Axia Forte

PATIENT INFORMATION LEAFLET: USER INFORMATION

Axia Forte, 0.03 mg + 3 mg, coated tablets

Ethinylestradiol +Drospirenone

You should carefully read the contents of this 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 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 the veins and arteries, especially in the first year of use or after a break of 4 weeks or more
• You should be vigilant and consult your doctor if you suspect that you have symptoms of a blood clot (see section 2 "Blood clots")

Table of contents:

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

2. Important information before taking Axia Forte

3. How to take Axia Forte

4. Possible side effects

5. How to store Axia Forte

6. Contents of the pack and other information

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

Axia Forte 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 TAKING AXIA FORTE

General notes

Before starting to take Axia Forte, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of a blood clot (see section 2 "Blood clots").
Before starting to take Axia Forte, 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 may also perform other examinations, depending on the case.
This leaflet describes situations where you should stop taking Axia Forte or where its effectiveness may be reduced. You should then refrain from intercourse 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 changes. These methods may be ineffective because Axia Forte disrupts the monthly cycle of temperature changes and cervical mucus secretion.

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

When not to take Axia Forte:

You should not take Axia Forte if you have any of the conditions listed below. If you have any of these conditions, 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 section 6). This may cause itching, rash, or swelling;
• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know that you have blood clotting disorders - 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 "Blood clots");
• if you have ever 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 transient ischemic attack (temporary stroke symptoms);
• if you have any of the following diseases, which 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 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 abnormal;
• if you have kidney problems (kidney failure);
• if you have been diagnosed with a liver tumor;
• if you have been diagnosed with or suspected to have breast cancer or genital cancer;
• if you have unexplained vaginal bleeding;

You should not take Axia Conti if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also "Axia Conti 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 disease
You should not take Axia Conti if you have liver disease. See also "When not to take Axia Conti" and "Warnings and precautions".
Patients with kidney disease
You should not take Axia Conti if you have kidney failure or acute kidney failure. See also "When not to take 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), a blood clot in your lungs (pulmonary embolism), a heart attack, or a stroke (see 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 taking Axia Forte 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 taking Axia Forte, you should also tell your doctor:

• if any of your close relatives have had breast cancer;
• 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 a high level 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 "Blood clots");
• if you are immediately after childbirth, you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Axia Forte 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 "Axia Forte and other medicines");
• if you have a disease that first occurred during pregnancy or while taking sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters that occurs during pregnancy (pregnancy pemphigoid), a nervous system disease that causes sudden movements of the body (Sydenham's chorea));
• if you have chloasma (skin discoloration, especially on the face and neck, called "pregnancy spots"). In this case, you should avoid direct exposure to sunlight and ultraviolet radiation;
• if you have symptoms such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives with difficulty breathing, you should contact your doctor immediately. Estrogen-containing products may cause or worsen the symptoms of hereditary angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Axia Forte, 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 the veins (called "venous thromboembolism" or "deep vein thrombosis"),
• in the arteries (called "arterial thromboembolism" or "arterial thrombosis").

Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.
Why might the patient be suffering?
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 pain or swelling in the calf, increased temperature in the affected leg, discoloration of 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 most often occur in one eye:
• sudden loss of vision or Central retinal vein thrombosis (blood clot in the eye)
• painless vision disturbances, which can lead to loss of vision.

Why might the patient be suffering?
Is the patient experiencing any of these symptoms?

• chest pain, discomfort, feeling of pressure or heaviness;
• feeling of squeezing or fullness in the chest, arm, or area below the breastbone;
• feeling of fullness, symptoms similar to indigestion or choking; Heart attack
• discomfort in the upper body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or fainting;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat.
• sudden weakness or numbness of the face, arm, or leg, especially on one side of the body;
• sudden confusion, difficulty speaking or understanding speech;
• sudden vision disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance, or coordination; Stroke
• sudden, severe, or prolonged headache without a known cause;
• loss of consciousness or fainting with or without seizures. In some cases, stroke symptoms may be transient with almost immediate and complete recovery, however, you should contact your doctor immediately, as you may be at risk of having another stroke.
• swelling and slight blue discoloration of the skin of the legs or arms; Blood clots blocking other blood vessels
• severe abdominal pain (acute abdomen).

BLOOD CLOTS IN VEINS

What can cause a blood clot in a vein?

• Taking 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 taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot breaks loose from the leg and travels to 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 (central retinal vein thrombosis).

When is the risk of blood clots in veins highest?

The risk of 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, but it is always higher than when not taking combined hormonal contraceptives.
If you stop taking Axia Forte, 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 due to Axia Forte is small.

• -In one year, about 2 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• -In one year, about 5-7 out of 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• -In one year, about 9-12 out of 10,000 women who take combined hormonal contraceptives containing drospirenone, such as Axia Forte, will develop blood clots.
• -The risk of blood clots depends on individual 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 due to Axia Forte is small, but some factors can increase this risk. The risk is higher:

• if you are overweight (body mass index (BMI) over 30 kg/m2);
• 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 genetic 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 taking Axia Forte for a few weeks before surgery or immobilization. If you need to stop taking Axia Forte, you should ask your doctor when you can start taking it again;
• with age (especially over 35 years old);
• if you smoke. If you are taking a hormonal contraceptive like Axia Forte, you are advised to stop smoking. If you are over 35 years old and cannot stop smoking, your doctor may advise you to use a different type of contraception;

BLOOD CLOTS IN ARTERIES

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

Similar to blood clots in veins, blood clots in arteries can cause serious complications, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

Factors that increase the risk of blood clots in arteries
It is important to note that the risk of heart attack or stroke due to Axia Forte is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke. If you are taking a hormonal contraceptive like Axia Forte, you are advised to stop smoking. If you are over 35 years old and cannot stop smoking, your doctor may advise you to use 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 had 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, irregular heartbeat called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe, the risk of blood clots may be even higher.
You should inform your doctor if any of these conditions change while taking Axia Forte, e.g., if you start smoking, if someone in your immediate family has a blood clot without a known cause, or if you gain weight significantly.

Axia Forte and cancer

Women taking combined hormonal contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by the contraceptives. It is possible, for example, that women taking combined hormonal contraceptives are more likely to have breast cancer detected, as they are more likely to have regular check-ups with their doctor. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have regular breast exams and to contact your doctor if you notice any lump.
In rare cases, women taking oral contraceptives have been found to have benign liver tumors, and in even rarer cases, malignant liver tumors. If you experience severe abdominal pain, you should contact your doctor.

Psychiatric disorders

Some women taking hormonal contraceptives, including Axia Forte, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, you should contact your doctor as soon as possible for further medical advice.

Irregular bleeding

During the first few months of taking Axia Forte, you may experience unexpected bleeding (bleeding outside of the withdrawal bleeding). 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

If you have taken all the tablets correctly, have not vomited, or had severe diarrhea, and have not taken any other medicines, it is very unlikely that you are pregnant.
If withdrawal bleeding does not occur twice in a row, 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 Forte 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 taking Axia Forte. They may tell you if you need to use additional contraceptive methods (e.g., condoms) and for how long or if you need to change the way you take another necessary medicine.
Some medicines may affect the level of Axia Forte in your blood, reduce its effectiveness in preventing pregnancy, or cause unexpected bleeding. These include:

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

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

• medicines containing cyclosporin;
• antiepileptic medicines: lamotrigine (which may lead to an increased risk of seizures);
• theophylline (used to treat breathing problems);
• tizanidine (used to treat muscle pain and/or muscle spasms)

You should not take Axia Forte if you have hepatitis C and are taking antiviral medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause elevated liver function tests (increased ALT enzyme levels).
Your doctor will recommend a different type of contraception before starting these medicines.
You can start taking Axia Forte again about 2 weeks after stopping the above treatment. See "When not to take Axia Forte".
Before taking any medicine, you should consult your doctor or pharmacist.

Axia Forte with food and drink

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

Lab 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 take Axia Forte. If you become pregnant while taking Axia Forte, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Axia Forte at any time (see also "Stopping Axia Forte").

Breastfeeding

Axia Forte is not recommended during breastfeeding. If you are breastfeeding and want to take Axia Forte, you should consult your doctor.

Driving and using machines

There is no information suggesting that taking Axia Forte affects the ability to drive or operate machines.

Important information about some of the ingredients of Axia Forte

Axia Forte contains lactose.
If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. HOW TO TAKE AXIA FORTE

You should take one Axia Forte 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. Each tablet has the day of the week printed on it. 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 arrows on the blister pack until you have taken all 21 tablets.
Then, you should not take any tablets for the next 7 days. During this 7-day break (also called the withdrawal bleed period), you should have your withdrawal bleeding. This is usually called "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the break.
On the 8th day after taking the last Axia Forte 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 the next blister pack on the same day of the week and that the withdrawal bleeding should occur on the same days every month.
By taking Axia Forte 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 taking a hormonal contraceptive in the previous monthYou should start taking Axia Forte on the first day of your period (i.e., the first day of bleeding). If you start taking Axia Forte on the first day of your period, you are immediately protected against pregnancy. There is also the possibility of starting to take Axia Forte between days 2-5 of your period, but in this case, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Axia Forte.
• Changing from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or transdermal patchThere is the possibility of starting to take Axia Forte the next day after taking the last active tablet from the previous contraceptive or no later than the day after the usual withdrawal bleeding (or the last inactive tablet from the previous contraceptive). When changing from a combined hormonal contraceptive vaginal ring or patch, you should follow your doctor's advice.
• Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system)There is the possibility of changing on any day of taking progestogen-only pills (or on the day the implant or intrauterine system is removed or when the next progestogen-only injection would be due), but in all cases, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Axia Forte.
• After a miscarriageYou should follow your doctor's advice.
• After childbirthAxia Forte can be started between 21 and 28 days after giving birth. If you start taking Axia Forte later than 28 days after giving birth, you should use a barrier method (e.g., condoms) for the first 7 days of taking Axia Forte. If you have had sex after childbirth and before starting or restarting Axia Forte, you should first make sure that you are not pregnant or wait for your first menstrual period.
• If you are breastfeeding and want to start or restart Axia Forte after childbirthYou should read the section "Breastfeeding".

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

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

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

What to do if you forget to take Axia Forte

• If it has been less than 12 hourssince 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 it has been more than 12 hourssince 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 pack. Therefore, you should follow the instructions below (see the diagram below):

• You missed more than one tablet in this packYou should contact your doctor.
• You missed one tablet in week 1You 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 first 7 days. If you had sex in the week before missing the tablet, you should be aware that you may be at risk of pregnancy. In this case, you should contact your doctor.
• You missed one tablet in week 2You 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 missed one tablet in week 3You 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 packs. Start the next pack immediately.

It is likely that you will have withdrawal bleeding at the end of the second pack, but you may experience spotting or breakthrough bleeding while taking tablets from the second pack.

• 2. You can also stop taking tablets from the pack and have a 7-day break ( make a note of the day you missed the tablet). If you want to start the next pack on the usual start day, you can make the break shorter than 7 days.

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

• If you forget to take any tablet from the pack and do not have withdrawal bleeding in the first break, you may be pregnant. Before starting the next pack, you should contact your doctor.

4. POSSIBLE UNDESIRABLE EFFECTS

Like all medicines, Axia Forte can cause undesirable effects, although they do not occur in everyone. If any undesirable effects occur, especially severe and persistent ones or changes in health that the patient considers to be related to the use of Axia Forte, 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 taking Axia Forte".
Below is a list of undesirable effects associated with the use of Axia Forte.
Common undesirable effects(observed in less than 1 in 10 patients):

• headache;
• menstrual disorders; intermenstrual bleeding;
• acne;
• mood swings, depression;
• migraine;
• breast pain, breast enlargement, breast tenderness, painful or irregular menstrual periods;
• thick, white vaginal discharge and vaginal yeast infections.

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

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

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/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 contact a doctor if you experience 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 the "Warnings and precautions" section).

Reporting undesirable effects

If you experience any undesirable effects, including any 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,
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 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 to gather more information on the safety of the medicine.

5. HOW TO STORE AXIA FORTE

Axia Forte should be stored out of sight and reach of children.
Store at a temperature below 30°C.
Do not use this medicine 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENT OF THE PACKAGING AND OTHER INFORMATION

What Axia Forte contains:

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

What Axia Forte looks like and what the packaging contains

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

Some pack sizes may not be marketed.

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 in the Member States of the European Economic Area under the following names:
Netherlands:
Baradly 0.03 mg/3 mg, film-coated tablets
Poland:
Axia Forte
Estonia:
Orindille
Lithuania:
Orindille 3 mg/0.03 mg film-coated tablets
Latvia:
Orindille 0.03 mg/3 mg coated tablets
Slovakia
Czech Republic
Axia 0.03 mg/3 mg film-coated tablets
Axia 0.03 mg/3 mg coated tablets
Date of last revision of the leaflet: December 2024