Hastina 21+7

Leaflet accompanying the packaging: patient information

Hastina 21+7, 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.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• -The leaflet should be kept in case it needs to be read again.
• -In case of any doubts, a doctor, pharmacist, or nurse should be consulted.
• -This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• -If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Hastina 21+7 and what is it used for
• 2. Important information before using Hastina 21+7
• 3. How to use Hastina 21+7
• 4. Possible side effects
• 5. How to store Hastina 21+7
• 6. Contents of the packaging and other information

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

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

2. Important information before using Hastina 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 especially important to read about the symptoms of blood clots (see "Blood clots").
Before you can start taking Hastina 21+7, your doctor will ask you a few questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on the individual case, may also perform some 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 not have sexual intercourse or use additional non-hormonal contraceptives, such as condoms or other mechanical methods. You should not use the calendar method or the 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

Hastina 21+7 should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• -if the patient is allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). This allergy may cause itching, rash, or swelling;
• -if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• -if the patient knows that they have blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• -if the patient needs to undergo surgery or will be immobilized for a long time (see "Blood clots");
• -if the patient has had a heart attack or stroke;
• -if the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• -if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• a disease called hyperhomocysteinemia;
• -if the patient has (or has 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 a liver disease caused by hepatitis C and is taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir, they should not take Hastina 21+7 (see also "Hastina 21+7 and other medicines").

Warnings and precautions

When should you contact your doctor?
You should contact your doctor immediately

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

To find a description of the symptoms of these serious side effects, see "How to recognize a blood clot".
In some situations, you should be particularly careful when taking Hastina 21+7 or any other combined hormonal contraceptive and may also need to be regularly examined by your doctor.

You should tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen while taking Hastina 21+7, you should also tell your doctor.

• if someone in your immediate family has had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression. Some women taking hormonal contraceptives, including Hastina 21+7, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice;
• if you have epilepsy (see "Hastina 21+7 and other medicines");
• if you have a disease that first appeared during pregnancy or while taking sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy (pemphigoid gestationis), a nervous system disease characterized by involuntary movements of the body (Sydenham's chorea));
• if you have chloasma (skin discoloration, especially on the face and neck, so-called "pregnancy spots"). If so, you should avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary angioedema, estrogen-containing products may cause or worsen its symptoms. You should contact your doctor immediately if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives with possible accompanying difficulty breathing;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you have been told that you have high levels of fats in the blood (hypertriglyceridemia) or if someone in your immediate family has been told that they have high levels of fats in the blood. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to undergo surgery or will be immobilized for a long time (see "Blood clots");
• if you have just given birth, you are at a higher risk of blood clots. You should ask your doctor how soon you can start taking Hastina 21+7 after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you experience any symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives with possible accompanying difficulty breathing, you should contact your 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+7, is associated with an increased risk of blood clots compared to not using hormonal contraceptives. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• in veins (hereinafter referred to as "venous thromboembolism" or "venous thrombotic events"),
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thrombotic events").

Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

It is essential to remember that the overall risk of harmful blood clots caused by taking Hastina 21+7 is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
Why is the patient likely to be suffering from

• 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 only be felt when standing or walking;
• -increased temperature in the affected leg;
• -change in skin 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 stomach pain.

If you are unsure, you should contact your doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur most often in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves 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 you stop taking Hastina 21+7, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

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+7 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+7, 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+7 is small, but some factors can increase this risk. The risk is higher:

• if you are significantly overweight (body mass index (BMI) over 30 kg/m^2);
• if someone in your immediate 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, you may have a hereditary blood clotting disorder;
• if you need to undergo surgery or will be immobilized for a long time (see "Blood clots"). It may be necessary to stop taking Hastina 21+7 for a few weeks before surgery or immobilization. If you need to stop taking Hastina 21+7, you should ask your doctor when you can resume taking the medicine;
• with age (especially over 35 years old);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (over 4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop you from taking Hastina 21+7.
You should inform your doctor if any of the above conditions change while taking Hastina 21+7, for example, if you start smoking, someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Similar 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+7 is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke.While taking a hormonal contraceptive like Hastina 21+7, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at a higher risk of having a heart attack or stroke;
• if you or someone in your immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, irregular heartbeat called atrial fibrillation);
• if you have diabetes. If you have more than one of these conditions or if any of them are particularly severe, the risk of blood clots may be even higher.

You should inform your doctor if any of the above conditions change while taking Hastina 21+7, for example, if you start smoking, someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

Hastina 21+7 and cancer

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

Irregular bleeding

During the first few months of taking Hastina 21+7, you may experience unexpected bleeding (bleeding outside of the placebo phase). If such bleeding lasts longer than a few months or starts after a few months, your doctor should determine the cause.

What to do if bleeding does not occur during the placebo phase

• If you have taken all the pink tablets according to the schedule, have not vomited, or have not had severe diarrhea, and have not taken any other medicines, it is very unlikely that you are pregnant.
• If the expected bleeding does not occur for two consecutive times, it may mean that you are pregnant. You should contact your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Hastina 21+7 and other medicines

Always tell your doctor which medicines or herbal products you are already taking. You should also tell any other doctor, including your dentist or pharmacist, that you are taking Hastina 21+7. They may tell you if you need to use additional contraceptives (e.g., condoms) and for how long.
If you have a liver disease caused by 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, 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, your doctor will recommend a different contraceptive method.
You can resume taking Hastina 21+7 about 2 weeks after finishing treatment with these medicines.
See also "Warnings and precautions".
Certain medicines may affect the levels of Hastina 21+7 in your blood and make it less effective 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 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+7 may affect the action of other medicines, such as:

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

Before taking any medicine, you should consult your doctor or pharmacist.

Hastina 21+7 with food and drink

Hastina 21+7 can be taken with or without food, if necessary with a small amount of water.

Lab tests

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, you should not take Hastina 21+7. If you become pregnant while taking Hastina 21+7, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Hastina 21+7 at any time (see also "Stopping Hastina 21+7").
Before taking any medicine, you should consult your doctor or pharmacist.
Breastfeeding
It is usually not recommended to take Hastina 21+7 while breastfeeding. If you want to take contraceptive pills while breastfeeding, you should contact your doctor.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

Hastina 21+7 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+7 contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Hastina 21+7

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should contact your doctor or pharmacist.
Each pack contains 21 active pink tablets and 7 inactive white tablets. The tablets in two different colors of Hastina 21+7 are arranged in a sequence. The blister pack contains 28 tablets.
You should take one Hastina 21+7 tablet every day, if necessary with a small amount of water.
You can take the tablets with or without food, but you should take them every day at about the same time.
Do not confuse the tablets:the pink tablets are taken once a day for the first 21 days, and then one white tablet is taken for the last 7 days. Then, you should start taking the tablets from a new pack (21 pink tablets and 7 white tablets). As a result, there is no break between packs.
Due to the different composition of the tablets, you should take the first tablet from the top left corner of the blister pack and continue taking the tablets every day. To maintain the correct order, you should move in the direction indicated by the arrows on the blister pack.

Preparing the blister pack

To check that you have taken a tablet every day, each Hastina 21+7 blister pack comes with 7 self-adhesive strips with the days of the week printed on them. You should know the day of the week you start taking the tablets.
You should choose the strip that matches the first day of the week you start the pack. You should stick the strip in the top left corner of the blister pack, where it says "Start/Place the label here". This way, each tablet has the corresponding day of the week, and you can check if you have taken a tablet. The arrows indicate the order in which to take the tablets.
During the 7 days of taking the placebo tablets (placebo week), you will usually have bleeding (so-called withdrawal bleeding). This bleeding usually starts on the 2nd or 3rd day after taking the last active pink tablet of Hastina 21+7. After taking the last white tablet, you should start a new pack without waiting for the bleeding to stop. This means that you will start a new pack on the same day of the week, and the bleeding should also occur on the same days every month.
If you take Hastina 21+7 in this way, you are also protected against pregnancy during the 7 days of taking the placebo tablets.

When can you start the first pack?

• If you are not using hormonal contraceptives in the previous month.You should start taking Hastina 21+7 on the first day of your cycle (i.e., the first day of your period). If you start taking Hastina 21+7 on the first day of your period, you are immediately protected against pregnancy. You can also start taking the medicine from the 2nd to the 5th day of your cycle, but then you should use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch.You can start taking Hastina 21+7 the next day after taking the last active tablet (the last tablet containing active substances) from the previous pack, but no later than the day after the end of the previous contraceptive's tablet-free period (or after the last inactive tablet of the previous contraceptive). When switching from a combined hormonal contraceptive vaginal ring or patch, you should follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen).You can switch at any time from a progestogen-only pill (from an implant or intrauterine system on the day of its removal, or from injections when the next injection would be due), but in all these cases, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Hastina 21+7.
• After a miscarriage.Follow your doctor's advice.
• After childbirth.You can start taking Hastina 21+7 from the 21st to the 28th day after giving birth. If you start taking the medicine later than on the 28th day, you should use a mechanical contraceptive method (e.g., condoms) for the first 7 days of taking Hastina 21+7. If you have had sexual intercourse after giving birth, before (re)starting Hastina 21+7, you should first make sure that you are not pregnant or wait for your next period.
• If you are breastfeeding and want to (re)start taking Hastina 21+7 after childbirth.You should read the section "Breastfeeding".

If you are unsure when to start taking Hastina 21+7, you should consult your doctor.

What to do if you take more than the recommended dose of Hastina 21+7

There are no reports of serious, harmful effects from taking too many Hastina 21+7 tablets.
If several tablets are taken at the same time, nausea and vomiting may occur. In young girls, vaginal bleeding may occur.
If you have taken too many Hastina 21+7 tablets or if a child has swallowed them, you should consult your doctor or pharmacist.

What to do if you miss a dose of Hastina 21+7

The last tablets in the fourthrow of the blister pack are placebo tablets. If you miss one of these tablets, it will not affect the effectiveness of Hastina 21+7. You should discard the missed placebo tablet.
If you miss an active pink tablet from the first, second, or thirdrow, you should:

• If it has been less than 12 hourssince you missed the tablet, your protection against pregnancy is not reduced. You should take the tablet as soon as possible and then take the next tablets at the usual time.
• If it has been more than 12 hourssince you missed the tablet, your protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

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

• Missing more than one tablet in the packYou should contact your doctor.
• Missing one tablet in week 1.You should take the missed tablet as soon as possible (even if it means taking two tablets at once). You should then take the next tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If you had sexual intercourse in the week before missing the tablet, there is a risk of pregnancy. In this case, you should contact your doctor.
• Missing one tablet in week 2.You should take the missed tablet as soon as possible (even if it means taking two tablets at once). You should then take the next tablets at the usual time. Your protection against pregnancy is not reduced, and you do not need to use additional protection.
• Missing one tablet in week 3.There are two options to choose from:
• 1. Take the missed tablet as soon as possible (even if it means taking two tablets at once). Take the next tablets at the usual time. Instead of taking the white placebo tablets from the same pack, you should discard them and start taking the tablets from a new pack. You will probably have your period at the end of the second pack – during the placebo phase – but you may also experience spotting or breakthrough bleeding during the second pack.

• 2. You can also stop taking the active pink tablets and go directly to the white placebo tablets ( before taking the placebo tablets, you should note the day you missed the tablet). If you want to start a new pack on your usual start day, you should take the placebo tablets for less than 7 days.

If you follow one of these two instructions, your protection against pregnancy will be maintained.

• If you have missed any of the tablets in the pack and you do not have bleeding during the placebo phase, it may mean that you are pregnant. In this case, before starting the next pack, you should contact your doctor.

What to do if you have vomiting or severe diarrhea

If you vomit within 3 to 4 hours after taking an active pink tablet or have severe diarrhea, there is a risk that the active substances from the tablet have not been fully absorbed into your body. The situation is similar to missing a tablet.
After vomiting or diarrhea, you should take another active pink tablet from a reserve pack as soon as possible. If possible, you should take it within 12 hours of the normal time you take your tablet.
If this is not possible or more than 12 hours have passed, you should follow the instructions given in the section "What to do if you miss a dose of Hastina 21+7".

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, especially severe and persistent ones or changes in your health that you consider related to the use of Hastina 21+7, you should consult your doctor.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the different risk factors associated with the use of combined hormonal contraceptives, you should read section 2. "Important information before taking Hastina 21+7".
The following side effects have been associated with the use of Hastina 21+7.

Severe Side Effects

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

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

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

• -candidiasis (fungal infection)
• -herpes simplex
• -allergic reactions
• -increased appetite
• -depression, nervousness, sleep disorders
• -feeling of tingling and numbness, dizziness
• -vision problems
• -heart rhythm disorders or extremely rapid heart rate
• -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, diarrhea, constipation
• -sudden swelling of the skin and/or mucous membranes (e.g., tongue or throat), and/or difficulty swallowing or hives with accompanying difficulty breathing (angioedema), hair loss (alopecia), eczema (dermatitis), itching, rash, dry skin, seborrheic dermatitis
• -neck pain, limb pain, muscle cramps
• -urinary tract infection
• -breast tumor (benign and malignant), milk secretion in non-pregnant women (galactorrhea), ovarian cysts, sudden flushing of the face, absence of menstruation, very heavy menstruation, discharge, vaginal dryness, pain in the lower abdomen (pelvis), abnormal Pap smear
• -decreased libido
• -fluid retention, lack of energy, strong desire, increased sweating
• -weight loss.

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

• -asthma
• -hearing problems
• -erythema nodosum (characterized by painful, red nodules on the skin)
• -erythema multiforme (characterized by a rash with red, painful borders)
• -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
or
mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack
or
blood clots in the liver, stomach/intestine, kidneys, or eye.
The likelihood of developing blood clots may be higher if you have any other risk factors (for more information on risk factors for blood clots and symptoms of blood clots, see section 2).

Reporting Side Effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181 C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Hastina 21+7

The medicine should be stored 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 pack and carton after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Does Hastina 21+7 Contain

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

• -The active substances of the medicine are: ethinylestradiol and drospirenone. Each pink active film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone. The white film-coated tablets do not contain active substances.
• -The other ingredients of the medicine are: Active film-coated tablet in pink color:
• -tablet core: lactose monohydrate, cornstarch, povidone K-30, croscarmellose sodium, 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). Inactive film-coated tablet in white color:
• -tablet core: anhydrous lactose, povidone K-30, magnesium stearate.
• -tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

What Does Hastina 21+7 Look Like and What Does the Package Contain

Each blister pack contains 21 active, pink, round film-coated tablets and 7 white, round film-coated placebo tablets.
Hastina 21+7 is available in packs of 1 or 3 blister packs, each containing 28 film-coated tablets (21 active film-coated tablets + 7 placebo 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 the last update of the leaflet:December 2024