Hastina 21

Package leaflet: Information for the patient

Hastina 21, 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 your doctor if you suspect 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, so you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The 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.

Table of contents of the leaflet

1. What Hastina 21 is and what it is used for
2. What you need to know 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 Hastina 21 is and what it is used for

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

2. Important information before using Hastina 21

General notes
Before starting to take Hastina 21, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots (see section "Blood clots").
Before you can start taking Hastina 21, your doctor will ask you 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 certain other tests.
This leaflet describes several situations in which you should stop taking Hastina 21 or in which the effectiveness of Hastina 21 may be reduced. In such cases, 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 temperature measurement method. These methods may be unreliable because Hastina 21 alters the monthly changes in body temperature and cervical mucus.
Hastina 21, like other hormonal contraceptives, does not protect against infection with the HIV virus (AIDS) or other sexually transmitted diseases.

When not to use Hastina 21
Do not take Hastina 21 if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which other method of contraception would be more suitable.

• if you are 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 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 blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies;
• if you require surgery or will be immobile for a long time (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you suffer from (or have suffered 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 suffer from any of the following conditions which 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 function disorders (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 genital organ cancer;
• if you have any unexplained vaginal bleeding;
• if you have viral 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 21 (see also "Hastina 21 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 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 21 or any other combined hormonal contraceptive, and regular medical check-ups may also 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 21, you should also inform your doctor:

• if there is currently or has ever been 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 21, 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 21 and other medicines");
• if you have a disease 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, so-called "pregnancy mask"). If so, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary angioedema, products containing estrogens may trigger or worsen its 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 causing 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 it. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a long time (see section "Blood clots");
• if you have recently given birth, as you are then at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Hastina 21 after childbirth;
• 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 with possible breathing difficulties, 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 21 is associated with an increased risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

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

Recovery after a blood clot is not always complete. 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 21 is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.
Is the patient experiencing any of these symptoms? What is the likely cause?

• swelling of the leg and/or swelling along a vein in the leg or foot, especially if accompanied by:
  • pain or tenderness in the leg, which may only be felt when standing or walking;
  • increased warmth in the affected leg;
  • change in skin colour of the leg, e.g. paleness, redness, blueness.
• sudden unexplained shortness of breath or rapid breathing;
• sudden coughing without an obvious cause, which may be associated with 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, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infection (e.g. cold).

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis), although these adverse events are rare. They occur most frequently 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 blood clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher 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 patient stops taking Hastina 21, the risk of blood clots returns to normal within a few weeks.

What does the risk of blood clots in veins 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 21 is low.

• In the course of 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 the course of 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 the course of one 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 developing blood clots depends on the patient's individual medical history (see "Factors increasing 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 21 is small, however,
some factors may increase this risk. The risk is greater:

• if the patient has significant 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). In this case, the patient may have an inherited clotting disorder;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue the use of Hastina 21 several weeks before surgery or period of immobility. If the patient must stop taking Hastina 21, ask the doctor 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 last 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 listed above.
It is important to inform the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to discontinue the use of
Hastina 21.
Inform the doctor if any of the above conditions change during treatment with Hastina 21, 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 the arteries?
As with venous blood clots, arterial clots can cause 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 21 is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Hastina 21, it is recommended to stop smoking. If the patient is unable to stop 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 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 fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes. If the patient has more than one of the above conditions or if any of them is particularly severe, the risk of blood clots may be further increased.

Inform the doctor if any of the above conditions change during treatment with Hastina 21, for example, if the patient starts smoking, if a close family member is diagnosed with thrombosis without a known cause, or if the patient gains significant weight.

Hastina 21 and cancer
In women using combined hormonal contraceptives, breast cancer is observed slightly more frequently, but it is not known whether this is caused by the use of the medicine. For example, it may be that more cancers are detected in women using combined hormonal contraceptives because these women are examined more frequently by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to examine the breasts regularly and contact the doctor if any lump is detected.

Benign liver tumors have been reported rarely, and malignant liver tumors very rarely, in women using combined hormonal contraceptives. If the patient experiences unusual severe abdominal pain, she should contact the doctor.

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

What to do if no bleeding occurs during the pill-free week

• If all tablets have been taken according to schedule, without vomiting or severe diarrhea, and no other medicines have been taken, it is very unlikely that pregnancy has occurred.
• If the expected withdrawal bleeding does not occur twice in succession, this may indicate that the patient is pregnant. Contact the doctor immediately. Do not start the next blister pack until pregnancy has been ruled out.

Hastina 21 and other medicines
Always inform the doctor about any medicines or herbal products currently being used. Also inform any other doctor, including a dentist or pharmacist, that you are using Hastina 21. 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 and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, or glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, she should not use Hastina 21, as this may lead to increased liver enzyme activity in blood tests (increased alanine aminotransferase (AlAT) liver enzyme activity).

Before starting treatment with these medicines, the doctor will recommend another form of contraception.
Hastina 21 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 levels of Hastina 21 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 21 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 21 with food and drink
Hastina 21 may be taken with or without food, and if necessary, with a small amount of water.

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

Pregnancy, breastfeeding and fertility
If the patient is pregnant, she must not take Hastina 21. If pregnancy occurs while taking Hastina 21, she should stop taking the medicine immediately and contact her doctor.
If the patient wishes to become pregnant, she may stop taking Hastina 21 at any time (see also “Discontinuing Hastina 21”).

Before taking any medicine, consult a doctor or pharmacist.
Breastfeeding
Hastina 21 is generally not recommended during breastfeeding. If the patient wishes to use oral contraceptives while breastfeeding, she should contact her doctor.

Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Hastina 21 has no effect or has a negligible effect on the ability to drive and operate machinery. However, no specific studies have been conducted on the effect of the medicine on driving and operating machinery.

Hastina 21 contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, she should contact her doctor before taking this medicine.

3. How to use Hastina 21

This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Take one tablet of Hastina 21 every day, with a small amount of water if needed.
The tablets may be taken with or without food, but they should be taken daily at approximately the same time.
The blister pack contains 21 tablets. Next to each tablet is printed the day of the week on which the tablet should be taken. For example, if tablet-taking begins on Wednesday, take the tablet marked “Wed”. Proceed in the direction of the arrows on the blister until all 21 tablets have been taken.
Then, do not take any tablets for 7 days. During these 7 days, when no tablets are taken (also known as the "tablet-free week"), withdrawal bleeding is expected to occur. This is called "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the 7-day tablet-free interval.
On the 8th day after taking the last tablet of Hastina 21 (i.e. after the 7-day break), start the next blister pack regardless of whether bleeding has stopped or not. This means that each new pack should be started on the same day of the week, and withdrawal bleeding should occur on the same days each month.
If the patient uses Hastina 21 as described above, she is protected against pregnancy also during the 7 days when no tablets are taken.

When to start the first blister pack?

• If no hormonal contraceptives were used in the previous month: Begin taking Hastina 21 on the first day of the menstrual cycle (i.e. the first day of menstruation). If the patient starts taking Hastina 21 on the first day of her period, she is immediately protected against pregnancy. Alternatively, treatment may be started between the 2nd and 5th day of the cycle, but in this case, additional contraceptive methods (e.g. condoms) must be used for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined vaginal contraceptive system or transdermal contraceptive system: Begin taking Hastina 21 the day after the last active tablet (i.e. the last tablet containing active substances) from the previous pack is taken, but no later than the day after the tablet-free interval of the previous contraceptive ends (or after the last inactive tablet of the previous contraceptive). When switching from a combined vaginal contraceptive system or transdermal contraceptive system, follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen): Switching may occur on any day from the progestogen-only pill (on the day of removal for an implant or intrauterine system, or on the day of the next scheduled injection for injectable contraceptives), but in all these cases, additional contraceptive methods (e.g. condoms) must be used for the first 7 days of taking Hastina 21 tablets.
• After miscarriage: Follow your doctor's advice.
• After childbirth: Begin taking Hastina 21 between 21 and 28 days after delivery. If the patient starts taking the medicine later than on day 28, a mechanical contraceptive method (e.g. condoms) must be used for the first seven days of taking Hastina 21. If the patient has had sexual intercourse after childbirth, she must ensure she is not pregnant before (re)starting Hastina 21, or wait until the next menstrual bleeding occurs.
• If the patient is breastfeeding and wishes to (re)start taking Hastina 21 after childbirth: Please read section “Breastfeeding”.

If the patient is unsure when to start taking the medicine, she should consult her doctor.
Overdose of Hastina 21
There are no reports of serious harmful effects from taking too many tablets of Hastina 21.
If several tablets are taken at the same time, nausea and vomiting may occur.
In young girls, vaginal bleeding may occur.
If an overdose of Hastina 21 tablets is taken or if a child swallows any tablets, consult a doctor or pharmacist immediately.
Missed dose of Hastina 21

• If less than 12 hours have passed since the missed tablet, contraceptive protection is not reduced. Take the missed tablet as soon as possible, then continue taking the next tablets at the usual time.

• If more than 12 hours have passed since the missed tablet, contraceptive protection may be reduced. The more tablets missed, the greater the risk of pregnancy.

The risk of inadequate contraceptive protection is greatest if a tablet is missed at the beginning or end of the pack. Therefore, follow the rules below (see chart):

• Missing more than one tablet in a pack: Contact your doctor.
• Missing one tablet in Week 1: Take the missed tablet as soon as possible (even if this means taking two tablets at once). Continue taking the remaining tablets at the usual time and use additional contraception, such as condoms, 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, consult your doctor.
• Missing one tablet in Week 2: Take the missed tablet as soon as possible (even if this means taking two tablets at once). Continue taking the remaining tablets at the usual time. Contraceptive protection is not reduced, and additional contraception is not required.
• Missing one tablet in Week 3: Two options are available:
  1. Take the missed tablet as soon as possible (even if this means taking two tablets at once). Continue taking the remaining tablets at the usual time. Instead of the tablet-free week, immediately start the next pack. Withdrawal bleeding will most likely occur at the end of the second pack, but spotting or breakthrough bleeding may occur during the second pack.
  2. Alternatively, stop taking tablets from the current pack and proceed directly to the 7-day tablet-free interval (note the day on which the tablet was missed). If you wish to start a new pack on your usual day, the tablet-free interval may be shortened to less than 7 days.

If either of these two options is followed, contraceptive protection will be maintained.

• If any tablet from the pack was missed and no bleeding occurred during the first tablet-free interval, this may indicate that the patient is pregnant. In this case, consult your doctor before starting the next pack.

What to do if vomiting or severe diarrhoea occurs
If vomiting occurs within 3 to 4 hours after taking a tablet or if severe diarrhoea occurs, there is a risk that the active substances in the tablet have not been completely absorbed.
This situation is similar to missing a tablet.
After vomiting or diarrhoea, take another tablet from a spare blister pack as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time.
If this is not possible or more than 12 hours have passed, follow the instructions under “Missed dose of Hastina 21”.
Delaying withdrawal bleeding: what to know
Although not recommended, it is possible to delay withdrawal bleeding by moving directly to a new pack of Hastina 21, skipping the tablet-free interval until its end.
Spotting or breakthrough bleeding may occur during the second pack. After the usual 7-day tablet-free interval, start taking tablets from the next pack.
Consult your doctor for advice before deciding to delay withdrawal bleeding.
Changing the day of withdrawal bleeding: what to know
If the patient takes tablets as instructed, withdrawal bleeding will occur during the tablet-free week. To change this day, shorten (but never extend—maximum 7 days!) the tablet-free interval. For example, if the tablet-free interval starts on Friday and the patient wishes to change it to Tuesday (3 days earlier), start the new pack 3 days earlier than usual. If the break is very short (e.g. 3 days or less), bleeding may occur during these days, which may lead to spotting or breakthrough bleeding.
If the patient is unsure how to proceed, she should contact her doctor.
Stopping treatment with Hastina 21
You may stop taking Hastina 21 at any time.
If the patient does not wish to become pregnant, she should consult her doctor about other effective methods of birth control. If the patient wishes to become pregnant, she should stop taking Hastina 21 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 how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or any changes in health which the patient considers to be related to the use of Hastina 21, medical advice should be sought from a doctor.
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 the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Hastina 21".
The following adverse reactions have been associated with the use of Hastina 21.

Serious adverse reactions
Seek immediate medical attention if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat, and/or difficulty swallowing, or urticaria accompanied by possible breathing difficulties (see also section "Warnings and precautions").

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

• mood swings
• headache
• abdominal pain (stomach pain)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular menstruation
• weight gain

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

• candidiasis (fungal infection)
• herpes simplex
• allergic reactions
• increased appetite
• depression, nervousness, sleep disturbances
• sensations of tingling and numbness, dizziness
• vision problems
• heart rhythm disorders or abnormally rapid heartbeat
• blood clot (thrombosis) in the lung (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, gastritis and/or enteritis, diarrhoea, constipation
• sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing or urticaria with breathing difficulties (angioedema), hair loss (alopecia), eczema (rash), itching, rash, dry skin, seborrhoeic dermatitis
• neck pain, limb pain, muscle cramps
• urinary tract infection
• breast lump (benign and malignant), milk discharge in women who are not pregnant (galactorrhoea), ovarian cysts, sudden flushing of the face, absence of menstruation, very heavy menstrual bleeding, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic), abnormal cervical smear (Pap test)
• decreased sexual desire
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss

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

• asthma
• hearing problems
• erythema nodosum (characterized by painful red nodules on the skin)
• erythema multiforme (characterized by a rash with red, painful rings)
• 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
  • transient ischaemic attack or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestines, 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 increasing the likelihood of blood clots and symptoms of blood clots, see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Hastina 21

Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 30°C.
Expiry date
Do not use this medicine after the expiry date stated on the blister and carton following: 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 in use. This will help
protect the environment.

6. Contents of the packaging and other information

What Hastina 21 contains

• The active substances are: ethinylestradiol and drospirenone. Each coated tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
• Other components of the medicine are:
• 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).

What Hastina 21 looks like and contents of the pack
Each blister contains 21 pink, round coated tablets.
Hastina 21 is available in packs containing 1 or 3 blisters, each blister containing 21 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