CLIO

Package leaflet: Information for the user

Clio 0.02 mg / 3 mg film-coated tablets

Ethinylestradiol / drospirenone
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (CHCs):

• CHCs 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 Clio is and what it is used for
2. What you need to know before you use Clio
3. How to use Clio
4. Possible side effects
5. How to store Clio
6. Contents of the pack and other information

1. What Clio is and what it is used for

• Clio is a contraceptive pill used to prevent pregnancy.
• Each of the 24 tablets contains a small amount of two different female hormones, drospirenone and ethinylestradiol.
• Contraceptive pills containing two hormones are called "combined" pills.

2. What you should know before using Clio

Before starting Clio for the first time, you must speak with your doctor about how to use this product.
Before you start using Clio, you should 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 you start taking Clio, your doctor will ask you some questions about your personal health and that of your close family members. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.
This patient leaflet describes various situations in which you must stop taking Clio, or in which the effectiveness of Clio may be reduced. In these situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use the rhythm method or basal body temperature method. These methods may be unreliable because Clio alters the monthly changes in body temperature and cervical mucus.
Like other hormonal contraceptives, Clio does not protect against HIV infection (AIDS) or other sexually transmitted infections.

Do not use Clio
Do not use Clio 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 methods of birth control that may be more suitable for your situation.

• if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or 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 will be bedridden for a prolonged period (see section “Blood clots”);
• if you have (or 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 conditions, which may increase the risk of developing clots in the arteries:
  o severe diabetes with blood vessel damage
  o very high blood pressure
  o very high levels of fats (cholesterol or triglycerides) in the blood
  o 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) a liver disease and your liver function has not yet returned to normal
• if your kidneys do not function properly (renal failure)
• if you have (or have ever had) liver cancer
• if you have (or have ever had) or suspect you may have breast or genital organ cancer
• if you have unexplained vaginal bleeding
• if you are allergic to ethinylestradiol or drospirenone or to any of the excipients of Clio (listed in section 6). This condition may manifest as itching, rash, or swelling

Do not use Clio if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Clio”).

• Additional information on special populations

Children and adolescents
Clio is not intended for use in females whose menstrual cycle has not yet begun.
Elderly women
Clio is not intended for use after menopause.
Women with hepatic impairment
Do not take Clio if you suffer from liver disease. See also sections "Do not use Clio" and "Warnings and precautions".
Women with renal impairment
Do not take Clio if you suffer from poorly functioning kidneys or acute renal failure. See also sections "Do not use Clio" and "Warnings and precautions".

Warnings and precautions
When should you 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 the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section "Blood clot (thrombosis)"). For a description of the symptoms of these serious side effects, see section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
In certain situations, you should exercise particular caution when using Clio or any other combined oral contraceptive, and your doctor may need to examine you regularly. If any of these conditions develop or worsen while you are using Clio, you must inform your doctor.

• if a close relative has or has ever had breast cancer
• if you have liver or gallbladder disease
• if you have diabetes
• 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 defense 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 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 Clio;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins
• if you suffer from epilepsy (see section "Other medicines and Clio")
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disorder involving sudden body movements (Sydenham’s chorea))
• if you have or have ever had chloasma (brown-golden patches, especially on the face, known as “pregnancy mask”). In this case, you should avoid direct sunlight and ultraviolet light.
• if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives possibly with breathing difficulties, contact a doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
The use of a combined hormonal contraceptive such as Clio 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, serious long-term 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 Clio 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?
Likely condition?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:

• pain or tenderness in the leg, felt especially when standing or walking

• increased warmth in the affected leg

• change in skin colour of the leg, such as paleness, reddish or bluish discolouration
  → Deep vein thrombosis

• sudden unexplained shortness of breath or rapid breathing

• sudden cough without an obvious cause, possibly with coughing up blood

• sharp chest pain that may worsen when breathing deeply

• severe dizziness or lightheadedness

• rapid or irregular heartbeat

• severe stomach pain
  → Pulmonary embolism

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”).

Symptoms occurring more frequently in an eye:

• sudden loss of vision

• painless blurring of vision that may progress to vision loss
  → Retinal vein thrombosis (blood clot in the eye)

• sudden pain, discomfort, pressure, or heaviness in the chest

• squeezing or fullness sensation in the chest, arm, or behind the breastbone

• feeling of fullness, indigestion, or suffocation

• discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach

• sweating, nausea, vomiting, or dizziness

• extreme weakness, anxiety, or shortness of breath

• rapid or irregular heartbeat
  → Heart attack

Do you have?
Likely condition?

• 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 with one or both eyes
• sudden difficulty walking, dizziness, loss of balance or coordination
• sudden, severe or prolonged headache without known cause
• loss of consciousness or fainting with or without seizures
  → Stroke

Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still contact a doctor urgently, as you may be at risk of another stroke.

Blood clots blocking other vessels:

• swelling and pale blue discolouration of a limb
• severe abdominal pain (acute abdomen)

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 blood clots forming in veins (venous thrombosis). However, these side effects are rare. Most cases 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, the 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 when you start taking a combined hormonal contraceptive for the first time. The risk may be even higher if you restart taking a combined hormonal contraceptive (the same or a different product) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Clio, 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 VTE and the type of combined hormonal contraceptive you are using.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Clio 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 Clio, about 9–12 will develop a blood clot in one year.
• The risk of developing a blood clot depends on your medical history (see below “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 Clio 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 a leg, lung, or another organ at a young age (e.g. under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you need to undergo surgery or must 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 Clio several weeks before surgery or during periods of reduced mobility. If you need to stop taking Clio, 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, especially 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 have you stop taking Clio.
If any of the conditions listed above change while you are using Clio—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 Clio is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Clio, 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 fats 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 Clio—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.

Clio and cancer
Breast cancer occurs slightly more frequently in women who use combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, more tumors may be detected in women taking combined pills because they undergo more frequent medical check-ups. The occurrence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to regularly examine your breasts and contact your doctor if you notice a lump.
In rare cases, benign liver tumors have been reported in users of oral contraceptives, and even more rarely, malignant liver tumors. Contact your doctor if you experience unusual, severe abdominal pain.

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

Intermenstrual bleeding
During the first few months of taking Clio, you may experience unexpected bleeding (bleeding outside the tablet-free interval). If this bleeding occurs for more than a few months or starts after several months, your doctor should evaluate the cause.

What to do if menstruation does not occur during the 4-day tablet-free interval
If you have taken all tablets correctly, have not experienced vomiting or severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.
If the expected period does not occur for two consecutive cycles, you may be pregnant. Contact your doctor immediately.
If you are using Clio to delay menstruation, bleeding normally does not occur every 4 weeks, but less frequently, with intervals up to 120 days. It may be difficult to recognize an unexpected pregnancy. If for any reason you suspect you are pregnant, perform a pregnancy test. If the test is positive, or if you remain uncertain, contact your doctor.
Start the next blister pack only if you are certain you are not pregnant.

Children and adolescents
Clio is indicated only after menarche.

Other medicines and Clio
Always inform your doctor about any medicines or herbal products you are currently using. Also inform any other doctor or dentist who prescribes additional medicines (or your pharmacist) that you are using Clio. They may advise you whether you need to take additional contraceptive precautions (e.g. condoms), and if so, for how long, or whether the dosing regimen of another medicine you are taking needs to be adjusted.
Some medicines:

• can affect Clio levels in the blood;
• can make Clio less effective in preventing pregnancy;
• can cause unexpected bleeding.

These include:

• medicines used to treat epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) or tuberculosis (e.g. rifampicin) or HIV and Hepatitis C virus infections (protease inhibitors or non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) or fungal infections (griseofulvin, ketoconazole) or arthritis, osteoarthritis (etoricoxib) or high blood pressure in the blood vessels of the lungs (bosentan);
• the herbal remedy St. John’s wort.

Clio can affect the effect of other medicines, such as:

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

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

Clio with food and drinks
Clio can be taken with or without food, and if necessary, with a small amount of water.

Laboratory tests
If you need to have 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
If you are pregnant, do not take Clio. If you become pregnant while taking Clio, stop taking it immediately and contact your doctor. If you wish to become pregnant, you can stop taking Clio at any time (see also "If you wish to stop treatment with Clio").
Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding
The use of Clio is generally not recommended during breast-feeding. If you wish to take the pill while breast-feeding, contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and use of machines
There is no information suggesting that the use of Clio affects the ability to drive or use machines.

Clio contains lactose and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to use Clio

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Each blister contains 24 tablets.
Take one tablet of Clio daily, if necessary with a small amount of water. You may take the
tablets with or without food, but you must take them every day at approximately the same time.
Taking the tablets
Mandatory phase (days 1-24)
Start taking the tablet marked with the correct day of the week. When starting to take
Clio, the tablets must be taken continuously for at least 24 days, after which you may:

• stop taking the tablets for a 4-day tablet-free interval, during which menstruation will begin,
• or continue taking them for up to a maximum of 120 days (see flexible phase); this will delay menstruation.

Flexible phase (days 25-120)
During days 25-120, the tablets may be taken continuously for a maximum of 120 days. During this
period, you may decide whether you wish to delay menstruation or to take a 4-day tablet-free interval. If you decide to continue taking the tablets for 120 days, proceed
directly to a 4-day tablet-free interval after completing the 120 days of tablet intake. Menstruation will begin during this 4-day tablet-free interval. This will normally cause bleeding.
If you experience continuous bleeding (three consecutive days) during the tablet-taking period in the flexible phase (days 25-120), it is recommended to take a 4-day tablet-free interval, which will induce menstruation. This 4-day tablet-free interval will reduce the total number of bleeding days.
Tablet-free interval
A tablet-free interval must never exceed 4 days and should only be started if the tablets have been taken continuously for 24 days.
During the 4-day tablet-free interval, bleeding normally occurs and may not have finished before the start of the next cycle of tablet intake.
After each 4-day tablet-free interval, begin a new cycle of taking tablets for at least 24 days, up to a maximum of 120 days. After the mandatory phase of 24 consecutive days of tablet intake, you may again choose when to take the 4-day tablet-free interval between day 25 and day 120.
It is recommended to start a new blister containing 24 tablets for the mandatory phase, and after a 4-day tablet-free interval, to help you follow the correct administration of the product.
General dosing rules:

• A 4-day tablet-free interval may be started only if the tablets have been taken continuously for 24 days, i.e. after completion of the mandatory phase.
• After each 4-day tablet-free interval, a new mandatory phase begins, meaning the tablets must be taken for at least 24 days before another interruption can be planned.

Preparing the blister
To help you remember to take your contraceptive, each Clio pack contains 35 (5x7) stickers showing the days of the week, except for the pack containing only one 24-tablet blister, which contains only 7 (1x7) stickers. You should know on which day of the week you will start taking the tablets.
Choose the weekly sticker that starts with the day on which you begin taking the tablets. For example, if you start on Wednesday, use the sticker beginning with “WED”.
Apply the weekly sticker along the top edge of the blister, where you can read “apply weekly label here”. This way, each tablet will have a day marked above it, and you can see whether you have taken a particular tablet. The arrows indicate the order in which you should take the tablets.
If you use Clio in this way, you are protected against pregnancy even during the 4 days when you do not take tablets.
If you have incomplete blisters, you may take the remaining tablets during the flexible phase. Choose a new weekly sticker with the day of the week corresponding to the day you start taking the remaining tablets, and place it above the first remaining tablet you will take. Apply the new weekly sticker over the previous weekly sticker. See Preparing the blister.
The prescription for the next pack should be obtained in time, i.e. before using the last blister in the pack, to ensure you do not run out of tablets.
If you are unsure what to do, ask your doctor.
When can you start the first blister?

• If you have not used a hormonal contraceptive in the previous month Start taking Clio on the first day of your cycle (i.e. the first day of menstruation). If you start taking Clio on the first day of menstruation, protection against pregnancy is immediate. You may also start between the second and fifth day of the cycle, but you must use additional contraceptive precautions (e.g. a condom) for the first 7 days.

• Switching from a combined hormonal contraceptive or from a combined vaginal ring or contraceptive patch You may preferably start taking Clio the day after the last active tablet (the last tablet containing active ingredients) of the previous contraceptive, or at the latest the day after the tablet-free interval of the previous contraceptive ends (or after the last placebo tablet of the previous contraceptive). If you previously used a vaginal ring or contraceptive patch, follow your doctor’s advice.

• Switching from a progestogen-only method (progestogen-only pill, injectable contraceptive, implant, or progestogen-releasing IUD) You may switch from the progestogen-only pill on any day (from an implant or IUD on the day of its removal, from an injectable product at the time the next injection would have been due), but in all these cases, use additional contraceptive precautions (e.g. a condom) for the first 7 days of tablet intake.

• After an abortion Follow your doctor’s advice.

• After childbirth You may start taking Clio between day 21 and day 28 after childbirth. If you start after day 28, use a barrier method (e.g. a condom) during the first seven days of using Clio. If you have had sexual intercourse after childbirth before starting (or restarting) Clio, make sure you are not pregnant or wait until your next menstruation.

• If you are breastfeeding and wish to start (or restart) Clio after childbirth Read the section “Breast-feeding”.

Ask your doctor for advice if you are unsure when to start.
If you take more Clio than you should
No serious harmful effects have been reported related to taking too many Clio tablets.
If you take several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. Even girls who have not yet had their periods but have accidentally taken this medicine may experience such bleeding.
If you have taken too many Clio tablets or if you find that a child has taken some, consult your doctor or pharmacist.
If you forget to take Clio
If you forget to take a tablet (one of the 24 tablets in the blister), do the following:

• If less than 24 hours have passed since your usual tablet-taking time, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, then continue taking the following tablets at your usual time.
• If more than 24 hours have passed since your usual tablet-taking time, protection against pregnancy may be reduced. The greater the number of missed tablets, the higher the risk of pregnancy.

The risk of incomplete protection against pregnancy is greater if you forget to take a
tablet at the beginning or end of the pack. Therefore, follow these rules (see the diagram below):

• More than one tablet missed in a pack Consult your doctor.
• One tablet missed between days 1 - 7 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 and use additional precautions for the next 7 days, e.g. a condom. If you had sexual intercourse in the week before the missed tablet, be aware that there is a risk of pregnancy. In this case, consult your doctor.
• One tablet missed between days 8 - 14

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. Protection against pregnancy is not reduced and you do not need to take additional precautions.

• One tablet missed between days 15 - 24 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 until all 24 tablets have been taken. Skip the 4-day tablet-free interval and start the next blister (the starting day will be different from before). Menstruation will most likely occur at the end of the second pack – during the 4-day tablet-free interval – or you may experience light bleeding or menstruation-like bleeding during the second pack.
  2. You may also stop taking tablets and go directly to the 4-day tablet-free interval (before starting this tablet-free interval, note the day on which you forgot to take the tablet). If you wish to start a new pack on the day you usually start, make the tablet-free interval shorter than 4 days.

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

• One tablet missed between days 25 - 120 You may choose one of the following options without needing additional contraceptive precautions.
  1. Take the missed tablet as soon as possible, even if this means taking two tablets at the same time, and continue taking the following tablets at your usual time until you have taken at least 7 tablets without interruption.
  2. Stop taking tablets, take a 4-day tablet-free interval (including the day you missed the tablet), and then continue with a new cycle of taking Clio.
• If you missed a tablet in the blister and do not have bleeding during the 4-day tablet-free interval, this may indicate pregnancy. You must contact your doctor before starting the next pack.

More than 1 tablet
Ask your doctor
missed in 1 pack
Yes
Did you have sexual intercourse in
Days 1 - 7
the week before the missed tablet?
No

Take the missed tablet

• Use a barrier method (condom) for the next 7 days and
• Finish the pack

Take the missed tablet
Days 8-14

• Finish the pack

Only 1 tablet
missed (taken

• Take the missed tablet more than 24 hours • Finish the pack late) • Skip the 4-day tablet-free interval
• Start the new blister

Days 15-24 O

• Stop taking tablets immediately
• Go directly to the 4-day tablet-free interval
• Then start the new blister

Take the missed tablet

• Take the following tablets until you have taken at least 7 tablets without interruption

Days 25-120
O

• Stop taking tablets immediately
• Go directly to the 4-day tablet-free interval
• Then start the new blister

What to do in case of vomiting or severe diarrhoea
If vomiting or severe diarrhoea occurs within 3-4 hours after taking a tablet, there is a risk that the active ingredients of the tablet have not been completely absorbed by your body. This is similar to having forgotten to take a tablet. After vomiting or severe diarrhoea, take another tablet as soon as possible from a spare pack. If possible, take it within 24 hours of your usual tablet-taking time. If this is not possible or if more than 24 hours have passed, follow the advice given in the section “If you forget to take Clio”.
If you wish to stop taking Clio
You may stop taking Clio at any time. If you do not wish to become pregnant, ask your doctor for advice on other reliable methods of birth control. If you wish to become pregnant, stop taking Clio and wait for a menstrual period before trying to conceive. This will allow you to calculate the expected delivery date more easily.
If you have any questions about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clio can cause side effects, although not everyone experiences them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Clio, inform your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the various risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before using Clio”.
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 potentially accompanied by breathing difficulties (see also section “Warnings and precautions”).
The following side effects have been associated with the use of Clio.

• Common side effects (affecting 1 to 10 users out of 100):
  o mood swings or headache or nausea or breast pain, menstrual disorders such as irregular periods, absence of periods or emotional lability, depression, decreased libido

• Uncommon side effects (affecting 1 to 10 users out of 1,000):
  o depression, nervousness, drowsiness or dizziness, “pins and needles” sensations or migraine, varicose veins, increased blood pressure or stomach ache, vomiting, indigestion, flatulence, gastritis, diarrhoea or acne, itching, rash or pain, for example in the back, limbs, muscle cramps or fungal infections of the vagina, pelvic pain, breast enlargement, benign breast nodules, uterine/vaginal bleeding (which usually decreases with continued treatment), genital discharge, hot flushes, inflammation of the vagina (vaginitis), menstrual problems, painful periods, reduced periods, very heavy periods, vaginal dryness, abnormal cervical smear, reduced interest in sex
  o lack of energy, increased sweating, fluid retention
  o weight gain
  Depression, reduced interest in sex and migraine are common side effects associated with the use of Clio in a flexible regimen up to 120 days.

• Rare side effects (affecting 1 to 10 users out of 10,000):
  o candidiasis (a fungal infection) or anaemia, increased number of platelets in the blood or allergic reactions or endocrine disorders or increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood or inability to achieve orgasm, insomnia or dizziness, tremor or eye disorders, for example eyelid inflammation, dry eyes or abnormally rapid heartbeat or inflammation of a vein, nosebleed, fainting or abdominal swelling, intestinal disorder, bloated feeling, stomach hernia, fungal infection of the mouth, constipation, dry mouth or pain in the bile ducts or gallbladder, inflammation of the gallbladder or yellow-brown spots on the skin, eczema, hair loss, acne-like skin inflammation, dry skin, nodular skin inflammation, excessive hair growth, skin disorders, stretch marks, skin inflammation, photosensitive skin inflammation, skin nodules.
  o difficult or painful sexual intercourse, inflammation of the vagina (vulvovaginitis), bleeding after intercourse, breakthrough bleeding, breast cyst, increased number of breast cells (hyperplasia), malignant breast nodules, abnormal growth on the mucous surface of the cervix, narrowing or loss of the uterine lining, ovarian cysts, enlargement of the uterus or general malaise or weight loss or 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 symptoms similar to stroke, known as transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, 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).
The following side effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (skin rash with redness or target-shaped sores).

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 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 Clio

Keep this medicine out of the sight and reach of children.
Store below 30°C.
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 Clio Contains

• The active substances are ethinylestradiol and drospirenone. Each film-coated tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone.
• The other ingredients are monohydrate lactose, pregelatinized starch (from maize), povidone (E1201), croscarmellose sodium, polysorbate 80, magnesium stearate (E470b), polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Description of the Appearance of Clio and Contents of the Package

• Each Clio blister contains 24 film-coated tablets.
• Clio is available in cardboard boxes containing 1 or 5 blisters; the total number of tablets per package is 24 or 120 tablets.
• Each Clio package contains 7 (1x7) or 35 (5x7) adhesive labels printed with the days of the week.

Marketing Authorization Holder
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 – Rome
Italy

Manufacturer
Laboratorios León Farma, S.A.
C/ La Vallina s/n, Pol. Ind. Navatejera
24008 - Navatejera, León
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Velmari Langzyklus 0,02 mg/3 mg Filmtabletten
Netherlands: Talia 0.02 mg/3 mg filmomhulde tabletten
Austria: Velmari Langzyklus 0,02 mg/3 mg Filmtabletten
Belgium: Perynella 0,02 mg/3 mg filmomhulde tabletten
Spain: Drosbelalleflex 0,02 mg/3 mg comprimidos recubiertos con película
Finland: Diza 0,02 mg/3 mg kalvopäällysteiset tabletit
France: Perynella 0,02 mg/3 mg comprimé pelliculé
Hungary: Jangee Flexibilis 3mg/0.02 mg
Italy: Clio 0,02 mg/3 mg compresse rivestite con film
Luxembourg: Perynella 0,02 mg/3 mg comprimé pelliculé
Poland: Naraya Flex
Portugal: Velmari 0,02 mg/3 mg comprimido revestido
Sweden: Diza