Madinette

Package leaflet: Information for the user

Madinette
0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Chlormadinoni acetas
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or longer.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Madinette is and what it is used for
2. Important information before taking Madinette
3. How to take Madinette
4. Possible side effects
5. How to store Madinette
6. Contents of the pack and other information

1. What Madinette is and what it is used for

Madinette is a hormonal contraceptive medicine taken orally. A hormonal contraceptive containing two hormones, such as Madinette, is also known as a combined hormonal contraceptive. Since each of the 21 coated tablets in a pack intended for use over one cycle contains the same amount of both hormones, Madinette is also referred to as 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 take Madinette, you should read the information about blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Before starting treatment with Madinette, your doctor will perform a thorough general and gynaecological examination, confirm that you are not pregnant, and decide, taking into account contraindications and precautions, whether you can take Madinette. While using Madinette, such examinations should be repeated annually.

When not to use Madinette
Do not use Madinette if any of the following conditions apply to you. If any of the conditions listed below apply, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• 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) blood clots in the veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
• if you have early or warning symptoms of blood clots, phlebitis, or embolism, such as transient stabbing pain, chest pain, or a feeling of pressure in the chest;
• if you know you have disorders affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have diabetes and your blood sugar levels are uncontrolled;
• if you have high blood pressure that is difficult to control, or if your blood pressure rises significantly (persistent values above 140/90 mm Hg);
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots: severe diabetes with vascular damage; very high blood pressure; very high levels of blood lipids (cholesterol or triglycerides); a condition called hyperhomocysteinemia;
• if you currently have (or have had in the past) a type of migraine called "migraine with aura";
• if you have hepatitis (e.g. viral) or jaundice and liver function test results have not returned to normal;
• if you have generalized itching or bile flow disorders, particularly if such disorders occurred during a previous pregnancy or during oestrogen treatment;
• if you have elevated bilirubin levels (a breakdown product of blood pigment) in the blood, e.g. due to inherited excretion disorders (Dubin-Johnson syndrome or Rotor syndrome);
• if you currently have meningioma or have ever been diagnosed with meningioma (usually a benign tumour of the tissue layer between the brain and skull);
• if you currently have or have had liver cancer in the past;
• if you have severe abdominal pain, liver enlargement, or symptoms of intra-abdominal bleeding;
• if you experience a first attack of porphyria (a disorder of blood pigment metabolism) or recurrent porphyria attacks;
• if you currently have or have had hormone-dependent malignant tumours, such as breast or uterine cancer, or if such tumours are suspected;
• if you have severe lipid metabolism disorders;
• if you currently have or have had pancreatitis with high blood fat levels (triglycerides);
• if headaches are unusually frequent, persistent, or severe;
• if you experience sudden sensory disturbances (visual or hearing disturbances);
• if you experience movement disorders (especially paralysis);
• if your epileptic seizures have worsened;
• if you have severe depression;
• if you have a certain type of hearing loss (otosclerosis) that worsened during a previous pregnancy;
• if you have no menstrual bleeding for unknown reasons;
• if you have been diagnosed with abnormal endometrial hyperplasia (overgrowth of the uterine lining);
• if you have vaginal bleeding of unknown cause;
• 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 with other medicines").

If any of the above conditions occur while taking Madinette, you must stop taking the medicine immediately.
Do not take Madinette or stop taking it immediately if you develop one serious risk factor or several risk factors for blood clotting disorders (see section "Warnings and precautions").

Warnings and precautions
Before starting to take Madinette, discuss this with your doctor or pharmacist.

When should you contact your doctor?
Seek medical advice immediately if:

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

Tell your doctor if you have any of the following conditions:

• If you smoke. Smoking while using hormonal contraceptives increases the risk of serious cardiovascular side effects. This risk increases with age and the number of cigarettes smoked. This particularly affects women over 35 years of age. Women over 35 who smoke should use alternative methods of contraception.

If any of these symptoms appear or worsen during treatment with Madinette, inform your doctor:

• seek immediate medical advice if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria potentially with breathing difficulties. Medicines containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you have high blood pressure, abnormal increases in blood lipid levels, overweight, or diabetes (see also section 2 "When not to use Madinette", "Other diseases"). In such cases, the risk of serious adverse effects (such as myocardial infarction, embolism, stroke, or liver tumour) during 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 affecting the body's natural defence system);
• if you have haemolytic-uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high blood fat levels (hypertriglyceridaemia) or have a positive family history for this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are then at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Madinette after delivery;
• if you have phlebitis of superficial veins (superficial thrombophlebitis);
• if you have varicose veins.

BLOOD CLOTS
Using combined hormonal contraceptives such as Madinette is associated with an increased risk of blood clots compared to not using such treatment. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur
in veins (referred to as "venous thrombosis" or "venous thromboembolic disease"),
or in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic disorders").
Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using Madinette is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.

Are you experiencing any of these symptoms? Likely reason

• Swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by:
• Pain or tenderness in the leg, which may occur only when standing or walking,
• Increased warmth in the affected leg,
• Change in skin colour of the leg, e.g. pallor, redness, or blueness.
• Sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
• Sudden cough without obvious cause, possibly with coughing up blood;
• Sharp chest pain, which may worsen on deep breathing;
• Severe dizziness or lightheadedness;
• Rapid or irregular heartbeat;
• Severe stomach pain.

If you are unsure, you should consult your doctor.

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis), although these adverse effects are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or longer.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a patient stops taking Madinette, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Madinette is low.
In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
Among 10,000 women using combined hormonal contraceptives containing chlormadinone, such as Madinette, approximately 6 to 9 women will develop blood clots within one year.
The risk of developing blood clots depends on the individual's medical history (see "Factors that increase the risk of developing blood clots in veins" below).

You should contact your doctor as soon as possible if, while taking Madinette,
the patient experiences more frequent or more severe migraine attacks (which may indicate
cerebral circulation disorders). The doctor may recommend immediate discontinuation of Madinette.
Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Madinette is small, however
some factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the patient may have inherited coagulation disorders;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Madinette several weeks before surgery or immobilization. If the patient must stop taking Madinette, ask the doctor when it is safe to resume treatment.
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the last few weeks).

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 the patient has another listed risk factor.
It is important to inform the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to discontinue Madinette.
Inform the doctor if any of the above conditions change during Madinette treatment, e.g., if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.
ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
Similar to venous blood clots, arterial clots can cause serious
consequences, such as heart attack or stroke.
Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with Madinette
is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Madinette, smoking cessation is recommended. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under
  50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high blood fat levels (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes. If the patient has more than one of the above conditions or any of them is particularly severe, the risk of blood clots may be further increased. Inform the doctor if any of the above conditions change during Madinette treatment, e.g., the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or the patient gains significant weight.

Tumors
Several clinical studies have shown an increased risk of cervical cancer in women infected
with a sexually transmitted virus (HPV, human papillomavirus) who have long-term
used hormonal contraceptives. However, it has not been clarified what influence
other additional factors have on these results (e.g., different numbers of sexual partners and use of barrier contraceptive methods).
Clinical studies have shown a slightly increased risk of breast cancer in women using
combined hormonal contraceptives. This increased risk decreases within 10 years after
discontinuation of combined hormonal contraceptives to the baseline risk related to age. Since breast cancer is rare in women under 40 years of age,
the increase in diagnosed cases in women currently or recently
using hormonal contraceptives is small relative to the overall risk of
developing breast cancer.
In rare cases, hormonal contraceptives have led to
the development of benign, or even more rarely, malignant, liver tumors. These may
cause dangerous internal bleeding. If the patient experiences severe, persistent
abdominal pain, contact the doctor.
The use of chlormadinone acetate has been associated with the development of usually benign tumors of the tissue layer between the brain and skull (meningioma). This risk increases especially with
high doses and prolonged use (several months or years). If a meningioma is
diagnosed in the patient, the doctor will discontinue Madinette treatment (see section “When not to use Madinette”). If the patient notices any symptoms such as vision changes (e.g.,
double or blurred vision), hearing loss or ringing in the ears, loss of smell, headache
that worsens over time, memory loss, seizures, or weakness in arms or legs,
inform the doctor immediately.
Other diseases
Psychiatric 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, contact the
doctor as soon as possible for further medical advice.
Many women using hormonal contraceptives experience a slight increase
in blood pressure. If significant blood pressure increase occurs during Madinette use,
the doctor will recommend discontinuing Madinette and prescribe medication to lower blood pressure. Madinette may be restarted once blood pressure returns to normal.
Women who previously experienced chloasma during pregnancy may have a recurrence while using hormonal contraceptives.
If the patient has a certain blood fat disorder (hypertriglyceridemia) or such a disorder occurred in family members, there is an increased risk of pancreatitis.
If the patient has acute or chronic liver function disorders, the doctor may recommend
discontinuing Madinette until liver function parameters return to
normal values. If the patient previously had jaundice during pregnancy or while using hormonal contraceptives and it recurs, Madinette should be discontinued.
If the patient with diabetes using Madinette has well-controlled blood glucose levels, the doctor will carefully monitor the patient during Madinette treatment. Adjustment of antidiabetic treatment may be necessary.
Brown skin patches (chloasma) may occur not infrequently, especially if such changes occurred during previous pregnancies. If the patient knows she is prone to chloasma, she should avoid direct exposure to sunlight or ultraviolet radiation (e.g., tanning beds) while using Madinette.
Negative impact on other disorders
Special medical supervision is also required:

• if the patient has epilepsy;
• if the patient has multiple sclerosis;
• if the patient has very severe muscle cramps (tetany);
• if the patient has migraine (see also section “When not to use Madinette”);
• if the patient has bronchial asthma;
• if the patient has impaired heart or kidney function (see also section 2 “When not to use Madinette”);
• if the patient has Huntington's chorea (St. Vitus' dance);
• if the patient has diabetes (see also section “When not to use Madinette” and “Other diseases”);
• if the patient has liver disease (see also section “When not to use Madinette”);
• if the patient has fat metabolism disorders (see also section “When not to use Madinette”);
• if the patient has immune system disorders (including systemic lupus erythematosus);
• if the patient has significant overweight;
• if the patient has hypertension (see also section “When not to use Madinette”);
• if the patient has endometriosis (when endometrial tissue occurs outside the uterine cavity) (see also section “When not to use Madinette”);
• if the patient has varicose veins or phlebitis (see also section “When not to use Madinette”);
• if the patient has blood coagulation disorders (see also section “When not to use Madinette”);
• if the patient previously had benign uterine tumors (fibroids);
• if the patient has breast disease (mastopathy);
• if the patient previously had bullous eruptions (chloasma gravidarum) during pregnancy;
• if the patient has depression (see also section “When not to use Madinette”);
• if the patient has chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis). Inform the doctor if any of the above diseases occurred in the past, currently, or during Madinette treatment.

Effectiveness
Contraceptive effectiveness may be altered if the contraceptive is not taken
regularly or if vomiting or diarrhea occurs after taking the tablet (see section “What to do in case of vomiting or diarrhea during Madinette use”), or if the patient is simultaneously using certain medications (see section “Madinette and other medicines”). In very
rare cases, metabolic disorders may negatively affect contraceptive effectiveness.
Even if hormonal contraceptives are taken correctly, full protection against pregnancy cannot be
guaranteed.
Irregular bleeding
Especially during the first months of using hormonal contraceptives, irregular vaginal bleeding (intermenstrual bleeding/spotting) may occur. Consult a doctor if irregular bleeding persists after 3 months of tablet use or if it occurs after previously regular menstrual cycles.
Spotting may also indicate reduced contraceptive effectiveness.
Some patients may not experience withdrawal bleeding after 21 days of Madinette use. If Madinette was taken according to the instructions in section 3
below, pregnancy is unlikely. If Madinette was not taken according to
instructions before the first missed withdrawal bleed, confirm that the patient
is not pregnant before continuing treatment.
Children and adolescents
Madinette is indicated only after the onset of menstruation. The safety and effectiveness of Madinette have not been established in adolescents under 16 years of age.
Elderly patients
Madinette is not indicated after menopause.
Madinette and other medicines
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines the patient plans to use.
Do not use Madinette if the patient has hepatitis C and is 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 AlAT activity).
The doctor will recommend another type of contraception before starting these medicines.
Madinette may be restarted approximately 2 weeks after completing
treatment. See section “When not to use Madinette”.
Some medicines may affect the blood concentration of Madinette and cause reduced
effectiveness in preventing pregnancy or cause 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 (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
  • fungal infections (griseofulvin),
  • high blood pressure in pulmonary blood vessels (bosentan),
• herbal products containing St. John's wort (Hypericum perforatum). If the patient wishes to use herbal products containing St. John's wort while taking Madinette, she should first consult her doctor.

Medicines stimulating intestinal motility (such as metoclopramide) and activated charcoal may alter the absorption of Madinette's active substances and weaken their effect.
During treatment with these medicines, use an additional barrier contraceptive method (e.g.,
condom). Additional barrier methods should be used throughout the duration of
concomitant therapy and for 28 days after stopping treatment. If concomitant therapy
lasts longer than the duration of tablets in the current pack of combined hormonal contraceptive, start the next pack of combined hormonal contraceptive without the usual break between packs.
If long-term treatment with the above-mentioned medicines is necessary, use non-hormonal contraceptive methods. Consult your doctor or pharmacist.
Interactions between Madinette and other medicines may increase or intensify adverse effects of Madinette. The following medicines may negatively affect Madinette's tolerability:

• ascorbic acid (a preservative, also known as vitamin C),
• paracetamol (painkiller and fever reducer),
• atorvastatin (cholesterol-lowering medicine),
• troleandomycin (antibiotic),
• imidazole antifungals - e.g., fluconazole (used to treat fungal infections),
• indinavir (medicine used to treat HIV infection).

Madinette may affect the action of other medicines. The effectiveness or tolerability of the following
medicines may be reduced due to Madinette use:

• certain benzodiazepines, e.g., diazepam (used to treat sleep disorders),
• cyclosporine (suppresses immune system function),
• 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 levels),
• paracetamol (painkiller and fever reducer),
• morphine (specific strong painkiller),
• lorazepam (used to treat anxiety disorders).

Also refer to the package leaflets of other prescribed medicines.
Inform the doctor if the patient is using insulin or other blood glucose-lowering medicines. Dose adjustment of these medicines may be necessary.
Remember that the above information also applies if one of these medicines was
used shortly before starting Madinette.
Madinette use may affect the results of certain liver, kidney, adrenal, and thyroid function tests, certain blood proteins, carbohydrate metabolism parameters, and blood coagulation parameters. Changes usually remain within normal laboratory ranges. Inform the doctor about Madinette use before undergoing tests.
Pregnancy, breastfeeding and effect on fertility
Madinette use is contraindicated during pregnancy. If the patient becomes pregnant
while taking Madinette, she must immediately discontinue use. However,
prior use of Madinette does not justify terminating the pregnancy.
Note that while using Madinette during breastfeeding, milk production
may be reduced and milk composition may be altered. Very small amounts of active
substances pass into breast milk. Hormonal contraceptives such as Madinette
may only be used after discontinuation of breastfeeding.
Driving and operating machinery
The effect of combined hormonal contraceptives on the ability to
drive and operate machinery is unknown.
Madinette contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult the doctor before taking the medicine.

3. How to take Madinette

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Method of administration
For oral use.
How and when to take Madinette
From the pack intended for one cycle, press out the first tablet from the compartment marked with
the appropriate day of the week (e.g. "Sat" for Saturday), and swallow it whole without chewing.
Then take one tablet daily, following the direction of the arrow, preferably at the same time each
day, ideally in the evening. The interval between two tablets should always be 24 hours, if possible.
The day-of-the-week markings on the pack will help the patient check whether the tablet for that
day has already been taken.
Take one tablet daily for 21 consecutive days. Then take a 7-day break from tablets. Withdrawal
bleeding, similar to menstruation, usually occurs 2 to 4 days after taking the last tablet. Start the
next pack of Madinette after the 7-day break, regardless of whether bleeding has stopped or is still
ongoing.
When to start taking Madinette
If the patient has not previously used hormonal contraceptives (during the previous menstrual cycle)
Take the first tablet of Madinette on the first day of menstrual bleeding.
Contraceptive protection begins on the first day of tablet intake and continues throughout the 7-day
tablet-free interval.
If menstrual bleeding has already started, take the first tablet between day 2 and day 5 of the cycle,
regardless of whether bleeding has ended or is still ongoing. However, in this case, use an additional
barrier method of contraception (e.g. condom) for the first 7 days of tablet intake (the 7-day rule).
If more than 5 days have passed since the start of menstrual bleeding, wait until the next menstrual
bleeding occurs before starting Madinette.
If the patient has previously used another combined hormonal contraceptive
Take all tablets from the current pack of the previously used contraceptive. Take the first tablet of
Madinette the day after the usual tablet-free interval or the day after taking the last placebo tablet
of the previously used combined hormonal contraceptive.
If the patient has previously used a progestogen-only hormonal contraceptive (progestogen-only pill, POP)
If the patient has previously used a progestogen-only hormonal contraceptive, withdrawal bleeding
similar to menstruation may not occur. Take the first tablet of Madinette the day after taking the last
progestogen-only tablet. Use an additional barrier method of contraception for the first 7 days of
tablet intake.
If the patient has previously used hormonal contraception in the form of injections or an implant
Start taking Madinette on the day of implant removal or on the day the next injection was due. In this
case, use an additional barrier method of contraception for the first 7 days of tablet intake.
After miscarriage or abortion during the first three months of pregnancy
Madinette may be started immediately after miscarriage or abortion. In this case, no additional
barrier method of contraception is required.
After childbirth or miscarriage from the 3rd to the 6th month of pregnancy
Women who are not breastfeeding may start taking Madinette between day 21 and day 28 after
childbirth. No additional method of contraception is required.
However, if more than 28 days have passed since childbirth, use an additional barrier method of
contraception for the first 7 days of tablet intake.
If sexual intercourse has already occurred, before starting Madinette, ensure the patient is not
pregnant or wait until the next menstrual period before starting tablets.
Note that breastfeeding women should not take Madinette (see section 2. "Pregnancy, breastfeeding
and fertility").
How long to take Madinette
Madinette may be taken for as long as the patient wishes to use hormonal contraception and as
long as there are no health-related restrictions (see section "When not to take Madinette" and
"Warnings and precautions"). After stopping Madinette, the next menstrual bleeding may be
delayed by about one week.
What to do if vomiting or diarrhoea occurs while taking Madinette
If vomiting or diarrhoea occurs within 4 hours of taking a tablet, the active substances in Madinette
may not be completely absorbed. This situation is similar to missing a tablet. Take a new tablet from
the next blister as soon as possible, within 12 hours of taking the last tablet, if possible, and continue
taking Madinette at the usual time. If this is not possible or more than 12 hours have passed, follow
the advice given in the section "Missed dose of Madinette" or contact your doctor.
Overdose of Madinette
There are no reports of serious symptoms following ingestion of a large number of tablets in a single
dose. Symptoms may include nausea, vomiting, and, particularly in young girls, slight vaginal bleeding.
In such cases, consult a doctor. If necessary, the doctor may monitor electrolyte and fluid balance and
liver function.
Missed dose of Madinette

• If the patient forgets to take a tablet at the usual time, she should take it within the next 12 hours. In this case, no additional contraceptive method is required, and tablet intake may continue at the usual time.
• If the delay is more than 12 hours, the contraceptive effectiveness of Madinette may be reduced. In this case, take the missed tablet as soon as possible and continue taking Madinette at the usual time. This may mean taking two tablets on the same day. However, in this case, use an additional barrier method of contraception (e.g. condom) for the next 7 days. If the current pack is finished during these 7 days, start immediately with the tablets from the next pack of Madinette—this means no break between packs (the 7-day rule). Withdrawal bleeding will probably not occur until after the second pack is completed. However, breakthrough bleeding or spotting may occur during the days when tablets from the new pack are taken.

The more tablets missed or taken late, the greater the risk of reduced protection against pregnancy.
If the patient missed one or more tablets in the first week and had sexual intercourse in the week
before the missed tablets, consider the possibility of pregnancy. This also applies if the patient
forgot to take one or more tablets and no bleeding occurred during the subsequent tablet-free
interval. In such cases, consult a doctor.
Delaying the onset of menstrual bleeding
Although not recommended, it is possible to delay the onset of menstrual bleeding (withdrawal
bleeding) by immediately starting a new blister of Madinette without taking the usual tablet-free
break, continuing until the end of the second blister. Breakthrough bleeding or spotting may occur
during intake of the second blister. Then, after the usual 7-day break, continue taking tablets from the
next pack.
If the patient plans to delay menstrual bleeding, she should consult her doctor for advice.
Changing the day when menstrual bleeding starts
If the patient takes the tablets as directed, menstrual/withdrawal bleeding will occur during the
tablet-free week. If the patient wishes to change the day of bleeding, she may shorten the tablet-free
interval (but never extend it!). For example, if the tablet-free interval usually starts on Friday and the
patient wishes to change it to Tuesday (three days earlier), she should start the new blister three days
earlier than usual. If the tablet-free interval is very short (e.g. 3 days or less), bleeding may not occur.
Spotting or breakthrough bleeding may then occur.
If the patient has any doubts about how to proceed, she should consult her doctor for advice.
Stopping Madinette
After stopping Madinette, ovarian function quickly resumes and the patient may become pregnant.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in every woman.
If any adverse effects occur, especially severe and persistent ones, or changes in health status which the woman considers related to the use of Madinette, she should consult her doctor.
The woman should contact her doctor immediately if she experiences any of the following symptoms of angioedema: swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or hives possibly causing breathing difficulties (see also section 2 "Warnings and precautions").
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before using Madinette".
The frequency of adverse effects is defined as follows:
Very common (may affect more than 1 in 10 women):
Nausea, vaginal discharge, painful menstruation, absence of menstruation, headache, unusual breast discomfort.
Common (may affect up to 1 in 10 women):
Depression, nervousness, irritability, dizziness, migraine (and/or worsening of migraine), visual disturbances, vomiting, acne, feeling of heaviness in the legs, abdominal pain, fatigue, fluid retention in the body, weight gain, increased blood pressure.
Uncommon (may affect up to 1 in 100 women):
Vaginal fungal infection, benign changes in breast connective tissue, hypersensitivity to the medicine, including skin allergic reactions, changes in blood lipid levels, including increased triglyceride levels, decreased libido, abdominal pain, bloating, diarrhoea, pigmentary disturbances, brown spots on the skin, hair loss, dry skin, excessive sweating, back pain, muscle complaints, breast discharge.
Rare (may affect up to 1 in 1000 women):
Vaginitis, increased appetite, conjunctivitis, discomfort when wearing contact lenses, sudden deafness, tinnitus, high blood pressure, low blood pressure, circulatory collapse, varicose veins, urticaria, rash, dermatitis, itching, exacerbation of psoriasis, excessive body or facial hair growth, breast enlargement, prolonged and (or) heavy menstrual bleeding, premenstrual tension syndrome (physical and emotional disturbances before the onset 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 transient ischaemic attack
• blood clots in the liver, stomach/intestine, kidneys or eye. The likelihood of developing blood clots may be higher if the woman has any other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).

Very rare (may affect up to 1 in 10,000 women):
Erythema nodosum (red nodules on the skin).
Additionally, the following adverse effects have been reported after the medicine was placed on the market and are associated with the active substances, ethinylestradiol and chlormadinone acetate: weakness and allergic reactions, including swelling of deeper skin layers (angioedema).
Furthermore, the use of combined hormonal contraceptives has been associated with an increased risk of serious diseases and adverse effects:

• venous or arterial thrombosis (see section 2);
• risk of disorders of the biliary system (see section 2);
• risk of tumours (such as liver tumours, which in isolated cases may cause life-threatening intra-abdominal bleeding, cervical cancer and breast cancer);
• exacerbation of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis, see section 2).

Please read carefully the information provided in section 2 and, if necessary, consult your doctor for advice.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Madinette

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the blister pack (the packaging intended for a given cycle) and the cardboard box, following the words "Expiry date" or "EXP".
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Madinette contains

• The active substances in this medicine are ethinylestradiol and chloromadinone acetate. Each coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of chloromadinone acetate.
• Other ingredients are:
  Tablet core: monohydrate lactose, maize starch, maltodextrin, magnesium stearate
  Tablet coating: hypromellose, titanium dioxide (E 171), polyethylene glycol 400, iron oxide red (E 172), iron oxide yellow (E 172)

What Madinette looks like and contents of the pack
Madinette is a round, pink, coated tablet.
Madinette is available in packs containing:
1 blister with 21 coated tablets (pack intended for one cycle)
3 blisters, each containing 21 coated tablets
6 blisters, each containing 21 coated tablets
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, 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 authorised in the European Economic Area countries under the following names: