Crypineo 3 mg / 0,03 mg. 21 tablets

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

Each tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.

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

Quantity

What Cripineo is and what it is used for

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

Each tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.

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

2. What you need to know before you take Cripineo

Before you start using Cripineo, 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 Cripineo, 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 Cripineo, or when the reliability of Cripineo 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 Cripineo causes monthly changes in body temperature and cervical mucus.

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

When you should not use Cripineo

You should not use Cripineo 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 Cripineo

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 leg (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 the 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 blood vessel damage 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 Cripineo").

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 Cripineo. In some situations, you need to take special care when using Cripineo 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 Cripineo.

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 Cripineo, develop depression or depressed mood. Depression can be severe and can sometimes lead to suicidal thoughts. If you have mood swings and depressive symptoms, contact your doctor for additional honey

Blood clots may form

in the veins (called 'venous thrombosis', 'venous thromboembolism' or VTE);

in the arteries (called "arterial thrombosis", "arterial thromboembolism" or ATE);

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 Cripineo is small.

How to recognize a blood clot

Seek emergency medical attention if you notice any of the following signs or symptoms.

Do you have any of the following signs? What could you be suffering from?

swelling in one leg or along a vein in the leg or foot, especially when accompanied by;

pain or tenderness in the leg that

can only be felt when standing or walking

warming the affected leg

a change in the color of the skin on the leg,

for example, becoming pale, red, or blue

deep vein thrombosis

sudden unexplained shortness of breath or rapid breathing;

sudden cough for no apparent reason, in which blood may be coughed up;

sharp pain in the chest that may increase with deep breathing;

severe dizziness or lightheadedness;

fast or irregular heartbeat;

severe stomach pain;

If you are not sure, talk to a doctor, as some of these symptoms, such as a cough or shortness of breath, can be confused with a milder illness such as a respiratory infection (such as the common cold).

Pulmonary embolism

Symptoms most common in one eye:

sudden loss of vision or

painless blurring of vision that can progress to vision loss

Retinal venous thrombosis

(blood clot in the eye)

pain, discomfort, tension, heaviness in the chest

a feeling of tightness or fullness in the chest, arm, or under the breastbone;

feeling full, indigestion or choking;

discomfort in the upper body, spreading to the back, jaw, throat, arm and stomach;

sweating, nausea, vomiting, or dizziness;

excessive weakness, anxiety, or shortness of breath;

fast or irregular heartbeat Heart attack

sudden numbness or weakness of the face, arm, or leg, especially on one side of the body;

sudden confusion, difficulty speaking or understanding;

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 of 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 are not using a combined hormonal contraceptive.

When you stop using Cripineo, 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) with Cripineo 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 in 1 will develop a blood clot within a year.

Out of 10,000 women using a combined hormonal contraceptive that contains drospirenone such as Cripineo, between 9 and 12 women will develop a blood clot within 1

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

The risk of a blood clot with Cripineo 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 Cripineo for a few weeks before surgery or while you are less mobile. If you need to stop taking Cripineo 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 Cripineo should be stopped.

If any of the above conditions change while you are using Cripineo, 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 Cripineo is very small, but may increase:

with advancing age (over 35 years);

if you smoke. When using a combined hormonal contraceptive such as Cripineo, 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.

If you have more than one of these conditions, or if any of them are particularly severe, your risk of a blood clot may increase even more.

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

Crippineo and cancer

Breast cancer is slightly more common in women using combined pills, but it is not known whether this is due to the treatment itself. For example, it may be found that more tumors are detected in women who use combined pills because they are examined more often by a doctor. The risk of breast tumors gradually decreases after stopping the use of combined hormonal contraceptives. It is important to check your breasts regularly and you should contact your doctor if you feel a lump.

In rare cases, benign liver tumors have been reported in pill users, and in even rarer cases, malignant liver tumors. Consult your doctor if you have unusually severe abdominal pain.

Bleeding between periods

During the first few months of taking Cripineo, you may have unexpected bleeding (bleeding outside of the 7 tablet-free days). If this bleeding continues for more than a few months or if it starts after a few months, contact your doctor as they need to know what is wrong.

What to do if no bleeding occurs during the 7 days without taking tablets

If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea, and have not taken any other medicines, it is very unlikely that you are pregnant.

If the expected bleeding does not occur twice in a row, you may be pregnant. Contact your doctor immediately. Start the next blister only if you are sure you are not pregnant.

Children

Cripineo is not intended for use in children and adolescent females whose menstrual cycle has not yet started.

Other medicines and Cripineo

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Always inform you

When can you start with the first bar?

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

Start Cripineo on the first day of your cycle (ie the first day of your period). If you start Cripineo 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 extra protection (eg a condom) for the first 7 days.

Switching from a combined hormonal contraceptive or a combined contraceptive vaginal ring or patch

You can start taking Cripineo preferably on the day after taking the last active tablet (the last tablet containing the active substances) of the previous pill, but at the latest on the next day after the tablet-free interval (or after the last inactive tablet of your previous pill). When switching from a combined contraceptive vaginal ring or patch, follow your doctor's advice.

Switching from a progestogen-only method (pill, injection, progestogen-only implant, or progestogen-releasing IUD).

You can switch on any day from a progestogen-only pill (from an implant or IUD on the day of its removal, from an injectable form when the next injection is due), but in all these cases you must use additional protective measures (for example condom) for the first 7 days of taking Cripineo.

After an abortion

Follow your doctor's advice.

After giving birth

You can start taking Cripineo between 21 and 28 days after birth. If you start later than day 28, use a so-called barrier method (eg a condom) for the first seven days of using Cripineo.

If you have had intercourse after giving birth, before you start taking Cripineo (again), you must first make sure you are not pregnant or wait until your next period.

If you are breast-feeding and want to start taking Cripineo after birth Read the information in "Breast-feeding".

Ask your doctor what to do if you are not sure when to start.

If you have taken more than the required dose of Cripineo

There have been no reports of serious side effects from taking too many Cripineo tablets.

If you take several tablets at once, you may feel sick or vomit, or vaginal bleeding may occur.

Even girls who haven't started menstruating yet but accidentally took this

medicine, may experience such bleeding.

If you have taken too many Cripineo tablets or find that a child has taken a few, seek advice from your doctor or pharmacist.

If you forget to take Cripineo

If you are less than 12 hours late taking a tablet, your protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the next tablet at the usual time.

If you are more than 12 hours late taking a tablet, your protection against pregnancy may be reduced.

The greater the number of forgotten tablets, the greater the risk of pregnancy.

The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or at the end of the strip. Therefore, you must observe the following rules (see the diagram below):

More than one forgotten tablet in this strip

Contact your doctor.

One forgotten tablet on days 1 to 7

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue to take the tablets at the usual time and use extra precautions for the next 7 days, for example a condom. If you have had sexual intercourse in the week before you forget the tablet, you should contact your doctor, as there is a possibility that you may become pregnant. In this case, contact your doctor.

One forgotten tablet on days 8 to 14

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue to take the tablets at the usual time. Protection against pregnancy is not reduced and no additional precautions need to be taken,

One forgotten tablet on days 15 to 21

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means you have to

to take two tablets at the same time. Continue to take the tablets at the usual time. Instead of not taking a tablet for 7 days, start the next strip immediately after taking the last tablet.

You will most likely have your period at the end of the second strip, but you may have light or period-like bleeding during the second strip.

2. You can also stop taking the active tablets and go directly to

the tablet-free period (write down the day you forgot the tablet). If you want to start a new strip on the day you always start, make the tablet-free period less than 7 days.

If you follow one of the

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

breast enlargement

changed interest in sex

high blood pressure, low blood pressure

vomiting, diarrhea

acne, severe itching, skin rash, hair loss (alopecia)

vaginal infection, fluid retention

changes in body weight

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

hearing impairment

asthma

discharge from the breast

allergic reaction (hypersensitivity)

the skin condition erythema nodosum (characterized by painful reddish skin nodules) or erythema multiforme (characterized by a rash with redness in the form of a target or sores).

damaging blood clots in a vein or artery, for example:

in the leg or foot (ie DVT)

in lung (ie BE)

heart attack

a stroke

mini-stroke or transient stroke-like symptoms known as a transient ischemic attack (TIA)

blood clots in the liver, stomach/bowel, kidney or eye

You may be more likely to develop a blood clot if you have other conditions that increase this risk (see section 2 for more information about conditions that increase the risk of blood clots and the symptoms of a blood clot).

5. How to store Cripineo

Keep out of the reach of children.

This medicinal product does not require special temperature conditions for storage.

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

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 pack and other information What Cripineo contains

The active substances are: drospirenone and ethinylestradiol.

Each tablet contains 3 mg of drospirenone and 0.03 mg of ethinylestradiol.

Tablet core: lactose monohydrate, corn starch, pregelatinized starch, crospovidone, povidone, polysorbate 80, magnesium stearate.

Film-coated tablet: Opadry II yellow (polyvinyl alcohol-partially hydrolyzed, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172)

What Cripineo looks like and contents of the pack

Smooth, round, yellow film-coated tablets with a diameter of 5.7 mm.

The tablets are packed in a PVC/PVDC/aluminum blister.

The blister contains 21, located in three rows (each row contains 7 tablets).

The cardboard box contains one blister with 21 tablets and a leaflet.

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