Hastina 24+4

Package leaflet: information for the patient

Hastina 24+4, 0.02 mg + 3 mg, coated tablets
Ethinylestradiolum + Drospirenonum
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 a doctor if the patient suspects symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Leaflet contents

1. What is Hastina 24+4 and what is it used for
2. What you need to know before taking Hastina 24+4
3. How to take Hastina 24+4
4. Possible side effects
5. How to store Hastina 24+4
6. Contents of the pack and other information

1. What is Hastina 24+4 and what is it used for

Hastina 24+4 is a contraceptive tablet used to prevent pregnancy.
Each of the 24 pink coated tablets contains a small amount of two different female hormones, namely ethinylestradiol and drospirenone.
The 4 white coated tablets do not contain any active substances and are therefore called placebo tablets.
Contraceptive tablets containing two hormones are known as "combined" tablets.

2. Important information before using Hastina 24+4

General information
Before starting to take Hastina 24+4, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section “Blood clots”).
Before you can start taking Hastina 24+4, your doctor will ask 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 additional tests.
This leaflet describes several situations in which you should stop taking Hastina 24+4, or in which the effectiveness of Hastina 24+4 may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use the calendar method or body temperature measurement. These methods may be unreliable because Hastina 24+4 alters the monthly changes in body temperature and cervical mucus.
Hastina 24+4, like other hormonal contraceptives, does not protect against infection with HIV (AIDS) or other sexually transmitted diseases.

When not to use Hastina 24+4
Do not take Hastina 24+4 if you have any of the conditions listed below. If any of these conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). This allergy may cause itching, rash, or swelling;
• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have disorders affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section “Blood clots”);
• if you have had a heart attack or stroke;
• if you have (or have had in the past) 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 had in the past) a type of migraine called “migraine with aura”;
• if you currently have (or have ever had in the past) pancreatitis;
• if you currently have (or have ever had in the past) liver disease and liver function remains abnormal;
• if you have kidney dysfunction (kidney failure);
• if you currently have (or have ever had in the past) liver tumour;
• if you currently have (or have ever had in the past) or are suspected of having breast cancer or cancer of the genital organs;
• if you have any unexplained vaginal bleeding;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, or glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, you should not take Hastina 24+4 (see also “Hastina 24+4 and other medicines”).

Warnings and precautions
When should you contact your doctor?
You should contact your doctor immediately

• if you notice possible 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 a stroke (see section “Blood clots”).

For a description of the symptoms of these serious adverse effects, see section “How to recognize the occurrence of blood clots”.
In certain situations, special caution is required when using Hastina 24+4 or any other combined hormonal contraceptive, and regular check-ups by your doctor may be necessary.
You should inform your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Hastina 24+4, you should also inform your doctor.

• if there is a history of breast cancer in your close family;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression. Some women using hormonal contraceptives, including Hastina 24+4, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor as soon as possible for further medical advice;
• if you have epilepsy (see section “Hastina 24+4 and other medicines”);
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (for example: hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (pemphigoid gestationis), a nervous system disorder with involuntary body movements (Sydenham’s chorea));
• if you currently have or have ever had chloasma (skin pigmentation, especially on the face and neck, also known as “melasma”). If so, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary angioedema, products containing estrogens may trigger or worsen symptoms. Seek immediate medical attention if symptoms of angioedema occur, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with breathing difficulties;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (a hereditary disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or if someone in your immediate family has 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 “Blood clots”);
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Hastina 24+4;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you experience any symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives possibly accompanied by breathing difficulties, you should contact your doctor immediately. Products containing estrogens may trigger or worsen symptoms of inherited or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives, such as Hastina 24+4, increases the risk of developing blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as “venous thrombosis” or “venous thromboembolic disease”),
• in arteries (referred to as “arterial thrombosis” or “arterial thromboembolic events”).

Complete recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using Hastina 24+4 is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you experience any of the following symptoms.
Is the patient experiencing any of these symptoms? What is the likely cause?

• 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 occur only when standing or walking;
  • increased warmth in the affected leg;
  • change in skin colour of the leg, such as pallor, redness, or bluish discolouration.
• sudden unexplained shortness of breath or rapid breathing;
• sudden coughing without an obvious cause, possibly accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or vertigo;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, contact your doctor, as some of these symptoms, such as cough or shallow breathing, may be mistaken for milder conditions.

VENOUS BLOOD CLOTS
What can happen if blood clots form in a vein?

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

When is the risk of venous blood clots the highest?
The risk of developing venous blood clots is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Hastina 24+4, the risk of blood clots returns to normal within a few weeks.

What does the risk of venous blood clots depend on?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive being used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Hastina 24+4 is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5 to 7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Hastina 24+4, will develop blood clots.
• The risk of developing venous blood clots depends on the individual's medical history (see "Factors that increase the risk of venous blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Hastina 24+4 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 of age). In such case, the patient may have an inherited clotting disorder;
• if the patient requires 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 use of Hastina 24+4 several weeks before surgery or immobilization. If the patient must stop taking Hastina 24+4, consult the doctor about when it is safe to resume taking the medicine;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of developing blood clots increases with the number of risk factors present
in the patient.
Air travel (over 4 hours) may temporarily increase the risk of venous blood clots,
particularly if the patient has another risk factor present.
It is important to inform the doctor if any of the listed risk factors apply to the patient,
even if uncertain. The doctor may decide to discontinue the use of
Hastina 24+4.
The patient should inform the doctor if any of the above conditions change during
treatment with Hastina 24+4, for example, if a close family member is diagnosed with
thrombosis without a known cause, or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to 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
Hastina 24+4 is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes cigarettes. While using a hormonal contraceptive such as Hastina 24+4, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, 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, especially 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 blood clots may be further increased.

The patient should inform the doctor if any of the above conditions change during
treatment with Hastina 24+4, for example, if the patient starts smoking, a close family member is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.

Hastina 24+4 and cancer
In women using combined hormonal contraceptives, a slightly increased incidence of
breast cancer has been observed, but it is not known whether this is caused by the medication. For example,
more cancers may be detected in women using combined hormonal
contraceptives because these women undergo more frequent medical examinations. The incidence of
breast cancer gradually decreases after stopping combined hormonal
contraceptives. It is important to perform regular breast examinations and contact
the doctor if any lump is detected.
In rare cases, benign liver tumours and, even more rarely, malignant liver tumours have been reported
in women using combined hormonal contraceptives. If the patient experiences an unusual, severe abdominal pain, she should contact the doctor.

Intermenstrual bleeding
During the first few months of taking Hastina 24+4, unexpected bleeding (bleeding outside the phase of taking white-coated tablets) may occur. If such bleeding persists for longer than a few months, or if it starts after several months of use, the doctor should investigate the cause.

What to do if no bleeding occurs during the placebo tablet phase

• If all pink tablets have been taken according to schedule, without vomiting, severe diarrhoea, or concomitant use of other medications, the likelihood of pregnancy is very low.
• If expected withdrawal bleeding does not occur consecutively for two cycles, this may indicate pregnancy. The patient should contact her doctor immediately. The next blister pack should not be started until pregnancy has been ruled out.

Hastina 24+4 and other medicines
Always inform the doctor about any medicines or herbal products currently being taken. The patient should also inform any other doctor, including a dentist or pharmacist, that she is using
Hastina 24+4. They may advise whether additional contraceptive methods (e.g. condoms) should be used, and if so, for how long.
If the patient has hepatitis C virus infection and is taking medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir, or glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, she should not use Hastina 24+4, as this may
lead to increased liver enzyme activity in blood tests (increased AlAT liver enzyme activity).
Before starting treatment with these medicines, the doctor will recommend an alternative contraceptive method.
Hastina 24+4 may be restarted approximately 2 weeks after completing treatment with the above-mentioned medicines.
See also section “Warnings and precautions”.
Some medicines may affect the blood concentration of Hastina 24+4 and may reduce its effectiveness in preventing pregnancy or cause unexpected bleeding.
These include:

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

Hastina 24+4 may affect the action of other medicines, for example:

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

Before taking any medicine, consult a doctor or pharmacist.

Hastina 24+4 with food and drink
Hastina 24+4 may be taken with or without food, as needed, with a small amount of water.

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

Pregnancy, breastfeeding and fertility
If the patient is pregnant, she must not take Hastina 24+4. If the patient becomes pregnant while taking Hastina 24+4, she should stop taking it immediately and contact her doctor.
If the patient wishes to become pregnant, she may stop taking Hastina 24+4 at any time (see also “Discontinuation of Hastina 24+4”).
Before taking any medicine, consult a doctor or pharmacist.

Breastfeeding
Hastina 24+4 is generally not recommended during breastfeeding. If the patient wishes to use oral contraceptives while breastfeeding, she should consult her doctor.
Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
Hastina 24+4 has no effect or negligible effect on the ability to drive and operate machinery. However, no studies have been conducted on the effect of the medicine on driving and operating machinery.

Hastina 24+4 contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use Hastina 24+4

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Each blister pack contains 24 active pink coated tablets and 4 inactive white placebo tablets.
The tablets of two different colours in Hastina 24+4 are arranged in sequence. The blister contains
28 coated tablets.
Take one tablet of Hastina 24+4 every day, with a small amount of water if needed.
You may take the tablets with or without food, but they should be taken daily at approximately the
same time.
Do not confuse the tablets: pink tablets are taken for the first 24 days, followed by the white
tablets for the last 4 days. After completing the pack, you must immediately start taking tablets from
a new pack (24 pink coated tablets and 4 white coated tablets). As a result, there is no break between
packs.
Due to the different composition of the tablets, you must take the first tablet from the top left corner
of the blister and continue taking the tablets daily. To maintain the correct order, follow the direction
indicated by the arrows printed on the blister.
Preparing the blister
To help track daily tablet intake, each blister of Hastina 24+4 includes 7 self-adhesive labels marked
with the days of the week. You should know the day of the week on which you start taking the tablets.
Choose the appropriate label so that the first day of the week corresponds to the day you start the
pack. For example, if the first day of use was Wednesday, apply the label starting with “Wed.”.
Attach the label to the top left corner of the blister, in the area marked “Start/Place label here”. This
way, each tablet is marked with the correct day of the week, allowing you to check whether a tablet
has been taken. The arrows indicate the order for taking the tablets.
During the 4 days of taking the placebo tablets (placebo phase), withdrawal bleeding usually occurs.
This bleeding typically starts on the 2nd or 3rd day after taking the last active pink tablet of Hastina
24+4. After taking the last white tablet, you must start a new blister pack regardless of whether
bleeding is still ongoing. This means that each new pack will begin on the same day of the week, and
bleeding should also occur on the same days each month.
If you take Hastina 24+4 as directed, you are protected against pregnancy during the 4 days when
you take the placebo tablets.
When to start the first blister?

• If you have not used any hormonal contraceptives in the previous month: Start taking Hastina 24+4 on the first day of your cycle (i.e. the first day of your menstrual period). If you start taking Hastina 24+4 on the first day of your period, you are protected against pregnancy immediately. You may also start between day 2 and day 5 of your cycle, but in this case, you must use additional contraceptive methods (e.g. condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined vaginal contraceptive system or transdermal system: You may start taking Hastina 24+4 the next day after taking the last active tablet (the last tablet containing active substances) from your previous pack, but no later than the day after the tablet-free interval of your previous contraceptive ends (or the day after the last inactive tablet of your previous contraceptive). If switching from a combined vaginal contraceptive system or transdermal system, follow your doctor’s advice.
• Switching from a progestogen-only method (progestogen-only mini-pill, injection, implant, or intrauterine system releasing progestogen): You may switch at any time from progestogen-only mini-pills (on the day of removal of an implant or intrauterine system, or on the day of the next scheduled injection), but in all these cases, you must use additional contraceptive methods (e.g. condoms) for the first 7 days of taking the tablets.
• After miscarriage: Follow your doctor’s advice.
• After childbirth: You may start taking Hastina 24+4 between day 21 and day 28 after delivery. If you start later than day 28, you must use a mechanical contraceptive method (e.g. condoms) for the first 7 days of taking Hastina 24+4.

If you have had sexual intercourse after childbirth, before (re)starting Hastina 24+4, you must first
ensure that you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and wish to (re)start taking Hastina 24+4 after childbirth: Please read section “Breast-feeding”.

If you are unsure when to start taking the medicine, consult your doctor.
Taking more Hastina 24+4 than recommended
There are no reports of serious harmful effects from taking too many tablets of Hastina 24+4.
If several tablets are taken at the same time, nausea and vomiting may occur.
In young girls, vaginal bleeding may occur.
If you take too many tablets of Hastina 24+4 or if a child swallows them, consult your doctor or
pharmacist.
Missed dose of Hastina 24+4
The last four tablets in the fourth row of the blister are placebo tablets. If one of these tablets is missed,
this will not affect the effectiveness of Hastina 24+4. Missed placebo tablets should be discarded.
If you forget to take one of the active pink tablets (tablets 1–24 in the blister), you must follow these
instructions:

• If less than 24 hours have passed since you missed the tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as possible, then continue taking the next tablets at your usual time.
• If more than 24 hours have passed since you missed the tablet, protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if you miss a pink tablet at the
beginning or end of the blister. Therefore, follow the rules below (see chart):

• Missing more than one tablet in a blister: Contact your doctor.
• Missing one tablet between days 1 and 7 (1st row): Take the missed tablet as soon as possible (even if this means taking two tablets at the same time). Continue taking the remaining tablets at your usual time and use additional contraception, such as condoms, for the next 7 days. If you had sexual intercourse in the week before missing the tablet, there is a risk of pregnancy. In this case, consult your doctor.
• Missing one tablet between days 8 and 14 (2nd row): Take the missed tablet as soon as possible (even if this means taking two tablets at the same time). Continue taking the remaining tablets at your usual time. Protection against pregnancy is not reduced and additional contraception is not needed.
• Missing one tablet between days 15 and 24 (3rd and 4th rows): You have two options:

  1. Take the missed tablet as soon as possible (even if this means taking two tablets at the same time). Continue taking the remaining tablets at your usual time. Instead of taking the white placebo tablets from the same blister, discard them and immediately start taking tablets from the next blister pack (your starting day will change).
     Menstruation will most likely occur at the end of the second blister – during the intake of the white placebo tablets – but spotting or breakthrough bleeding may also occur during the second blister.

  2. You may also stop taking the active pink tablets and go directly to the 4 white placebo tablets ( before taking the placebo tablets, you must note the day on which you missed the tablet ). If you wish to start the next blister on your usual starting day, take fewer than 4 placebo tablets.

If you follow either of these two options, protection against pregnancy will be maintained.

• If you have missed any tablet from the blister and do not have bleeding during the placebo tablet phase, this may indicate that you are pregnant. In this case, consult your doctor before starting the next blister.

What to do if you vomit or have severe diarrhoea
If you vomit within 3 to 4 hours after taking an active pink tablet or have severe diarrhoea, there is a
risk that the active substances in the tablet have not been fully absorbed. This situation is similar to
missing a tablet.
After vomiting or severe diarrhoea, take another pink tablet from a spare blister as soon as possible.
If possible, take it within 24 hours of your usual tablet-taking time.
If this is not possible or more than 24 hours have passed, follow the instructions under “Missed dose of
Hastina 24+4”.
Delaying the onset of bleeding: what you should know
Although not recommended, it is possible to delay the onset of bleeding by not taking the white
placebo tablets from the 4th row of the blister and instead starting directly with a new blister of
Hastina 24+4, continuing until the end of that blister. Spotting or breakthrough bleeding may occur
during the second blister. Complete the second blister by taking the 4 white tablets from the 4th row
of the blister. Then start taking tablets from the next blister.
You may consult your doctor for advice before deciding to delay bleeding.
Changing the first day of bleeding: what you should know
If you take the tablets as directed, bleeding will begin during the placebo tablet phase.
To change this day, shorten the placebo phase by taking fewer than 4 white placebo tablets (but never
extend it – the placebo phase must not exceed 4 days). For example, if the placebo phase normally
starts on Friday and you wish to change it to Tuesday (3 days earlier), start the new blister 3 days
earlier than usual. Bleeding may not occur during these days. As a result, spotting or breakthrough
bleeding may occur.
If you are unsure how to proceed, you should contact your doctor.
Stopping use of Hastina 24+4
You may stop taking Hastina 24+4 at any time.
If you do not wish to become pregnant, consult your doctor about other effective methods of birth
control. If you wish to become pregnant, stop taking Hastina 24+4 and wait for a menstrual period
before trying to conceive. This makes it easier to calculate the expected date of delivery.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Hastina 24+4, medical advice should be sought.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, see section 2, "Important information before taking Hastina 24+4".

The following adverse effects have been associated with the use of Hastina 24+4.

Serious adverse effects
Seek immediate medical advice if the patient experiences any symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or urticaria with possible accompanying breathing difficulties (see also section "Warnings and precautions").

Common adverse effects (may affect up to 1 in 10 women):

• mood swings
• headache
• nausea
• breast pain, menstrual problems such as irregular or absent periods.

Uncommon adverse effects (may affect up to 1 in 100 women):

• depression, nervousness, sleep disturbances
• dizziness, tingling and numbness
• migraine, varicose veins, increased blood pressure
• abdominal pain, vomiting, indigestion, flatulence, diarrhoea, gastritis
• acne, itching, rash
• pain, e.g. back pain, limb pain, muscle cramps
• fungal vaginal infections, pelvic pain, breast enlargement, benign breast tumour, uterine/vaginal bleeding (which usually resolves during treatment with Hastina 24+4), vaginal discharge, hot flushes, vaginal inflammation, menstrual disorders, painful periods, scanty periods, very heavy periods, vaginal dryness, abnormal cervical smear
• decreased sexual drive
• lack of energy, excessive sweating, fluid retention
• weight gain.

Rare adverse effects (may affect up to 1 in 1,000 women):

• candidiasis (fungal infection)
• anaemia, increased platelet count
• allergic reaction
• endocrine disorders (hormonal disturbances)
• increased appetite, loss of appetite, markedly increased blood potassium levels, marked decrease in blood sodium levels
• anorgasmia
• insomnia
• dizziness, chills
• eye disorders, e.g. eyelid inflammation, dry eyes
• rapid heartbeat
• phlebitis, nosebleeds, fainting
• abdominal distension, intestinal disease, bloating, hiatal hernia, fungal infection of the mouth, constipation, dry mouth
• pain in the biliary tract or gallbladder, cholecystitis
• brownish skin patches, rash, hair loss, acne-like skin inflammation, dry skin, nodular skin inflammation, hirsutism, skin disorders, striae, dermatitis, photosensitivity, skin nodules
• dyspareunia or painful intercourse, vaginal inflammation, post-coital bleeding, withdrawal bleeding, breast cyst, breast cell proliferation (hyperplasia), malignant breast tumour, marked cervical endometrial hyperplasia, endometrial contraction or atrophy, ovarian cyst, uterine enlargement
• malaise
• weight loss
• 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)
  • heart attack
  • stroke
  • mini-stroke or transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors that increase this risk (for further information on risk factors for blood clots and symptoms of blood clots, see section 2).

The following adverse effects have also been reported: hypersensitivity, erythema multiforme (rash and redness or ulceration), but based on available data, the frequency of these reactions cannot be determined.

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

5. How to store Hastina 24+4

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Expiry date
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Hastina 24+4 contains

• The active substances in this medicine are: ethinylestradiol and drospirenone. Each pink coated active tablet contains 0.02 mg ethinylestradiol and 3 mg drospirenone. The white coated tablets do not contain any active substances.
• Other components of the medicine are:
  Pink coated active tablet:
• Tablet core: monohydrate lactose, pregelatinized corn starch, povidone K-30, sodium croscarmellose, polysorbate 80, magnesium stearate.
• Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).
  White coated inactive tablet:
• Tablet core: anhydrous lactose, povidone K-30, magnesium stearate.
• Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

What Hastina 24+4 looks like and contents of the pack
Each blister contains 24 active pink coated tablets in rows 1, 2, 3 and 4, and 4 white coated placebo tablets in row 4.
Hastina 24+4 consists of pink and white film-coated tablets with a tablet core covered by a coating.
Hastina 24+4 is available in packs containing 1 or 3 blisters, each containing 28 film-coated tablets (24 active film-coated tablets + 4 placebo film-coated tablets).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Tel. 22 855 40 93

Manufacturer
Laboratorios León Farma, S.A.
C/La Vallina s/n, Polígono Industrial Navatejera
Villaquilambre, 24193 León
Spain