Axia conti

Patient Information Leaflet

Axia Conti, 0.02 mg + 3 mg, film-coated tablets
Ethinylestradiolum + Drospirenonum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Important information about combined hormonal contraceptives

• When 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 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 a blood clot (see section 2: "Blood clots").

Leaflet Contents

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

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

• Axia Conti is a contraceptive tablet 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 any active substance and are also known as placebo tablets.
• Contraceptive tablets containing 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 the occurrence of blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Before starting treatment with Axia Conti, 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, in individual cases, may perform additional tests.
This leaflet describes several situations in which you should stop taking the medicine or when its effectiveness may be reduced. In such cases, 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 methods or temperature measurement, as these methods may be unreliable since Axia Conti affects monthly changes in body temperature and cervical mucus.
Like other hormonal contraceptives, Axia Conti does not protect against HIV (AIDS) and other sexually transmitted infections.

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

• 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 you have 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 "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have previously had) 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 have 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 blood fats (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia;
• if you currently have (or have previously had) a type of migraine called "migraine with aura";
• if you have (or have previously had) liver disease and liver function remains abnormal;
• if you have kidney problems (kidney failure);
• if you have (or have previously had) liver tumour;
• if you have (or have previously had) or are suspected of having 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). Symptoms may include itching, rash, or swelling.

Do not take Axia Conti if you have hepatitis C and are being treated with medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, 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 the onset of menstruation.

Elderly patients
Axia Conti is not intended for use after menopause.

Patients with liver function disorders
Do 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
Do 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?
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a 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".

Tell your doctor if you have any of the following conditions.
Special caution may be needed when using Axia Conti or any other combined hormonal contraceptive. Regular medical check-ups may also be necessary. Inform your doctor before starting Axia Conti if you have any of the following conditions. If any of these symptoms develop or worsen during treatment with Axia Conti, you should also inform your doctor:

• if a close relative has or has had 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 low mood. Depression can be severe and, in some cases, may lead to suicidal thoughts. If you experience mood changes or symptoms of depression, 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 affecting the body's natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have high blood fat levels (hypertriglyceridaemia) or a 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 have recently given birth, as you are then at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Axia Conti;
• if you have inflammation of superficial veins (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see "Axia Conti and other medicines");
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nervous system disorder with involuntary body movements (Sydenham's chorea));
• if you have or have ever had brownish pigmentation spots, so-called pregnancy mask, especially on the face (chloasma). In such cases, you should 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 hives with difficulty breathing — seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Discuss this with your doctor before starting Axia Conti.

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

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events"). Full 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 using Axia Conti is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.

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 venous blood clots (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 venous blood clots the highest?
The risk of developing venous blood clots 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 than in women who do not use combined hormonal contraceptives.
If a patient stops taking Axia Conti, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on the individual's natural risk of developing 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 Conti is low.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of 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 the course of one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Axia Conti, will develop blood clots.
• The risk of developing blood clots depends on the patient's individual medical history (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 Conti is small, 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 has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In this case, the patient may have an inherited clotting disorder;
• if the patient is due to undergo surgery, will be immobile for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Axia Conti several weeks before surgery or planned immobility. If the patient must stop taking Axia Conti, ask the doctor when it is safe to restart;
• with increasing age (especially over 35 years);
• if the patient has given birth within the last few weeks.

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

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with 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 Axia Conti is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Axia Conti, smoking should be stopped. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different 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 this 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 fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve problems, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any condition is particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Axia Conti, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Axia Conti and cancer
A slightly increased incidence of breast cancer has been observed in women using combined hormonal contraceptives, but it is not known whether this is caused by taking the pills. It is possible, for example, that more tumours are detected in women using combined hormonal 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 a doctor if any lump is detected.
Rarely, benign liver tumours and even more rarely malignant liver tumours have been reported in women using contraceptive pills. If the patient experiences unusual, severe abdominal pain, she should contact a doctor.

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

What to do if no bleeding occurs during the placebo tablet days
If all the pink active tablets have been taken correctly, without vomiting, severe diarrhoea, or use of other medications, it is very unlikely that the woman is pregnant.
If the expected withdrawal bleed does not occur twice in succession, pregnancy may be possible. Contact the doctor immediately. The next pack of tablets should only be started once pregnancy has been ruled out.

Axia Conti and other medicines
Inform the doctor about all recently taken medicines and herbal products. Also inform any other doctor, including a dentist prescribing other medicines, or a pharmacist dispensing them, that you are taking Axia Conti. They will advise whether additional contraceptive methods (e.g. condoms) are needed, for how long, or whether changes to other necessary medicines are required.
Some medicines may affect the blood levels of Axia Conti and may make it less effective in preventing pregnancy or may cause unexpected bleeding:

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

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

• medicines containing cyclosporine,
• the antiepileptic drug lamotrigine (this may lead to increased frequency of seizures),
• theophylline (used to treat breathing problems),
• tizanidine (used to treat muscle pain and/or muscle spasms).

Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not use Axia Conti in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may lead to abnormal liver function test results (increased liver enzyme ALT activity).
Before starting these medicines, the doctor will prescribe a different type of contraception.
Axia Conti may be restarted approximately 2 weeks after stopping the above-mentioned treatment. See section “When not to use Axia Conti”.
Before taking any medicine, consult a doctor or pharmacist.

Taking Axia Conti with food and drink
The medicine may be taken with or without food, and if necessary, with a small amount of water.

Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that you are taking contraceptive pills, as hormonal contraceptives may affect the results of certain tests.

Pregnancy
Axia Conti must not be taken during pregnancy. If the patient becomes pregnant while taking the medicine, she should stop immediately and contact her doctor. If the patient wishes to become pregnant, she may stop taking the medicine at any time (see also: “Discontinuation of Axia Conti”).

Before taking any medicine, consult a doctor or pharmacist.

Breast-feeding
Axia Conti is generally not recommended while breast-feeding. If the patient wishes to take contraceptive pills during breast-feeding, she should contact her doctor.

Before using any medicine, consult a doctor or pharmacist.

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

Axia Conti contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, she should consult her doctor before starting this medicine.

Axia Conti contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered “sodium-free”.

3. How to use Axia Conti

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult
your doctor or pharmacist.
Each blister contains 24 pink active tablets and 4 white placebo tablets.
The Axia Conti tablets in two different colours are arranged in the correct order. Each blister contains 28
tablets.
Take one Axia Conti tablet daily, swallowing it with a small amount of water if necessary. Tablets may be taken
independently of meals, but should be taken at approximately the same time each day.
Be careful not to confuse the tablets: for the first 24 days take the pink tablet, then the white tablet for the final 4 days. After that, start taking tablets from a new blister pack immediately (24
pink tablets and 4 white tablets). Therefore, there is no break between packs.
Due to differences in tablet composition, it is essential to start from the tablet located in the top left corner of the blister and take them daily in sequence. To maintain the correct order, proceed in the direction of the arrows on the blister.
Preparing the blister pack
To ensure proper daily tablet intake, each Axia Conti blister pack is supplied with 7 self-adhesive strips printed with the 7 days of the week. Choose the strip where the first day of the week corresponds to the day you start taking the tablets. For example, if the first day of use is Wednesday, apply the strip where the first day of the week is “WE.”
Apply the label to the top left corner of the blister, at the place marked “Start.” This way, each tablet will be labelled above, allowing you to check whether the correct tablets have been taken. Arrows indicate the order of tablet intake.
During the 4 days when the patient takes the white placebo tablets (placebo days), withdrawal bleeding (so-called withdrawal bleed) should begin. It usually starts on the 2nd or 3rd day after taking the last pink active tablet. After taking the last white placebo tablet, start the next blister pack immediately, regardless of whether bleeding has stopped. This means that starting a new blister pack should always occur on the same day of the week, and withdrawal bleeding should begin on the same day each month.
Axia Conti, when used in this way, provides protection against pregnancy even during these 4 days when the patient takes placebo tablets.
When to start the first blister pack?

• If no hormonal contraceptives were used in the previous month

Begin taking Axia Conti on the first day of the cycle (i.e. the first day of menstruation). If the medicine is started on the first day of menstruation, immediate protection against pregnancy is provided. The medicine 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 of tablet intake.

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

You may start taking Axia Conti the next day after taking the last active tablet (containing active ingredients) of the previous contraceptive, but no later than the day following the tablet-free interval of the previous contraceptive (or after taking the last inactive tablet of the previously used contraceptive). When switching from a combined vaginal ring or transdermal system, follow your doctor’s advice.

• Switching from a progestogen-only method (progestogen-only pills, injections, implant, or intrauterine device (IUD) releasing progestogen)

You may switch at any time from a progestogen-only pill (from an implant or intrauterine system (IUD) on the day of removal, or from an injectable form on the day of the next scheduled injection), but in all cases, additional barrier methods (e.g. condoms) must be used for the first 7 days of tablet intake.

• After miscarriage

Follow your doctor’s advice.

• After childbirth

Axia Conti may be started between day 21 and day 28 after childbirth. If the medicine is started later than day 28, a barrier method (e.g. condoms) must be used for the first 7 days of taking the medicine. If sexual intercourse occurred before (re)starting Axia Conti, first ensure that you are not pregnant or wait until the next menstruation occurs.

• If the patient is breastfeeding and wishes to (re)start taking Axia Conti after childbirth

See section “Breastfeeding”.
If the patient is unsure when to start taking the medicine, she should consult her doctor.
Taking more than the recommended dose of Axia Conti
There are no reports of serious harmful effects from taking too many tablets.
If several tablets are taken at once, symptoms such as nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but accidentally took this medicine.
If too many Axia Conti tablets are taken or if a child swallows some tablets, consult a doctor or pharmacist immediately.
Missed dose of Axia Conti
The last 4 tablets in the fourth row of the blister are placebo tablets. If one of these tablets is missed, it will not affect the effectiveness of Axia Conti. Any missed placebo tablets should be discarded.
If the patient forgets to take a pink active tablet (tablets 1–24 in the blister), follow these instructions:

• If the delay in taking the tablet is less than 24 hours, contraceptive effectiveness is maintained. Take the tablet as soon as remembered, then continue taking the next tablets at the usual time.
• If the delay in taking the tablet is more than 24 hours, contraceptive effectiveness may be reduced. The more tablets the patient forgets, the greater the risk of pregnancy.

The risk of incomplete protection against pregnancy is greatest if the patient forgets a pink tablet 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 from the blister has been missed

Contact your doctor.

• One tablet was missed between days 1 and 7 (first row of tablets)

Take the missed tablet as soon as remembered, even if this means taking two tablets at the same time. Continue taking the next tablets at the usual time and use additional protection, e.g. 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, contact your doctor.

• One tablet was missed between days 8 and 14 (second row of tablets)

Take the missed tablet as soon as remembered, even if this means taking two tablets at once. Continue taking the next 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 between days 15 and 24 (third or fourth row of tablets)

Two options are available:

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

Withdrawal bleeding (similar to menstruation) will most likely occur at the end of the second blister pack, during the intake of the white placebo tablets, but spotting or breakthrough 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 4 white placebo tablets (before taking the placebo tablets, write down the day on which the patient forgot to take the tablet). If the patient wishes to start the next pack on the same day as usual, the placebo tablets may be taken for fewer than 4 days.

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

• If the patient forgets to take any tablet from the blister and no bleeding occurs during the placebo tablet days, this may indicate pregnancy. Contact a doctor before starting the next blister pack.

Contact your doctor.
More than one
pink tablet
missed from 1 blister

ta k

Days 1–7 Did sexual intercourse occur in the previous
week?

No

• Take the missed tablet
• Use a barrier method (condoms) for the next 7 days.
• Finish taking tablets from the blister.

One pink tablet
missed (taken with
Days 8–14 – Take the missed tablet
delay over 24 hours).

• Take the missed tablet and
• Finish taking the pink tablets.
• Discard the 4 white tablets.
• Start the next blister pack.

Days 15–24 or

• Immediately stop taking tablets.
• Immediately start taking the white tablets.
• Then start the next blister pack.

What to do in case of vomiting or severe diarrhoea
If vomiting occurs within 3–4 hours after taking a pink active tablet or if severe diarrhoea occurs, there is a risk that the active ingredients have not been fully absorbed into the body. The situation is similar to missing tablets. If vomiting or diarrhoea occurs, take another pink active tablet from a spare pack as soon as possible. If possible, take it within 24 hours of the usual tablet-taking time. If this is not possible or more than 24 hours have passed, follow the advice given in the section “Missed dose of Axia Conti”.
Delayed withdrawal bleeding: what you should know
Although not recommended, the patient may delay withdrawal bleeding by skipping the white placebo tablets in the fourth row and going directly to a new blister pack of Axia Conti, continuing until the pack is finished. During intake of the second blister pack, light bleeding or breakthrough bleeding similar to menstruation may occur. Tablets from the second blister pack should be taken until the end, including the 4 white placebo tablets in the fourth row. Then start the next blister pack.
Before deciding to delay the withdrawal bleed, consult your doctor.
Changing the first day of withdrawal bleeding: what you should know
If the patient takes the tablets as directed, bleeding will begin during the placebo tablet days. If the patient wishes to shift the day of bleeding onset, she should reduce the number of days taking placebo tablets — by shortening the intake of white placebo tablets (but never extend this period — it must not exceed 4 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 should start the new blister pack 3 days earlier than usual. Bleeding may not occur at that time. Light bleeding or breakthrough bleeding may occur instead.
If the patient is unsure how to proceed, she should contact her doctor.
Stopping Axia Conti
Axia Conti may be discontinued at any time. If the patient does not wish to become pregnant, she should consult her doctor about other effective methods of contraception. If the patient wishes to become pregnant, she should stop taking Axia Conti, use another contraceptive method, and wait for the first menstruation before trying to conceive. This will make it easier to calculate the expected date of delivery.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Axia Conti, medical advice should be sought immediately.
All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2, "Important information before taking Axia Conti".
Immediate medical attention is required 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").
Below is a list of adverse effects associated with the use of Axia Conti.

• Common adverse effects (may occur in less than 1 in 10 people)

• mood changes,

• headache,

• nausea,

• breast pain, menstrual disorders such as irregular or absent periods.

• Uncommon adverse effects (may occur in less than 1 in 100 people)

• depression, nervousness, drowsiness,

• dizziness, tingling sensation,

• migraine, varicose veins, increased blood pressure,

• abdominal pain, vomiting, dyspepsia, flatulence, gastritis, diarrhoea,

• acne, itching, rash,

• pain-related symptoms, e.g. back, limb pain, muscle cramps,

• vaginal fungal infections, pelvic pain, breast enlargement, benign breast nodules, uterine and/or vaginal bleeding (which usually decreases with continued use of the medicine), vaginal discharge, hot flushes, vaginal inflammation, menstrual disorders, painful, scanty or very heavy periods, vaginal dryness, abnormal cervical smear test results, decreased interest in sex,

• lack of energy, excessive sweating, fluid retention,

• weight gain.

• Rare adverse effects (may occur in less than 1 in 1000 people)

• candidiasis (fungal infection),

• anaemia, increased platelet count,

• allergic reaction,

• endocrine disorders (hormonal imbalances),

• increased appetite, loss of appetite, abnormally high blood potassium levels, abnormally low blood sodium levels,

• inability to achieve orgasm, insomnia,

• dizziness, tremor,

• eye disorders, e.g. eyelid inflammation, dry eyes,

• abnormally rapid heartbeat,

• harmful blood clots in veins or arteries, 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 transient ischaemic attack,

• blood clots in the liver, stomach, intestines, kidneys or eye. The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots):

• phlebitis, nosebleeds, fainting,

• abdominal swelling, intestinal disorders, bloating, abdominal hernia, oral fungal infection, constipation, dry mouth,

• biliary or gallbladder pain, cholecystitis,

• yellowish-brown skin patches, eruptions, hair loss, acneiform dermatitis, dry skin, nodular dermatitis, excessive hair growth, skin disorders, stretch marks, dermatitis, photosensitive dermatitis, skin nodules,

• painful or difficult sexual intercourse, vaginal inflammation (vulvovaginitis), post-coital bleeding, cessation of bleeding, breast cysts, increased number of breast gland cells (hyperplasia), malignant breast tumours, abnormal endometrial hyperplasia, endometrial atrophy or shrinkage, ovarian cysts, uterine enlargement,

• general malaise,

• weight loss.

The following adverse effects have also been reported; however, based on currently available data, their frequency cannot be determined: hypersensitivity, erythema multiforme (rash with target-shaped redness or ulceration).
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Adverse effects can also be reported to the marketing authorisation holder.

5. How to store Axia Conti

Store below 30°C.
Keep the medicine in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging after "Do not use after" or "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of down the drain or in household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Axia Conti contains

• The active substances are ethinylestradiol and drospirenone.

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

• Other ingredients are:

Pink active coated tablets: lactose monohydrate, maize starch gelatinised, povidone
K30, sodium croscarmellose, 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 coated tablets: anhydrous lactose, povidone K30, magnesium stearate,
polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

What Axia Conti looks like and contents of the pack

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

Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area under the following names:
Netherlands: Ethinylestradiol/Drospirenone 0.02 mg/3 mg, Focus, filmomhulde
tabletten
Poland: Axia Conti
Romania: Xanthadu 3 mg/0.02 mg comprimate filmate
United Kingdom: Xanthadu 3 mg/0.02 mg, film-coated tablets
France: Phizoe 0.02 mg/3 mg, comprimé pelliculé
Denmark: Etindros 24
Czech Republic: AXIA DAILY 0.02 mg/3 mg potahované tablety
Slovakia: AXIA DAILY 0.02/3 mg filmom obalené tablety
Greece: Xanthadu 3 mg/0.02 mg