Axia

PATIENT INFORMATION LEAFLET: USER INFORMATION

Axia, 0.02 mg + 3 mg, coated tablets

Ethinylestradiol +Drospirenone

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 the veins and arteries, especially in the first year of use or after restarting use after a break of 4 weeks or more
• Caution should be exercised and a doctor should be consulted if the patient suspects that blood clot symptoms have occurred (see: point 2. "Blood clots")

YOU SHOULD CAREFULLY READ THE CONTENT OF THE LEAFLET BEFORE TAKING THE MEDICINE.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See point 4.

TABLE OF CONTENTS:

1. WHAT IS AXIA AND WHAT IS IT USED FOR

2. IMPORTANT INFORMATION BEFORE USING AXIA

3. HOW TO USE 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 used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, namely drospirenone and
ethinylestradiol.
Contraceptive tablets that contain two hormones are called "combined" tablets.

2. IMPORTANT INFORMATION BEFORE USING AXIA

GENERAL NOTES

Before starting to use Axia, you should read the information about blood clots (thrombosis) in point 2. It is especially important to read about the symptoms of blood clots (see point 2 "Blood clots").
Before starting to use Axia, your doctor will ask you some questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on the case, may also perform other tests.
This leaflet describes situations in which you should stop using Axia or in which its effectiveness may be reduced. You should then abstain from sex or use additional, non-hormonal methods of contraception, such as a condom or another mechanical method. You should not use the rhythm method or temperature change method. These methods may be ineffective because Axia disrupts the monthly cycle of temperature changes and cervical mucus secretion.

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

WHEN NOT TO USE AXIA:

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

• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in point 6). This may cause itching, rash or swelling;
• if you currently have (or have ever had) a blood clot in the deep veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
• if you know you have a blood clotting disorder - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, Leiden factor V mutation, or the presence of antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see: point "Blood clots");
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary 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 condition called hyperhomocysteinemia,
• if you have (or have ever had) a type of migraine called "migraine with aura";
• if you have (or have ever had) liver disease, and your liver function is still abnormal;
• if you have kidney problems (kidney failure);
• if you have (or have ever had) a liver tumor;
• if you have (or have ever had) breast cancer or cancer of the genital organs;
• if you have unexplained vaginal bleeding;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also point "Axia and other medicines").

ADDITIONAL INFORMATION FOR SPECIAL POPULATIONS

Children and adolescents
Axia Conti is not intended for use in girls before their menarche.
Elderly patients
Axia Conti is not intended for use after menopause.
Patients with liver function disorders
Axia Conti should not be taken if you have liver disease. See also points "When not to use Axia Conti" and "Warnings and precautions".
Patients with kidney function disorders
Axia Conti should not be taken if you have kidney failure or acute kidney failure. See also points "When not to use Axia Conti" and "Warnings and precautions".

WARNINGS AND PRECAUTIONS

When should you contact your doctor?
You should contact your doctor immediately if:

• -if you notice any of the 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: point below "Blood clots (thrombosis)"). To get a description of these serious side effects, see "How to recognize a blood clot".

In some situations, it is necessary to exercise special caution when using Axia or other combined hormonal contraceptives. Your doctor may then require you to undergo regular check-ups.

YOU SHOULD TELL YOUR DOCTOR IF YOU HAVE ANY OF THE FOLLOWING CONDITIONS.

If these symptoms occur or worsen while using Axia, you should also tell your doctor:

• if breast cancer has occurred or is present in any of your close relatives;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disorder of red blood cells);
• if you have elevated levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see: point 2 "Blood clots");
• if you are immediately after childbirth, you are at increased risk of blood clots. You should ask your doctor how soon you can start using Axia after childbirth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see: point "Axia and other medicines");
• if you have a disease that first occurred during pregnancy or while using sex hormones (e.g. hearing loss, a blood disease called porphyria, a skin rash with blisters occurring during pregnancy (pregnancy pemphigoid), a nervous system disease that causes sudden movements of the body (Sydenham's chorea));
• if you have or have had chloasma (skin discoloration, especially on the face and neck, called "pregnancy patches"); in this case, you should avoid direct exposure to sunlight and ultraviolet radiation;
• if you have symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives with difficulty breathing, you should contact your doctor immediately; products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Axia, is associated with an increased risk of blood clots compared to when no therapy is used. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in the veins (also known as "venous thromboembolism" or "venous thrombotic events"),
• in the arteries (also known as "arterial thromboembolism" or "arterial thrombotic events").

Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

REMEMBER THAT THE OVERALL RISK OF HAVING A HARMFUL BLOOD CLOT WHILE USING AXIA IS SMALL.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.
Why is the
patient likely to be
suffering from?
Is the patient experiencing any of these symptoms?

• 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; Deep vein thrombosis
• increased temperature in the affected leg;
• skin color change in the leg, such as pallor, redness, or 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;
• severe dizziness or fainting; Pulmonary embolism
• rapid or irregular heartbeat;
• severe abdominal pain. If the patient is unsure, they should contact their 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). Symptoms usually occur in one eye:
• sudden loss of vision or Retinal vein thrombosis (blood clot in the eye)
• painless vision disturbances, which can lead to loss of vision.

BLOOD CLOTS IN THE VEINS

WHAT CAN CAUSE A BLOOD CLOT IN A VEIN?

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

WHEN IS THE RISK OF BLOOD CLOTS IN THE VEINS THE HIGHEST?

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

WHAT FACTORS INCREASE THE RISK OF BLOOD CLOTS IN THE VEINS?

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

• if you are overweight (body mass index (BMI) over 30 kg/m);
• if someone in your immediate 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 a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop using Axia for a few weeks before surgery or immobilization. If you need to stop using Axia, you should ask your doctor when you can restart the medicine;
• with age (especially over 35 years old);
• if you have had a baby in the last few weeks. The risk of blood clots increases with the number of risk factors present in you. 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. You should inform your doctor if any of the above conditions change while using Axia, e.g. if someone in your immediate family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN THE ARTERIES

WHAT CAN HAPPEN IF BLOOD CLOTS FORM IN AN ARTERY?

Similarly to blood clots in the veins, blood clots in an artery can cause serious consequences, such as a heart attack or stroke.

FACTORS THAT INCREASE THE RISK OF BLOOD CLOTS IN THE ARTERIES

Factors that increase the risk of blood clots in the arteries.
It is essential to note that the risk of heart attack or stroke associated with Axia is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke. If you are using a hormonal contraceptive like Axia, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, heart rhythm disturbance 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 using Axia, e.g. if you start smoking, someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

AXIA AND CANCER

In women using combined hormonal contraceptives, breast cancer is slightly more common, but it is not known if this is caused by the use of these contraceptives. It is possible, for example, that women using combined hormonal contraceptives are more likely to have breast cancer diagnosed, as they are more likely to have regular check-ups with their doctor. The incidence of breast cancer gradually decreases after stopping the use of combined hormonal contraceptives. It is essential to have regular breast exams and to contact your doctor if you notice any lump.

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 and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.

INTERMENSTRUAL BLEEDING

During the first few months of using Axia, you may experience unexpected bleeding (bleeding outside of the withdrawal bleeding week). If such bleeding persists for a longer period or occurs after a few months, your doctor should investigate the cause.

WHAT TO DO IF WITHDRAWAL BLEEDING DOES NOT OCCUR DURING THE WITHDRAWAL WEEK

If all the tablets were taken correctly, there was no vomiting or severe diarrhea, and no other medicines were taken, it is very unlikely that you are pregnant.
If the expected withdrawal bleeding does not occur for two consecutive times, it may indicate pregnancy. You should contact your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

AXIA AND OTHER MEDICINES

You should always inform your doctor about all the medicines you are currently taking or using herbal products. You should also inform any other doctor (including dentists) who prescribes another medicine (or pharmacist who dispenses a medicine) that you are using Axia. They may tell you if you need to use additional contraceptive methods (e.g. condoms) and if so, for how long.
You should not use Axia if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause abnormal liver function test results in the blood (increased liver enzyme activity ALT).
Before starting these medicines, your doctor will prescribe a different contraceptive method.
You can start taking Axia again about 2 weeks after stopping the above treatment. See point "When not to use Axia".
Certain medicines may affect the level of Axia in your blood and may reduce its effectiveness in preventing pregnancy or cause unexpected bleeding. These include:

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

Axia may affect the action of other medicines, such as:

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

Before taking any medicine, you should consult your doctor or pharmacist.

AXIA WITH FOOD AND DRINK

Axia can be taken with or without food. If necessary, the tablets can be taken with a small amount of water.

Laboratory TESTS

If a blood test is necessary, you should inform your doctor or laboratory staff that you are taking this medicine, as hormonal contraceptives may affect the results of some tests.

PREGNANCY AND BREASTFEEDING

PREGNANCY

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

BREASTFEEDING

Axia is not usually recommended during breastfeeding. If a breastfeeding woman wants to use Axia, she should contact her doctor.

DRIVING AND USING MACHINES

There is no evidence to suggest that using Axia affects your ability to drive or use machines.

IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF AXIA

AXIA CONTAINS LACTOSE.

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

AXIA CONTI CONTAINS SODIUM

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is essentially "sodium-free".

3. HOW TO USE AXIA

You should take one Axia tablet every day, if necessary with a small amount of water. The tablets can be taken with or without food, but you should take them at the same time every day.
The blister pack contains 21 tablets. Next to each tablet, the day of the week is printed on which it should be taken. If, for example, you start taking the tablets on a Wednesday, you should take the tablet marked "Wed". You should move in the direction of the arrow on the blister pack until you have taken all 21 tablets from the blister pack.
Then you should not take any tablets for the next 7 days. During this 7-day break (also called the withdrawal week), you should have withdrawal bleeding. This is usually called "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the withdrawal week.
On the 8th day after taking the last Axia tablet (i.e. after the 7-day break), you should start taking the tablets from the next blister pack, regardless of whether the bleeding has stopped. This means that you will start each subsequent blister pack on the same day of the week, and your withdrawal bleeding should occur on the same days every month.
By taking Axia in this way, you are also protected against pregnancy during the 7 days when you are not taking tablets.

WHEN CAN YOU START THE FIRST BLISTER PACK?

• If you are not using a hormonal contraceptive method in the previous monthYou should start taking Axia on the first day of your cycle (i.e. on the first day of your period). If you start taking Axia on the first day of your period, you are immediately protected against pregnancy. There is also the possibility of starting to use Axia between days 2-5 of your cycle, but in this case, you should use additional contraceptive methods (e.g. condoms) for the first 7 days of taking Axia.

If you are unsure when to start using Axia, you should consult your doctor.

WHAT TO DO IF YOU TAKE MORE AXIA THAN YOU SHOULD

There is no evidence of serious, harmful effects from taking too many Axia tablets at once.
If you take several tablets at the same time, you may experience symptoms such as nausea or vomiting. In young girls, it may lead to vaginal bleeding.
If you take too many Axia tablets or if a child accidentally swallows some, you should consult your doctor or pharmacist.

WHAT TO DO IF YOU MISS A DOSE OF AXIA

• If less than 12 hourshave passed since you missed a tablet, your protection against pregnancy is not reduced. You should take the tablet as soon as possible and then take the next tablets at the usual time.
• If more than 12 hourshave passed since you missed a tablet, your protection against pregnancy may be reduced. The more tablets you miss, the greater the risk of becoming pregnant.

The risk of reduced protection against pregnancy is greatest if you miss a tablet at the beginning or end of the blister pack. Therefore, you should follow the rules below (see the chart below):

• You have missed more than one tablet in this blister packYou should contact your doctor.
• You have missed one tablet in week 1.You should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Take the next tablets at the usual time and use additional contraceptive methods(e.g. condoms) for the next 7 days. If you had sex in the week before missing the tablet, you should be aware that there is a risk of pregnancy. In this situation, you should contact your doctor.
• You have missed one tablet in week 2.You should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Take the next tablets at the usual time. Your protection against pregnancy is not reduced. There is no need to use additional contraceptive methods.
• You have missed one tablet in week 3.You can do one of the following:
• 1. Take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Take the next tablets at the usual time. Do not take a break between blister packs. Instead, start the next blister pack immediately.

You will probably have withdrawal bleeding at the end of the second blister pack, but you may have spotting or breakthrough bleeding during the second blister pack.

• 2. You can also stop taking tablets from the blister pack and go straight to the 7-day break ( make a note of the day you missed the tablet). If you want to start the next blister pack on the scheduled start day, you can shorten the break to less than 7 days.

Following one of the above recommendations will provide protection against pregnancy.

• If you have missed any tablets in the blister pack and you do not have withdrawal bleeding during the first withdrawal week, you may be pregnant. Before starting the next blister pack, you should contact your doctor.

4. POSSIBLE UNDESIRABLE EFFECTS

Like all medications, Axia may cause undesirable effects, although they do not occur in everyone. If any undesirable effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Axia, they should consult a doctor.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disease). 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".
Below is a list of undesirable effects associated with the use of Axia.
Common undesirable effects(observed in less than 1 in 10 patients):

• mood swings;
• headache;
• abdominal pain (stomach pain);
• acne;
• breast pain, breast enlargement, breast tenderness, painful or irregular menstrual periods;
• weight gain.

Uncommon undesirable effects(observed in less than 1 in 100 patients):

• Candida (fungal infection);
• herpes simplex;
• allergic reactions;
• increased appetite;
• depression, nervousness, sleep disorders;
• feeling of "tingling", dizziness;
• vision problems;
• heart rhythm disorders or extremely rapid heart rate;
• high blood pressure, low blood pressure, migraine, varicose veins;
• sore throat;
• nausea, vomiting, gastritis and/or enteritis, diarrhea, constipation;
• sudden swelling of the skin and/or mucous membranes (e.g., tongue or throat) and/or difficulty swallowing or hives with accompanying difficulty breathing (angioedema), hair loss (alopecia), rash, itching, skin rashes, dry skin, seborrheic dermatitis;
• neck pain, limb pain, muscle cramps;
• urinary tract infection;
• breast tumor (benign and malignant), milk secretion in non-pregnant women (galactorrhea), ovarian cysts, sudden facial flushing, absence of menstruation, very heavy menstrual periods, discharge, vaginal dryness, pain in the lower abdomen (pelvic pain), abnormal Pap smear;
• fluid retention, lack of energy, strong thirst, excessive sweating;
• weight loss.

Rare undesirable effects(observed in less than 1 in 1000 patients):

• asthma;
• hearing disorders;
• erythema nodosum (characterized by painful, red nodules on the skin);
• erythema multiforme (rash with redness or blisters in a target shape);
• dangerous blood clots in the veins or arteries, such as: o in the leg or foot (e.g., deep vein thrombosis); o in the lung (e.g., pulmonary embolism); o heart attack; o stroke; o mini-stroke or transient symptoms resembling a stroke, known as a transient ischemic attack; o 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 more information on risk factors and symptoms of blood clots).
You should immediately consult a doctor if you experience any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives with potential difficulty breathing (see also the "Warnings and precautions" section).

Reporting undesirable effects

If you experience any undesirable effects, including those not listed in the leaflet, you should inform your doctor, pharmacist, or nurse.
Undesirable effects can be reported directly to the Department of Monitoring of Undesirable Effects of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: 22 49-21-301,
fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl .
Undesirable effects can also be reported to the marketing authorization holder.
Reporting undesirable effects will help gather more information on the safety of the medication.

5. HOW TO STORE AXIA MEDICATION

Axia medication should be stored out of sight and reach of children.
Store at a temperature below 30°C.
Do not use this medication after the expiration date stated on the packaging after the words
"Expiration date:" or "EXP:". The expiration date refers to the last day of the given month.
Medications should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Axia medication contains:

• The active substances of Axia are ethinylestradiol and drospirenone. Each tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
• The other ingredients (excipients) are lactose monohydrate, cornstarch, 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 medication looks like and what the packaging contains

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

Some package sizes may not be available on the market.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized for marketing in the Member States of the European Economic Area under the following names:
Netherlands:
Modolew 0.02 mg/3 mg, film-coated tablets
Poland:
Axia
Estonia:
Orindille
Lithuania:
Orindille 3 mg/0.02 mg film-coated tablets
Latvia:
Orindille 0.02 mg/3 mg coated tablets
Date of last revision of the leaflet: December 2024