Astha

Leaflet accompanying the packaging: information for the user

Astha, 0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Dienogest

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.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for this person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Astha and what is it used for
• 2. Important information before taking Astha
• 3. How to take Astha
• 4. Possible side effects
• 5. How to store Astha
• 6. Contents of the pack and other information

1. What is Astha and what is it used for

Astha is a combined oral contraceptive.
Each tablet contains two different hormones. These are: ethinylestradiol (estrogen) and dienogest
(progestogen).
When taking Astha as directed in this leaflet, the likelihood of becoming pregnant is very low.

Indications for use

• Prevention of pregnancy.
• For the treatment of women with moderate acne who have decided to use oral contraceptives and have not responded to appropriate local treatment or oral antibiotic treatment.

Treatment of acne in women who want to use a contraceptive method at the same time, to achieve optimal drug efficacy, it is necessary to use it for at least six
months. Longer use is also possible after consulting a doctor.

2. Important information before taking Astha

General notes

Before starting to take Astha, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see "Blood clots").

When not to take Astha

Astha should not be taken if the patient has any of the conditions listed below. If the patient has any of these conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient is allergic to ethinylestradiol or dienogest or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has 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 (transient symptoms of stroke);
• if the patient has 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);
• hyperhomocysteinemia;
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) severe liver disease (until liver function tests return to normal);
• if the patient has (or has had in the past) benign or malignant liver tumors;
• if the patient has (or has had in the past) a hormone-dependent tumor (breast or genital cancer);
• if the patient has bleeding from the genital tract of unknown cause;
• if the patient is pregnant or suspects they are pregnant;
• if the patient has liver disease caused by hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Astha and other medicines").

If any of these symptoms occur for the first time while taking Astha, the medicine should be stopped immediately and a doctor should be consulted. During this time, non-hormonal methods of contraception should be used.
The improvement in acne symptoms usually occurs within three to six months of treatment, but skin condition may continue to improve even after six months of treatment. The patient should discuss with their doctor the need to continue treatment after three to six months, and then at regular intervals.

Warnings and precautions

Before starting to take Astha, the patient should discuss it with their doctor or pharmacist.
When should the patient contact their doctor?
The patient should contact their doctor immediately

• if they notice any symptoms that may indicate the occurrence of blood clots, which may indicate that they have blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see "Blood clots" (thrombosis)).

To find a description of the serious side effects listed above, see "How to recognize the occurrence of blood clots".
If the patient is taking oral contraceptives in any of the following situations, close medical supervision is necessary.

The patient should tell their doctor if they have any of the following conditions.

If these symptoms appear or worsen while taking Astha, the patient should also tell their doctor.

• if they smoke;
• if they have diabetes;
• if they are obese;
• if they have high blood pressure;
• if they have heart valve problems or heart rhythm disorders;
• if they have superficial thrombophlebitis (inflammation of the veins under the skin);
• if they have varicose veins;
• if there have been cases of thrombosis, heart attack, or stroke in close relatives;
• if they have migraines;
• if they have epilepsy;
• if they or a close relative have had breast cancer in the past;
• if they have liver or gallbladder disease;
• if they have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if they have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if they have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if they have sickle cell anemia (a hereditary disease of red blood cells);
• if they or a close relative have been found to have high levels of fats in the blood (hypertriglyceridemia). Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if they need to have surgery or will be immobilized for a long time (see "Blood clots");
• if they have recently given birth, as they are at increased risk of blood clots. The patient should consult their doctor about how soon they can start taking Astha after giving birth;
• if they have a disease that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g., hearing loss, porphyria, herpes during pregnancy, Sydenham's chorea);
• if they have or have had skin discoloration (yellow-brown pigment spots, so-called chloasma) - they should then avoid excessive exposure to the sun or ultraviolet radiation;
• if they experience any symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives with possible breathing difficulties, they should contact their doctor immediately.

Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
If any of the above symptoms occur for the first time, recur, or worsen while taking Astha, the patient should contact their doctor.
Psychiatric disorders
Some women taking hormonal contraceptives, including Astha, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, the patient should contact their doctor as soon as possible for further medical advice.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Astha, 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" or "arterial thrombosis").

Not all patients who have had a blood clot will make a full recovery. In rare cases, the effects of a blood clot can be long-lasting or even fatal.

It should be remembered that the overall risk of serious blood clots caused by taking Astha is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

The patient should contact their doctor immediately if they notice any of the following symptoms.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be suffering from
Deep vein thrombosis

• swelling of the legs and/or swelling along a vein in the leg or foot, especially if 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, redness, or cyanosis.

Pulmonary embolism

• 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 abdominal pain.

If the patient is unsure, they should contact their doctor,
as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions,
such as a respiratory infection (e.g., a cold).
Symptoms usually occur in one eye:

• instantaneous loss of vision or
• painless vision disturbances, which may progress to loss of vision. Retinal vein thrombosis (blood clot in the eye)

Heart attack

• chest pain, discomfort, pressure, tightness;
• feeling of squeezing, fullness, or pressure in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the upper body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or fainting;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat.

Stroke

• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, speech, or vision disturbances;
• sudden vision disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance, or coordination;
• sudden, severe, or prolonged headaches without a known cause;
• loss of consciousness or fainting with or without seizures.

In some cases, stroke symptoms may be transient with almost immediate and complete recovery,
however, the patient should contact their doctor immediately, as they may be at risk of having another stroke.
Blood clots blocking other blood vessels

• swelling and slight blue discoloration of the skin of the legs or arms;
• severe abdominal pain (acute abdomen).

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 most often occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles 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 medicine) 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 the patient stops taking Astha, the risk of blood clots returns to normal within a few weeks.

What affects 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.

• During a year, about 2 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5 to 7 out of 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestrel will develop blood clots.
• It has not been established how the risk of blood clots associated with taking Astha compares to the risk associated with taking combined hormonal contraceptives containing levonorgestrel.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots in veins").

Risk of blood clots in a year

Women who do not takecombined hormonal pills/plasters/systems and are not
pregnant
About 2 out of 10,000 women
Women taking combined hormonal contraceptive pills containing levonorgestrel,
norethisterone or norgestrel
About 5 to 7 out of 10,000 women
Women taking Astha
Not yet known

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with taking Astha is small, but some factors can increase this risk. The risk is higher:

• if the patient is severely overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Astha for a few weeks before surgery or immobilization. If the patient needs to stop taking Astha, they should ask their doctor when they can resume taking it;
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (over 4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop the patient from taking Astha.
The patient should tell their doctor if any of the above conditions change while taking Astha, e.g., if they start smoking, if someone in their close family is found to have a blood clot without a known cause, or if they 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 essential to note that the risk of heart attack or stroke associated with taking Astha is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes. While taking a hormonal contraceptive like Astha, it is recommended to quit 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 someone in the patient's close family has had a heart attack or stroke at a young age (under 50). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their close family has been found to have high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
The patient should tell their doctor if any of the above conditions change while taking Astha, e.g., if they start smoking, if someone in their close family is found to have a blood clot without a known cause, or if they gain weight significantly.

In case of symptoms suggesting a blood clot, the patient should stop taking the tablets and consult their doctor immediately (see also "When to contact a doctor").

Oral contraception and cancer

In women taking oral contraceptives, breast cancer is slightly more common than in women of the same age who do not take them. It is not known if this difference is caused solely by the use of hormonal contraceptives. The reason may also be that women taking hormonal contraceptives are more likely to be examined and have breast cancer detected earlier. The described difference in the incidence of breast cancer decreases gradually and disappears within 10 years of stopping oral contraceptives.
In women taking combined oral contraceptives, rare cases of benign or, even more rarely, malignant liver tumors have been reported, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, the patient should contact their doctor immediately.
Malignant tumors can be life-threatening or cause death.
There are reports of a more common occurrence of cervical cancer in women who have taken oral contraceptives for a long time. However, this relationship may not be related to taking the pills but to sexual behavior or other factors.

Medical examinations

Before starting to take Astha, the doctor will conduct a thorough medical history of the patient and their close relatives. The doctor will perform a thorough general and gynecological examination, including a breast examination and a smear test. The patient should be sure they are not pregnant. If the patient is taking oral contraceptives, these examinations should be repeated regularly. If the patient smokes or takes other medicines, they should inform their doctor.

Astha and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Astha should not be taken if the patient has liver disease caused by hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause an increase in liver enzyme activity in blood test results (increase in liver enzyme ALT).
Before starting treatment with these medicines, the doctor will prescribe the patient a different type of contraception.
Astha can be taken again about 2 weeks after finishing treatment with these medicines. See also "When not to take Astha".
Certain medicines may affect the level of Astha in the blood and cause it to be less effective in preventing pregnancy or may cause unexpected bleeding.
These include:

• medicines that increase intestinal motility (e.g., metoclopramide)
• medicines used to treat epilepsy, such as hydantoins or phenytoin, barbiturates, barbexaclone, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate
• certain antibiotics used to treat tuberculosis (e.g., rifampicin)
• medicines used to treat HIV or hepatitis C infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) or other infections (griseofulvin)
• medicines used to treat narcolepsy, a nervous system disorder (modafinil)
• herbal medicines containing St. John's wort (Hypericum perforatum)

While taking any of the above medicines, the patient should also use a mechanical method of contraception (e.g., a condom) in addition to Astha. For the above medicines, these additional contraceptive measures should be used not only while taking the medicine but also for 7 to 28 days after finishing treatment, depending on the medicine being taken.
In case of doubt, the patient should consult their doctor or pharmacist.
If a mechanical method is necessary, the patient should take the next blister pack of Astha without interruption, without the usual 7-day break in tablet taking.

Interactions with other medicines

Astha may interact with other medicines, including:

• cyclosporin (a medicine that suppresses the immune system)
• theophylline (used to treat asthma)
• corticosteroids (e.g., cortisone)
• certain benzodiazepines (sedatives), such as diazepam or lorazepam
• clofibrate (used to lower lipid levels in the blood)
• paracetamol (used to treat pain and fever)
• morphine (a strong pain reliever)
• lamotrigine (used to treat epilepsy)

The patient should read the leaflets for all other medicines they are taking.

When to contact a doctor

The patient should contact their doctor immediately if:

• they notice any worrying changes in their health, especially any of the symptoms listed in this leaflet (see also "When to be careful when taking Astha" and "How to take Astha")
• there are cases of thrombosis, heart attack, or stroke in close relatives
• a breast lump is found
• they plan to take other medicines (see "Astha and other medicines")
• they plan to have surgery or be immobilized (they should inform their doctor at least 4 weeks in advance)
• they experience heavy vaginal bleeding
• they miss tablets in the first week of the cycle (every first week of the month while taking Astha), and they had sex during the previous 7 days
• they experience severe diarrhea
• they do not have withdrawal bleeding or suspect they are pregnant (they should not start the next pack without their doctor's decision).

The patient should stop taking Astha and contact their doctor immediately if they notice any symptoms that may indicate a blood clot, heart attack, or stroke:

• cough without an obvious cause
• severe chest pain that may radiate to the left arm
• shortness of breath
• headache of unprecedented severity or migraine attack
• partial or complete loss of vision or double vision
• slurred speech or loss of speech
• sudden disturbances of the senses (hearing, smell, or touch)
• dizziness or fainting
• numbness or paralysis of part of the body
• severe abdominal pain
• severe pain or swelling in the legs.

The situations and symptoms listed above are described in more detail in other parts of this leaflet.

Diabetes

In patients with diabetes, it may be necessary to adjust the dose of their antidiabetic medicine (e.g., insulin).

Effect on laboratory tests

If the patient needs to have blood tests, they should inform their doctor or laboratory staff that they are taking oral contraceptives, as this may affect the results of some laboratory tests, including liver function, adrenal function, kidney function, and thyroid function, as well as the levels of certain proteins in the blood, such as those involved in lipid metabolism, carbohydrate metabolism, blood clotting, and fibrinolysis. However, these changes usually remain within the normal range.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or is planning to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Astha should not be taken during pregnancy. Before starting to take Astha, the patient must make sure they are not pregnant. If the patient becomes pregnant while taking Astha, they should stop taking it immediately and contact their doctor without delay.
Breastfeeding
The patient should not take Astha while breastfeeding, as it may reduce the amount of milk produced, and the active substance may pass into the breast milk in small amounts. During breastfeeding, non-hormonal methods of contraception should be used.

Driving and using machines

Astha does not affect the ability to drive or use machines.

Astha contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Astha

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
The leaflet describes many situations in which the patient should stop taking Astha or in which the effectiveness of the medicine may be reduced. It also lists circumstances in which the patient should not have sex or should use additional mechanical methods of contraception, e.g., a condom. The calendar method and temperature method cannot be used, as Astha affects temperature changes and the properties of cervical mucus characteristic of the menstrual cycle.

Astha, like other oral contraceptives, does not protect against HIV (AIDS) or other sexually transmitted diseases.

Unless the doctor has prescribed otherwise, the usual dose is one Astha tablet per day.
The tablet should be swallowed whole, if necessary with a small amount of water.
The tablets must be taken at about the same time every day, following the direction of the arrows until the end of the pack (for 21 consecutive days). The first tablet should be taken from the place on the blister marked with the day of the week on which the patient starts taking Astha (e.g., "Mon" if the patient starts on a Monday).
After finishing the blister pack, there is a 7-day break in tablet taking. During this break, withdrawal bleeding occurs. It usually starts within two to four days after taking the last tablet.
Taking tablets from the next blister pack should start on the 8th day, regardless of whether the withdrawal bleeding has stopped or is still ongoing. This means that starting a new blister pack should always fall on the same day of the week, and bleeding should occur on the same day of each menstrual cycle.
If Astha is taken in this way, contraceptive protection also covers the 7-day break in tablet taking.

When to start taking Astha

• If the patient has not taken any oral contraceptives in the previous monthThe patient should start taking Astha on the first day of their menstrual cycle, i.e., on the first day of menstrual bleeding. If the patient takes Astha correctly, its contraceptive effect begins on the first day of use. If the patient starts taking Astha between the 2nd and 5th day of their cycle, they should also use a mechanical method of contraception for the first 7 days of tablet taking.
• If the patient is changing their contraceptive method from another pill (with two hormonally active substances),a vaginal ring, or a transdermal patch
• If the patient has been taking oral contraceptives (in which case there is a break in tablet taking after taking the last active tablet), they should start taking Astha the next day after this break.
• If the patient has been taking oral contraceptives from a pack that contains both active and inactive tablets (so-called placebo tablets), they should start taking Astha the day after taking the last inactive tablet. If the patient is unsure which tablet is inactive, they should consult their doctor or pharmacist.
• If the patient has been using a vaginal ring or transdermal patch, they should follow their doctor's advice.
• If the patient is changing their contraceptive method from a pill containing only one hormone (progestogen),so-called minipill

The patient can stop taking the minipill at any time. They should start taking Astha the next day. During the first 7 days, they should also use a mechanical method of contraception (e.g., a condom).

• If the patient is changing their contraceptive method from injections (so-called "3-month injections"),an implant, or an intrauterine system (IUS)The patient should start taking Astha on the day they are scheduled to have the injection or on the day the implant or intrauterine system is removed. During the first 7 days, they should also use a mechanical method of contraception (e.g., a condom).
• If the patient has recently given birth and is not breastfeedingThe patient should not start taking Astha for at least 21 to 28 days after giving birth. During the first 7 days of tablet taking, they should also use a mechanical method of contraception (e.g., a condom). If the patient has had sex before starting to take Astha, they should make sure they are not pregnant or wait for their first menstrual period.
• During breastfeedingIf the patient is breastfeeding and wants to start taking Astha, they should discuss this with their doctor (see "Breastfeeding").
• In case of miscarriage or abortionThe patient should consult their doctor about the possibility of taking Astha.

Duration of treatment

Astha can be taken for as long as the patient wants to use a hormonal contraceptive method and no health risks are found (see "When not to take Astha" and "When to contact a doctor") .
Regular check-ups are highly recommended (see "Medical examinations").

Overdose

In case of overdose, the patient should contact their doctor or pharmacist.
Possible symptoms of overdose include: nausea, vomiting (usually within 12 to 24 hours, may persist for several days), breast tenderness, dizziness, abdominal pain, drowsiness, and/or fatigue. In women and girls, vaginal bleeding may occur. The patient should contact their doctor if they have taken too much Astha.

4. Possible Side Effects

Like all medications, Astha can cause side effects, although not everybody gets them. If side effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Astha, the patient should consult their 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 thrombosis). 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 Using Astha".

Severe Side Effects

Severe side effects associated with the use of Astha and their symptoms are listed in the "Warnings and Precautions" section. The patient will find detailed information there. In case of side effects, the patient should immediately consult their doctor.
The patient should immediately consult their doctor if they experience any of the following symptoms of angioedema: facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing or urticaria with possible accompanying breathing difficulties (see also "Warnings and Precautions").

Other Possible Side Effects

Common Side Effects(may affect up to 1 in 10 patients):

• headache
• breast pain, including discomfort and breast tenderness.

Uncommon Side Effects(may affect up to 1 in 100 patients):

• vaginitis and/or vulvovaginitis (inflammatory conditions of the genital organs)
• vaginal candidiasis (thrush) or symptoms of fungal infection of the vagina and vulva
• increased appetite
• depressed mood
• dizziness
• migraine
• high or low blood pressure
• abdominal pain (including upper and lower abdominal pain, discomfort, or bloating)
• nausea, vomiting, or diarrhea
• acne
• hair loss (alopecia)
• rash (including rash, erythema multiforme, or urticaria)
• pruritus (sometimes whole-body itching)
• irregular withdrawal bleeding, including heavy bleeding (menstruation), scanty and short-lasting menstruation, sporadic menstruation, or absence of menstruation (amenorrhea)
• intermenstrual bleeding, vaginal bleeding, or metrorrhagia
• breast enlargement, including congestion and breast swelling
• painful menstruation (dysmenorrhea)
• changes in vaginal discharge
• ovarian cysts
• pelvic pain
• fatigue (including weakness and malaise)
• weight changes (increase, decrease, or fluctuations).

Rare Side Effects(may affect up to 1 in 1,000 patients):

• ovarian and fallopian tube inflammation
• urinary tract infections
• cystitis (urinary bladder inflammation)
• mastitis (breast inflammation)
• cervicitis (cervical inflammation)
• fungal infections (candidiasis)
• oral thrush
• influenza
• bronchitis
• sinusitis
• upper respiratory tract infections
• viral infections
• uterine fibroids
• breast fibroadenoma
• anemia
• hypersensitivity (allergic reaction)
• masculinization in women (development of male secondary sexual characteristics)
• anorexia (severe loss of appetite)
• depression
• psychiatric disorders
• insomnia
• sleep disorders
• aggression
• stroke (reduced or interrupted blood flow to part of the brain)
• cerebrovascular disorders (disorders of blood flow to the brain)
• dystonia (persistent muscle contractions causing, e.g., twisting or abnormal posturing)
• dry or irritated eyes
• oscillopsia (subjective sensation of image vibration) or other vision disorders
• sudden hearing loss
• tinnitus
• vertigo
• hearing disorders
• cardiovascular disorders (disorders of blood flow to the heart)
• tachycardia (rapid heart rate)
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g., deep vein thrombosis)
• in the lungs (e.g., pulmonary embolism)
• myocardial infarction
• mini-stroke or transient stroke symptoms, known as a transient ischemic attack

ischemic

• blood clots in the liver, stomach, or intestine, kidneys, or eye
• thrombosis (blood clots in blood vessels)
• pulmonary embolism (a blood clot moving to the lungs)
• thrombophlebitis (inflammation of a vein with blood clots)
• increased diastolic blood pressure (the lowest level to which blood pressure drops between heartbeats)
• orthostatic hypotension (dizziness or fainting when standing up from a sitting or lying position)
• hot flashes
• varicose veins
• venous disorders or vein pain
• asthma
• hyperventilation
• gastritis
• enteritis
• indigestion
• skin reactions
• skin diseases, including allergic dermatitis, neurodermatitis, and/or atopic dermatitis, eczema, psoriasis
• excessive sweating
• chloasma (pigmentation on the face)
• changes in pigmentation and/or discoloration
• seborrhea
• dandruff
• excessive hair growth
• skin disorders, skin reactions, "orange peel" skin
• hemangioma
• back pain
• musculoskeletal disorders
• muscle pain
• arm and leg pain
• cervical dysplasia (abnormal cell growth on the surface of the cervix)
• adnexal pain or cysts (ovaries and fallopian tubes)
• breast cysts
• fibrocystic breast disease
• painful sexual intercourse
• galactorrhea
• menstrual disorders
• chest pain
• edema of the legs and arms
• flu-like symptoms
• inflammation
• fever
• irritability
• hypercholesterolemia
• increased triglyceride levels in the blood
• revealing the presence of an additional breast.

Frequency Not Known(frequency cannot be determined from available data):

• mood changes
• decreased or increased libido (sexual desire)
• intolerance to contact lenses
• skin changes (urticaria, erythema multiforme, or Stevens-Johnson syndrome)
• breast discharge
• fluid retention.

The probability of blood clots may be higher if the patient has other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).
In women with hereditary angioedema, exogenous estrogens may induce or worsen symptoms of angioedema.

Reporting Side Effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist, or nurse. 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 gather more information on the safety of the medication.

5. How to Store Astha

The medication should be stored out of sight and reach of children.
Do not store above 30°C.
Store in the outer packaging to protect from light.

Expiry Date

Do not use this medication after the expiry date stated on the carton and blister pack after: EXP.
The expiry date stated is the last day of the given month.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Astha Contains

• The active substances of Astha are ethinylestradiol and dienogest. Each film-coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of dienogest.
• The other ingredients of Astha are: Core:lactose monohydrate, cornstarch, povidone K-30, magnesium stearate. Coating:hypromellose 2910, macrogol 400, titanium dioxide (E 171).

Appearance and Pack Contents of Astha

Astha is a white, round, film-coated tablet.
Astha is available in packs containing: 1 or 3 blisters of 21 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
tel. +48 22 855 40 93

Manufacturer

Laboratorios León Farma, S.A.
C/ La Vallina s/n, Poligono Industrial Navatejera
Villaquilambre, 24193 León
Spain
Date of Last Revision of the Leaflet:December 2024