Hastina 24+4

Leaflet accompanying the packaging: patient information

Hastina 24+4, 0.02 mg + 3 mg, film-coated tablets

Ethinylestradiol + Drospirenone

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they 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 patient should carefully read the contents of the leaflet before using 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, pharmacist, or nurse should be consulted.
• -This medicine has been prescribed to a specific 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 adverse reactions, including any adverse reactions not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Hastina 24+4 and what is it used for
• 2. Important information before using Hastina 24+4
• 3. How to use 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 pill and is used to prevent pregnancy.
Each of the 24 film-coated tablets in pink contains a small amount of two different
female hormones, namely ethinylestradiol and drospirenone.
The 4 film-coated tablets in white do not contain active substances and are therefore called
placebo tablets.
Contraceptive pills containing two hormones are called "combined" pills.

2. Important information before using Hastina 24+4

General notes

Before starting to take Hastina 24+4, the patient 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").
Before starting to take Hastina 24+4, the doctor will ask the patient a few questions about their health and the health of their close relatives. The doctor will also measure the patient's blood pressure and, depending on the individual case, may also perform some other examinations.
This leaflet describes several situations in which the patient should stop taking Hastina 24+4 or in which the effectiveness of Hastina 24+4 may be reduced. In such situations, the patient should not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. The patient should not use the calendar method or the temperature measurement method. These methods may be unreliable because Hastina 24+4 modifies the monthly changes in body temperature and cervical mucus.

Hastina 24+4, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Hastina 24+4

Hastina 24+4 should not be used if the patient has any of the following conditions. If the patient has any of the following 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 drospirenone, or any of the other ingredients of this medicine (listed in section 6). This allergy may cause itching, rash, or swelling;
• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows they have blood clotting disorders - 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 ever had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases, which 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 the patient has (or has ever had) a type of migraine called "migraine with aura";
• if the patient currently has (or has ever had) pancreatitis;
• if the patient currently has (or has ever had) liver disease, and liver function is still abnormal;
• if the patient has kidney problems (renal insufficiency);
• if the patient currently has (or has ever had) a liver tumor;
• if the patient currently has (or has ever had) or suspects they have breast cancer or cancer of the genital organs;
• if the patient has unexplained vaginal bleeding;
• if the patient has hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir, they should not take Hastina 24+4 (see also "Hastina 24+4 and other medicines").

Warnings and precautions

When should the patient contact their doctor?
The patient should contact their doctor immediately

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

To find out about the symptoms of these serious side effects, see the section "How to recognize a blood clot".
In some situations, the patient should be extra careful when taking Hastina 24+4 or any other combined hormonal contraceptive and may need to be regularly checked by their doctor.

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

If these symptoms occur or worsen while taking Hastina 24+4, the patient should also tell their doctor

• if there is a history of breast cancer in their close relatives;
• if the patient has liver or gallbladder disease;
• if the patient has diabetes;
• if the patient has depression. Some women taking hormonal contraceptives, including Hastina 24+4, have reported depression or mood swings. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact their doctor as soon as possible for further medical advice;
• if the patient has epilepsy (see "Hastina 24+4 and other medicines");
• if the patient has a disease that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy (pregnancy pemphigoid), a nervous system disease characterized by involuntary movements of the body (Sydenham's chorea));
• if the patient has chloasma (skin discoloration, especially on the face and neck, so-called "pregnancy spots"). If so, they should avoid direct exposure to sunlight or ultraviolet radiation;
• if the patient has hereditary angioedema, estrogen-containing products may cause or worsen the symptoms of hereditary angioedema. The patient should contact their doctor immediately if they experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with possible accompanying difficulty breathing;
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle-cell anemia (a hereditary disease of red blood cells);
• if the patient has been told they have a high level of fats in the blood (hypertriglyceridemia) or if someone in their close family has it. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see "Blood clots");
• if the patient has just given birth, they are at a higher risk of blood clots. The patient should ask their doctor how soon they can start taking Hastina 24+4 after giving birth;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has varicose veins;
• if the patient experiences any symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with possible accompanying difficulty breathing, they should contact their doctor immediately. Estrogen-containing products may cause or worsen the symptoms of hereditary angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Hastina 24+4, is associated with an increased risk of blood clots compared to not using them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• in the veins (also known as "venous thromboembolism" or "deep vein thrombosis"),
• in the arteries (also known as "arterial thromboembolism").

Not everyone who has a blood clot will recover fully. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

It should be remembered that the overall risk of serious blood clots caused by taking Hastina 24+4 is small.

HOW TO RECOGNIZE A BLOOD CLOT

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
these symptoms?

• swelling of the legs and/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 the color of the skin of the leg, such as pallor, redness, or cyanosis. Deep vein thrombosis

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 stomach pain.

If the patient is unsure, they should contact their 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?

• The use of 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 in the first year of using 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 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 using 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 using combined hormonal contraceptives.
If the patient stops taking Hastina 24+4, the risk of blood clots returns to normal within a few weeks.

What factors can increase the risk of blood clots in a vein?

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 taking Hastina 24+4 is small.

• -In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• -In a 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 a 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 blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots in veins", below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with taking Hastina 24+4 is small, but some factors can increase this risk. The risk is higher:

• if the patient is 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 inherited blood clotting disorders;
• if the patient needs to have surgery or will be immobilized for a long time (see "Blood clots"). It may be necessary to stop taking Hastina 24+4 for a few weeks before surgery or immobilization. If the patient needs to stop taking Hastina 24+4, they should ask their doctor when they can resume taking it;
• with increasing age (especially over 35 years);
• if the patient has just given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (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 Hastina 24+4.
The patient should inform their doctor if any of these conditions change while taking Hastina 24+4, e.g., if someone in their close family is diagnosed with a blood clot without a known cause or if the patient gains 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 Hastina 24+4 is very small, but it may increase:

• with age (over about 35 years);
• if the patient smokes. While taking a hormonal contraceptive like Hastina 24+4, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, their doctor may recommend 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 a higher risk of having a heart attack or stroke;
• if the patient or someone in their close family has 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, irregular heartbeat);
• if the patient has diabetes. If the patient has more than one of these conditions or if any of them are severe, the risk of blood clots may be even higher.

The patient should inform their doctor if any of these conditions change while taking Hastina 24+4, e.g., if they start smoking, someone in their close family is diagnosed with a blood clot without a known cause, or if they gain weight significantly.

Hastina 24+4 and cancer

Women taking combined contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by the medicine. For example, it may be that more tumors are detected in women taking combined contraceptives because they are examined by doctors more often. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is essential to examine the breasts regularly and contact a doctor if a lump is found.
Women taking combined contraceptives have also been reported to have rare cases of benign liver tumors and, even more rarely, malignant liver tumors. If the patient experiences severe abdominal pain, they should contact their doctor.

Irregular bleeding

During the first few months of taking Hastina 24+4, the patient may experience unexpected bleeding (bleeding outside of the withdrawal bleeding phase). If such bleeding continues for longer than a few months or starts after a few months, the doctor should investigate the cause.

What to do if withdrawal bleeding does not occur

• If the patient has taken all the pink tablets according to the schedule, has not vomited, or has not had severe diarrhea, and has not taken any other medicines, it is very unlikely that they are pregnant.
• If the expected withdrawal bleeding does not occur for two consecutive cycles, the patient may be pregnant. They should contact their doctor immediately. The patient should not start the next pack until they are sure they are not pregnant.

Hastina 24+4 and other medicines

The patient should always tell their doctor which medicines or herbal products they are already taking. They should also tell any other doctor, dentist, or pharmacist that they are taking Hastina 24+4. These healthcare professionals may tell them if they need to use additional contraceptive methods (e.g., condoms) and for how long.
If the patient has hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir, they should not take Hastina 24+4, as this 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 recommend a different contraceptive method.
The patient can resume taking Hastina 24+4 about 2 weeks after finishing treatment with these medicines.
See also "Warnings and precautions".
Some medicines may affect the levels of Hastina 24+4 in the blood and make it less effective in preventing pregnancy or cause unexpected bleeding.

• medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• tuberculosis (e.g., rifampicin)
• HIV or hepatitis C infections (protease inhibitors or 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, such as:

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

Before taking any medicine, the patient should consult their doctor or pharmacist.

Hastina 24+4 with food and drink

Hastina 24+4 can be taken with or without food, if necessary with a small amount of water.

Lab tests

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, they should not take Hastina 24+4. If the patient becomes pregnant while taking Hastina 24+4, they should stop taking it immediately and contact their doctor.
If the patient wants to become pregnant, they can stop taking Hastina 24+4 at any time (see also "Stopping Hastina 24+4").
Before taking any medicine, the patient should consult their doctor or pharmacist.
Breastfeeding
It is usually not recommended to take Hastina 24+4 while breastfeeding. If the patient wants to take contraceptive pills while breastfeeding, they should contact their doctor.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Hastina 24+4 has no or negligible influence on the ability to drive and use machines. However, no studies have been conducted on the effects of the medicine on the ability to drive and use machines.

Hastina 24+4 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 Hastina 24+4

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should contact their doctor or pharmacist.
Each pack contains 24 active pink film-coated tablets and 4 inactive white film-coated tablets.
The tablets in the two different colors of Hastina 24+4 are arranged in a sequence. The blister pack contains 28 film-coated tablets.
The patient should take one Hastina 24+4 tablet every day, if necessary with a small amount of water.
The tablets can be taken with or without food, but the patient should take them every day at about the same time.
Do not mix up the tablets:the pink tablets should be taken for the first 24 days, followed by the white tablets for the last 4 days. Then, the patient should start taking the tablets from a new pack (24 pink film-coated tablets and 4 white film-coated tablets) immediately. As a result, there is no gap between the two packs.
Due to the different composition of the tablets, the first tablet must be taken from the top left corner of the blister pack and the patient should continue taking the tablets every day, following the direction of the arrows on the blister pack.

Preparing the blister pack

To check that the patient has taken a tablet every day, each blister pack of Hastina 24+4 comes with 7 self-adhesive strips with the days of the week printed on them. The patient should know the day of the week they start taking the tablets.
The patient should choose the strip that starts with the first day of their period. For example, if the first day of their period is a Wednesday, they should use the strip that starts with "Wed". The strip should be stuck to the top left corner of the blister pack, where it says "Start/Place the label here". This way, the patient can see the day of the week for each tablet and check if they have taken it. The arrows show the order in which the tablets should be taken.
During the 4 days of taking the white placebo tablets (the withdrawal phase), the patient usually experiences bleeding (so-called withdrawal bleeding). This bleeding usually starts on the 2nd or 3rd day after taking the last active pink tablet of Hastina 24+4. After taking the last white tablet, the patient should start a new pack, regardless of whether the bleeding has stopped. This means that the patient will start a new pack on the same day of the week, and the bleeding should also occur on the same days every month.
If the patient takes Hastina 24+4 in this way, they are also protected against pregnancy during the 4 days of taking the white placebo tablets.

When can the patient start the first pack?

• If the patient has not used hormonal contraceptives in the previous month.The patient should start taking Hastina 24+4 on the first day of their period (i.e., the first day of menstrual bleeding). If the patient starts taking Hastina 24+4 on the first day of their period, they are immediately protected against pregnancy. The patient can also start taking it from the 2nd to the 5th day of their period, but in this case, they should use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Changing from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch.The patient can start taking Hastina 24+4 the next day after taking the last active tablet (the last tablet containing active substances) from the previous pack, but no later than the day after the end of the previous contraceptive's tablet-free period (or the last inactive tablet). When changing from a combined hormonal contraceptive vaginal ring or patch, the patient should follow their doctor's advice.
• Changing from a progestogen-only method (minipill, injection, implant, or intrauterine system releasing progestogen).The patient can switch from a minipill on any day, from an implant or intrauterine system on the day of its removal, or from an injection when the next injection is due. In all these cases, the patient should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Hastina 24+4.
• After a miscarriage.The patient should follow their doctor's advice.
• After childbirth.The patient can start taking Hastina 24+4 from the 21st to the 28th day after giving birth. If the patient starts taking it later than on the 28th day, they should use a barrier method (e.g., condoms) for the first 7 days of taking Hastina 24+4.

If the patient has had sex after giving birth, before (re)starting Hastina 24+4, they should first make sure they are not pregnant or wait until their next menstrual period.

• If the patient is breastfeeding and wants to (re)start taking Hastina 24+4 after childbirth.The patient should read the section on "Breastfeeding".

If the patient is unsure when to start taking Hastina 24+4, they should consult their doctor.

What to do if the patient takes more Hastina 24+4 than they should

There are no reports of serious, harmful effects from taking too many Hastina 24+4 tablets at the same time.
If several tablets are taken at the same time, the patient may experience nausea and vomiting.
In young girls, vaginal bleeding may occur.
If the patient takes too many Hastina 24+4 tablets or if a child accidentally swallows some, they should consult their doctor or pharmacist.

What to do if the patient misses a dose of Hastina 24+4

The last four tablets in the fourthrow of the blister pack are placebo tablets. If one of these tablets is missed, it will not affect the effectiveness of Hastina 24+4. The missed placebo tablet should be discarded.
If the patient misses an active pink tablet (tablets 1-24 from the blister pack), they should do the following:

• If it has been less than 24 hourssince the missed tablet, the patient's protection against pregnancy is not reduced. The patient should take the missed tablet as soon as possible and then take the next tablets at the usual time.
• If it has been more than 24 hourssince the missed tablet, the patient's protection against pregnancy may be reduced. The more tablets the patient misses, the higher the risk of becoming pregnant.

The risk of reduced protection against pregnancy is highest if the patient misses tablets at the beginning or end of the pack. Therefore, the patient should follow these rules (see diagram):

• Missing more than one tablet in the packThe patient should contact their doctor.
• Missing one tablet between days 1 and 7 (1st row)The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time). The patient should then take the next tablets at the usual time and use additional contraceptive methods, such as condoms, for the next 7 days. If the patient had sex during the week before missing the tablet, there is a risk of pregnancy. In this case, the patient should contact their doctor.
• Missing one tablet between days 8 and 14 (2nd row)The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time). The patient should then take the next tablets at the usual time. The patient's protection against pregnancy is not reduced, and they do not need to use additional contraceptive methods.
• Missing one tablet between days 15 and 24 (3rd and 4th rows)There are two options to choose from:
• 1. The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time). The patient should then take the next tablets at the usual time. Instead of taking the white placebo tablets from the same blister pack, the patient should discard them and start taking the tablets from a new pack (24 pink film-coated tablets and 4 white film-coated tablets) immediately. The patient will probably have their period at the end of the second pack – during the withdrawal phase – but they may also experience spotting or breakthrough bleeding during the second pack.

It is essential to note that if the patient misses a tablet, they should not miss the next tablet. If the patient vomits or has severe diarrhea within 3-4 hours of taking an active pink tablet, the patient should follow the same advice as if they had missed a tablet.

What to do if the patient experiences vomiting or severe diarrhea

If the patient vomits within 3-4 hours of taking an active pink tablet or experiences severe diarrhea, there is a risk that the active substances from the tablet may not have been fully absorbed into the bloodstream. The situation is similar to missing a tablet.
After vomiting or diarrhea, the patient should take another active pink tablet from the reserve pack as soon as possible. If possible, the patient should take it within 24 hours of the normal time for taking the tablet.
If this is not possible or more than 24 hours have passed, the patient should follow the advice given in the section "What to do if the patient misses a dose of Hastina 24+4".

Delaying withdrawal bleeding: what the patient needs to know

Even though it is not recommended, the patient can delay their period by not taking the white placebo tablets from the 4th row of the blister pack and starting a new pack of Hastina 24+4 immediately. The patient may experience spotting or breakthrough bleeding while taking the tablets from the second pack. The second pack should be finished by taking the 4 white placebo tablets from the 4th row of the blister pack. Then, the patient should start taking the tablets from the next pack.
The patient can ask their doctor for advice before deciding to delay their period.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Hastina 24+4, consult a 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, see section 2 "Important information before taking Hastina 24+4". The following side effects have been associated with the use of Hastina 24+4.

Severe side effects

Consult a doctor immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with possible accompanying difficulty breathing (see also "Warnings and precautions"). Frequent side effects(may affect up to 1 in 10 patients):

• mood swings
• headache
• nausea
• breast pain, menstrual disorders, such as irregular menstruation or absence of menstruation.

Uncommon side effects(may affect up to 1 in 100 patients):

• depression, nervousness, sleep disorders
• dizziness, tingling, numbness
• migraine, varicose veins, increased blood pressure
• abdominal pain, vomiting, indigestion, gas, diarrhea, gastritis
• acne, itching, rash
• pain, e.g., back pain, limb pain, muscle cramps
• fungal infections of the vagina, pelvic pain, breast enlargement, benign breast tumor, uterine/vaginal bleeding (which usually subsides during the use of Hastina 24+4), discharge, hot flashes, vaginal inflammation, menstrual problems, painful menstruation, scanty menstruation, very heavy menstruation, vaginal dryness, abnormal cervical smear
• decreased libido
• fatigue, increased sweating, fluid retention
• weight gain.

Rare side effects(may affect up to 1 in 1,000 patients):

• candidiasis (fungal infection)
• anemia, increased platelet count
• allergic reaction
• hormonal disorders (endocrine)
• increased appetite, loss of appetite, significantly increased potassium levels in the blood, significantly decreased sodium levels in the blood
• anorgasmia
• insomnia
• dizziness, chills
• eye disorders, e.g., conjunctivitis, dry eyes
• rapid heartbeat
• phlebitis, nosebleeds, fainting
• abdominal distension, gastrointestinal disease, feeling of bloating, gastric hernia, oral fungal infection, constipation, dry mouth
• biliary colic or cholecystitis
• chloasma, rash, hair loss, acne-like skin inflammation, dry skin, nodular skin inflammation, excessive hair growth, skin diseases, striae, skin inflammation, skin sensitivity to light, skin nodules
• difficult or painful intercourse, vaginal inflammation, post-coital bleeding, withdrawal bleeding, breast cyst, increased number of breast cells (hyperplasia), malignant breast tumor, significant cervical hypertrophy, cervical 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 stroke-like symptoms, known as a transient ischemic attack blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood of blood clots may be higher if the patient has any other risk factors (for further information on risk factors for blood clots and symptoms of blood clots, see section 2). The following side effects have also been reported: hypersensitivity, erythema multiforme (rash and redness or ulcers), but based on available data, it is not possible to determine their frequency.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hastina 24+4

Store in a place 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 given 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. Package contents and other information

What Hastina 24+4 contains

• -The active substances of the medicinal product are: ethinylestradiol and drospirenone. Each active pink film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone. The white film-coated tablets do not contain active substances.
• -The other ingredients of the medicinal product are: Active pink film-coated tablet:
• -tablet core: lactose monohydrate, cornstarch, povidone K-30, croscarmellose sodium, polysorbate 80, magnesium stearate.
• -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 film-coated tablet:
• -tablet core: anhydrous lactose, povidone K-30, magnesium stearate.
• -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 film-coated tablets in rows 1, 2, 3, and 4, and 4 white film-coated placebo tablets in row 4. Hastina 24+4 is pink and white film-coated tablets with a tablet core coated with a coating. Hastina 24+4 is available in packs of 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 authorization holder

Aristo Pharma Sp. z o.o. ul. Baletowa 30 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 Date of last revision of the leaflet:December 2024