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Cricea 3 mg/0,02 mg. 28 tablets

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Cricea is a birth control pill and is used to prevent pregnancy.

Each of the 24 pink tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.

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What Cricea is and what it is used for

Cricea is a birth control pill and is used to prevent pregnancy.

Each of the 24 pink tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.

The 4 white tablets do not contain active substances and are also called placebo tablets.

Birth control pills that contain two hormones are called "combined" pills.

2. What you need to know before you take Cricea

Before you start using Cricea, you should read the information about blood clots in section 2. It is especially important to read the symptoms of a blood clot - see section 2 "Blood clots".

Before you start taking Cricea, your doctor will ask you several questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending on your condition, may do other tests.

This leaflet describes several situations in which you should stop using Cricea, or when the reliability of Cricea may be reduced. In such cases, you should either avoid sexual contact or take additional non-hormonal precautions, such as using a condom or other barrier method. Do not use the rhythm or temperature methods. These methods can be unreliable because Cricea causes monthly changes in body temperature and cervical mucus.

Kricea, like other hormonal contraceptives, does not protect against HIV infections (AIDS) or other sexually transmitted diseases.

When you should not use Cricea

You should not use Cricea if you have any of the conditions listed below. If you have any of the conditions listed below, you should tell your doctor. Your doctor will discuss with you what other form of contraception would be more suitable.

Do not take Cricea

if you are allergic to drospirenone, ethinylestradiol or any of the other ingredients of this medicine (listed in section 6), This may cause itching, rash or swelling;

if you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE) or other organs;

if you know you have a disorder that affects blood clotting, for example protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden or antiphospholipid antibodies;

if you need surgery or if you are immobilized for a long period of time (see section "Blood clots");

if you have ever had a heart attack or stroke;

if you have (or have ever had) angina (a condition that causes severe chest pain and may be the first sign of a heart attack) or transient ischemic attack (TIA - transient symptoms of stroke);

if you have any of the following conditions that may increase the risk of a clot forming in the arteries:

severe diabetes with damage to blood vessels

very high blood pressure

a very high level of fat in the blood (cholesterol or triglycerides)

a condition known as hyperhomocysteinemia

if you have (or have ever had) a type of migraine called 'migraine with aura';

if you have (or have ever had) liver disease and your liver function has not yet returned to normal;

if your kidneys are not working well (kidney failure);

if you have (or have ever had) a tumor in your liver;

if you have (or have ever had) or are suspected of having breast or genital cancer;

if you have unexplained vaginal bleeding;

if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir (see also section "Other medicines and Cricea")

Warnings and precautions

Seek emergency medical attention

if you notice possible signs of a blood clot, which could mean you have a blood clot in the leg (ie deep vein thrombosis), a blood clot in the lung (ie Pulmonary embolism), heart attack or stroke ( see Blood Clots below).

For a description of the symptoms of these serious side effects, please see "How to recognize a blood clot".

Tell your doctor if any of the following conditions apply to you

Talk to your doctor before taking Cricea· In some situations you need to take special care when using Cricea or any other combination pill, and you may need to have regular check-ups with your doctor. You should also inform your doctor if the condition develops or worsens while you are using Cricea,

if a close relative has or has had breast cancer;

if you have liver or gallbladder disease;

if you have diabetes;

if you have depression. Some women who use hormonal contraceptives, including Cricea, develop depression or depressed mood. Depression can be severe and can sometimes lead to suicidal thoughts. If you have mood swings and de

Recovery from blood clots is not always complete. Rarely, there can be serious, lasting effects or, very rarely, they can be fatal.

It is important to remember that the overall risk of a damaging blood clot from Cricea is small.

How to recognize a blood clot

sudden difficulty seeing in one or both eyes;

sudden difficulty walking, dizziness, loss of balance or coordination;

sudden, severe or prolonged headache for no known reason; loss of consciousness or fainting with or without a seizure.

Sometimes stroke symptoms can be brief with almost immediate and full recovery, but you should still seek emergency medical attention as you may be at risk of another stroke.

Stroke

swelling and slight bruising of a limb;

severe stomach pain (acute abdomen)

Blood clots blocking other blood vessels

Blood clots in a vein

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 thrombosis). However, these side effects are rare. Most often they occur in the first year of using a combined hormonal contraceptive.

If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).

If the blood clot travels through the leg and enters the lung, it can cause a pulmonary embolism.

Very rarely, a clot can form in a vein in another organ such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein the highest?

The risk of developing a blood clot in a vein is highest in the first year after taking a combined hormonal contraceptive for the first time. The risk may also be higher if you resume taking a combined hormonal contraceptive (the same or another product) after a break of 4 weeks or more.

After the first year, the risk becomes smaller, but is always slightly higher than if you were not using a combined hormonal contraceptive.

When you stop using Cricea, the risk of blood clots returns to normal after a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) when using Cricea is small.

Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot within a year.

Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot within a year.

Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone such as Cricea, between 9 and 12 women will develop a blood clot within a year.

Your risk of developing a blood clot varies depending on your personal medical history (see Factors

which increase the risk of a blood clot" below).

More about

Cricea, between 9 and 12 women will develop a blood clot within a year.

Your risk of developing a blood clot varies depending on your personal medical history (see Factors

which increase the risk of a blood clot" below).

Risk of blood clot formation within one year

Women not using a combined hormonal contraceptive pill and not pregnant About 2 in 10,000 women

Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate About 5-7 in 10,000 women

Women who use Cricea Women who use Cricea About 9-12 in 10,000 women

Factors that increase the risk of a blood clot in a vein

The risk of a blood clot with Cricea is small, but some conditions increase it. Your risk is higher:

if you are overweight (body mass index or BMI over 30 kg/m2);

if any of your close relatives had a blood clot in the leg, lungs or other organs at an early age (for example, under the age of 50). In this case, you may have a hereditary blood clotting disorder;

if you need surgery or if you are immobilized for a long time due to injury or illness, or if your leg is in a plaster cast. You may need to stop using Cricea for a few weeks before surgery or while you are less mobile. If you need to stop taking Cricea, ask your doctor when you can start using it again;

with advancing age (especially over 35);

if you gave birth less than a few weeks ago.

The risk of a blood clot increases with the number of medical conditions you have.

Traveling by plane (>4 hours) may temporarily increase your risk of a blood clot, especially if you have any of the other factors listed.

It is important to tell your doctor if any of these conditions apply to you, even if you are not sure. Your doctor may decide that you should stop taking Cricea.

If any of the above conditions change while you are using Cricea, for example a close relative gets a thrombosis for no known reason or if you gain a lot of weight, tell your doctor.

Blood clots in an artery

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

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

Factors that increase the risk of a blood clot forming in an artery

It is important to note that the risk of heart attack or stroke due to the use of Cricea is very small, but may increase:

with advancing age (over 35 years);

if you smoke. When using a combined hormonal contraceptive such as Cricea, it is recommended that you stop smoking. If you are unable to stop smoking and are over 35, your doctor may advise you to use another type of contraceptive;

if you are overweight;

if you have high blood pressure;

if one of your closest relatives had a heart attack or stroke at a young age (under about 50 years), In this case your risk of heart attack or stroke may be higher;

if you or one of your close relatives has a high level of fat in the blood (cholesterol or triglycerides);

if you have migraine, especially migraine with aura;

if you have a heart problem (valve disease, a rhythm disorder called atrial fibrillation);

if you have diabetes.

Laboratory researches

If you need a blood test, tell your doctor or the laboratory staff that you are taking Cricea, as hormonal contraceptives can affect the results of some tests.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

If you are pregnant, you should not take Cricea. If you become pregnant while taking Cricea, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Cricea at any time (see also "If you stop taking Cricea")-

Breastfeeding

The use of Cricea is generally not recommended for women who are breastfeeding. If you want to take pills while breastfeeding, you should contact your doctor.

Driving and using machines

There is no information to suggest that the use of Cricea affects driving or using machines.

Cricea contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it can be said to be practically sodium-free.

3. How to take Cricea

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Each blister contains 24 active pink tablets and 4 white inactive (placebo) tablets.

The two differently colored tablets of Cricea are arranged consecutively. One strip contains 28 tablets.

Take one Cricea tablet daily as needed with a small amount of water. You can take the tablets with or without food, but you must take them at the same time every day.

Do not mix up the tablets: take a pink tablet for the first 24 days and then a white tablet for the last 4 days. Then you should start a new strip immediately (24 pink and then 4 white tablets). Therefore, there is no break between the two bars.

Due to the different composition of the tablets, it is necessary to start with the first tablet in the upper left corner and take the tablets every day. For the correct sequence, follow the direction of the tape arrows.

Tape preparation

To keep track of daily intake, there are 7 stickers, each with 7 days of the week. Choose the weekly sticker that starts with the day you start taking the tablets. For example, if you start on Wednesday, use the weekly sticker that starts with "CP".

Stick the weekly sticker at the top of the blister where it says "Place a label here" so that the first day is above the tablet marked "start". There is now a day listed above each pill and you can see if you have taken a particular pill. The arrows show the order of taking the pills.

During the 4 days when you take white placebo tablets (placebo days), bleeding should start (so-called "breakthrough" bleeding). This usually starts on the 2nd or 3rd day after the last pink active tablet of Cricea. After taking the last white tablet, you must start with the next strip, regardless of whether the bleeding has stopped or not. This means that you must start each strip on the same day of the week and that the "break" bleeding must start on one and same day every month.

If you use Cricea in this way, you are also protected from pregnancy during the 4 days you take the placebo tablet.

When can you start with the first tape?

If you have not used a contraceptive with hormones in the previous month

Start with Cricea on the first day of your cycle (ie the first day of your period). If you start with

Cricea on the first day of your period, you are immediately protected from pregnancy. You can also start on day 2-5 of your cycle, but you will need to use additional protective measures (e.g. a condom) before

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours of taking an active pink tablet or have severe diarrhoea, there is a risk that the active substances in the pill will not be fully absorbed by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhea, take another tablet from a spare strip as soon as possible. If possible, take it within 24 hours of the time you usually take it. If this is not possible or 24 hours have passed, you should follow the advice given in "If you forget to take Cricea".

Delayed periods: what you need to know

Although not recommended, you can delay your period by not taking the white inactive tablets in the 4th row and going straight to a new Cricea strip to finish. Light or period-like bleeding may occur while using the second strip. Complete the second lane by taking the 4 inactive white tablets from the 4th row. Then start the next bar.

It is recommended that you consult your doctor for advice before deciding to delay your menstrual cycle.

Changing the first day of the menstrual cycle: what you need to know

If you take the tablets as directed, your cycle will start during the placebo days. If you need to change this day, reduce the number of placebo days - when you take the white inactive tablets (but never increase them - 4 is the maximum number of days!). For example, if you start taking the white inactive tablets on Friday and want to change this to Tuesday (3 days earlier), start a new strip 3 days earlier than usual. You may not experience any bleeding during this period. Light or period-like bleeding may occur.

If you are not sure what to do, consult your doctor.

If you have stopped taking Cricea

You can stop taking Cricea whenever you want. If you do not want to get pregnant, ask your doctor about other reliable methods of birth control. If you want to get pregnant, stop taking Cricea and wait for your period to start before trying to get pregnant. You will be able to calculate the expected due date more easily.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

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 if they are severe and persistent, or you have any change in your health that you think may be due to Cricea, please tell your doctor.

An increased risk of blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) is seen in all women taking combined hormonal contraceptives. For more detailed information about the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before you take Cricea".

Below is a list of side effects associated with the use of drospirenone/ethinyl estradiol:

Serious side effects

Contact a doctor immediately if you experience any of the following symptoms of angioedema; swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, which may be accompanied by difficulty breathing (see also section "Warnings and precautions").

Common side effects (may affect up to 1 in 10 users):

mood swings

headache

nausea

breast pain, menstrual cycle problems such as irregular periods, no periods

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

depression, nervousness, drowsiness

dizziness, numbness of the limbs

migraine, varicose veins, high blood pressure

stomach pain, vomiting, indigestion, flatulence, inflammation of the stomach, diarrhea

acne, itching, rash

aches, eg back pain, pain in limbs, muscle cramps

vaginal yeast infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually decreases with continued treatment), genital discharge, hot flashes, inflammation of the vagina (vaginitis), problems with menstrual cycles, painful cycles, shortened cycles, very heavy cycles, vaginal dryness» abnormal pap smear, decreased interest in sex

lack of energy, increased sweating, fluid retention

increase in body weight

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

candidiasis (fungal infection)

anemia, increase in the number of platelets in the blood

alergic reaction

hormonal (endocrine) disorder

increased appetite, loss of appetite, abnormally high concentration of potassium in the blood, abnormally low concentration of sodium in the blood

inability to experience orgasm, insomnia

dizziness, tremors

eye disorders, eg inflamed

5. How to store Cricea

Keep out of the reach of children. To be stored below 30°C

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date corresponds to the last day of the month indicated.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Cricea contains

The active substances are: drospirenone and ethinylestradiol.

Each pink active tablet contains 3 mg drospirenone and 0.02 mg stynilestradiol.

The white film-coated tablets do not contain active substances.

The other ingredients are:

Pink active film-coated tablets:

Tablet core: lactose monohydrate, pregelatinized starch, povidone, croscarmellose sodium, polysorbate 80, magnesium stearate.

Film-coated tablet: Opadry II pink (polyvinyl alcohol-partially hydrolyzed, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E172), black iron oxide (E172))

White inactive film-coated tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

Film-coated tablet: Opadry II white (polyvinyl alcohol, titanium dioxide (E171), macrogol, talc)

What Cricea looks like and contents of the pack

The active tablet is a pink, round, smooth film-coated tablet with a diameter of 5.7 mm.

The inactive tablet is a white, round, smooth film-coated tablet with a diameter of 5.7 mm.

The film-coated tablets are packed in PVC/PVDC/aluminum blisters.

Each blister contains 24 pink active film-coated tablets in rows 1, 2, 3 and 4, and 4 white placebo film-coated tablets in row 4.

The cardboard box contains one blister with 28 tablets (24 pink and 4 white tablets), a self-adhesive strip with 7 days of the week and a leaflet.

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