Hastina 21+7

Patient Information Leaflet

Hastina 21+7, 0.02 mg + 3 mg, coated tablets
Ethinylestradiolum + Drospirenonum
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult a doctor if you suspect symptoms of blood clots (see section 2, "Blood clots").

Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms appear to be the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Hastina 21+7 is and what it is used for
2. What you need to know before taking Hastina 21+7
3. How to take Hastina 21+7
4. Possible side effects
5. How to store Hastina 21+7
6. Contents of the pack and other information

1. What Hastina 21+7 is and what it is used for

Hastina 21+7 is a contraceptive tablet used to prevent pregnancy.
Each of the 21 pink coated tablets contains a small amount of two different female hormones, namely ethinylestradiol and drospirenone.
The 7 white coated tablets do not contain any active substances and are therefore called placebo tablets.
Contraceptive tablets containing two hormones are known as "combined" tablets.

2. Important information before using Hastina 21+7

General notes
Before starting to take Hastina 21+7, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section "Blood clots").
Before you can start taking Hastina 21+7, 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 case, may carry out certain other tests.
This leaflet describes several situations in which you should stop taking Hastina 21+7 or in which the effectiveness of Hastina 21+7 may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use the calendar method or temperature measurement method. These methods may be unreliable because Hastina 21+7 modifies the monthly changes in body temperature and cervical mucus.
Hastina 21+7, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Hastina 21+7
Do not use Hastina 21+7 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 alternative 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 antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following diseases that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage;
  • very high blood pressure;
  • very high levels of fats in the blood (cholesterol or triglycerides);
  • a condition called hyperhomocysteinemia;
• if you currently have (or have previously had) a type of migraine called "migraine with aura";
• if you currently have (or have previously had) pancreatitis;
• if you currently have (or have previously had) liver disease and liver function remains abnormal;
• if you have kidney dysfunction (kidney failure);
• if you currently have (or have previously had) a liver tumour;
• if you currently have (or have previously had) or suspect breast cancer or genital organ cancer;
• if you have any unexplained vaginal bleeding;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, or glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, you should not take Hastina 21+7 (see also "Hastina 21+7 and other medicines").

Warnings and precautions
When should you contact your doctor?
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section "Blood clots").

For a description of the symptoms of these serious adverse effects, see section "How to recognize the occurrence of blood clots".
In certain situations, particular caution is required when using Hastina 21+7 or any other combined hormonal contraceptive, and regular medical check-ups may be necessary.
Tell your doctor if you have any of the following conditions.
If any of these conditions appear or worsen during treatment with Hastina 21+7, inform your doctor:

• if there is a history of breast cancer in your close family;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression. Some women using hormonal contraceptives, including Hastina 21+7, 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+7 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 previously had chloasma (skin pigmentation, especially on the face and neck, also known as "melasma"). If so, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary angioedema, products containing estrogens may trigger or worsen symptoms. Seek immediate medical attention if symptoms of angioedema occur, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or urticaria accompanied by 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 immune system);
• if you have hemolytic uremic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anemia (a hereditary disorder of red blood cells);
• if you have hypertriglyceridemia (elevated blood fat levels) or if someone in your immediate family has it. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have recently given birth, as you are then at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Hastina 21+7 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 urticaria possibly accompanied by 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+7 increases the risk of blood clots compared to not using such medication. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

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

Recovery from 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+7 is low.

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

• swelling of the legs and/or swelling along a vein in the leg or foot, especially if accompanied by:
  • pain or tenderness in the leg, which may occur only when standing or walking;
  • increased warmth in the affected leg;
  • change in skin colour of the leg, such as pallor, redness, or blueness.
• sudden unexplained shortness of breath or rapid breathing;
• sudden cough without obvious cause, which may be associated with coughing up blood;
• sharp chest pain, which may worsen on deep breathing;
• severe dizziness or vertigo;
• rapid or irregular heartbeat;
• severe abdominal pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shallow breathing, may be mistaken for milder conditions such as a 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 most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be increased when restarting combined hormonal contraceptives (either 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 compared to not using combined hormonal contraceptives.
If a woman stops taking Hastina 21+7, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Hastina 21+7 is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5 to 7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Hastina 21+7, will develop blood clots.
• The risk of developing blood clots depends on the woman's individual medical history (see "Factors that increase the risk of developing blood clots in veins" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Hastina 21+7 is small,
however, certain factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In this case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, will be 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+7 several weeks before surgery or immobilization. If the patient must stop taking Hastina 20+7, consult the doctor about when it is safe to restart the medication;
• with increasing age (particularly over 35 years);
• if the patient has given birth within the last few weeks.

The risk of venous 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,
especially 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+7.
Inform the doctor if any of the above conditions change during treatment with
Hastina 21+7, for example, if a close family member is diagnosed with thrombosis of unknown 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+7 is very small, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Hastina 21+7, 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 blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly 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 are 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+7, for example, if the patient starts smoking, a close family member is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.

Hastina 21+7 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 medication. For example, more cancers may be 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, in women using combined hormonal contraceptives, and malignant liver tumors even more rarely. If the patient experiences unusual severe abdominal pain, she should contact the doctor.

Breakthrough bleeding
During the first few months of taking Hastina 21+7, unexpected bleeding (bleeding outside the phase of taking white-coated tablets) may occur. If such bleeding persists for longer than a few months, or if it starts after several months, the doctor should determine the cause.

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

• If all pink-coated tablets were taken according to schedule, there were no episodes of vomiting or severe diarrhea, and no other medications were taken, the likelihood of pregnancy is very low.
• If expected withdrawal bleeding does not occur in two consecutive cycles, this may indicate that the patient is pregnant. Contact the doctor immediately. Do not start the next pack until pregnancy has been ruled out.

Hastina 21+7 and other medicines
Always inform the doctor about any medicines or herbal products currently being taken. Also inform any other doctor, including a dentist or pharmacist, that Hastina 21+7 is being used. They may advise whether additional contraceptive methods (e.g. condoms) should be used, and if so, for how long.

If the patient has hepatitis C virus infection and is taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, or glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, she should not use Hastina 21+7, as this may lead to increased liver enzyme activity in blood tests (increased activity of the liver enzyme AlAT).

Before starting treatment with these medications, the doctor will recommend another type of contraception for the patient.
Resuming use of Hastina 21+7 can be started approximately 2 weeks after completing treatment with the above medications.
See also section "Warnings and precautions".

Some medicines may affect the blood levels of Hastina 21+7 and 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 (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 remedies containing St John's wort (Hypericum perforatum).

Hastina 21+7 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+7 with food and drink
Hastina 21+7 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 the patient is taking oral contraceptives, as combined oral contraceptives may affect the results of certain tests.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, she must not take Hastina 21+7. If the patient becomes pregnant while taking Hastina 21+7, she should stop taking it immediately and contact her doctor. If the patient wishes to become pregnant, she may stop taking Hastina 21+7 at any time (see also "Discontinuation of Hastina 21+7").

Before taking any medicine, consult a doctor or pharmacist.

Breastfeeding
Hastina 21+7 is generally not recommended during breastfeeding. If the patient wishes to use contraceptive tablets while breastfeeding, she should consult her doctor.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines
Hastina 21+7 has no effect or has a negligible effect on the ability to drive and use machines. However, no studies have been conducted on the effect of the medicine on driving and machine operation.

Hastina 21+7 contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use Hastina 21+7

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Each blister pack contains 21 active pink coated tablets and 7 inactive placebo tablets in white.
The tablets of two different colours in Hastina 21+7 are arranged in sequence. The blister contains
28 coated tablets.
Take one tablet of Hastina 21+7 every day, with or without a small amount of water.
You may take the tablets with or without food, but they should be taken daily at approximately the
same time.
Do not confuse the tablets: pink tablets are taken once daily for the first 21 days, followed by one
white tablet daily for the last 7 days. Then start a new pack (21 pink coated tablets and 7 white
coated tablets). As a result, there is no break between packs.
Due to the different composition of the tablets, the first tablet should be taken from the top left
corner of the blister, and tablets should be taken daily in the order indicated by the arrows on the
blister.
Preparing the blister
To help track daily tablet intake, each blister of Hastina 21+7 includes 7 self-adhesive strips
printed with days of the week. You should know the day of the week on which you start taking the
tablets.
Select the appropriate strip so that the first day of the week corresponds to the day you start the
pack. For example, if the first day of use was Wednesday, apply the strip starting with “Wed.”
Attach the label to the top left corner of the blister, in the area marked “Start/Place label here”. This
way, each tablet is marked with the correct day of the week, allowing you to verify whether a tablet
has been taken. Arrows indicate the order of tablet intake.
During the 7 days of taking placebo tablets (placebo week), withdrawal bleeding usually occurs. This
bleeding typically begins on the 2nd or 3rd day after taking the last active pink tablet of Hastina
21+7. After taking the last white tablet, start the next blister immediately, regardless of whether
bleeding is still ongoing. This means each new pack will begin on the same day of the week, and
bleeding should also occur on the same days each month.
If the patient takes Hastina 21+7 as directed, she is protected against pregnancy also during the 7
days when taking placebo tablets.
When to start the first blister?

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

If the patient is unsure when to start taking the medicine, she should consult her doctor.
Taking more than the recommended dose of Hastina 21+7
There are no reports of serious harmful effects from taking too many tablets of Hastina 21+7.
If several tablets are taken at the same time, nausea and vomiting may occur. In young girls, vaginal
bleeding may occur.
If too many tablets of Hastina 21+7 are taken or if a child swallows them, consult a doctor or
pharmacist.
Missed dose of Hastina 21+7
The last tablets in the fourth row of the blister are placebo tablets. If one of these tablets is missed,
it will not affect the effectiveness of Hastina 21+7. Missed placebo tablets should be discarded.
If the patient misses one of the active pink tablets from the first, second, or third row, the following
steps should be taken:

• If less than 12 hours have passed since the missed tablet, protection against pregnancy 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, protection against pregnancy may be reduced. The greater the number of missed tablets, the higher the risk of pregnancy.

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

• Missing more than one tablet in a blister: Contact your doctor.
• Missing one tablet in week 1: Take the missed tablet as soon as possible (even if this means taking two tablets at the same time). Continue taking the next tablets at the usual time and use additional protection, 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, contact your doctor.
• Missing one tablet in week 2: Take the missed tablet as soon as possible (even if this means taking two tablets at the same time). Continue taking the next tablets at the usual time. Protection against pregnancy is not reduced and no additional protection is needed.
• 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 the same time). Continue taking the next tablets at the usual time. Instead of taking the white placebo tablets from the same blister, discard them and immediately start taking tablets from the next blister. Menstruation will most likely occur at the end of the second blister – during the intake of white placebo tablets – but spotting or breakthrough bleeding may also occur during the intake of tablets from the second blister.

  2. Alternatively, stop taking the active pink tablets and go directly to the white placebo tablets ( before taking the placebo tablets, record the day on which the tablet was missed ). If you wish to start the next blister on your usual day, take the placebo tablets for fewer than 7 days.

If either of these two recommendations is followed, protection against pregnancy will be maintained.

• If the patient has missed any tablet and no bleeding occurs during the placebo tablet period, this may indicate that the patient is pregnant. In this case, contact your doctor before starting the next blister.

What to do if vomiting or severe diarrhoea occurs
If vomiting occurs within 3 to 4 hours after taking an active pink tablet or if severe diarrhoea occurs,
there is a risk that the active substances have not been completely absorbed. This situation is
similar to missing a tablet.
After vomiting or diarrhoea, take another pink tablet from a spare blister as soon as possible. If
possible, take it within 12 hours of the 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+7”.
Delaying the onset of bleeding: what to know
Even though not recommended, delaying the onset of bleeding is possible by not taking the white
placebo tablets from the 4th row of the blister and immediately starting a new blister of Hastina
21+7 until its end. Spotting or breakthrough bleeding may occur during the intake of tablets from
the second blister. End the second blister by taking 7 white tablets from the 4th row of the blister.
Then start taking tablets from the next blister.
You may consult your doctor for advice before deciding to delay the onset of bleeding.
Changing the first day of bleeding: what to know
If the patient takes the tablets as instructed, bleeding will begin during the placebo tablet phase.
To change this day, shorten the placebo phase by reducing the number of white placebo tablets
taken (but never extend it – maximum 7 days!). For example, if the placebo phase starts on Friday
and the patient wishes to change it to Tuesday (3 days earlier), start the new blister 3 days earlier
than usual. If the placebo phase is very short (e.g., 3 days or less), bleeding may occur during these
days. This may result in spotting or breakthrough bleeding.
If the patient is unsure how to proceed, she should contact her doctor.
Stopping use of Hastina 21+7
You may stop taking Hastina 21+7 at any time.
If the patient does not wish to become pregnant, she should consult her doctor about other effective
contraceptive methods. If the patient wishes to become pregnant, she should stop taking Hastina
21+7 and wait for a menstrual period before trying to conceive. This makes it easier to calculate the
expected date of delivery.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Hastina 21+7, medical advice should be sought immediately.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2. "Important information before taking Hastina 21+7".
The following adverse reactions have been associated with the use of Hastina 21+7.
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 possibly accompanied by difficulty breathing (see also section "Warnings and precautions").
Common adverse reactions (may affect up to 1 in 10 women):

• mood swings
• headache
• abdominal pain (stomach)
• 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
• tingling and numbness, dizziness
• vision problems
• heart rhythm disorders or abnormally fast heartbeat
• blood clots (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 accompanied by breathing difficulties (angioedema), hair loss (alopecia), eczema (rash), itching, rash, dry skin, seborrhoeic skin disorders (seborrhoeic dermatitis)
• neck pain, limb pain, muscle cramps
• urinary tract infection
• breast tumour (benign and malignant), milk discharge in women who are not pregnant (galactorrhoea), ovarian cysts, sudden flushing of the face, absence of menstruation, very heavy menstruation, vaginal discharge, vaginal dryness, lower abdominal pain (pelvis), abnormal cervical smear (Papanicolaou 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:
  o in the leg or foot (e.g. deep vein thrombosis)
  o in the lungs (e.g. pulmonary embolism)
  o heart attack
  o stroke
  o mini-stroke or transient stroke-like symptoms, known as transient ischaemic attack
  o blood clots in the liver, stomach/intestine, kidneys or eye.
  The likelihood of developing blood clots may be higher if the patient has other risk factors (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 adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 to provide more information on the safety of this medicine.

5. How to store Hastina 21+7

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

6. Contents of the pack and other information

What Hastina 21+7 contains
The Hastina 21+7 blister pack contains 21 pink active tablets in the first, second, and third rows of the blister, and 7 white placebo tablets in the fourth row.

• The active substances are ethinylestradiol and drospirenone. Each pink coated active tablet contains 0.02 mg ethinylestradiol and 3 mg drospirenone. The white coated tablets do not contain any active substances.
• Other components of the medicinal product are:
  Coated active tablet in pink:
• 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).
  Coated inactive tablet in white:
• tablet core: anhydrous lactose, povidone K-30, magnesium stearate.
• tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

What Hastina 21+7 looks like and contents of the pack
Each blister contains 21 pink, round, coated active tablets and 7 white, round, coated placebo tablets.
Hastina 21+7 is available in packs containing 1 or 3 blisters, each with 28 coated tablets (21 coated active tablets + 7 coated placebo 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