Axia forte

Axia Forte, 0.03 mg + 3 mg, coated tablets
Ethinylestradiolum + Drospirenonum
Please read the entire leaflet carefully before taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If any of the side effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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 blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

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

1. WHAT AXIA FORTE IS AND WHAT IT IS USED FOR

Axia Forte is a contraceptive medicine used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones: drospirenone and ethinylestradiol.
Contraceptive tablets containing two hormones are called "combined" tablets.

2. IMPORTANT INFORMATION BEFORE TAKING AXIA FORTE

General remarks

Before starting Axia Forte, please read the information about blood clots (thrombosis) in section 2. It is especially important to be aware of the symptoms of blood clots (see section 2: "Blood clots").
Before starting Axia Forte, your doctor will ask you several questions about your health and that of your close relatives. The doctor will also measure your blood pressure and may perform other tests as appropriate.
This leaflet describes situations in which you should stop taking Axia Forte or when its effectiveness may be reduced. In such cases, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not rely on cycle monitoring or temperature methods. These methods may be ineffective because Axia Forte alters the monthly cycle of body temperature changes and cervical mucus secretion.

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

When not to take Axia Forte:

Do not take Axia Forte if you have any of the conditions listed below. If any of these apply to you, inform your doctor. Your doctor will discuss with you which alternative contraceptive method may be more suitable:

• If you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling;
• If you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• If you know you have a blood clotting disorder — for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies;
• If you require surgery or will be immobile for a long time (see section "Blood clots");
• If you have ever had a heart attack or stroke;
• If you have (or have previously had) 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 blood vessel damage,
  • Very high blood pressure,
  • Very high levels of fats in the blood (cholesterol or triglycerides),
  • A condition called hyperhomocysteinemia;
• If you currently have (or have previously had) a type of migraine called "migraine with aura";
• If you have (or have previously had) liver disease and liver function is still abnormal;
• If you have kidney function disorders (kidney failure);
• If you currently have (or have previously had) a liver tumour;
• If you currently have (or have previously had) or are suspected of having breast cancer or cancer of the reproductive organs;
• If you have unexplained vaginal bleeding.

Do not take Axia Forte if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (also see section "Axia Forte and other medicines").

Additional information for special populations

Children and adolescents
Axia Forte is not intended for use in girls before the onset of menstruation.

Elderly patients
Axia Forte is not intended for use after menopause.

Patients with liver function disorders
Do not take Axia Forte if you have liver disease. See also sections "When not to take Axia Forte" and "Warnings and precautions".

Patients with kidney function disorders
Do not take Axia Forte if you have kidney failure or acute kidney failure. See also sections "When not to take Axia Forte" and "Warnings and precautions".

Warnings and precautions

When should you contact your doctor?

Seek immediate medical advice if:

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

In certain situations, special caution is required when using Axia Forte or other combined hormonal contraceptives. Your doctor may then require you to undergo regular check-ups.

Tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Axia Forte, inform your doctor:

• If there is a family history of breast cancer;
• If you suffer from liver or gallbladder disease;
• If you have diabetes;
• If you suffer from depression;
• 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 leading to kidney failure);
• If you have sickle cell anaemia (a hereditary disorder of red blood cells);
• If you have high levels of fats in the blood (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of pancreatitis;
• If you require surgery or will be immobile for a long time (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 after delivery you can start taking Axia Forte;
• If you have superficial thrombophlebitis (inflammation of veins under the skin);
• If you have varicose veins;
• If you have epilepsy (see section "Axia Forte and other medicines");
• If you have a condition that first occurred during pregnancy or during previous use of sex hormones (e.g., hearing loss, porphyria, pregnancy-related blistering skin rash (prurigo of pregnancy), Sydenham’s chorea — a nervous system disorder causing sudden body movements);
• If you have melasma (skin pigmentation, especially on the face or neck, known as "chloasma"). In such cases, avoid direct exposure to sunlight and ultraviolet radiation;
• If you experience symptoms such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with breathing difficulties — seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using combined hormonal contraceptives, such as Axia Forte, is associated with an increased risk of blood clots compared to not using such therapy. 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"),
• In arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

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.

It should be remembered that the overall risk of harmful blood clots caused by taking Axia Forte is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attention if you notice any of the following symptoms.

| Symptoms | Possible condition | |--------------|------------------------| | Swelling in the leg or along a vein in the leg or foot, especially if accompanied by:
• Pain or tenderness in the leg, felt only when standing or walking,
• Increased warmth in the affected leg,
• Skin discoloration of the leg (e.g., paleness, redness, blueness) | Deep vein thrombosis | | Sudden unexplained shortness of breath or rapid breathing; | | | Sudden cough without apparent cause, possibly with coughing up blood; | | | Sharp chest pain, which may worsen on deep breathing; | | | Severe dizziness or lightheadedness; | Pulmonary embolism | | Rapid or irregular heartbeat; | | | Severe stomach pain. | | | Note: If unsure, consult a doctor, as some of these symptoms (e.g., cough, breathlessness) may be mistaken for milder conditions such as respiratory infections (e.g., cold). | | Sudden loss of vision or painless visual disturbance in one eye, possibly leading to vision loss | Retinal vein thrombosis (blood clot in the eye) | | Chest pain, discomfort, pressure, or heaviness; | | | Sensation of squeezing or fullness in the chest, arm, or epigastric region; | | | Feeling of fullness, indigestion-like symptoms, or choking sensation; | Myocardial infarction (heart attack) | | Discomfort in the upper body radiating to the back, jaw, throat, arm, or stomach; | | | Sweating, nausea, vomiting, or dizziness; | | | Extreme weakness, anxiety, or breathlessness; | | | Rapid or irregular heartbeat. | | | Sudden weakness or numbness of facial muscles, arm, or leg, especially on one side of the body; | | | Sudden confusion, difficulty speaking or understanding speech; | | | Sudden visual disturbances in one or both eyes; | | | Sudden difficulty walking, dizziness, loss of balance or coordination; | | | Sudden, severe, or prolonged headache without known cause; | Stroke | | Loss of consciousness or fainting, with or without seizures. | | | Note: In some cases, stroke symptoms may be transient with almost immediate and complete recovery, but immediate medical attention is required as you may be at risk of a further stroke. | | Swelling and slightly blue discoloration of the skin in legs or arms | Blood clots blocking other blood vessels | | Acute abdominal pain ("acute abdomen") | |

BLOOD CLOTS IN VEINS

What can cause a blood clot in a vein?

• Using combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thrombosis). However, these side 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 deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, this may cause pulmonary embolism.
• In very rare cases, a clot may form in a vein in another organ, e.g., in the eye (retinal vein thrombosis).

When is the risk of venous blood clots highest?

The risk of venous blood clots is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more. After the first year, the risk decreases but remains higher than in women not using combined hormonal contraceptives. If you stop taking Axia Forte, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of blood clots?

The risk depends on your natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.

The overall risk of blood clots in the legs or lungs associated with taking Axia Forte is small.

• In 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 one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Axia Forte, will develop blood clots.
• The risk of blood clots depends on your individual medical history (see "Factors that increase the risk of blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Axia Forte is low, however
some factors may increase this risk. The risk is higher:

• if the patient has a high body weight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs or other organs at a young age (e.g. below 50 years). In this case, the patient may have an inherited clotting disorder;
• if the patient needs to undergo surgery, is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Axia Forte several weeks before surgery or immobilisation. If the patient needs to stop taking Axia Forte, ask the doctor when it is safe to restart the medication;
• with increasing age (especially above 35 years);
• if the patient has given birth within the last few weeks. The risk of venous blood clots increases with the number of risk factors present in the patient. Air travel (>4 hours) may temporarily increase the risk of venous blood clots, particularly if the patient has another risk factor listed above. 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 Axia Forte. Inform the doctor if any of the above conditions change during treatment with Axia Forte, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.
Factors increasing the risk of arterial blood clots
Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Axia Forte is very low, but may increase:

• with age (above approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Axia Forte, it is recommended to stop smoking. If the patient cannot 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 family member has had a heart attack or stroke at a young age (below 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them is particularly severe, the risk of arterial blood clots may be further increased. Inform the doctor if any of the above conditions change during treatment with Axia Forte, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.
Axia Forte and tumours
Breast cancer is observed slightly more frequently in women using combined hormonal contraceptives, but it is not known whether this is caused by the use of these contraceptives. It is possible, for example, that tumours are detected more frequently in women using combined hormonal contraceptives because these women are examined more regularly by doctors. The incidence of breast tumours gradually decreases after stopping combined hormonal contraceptives. Regular breast examinations and consulting a doctor upon detecting any lump are important.
In rare cases, benign liver tumours have been observed in women using oral contraceptives, and even more rarely, malignant liver tumours. If unusually severe abdominal pain occurs, consult a doctor.
Psychiatric disorders
Some women using hormonal contraceptives, including Axia Forte, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor as soon as possible for further medical advice.
Intermenstrual bleeding
During the first few months of using Axia Forte, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding persists for longer than a few months or occurs after several months of use, the cause should be investigated by a doctor.
What to do if bleeding does not occur during the pill-free week
If all tablets have been taken correctly, without vomiting or severe diarrhoea, and no other medications have been taken, it is very unlikely that the patient is pregnant.
If expected bleeding does not occur for two consecutive cycles, this may indicate pregnancy. Contact a doctor immediately. Do not start the next pack until pregnancy has been ruled out.
Axia Forte and other medicines
Always inform the doctor about all current medications or herbal products being used. Also inform any other doctor, including a dentist, or pharmacist prescribing or dispensing another medicine about the use of Axia Forte. They may advise whether additional contraceptive methods (e.g. condoms) are needed, for how long, or whether the use of another required medicine should be changed.
Some medicines may affect the blood levels of Axia Forte, reduce its contraceptive effectiveness, or cause unexpected bleeding. These include:

• medicines used to treat epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine);
• medicines used to treat tuberculosis (e.g. rifampicin);
• medicines used to treat HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) and other infections (griseofulvin);
• antifungal medicines (e.g. griseofulvin, ketoconazole);
• medicines used for arthritis, osteoarthritis (etoricoxib);
• high blood pressure in the pulmonary blood vessels (bosentan);
• herbal products containing St. John’s wort (Hypericum perforatum).

Axia Forte may affect the action of other medicines, for example:

• those containing cyclosporine;
• antiepileptic lamotrigine (which may lead to increased frequency of seizures);
• theophylline (used to treat breathing problems);
• tizanidine (used to treat muscle pain and/or muscle spasms).

Do not use Axia Forte if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause elevated liver function test results (increased levels of the liver enzyme ALT). The doctor will recommend another type of contraception before starting these treatments. Axia Forte may be restarted approximately 2 weeks after completing the above treatment. See section “When not to use Axia Forte”.
Before taking any medicine, consult a doctor or pharmacist.
Axia Forte with food and drink
Axia Forte may be taken during meals or between meals. If necessary, tablets may be taken with a small amount of water.
Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that this medicine is being taken, as hormonal contraceptives may affect the results of certain tests.
Pregnancy and breastfeeding
Pregnancy
Axia Forte must not be used during pregnancy. If the patient becomes pregnant while taking Axia Forte, stop taking it immediately and contact a doctor. If pregnancy is desired, Axia Forte may be discontinued at any time (see also “Discontinuing Axia Forte”).
Breastfeeding
Axia Forte is generally not recommended during breastfeeding. However, if a breastfeeding woman wishes to use the medicine, she should consult her doctor.
Driving and using machines
There is no information suggesting that Axia Forte affects the ability to drive or operate machinery.
Important information about some ingredients of Axia Forte
Axia Forte contains lactose.
If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. HOW TO USE AXIA FORTE

One tablet of Axia Forte should be taken daily, if necessary with a small amount of water. Tablets may be taken during or between meals, but they should be taken every day at approximately the same time.
The blister pack contains 21 tablets. Each tablet is marked with the day of the week on which it should be taken. For example, if tablet intake begins on Wednesday, take the tablet marked "Wed". Proceed in the direction of the arrow on the blister until all 21 tablets have been taken.
After that, no tablets should be taken for the next 7 days. During this 7-day break (also called the "tablet-free week"), withdrawal bleeding usually occurs. This so-called "withdrawal bleeding" typically starts on the 2nd or 3rd day of the tablet-free week.
On the 8th day after taking the last tablet of Axia Forte (i.e., after the 7-day break), start taking tablets from the next blister pack, regardless of whether bleeding has stopped. This means that each new blister pack should be started on the same day of the week, and withdrawal bleeding should occur on the same days each month.
By taking Axia Forte as described above, the patient is protected against pregnancy even during the 7 days when no tablets are taken.

When can the first blister pack be started?

• If the patient has not used a hormonal contraceptive in the previous month
  Start taking Axia Forte on the first day of the menstrual cycle (i.e., the first day of menstruation). If the patient starts taking Axia Forte on the first day of her period, she is immediately protected against pregnancy. It is also possible to start taking the medication on days 2–5 of the cycle; however, in this case, additional contraceptive methods (e.g., condoms) should be used for the first 7 days of tablet use.

• Switching from a combined hormonal contraceptive or a combined hormonal vaginal ring or transdermal patch
  You may start taking Axia Forte the day after taking the last active tablet of the previous contraceptive, but no later than the day after completing the 7-day tablet-free interval of the previous pill (or after the last inactive tablet of the previous medication). If switching from a combined hormonal vaginal ring or contraceptive patch, follow your doctor's advice.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)
  You may switch at any time from progestogen-only pills (or on the day of removal of an implant or intrauterine system, or on the day of the next scheduled injection), but in all cases, additional contraceptive protection (e.g., condoms) should be used for the first 7 days of taking Axia Forte.

• After miscarriage
  Follow your doctor's advice.

• After childbirth
  Axia Forte may be started between days 21 and 28 after delivery. If starting later than day 28, a barrier method (e.g., condoms) should be used for the first 7 days of taking Axia Forte. If sexual intercourse occurred before starting or resuming Axia Forte after childbirth, ensure that pregnancy has not occurred, or wait until the next menstrual bleeding.

• If the patient is breastfeeding and wants to start or resume taking Axia Forte after childbirth
  Please read the section "Breastfeeding".

If it is unclear when to start taking the medication, consult your doctor.

Overdose of Axia Forte
There is no information about serious harmful effects from taking too many Axia Forte tablets.
If several tablets are taken at once, symptoms such as nausea or vomiting may occur. In young girls, vaginal bleeding may occur.
If an excessive number of Axia Forte tablets are taken or if a child swallows several tablets, consult a doctor or pharmacist.

Missed dose of Axia Forte

• If less than 12 hours have passed since the missed tablet, contraceptive protection is not reduced. Take the missed tablet as soon as possible, then continue taking the following tablets at the usual time.
• If more than 12 hours have passed since the missed tablet, contraceptive protection may be reduced. The more tablets missed, the higher the risk of pregnancy.

The risk of inadequate contraceptive protection is greatest if a tablet is missed at the beginning or end of the blister pack. Therefore, follow the rules below (see chart below):

• More than one tablet missed in this blister pack
  Contact your doctor.

• One tablet missed in week 1
  Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time, and use additional contraceptive protection (e.g., condoms) for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, be aware that there is a risk of pregnancy. In such a case, contact your doctor.

• One tablet missed in week 2
  Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time. Contraceptive protection is not reduced. There is no need to use additional contraceptive methods.

• One tablet missed in week 3
  There are two options:

  1. Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time. Do not take a break—start the next blister pack immediately.
     Withdrawal bleeding will most likely occur at the end of the second blister pack, but breakthrough bleeding or spotting may occur during the second pack.
  2. Alternatively, stop taking tablets from the current blister pack and proceed directly to the 7-day break (note the day on which the tablet was missed). If the patient wishes to start the next blister pack on her usual starting day, the break may be shortened to less than 7 days.
     Following either of these options ensures continued contraceptive protection.

• If a patient misses any tablet from the blister pack and does not experience bleeding during the first tablet-free interval, this may indicate pregnancy. Contact a doctor before starting the next blister pack.

What to do in case of vomiting or severe diarrhoea
If vomiting occurs within 3–4 hours after taking a tablet, or if severe diarrhoea occurs, there is a risk that the active ingredients have not been completely absorbed. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister pack as soon as possible. If possible, take it within 12 hours of the usual tablet-taking time. If this is not possible or if more than 12 hours have passed, follow the instructions under "Missed dose of Axia Forte".

Delaying withdrawal bleeding: what you should know
Although this is not recommended, it is possible to delay withdrawal bleeding by starting the next blister pack of Axia Forte immediately, without taking the usual 7-day break, continuing until the second blister pack is finished. Breakthrough bleeding or spotting may occur during the second pack. After the usual 7-day break, start taking tablets from the next blister pack.
Before deciding to delay withdrawal bleeding, consult your doctor.

Changing the day withdrawal bleeding starts: what you should know
If the patient takes the tablets as instructed, withdrawal bleeding will start during the tablet-free week. If it is necessary to change the day on which bleeding starts, shorten the tablet-free interval (but never extend it—7 days is the maximum!). For example, if the break normally starts on Friday, but the patient wants to change it to Tuesday (3 days earlier), start the new blister pack 3 days earlier than usual. If the break is very short (3 days or less), bleeding may not occur at all during this time. Spotting may occur.
If the patient is unsure how to proceed, she should consult her doctor.

Stopping use of Axia Forte
Axia Forte may be discontinued at any time. If the patient does not wish to become pregnant, she should consult her doctor about other effective methods of contraception. If the patient wishes to become pregnant, she should stop taking Axia Forte and wait for a menstrual period before trying to conceive. This makes it easier to calculate the expected date of delivery.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, Axia Forte may cause adverse reactions, although not everyone experiences them. If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Axia Forte, medical advice should be sought from a physician.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolic disease) or blood clots in arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using Axia Forte".

Below is a list of adverse reactions associated with the use of Axia Forte.

Common adverse reactions (observed in less than 1 in 10 patients):

• headache;
• menstrual disorders; intermenstrual bleeding;
• acne;
• mood changes, depression;
• migraine;
• breast pain, breast enlargement, breast tenderness, painful or irregular menstruation;
• thick, whitish vaginal discharge and yeast infections of the vagina.

Uncommon adverse reactions (observed in less than 1 in 100 patients):

• high blood pressure, low blood pressure, migraine;
• changes in sexual desire;
• breast enlargement;
• vomiting, diarrhea;
• acne, rash, severe itching, hair loss (alopecia);
• urinary bladder infection;
• fluid retention and changes in body weight.

Rare adverse reactions (observed in less than 1 in 1000 patients):

• asthma;
• hearing disorders;
• nodular erythema (characterized by painful, reddish nodules on the skin);
• erythema multiforme (rash with redness or target-shaped blisters);
• dangerous blood clots in veins or arteries, e.g.:
  • in the leg or foot (e.g. deep vein thrombosis);
  • in the lungs (e.g. pulmonary embolism);
  • heart attack;
  • stroke;
  • mini-stroke or transient symptoms resembling stroke, known as transient ischemic attack (TIA);
  • blood clots in the liver, stomach/intestines, kidneys, or eye.

The likelihood of developing a blood clot may be higher if the patient has any other risk factors increasing this risk (see section 2 for further information on risk factors for blood clots and symptoms of blood clot occurrence).

Immediate medical attention should be sought if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially accompanied by breathing difficulties (see also section "Warnings and precautions").

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl .

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE AXIA FORTE

Keep Axia Forte out of the sight and reach of children.
Store below 30°C.
Do not use this medicinal product after the expiry date stated on the packaging after the words
"Expiry date:" or "EXP:". The expiry date refers to the last day of the stated month.
Medicinal products 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 Axia Forte contains:

• The active substances are ethinylestradiol and drospirenone. Each tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone.
• The other components (excipients) are monohydrate lactose, corn starch, pregelatinized starch (corn), crospovidone type B, crospovidone type A, povidone K-30, polysorbate 80, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

What Axia Forte looks like and contents of the pack

• Each blister contains 21 yellow, round, film-coated tablets of Axia Forte.
• Axia Forte is available in packages containing 1, 2, 3, 6 or 13 blisters, each blister containing 21 tablets.

Some pack sizes may not be marketed.
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Manufacturer
Laboratorios León Farma, S.A.
C/ La Vallina s/n,
Pol. Ind. Navatejera.
24193 -Villaquilambre, León.
Spain
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Baradly 0.03 mg/3 mg, filmomhulde tabletten
Poland: Axia Forte
Estonia: Orindille
Lithuania: Orindille 3 mg/0.03 mg plėvele dengtos tabletės
Latvia: Orindille 0.03 mg/3 mg apvalkotās tabletes
Slovakia: Axia 0.03 mg/3 mg filmom obalené tablety
Czech Republic: Axia 0.03 mg/3 mg potahované tablety