Axia Plus

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Axia Plus, 0.02 mg + 3 mg, coated tablets

Ethinylestradiol + Drospirenone

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

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives

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

Table of contents of the leaflet

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

1. What is Axia Plus and what is it used for

• Axia Plus is a contraceptive pill and is used to prevent pregnancy.
• Each of the 21 pink tablets contains a small amount of two different female hormones called drospirenone and ethinylestradiol.
• The seven white tablets do not contain active substances and are also called placebo tablets.
• Contraceptives containing two hormones are called combined contraceptives.

2. Important information before taking Axia Plus

General notes

Before starting to take Axia Plus, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before you can start taking Axia Plus, your doctor will ask you a few questions about your health and about the health of your close relatives. Your doctor will also measure your blood pressure and, depending on the individual case, may also perform some other tests.
This leaflet describes several situations in which you should stop taking Axia Plus or in which the effectiveness of Axia Plus may be reduced. In such situations, you should either not have sexual intercourse or use additional non-hormonal contraceptives, such as condoms or other mechanical methods. You should not use the observation method or the temperature measurement method. These methods may be unreliable because Axia Plus modifies the monthly changes in body temperature and cervical mucus.

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

When not to take Axia Plus

You should not take Axia Plus if you have any of the following conditions. If you have any of the following conditions, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable:

• if you currently have (or have ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient stroke symptoms);
• if you have any of the following diseases that may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia;
• if you have (or have 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 is still not normal;
• if you have kidney function disorders (kidney failure);
• if you have (or have had in the past) liver cancer;
• if you have (or have had in the past) or suspect breast cancer or genital cancer;
• if you have any vaginal bleeding of unknown origin;
• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity may include: itching, rash, or swelling.

Axia Plus should not be taken by women with hepatitis C virus infection who are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Axia Plus and other medicines").

Additional information for special populations

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

Warnings and precautions

Before starting to take Axia Plus, you should discuss it with your doctor or pharmacist.
When should you contact your doctor?
You should contact your doctor immediately

• if you notice any possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), blood clot in your lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots (thrombosis)").

In order to describe the symptoms of these serious side effects, see "How to recognize a blood clot".

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

If these symptoms occur or worsen while taking Axia Plus, you should also tell your doctor. In certain situations, you should be particularly careful when taking Axia Plus or any other combined contraceptive pill. You may need to be regularly examined by your doctor.
If any of the following conditions occur, you should inform your doctor or pharmacist before starting to take Axia Plus:

• if any of your close relatives have had breast cancer;
• if you have cancer;
• if you have liver disease (such as bile duct obstruction, which can lead to jaundice and symptoms such as itching) or gallstones (e.g., gallstones);
• if you have kidney problems and are taking medications that increase potassium levels in the blood;
• if you have diabetes;
• if you have depression; some women taking hormonal contraceptives, including Axia Plus, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice;
• if you have Crohn's disease or ulcerative colitis (a chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disease of red blood cells);
• if you have been told you have high levels of fats in the blood (hypertriglyceridemia) or have a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have just given birth, you are at a higher risk of blood clots. You should consult your doctor to find out how soon you can start taking Axia Plus after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Axia Plus and other medicines");
• if you have a disease that first appeared during pregnancy or while taking sex hormones (e.g., hearing loss, a blood disease called porphyria, herpes gestationis (a skin rash that occurs during pregnancy), Sydenham's chorea (a neurological disorder characterized by involuntary movements of the body));
• if you have high blood pressure that persists despite taking medications;
• if you have chloasma (brown spots on the skin, also known as melasma), especially on the face. In this case, you should avoid direct exposure to sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing or hives with difficulty breathing, you should contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Axia Plus, is associated with an increased risk of blood clots compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• in veins (also known as "venous thromboembolism" or "venous thrombosis");
• in arteries (also known as "arterial thromboembolism" or "arterial thrombosis"). Not all people recover fully from a blood clot, and in rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to taking Axia Plus is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
Probable cause
of the condition

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color in the affected leg, such as pallor; Deep vein thrombosis

redness, cyanosis.

• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing; Pulmonary embolism

If you are unsure, you should contact your doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

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

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

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

What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with taking Axia Plus is small.

• During a year, about 2 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a year, about 9-12 out of 10,000 women who take combined hormonal contraceptives containing drospirenone, such as Axia Plus, will develop blood clots.
• The risk of blood clots depends on the individual's medical history (see "Factors that increase the risk of blood clots" below).

Factors that increase the risk of blood clots in veins

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

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

The risk of blood clots increases with the number of risk factors present in the individual.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop Axia Plus.
You should inform your doctor if any of the above conditions change while taking Axia Plus, e.g., if someone in your close family is diagnosed with a blood clot without a known cause or if you gain significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

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

Factors that increase the risk of blood clots in arteries

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

• with age (over approximately 35 years old);
• if you smoke.While taking a hormonal contraceptive like Axia Plus, it is recommended to quit smoking. If you cannot quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at a higher risk of having a heart attack or stroke;
• if you or someone in your close family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, arrhythmia called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change while taking Axia Plus, e.g., if you start smoking, someone in your close family is diagnosed with a blood clot without a known cause, or if you gain significant weight.

Axia Plus and cancer

Women taking combined oral contraceptives have a slightly higher incidence of breast cancer, but it is not known if this is caused by the pills. For example, more tumors may be detected in women taking combined oral contraceptives because they are examined by doctors more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is essential to regularly examine your breasts and contact your doctor if you feel any lump.
Women taking oral contraceptives have been reported to have, in rare cases, benign liver tumors, and in even rarer cases, malignant liver tumors. If you experience unusual, severe abdominal pain or abdominal distension, you should contact your doctor.

Irregular bleeding

During the first few months of taking Axia Plus, you may experience unexpected bleeding (bleeding outside of the period of taking white placebo tablets). If such bleeding persists for more than a few months or starts after a few months, your doctor should investigate the cause.

What to do if you do not experience withdrawal bleeding during the days of taking placebo tablets

If you have taken all the active tablets containing the active substance correctly, have not vomited, or have not had severe diarrhea, and have not taken any other medications, it is very unlikely that you are pregnant.
If the expected withdrawal bleeding does not occur twice in a row, it may indicate pregnancy. You should contact your doctor immediately. You can start the next pack of Axia Plus only when you are sure you are not pregnant.

Axia Plus and other medicines

You should tell your doctor about all the medicines you are currently taking or have recently taken and any herbal products, as well as any medicines you plan to take.
You should inform other doctors or dentists who prescribe other medicines (or pharmacists) that you are taking Axia Plus. Your doctor will tell you if there is a need to use additional contraception (e.g., condoms) and if so, for how long.
Certain medicines may affect the level of Axia Plus in the blood and may reduce its effectiveness in preventing pregnancy or may cause unexpected bleeding. These include:

• medicines used to treat: epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate); tuberculosis (e.g., rifampicin); HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz); fungal infections (e.g., griseofulvin, ketoconazole); arthritis and degenerative joint disease (etoricoxib); high blood pressure in the blood vessels of the lungs (bosentan);
• herbal products containing St. John's Wort (Hypericum perforatum).

If you are taking any of these medicines with Axia Plus, you should use additional contraception (e.g., condoms) during treatment and for 28 days after stopping treatment.
Axia Plus may affect the action of other medicines, such as:

• medicines containing cyclosporin;
• the antiepileptic medicine lamotrigine (may increase the frequency of seizures);
• theophylline (a medicine used to treat respiratory disorders);
• tizanidine (a medicine used to treat pain and/or muscle spasms).

If you are taking certain medicines used to treat heart conditions (such as diuretics), your doctor may decide to monitor your potassium levels in the blood.
You should not take Axia Plus if you have hepatitis C virus infection and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause elevated liver enzyme levels in the blood (increased ALT activity).
Your doctor will prescribe a different type of contraception before starting treatment with these medicines.
Axia Plus can be resumed about 2 weeks after stopping this treatment.
See section "When not to take Axia Plus".

Lab tests

If you need to have a blood test, you should tell your doctor or laboratory staff that you are taking contraceptive pills, as hormonal contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy

Pregnant women should not take Axia Plus. If you become pregnant while taking Axia Plus, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Axia Plus at any time (see section "Stopping Axia Plus").

Breastfeeding

Generally, Axia Plus is not recommended for use during breastfeeding. If you want to take contraceptive pills while breastfeeding, you should contact your doctor.

Driving and using machines

There is no information to suggest that taking Axia Plus affects your ability to drive or use machines.

Axia Plus contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Axia Plus

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should contact your doctor or pharmacist.
Each blister pack contains 21 active pink tablets and 7 white placebo tablets. The Axia Plus tablets in two different colors are arranged in the correct order. The blister pack contains 28 tablets.
You should take one Axia Plus tablet every day, with a small amount of water if necessary. The tablets can be taken independently of meals, but each day at about the same time.

Preparing the blister pack.

The Axia Plus packaging contains 7 stickers in the form of strips marked with the days of the week. Each strip starts on a different day of the week. You should choose a strip that starts on the day you intend to start taking the tablets. For example, if you want to start taking Axia Plus on a Wednesday, you should use the strip that starts with "WED". This strip should be stuck in the marked place on the packaging. The first day marked on the strip must be directly below the groove marked "START". The packaging should always be started with the pink tablets and finished with the white tablets.
The medicine should be taken by moving in the direction of the arrows.
Each subsequent row of tablets should be started from the left side.
During the 7 days when you take the white placebo tablets (placebo days), you should experience bleeding (so-called withdrawal bleeding). This usually starts on the 2nd or 3rd day after taking the last pink tablet containing the active substance. After taking the last white placebo tablet, you should start a new blister pack, regardless of whether the bleeding has stopped or not. This means that you should always start taking tablets from a new pack on the same day of the week, and the withdrawal bleeding should start on the same day of the monthevery month.
Axia Plus taken in this way also protects against pregnancy during these 7 days when you take the placebo tablets.

When can you start the first blister pack?

• If you have not taken hormonal contraceptives in the previous monthYou should start taking Axia Plus on the first day of your cycle (i.e., the first day of your period). If you start taking Axia Plus on the first day of your period, it will protect you against pregnancy immediately. You can also start taking Axia Plus between the 2nd and 5th day of your cycle. However, in this case, you should use additional contraception (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or patch)You can start taking Axia Plus the day after taking the last active tablet (containing the active substance) of your previous combined oral contraceptive, but no later than the day after the usual break in taking your previous combined oral contraceptive (or after taking the last inactive tablet of your previous contraceptive pills). In the case of switching from a vaginal ring or transdermal patch, it is best to start taking Axia Plus on the day the ring or patch is removed, but no later than the day you would apply a new ring or patch.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen, IUS)You can switch from a progestogen-only pill (from an implant or intrauterine system releasing progestogen, IUS) on any day (on the day of its removal or on the day a new implant or IUS would be applied), but in all cases, you should use additional contraception (e.g., condoms) for the first 7 days of taking Axia Plus.
• After a miscarriage or abortionFollow your doctor's advice.
• After childbirthYou can start taking Axia Plus between the 21st and 28th day after giving birth. If you start taking Axia Plus later than 28 days after giving birth, you should use a mechanical method (e.g., condoms) for the first 7 days of taking Axia Plus. If you have had sexual intercourse after giving birth before starting to take Axia Plus again, you should first make sure you are not pregnant or wait for your next period.
• If you are breastfeeding and want to start taking Axia Plus again after giving birthYou should read the section "Breastfeeding".

If you are unsure when to start the first blister pack, you should contact your doctor.

What to do if you take more Axia Plus than you should

There are no reports of serious harmful effects from taking too many Axia Plus tablets at once.
If you have taken several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. Vaginal bleeding may also occur in young girls who have not yet started menstruating if they have taken Axia Plus.
If you have taken too many Axia Plus tablets or if a child has swallowed some, you should contact your doctor or pharmacist.

What to do if you forget to take Axia Plus

The tablets in the fourthrow of the blister pack are placebo tablets. If you miss one of these tablets, it will not affect the effectiveness of Axia Plus. You should discard the missed placebo tablet.
If you forget to take a pink active tablet from the first, second, or thirdrow of the blister pack, you should follow these rules:

• if it has been less than 24 hourssince you missed the tablet, your protection against pregnancy is not reduced. You should take the tablet as soon as you remember, and then take the next tablets at the usual time.
• if it has been more than 24 hourssince you missed the tablet, your protection against pregnancy may be reduced. The more tablets you have missed, the higher the risk of pregnancy.

The risk of reduced protection against pregnancy is highest if you miss a pink tablet at the beginning or end of the blister pack. In this situation, you should follow the rules below (see also the diagram below):

• You have missed more than one tablet from the blister packYou should consult your doctor.
• You have missed one tablet in week 1.You should take the missed tablet as soon as you remember, even if it means taking two tablets at once. Take the next tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If you have had sexual intercourse in the week before missing the tablet, you should be aware that there is a risk of pregnancy. In this case, you should contact your doctor.
• You have missed one tablet in week 2.You should take the missed tablet as soon as you remember, even if it means taking two tablets at once. Take the next tablets at the usual time. Your protection against pregnancy is not reduced, so you do not need to use additional contraception.

You should take the missed tablet as soon as you remember, even if it means taking two tablets at once. Then, continue taking the tablets at the usual time.

• 1. You should take the missed tablet as soon as you remember, even if it means taking two tablets at once. Then, continue taking the tablets at the usual time. Instead of taking the white placebo tablets from the pack, you should skip them (discard them) and start a new pack.

Most likely, your period will occur at the end of the second pack, during the white placebo tablets, but you may experience spotting or bleeding similar to a period while taking the tablets from the second pack.

• 2. You can also stop taking the pink active tablets and go directly to taking the 7 white placebo tablets ( before taking the placebo tablets, make a note of the day you missed the tablet). If you want to start the next pack on the same day as before, you can take the placebo tablets for less than 7 days.

If you follow one of these rules, your protection against pregnancy will be maintained.

• If you have missed any tablets from the blister pack and have not experienced bleeding during the placebo days, it may mean that you are pregnant. You should contact your doctor before starting the next blister pack.

The following diagram shows how to proceed if you miss a tablet

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Axia Plus, a doctor should be consulted.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before using Axia Plus".
Below is a list of side effects associated with the use of Axia Plus.
Commonside effects (may occur in up to 1 in 10 people):

• mood swings,
• headache,
• abdominal pain,
• acne,
• breast pain, breast enlargement, breast tenderness, painful or irregular periods,
• weight gain.

Uncommonside effects (may occur in up to 1 in 100 people):

• candidiasis (thrush),
• herpes simplex,
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disorders,
• tingling sensation, dizziness,
• vision disturbances,
• irregular or abnormally rapid heartbeat,
• high blood pressure, low blood pressure, migraine, varicose veins,
• sore throat,
• nausea, vomiting, gastritis and/or enteritis, diarrhea, constipation,
• hair loss, skin rash, itching, hives, dry skin, seborrheic dermatitis,
• neck pain, limb pain, muscle cramps,
• urinary tract infection,
• breast lump (benign), milk secretion when not pregnant (galactorrhea), ovarian cyst, hot flashes, amenorrhea, very heavy periods, vaginal discharge, vaginal infections or vaginitis, vaginal dryness, pelvic pain, abnormal Pap smear result, decreased libido,
• fluid retention, lack of energy, increased thirst, excessive sweating,
• weight loss,

Rareside effects (may occur in up to 1 in 1000 people):

• asthma,
• hearing impairment,
• erythema nodosum (characterized by painful red lumps on the skin),
• erythema multiforme (rash with redness and pain),
• harmful blood clots in a vein or artery, for example: in the leg or foot (deep vein thrombosis), in the lungs (pulmonary embolism), heart attack, stroke, mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack, blood clots in the liver, stomach, and intestines, kidneys, or eyes.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).
A doctor should be consulted immediately if the patient experiences any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria potentially with difficulty breathing (see also "Warnings and precautions").

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C PL-02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Axia Plus

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The medicine should not be used after the expiry date stated on the package and blister in the place marked "Do not use after:" or after "EXP". The expiry date "Lot" means the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Axia Plus contains

Axia Plus blister contains 21 pink, active tablets in the first, second, and third rows and 7 white placebo tablets in the fourth row.

Active tablets:

The active substances are: ethinylestradiol (0.02 mg) and drospirenone (3 mg).
Other ingredients are:
Tablet core: lactose monohydrate, maize starch, povidone, sodium croscarmellose, Polysorbate 80, magnesium stearate
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), Macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)

Placebo tablets:

Tablet core: lactose monohydrate, povidone, magnesium stearate
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), Macrogol 3350, talc

What Axia Plus looks like and what the pack contains

Active tablets - pink, round, film-coated tablets.
Placebo tablets - white, round, film-coated tablets.
Axia Plus is available in packs containing 1, 2, 3, 6, and 13 blisters, each containing 28 tablets (21 active tablets and 7 placebo tablets).
Not all pack sizes may be marketed.

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Laboratorios Leon Farma, S.A.
C/ La Vallina, s/n,
Polígono Industrial Navatejera,
Villaquilambre 24193 (León),
Spain

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

France
DROSPIRENONE / ETHINYLESTRADIOL VIATRIS CONTINU 3 mg/ 0,02
mg, film-coated tablet
Norway
Iren 28
Sweden
Estron 0,02 mg/3 mg, film-coated tablet
Poland
Axia Plus
Date of last revision of the leaflet:December 2024