AXIA 0.02 mg/3 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Axia Conti, 0.02 mg + 3 mg, coated tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Important information about combined hormonal contraceptives
   3. Table of contents of the leaflet
3. What is Axia Conti and what is it used for
4. Important information before using Axia Conti
   1. General notes
   2. Similarly to other hormonal contraceptives, Axia Conti does not protect against HIV (AIDS) and other sexually transmitted diseases.
   3. When not to use Axia Conti
   4. Additional information for special populations
   5. Warnings and precautions
   6. You should tell your doctor if you have any of the following conditions.
   7. BLOOD CLOTS
   8. Remember that the overall risk of having a harmful blood clot due to Axia Conti is small.
   9. HOW TO RECOGNIZE A BLOOD CLOT
   10. BLOOD CLOTS IN VEINS
   11. What can happen if a blood clot forms in a vein?
   12. When is the risk of blood clots in veins highest?
   13. What factors increase the risk of blood clots in veins?
   14. BLOOD CLOTS IN ARTERIES
   15. What can happen if a blood clot forms in an artery?
   16. Factors that increase the risk of blood clots in arteries
   17. Axia Conti and cancer
   18. Irregular bleeding
   19. What to do if bleeding does not occur during the placebo period
   20. Axia Conti and other medicines
   21. Using Axia Conti with food and drink
   22. Lab tests
   23. Pregnancy
   24. Breast-feeding
   25. Driving and using machines
   26. Axia Conti contains lactose
   27. Axia Conti contains sodium
5. How to use Axia Conti
   1. Preparing the blister pack
   2. When can you start the first blister pack?
   3. What to do if you have taken more than the recommended dose of Axia Conti
   4. What to do if you forget to take Axia Conti
   5. If you have missed more than one tablet from the blister pack
   6. If you have missed one tablet between days 1 and 7 (first row of tablets)
6. Possible side effects
   1. Reporting side effects
7. How to store Axia Conti
8. Package contents and other information
   1. What Axia Conti contains
   2. What Axia Conti looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: information for the user

Axia Conti, 0.02 mg + 3 mg, coated tablets

Ethinylestradiol + Drospirenone

You should carefully read the contents of the leaflet before using 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 as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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 you have symptoms of a blood clot (see: section 2 "Blood clots")

Table of contents of the leaflet

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

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

• Axia Conti is a contraceptive pill and is used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
• The four white tablets do not contain active substances and are also called placebo tablets.
• Contraceptive pills that contain two hormones are called combined hormonal contraceptives.

2. Important information before using Axia Conti

General notes

Before starting to take Axia Conti, 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 you can start using Axia Conti, your doctor will ask you a few questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and may perform some other examinations in individual cases.
This leaflet describes several situations in which you should stop using the medicine or in which the effectiveness of the medicine may be reduced. In such situations, you should either not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. You should not use the rhythm method or temperature measurement. These methods can be unreliable, as Axia Conti affects the monthly changes in body temperature and cervical mucus.

Similarly to other hormonal contraceptives, Axia Conti does not protect against HIV (AIDS) and other sexually transmitted diseases.

When not to use Axia Conti

You should not use Axia Conti 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 for you:

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know that you have blood clotting 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 "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have 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 (transient 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 disease called hyperhomocysteinemia;
• if you have (or have had) a type of migraine called "migraine with aura";
• if you have (or have had) liver disease, and liver function is still abnormal;
• if you have kidney problems (kidney failure);
• if you have (or have had) liver cancer;
• if you have (or have had) or suspect you have breast cancer or cancer of the genital organs;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol, drospirenone, or any of the other ingredients of this medicine (listed in section 6). Itching, rash, or swelling may occur;

You should not use Axia Conti if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentaswir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Axia Conti and other medicines").

Additional information for special populations

Children and adolescents
Axia Conti is not intended for use in girls before their first menstrual period.
Elderly patients
Axia Conti is not intended for use after menopause.
Patients with liver function disorders
You should not take Axia Conti if you have liver disease. See also sections "When not to use Axia Conti" and "Warnings and precautions".
Patients with kidney function disorders
You should not take Axia Conti if you have kidney failure or acute kidney failure. See also sections "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 you notice any of the following symptoms, which could indicate that you have a blood clot, such as deep vein thrombosis, pulmonary embolism, heart attack, or stroke (see below "Blood clots (thrombosis)").

To find a description of 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.

In certain situations, you should be particularly careful when using Axia Conti or any other combined hormonal contraceptive. Regular examination by a doctor may also be necessary. If any of the following conditions occur, you should inform your doctor before starting to use Axia Conti. If these symptoms occur or worsen while using Axia Conti, you should also tell your doctor:

• if a close relative has had or has breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression; Some women using hormonal contraceptives, including Axia Conti, have reported depression or mood swings. 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 (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 hereditary disease 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 section 2 "Blood clots");
• if you have just given birth, as you are at increased risk of blood clots. You should consult your doctor about how soon you can start taking Axia Conti 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 Conti and other medicines");
• if you have a disease that first appeared during pregnancy or while using sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy (pregnancy pemphigoid), a nervous system disease characterized by involuntary movements of the body (Sydenham's chorea));
• if you have or have ever had chloasma (melasma), especially on the face. In such a case, you should avoid direct exposureto sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, 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.

You should discuss this with your doctor before starting to use Axia Conti.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Axia Conti, is associated with an increased risk of blood clots compared to not using the therapy. In rare cases, a blood clot can block a blood vessel and cause serious complications. Blood clots can occur

• in veins (deep vein thrombosis or venous thromboembolism);
• in arteries (arterial thrombosis or arterial thromboembolism). Not everyone who has a blood clot will recover completely, and in rare cases, the effects of a blood clot can be long-lasting or even fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.

BLOOD CLOTS IN VEINS

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

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). Although 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 another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins highest?

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of 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 not using combined hormonal contraceptives.
If you stop using Axia Conti, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk of blood clots associated with Axia Conti 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 a hereditary blood clotting disorder;
• if you need to have surgery, if you are immobilized for a long time due to injury or illness, or if you have a leg in a cast. It may be necessary to stop using Axia Conti for a few weeks before surgery or planned immobilization. If you need to stop using Axia Conti, you should ask your doctor when you can resume using the medicine;
• 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 patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has 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 using Axia Conti.
You should inform your doctor if any of the above conditions change while using Axia Conti, 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 to 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 a heart attack or stroke associated with Axia Conti is very small, but it may increase:

• with age (over approximately 35 years old);
• if you smoke.While using a hormonal contraceptive like Axia Conti, it is recommended to quit smoking. If you are unable to 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 increased 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 particularly 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 Conti, e.g., if you start smoking, if someone in your close family is diagnosed with a blood clot without a known cause, or if you gain significant weight.

Axia Conti and cancer

Women using combined contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by the pills. It is possible that more tumors are detected in women using combined contraceptives because they are examined by doctors more often. The frequency of breast tumors decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to examine your breasts regularly and contact your doctor if you feel any lump.
Women using contraceptive pills have rarely reported benign liver tumors, and even more rarely, malignant liver tumors. If you experience unusual, severe stomach pain, you should contact your doctor.

Irregular bleeding

During the first few months of using Axia Conti, you may experience unexpected bleeding (bleeding outside of the placebo period). 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 bleeding does not occur during the placebo period

If all the active tablets have been taken correctly, no vomiting or severe diarrhea has occurred, and no other medicines have been taken, it is very unlikely that you are pregnant.
If the expected bleeding does not occur twice in a row, it may indicate pregnancy. You should contact your doctor immediately. You should only start the next pack of Axia Conti when you are sure you are not pregnant.

Axia Conti and other medicines

You should tell your doctor about all the medicines and herbal products you have taken recently or are planning to take. You should also tell any other doctor or dentist prescribing other medicines or pharmacist dispensing the medicines about using Axia Conti. 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 use of another necessary medicine.
Certain medicines may affect the level of Axia Conti in your blood and may cause it to be less effective in preventing pregnancy or may cause unexpected bleeding:

• these include medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• 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) and fungal infections (griseofulvin or ketoconazole);
• rheumatoid arthritis, osteoarthritis (etoricoxib);
• high blood pressure in the blood vessels of the lungs (bosentan),
• herbal products containing St. John's Wort (Hypericum perforatum). Axia Conti may affect the action of other medicines, e.g.,:
• medicines containing cyclosporin,
• the antiepileptic medicine lamotrigine (this may lead to an increased frequency of seizures),
• theophylline (used to treat respiratory problems),
• tizanidine (used to treat muscle pain and/or muscle spasms).

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken and any medicines you plan to take.
Do not use Axia Conti in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentaswir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause abnormal liver function test results (elevated liver enzymes).
Before starting these medicines, your doctor will prescribe a different contraceptive method.
You can start taking Axia Conti again after about 2 weeks after stopping the above treatment. See section "When not to use Axia Conti".
Before taking any medicine, consult your doctor or pharmacist.

Using Axia Conti with food and drink

The tablet can be taken with or without food, if necessary, with a small amount of water.

Lab tests

If a blood test is necessary, 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

Pregnant women should not take Axia Conti. If you become pregnant while using Axia Conti, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop using Axia Conti at any time (see also: "Stopping Axia Conti").
Before taking any medicine, consult your doctor or pharmacist.

Breast-feeding

Generally, Axia Conti is not recommended for use during breast-feeding. If you want to take contraceptive pills while breast-feeding, you should contact your doctor.
Before using any medicine, consult your doctor or pharmacist.

Driving and using machines

There is no information suggesting that the use of Axia Conti affects the ability to drive or operate machines.

Axia Conti contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before starting to use this medicine.

Axia Conti contains sodium

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

3. How to use Axia Conti

This medicine should always be taken as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
Each blister pack contains 24 pink active tablets and 4 white placebo tablets.
The Axia Conti tablets in two different colors are arranged in the correct order. The blister pack contains 28 tablets.
You should take one Axia Conti tablet every day, with a small amount of water if necessary. The tablets can be taken with or without food, but you should take them at the same time every day.
You should be careful not to mix up the tablets:for the first 24 days, you should take a pink active tablet, and then a white tablet for the last 4 days. Then, you should start taking the tablets from a new blister pack (24 pink active tablets and 4 white tablets) immediately. There is no break between the two packs.
Due to the differences in the composition of the tablets, you should start taking the medicine from the tablet located in the top left corner of the blister pack and take them in the order indicated by the arrows on the blister pack.

Preparing the blister pack

To ensure that you take the tablets correctly every day, each Axia Conti blister pack comes with 7 self-adhesive strips with the days of the week printed on them. You should choose a strip that starts with the first day of your period. For example, if your period starts on a Wednesday, you should use the strip that starts with "WED".
You should stick the strip onto the blister pack in the top left corner, where it says "Start". This way, each tablet is marked, and you can check if you have taken the correct tablets. The arrows show the order in which you should take the tablets.
During the 4 days when you take the white placebo tablets (placebo days), you should experience bleeding (so-called withdrawal bleeding). It usually starts on the 2nd or 3rd day after taking the last pink active tablet. After taking the last white placebo tablet, you should start a new blister pack, regardless of whether the bleeding has stopped. This means that you should always start a new pack of Axia Conti on the same day of the week, and the withdrawal bleeding should start on the same day of the month.
Axia Conti used in this way will also protect you against pregnancy during these 4 days when you are taking the placebo tablets.

When can you start the first blister pack?

• If you have not used hormonal contraceptives in the previous month

You should start using Axia Conti on the first day of your period (i.e., the first day of menstruation). If you start using Axia Conti on the first day of your period, it will protect you against pregnancy immediately. You can also start taking Axia Conti between the 2nd and 5th day of your period. However, in this case, you should use an additional contraceptive method (e.g., condoms) for the first 7 days of tablet intake.

• Switching from another combined hormonal contraceptive, a vaginal ring system, or a transdermal patch system

You can start using Axia Conti the day after taking the last active tablet (containing active substances) of your previous contraceptive or at the latest on the day following the break in taking the tablets of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive pills). When switching from a combined vaginal ring system or a transdermal patch system, you should follow your doctor's instructions.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system (IUS) releasing progestogen)

You can switch from a progestogen-only pill (from an implant or an IUS) on any day (from an injection when the next injection is due), but in all cases, you should use additional barrier methods (e.g., condoms) for the first 7 days of tablet taking.

• After a miscarriage

You should follow your doctor's instructions.

• After childbirth

You can start using Axia Conti between the 21st and 28th day after giving birth. If you start using Axia Conti later than 28 days after giving birth, you should use a barrier method (e.g., condoms) for the first 7 days of tablet taking. If you have had sexual intercourse after giving birth before (re)starting Axia Conti, you should first make sure you are not pregnant or wait for your next period.

• If you are breast-feeding and want to start using Axia Conti after giving birth

See section "Breast-feeding".
If you are unsure when to start using Axia Conti, you should consult your doctor.

What to do if you have taken more than the recommended dose of Axia Conti

There are no reports of serious harmful effects from taking too many Axia Conti tablets at once.
If you have taken several tablets at once, you may experience symptoms such as nausea, vomiting, or vaginal bleeding. This type of bleeding may occur even in girls who have not yet started their periods, but have taken the medicine by mistake.
If you have taken too many Axia Conti tablets or if a child has swallowed some, you should contact your doctor or pharmacist immediately.

What to do if you forget to take Axia Conti

The last 4 tablets in the fourth rowof the blister pack are placebo tablets. If you miss one of these tablets, it will not affect the effectiveness of Axia Conti. You should discard any placebo tablets that you miss.
If you forget to take one of the pink active tablets (tablets 1-24 in the blister pack), you should:

• If the delay in taking the tablet is less than 24 hours, the contraceptive effectiveness is maintained. You should take the tablet as soon as you remember, and then take the next tablets at the usual time.
• If the delay in taking the tablet is more than 24 hours, the contraceptive effectiveness may be reduced. The more tablets you miss, the higher the risk of pregnancy.

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

If you have missed more than one tablet from the blister pack

You should contact your doctor.

If you have missed one tablet between days 1 and 7 (first row of tablets)

You should take the missed tablet as soon as you remember, even if it means taking two tablets at once. You should then take the next tablets at the usual time and use additional barrier methods, such as condoms, for the next 7 days. If you have had sexual intercourse during 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effects, especially serious or persistent ones, or changes in your health that you think are related to the use of Axia Conti, consult your doctor. 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 thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, see section 2 "Important information before taking Axia Conti". You should contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with difficulty breathing (see also "Warnings and precautions"). The following side effects have been reported with the use of Axia Conti.

• Common side effects(may affect up to 1 in 10 people)
• mood changes,
• headaches,
• nausea,
• breast pain, menstrual problems, such as irregular menstruation or absence of menstruation.
• Uncommon side effects(may affect up to 1 in 100 people)
• depression, nervousness, drowsiness,
• dizziness, tingling sensation,
• migraine, varicose veins, high blood pressure,
• abdominal pain, vomiting, indigestion, gas, gastritis, diarrhea,
• acne, itching, rash,
• painful conditions, e.g. back pain, limb pain, muscle cramps,
• vaginal fungal infections, pelvic pain, breast enlargement, benign breast tumors, uterine and/or vaginal bleeding (which usually decreases during continued use of the medicine), vaginal discharge, hot flashes, vaginitis, menstrual disorders, painful, scanty or very heavy menstruation, vaginal dryness, abnormal Pap smear result, decreased libido,
• lack of energy, excessive sweating, fluid retention in the body,
• weight gain.
• Rare side effects(may affect up to 1 in 1000 people)
• candidiasis (fungal infection),
• anemia, increased platelet count,
• allergic reaction,
• hormonal disorders (endocrine),
• increased appetite, loss of appetite, abnormal high potassium levels in the blood, abnormal low sodium levels in the blood,
• difficulty achieving orgasm, insomnia,
• dizziness, tremors,
• eye disorders, e.g. blepharitis, dry eye,
• abnormal rapid heartbeat,
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g. deep vein thrombosis),
• in the lungs (e.g. pulmonary embolism),
• heart attack,
• stroke,
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach, intestine, kidneys, or eye. The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots):

blood clots in the veins, nosebleeds, fainting,

The following side effects have also been reported, but their frequency cannot be determined from the available data: hypersensitivity, erythema multiforme (rash with redness in the shape of targets or ulcers).

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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.

5. How to store Axia Conti

Store below 30°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the package after "Do not use after" or "EXP". The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Axia Conti contains

• The active substances of Axia Conti are ethinylestradiol and drospirenone.

Each active pink film-coated tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone. The white film-coated tablet does not contain active substances.

• Other ingredients are:

Pink active film-coated tablets: lactose monohydrate, cornstarch, povidone K30, croscarmellose sodium, polysorbate 80, magnesium stearate, polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172). White inactive film-coated tablets: anhydrous lactose, povidone K30, magnesium stearate, polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc

What Axia Conti looks like and what the package contains

• Each Axia Conti blister contains 24 pink active film-coated tablets in the first, second, third, and fourth rows of the package and 4 white film-coated placebo tablets in the fourth row.
• Axia Conti tablets are film-coated tablets; the tablet core is coated.
• Axia Conti is available in boxes containing 1, 3, 6, and 13 blisters, each containing 28 (24+4) tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

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

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Netherlands
Ethinylestradiol/Drospirenon 0.02 mg/3 mg, Focus, film-coated tablets
Poland:
Axia Conti
Romania
Xanthadu 3 mg/ 0.02 mg film-coated tablets
United Kingdom
Xanthadu 3 mg/0.02 mg, film-coated tablets
France
Phizoe0.02 mg/3 mg, film-coated tablet
Denmark
Etindros 24
Czech Republic
AXIA DAILY 0.02 mg/3 mg film-coated tablets
Slovakia
AXIA DAILY 0.02/3 mg film-coated tablets
Greece
Xanthadu 3 mg/0.02 mg
Date of last revision of the leaflet: April 2024