Axia plus

Package leaflet: information for the patient

Axia Plus, 0.02 mg + 3 mg, coated tablets
Ethinylestradiolum + Drospirenonum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives

• When used correctly, they are among the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2. "Blood clots").

Leaflet contents

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

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

• Axia Plus is a contraceptive tablet used to prevent pregnancy.
• Each of the 21 pink tablets contains a small amount of two different female hormones called drospirenone and ethinylestradiol.
• The seven white tablets contain no active substances and are also known as placebo tablets.
• Contraceptives containing two hormones are called combined hormonal contraceptives.

2. Important information before taking Axia Plus

General notes
Before starting to take Axia Plus, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2 "Blood clots").
Before you can start using Axia Plus, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual case, may carry out some other tests.
This leaflet describes several situations in which you should stop taking Axia Plus or in which the effectiveness of Axia Plus may be reduced. In such situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use fertility awareness-based methods or temperature monitoring methods. These methods may be unreliable because Axia Plus alters the monthly changes in body temperature and cervical mucus.
Axia Plus, like other hormonal contraceptives, does not protect against infection with HIV (AIDS) or other sexually transmitted diseases.

When not to take Axia Plus
Do not take Axia Plus if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which other method of contraception may be more suitable:

• if you currently have (or have ever had) a blood clot in the blood vessels of your legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have blood clotting disorders — for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have had a heart attack or stroke;
• if you suffer (or have suffered in the past) from: angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you suffer from any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a condition called hyperhomocysteinemia;
• if you currently have (or have had in the past) a type of migraine called "migraine with aura";
• if you currently have (or have had in the past) liver disease and liver function is still abnormal;
• if you have kidney function disorders (kidney failure);
• if you currently have (or have had in the past) liver tumour;
• if you currently have (or have had in the past) or are suspected of having breast cancer or genital organ cancer;
• if you have any unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity may include: itching, rash, or swelling.

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

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

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

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

For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".
You should tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Axia Plus, you should also inform your doctor. In certain situations, special caution is required when using Axia Plus or any other combined oral contraceptive. Regular medical check-ups may also be necessary.
Inform your doctor or pharmacist before starting Axia Plus if you have any of the following:

• if close relatives currently have or have had breast cancer;
• if you suffer from cancer;
• if you have liver disease (such as cholestasis, which may lead to jaundice and symptoms such as itching) or gallbladder disease (e.g. gallstones);
• if you suffer from kidney disorders and are taking medicines that increase potassium levels in the blood;
• if you have diabetes;
• if you have depression; some women using hormonal contraceptives, including Axia Plus, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (a disease affecting the body's natural immune system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you are immediately postpartum, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Axia Plus;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Axia Plus and other medicines");
• if you have a condition that first appeared during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, herpes gestationis (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous system disorder causing involuntary body movements));
• if you develop high blood pressure during treatment that persists despite medication;
• if you have or have ever had brownish patches (chloasma), also known as melasma, especially on the face. In such cases, avoid direct exposure to 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 urticaria accompanied by breathing difficulties, seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Axia Plus is associated with an increased risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious problems.
Blood clots may occur:

• in veins (called "venous thrombosis" or "venous thromboembolic disease");
• in arteries (called "arterial thrombosis" or "arterial thromboembolic disorders").
  Complete recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

It is important to remember that the overall risk of harmful blood clots caused by taking Axia Plus is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.
Possible cause
Are you experiencing any of these symptoms?
Symptoms

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:

• pain or tenderness in the leg, which may occur only when standing or walking; Deep vein thrombosis

• increased warmth in the affected leg;

• change in skin colour of the leg, e.g. paleness, redness, or blueness.

• sudden unexplained shortness of breath or rapid breathing;

• sudden cough without an obvious cause, which may be associated with coughing up blood; Pulmonary embolism

• sudden sharp chest pain, which may worsen when breathing in;

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in the veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher compared to not using combined hormonal contraceptives.
If a woman stops taking Axia Plus, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Axia Plus is low.

• In one year, about 2 out of 10,000 women who are not using combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9–12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Axia Plus, will develop blood clots.
• The risk of developing blood clots depends on the individual medical history of the woman (see "Factors that increase the risk of blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Axia Plus is low, but certain factors may increase this risk.
The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years of age). In such a case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, will be immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Axia Plus several weeks before surgery or immobilization. If the patient needs to stop taking Axia Plus, she should consult her doctor about when she can resume taking the medicine;
• with increasing age (particularly over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor listed above.
It is important to inform the doctor if any of these risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue Axia Plus.
The patient should inform her doctor if any of the above conditions change during treatment with Axia Plus, for example, if a close family member is diagnosed with thrombosis of unknown cause or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
Similar to venous blood clots, arterial clots can cause serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Axia Plus is very low, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Axia Plus, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In such a case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac arrhythmia known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
The patient should inform her doctor if any of the above conditions change during treatment with Axia Plus, for example, if she starts smoking, a close family member is diagnosed with thrombosis of unknown cause, or if she gains significant weight.

Axia Plus and cancer
Breast cancer is diagnosed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is caused by the use of the pills. For example, it may be that more cancers are detected in women using combined oral contraceptives because they are examined more frequently by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to examine the breasts regularly and to contact the doctor if any lump is detected.
Benign liver tumors have been reported rarely, and malignant liver tumors very rarely, in women using oral contraceptives. If the patient experiences unusual, severe abdominal pain or abdominal distension, she should contact her doctor.

Intermenstrual bleeding
During the first few months of taking Axia Plus, unexpected bleeding (bleeding outside the period of taking the white placebo tablets) may occur. If such bleeding persists for longer than a few months, or if it starts after several months, the doctor should investigate the cause.

What to do if withdrawal bleeding does not occur during the placebo tablet days
If all the pink active tablets have been taken correctly, without vomiting or severe diarrhoea, and no other medicines have been taken, it is very unlikely that the woman is pregnant.
If withdrawal bleeding does not occur consecutively for two cycles, pregnancy may be possible. The patient should contact her doctor immediately. The next pack of Axia Plus should only be started once pregnancy has been ruled out.

Axia Plus and other medicines
The patient should inform her doctor about all medicines currently or recently taken, including herbal products, and about any medicines she plans to take.
She should also inform other doctors, dentists, or pharmacists prescribing other medicines that she is using Axia Plus. The doctor will advise whether additional contraceptive methods (e.g., condoms) are needed and, if so, for how long.
Some medicines may affect the blood levels of Axia Plus and may reduce its effectiveness in preventing pregnancy or may cause unexpected bleeding. These include:

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

If the patient takes any of the above medicines together with Axia Plus, she should use additional contraceptive methods (e.g., condoms) during treatment and for 28 days after stopping the treatment.

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

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

If the patient is taking certain medicines used to treat heart conditions (such as diuretics), the doctor may decide to monitor blood potassium levels.
Axia Plus should not be given to patients with hepatitis C virus infection who are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause elevated liver function test parameters in blood (increased activity of the liver enzyme AlAT).
The doctor will prescribe another type of contraception before starting treatment with these medicinal products.
Axia Plus may be restarted approximately 2 weeks after completion of such treatment.
See section "When Axia Plus must not be used".

Laboratory tests
If blood tests are required, the patient should inform the doctor or laboratory staff that she is taking oral contraceptives, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
Axia Plus must not be taken during pregnancy. If the patient becomes pregnant while taking Axia Plus, she should stop taking it immediately and contact her doctor. If the patient wishes to become pregnant, she may discontinue Axia Plus at any time (see section: "Discontinuing Axia Plus").

Breastfeeding
Axia Plus is generally not recommended during breastfeeding. If the patient wishes to take oral contraceptives while breastfeeding, she should consult her doctor.

Driving and operating machinery
There is no information indicating that Axia Plus affects the ability to drive or operate machinery.

Axia Plus contains lactose and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Axia Plus

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Each blister contains 21 active pink tablets and 7 white placebo tablets.
The Axia Plus tablets in two different colours are arranged in the correct order. Each blister contains
28 tablets.
Take one tablet of Axia Plus every day, swallowing it with a small amount of water if necessary. The tablets may be taken regardless of meals, but should be taken at about the same time each day.
Preparing the blister pack.
The Axia Plus package contains 7 adhesive strips marked with days of the week. Each strip starts with a different day of the week. Choose one strip that begins with the day on which the patient intends to start taking the tablets. For example, if starting the medication on Wednesday, use the strip beginning with "WED". Apply this strip to the designated area on the packaging. The first day marked on the strip must be positioned directly below the groove marked "START". The pack should always be started with the light pink tablets and finished with the white tablets.
Take the medicine by moving in the direction of the arrows.
Each new row of tablets should be started from the left side.
During the 7 days when the patient takes the white placebo tablets (placebo days), withdrawal bleeding should occur (so-called withdrawal bleeding). This usually begins on the 2nd or 3rd day after taking the last active pink tablet of Axia Plus containing the active substances. After taking the last white placebo tablet, start the next blister pack immediately, regardless of whether bleeding has stopped or not. This means that starting a new pack should always occur on the same day of the week, and withdrawal bleeding should begin on the same day each month.
Axia Plus, when used in this way, provides protection against pregnancy also during these 7 days when the patient is taking placebo tablets.
When to start the first blister pack?

• If no hormonal contraceptives were used in the previous month Start taking Axia Plus on the first day of the cycle (i.e. the first day of menstruation). If Axia Plus is started on the first day of menstruation, it provides immediate protection against pregnancy. Axia Plus may also be started between day 2 and day 5 of the cycle. However, in this case, the patient must use an additional contraceptive method (e.g. condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or contraceptive patch) You may start taking Axia Plus the day after taking the last active tablet (containing active substances) of the previous combined oral contraceptive, but no later than the day following the tablet-free interval of the previous combined oral contraceptive (or after the last inactive tablet of the previously used contraceptive tablets). When switching from a vaginal ring or transdermal system, it is best to start Axia Plus on the day of removal, but no later than the day the next vaginal/transdermal system would have been applied.
• Switching from a progestogen-only method (progestogen-only pills, injection, implant, or intrauterine system releasing progestogen, IUS) You may switch on any day from progestogen-only pills (from an implant or intrauterine system releasing progestogen, IUS, on the day of removal, or from an injectable form on the day the next injection is due), but in all cases, additional barrier methods (e.g. condoms) must be used for the first 7 days of taking Axia Plus.
• After miscarriage or termination of pregnancy Follow your doctor's advice.
• After childbirth Axia Plus may be started on day 21–28 after delivery. If Axia Plus is started later than day 28, a mechanical method (e.g. condoms) must be used for the first 7 days of taking Axia Plus. If the patient had sexual intercourse after childbirth before starting Axia Plus (again), she should first ensure she is not pregnant or wait until the next menstruation occurs.
• If the patient is breastfeeding and wishes to start (or restart) taking Axia Plus after childbirth Please read the section "Breast-feeding".

If in doubt about when to start the first blister pack, consult your doctor.
Taking more than the recommended dose of Axia Plus
There are no reports of serious harmful effects from taking too many Axia Plus tablets.
If several tablets are taken at once, nausea, vomiting, or vaginal bleeding may occur. Vaginal bleeding may also occur in young girls who have not yet started menstruating if they have taken Axia Plus.
If too many Axia Plus tablets are taken or if a child accidentally swallows some, consult a doctor or pharmacist.
Missed dose of Axia Plus
The tablets in the fourth row of the blister are placebo tablets. If one of these placebo tablets is missed, it will not affect the effectiveness of Axia Plus. The missed placebo tablet should be discarded.
If the patient forgets to take a pink, active tablet from the first, second, or third row of the blister, follow the rules below:

• if less than 24 hours have passed since the missed tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as remembered, then continue taking the following tablets at the usual time.
• if more than 24 hours have passed since the missed tablet, protection against pregnancy may be reduced. The more tablets missed, the greater the risk of pregnancy.

The risk of incomplete protection against pregnancy is greatest if a white tablet is missed at the beginning or end of the blister pack. In such cases, follow the rules below (see also the chart below):

• More than one tablet has been missed from the pack Consult your doctor.

• One tablet was missed in week 1 Take the missed tablet as soon as remembered, even if this means taking two tablets at once. Continue taking the following tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, be aware that there is a risk of pregnancy. In this case, consult your doctor.

• One tablet was missed in week 2 Take the missed tablet as soon as remembered, even if this means taking two tablets at once. Continue taking the following tablets at the usual time.
  Contraceptive protection is not reduced, so there is no need to use an additional contraceptive method.

• One tablet was missed in week 3 Two options are available:

  1. Take the missed tablet as soon as remembered, even if this means taking two tablets at once. Then continue taking tablets at the usual time. Instead of taking the white placebo tablets from the pack, skip (discard) them and start the next pack immediately.

Menstruation will most likely occur at the end of the second blister pack, during the intake of the white placebo tablets, but spotting or menstrual-like bleeding may also occur during the intake of tablets from the second blister pack.

2. Alternatively, stop taking the pink active tablets and go directly to taking the 7 white placebo tablets ( before taking the placebo tablets, record the day on which the tablet was forgotten ). If the patient wishes to start the next pack on the same day as before, the placebo tablets may be taken for less than 7 days.

If either of these recommendations is followed, protection against pregnancy will be maintained.

• If the patient has missed any tablet from the pack and no bleeding occurs during the placebo days, this may indicate pregnancy. Consult a doctor before starting the next blister pack.

The following chart illustrates the procedure in case of a missed tablet:

What to do in case of vomiting or severe diarrhoea
If vomiting occurs within 3–4 hours after taking the pink tablet containing active substances, or if severe diarrhoea occurs, there is a risk that the active substances have not been completely absorbed. In such a case, additional contraceptive protection (e.g. condoms) may be necessary to avoid pregnancy. The situation is almost the same as in the case of missed tablets. If vomiting or diarrhoea occurs, take another pink tablet from a spare pack as soon as possible. If possible, take it within 12 hours of the usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the advice given in the section "Missed dose of Axia Plus".
Delayed withdrawal bleeding: what to know
Even though not recommended, the patient may delay the onset of bleeding by skipping the white placebo tablets in the fourth row and proceeding directly to a new blister pack of Axia Plus until its contents are exhausted. During the intake of tablets from the second blister pack, menstrual-like bleeding or spotting may occur. Tablets from the second blister pack should be taken until the end, including the 7 white placebo tablets in the fourth row. Then start the next blister pack.
Before deciding to delay bleeding, it is advisable to consult a doctor.
Changing the first day of bleeding: what to know
If the patient takes the tablets as directed, bleeding will occur during the placebo week. If the patient wishes to change the day when bleeding starts, she should reduce the number of placebo days (i.e. the days when white placebo tablets are taken) ( but never increase them
maximum 7 days! ). For example, if the patient usually starts taking placebo tablets on Friday, but would like bleeding to start on Tuesday (3 days earlier), she must start the new blister pack 3 days earlier than usual. Bleeding may not occur at that time. However, menstrual-like bleeding or spotting may occur later.

If the patient is unsure how to proceed, she should consult a doctor.
Stopping use of Axia Plus
Use of Axia Plus may be stopped at any time. If the patient does not wish to become pregnant, consult a doctor regarding other effective methods of birth control. If the patient wishes to become pregnant, she should stop taking Axia Plus and wait for the first menstruation. This will make it easier to calculate the expected date of delivery.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health that the patient considers to be related to the use of Axia Plus, medical advice should be sought from 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 disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using Axia Plus".

Below is a list of adverse reactions associated with the use of Axia Plus.
Common adverse reactions (may occur in up to 1 in 10 people):

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

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• candidiasis (fungal infection),
• herpes simplex,
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disorders,
• tingling sensation, dizziness,
• visual disturbances,
• irregular or abnormally rapid heartbeat,
• high blood pressure, low blood pressure, migraine, varicose veins,
• sore throat,
• nausea, vomiting, gastritis and/or enteritis, diarrhoea, constipation,
• alopecia, skin eruptions, itching, rash, dry skin, seborrhoeic dermatitis (disorder of sebum secretion by the skin),
• neck pain, limb pain, muscle cramps,
• urinary tract infection,
• benign breast lump, lactation (milk secretion) when not pregnant, ovarian cyst, hot flushes, absence of menstruation, very heavy menstrual bleeding, vaginal discharge, vaginal infections or vaginitis, vaginal dryness, pelvic pain,
• fluid retention, fatigue, excessive thirst, excessive sweating,
• weight loss.

Rare adverse reactions (may occur in up to 1 in 1000 people):

• asthma,
• hearing impairment,
• erythema nodosum (characterized by painful, red skin nodules),
• erythema multiforme (rash with redness and pain),
• harmful blood clots in veins or arteries, for example:
  o in the leg or foot (so-called deep vein thrombosis),
  o in the lungs (so-called pulmonary embolism),
  o heart attack,
  o stroke,
  o transient ischaemic attack (TIA) or temporary stroke-like symptoms,
  o blood clots in the liver, stomach and intestine, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors increasing this risk (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).
Immediate medical attention should be sought if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially associated with breathing difficulties (see also section "Warnings and precautions").

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C PL-02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Axia Plus

Keep the medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack in the space
marked “Do not use after:” or “EXP”. The expiry date “Lot” refers to the last day of the stated
month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Axia Plus contains
The Axia Plus blister pack contains 21 pink, active tablets in the first, second, and third rows
and 7 white placebo tablets in the fourth row.
Active tablets:
The active substances are: ethinylestradiol (0.02 mg) and drospirenone (3 mg).
Other ingredients are:
Tablet core: monohydrate lactose, pregelatinized corn starch, polyvinylpyrrolidone,
sodium croscarmellose, Polysorbate 80, magnesium stearate
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171),
Macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)
Placebo tablets:
Tablet core: monohydrate lactose, polyvinylpyrrolidone, magnesium stearate
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), Macrogol 3350, talc
What Axia Plus looks like and contents of the pack
Active tablets – pink, round, film-coated tablets.
Placebo tablets – white, round, film-coated tablets.
Axia Plus is available in packs containing 1, 2, 3, 6 and 13 blisters, each blister containing
28 tablets (21 active tablets and 7 placebo tablets).
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Laboratorios Leon Farma, S.A.
C/ La Vallina, s/n,
Polígono Industrial Navatejera,
Villaquilambre 24193 (León),
Spain
This medicinal product is authorised for marketing in the European Economic Area under the following names:
France DROSPIRENONE / ETHINYLESTRADIOL VIATRIS CONTINU 3 mg/ 0.02 mg, comprimé pelliculé
Norway Iren 28
Sweden Estron 0.02 mg/3 mg, filmdragerad tablett
Poland Axia Plus