Axia

Axia, 0.02 mg + 3 mg, coated tablets
Ethinylestradiolum + Drospirenonum
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 following a break of 4 weeks or more
• Be vigilant and consult a doctor if a woman suspects symptoms of blood clot formation (see: section 2. "Blood clots")

Please read this leaflet carefully before taking the medicine.

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

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

1. WHAT IS AXIA AND WHAT IS IT USED FOR?
Axia 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 known as "combined" pills.

2. WHAT YOU NEED TO KNOW BEFORE TAKING AXIA

General notes
Before starting Axia, read the information about blood clots (thrombosis) in section 2. It is particularly important to understand the symptoms of blood clots (see section 2 "Blood clots").
Before starting Axia, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your situation, may perform other tests.
This leaflet describes situations in which you should stop taking Axia or when its effectiveness may be reduced. In such cases, avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use fertility awareness methods or temperature monitoring. These methods may be ineffective because Axia disrupts the monthly cycle of body temperature changes and cervical mucus secretion.
Axia, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted infections.

When not to take Axia:
Do not take Axia if any of the following conditions apply to you. If any of these conditions affect 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 deep leg veins (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders — 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 suffer from (or have suffered 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 suffer from 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 blood lipids (cholesterol or triglycerides),
  • a condition called hyperhomocysteinaemia;
• if you currently have (or have had in the past) a type of migraine called "migraine with aura";
• if you have (or have had in the past) liver disease and liver function remains abnormal;
• if you have kidney function disorders (kidney failure);
• if you currently have (or have had in the past) a liver tumour;
• if you currently have (or have had in the past) breast cancer or cancer of the genital organs;
• if you have vaginal bleeding of unknown cause;
• if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Axia with other medicines").

Additional information for special populations
Children and adolescents
Axia Conti is not intended for use in girls before the onset of menstruation.
Elderly patients
Axia Conti is not intended for use after menopause.
Patients with liver function disorders
Do not take Axia Conti if you have liver disease. See also sections "When not to take Axia Conti" and "Warnings and precautions".
Patients with kidney function disorders
Do not take Axia Conti if you have kidney failure or acute kidney failure. See also sections "When not to take Axia Conti" and "Warnings and precautions".

Warnings and precautions
When should you contact your doctor?
Contact your doctor immediately if:

• you notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your 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 or other combined hormonal contraceptives. Your doctor may then require regular check-ups.
Inform your doctor if you have any of the following conditions. If any of these conditions develop or worsen during treatment with Axia, inform your doctor:

• if breast cancer occurs or has occurred in close relatives;
• 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 (an inherited red blood cell disorder);
• if you have high blood lipid levels (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a long time (see: section 2 "Blood clots");
• if you are in the immediate postpartum period, as you are at increased risk of blood clots. Consult your doctor to determine how soon after delivery you can start taking Axia;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you suffer from epilepsy (see: section "Axia with other medicines");
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria (a blood disorder), pregnancy-related blistering skin rash (herpes gestationis), 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 of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or urticaria accompanied by breathing difficulties — seek immediate medical attention; medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Axia is associated with an increased risk of blood clots compared to not using such medicines. 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.
Remember that the overall risk of harmful blood clots caused by taking Axia is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you experience any of the following symptoms.

| Symptom | Likely condition | |--------|------------------| | Swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by: | Deep vein thrombosis | | Pain or tenderness in the leg, felt only when standing or walking; | | | Increased warmth in the affected leg; | | | Change in skin colour of the leg, e.g. paleness, redness, blueness. | | | Sudden unexplained shortness of breath or rapid breathing; | Pulmonary embolism | | Sudden cough without obvious cause, possibly with coughing up blood; | | | Sudden sharp chest pain, which may worsen on deep breathing; | | | Severe dizziness or vertigo; | | | Rapid or irregular heartbeat; | | | Severe stomach pain. | | | Sudden loss of vision or | Retinal vein thrombosis (blood clot in the eye) | | Painless visual disturbances, which may lead to vision loss. | |

If in doubt, consult a doctor, as some of these symptoms, such as cough or breathlessness, may be mistaken for milder conditions such as respiratory tract infection (e.g. cold).
Note: Symptoms most commonly affect one eye.

BLOOD CLOTS IN VEINS
What can cause a blood clot to form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis). However, 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 a vein of another organ, for example in 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 highest during the first year of taking combined hormonal contraceptives for the first time. 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, although it remains higher compared to when not using combined hormonal contraceptives. If a woman stops taking Axia, 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 developing venous thromboembolic disease and the type of combined hormonal contraceptive being used.

The overall risk of developing blood clots in the legs or lungs associated with using
Axia is low.

• 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, will develop blood clots.
• 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).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Axia is small, but certain factors may increase this risk. The risk is higher:

• if the patient is very overweight (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. under 50 years). In this case, the patient may have an inherited tendency to clotting;
• if the patient is due to have surgery, if she is immobilized for a prolonged period due to injury or illness, or if she has a leg in plaster. It may be necessary to stop taking Axia for several weeks before surgery or immobilization. If the patient must stop taking Axia, she should ask her doctor when she can restart taking the medicine;
• with increasing age (especially over 35 years);
• if the patient has 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, particularly if the patient has another risk factor listed above. It is important to tell the doctor if any of these factors apply to the patient, even if she is uncertain. The doctor may decide to stop the use of Axia. The patient should inform her doctor if any of the above conditions change during treatment with Axia, for example, if a close family member is diagnosed with thrombosis without a known cause, or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with blood clots in veins, clots in arteries can cause serious consequences, such as heart attack or stroke.
Factors increasing the risk of blood clots in arteries
Factors that increase the risk of blood clots in arteries.
It is important to emphasize that the risk of heart attack or stroke associated with the use of Axia is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Axia, it is recommended to stop smoking. 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 family member 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 family member has high levels of fats in the blood (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 blood clots may be further increased. The patient should inform her doctor if any of the above conditions change during treatment with Axia, for example, if she starts smoking, if a close family member is diagnosed with thrombosis without a known cause, or if she gains significant weight.
Axia and tumors
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 tumors are detected more often in women using combined hormonal contraceptives because these women are examined more frequently by doctors. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. Regular breast examinations are important, and the patient should contact her doctor if she feels any lump.
In rare cases, benign liver tumors and, even more rarely, malignant liver tumors have been observed in women using contraceptive pills. If unusually severe abdominal pain occurs, the patient should contact her doctor.
Psychiatric disorders
Some women using hormonal contraceptives, including Axia, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact her doctor as soon as possible for further medical advice.
Intermenstrual bleeding
During the first few months of using Axia, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding persists for more than a few months or occurs after several months, the doctor should determine the cause.
What to do if bleeding does not occur during the pill-free week
If all tablets were taken correctly, no vomiting or severe diarrhea occurred, and no other medicines were taken, it is very unlikely that the patient is pregnant.
If the expected bleeding does not occur twice in a row, this may indicate pregnancy. The patient should contact her doctor immediately. She should not start the next pack until it is confirmed that she is not pregnant.
Axia and other medicines
The patient should always inform her doctor about all medicines or herbal products she is currently taking. She should also inform any other doctor, including her dentist, or pharmacist who prescribes or dispenses another medicine, that she is using Axia. They may advise whether additional contraceptive methods (e.g. condoms) should be used, and if so, for how long.
Axia should not be used in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may lead to abnormal liver function test results in blood (increased liver enzyme ALT activity). Before starting these medicines, the doctor will prescribe another type of contraception. Axia may be restarted approximately 2 weeks after stopping the above treatment. See section "When not to use Axia".
Some medicines may affect the blood levels of Axia and may reduce its effectiveness in preventing pregnancy or cause unexpected bleeding. These include:

• those used to treat epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine);
• those used to treat tuberculosis (e.g. rifampicin);
• those used to treat HIV infection and hepatitis C virus infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) and other infections (griseofulvin);
• those used to treat pulmonary hypertension (bosentan);
• herbal products containing St. John's wort (Hypericum perforatum).

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

• those containing cyclosporine;
• antiepileptic medicines: lamotrigine (which may lead to an increased frequency of seizures).

Before taking any medicine, the patient should consult her doctor or pharmacist.
Axia with food and drink
Axia can be taken during meals or between meals. If necessary, the tablets can be taken with a small amount of water.
Laboratory tests
If a blood test is required, the patient should inform her doctor or laboratory staff that she is taking this medicine, as hormonal contraceptives may affect the results of certain tests.
Pregnancy and breastfeeding
Pregnancy
Axia must not be used during pregnancy. If the patient becomes pregnant while taking Axia, she should stop taking it immediately and contact her doctor. If the patient wishes to become pregnant, she may stop taking Axia at any time (see also "Stopping use of Axia").
Breastfeeding
Axia is generally not recommended during breastfeeding. However, if a breastfeeding woman wishes to use the medicine, she should contact her doctor.
Driving and using machines
There is no information suggesting that Axia affects the ability to drive or operate machinery.
Important information on some ingredients of Axia
Axia contains lactose.
If the patient has been diagnosed with an intolerance to certain sugars, she should consult her doctor before taking this medicine.
Axia Conti contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. HOW TO USE AXIA

One tablet of Axia 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. Next to each tablet, the day of the week on which it should be taken is printed. For example, if tablet intake begins on Wednesday, the tablet marked "Wed" should be taken. Proceed in the direction of the arrow on the blister until all 21 tablets have been taken.
After this, no tablets should be taken for the following 7 days. During this 7-day break (also referred to as the "tablet-free week"), withdrawal bleeding usually begins. 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 (i.e. after the 7-day break), a new blister pack should be started, regardless of whether bleeding has stopped. This means that each subsequent blister pack should be started on the same day of the week, and withdrawal bleeding should occur on the same days each month.
When Axia is taken as described above, the patient is protected against pregnancy also during the 7 days when no tablets are taken.

When can the first blister pack be started?

• If the patient has not used any hormonal contraceptive in the previous month
  Axia should be started on the first day of the cycle (i.e. the first day of menstruation). If Axia is started on the first day of menstruation, immediate protection against pregnancy is provided. It is also possible to start taking Axia between 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 from a combined contraceptive vaginal ring or transdermal patch
  Axia may be started the day after taking the last active tablet of the previously used contraceptive. Alternatively, it may be started no later than the day after completing the 7-day tablet-free interval of the previous contraceptive (or after the last inactive tablet of the previous product). When switching from a combined contraceptive vaginal ring or transdermal patch, follow the physician's instructions.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)
  It is possible to 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). However, additional contraceptive protection (e.g. condoms) must be used for the first 7 days of taking Axia tablets.

• After miscarriage
  Follow the physician's advice.

• After childbirth
  Axia may be started between day 21 and day 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. If sexual intercourse occurred before starting or resuming Axia after childbirth, pregnancy must first be ruled out, or the start of Axia should be delayed until the next menstrual bleeding.

• If the patient is breastfeeding and wishes to start or resume taking Axia after childbirth
  Read the section "Breast-feeding".

If it is unclear when to start taking the medication, consult a physician.

Taking more Axia tablets than recommended

There is no information on severe harmful effects following ingestion of a large number of Axia tablets. If several tablets are taken at the same time, symptoms such as nausea or vomiting may occur. Vaginal bleeding may occur in young girls.
If an excessive number of Axia tablets have been taken, or if a child has swallowed any tablets, consult a physician or pharmacist immediately.

Missed dose of Axia

• 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 when 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 the same blister pack
  Contact your physician.

• 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 physician.

• 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
  Either of the following two options may be followed:

  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 tablet-free break; instead, immediately start the next blister pack.

  Withdrawal bleeding will most likely occur at the end of the second blister pack, but spotting or breakthrough bleeding may occur during intake of the second blister.

  2. Alternatively, stop taking tablets from the current blister and proceed directly to the 7-day tablet-free interval (note the day on which the tablet was missed). If the patient wishes to start the new blister on the usual day, the tablet-free interval may be shortened to less than 7 days.

  Following either of the above recommendations ensures continued contraceptive protection.

• If any tablet from the blister pack is missed and no withdrawal bleeding occurs during the first tablet-free interval, pregnancy may have occurred. Consult a physician 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 the tablet or if severe diarrhoea develops,
there is a risk that the active substances from the tablet have not been completely absorbed by the body.
This situation is very similar to missing a tablet. After vomiting or diarrhoea, another tablet should be taken
from a spare blister pack as soon as possible. If possible, it should be taken within 12 hours of the usual
time of tablet intake. If this is not possible or more than 12 hours have passed, follow the instructions
given in the section “Missed dose of Axia medication”.
Delayed withdrawal bleeding: what you should know
Although not recommended, it is possible to delay withdrawal bleeding by starting the next pack of Axia tablets
immediately without taking the usual break, continuing until the second pack is finished. During intake of the
second pack, breakthrough bleeding or spotting may occur. After the usual break period, start taking tablets
from the next blister pack.
Before deciding to delay withdrawal bleeding, consult your doctor for advice.
Changing the day of withdrawal bleeding: what you should know
If the patient takes the tablets as directed, withdrawal bleeding will begin during the week of the break.
If there is a need to change this day, the break period should be shortened (but never extended — 7 days is
the maximum!). For example, if the break normally starts on Friday, and the patient wishes to change it to
Tuesday (3 days earlier), the new pack should be started 3 days earlier than usual. If the break period is very
short (3 days or less), withdrawal bleeding may not occur at all during that time. Spotting may occur instead.
If the patient is uncertain how to proceed, she should consult her doctor.
Discontinuing use of Axia medication
It is possible to discontinue use of Axia at any time. If the patient does not wish to become pregnant, she should
consult her doctor regarding other effective methods of contraception. If the patient wishes to become pregnant,
she should stop taking Axia and wait for the onset of menstruation before attempting to conceive. This will make
it easier to calculate the expected date of delivery.
In case of any further doubts regarding the use of this medication, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, the Axia medicine may cause adverse reactions, although not everyone will experience them. If any adverse reactions occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Axia, medical advice should be sought.

All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (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 Axia".

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

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

• Mood swings;
• Headache;
• Abdominal pain (stomach ache);
• Acne;
• Breast pain, breast enlargement, breast tenderness, painful or irregular menstruation;
• Weight gain.

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

• Candida (fungal infection);
• Herpes (herpes simplex);
• Allergic reactions;
• Increased appetite;
• Depression, nervousness, sleep disturbances;
• Tingling sensation, dizziness;
• Vision problems;
• Heart rhythm disorders or exceptionally rapid heartbeat;
• High blood pressure, low blood pressure, migraine, varicose veins;
• Sore throat;
• Nausea, vomiting, gastritis and/or enteritis, diarrhoea, constipation;
• Sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing, or urticaria accompanied by breathing difficulties (angioedema), hair loss (alopecia), rash, itching, skin eruptions, dry skin, seborrheic skin disorders (seborrheic dermatitis);
• Neck pain, limb pain, muscle cramps;
• Urinary tract infection;
• Breast lump (benign and cancer), milk discharge in non-pregnant women (galactorrhea), ovarian cysts, sudden facial flushing, absence of menstruation, very heavy menstruation, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic pain), abnormal cervical smear (by Papanicolaou or Pap test), decreased libido;
• Fluid retention, lack of energy, excessive thirst, excessive sweating;
• Weight loss.

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 ischaemic attack;
  • blood clots in the liver, stomach and/or intestines, kidneys or eye.

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

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 associated with 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 of the 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 responsible entity.

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

5. HOW TO STORE AXIA

Keep Axia 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.
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 Axia contains:

• The active substances are ethinylestradiol and drospirenone. Each tablet contains 0.02 mg ethinylestradiol and 3 mg drospirenone.
• The other ingredients (excipients) are monohydrate lactose, pregelatinized starch (corn), povidone K-30, sodium croscarmellose, polysorbate 80, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

What Axia looks like and contents of the pack

• Each blister contains 21 pink, round, film-coated tablets of Axia.
• Axia is available in packs containing 1, 2, 3, 6 and 13 blisters, each blister containing 21 tablets.

Some pack sizes may not be marketed.
Marketing Authorisation Holder and Manufacturer
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: Modolew 0.02 mg/3 mg, filmomhulde tabletten
Poland: Axia
Estonia: Orindille
Lithuania: Orindille 3 mg/0.02 mg plėvele dengtos tabletės
Latvia: Orindille 0.02 mg/3 mg apvalkotās tabletes