Cris

Package leaflet: Information for the user

Cris 0.03 mg / 3 mg film-coated tablets

Ethinylestradiol/Drospirenone
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others; it may be harmful for them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception, if used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet

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

1. What Cris is and what it is used for

Cris is a medication used to prevent pregnancy ("the pill"). Each tablet contains a small amount of two different female hormones, drospirenone and ethinylestradiol.
Contraceptive pills containing two hormones are known as "combined" pills.

2. What you should know before taking Cris

General notes
Before starting to use Cris, you must read the information about blood clots in section 2. It is
particularly important that you read about the symptoms of a blood clot – see section 2 “Blood clots”.
Before taking Cris, your doctor will carefully ask you questions about your personal medical history and
that of your family members. Your doctor will also measure your blood pressure and, depending on your
individual situation, may carry out further tests.
This leaflet describes various situations in which you must stop taking Cris or in which the reliability of
Cris may be reduced. In such cases, you must abstain from sexual intercourse or use additional non-
hormonal contraceptive measures, such as condoms or another barrier method. Do not use the rhythm
method or basal body temperature method. These methods may be unreliable because Cris alters the
monthly fluctuations in body temperature and cervical mucus.
Cris, like all hormonal contraceptives, does not protect against HIV (AIDS) infection or other
sexually transmitted infections.
When not to use Cris
Do not use Cris if you have any of the conditions listed below. If you have any of the conditions listed
below, consult your doctor. Your doctor will discuss with you other birth control methods that may be
more suitable for your case.
Do not use Cris:

• if you are allergic to ethinylestradiol or drospirenone or to any of the other ingredients of this medicine (listed in section 6). This condition may cause itching, skin rashes or swelling;
• if you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), in your lung (pulmonary embolism, PE), or in other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or if you will be bedridden for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following diseases, which could increase the risk of developing clots in the arteries:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a condition known as hyperhomocysteinaemia
• 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 liver function is still abnormal;
• if your kidneys do not work properly (renal insufficiency);
• if you have (or have ever had) liver tumours;
• if you have (or have ever had) or are suspected of having cancer of the breast or genital organs;
• if you have unexplained vaginal bleeding;

Do not use Cris if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir,
dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section 2 “Other
medicines and Cris”).
Additional information on specific populations
Children and adolescents
Cris is not indicated in women whose menstrual cycle has not yet begun.
Elderly patients
Cris is not indicated after menopause.
Women with impaired liver function
Do not take Cris if you suffer from liver disease. See also sections ‘Do not take Cris’ and ‘Warnings and
precautions’.
Women with impaired kidney function
Do not take Cris if you suffer from renal insufficiency or acute renal failure. See also sections ‘Do not take
Cris’ and ‘Warnings and precautions’.
Warnings and precautions
When to contact a doctor?
Contact a doctor urgently

• if you notice possible signs of a blood clot which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lung (pulmonary embolism), a heart attack or a stroke (see section 2 "Blood clots"). For a description of the symptoms of these serious side effects, go to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you
Contact your doctor before taking Cris. In some situations, you must be particularly careful when using
Cris or any other combined pill, and your doctor may need to examine you regularly.
If any of these conditions appear or worsen while you are taking Cris, you must inform your doctor.

• if a close relative has or has had breast cancer
• if you have liver or gallbladder disease
• if you have diabetes (diabetes mellitus)
• if you suffer from depression
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system)
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure)
• if you have sickle cell anaemia (an inherited red blood cell disorder)
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
• if you are due to undergo surgery or if you will be bedridden for a prolonged period (see section 2 “Blood clots”)
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Cris
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis)
• if you have varicose veins
• if you suffer from epilepsy (see section 2 “Other medicines and Cris”)
• if you have a disease that first appeared during pregnancy or during previous use of sex steroids (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disease causing sudden involuntary movements (Sydenham’s chorea))
• if you have or have ever had chloasma (skin discoloration, especially on the face or neck, known as “melasma” or “pregnancy mask”). In this case, avoid direct exposure to sunlight or ultraviolet rays.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with possible difficulty breathing, contact your doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Blood clots
Using a combined hormonal contraceptive such as Cris increases the risk of developing a blood clot
compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious
problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE)

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very
rarely, these effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Cris is low.
How to recognize a blood clot
Contact a doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or Deep vein thrombosis of the foot, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased warmth in the affected leg;
• change in skin colour of the leg, such as paleness, redness or bluish discolouration;
• sudden and unexplained shortness of breath or rapid breathing;
• sudden cough without an obvious cause, possibly with coughing up of blood;
• sharp chest pain that may worsen when breathing deeply;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain;

If you are unsure, contact your doctor, as some of these
symptoms such as cough or shortness of breath may be mistaken
for a milder condition such as a respiratory tract infection (e.g. a
“common cold”).

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

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (either the same or a different medicine) after a break of 4 or more weeks.
When you stop taking Cris, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Cris is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Cris, about 9–12 will develop a blood clot in one year.
• The risk of developing a blood clot depends on your medical history (see section 2 “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Cris is low, but certain conditions can increase this risk. Your risk is higher:

• if you are significantly overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in the leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Cris several weeks before surgery or during periods of reduced mobility. If you need to stop taking Cris, ask your doctor when you can start taking it again.
• as you get older (especially over 35 years of age);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, particularly if you have some of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you,
even if you are uncertain. Your doctor may decide to stop your use of Cris.
If any of the conditions listed above change while you are using Cris, for example, if a close relative develops thrombosis without a known cause or if you gain significant weight, contact your doctor.

Blood clots in an artery
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems. For example, they can lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Cris is very low but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Cris, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fat in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the conditions listed above change while you are using Cris, for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight, contact your doctor.

Cris and cancer
Breast cancer is observed slightly more frequently in women using "combined pills," but it is not known whether this is due to the treatment. For example, it is possible that more tumors are diagnosed in women using "the pill" because they undergo more frequent medical check-ups. The occurrence of breast cancer gradually decreases after discontinuation of "combined hormonal contraception." It is important that you regularly examine your breasts and contact your doctor if you feel any lumps.
In rare cases, benign liver tumors have been observed in women using "the pill," and even more rarely, malignant liver tumors. Contact your doctor if you experience unusually severe abdominal pain.

Psychiatric disorders
Some women using hormonal contraceptives, including Cris, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If mood changes or depressive symptoms occur, consult your doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking Cris, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding persists for more than a few months or begins after several months, your doctor should investigate the cause.

What to do if menstruation does not occur during the pill-free week?
If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.
If you miss two consecutive periods, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Children and adolescents
Cris is not indicated for women whose menstrual cycle has not yet started.

Other medicines and Cris
Always inform your doctor if you are taking any medicines or herbal products. Inform any other doctor or dentist (or pharmacist) who prescribes you another medicine that you are taking Cris. They will advise you whether you need to use additional contraceptive measures (for example, condoms) and, if so, for how long, or whether the use of another medicine you may need should be adjusted.
Some medicines:

• affect Cris levels in the blood;
• may make it less effective in preventing pregnancy;
• may 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 (ritonavir, nevirapine, efavirenz, known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors);
• fungal infections (griseofulvin, ketoconazole);
• arthritis, osteoarthritis (etoricoxib);
• high blood pressure in the pulmonary arteries (bosentan);
• St. John’s wort, a herbal remedy.

Cris may affect the action of other medicines, for example:

• medicines containing cyclosporine;
• the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures);
• theophylline (used to treat respiratory problems);
• tizanidine (used to treat muscle pain and/or muscle cramps).

Do not use Cris if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function blood test results (elevated liver enzyme ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Cris may be restarted approximately 2 weeks after completing this treatment. See section 2 “Do not use Cris.”
Ask your doctor or pharmacist for advice before taking any medicine.

Cris with food and drink
Cris may be taken with or without food, if necessary with a little water.

Laboratory tests
If you are having a blood test, inform your doctor or laboratory staff that you are taking the "pill," as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, do not take Cris. If you become pregnant while taking Cris, stop immediately and contact your doctor. If you wish to become pregnant, you may stop taking Cris at any time (see also section 3 “If you stop taking Cris”).
Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding
The use of Cris is generally not recommended during breastfeeding. If you wish to take the "pill" while breastfeeding, you must consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
There is no evidence to suggest that Cris affects the ability to drive or operate machinery.

Cris contains lactose and sodium
Each tablet contains 66.66 mg of lactose per tablet. If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dosage unit, i.e., essentially “sodium-free.”

3. How to take Cris

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Take one Cris tablet every day, if necessary with a little water. You should take the tablets at approximately the same time each day. You may take the tablets with or without food.
Each blister contains 21 tablets. On the back of the blister, the day of the week on which each tablet should be taken is marked. For example, if you start on Wednesday, take the tablet marked “Wed”. Follow the direction of the arrows on the blister until all 21 tablets have been taken.
Then, do not take any tablets for 7 days. During these 7 days (the so-called "tablet-free" or "rest" week), withdrawal bleeding (menstruation) should occur. This is called "withdrawal bleeding" and usually begins on the second or third day of the tablet-free week.
Start a new blister on the eighth day after the last Cris tablet (i.e. after the 7-day break), regardless of whether or not your bleeding has stopped. This means that you will start each new blister on the same day of the week, and your periods will also begin on the same day each month.
If you use Cris in this way, you are protected against pregnancy during the 7 days when you do not take tablets.

When can you start the first blister?
If you have not used a hormonal contraceptive ("pill") in the previous month
Start taking Cris on the first day of your cycle (i.e. the first day of menstruation). If you start on the first day of your period, you are immediately protected against pregnancy. You may also start taking Cris between days 2 and 5 of your cycle; however, in this case, you must use additional contraceptive measures (e.g. a condom) for the first 7 days.

Switching from a combined hormonal contraceptive ("pill" containing two active hormones), a combined contraceptive vaginal ring, or a contraceptive patch
Start taking Cris preferably on the day after the last active tablet (the last tablet containing active ingredients) of your previous "pill", or at the latest on the day after the end of 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 (progestogen-only pill, injection, implant, or intrauterine system (IUS) releasing progestogen)
You may switch on any day from the progestogen-only pill (or on the day of removal from an implant or IUS, or when your next injection is due from an injectable method); however, in all these cases, you must use additional contraceptive measures (e.g. a condom) for the first 7 days of tablet intake.

After an abortion
Follow your doctor's advice.

After childbirth
Do not start taking Cris before the period between day 21 and day 28 after delivery. If you start later than day 28, use a so-called barrier method (e.g. a condom) during the first 7 days of taking Cris.
If you have had sexual intercourse after childbirth before starting (or restarting) Cris, make sure you are not pregnant, or wait for your next period.

If you are breastfeeding and wish to start (or restart) taking Cris
Read section 2 “Breastfeeding”.
Ask your doctor for advice if you are unsure about when to start.

If you take more Cris than you should
There are no reports of serious harmful effects following an overdose of Cris tablets.
If you take several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. Even girls who have not yet had their first period but have accidentally taken this medicine may experience such bleeding.
If you have taken too many Cris tablets, or if you find that a child has taken any tablets, contact your doctor or pharmacist immediately.

If you forget to take Cris

• If the delay in taking a tablet is less than 12 hours, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, and then take the following tablets at your usual time.
• If the delay in taking a tablet is more than 12 hours, contraceptive protection may be reduced. The greater the number of tablets missed, the higher the risk of becoming pregnant.

The risk of incomplete contraceptive protection is greatest if you miss a tablet at the beginning or end of the blister. Therefore, follow the instructions below (see Figure 1).
More than one tablet missed in this pack
Consult your doctor.

One tablet missed in the first week
Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time and use additional contraceptive measures for the next 7 days, for example, a condom. If you had sexual intercourse in the week before the missed tablet, you may be pregnant. In this case, consult your doctor.

One tablet missed in the second week
Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Contraceptive protection is not reduced, so no additional precautions are necessary.

One tablet missed in the third week
You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Skip the tablet-free interval and start the next blister immediately. You will probably not have a period until the end of the second blister, or you may experience light bleeding or spotting during the second blister.
2. You may also stop taking tablets from the current pack and go directly to the 7-day break (including the day of the missed tablet in the count). If you wish to start the next blister on your usual day, observe an interval of less than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you have missed any tablet in the blister and do not have a period during the first tablet-free interval, you may be pregnant. Consult your doctor before starting a new blister.

Figure 1: If you forget to take Cris
What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking a tablet or have severe diarrhoea, the active ingredients of the "pill" may not be fully absorbed by your body. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare pack as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible, or if more than 12 hours have passed, follow the instructions in section 3 “If you forget to take Cris”.

How to delay menstruation: what you should know
Although not recommended, you may delay your period by continuing with a new blister of Cris instead of observing the usual 7-day break. During use of this second blister, you may experience light bleeding or spotting. Continue with the next blister after the usual 7-day break.
You may consult your doctor before deciding to delay your period.

Changing the day your period starts: what you should know
If you take the tablets as instructed, your periods will start during the tablet-free week. If you wish to change the day your period starts, shorten the normal break between two packs (but never extend it — 7 days is the maximum!). For example, if your break normally starts on Friday and you wish to move it to Tuesday (3 days earlier), start the next blister 3 days earlier. If you make the break between cycles very short (e.g. 3 days or less), you may not have any bleeding during this interval. You may experience light bleeding or spotting.
Consult your doctor if you are unsure what to do.

If you stop taking Cris
You may stop taking Cris at any time. If you still wish to avoid pregnancy, consult your doctor for advice on other reliable methods of birth control. If you wish to become pregnant, stop taking Cris and wait for your period before trying to conceive. This will help you calculate the expected date of delivery more easily.
If you have any doubts about using this medicine, consult 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 effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to Cris, tell your doctor.

An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives.

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 with possible difficulty breathing (see also section 2 “Warnings and precautions”).

For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before taking Cris”.

The following side effects have been reported with the use of Cris:

Common: may affect up to 1 in 10 women

• menstrual disorders
• intermenstrual bleeding
• breast pain
• breast tenderness
• headache
• depressed mood
• migraine
• nausea
• thick, whitish vaginal discharge
• candidiasis

Uncommon: may affect up to 1 in 100 women

• breast enlargement
• changes in sexual desire (libido)
• high blood pressure
• low blood pressure
• vomiting
• diarrhoea
• acne
• skin rash
• severe itching
• hair loss (alopecia)
• vaginal infection
• fluid retention
• changes in body weight

Rare: may affect up to 1 in 1,000 women

• allergic reactions (hypersensitivity)
• asthma
• breast discharge
• hearing impairment
• skin disorders such as nodular erythema (characterized by red, painful skin nodules) or erythema multiforme (characterized by target-shaped skin lesions or ulcers)
• harmful blood clots in a vein or an artery, for example: in a leg or foot (DVT), in a lung (PE), heart attack, stroke, mini-stroke or temporary stroke-like symptoms known as transient ischaemic attack (TIA), blood clots in the liver, stomach/intestines, kidneys or eye

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cris

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cris contains
The active substances are
Ethinylestradiol and drospirenone.
Each tablet contains 0.030 milligrams of ethinylestradiol and 3 milligrams of drospirenone.
The other ingredients (excipients) are
Tablet core: monohydrate lactose, hydroxypropylcellulose, crosslinked polyvinylpyrrolidone, sodium lauryl sulfate, magnesium stearate.
Film coating: Opadry II Yellow (titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), polyethylene glycol/macrogol (E1521), yellow iron oxide (E172)).
Description of the appearance of Cris and pack contents
Each Cris blister contains 21 yellowish, cylindrical, biconvex film-coated tablets.
Cris is available in packs containing 1, 3 or 6 blisters, each with 21 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
This medicinal product is authorised in the European Economic Area countries under the following
names:
Germany Xellia 30
Czech Republic Cris
Italy Cris