Arianna

Package leaflet: Information for the user

ARIANNA

60 micrograms/15 micrograms, film-coated tablets
Gestodene/Ethinylestradiol
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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, 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 contraceptive methods when 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 ARIANNA is and what it is used for
2. What you need to know before taking ARIANNA
3. How to take ARIANNA
4. Possible side effects
5. How to store ARIANNA
6. Contents of the pack and other information

1. What ARIANNA is and what it is used for

• ARIANNA is an oral contraceptive pill used to prevent pregnancy.
• Each of the 24 pale yellow tablets contains a small amount of two different female hormones, gestodene and ethinylestradiol.
• The 4 white tablets contain no active substances and are called "placebo tablets".
• Birth control pills that contain two hormones are called "combined" pills.

2. What you need to know before using ARIANNA

General information
Before starting to use ARIANNA, 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 you start taking ARIANNA, your doctor will ask you some questions about your personal and family
medical history. Your doctor will also measure your blood pressure and, depending on your individual
situation, may carry out other examinations.
This leaflet describes several conditions that require discontinuation of ARIANNA or in which the reliability of
ARIANNA may be reduced. In such cases, you should abstain from sexual intercourse or use other non-
hormonal contraceptive methods, such as condoms or other barrier methods. Do not use the rhythm method
or basal body temperature method. These methods may be unreliable because ARIANNA alters the monthly
changes in body temperature and cervical mucus.
ARIANNA, like all hormonal contraceptives, does not protect against HIV (AIDS) or other sexually
transmitted infections.
Do not use ARIANNA
Do not use ARIANNA 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 might be more
suitable for your case.

• If you are allergic (hypersensitive) to any of the active substances (gestodene or ethinylestradiol) or to any of the excipients of this medicine (a list of excipients is provided in section 6).
• 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 another organ.
• 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 about to undergo surgery or will be bedridden for a prolonged period (see section “Blood clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of a heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms).
• If you have any of the following conditions, which may increase the risk of arterial blood clots:
  • 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) heart or blood vessel disease, particularly:
  • a heart rhythm or heart valve disorder
  • disease of certain blood vessels of the heart (coronary arteries)
• If you have (or have ever had) a benign tumour (called focal nodular hyperplasia or hepatic adenoma) or a malignant tumour of the liver, or if you have recently had a liver disease. In these cases, your doctor will ask you to stop taking the tablets until your liver functions normally again.
• If you have unexplained vaginal bleeding.
• If you have breast cancer, uterine cancer, or a hormone-sensitive cancer, or if such a cancer is suspected.

Do not use Arianna 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 Arianna”).
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 your leg (deep vein thrombosis), in your lung (pulmonary embolism), a heart attack or a stroke (see the following section “Blood clots”).

For a description of the symptoms of these serious side effects, refer to the section “How to recognize a
blood clot”.
In certain situations, special care is needed when using ARIANNA or other combined hormonal contraceptives,
and you may need regular medical check-ups.
Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using ARIANNA, inform your doctor.

• if blood tests have shown that you have high blood sugar levels, high cholesterol levels, or high prolactin levels (a hormone that stimulates milk production);
• if you are obese;
• if you have a benign breast tumour or have a close relative who has had breast cancer;
• if you have a uterine disease (uterine dystrophy);
• 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 about 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 ARIANNA;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you or a close relative (parents, grandparents, siblings) have ever had a condition involving a tendency to form blood clots (in the legs, lungs, or elsewhere; heart attack; stroke);
• if you have epilepsy (see also “Taking other medicines”);
• if you have migraine;
• if you have hearing loss due to a condition known as otosclerosis;
• if you have asthma;
• if during a pregnancy or while using another contraceptive pill you developed a skin condition causing itching, red spots, and blisters (herpes gestationis);
• if you have had facial spots (chloasma) during pregnancy or while using another contraceptive pill. In this case, avoid direct exposure to sunlight while using ARIANNA;
• if you have gallstones;
• if you have heart, liver, or kidney disease;
• if you have depression;
• if you have high blood pressure;
• if you have a condition known as “chorea”, characterised by involuntary, irregular, and sudden movements.

If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty
swallowing or hives with possible breathing difficulties, inform your doctor immediately.
Medicines containing estrogens may induce or worsen symptoms of hereditary and acquired angioedema.
Do not hesitate to ask your doctor or pharmacist for advice if you have any doubts about using ARIANNA.
BLOOD CLOTS
Using a combined hormonal contraceptive such as ARIANNA 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 can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with ARIANNA 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 are you probably suffering from?
Deep vein thrombosis

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking
• increased warmth in the affected leg
• change in skin colour of the leg, such as paleness, reddish or bluish discolouration

Pulmonary embolism

• 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, inform 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: Retinal vein thrombosis

• sudden loss of vision or (blood clot in the eye)
• painless blurring of vision that may progress to loss of vision

Heart attack

• pain, discomfort, pressure, or heaviness in the chest
• squeezing or fullness in the chest, one arm, or under the breastbone
• feeling of fullness, indigestion, or choking
• 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

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 breaks loose from the leg and travels to 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 (the same or a different medicine) 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 ARIANNA, 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 ARIANNA 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 over 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 over one year.
• Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as ARIANNA, about 9–12 will develop a blood clot over 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 ARIANNA is low, but certain conditions can increase this risk. Your risk is higher:

• if you are very 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 (under approximately 50 years). In this case, you may 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 ARIANNA several weeks before surgery or during periods of reduced mobility. If you need to stop taking ARIANNA, 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 ARIANNA.
If any of the above conditions change while you are using ARIANNA—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 may 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 ARIANNA is very low but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as ARIANNA, 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 above conditions change while you are using ARIANNA—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.

ARIANNA and cancer
Breast cancer has been observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is caused by the pill. It may simply be that these women are examined more thoroughly and more frequently, leading to earlier detection of breast cancer.
In women who use combined oral contraceptives for a relatively long time, studies have reported cases of cervical cancer. It is currently unknown whether this is caused by the pill or attributable to sexual behavior (e.g., more frequent partner changes) and other factors.
In rare cases, benign liver tumors and, even more rarely, malignant liver tumors have been reported in women using the pill. If you experience unusually severe abdominal pain, contact your doctor.

Psychiatric disorders
Some women using hormonal contraceptives, including Arianna, have reported depression or depressed mood. Depression can be severe and sometimes may 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 ARIANNA, unexpected bleeding (bleeding outside the days when you take the placebo tablets) may occur. If such bleeding persists for more than a few months or starts after several months, your doctor should investigate the cause.

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

Other medicines and ARIANNA
Always inform your doctor about any medicines or herbal products you are currently taking, including those purchased without a prescription. Also, tell any other doctor or dentist who prescribes a medicine (or the pharmacist selling it) that you are using ARIANNA. They can advise you whether you need to use additional contraceptive precautions (e.g., condoms) and, if so, for how long.
Some medicines:

• May affect ARIANNA levels in the blood
• May make it less effective in preventing pregnancy
• May cause unexpected bleeding

These include:

• Medicines used to treat:
• HIV and Hepatitis C virus infections (known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
• epilepsy (e.g., phenobarbital, phenytoin, primidone, carbamazepine, topiramate, or felbamate)
• tuberculosis (e.g., rifabutin, rifampicin)
• fungal infections (griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole)
• bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin)
• certain heart conditions, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem)
• arthritis, osteoarthritis (etoricoxib)
• sleep disorders (modafinil)
• St. John’s wort, a herbal remedy used to treat certain types of depression
• Grapefruit juice

Do not use Arianna if you have hepatitis C and are taking medications 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 medications. Arianna may be resumed approximately 2 weeks after completion of this treatment. See the section “Do not use Arianna”.
Troleandomycin, when administered concomitantly with combined oral contraceptives, may increase the risk of intrahepatic cholestasis (bile retention in the liver).
ARIANNA may affect the action of other medicines, for example:

• Lamotrigine
• Cyclosporine
• Theophylline
• Tizanidine

Consult your doctor or pharmacist before taking any medicine.

Pregnancy
If you are pregnant, your doctor has no reason to prescribe you a contraceptive.
If you discover you are pregnant while taking ARIANNA, stop taking this pill and consult your doctor.
If you are planning a pregnancy, inform your doctor.
Consult your doctor or pharmacist before taking any medicine.

Breast-feeding
The use of ARIANNA is not recommended if you are breast-feeding.
If you wish to breast-feed, your doctor will advise you on a suitable form of contraception.
Consult your doctor or pharmacist before taking any medicine.

ARIANNA contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take ARIANNA

Dosage

• Begin taking ARIANNA by taking tablet number 1 located next to the word “START”.
• To help you keep track of your daily pill intake, 7 adhesive strips with the 7 days of the week are provided. Choose the strip starting with the day you begin taking the tablets. For example, if you start on Wednesday, use the adhesive strip beginning with “WED”. Apply the adhesive strip along the top of the ARIANNA blister pack, where it says “Apply adhesive strip here”.
• Each blister contains 28 tablets. Take one tablet at the same time every day for 28 consecutive days, following the direction of the arrows, without missing any: take one pale-yellow active tablet daily for the first 24 days, followed by one white placebo tablet daily for the last 4 days.
• After taking the last tablet, continue taking ARIANNA the next day by starting a new blister pack without any break between packs. You should always start a new blister on the same day of the week. Since there are no tablet-free intervals, it is important that you have already obtained a new blister pack before finishing the current one.
• Your menstrual period will usually begin 2 or 3 days after taking the last pale-yellow tablet of the pack and may not have finished before you start the next pack.

Method and route of administration
Take each tablet with a full glass of water.
If you have not used a hormonal contraceptive in the previous month
Take the first tablet on the first day of your menstrual period.
If you were using another oral contraceptive
Finish the current blister pack you are taking (if your current pill pack also contains hormone-free (inactive) tablets, do not take them). Then start the ARIANNA blister pack the next day, without leaving any tablet-free interval.
If you were using a progestogen-only method (progestogen-only pill, injectable or implant)

• Switching from a progestogen-only pill: You may start ARIANNA at any time during your menstrual cycle, the day after stopping the progestogen-only pill.
• Switching from an implant: Start ARIANNA on the day the implant is removed.
• Switching from an injectable contraceptive: Start ARIANNA on the day the next injection would have been due.

In all cases, you must use a barrier contraceptive method (e.g. a condom) for the first 7 days of tablet-taking.
If starting ARIANNA after a first-trimester abortion
You may start taking ARIANNA immediately, but you must follow your doctor’s advice before starting.
If starting ARIANNA after childbirth or a second-trimester abortion
As with any other oral contraceptive, ARIANNA should not be started earlier than 21–28 days after childbirth or abortion, because the risk of blood clots is higher. If you start later, we recommend using a barrier contraceptive method during the first 7 days of tablet-taking. If you have had sexual intercourse before starting ARIANNA, make sure you are not pregnant or wait for your next menstrual period.
Always consult your doctor.
Duration of use
Your doctor will advise you on how long you should take this pill.
If you take more ARIANNA than you should
An overdose may cause gastrointestinal problems (e.g. nausea, vomiting, abdominal pain), breast tenderness, dizziness, drowsiness/fatigue, and menstrual cycle irregularities (vaginal bleeding). Even girls who have not yet had their first period but have accidentally taken this medicine may experience such bleeding.
Consult your doctor.
If you forget to take ARIANNA
If you forget to take the pill, there is a risk you may become pregnant
If you realize you have missed a pale-yellow tablet within 12 hours of your usual intake time , take the missed tablet immediately and continue taking the tablets at your usual time until the end of the pack.
If you realize you have missed a pale-yellow tablet more than 12 hours after your usual intake time , there is a risk you may become pregnant. In this case:

• Take the missed tablet immediately, even if this means taking two tablets on the same day;
• Continue taking the contraceptive until the end of the pack;
• Additionally, use a barrier contraceptive method (condom, spermicide) for the next 7 days;
• If this 7-day period extends beyond the last pale-yellow tablet, discard the remaining tablets and start the next pack immediately.

If you have missed one or more pale-yellow tablets in a pack and do not have the expected menstrual period—which should start while taking the white tablets—you may be pregnant.
If you have missed one or more white tablets, you are still protected provided that no more than 4 days pass between the last pale-yellow tablet of the current pack and the first pale-yellow tablet of the next pack.
Consult your doctor.
If you vomit or have severe diarrhoea within 4 hours of taking the tablet, the situation is similar to that of a missed tablet. After vomiting or severe diarrhoea, you must take another tablet as soon as possible from a spare blister pack. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible, or if 12 hours have already passed, follow the instructions given under “If you forget to take ARIANNA”.
If episodes of vomiting or severe diarrhoea persist for several days, you must use a barrier contraceptive method (condom, spermicide, etc.) until the start of the next blister pack.
Consult your doctor.

4. Possible side effects

Like all medicines, ARIANNA may 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 ARIANNA, 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 different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before using ARIANNA”.

The most frequently reported side effects (occurring in more than 10%) in women using ARIANNA are infrequent or absent menstrual periods during or after stopping the pill, intermenstrual bleeding, or headache including migraine.

Common side effects (may affect from 1 to 10 in 100 people):

• vaginal infection, including vaginal candidiasis
• mood changes, including depression or altered libido
• nervousness or dizziness
• nausea, vomiting, or abdominal pain
• acne
• breast disorders, such as pain, tenderness, swelling, or discharge
• painful menstruation or changes in menstrual flow
• changes in vaginal discharge or changes in the cervix (ectropion)
• fluid retention in tissues or oedema (marked fluid retention)
• weight loss or weight gain

Uncommon side effects (may affect from 1 to 10 in 1,000 people):

• changes in appetite
• abdominal cramps or flatulence
• skin rash, excessive hair growth, hair loss, or facial pigmentation (chloasma)
• changes in laboratory test results: increased cholesterol or triglyceride levels, or increased blood pressure

Rare side effects (may affect from 1 to 10 in 10,000 people):

• allergic reactions (very rare cases of urticaria or severe respiratory or circulatory disturbances)
• glucose intolerance
• intolerance to contact lenses
• jaundice
• a type of skin reaction called “nodular erythema”
• harmful blood clots in a vein or artery, for example: in a leg or foot (DVT), in a lung (PE), heart attack, stroke, transient ischaemic attack (TIA), or temporary stroke-like symptoms, or 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)

Very rare side effects (may affect less than 1 in 10,000 people):

• benign liver tumour (called focal nodular hyperplasia or hepatic adenoma) or malignant liver tumour
• worsening of an autoimmune disease (lupus), liver disease (porphyria), or a condition known as “chorea”, characterised by irregular, sudden, and involuntary movements
• certain types of eye disorders, such as optic neuritis, which may lead to partial or complete vision loss, or a blood clot in the retina
• pancreatic disorders
• increased risk of gallstones or obstruction of bile flow
• liver or biliary disorders (such as hepatitis or abnormal liver function)
• blood and urinary system disorders (haemolytic uraemic syndrome)
• a type of skin reaction called “erythema multiforme”

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• exacerbation of symptoms of hereditary and acquired angioedema

Serious side effects
Contact your 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 urticaria with possible breathing difficulties (see also “Warnings and precautions”).
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

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 http://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 ARIANNA

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

6. Package contents and other information

What ARIANNA contains
Pale yellow tablet
The active substances are: 60 micrograms of gestodene and 15 micrograms of ethinylestradiol.
The excipients are: monohydrate lactose, microcrystalline cellulose, magnesium stearate, polacriline potassium,
Opadry yellow YS-1-6386-G [hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide
(E172)], macrogol 1450, wax E (montanglycol wax).
White tablet
Does not contain active substances.
The excipients are: monohydrate lactose, microcrystalline cellulose, magnesium stearate, polacriline potassium,
Opadry Y-5-18024-A [hypromellose, hydroxypropylcellulose, titanium dioxide (E171), macrogol 400], macrogol
1500, wax E (montanglycol wax).
Description of the appearance of ARIANNA and contents of the pack
ARIANNA is available as film-coated tablets.
Each pack contains 1, 3 or 6 blisters, each blister containing 28 tablets (24 pale yellow active tablets and 4 white placebo tablets).
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156 Milano
Manufacturer
Bayer Weimar GmbH und Co. KG
Doebereinerstrasse 20, 99427 Weimar
Germany