a medicine to lower high cholesterol),
• troleandomycin (an antibiotic),
• imidazole antifungal medicines - e.g., fluconazole (used to treat fungal infections),
• indinavir (a medicine used to treat HIV infection).

Madinette may affect the action of other medicines. The efficacy or tolerance of the following medicines may be reduced by the use of Madinette:

• certain benzodiazepines, e.g., diazepam (used to treat sleep disorders),
• cyclosporin (an immunosuppressant),
• theophylline (used to treat asthma symptoms),
• corticosteroids, e.g., prednisolone (known as steroids, anti-inflammatory medicines used to treat e.g., lupus, arthritis, psoriasis),
• lamotrigine (used to treat epilepsy),
• clofibrate (used to lower high cholesterol),
• paracetamol (a pain reliever and antipyretic),
• morphine (a specific strong pain reliever),
• lorazepam (used to treat anxiety disorders).

You should also read the information leaflets of other medicines prescribed by your doctor.
You should inform your doctor if you are taking insulin or other medicines to lower your blood sugar levels. It may be necessary to change the dosage of these medicines.
It is essential to remember that the above information also applies if one of these medicines was taken shortly before starting to use Madinette.
The use of Madinette may affect the results of certain liver, kidney, adrenal, and thyroid function tests, as well as certain blood proteins, carbohydrate metabolism parameters, and blood clotting parameters. Changes usually remain within the normal laboratory range. Before performing tests, you should tell your doctor that you are taking Madinette.

Pregnancy, breastfeeding, and fertility

The use of Madinette is contraindicated during pregnancy. If you become pregnant while using Madinette, you should stop taking it immediately. However, previous use of Madinette is not a reason to terminate the pregnancy.
It should be remembered that during the use of Madinette while breastfeeding, milk production may be reduced, and the composition of milk may be changed. Very small amounts of the active substances pass into the milk. Hormonal contraceptives like Madinette can only be used after weaning.

Driving and using machines

The effect of combined hormonal contraceptives on the ability to drive and use machines is not known.

Madinette contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Madinette.

3. How to use Madinette

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Method of administration

For oral use.

4. Possible side effects

Like all medicines, Madinette can cause side effects, although not everybody gets them.
If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Madinette, a doctor should be consulted.
A doctor should be contacted immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing (see also point 2 "Warnings and precautions").
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, point 2 "Important information before using Madinette" should be consulted.
The frequency of side effects is defined as follows:
Very common (may affect more than 1 in 10 patients):
Nausea, vaginal discharge, painful menstruation, absence of menstruation, headaches, unusual feeling in the breast.
Common (may affect up to 1 in 10 patients):
Depression, nervousness, irritability, dizziness, migraine (and/or migraine exacerbation), vision disturbances, vomiting, acne, feeling of heaviness in the legs, abdominal pain, fatigue, water retention, weight gain, increased blood pressure.
Uncommon (may affect up to 1 in 100 patients):
Vaginal fungal infection, benign breast tissue changes, hypersensitivity to the drug, including skin allergic reactions, changes in blood lipid levels, including increased triglycerides, decreased libido, abdominal pain, bloating, diarrhea, pigmentation changes, brown spots on the skin, hair loss, dry skin, excessive sweating, back pain, muscle discomfort, breast discharge.
Rare (may affect up to 1 in 1,000 patients):
Vaginitis, increased appetite, conjunctivitis, discomfort after wearing contact lenses, sudden hearing loss, tinnitus, high blood pressure, low blood pressure, circulatory collapse, varicose veins, hives, rash, skin inflammation, itching, exacerbation of psoriasis, excessive hair growth on the body or face, breast enlargement, prolonged and/or heavy menstrual bleeding, premenstrual syndrome (physical and emotional disturbances before the start of menstrual bleeding).
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)
• heart attack
• stroke
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack
• blood clots in the liver, stomach/intestine, kidneys, or eye. The risk of developing blood clots may be higher if the patient has any other risk factors (see point 2 for more information on risk factors for blood clots and symptoms of blood clots).

Very rare (may affect up to 1 in 10,000 patients):
Erythema nodosum (red nodules on the skin).
Additionally, after the marketing of the drug, the following side effects have been reported in relation to the active substances, ethinylestradiol and chlormadinone acetate: weakness and allergic reactions, including skin reactions. Furthermore, the use of combined hormonal contraceptives has been associated with an increased risk of serious diseases and side effects:

• venous or arterial thrombosis (see point 2);
• the risk of bile duct diseases (see point 2);
• the risk of tumors (such as liver tumors, which in individual cases can cause life-threatening bleeding into the abdominal cavity, cervical cancer, and breast cancer);
• exacerbation of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis, see point 2).

Point 2 should be read carefully, and if necessary, a doctor should be consulted for advice.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, a doctor or pharmacist should be informed. 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the drug.

5. How to store Madinette

The drug should be stored out of sight and reach of children.
There are no special precautions for storing the drug.
The drug should not be used after the expiration date stated on the blister (package intended for a given cycle) and the cardboard box after the term "Expiration date" or "EXP".
The expiration date indicates the last day of the given month.
Drugs should not be disposed of in the sewage system or household waste containers. A pharmacist should be asked how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Madinette contains

• The active substances of Madinette are ethinylestradiol and chlormadinone acetate. Each film-coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of chlormadinone acetate.
• Other ingredients of the drug are: Tablet core: lactose monohydrate, corn starch, maltodextrin, magnesium stearate; Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), iron oxide yellow (E 172)

What Madinette looks like and what the package contains

Madinette is available in the form of round, pink film-coated tablets.
Madinette is available in packages containing:
1 blister containing 21 film-coated tablets (package intended for a cycle)
3 blisters, each containing 21 film-coated tablets
6 blisters, each containing 21 film-coated tablets
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o., ul. Dolna 21, 05-092 Łomianki, tel. +48 22 350 66 69

Manufacturer

mibe GmbH Arzneimittel, Münchener Str. 15, 06796 Brehna, Germany
SUN-FARM Sp. z o.o., ul. Dolna 21, 05-092 Łomianki

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:08.2024