Axia forte plus

Package leaflet: Information for the patient

Axia Forte Plus, 0.03 mg + 3 mg, film-coated tablets
Ethinylestradiolum + Drospirenonum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, 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 one of 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 Forte Plus is and what it is used for
2. What you need to know before taking Axia Forte Plus
3. How to take Axia Forte Plus
4. Possible side effects
5. How to store Axia Forte Plus
6. Contents of the pack and other information

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

• Axia Forte Plus is a contraceptive tablet used to prevent pregnancy.
• Each of the 21 yellow tablets contains a small amount of two different female hormones called drospirenone and ethinylestradiol.
• The seven white tablets do not contain any active substances and are also known as placebo tablets.
• Contraceptives containing two hormones are called combined hormonal contraceptives.

2. Important information before taking Axia Forte Plus

General notes
Before starting to take Axia Forte Plus, you should read the information about blood clots (thrombosis) in section 2. It is especially important to become familiar with the symptoms of blood clots (see section 2. "Blood clots").
Before you can start using Axia Forte 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 situation, may carry out some other tests.
This leaflet describes several situations in which you should stop taking Axia Forte Plus 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 the rhythm method or temperature-based methods. These methods may be unreliable because Axia Forte Plus alters the monthly changes in body temperature and cervical mucus.
Axia Forte Plus, like other hormonal contraceptives, does not protect against infection with HIV (AIDS) or other sexually transmitted diseases.

When not to take Axia Forte Plus
Do not use Axia Forte Plus if you have any of the conditions listed below. If you have any of these conditions, 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 blood vessels of your legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in 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 presence of 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 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 fats in the blood (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 currently have (or have previously had) liver disease and liver function is still not normal;
• if you have kidney function disorders (kidney failure);
• if you currently have (or have previously had) liver tumour;
• if you currently have (or have previously had) or are suspected of having breast cancer or cancer of the genital organs;
• 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 Forte Plus should not be used by patients with hepatitis C virus infection who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Axia Forte Plus and other medicines").

Additional information for special populations
Children and adolescents
Axia Forte Plus is not intended for use in girls before the onset of menstruation.

Elderly patients
Axia Forte Plus is not intended for use after menopause.

Patients with liver function disorders
Do not take Axia Forte Plus if you have liver disease. See also sections "When not to use Axia Forte Plus" and "Warnings and precautions".

Patients with kidney function disorders
Do not take Axia Forte Plus if you have kidney failure or acute kidney failure. See also sections "When not to use Axia Forte Plus" and "Warnings and precautions".

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

You should immediately contact your doctor

• if you notice any probable symptoms of blood clots, which may indicate that you have a blood clot 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".

Tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Axia Forte Plus, you should also inform your doctor. In certain situations, special caution is required when using Axia Forte Plus or any other combined oral contraceptive. Regular check-ups by your doctor may also be necessary.
Inform your doctor or pharmacist before starting Axia Forte Plus if you have any of the following conditions:

• if close relatives currently have or have previously had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (a disease affecting the natural immune 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 been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have 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 developing blood clots. Consult your doctor for advice on how soon after delivery you can start taking Axia Forte Plus;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see "Axia Forte Plus 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, herpes gestationis (blistering skin rash during pregnancy), Sydenham's chorea (a nervous system disorder with involuntary body movements));
• if you have or have ever had brownish patches (chloasma), 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 with breathing difficulties, seek immediate medical attention. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Axia Forte Plus is associated with an increased risk of blood clots compared to not using such therapy. 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 disorders").
  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.

Remember that the overall risk of harmful blood clots caused by taking Axia Forte Plus is small.

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

Probable 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, blueness.

• sudden unexplained shortness of breath or rapid breathing;

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

• sharp chest pain, which may worsen with deep breathing;

• severe dizziness or vertigo;
  Pulmonary embolism

• rapid or irregular heartbeat;

• severe stomach pain.

If you are unsure, consult your doctor,
as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions,
such as respiratory tract infection (e.g., cold).

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 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 taking combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (either 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 woman stops taking Axia Forte Plus, the risk of developing 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 Forte Plus is low.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and who 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 9–12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Axia Forte Plus, will develop blood clots.
• The risk of developing blood clots depends on the individual's medical history (see "Factors that increase the risk of developing blood clots in veins" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Axia Forte Plus is low,
however, 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). In this case, the patient may have an inherited clotting disorder;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue the use of Axia Forte Plus several weeks before surgery or during immobilization. If the patient needs to stop taking Axia Forte Plus, consult the doctor about when it is safe to resume;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of developing venous blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of venous blood clots,
particularly if the patient has another risk factor.
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 the use of Axia Forte Plus.
Inform the doctor if any of the above conditions change during treatment with Axia Forte Plus, 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?
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 Forte Plus is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Axia Forte Plus, it is recommended to stop smoking. If the patient is unable to quit 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 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 such 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 arterial blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Axia Forte Plus, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Axia Forte Plus and cancer
A slightly increased incidence of breast cancer has been observed in women using combined oral contraceptives, but it is not known whether this is caused by the use of the pills. For example, more cancers may be 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 contact the doctor if any lump is detected.
Benign liver tumors have been reported rarely in women using oral contraceptives, and malignant liver tumors have been reported even more rarely. If the patient experiences unusual, severe abdominal pain or abdominal distension, medical advice should be sought immediately.

Psychiatric disorders
Some women using hormonal contraceptives, including Axia Forte Plus, have reported depression or mood disturbances. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking Axia Forte 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 starts after several months of use, the doctor should investigate the cause.

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

Axia Forte Plus and other medicines
Inform the doctor about all medicines currently or recently taken, including herbal products, and any medicines the patient plans to take.
The patient should inform other doctors, dentists, or pharmacists prescribing other medicines that she is using Axia Forte 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 Forte Plus and may reduce contraceptive effectiveness or 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 osteoarthritis (etoricoxib);
  • pulmonary hypertension (bosentan);
• herbal products containing St John's wort (Hypericum perforatum).

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

• medicines containing cyclosporine;
• the antiepileptic drug 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.
Do not administer Axia Forte Plus to patients with hepatitis C virus infection who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may lead to elevated liver function test parameters in blood (increased activity of the liver enzyme AlAT).
The doctor will prescribe another form of contraception before starting treatment with these medicinal products.
Axia Forte Plus may be restarted approximately 2 weeks after completing this treatment. See section "When not to use Axia Forte Plus".

Axia Forte Plus 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 blood tests are required, inform the doctor or laboratory staff that the patient is taking oral contraceptives, as hormonal contraceptives may affect the results of certain tests.

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

Breastfeeding
Axia Forte Plus is generally not recommended during breastfeeding. If the patient wishes to use oral contraceptives while breastfeeding, she should consult her doctor.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before using this medicine.

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

Axia Forte Plus contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before using this medicinal product.

3. How to use Axia Forte Plus

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Each blister contains 21 yellow active tablets and 7 white placebo tablets.
The Axia Forte Plus tablets in two different colours are arranged in the correct order. The blister
contains 28 tablets.
Take one tablet of Axia Forte Plus every day, with a small amount of water if necessary. Tablets may be taken independently of meals, but at approximately the same time each day.
One blister contains 28 tablets, each marked with a day of the week. Begin the pack with the tablet marked with the appropriate day of the week. For example, if starting treatment on Wednesday, take the tablet marked “WED”. Take one tablet daily.
Move in the direction of the arrow on the blister until all 28 tablets have been taken. Do not confuse the tablets: for the first 21 days, take one yellow tablet daily, then for the following 7 days, one white tablet daily, after which begin a new blister (21 yellow tablets and 7 white tablets). Thus, there is no break between taking tablets from one blister to the next.
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 yellow active tablet of Axia Forte Plus. After taking the last white placebo tablet, begin the next blister, regardless of whether bleeding has stopped or not. This means that starting tablets from a new blister should always occur on the same day of the week, and withdrawal bleeding should begin on the same day each month.
Axia Forte Plus, when used in this way, protects against pregnancy even during those
7 days when the patient is taking placebo tablets.

When to start the first blister?

• If no hormonal contraceptive has been used in the previous month Start taking Axia Forte Plus on the first day of the cycle (i.e. the first day of menstruation). If Axia Forte Plus is started on the first day of menstruation, it provides immediate protection against pregnancy. Axia Forte 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 transdermal patch) Start taking Axia Forte Plus the day after taking the last active tablet (containing active substances) of the previous combined oral contraceptive, but no later than the day after the tablet-free interval of the previous combined oral contraceptive (or after taking 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 Forte Plus on the day of removal of the system, 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) Switching may occur 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 of the next scheduled injection), but in all cases, additional barrier methods (e.g. condoms) must be used for the first 7 days of taking the tablets.
• After miscarriage or termination of pregnancy Follow the doctor’s advice.
• After childbirth Axia Forte Plus may be started on day 21–28 after delivery. If starting Axia Forte Plus later than day 28, a mechanical method (e.g. condoms) must be used for the first 7 days of taking Axia Forte Plus. If the patient had intercourse after childbirth before starting Axia Forte Plus, she should first confirm she is not pregnant or wait until the next menstruation occurs.
• If the patient is breastfeeding and wishes to start (or restart) taking Axia Forte Plus after childbirth Read section “Breast-feeding”.

If in doubt about when to start the first blister, consult a doctor.
Taking more than the recommended dose of Axia Forte Plus
There are no reports of serious harmful effects from taking too many Axia Forte 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 but have accidentally taken this medicine.
If an overdose of Axia Forte Plus is taken or if a child swallows some tablets, consult a doctor or pharmacist.

Missed dose of Axia Forte 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 Forte Plus. The missed placebo tablet should be discarded.
If the patient forgets to take a yellow, 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. In such cases, follow the rules below (see also the chart below):

• More than one tablet missed from the blister Consult a doctor.
• One tablet 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 intercourse occurred in the week before the missed tablet, be aware that there is a risk of pregnancy. In such a case, consult a doctor.
• One tablet 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 additional contraceptive methods are not necessary.
• One tablet 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, during the intake of the white placebo tablets, but spotting or menstrual-like bleeding may also occur during the second blister.

2. Alternatively, stop taking the active yellow tablets and proceed directly to 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 fewer than 7 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 days, this may indicate pregnancy. Consult a doctor before starting the next blister.

The following chart illustrates the recommended actions 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 a yellow active tablet or if severe diarrhoea occurs, there is a risk that the active substances from the tablet have not been fully absorbed. In such a case, additional contraceptive methods (e.g. condoms) may be necessary to prevent pregnancy. The situation is similar to that of a missed tablet. If vomiting or diarrhoea occurs, take another yellow 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 recommendations given in the section “Missed dose of Axia Forte Plus”.

Delayed withdrawal bleeding: what to know
Although not recommended, the patient may delay withdrawal bleeding by skipping the white placebo tablets in the fourth row and proceeding directly to a new blister of Axia Forte Plus until it is finished. During intake of the second blister, menstrual-like bleeding or spotting may occur. Tablets from the second blister should be taken until the end, including the 7 white placebo tablets in the fourth row. Then start the next blister.
Before deciding to delay bleeding, 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 shift the day of bleeding, she should reduce the number of placebo days (when taking the white placebo tablets) (never increase them—maximum 7 days!). For example, if the patient usually starts placebo tablets on Friday but wishes bleeding to start on Tuesday (3 days earlier), she should start the new blister 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 treatment with Axia Forte Plus
Treatment with Axia Forte Plus may be stopped at any time. If the patient does not wish to become pregnant, consult a doctor about other effective methods of birth control. If the patient wishes to become pregnant, she should stop taking Axia Forte Plus and wait for the first menstruation. This makes it easier to calculate the expected date of delivery.
If there are any further doubts regarding the use of this medicine, consult a 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 any changes in health that the patient considers to be related to the use of Axia Forte 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 disorders) 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 Forte Plus".

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

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
• headache, mood changes
• migraine
• nausea
• sticky, whitish vaginal discharge and fungal vaginal infection.

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

• breast enlargement, decreased or increased interest in sex
• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, skin rash, severe itching, hair loss
• vaginal infection
• fluid retention in the body, and increase or decrease in body weight.

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

• allergic reactions, asthma
• breast discharge
• impaired hearing
• skin disorders: nodular erythema (characterized by painful, red skin nodules) or erythema multiforme (rash with redness and pain)
• harmful blood clots in a vein or artery, for example:
  • in the leg or foot (so-called deep vein thrombosis)
  • in the lungs (so-called pulmonary embolism)
  • heart attack
  • stroke
  • mini-stroke or transient ischaemic attack (TIA)
  • blood clots in the liver, stomach and intestines, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (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 accompanied by breathing difficulties (see also section "Warnings and precautions").
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Axia Forte Plus

Keep this medicine out of sight and reach of children.
No special storage instructions apply for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack in the place 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. Such measures help protect the environment.

6. Contents of the package and other information

What Axia Forte Plus contains
The Axia Forte Plus blister pack contains 21 yellow, 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 (0.03 mg) and drospirenone (3 mg).
Other ingredients are:
Tablet core: monohydrate lactose, corn starch, pregelatinized corn starch,
crospovidone, polyvinylpyrrolidone, Polysorbate 80, magnesium stearate
Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171),
Macrogol 3350, talc, yellow iron oxide (E172),
Placebo tablets:
Tablet core: monohydrate lactose, polyvinylpyrrolidone, magnesium stearate
Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), Macrogol
3350, talc
What Axia Forte Plus looks like and contents of the pack
Active tablets – yellow, round coated tablets.
Placebo tablets – white, round coated tablets.
Axia Forte Plus is available in packages containing 1, 2, 3, 6 and 13 blisters, each
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 in the European Economic Area member states under the following names:
Norway Rosal 28
Netherlands Rosal 28
Sweden Rosal 28 0.03 mg/3 mg film-coated tablets
Poland Axia Forte Plus