Axia Forte Plus

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Axia Forte Plus, 0.03 mg + 3 mg, film-coated tablets

Ethinylestradiol + Drospirenone

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• You should be vigilant and consult a doctor if you suspect that you have symptoms of a blood clot (see section 2. "Blood clots").

Table of contents of the leaflet

• 1. What is Axia Forte Plus and what is it used for
• 2. Important information 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 packaging and other information

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

• Axia Forte Plus is a contraceptive pill and is 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 active substances and are also called placebo tablets.
• Contraceptives containing two hormones are called combined 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 read about the symptoms of a blood clot (see section 2. "Blood clots").
Before you can start taking Axia Forte Plus, your doctor will ask you a few questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual case, may also perform some other tests.
This leaflet describes several situations in which you should stop taking Axia Forte Plus or in which the effectiveness of Axia Forte Plus may be reduced. In such situations, you should either not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. You should not use the observation method or the temperature measurement method. These methods may be unreliable because Axia Forte Plus modifies the monthly changes in body temperature and cervical mucus.

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

When not to take Axia Forte Plus

You should not use Axia Forte Plus if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable for you:

• if you currently have (or have ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know that you have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section 2. "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (temporary stroke symptoms);
• if you have any of the following diseases that may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia;
• if you have (or have had in the past) a type of migraine called "migraine with aura";
• if you have (or have had in the past) liver disease, and liver function is still not normal;
• if you have kidney problems (kidney failure);
• if you have (or have had in the past) liver cancer;
• if you have (or have had in the past) or suspect you have breast cancer or cancer of the genital organs;
• if you have any vaginal bleeding of unknown origin;
• 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 women with hepatitis C virus infection who are taking medicines 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
Axia Forte Plus should not be taken if you have liver disease. See also sections "When not to take Axia Forte Plus" and "Warnings and precautions".
Patients with kidney function disorders
Axia Forte Plus should not be taken if you have kidney failure or acute kidney failure. See also sections "When not to take Axia Forte Plus" and "Warnings and precautions".

Warnings and precautions

Before starting to take Axia Forte Plus, you should discuss it with your doctor or pharmacist.
When should you contact your doctor?
You should contact your doctor immediately

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

To find a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

You should tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen while taking Axia Forte Plus, you should also tell your doctor. In some situations, you should be particularly careful when taking Axia Forte Plus or any other combined oral contraceptive pill. You may also need to have regular check-ups with your doctor.
If any of the following conditions occur, you should inform your doctor or pharmacist before starting to take Axia Forte Plus:

• if any of your close relatives have had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have Crohn's disease or ulcerative colitis (a chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2. "Blood clots");
• if you have just given birth, as you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Axia Forte Plus after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Axia Forte Plus and other medicines");
• if you have a disease that first appeared during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disease called porphyria, herpes gestationis (a skin rash that occurs during pregnancy), Sydenham's chorea (a neurological disorder characterized by involuntary movements of the body));
• if you have or have ever had chloasma (melasma), especially on the face. In this case, 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, you should contact your doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Axia Forte Plus, is associated with an increased risk of blood clots compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis");
• in arteries (also known as "arterial thromboembolism"). Not all patients who have a blood clot will recover fully. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
Probable cause of the complaint

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, such as pallor; Deep vein thrombosis

redness, cyanosis.

• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe stomach pain. Pulmonary embolism

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

BLOOD CLOTS IN VEINS

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

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. Most often, they occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and lodges in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming a blood clot in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not taking combined hormonal contraceptives.
If you stop taking Axia Forte Plus, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Axia Forte Plus is small.

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

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Axia Forte Plus is small, but some factors can increase this risk.
The risk is higher:

• if you are overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your close family has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years old). In this case, you may have a genetic blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time (see section 2. "Blood clots");
• with age (especially over 35 years old);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in your individual situation.
Long-distance air travel (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is important to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop Axia Forte Plus.
You should inform your doctor if any of the above conditions change while taking Axia Forte Plus, e.g. if someone in your close family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

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

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

Factors that increase the risk of blood clots in arteries

It is important to note that the risk of heart attack or stroke associated with Axia Forte Plus is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke. While taking a hormonal contraceptive, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your close family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, arrhythmia called atrial fibrillation);
• if you have diabetes.

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

Axia Forte Plus and cancer

Women taking combined oral contraceptives have a slightly higher risk of breast cancer, but it is not known whether this is caused by the pill. For example, more tumors may be detected in women taking combined oral contraceptives because they are examined by doctors more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is important to examine your breasts regularly and contact your doctor if you feel any lump.
Women taking oral contraceptives have been reported to have, in rare cases, benign liver tumors, and in even rarer cases, malignant liver tumors. If you feel severe abdominal pain or abdominal swelling, you should contact your doctor.

Psychiatric disorders

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

Irregular bleeding

During the first few months of taking Axia Forte Plus, you may experience unexpected bleeding (bleeding outside of the placebo period). If such bleeding persists for more than a few months or starts after a few months, your doctor should investigate the cause.

What to do if you do not experience withdrawal bleeding during the placebo days

If you have taken all the active tablets correctly, have not vomited, and have not had severe diarrhea, and have not taken any other medicines, it is very unlikely that you are pregnant.
If you do not experience withdrawal bleeding for two consecutive periods, it may mean that you are pregnant. You should contact your doctor immediately. You can only start the next pack of Axia Forte Plus when you are sure that you are not pregnant.

Axia Forte Plus and other medicines

You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any herbal products you are taking, and any medicines you plan to take.
You should inform other doctors or your dentist that you are taking Axia Forte Plus if they prescribe other medicines (or your pharmacist). Your doctor will tell you whether you need to use additional contraception (e.g. a condom) and if so, for how long.
Some medicines may affect the level of Axia Forte Plus in your blood 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); high blood pressure in the blood vessels of the lungs (bosentan);
• herbal products containing St. John's Wort (Hypericum perforatum).

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

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

If you are taking certain medicines for heart conditions (such as diuretics), your doctor may decide to monitor your potassium levels in your blood.
Axia Forte 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 enzymes in the blood (increased ALT activity).
Your doctor will prescribe a different type of contraception before starting treatment with these medicines.
Axia Forte Plus can be taken again about 2 weeks after the end of this treatment. See section "When not to take Axia Forte Plus".

Axia Forte Plus with food and drink

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

Lab tests

If a blood test is necessary, you should tell your doctor or laboratory staff that you are taking contraceptive pills, as hormonal contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy

Pregnant women should not take Axia Forte Plus. If you become pregnant while taking Axia Forte Plus, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Axia Forte Plus at any time (see section "Stopping Axia Forte Plus").

Breastfeeding

Axia Forte Plus is not recommended for use during breastfeeding. If you want to take contraceptive pills while breastfeeding, you should contact your doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

There is no information to suggest that taking Axia Forte Plus affects your ability to drive or use machines.

Axia Forte Plus contains lactose

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

3. How to take Axia Forte Plus

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should contact your doctor or pharmacist.
Each blister pack contains 21 active yellow tablets and 7 white placebo tablets. The Axia Forte Plus tablets in two different colors are arranged in the correct order. The blister pack contains 28 tablets.
You should take one Axia Forte Plus tablet every day, with a small amount of water if necessary. The tablets can be taken at any time of day, with or without food, but you should take them at the same time every day.
One blister pack contains 28 tablets, each marked with a day of the week. You should start the pack on the day of the week indicated on the tablet. For example, if you start on a Wednesday, take the tablet marked "WED". Take one tablet every day, following the direction of the arrows on the blister pack, until you have taken all 28 tablets. Do not confuse the tablets:for the first 21 days, take one yellow active tablet every day, then for the next 7 days, take one white placebo tablet every day, after which you should start a new blister pack (21 yellow active tablets and 7 white placebo tablets). Therefore, there is no break between one blister pack and the next.

When can you start the first blister pack?

• If you are not taking hormonal contraceptives in the previous monthYou should start taking Axia Forte Plus on the first day of your period (i.e. the first day of bleeding). If you start taking Axia Forte Plus on the first day of your period, you will be protected against pregnancy immediately. You can also start taking Axia Forte Plus between the 2nd and 5th day of your period, but you will need to use additional contraception (e.g. a condom) for the first 7 days.
• Changing from a combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or transdermal patch)You can start taking Axia Forte Plus the next day after taking the last active tablet (containing active substances) of your previous combined oral contraceptive, but no later than the day after the usual break from your previous combined oral contraceptive (or after taking the last inactive tablet of your previous contraceptive pills). If you are changing from a vaginal ring or transdermal patch, you can start taking Axia Forte Plus on the day you remove the ring or patch, but no later than the day you would normally apply a new ring or patch.
• Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system)You can switch from a progestogen-only pill on any day, from an implant or intrauterine system on the day of its removal, or from an injection when the next injection would be due. In all cases, you should use additional contraceptive methods (e.g. a condom) for the first 7 days of taking Axia Forte Plus.
• After a miscarriage or abortionFollow your doctor's advice.
• After childbirthYou can start taking Axia Forte Plus between 21 and 28 days after giving birth. If you start taking Axia Forte Plus more than 28 days after giving birth, you should use a barrier method (e.g. a condom) for the first 7 days of taking Axia Forte Plus. If you have had sex since giving birth, you should make sure you are not pregnant before starting Axia Forte Plus or wait until your next period.
• If you are breastfeeding and want to start taking Axia Forte Plus (again) after childbirthYou should read the section "Breastfeeding".

If you are unsure when to start the first blister pack, you should contact your doctor.

What to do if you have taken 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 at once.
In the event of taking several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. Vaginal bleeding may also occur in young girls who have not yet started their periods but have taken the medicine by mistake.
If you have taken too many Axia Forte Plus tablets or a child has swallowed some, you should contact your doctor or pharmacist.

What to do if you forget to take Axia Forte Plus

The tablets in the fourthrow of the blister pack are placebo tablets. If you miss one of these tablets, it will not affect the effectiveness of Axia Forte Plus. You should discard the missed placebo tablet.
If you forget to take a yellow active tablet from the first, second, or thirdrow of the blister pack, you should follow these rules:

• if it has been less than 24 hourssince you missed the tablet, your contraceptive protection is not reduced. Take the tablet as soon as you remember, and then take the next tablets at the usual time,
• if it has been more than 24 hourssince you missed the tablet, your contraceptive protection may be reduced. The more tablets you miss, the higher the risk of pregnancy.

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

• You have missed more than one tablet from the blister packYou should contact your doctor.
• You have missed one tablet in week 1.Take the missed tablet as soon as you remember, even if it means taking two tablets at the same time. Take the next tablets at the usual time and use additional contraception, such as a condom, for the next 7 days. If you had sex in the week before missing the tablet, you should be aware that you may be at risk of pregnancy. In this case, you should contact your doctor.
• You have missed one tablet in week 2.Take the missed tablet as soon as you remember, even if it means taking two tablets at the same time. Take the next tablets at the usual time. Your contraceptive protection is not reduced, so you do not need to use additional contraception.
• You have missed one tablet in week 3.You have two options:
• 1. Take the missed tablet as soon as you remember, even if it means taking two tablets at the same time. Then continue taking the tablets at the usual time. Instead of taking the white placebo tablets from the pack, you should skip them (discard them) and start a new pack.

Most likely, your period will occur at the end of the second pack, during the placebo days, but you may experience spotting or bleeding similar to a period during the second pack.

• 2. You can also stop taking the yellow active tablets and go directly to the 7 white placebo tablets ( before taking the placebo tablets, make a note of the day you missed the tablet). If you want to start the next pack on the same day as before, you can take the placebo tablets for less than 7 days.

If you follow one of these rules, your contraceptive protection will be maintained.

• If you forget to take any of the tablets from the blister pack and do not experience withdrawal bleeding during the placebo days, it may mean that you are pregnant. You should contact your doctor before starting the next pack.

The following diagram shows what to do if you miss a tablet

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Axia Forte Plus, she should consult her doctor.
All women using combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2. "Important information before taking Axia Forte Plus".
The following is a list of side effects associated with the use of Axia Forte Plus.

Other side effects

Commonside effects (may occur in up to 1 in 10 people):

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
• headache, mood swings
• migraine
• nausea
• vaginal discharge and vaginal yeast infection.

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

• breast enlargement, decreased or increased libido
• high blood pressure, low blood pressure
• vomiting, diarrhea
• acne, skin rash, severe itching, hair loss
• vaginal infection
• fluid retention and weight gain or loss.

Rareside effects (may occur in up to 1 in 1,000 people):

• allergic reactions, asthma
• breast discharge
• hearing impairment
• skin conditions: erythema nodosum (characterized by painful red nodules on the skin) or erythema multiforme (rash with redness and pain)
• harmful blood clots in a vein or artery, for example: in the leg or foot (deep vein thrombosis) or in the lungs (pulmonary embolism) or heart attack or stroke or mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack or blood clots in the liver, stomach, and intestine, kidneys, or eye.

The risk of blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).
The patient should immediately contact her doctor if she experiences any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria potentially with difficulty breathing (see also "Warnings and precautions").

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell her doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C PL-02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Axia Forte Plus

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The medicine should not be used after the expiry date stated on the package and blister in the place marked "Do not use after:" or "EXP". The expiry date "Lot" means the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask her pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Axia Forte Plus contains

Axia Forte Plus blister 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:
Core: lactose monohydrate, corn starch, pregelatinized corn starch, crospovidone, povidone, Polysorbate 80, magnesium stearate
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), Macrogol 3350, talc, yellow iron oxide (E172),

Placebo tablets:

Core: lactose monohydrate, povidone, magnesium stearate
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), Macrogol 3350, talc

What Axia Forte Plus looks like and what the pack contains

Active tablets - yellow, round, film-coated tablets.
Placebo tablets - white, round, film-coated tablets.
Axia Forte Plus is available in packs 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 authorization 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 authorized in the Member States of the European

Economic Area 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
Date of last revision of the leaflet:December 2024