Hastina 21

Leaflet accompanying the packaging: patient information

Hastina 21, 0.02 mg + 3 mg, coated tablets

Ethinylestradiol + Drospirenone

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").

It is essential to carefully read the leaflet before taking the medicine, as it contains important information for the patient.

• -The leaflet should be kept to be able to read it again if necessary.
• -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 inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Hastina 21 and what is it used for
• 2. Important information before taking Hastina 21
• 3. How to take Hastina 21
• 4. Possible side effects
• 5. How to store Hastina 21
• 6. Contents of the pack and other information

1. What is Hastina 21 and what is it used for

Hastina 21 is a contraceptive pill and is used to prevent pregnancy.
Each coated tablet contains a small amount of two different female hormones, namely
ethinylestradiol and drospirenone.
Contraceptive pills containing two hormones are called "combined" pills.

2. Important information before taking Hastina 21

General notes

Before starting to take Hastina 21, the information about
blood clots (thrombosis) in section 2 should be read. It is particularly important to read the symptoms
of blood clots (see the section "Blood clots").
Before starting to take Hastina 21, the doctor will ask the patient a few questions about her health
and the health of her close relatives. The doctor will also measure the patient's blood pressure and, depending on
the individual case, may also perform some other tests.
This leaflet describes several situations in which the use of Hastina 21 should be stopped, or
in which the effectiveness of Hastina 21 may be reduced. In such situations, sexual intercourse should not be maintained, or additional non-hormonal contraceptive measures should be used,
such as condoms or other mechanical methods. The calendar method or temperature measurement method should not be used. These methods may be unreliable, as Hastina 21 modifies
the monthly changes in body temperature and cervical mucus.

Hastina 21, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to take Hastina 21

Hastina 21 should not be taken 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 that she has 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 undergo surgery or will be immobilized for a long time (see the section "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient suffers (or has suffered in the past) from angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (transient 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 had in the past) a type of migraine called "migraine with aura";
• if the patient currently has (or has had in the past) pancreatitis;
• if the patient currently has (or has had in the past) liver disease, and liver function is still abnormal;
• if the patient has kidney dysfunction (renal failure);
• if the patient currently has (or has had in the past) liver cancer;
• if the patient currently has (or has had in the past) or suspects breast or genital cancer;
• 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, she should not take Hastina 21 (see also "Hastina 21 and other medicines").

Warnings and precautions

When should a doctor be contacted?
A doctor should be contacted immediately

• -if the patient notices any of the following symptoms, which may indicate that she has a blood clot in her leg (deep vein thrombosis), blood clot in her lungs (pulmonary embolism), heart attack, or stroke (see the section "Blood clots" (thrombosis)).

In order to obtain a description of the serious adverse reactions mentioned, see the section
"How to recognize a blood clot".
In some situations, it is necessary to exercise particular caution when taking Hastina 21
or any other combined hormonal contraceptive and regular medical check-ups may also be necessary.

The patient should tell her doctor if she has any of the following conditions.

If these symptoms occur or worsen while taking Hastina 21, the patient should also tell her doctor

• if a close relative has had breast cancer;
• 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 21, 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 her doctor as soon as possible;
• if the patient has epilepsy (see the section "Hastina 21 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, she should avoid direct exposure to sunlight or ultraviolet radiation;
• if the patient has hereditary angioedema, estrogen-containing products may cause or worsen its symptoms. The patient should contact her doctor immediately if she experiences 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 diagnosed with high levels of fats in the blood (hypertriglyceridemia) or if someone in her close family has been diagnosed with it. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to undergo surgery or will be immobilized for a long time (see the section "Blood clots");
• if the patient has recently given birth, she is at a higher risk of blood clots. The patient should contact her doctor for information on when to start taking Hastina 21 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, she should contact her doctor immediately. Estrogen-containing products may cause or worsen the symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Hastina 21, is associated with an increased risk of blood clots, compared to not using the therapy.
Blood clots can occur:

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

Not all patients who experience 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 a blood clot caused by taking Hastina 21 is small.

HOW TO RECOGNIZE A BLOOD CLOT

A doctor should be contacted immediately if any of the following symptoms are noticed.
Is the patient experiencing any of these symptoms?
Why is the patient
probably 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;
• -a change in the color 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 abdominal pain.

If the patient is unsure, she should contact her 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 adverse reactions are rare, they can occur most frequently in the first year of use of 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 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 the 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 the use of 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 21, 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 21 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 21, 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 21 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 years old). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to undergo 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 Hastina 21 for a few weeks before surgery or immobilization. If the patient needs to stop taking Hastina 21, she should ask her doctor when she can resume taking the medicine;
• 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 inform the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop the use of Hastina 21.
If any of the above conditions change while taking Hastina 21, such as if someone in the patient's close family is diagnosed with a blood clot without a known cause or if the patient gains significant weight, the patient should inform her doctor.

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 severe 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 a heart attack or stroke associated with taking Hastina 21 is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes.While taking a hormonal contraceptive like Hastina 21, 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 years old). 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 her close family has been diagnosed with 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 called atrial fibrillation);
• 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 a blood clot may be even higher.

The patient should inform her doctor if any of the above conditions change while taking Hastina 21, such as if she starts smoking, someone in her close family is diagnosed with a blood clot without a known cause, or if she gains significant weight.

Hastina 21 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 frequently. The incidence of breast tumors decreases gradually 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 reported, in rare cases, benign liver tumors, and in even rarer cases, malignant liver tumors. If the patient experiences severe abdominal pain, she should contact her doctor.

Vaginal bleeding

During the first few months of taking Hastina 21, unexpected bleeding (bleeding outside of the withdrawal week) may occur. If such bleeding lasts longer than a few months or starts after a few months, the doctor should determine the cause.

What to do if withdrawal bleeding does not occur

• If all the tablets have been taken according to the schedule, no vomiting or severe diarrhea has occurred, and no other medicines have been taken, it is very unlikely that the patient is pregnant.
• If the expected withdrawal bleeding does not occur for two consecutive times, it may mean that the patient is pregnant. The patient should contact her doctor immediately. The patient should not start the next blister pack until she is sure she is not pregnant.

Hastina 21 and other medicines

The patient should always tell her doctor which medicines or herbal products she is already taking. The patient should also tell any other doctor, including a dentist or pharmacist, that she is taking Hastina 21. They may tell her if she needs to use additional contraceptive measures (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, she should not take Hastina 21, as it 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 21 about 2 weeks after finishing treatment with these medicines.
See also the section "Warnings and precautions".
Some medicines may affect the levels of Hastina 21 in the blood and make it less effective in preventing pregnancy or cause unexpected bleeding.
This includes:

• medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• tuberculosis (e.g., rifampicin)
• HIV or hepatitis C infections (so-called 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 21 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 her doctor or pharmacist.

Hastina 21 with food and drink

Hastina 21 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 her doctor or laboratory staff that she is taking contraceptive pills, as oral hormonal contraceptives may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, she should not take Hastina 21. If the patient becomes pregnant while taking Hastina 21, she should stop taking it immediately and contact her doctor.
If the patient wants to become pregnant, she can stop taking Hastina 21 at any time (see also "Stopping Hastina 21").
Before taking any medicine, the patient should consult her doctor or pharmacist.
Breastfeeding
It is usually not recommended to take Hastina 21 while breastfeeding. If the patient wants to take contraceptive pills while breastfeeding, she should contact her doctor.
Before taking any medicine, the patient should consult her doctor or pharmacist.

Driving and using machines

Hastina 21 has no or negligible influence on the ability to drive and use machines. However, no studies have been conducted on the effect of the medicine on the ability to drive and use machines.

Hastina 21 contains lactose

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

3. How to take Hastina 21

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of doubt, the patient should contact her doctor or pharmacist.
The patient should take one tablet of Hastina 21 every day, if necessary with a small amount of water.
The tablets can be taken with or without food, but they should be taken every day at about the same time.
The blister pack contains 21 tablets. The day of the week is printed next to each tablet. If, for example, the patient starts taking the tablets on a Wednesday, she should take the tablet with "Wed" printed next to it. The patient should move in the direction of the arrows on the blister pack until all 21 tablets have been taken.
Then, the patient should not take any tablets for 7 days. During these 7 days, when no tablets are taken (also known as the withdrawal week), bleeding should occur. This is called "withdrawal bleeding", which usually starts on the 2nd or 3rd day of the 7-day break.
On the 8th day after taking the last tablet of Hastina 21 (i.e., after the 7-day break), the patient should start a new blister pack, regardless of whether the bleeding has stopped or not. This means that the patient should start each new blister pack on the same day of the week, and the withdrawal bleeding should occur on the same days every month.
If the patient takes Hastina 21 in this way, she is also protected against pregnancy during the 7 days when she is not taking tablets.

When can the first blister pack be started?

• If the patient has not used hormonal contraceptives in the previous month.The patient should start taking Hastina 21 on the first day of her menstrual cycle (i.e., the first day of her period). If the patient starts taking Hastina 21 on the first day of her period, she is immediately protected against pregnancy. The patient can also start taking Hastina 21 from the 2nd to the 5th day of her menstrual cycle, but in this case, she should use additional contraceptive measures (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch.The patient can start taking Hastina 21 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 tablet-free period of the previous contraceptive. In the case of switching from a combined hormonal contraceptive vaginal ring or patch, the patient should follow the doctor's instructions.
• Switching from a progestogen-only method (mini-pill, injection, implant, or intrauterine system releasing progestogen).The patient can switch at any time from a progestogen-only pill (from an implant or intrauterine system on the day it is removed, or from an injection when the next injection is due), but in all these cases, the patient should use additional contraceptive measures (e.g., condoms) for the first 7 days of tablet-taking.
• After a miscarriage.The patient should follow her doctor's instructions.
• After childbirth.The patient can start taking Hastina 21 from the 21st to the 28th day after giving birth. If the patient starts taking Hastina 21 later than on the 28th day, she should use a mechanical contraceptive method (e.g., condoms) for the first 7 days of tablet-taking. If the patient has had sexual intercourse after giving birth, before (re)starting Hastina 21, she should first make sure she is not pregnant or wait for her next menstrual period.
• If the patient is breastfeeding and wants to (re)start taking Hastina 21 after childbirth.The patient should read the section "Breastfeeding".

If the patient is unsure when to start taking Hastina 21, she should consult her doctor.

What to do if too much Hastina 21 is taken

There are no reports of serious, harmful effects from taking too many Hastina 21 tablets.
If several tablets are taken at the same time, nausea and vomiting may occur.
In young girls, vaginal bleeding may occur.
If too many Hastina 21 tablets are taken or if they are swallowed by a child, the patient should consult her doctor or pharmacist.

Missing a dose of Hastina 21

• If it has been less than 12 hourssince the missed tablet, the protection against pregnancy is not reduced. The tablet should be taken as soon as possible, and the next tablets should be taken at the usual time.

If it has been more than 12 hourssince the missed tablet, the protection against pregnancy may be reduced. The more tablets that are missed, the higher the risk of pregnancy.

• Missing more than one tablet in a blister packThe patient should contact her doctor.
• Missing one tablet in week 1The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time). The next tablets should be taken at the usual time, and additional contraceptive measures (e.g., condoms) should be used for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, there is a risk of pregnancy. In this case, the patient should contact her doctor.
• Missing one tablet in week 2The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time). The next tablets should be taken at the usual time. The protection against pregnancy is not reduced, and no additional contraceptive measures are needed.
• Missing one tablet in week 3There 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 next tablets should be taken at the usual time. Instead of the tablet-free period, the patient should start taking the tablets from the next blister pack immediately, continuing without a break. It is likely that the patient will experience bleeding towards the end of the second pack, but she may also experience spotting or breakthrough bleeding while taking the tablets from the second pack.
• 2. The patient can also stop taking the tablets from the blister pack and go directly to the 7-day tablet-free period ( make a note of the day the tablet was missed). If the patient wants to start the next blister pack on her usual start day, she can shorten the tablet-free period to less than 7 days.

If the patient follows one of these two instructions, the protection against pregnancy will be maintained.

• If the patient has missed any of the tablets in the blister pack and has not experienced withdrawal bleeding during the tablet-free period, she may be pregnant. In this case, before starting the next blister pack, the patient should contact her doctor.

What to do if vomiting or severe diarrhea occurs

If vomiting occurs within 3 to 4 hours after taking a tablet or if severe diarrhea occurs, there is a risk that the active substances from the tablet may not have been fully absorbed into the body.
The situation is similar to missing a tablet.
After vomiting or diarrhea, the patient should take another tablet from the reserve blister as soon as possible. If possible, she should take it within 12 hours of the normal time of taking the tablet.
If this is not possible or more than 12 hours have passed, the patient should follow the instructions given in the section "Missing a dose of Hastina 21".

Delaying withdrawal bleeding: what to know

Even if it is not recommended, it is possible to delay withdrawal bleeding by going directly to a new blister pack of Hastina 21, skipping the tablet-free period, until the end of the pack. The patient may experience spotting or breakthrough bleeding while taking the tablets from the second pack.
After the usual 7-day tablet-free period, the patient should start taking the tablets from the next blister pack.
The patient can ask her doctor for advice before deciding to delay withdrawal bleeding.

Changing the first day of withdrawal bleeding: what to know

If the patient is taking the tablets according to the instructions, withdrawal bleeding will occur during the tablet-free week. If the patient wants to change this day, she does so by shortening (but never lengthening - maximum 7 days!) the tablet-free period. For example, if the tablet-free period starts on a Friday and the patient wants to change the day to Tuesday (3 days earlier), she should start the new blister pack 3 days earlier than usual. If the break in taking the medicine is very short (e.g., 3 days or less), the patient may experience bleeding during those days. As a result, spotting or breakthrough bleeding may occur.
If the patient is unsure how to proceed, she should contact her doctor.

Stopping Hastina 21

The patient can stop taking Hastina 21 whenever she wants.
If the patient does not want to become pregnant, she should consult her doctor about other effective methods of birth control. If the patient wants to become pregnant, she can stop taking Hastina 21 and wait for her menstrual period to occur before trying to become pregnant. This way, it is easier to calculate the expected date of delivery.
In case of doubts about taking the medicine, the patient should contact her doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any side effects, especially serious and persistent ones or changes in her health that she thinks may be due to taking Hastina 21, she should consult her doctor.
All women taking combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For more detailed information on the different risk factors associated with the use of combined hormonal contraceptives, the patient should read section 2 "Important information before taking Hastina 21".
The following side effects have been associated with taking Hastina 21.

5. How to Store Hastina 21

The medicinal product should be stored out of sight and reach of children.
Do not store above 30°C.

Expiry Date

Do not use this medicinal product 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.
You should ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Does Hastina 21 Contain

• -The active substances of the medicinal product are: ethinylestradiol and drospirenone. Each film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
• -The other ingredients of the medicinal product are:
• -tablet core: lactose monohydrate, cornstarch, 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).

What Does Hastina 21 Look Like and What Does the Package Contain

Each blister pack contains 21 pink, round, film-coated tablets.
Hastina 21 is available in packs of 1 or 3 blister packs, each containing 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. 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 Update of the Leaflet:December 2024