АРИАННА 60 МКГ/15 МКГ Фильм-coated таблетки

Содержание инструкции

1. ARIANNA

ARIANNA

60 micrograms/15 micrograms, film-coated tablets
Gestodene/Ethinylestradiol
Read this leaflet carefully before 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, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Important things to know 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 blood clots forming 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
• Pay attention and see your doctor if you think you may 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 you take 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 do not contain any active substances and are called “placebo tablets”.
• Contraceptive pills that contain two hormones are called “combined” pills.
• 2. What you need to know before using ARIANNA

General notes
Before starting to use ARIANNA, read the information on blood clots in section 2.
It is particularly important that you read the symptoms of a blood clot (see section 2
“Blood clots”).
Before starting to take ARIANNA, your doctor will ask you some questions about your
personal and family medical history. The doctor will also measure your blood pressure and, depending on
your personal situation, may also perform other tests.
This leaflet describes several situations that require you to stop using ARIANNA or
where the reliability of ARIANNA may be reduced. In such situations, you should abstain from
sexual intercourse or use other non-hormonal contraceptive measures, such as
condoms or other barrier methods. Do not use the rhythm or basal temperature method. These
methods may be unreliable, because ARIANNA alters the monthly variations in
body temperature and cervical mucus.

ARIANNA, like all hormonal contraceptives, does not protect against HIV (AIDS) infection or other sexually transmitted diseases.
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. The doctor will discuss with you other methods of birth control that may be more suitable for your case.

• If you are allergic (hypersensitive) to any of the active ingredients (gestodene or ethinylestradiol) or to any of the excipients of this medicine (the list of excipients is given in paragraph 6). If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or in other organs;
• If you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• If you are going to have surgery or if you will be bedridden for a long 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 that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• If you have one of the following diseases, which may increase the risk of clots forming in the arteries:
• severe diabetes with damage to blood vessels
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a disease 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) heart or blood vessel disease, in particular:
• a heart rhythm disorder or heart valve disorders;
• disease of certain blood vessels of the heart (coronary arteries)
• If you have (or have ever had) a benign tumor (called focal nodular hyperplasia or hepatic adenoma) or a malignant liver tumor, or if you have recently had liver disease. In these cases, the doctor will ask you to stop taking the tablets until your liver is functioning normally.
• If you have vaginal bleeding of unknown cause.
• If you have breast cancer or uterine cancer or cancer sensitive to female sex hormones, or if you suspect you have one of these types of cancer.

Do not use Arianna if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other medicines and Arianna”).
Warnings and precautions
When to consult a doctor?
Seek medical attention urgently

• if you notice possible signs of a blood clot that may indicate you have a blood clot in the leg (deep vein thrombosis), a blood clot in the 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, see section “How to recognize a blood clot”.
In some situations, special care is needed when using ARIANNA or other combined hormonal contraceptives, and you may need to have regular medical check-ups.
Tell your doctor if any of the following conditions apply to you.
If this condition appears or worsens while you are using ARIANNA, you should tell your doctor.

• if blood tests have shown that you have a high level of sugars, a high level of cholesterol or a high level of prolactin (a hormone that stimulates milk production);
• if you are obese;
• if you have a benign breast tumor 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 that affects the body's defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disease);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are going to have surgery or if you will be bedridden for a long period (see section 2 “Blood clots”);
• if you have just given birth, your risk of developing blood clots is higher. Ask your doctor how long after childbirth you can start taking ARIANNA;
• if you have inflammation of the veins in the skin (superficial thrombophlebitis);
• if you have varicose veins.
• if you or a close relative (parents, grandparents, siblings) have ever suffered from a disease with a tendency to develop blood clots (in the legs, lungs or elsewhere; heart attack; stroke);
• if you suffer from epilepsy (see also “Taking other medicines”);
• if you suffer from migraine;
• if you have hearing loss due to a disease known as otosclerosis;
• if you suffer from asthma;
• if during a pregnancy, or during the use of another contraceptive pill, you have had a skin disease that has caused itching, red spots and blisters (herpes gestationis);
• if you have had spots on your face (chloasma) during pregnancy or during the use of another contraceptive pill. In this case, avoid direct exposure to sunlight while using ARIANNA;
• if you suffer from gallstones;
• if you suffer from heart, liver or kidney disease;
• if you suffer from depression;
• if you suffer from high blood pressure;
• if you suffer from a disease known as “chorea”, characterized by involuntary, irregular and sudden movements;

If you suffer from hereditary angioedema, products containing estrogens may induce or worsen the symptoms of angioedema. You should go to your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives accompanied by difficulty breathing.

Do not hesitate to ask your doctor or pharmacist if you have any doubts about using ARIANNA.
BLOOD CLOTS
The use of a combined hormonal contraceptive like ARIANNA causes an increased risk of developing a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in the veins (a condition called “venous thrombosis”, "venous thromboembolism” or VTE)
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or TEA).

Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, or, very rarely, these effects may 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
See a doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs?
What you probably suffer from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
• pain or sensitivity in the leg that may only be felt when standing or walking
• increased warmth in the affected leg
• change in skin color of the leg, such as paleness, redness or bluish discoloration Deep vein thrombosis
• sudden shortness of breath or rapid breathing;
• sudden cough without a clear cause, with possible blood production;
• sharp chest pain that may increase when breathing deeply;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain

If you are unsure, tell 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 infection (e.g. a “common cold”).
Pulmonary embolism
Symptoms that occur more frequently in one eye:

• sudden loss of vision or
• painless blurred vision that may progress to vision loss Retinal vein thrombosis (blood clot in the eye)
• pain, discomfort, pressure or heaviness in the chest
• feeling of squeezing or fullness in the chest, an arm or under the breastbone;
• feeling of fullness, indigestion or suffocation;
• discomfort in the upper body, radiating to the back, jaw, throat, arms and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety or shortness of breath;
• rapid or irregular heartbeat Heart attack

Stroke

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 in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot can 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 you take a combined hormonal contraceptive for the first time. The risk may also be higher if you restart a combined hormonal contraceptive (the same medicine or a different medicine) after a break of 4 or more weeks. After the first year, the risk decreases but is still 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 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.

• In about 2 out of 10,000 women who do not use any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• In about 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• In about 10,000 women who use a combined hormonal contraceptive containing gestodene, such as ARIANNA, about 9-12 will develop a blood clot in a year.
• The risk of a blood clot forming depends on your medical history (see “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 some conditions increase it.
Your risk is higher:

• if you are severely overweight (body mass index or BMI greater than 30 kg/m2);
• if a close relative has had a blood clot in a leg, lung or other organ at a young age (under about 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are going to have surgery or if you will be bedridden for a long period due to injury or illness, or if you have a leg in a cast. You may need to stop taking ARIANNA a few weeks before surgery or during the time you are less mobile. 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);
• 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.
Travel by aereo (of duration >4 hours) can temporarily increase the risk of a blood clot forming, especially if you have some of the other risk factors listed. It is important that you inform your doctor if any of these conditions apply to you, even if you are not sure. The doctor may decide to stop you from taking ARIANNA. If any of the above conditions change while you are using ARIANNA, for example if a close relative develops a thrombosis for no known reason or if you significantly increase in 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 cause 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 can increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like ARIANNA it is advisable to quit smoking. If you cannot quit smoking and you are over 35 years old, your doctor may advise you to use 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 about 50 years). In this case you may also be at high 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 (valve 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 serious, 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 a thrombosis for no known reason or if you significantly increase in weight, contact your doctor. ARIANNA and cancer Breast cancer has been observed slightly more frequently in women who use combined pills, but it is not known whether this is caused by the pill. It may be that these women were simply visited more carefully and more often and that therefore breast cancer was detected earlier. In women who use combined pills for a relatively long period of time, studies have reported cases of cervical cancer. Currently it is not known whether this is caused by the pill or is attributable to sexual behavior (e.g. more frequent changes of partners) 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 disordersSome women who use hormonal contraceptives including Arianna have reported depression or depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you experience changes in mood and 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 may occur (bleeding outside the days you take the placebo tablets). If this bleeding persists for more than a few months, or starts after a few months, your doctor should investigate the cause. What to do if your period does not occur during the placebo days If you have taken all the yellow-pale active tablets correctly, you have not had vomiting or severe diarrhea and you have not taken other medications, it is very unlikely that you are pregnant. If your period does not occur for two consecutive times, you may be pregnant. Contact your doctor immediately. Do not start the next blister until you are sure you are not pregnant. Other medicines and ARIANNA Always tell your doctor what medicines or herbal products you are already taking, including over-the-counter medicines. Also tell any other doctor or dentist who prescribes you medicine (or the pharmacist who sells it to you) that you are using ARIANNA. They can tell you if you need to use additional contraceptive precautions (e.g. a condom) and, if so, for how long. Some medicines

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

These include:

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

Do not use Arianna if you have Hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause increases in blood test results of liver function (increased liver enzyme ALT). Your doctor will prescribe you another type of contraceptive before starting treatment with these medicines. Arianna can be resumed about 2 weeks after completion of this treatment. See the paragraph “Do not use Arianna”. Troleandomycin, when administered with combined oral contraceptives, may increase the risk of cholestasis (retention of bile in the liver). ARIANNA can affect the effect of other medicines, e.g.:

• Lamotrigine
• Cyclosporine
• Theophylline
• Tizanidine

Ask your doctor or pharmacist for advice 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, tell your doctor. Ask your doctor or pharmacist for advice before taking any medicine. Breastfeeding The use of ARIANNA is not recommended if you are breastfeeding. If you wish to breastfeed, your doctor will advise you on a suitable form of contraception. Ask your doctor or pharmacist for advice before taking any medicine. ARIANNA contains lactose. If you suffer from intolerance to certain sugars, consult your doctor before taking ARIANNA.

• 3. How to take ARIANNA

Dosage

• Start taking ARIANNA by taking the tablet number 1 located next to the word “START”.
• To help you keep track of your daily pill intake, there are 7 self-adhesive strips with the 7 days of the week. Choose the strip that starts on the day you start taking the tablets. For example, if you start on Wednesday, use the adhesive strip that starts with “WED”. Apply the adhesive strip along the top of the ARIANNA blister, where it says “Apply adhesive strip here”.
• Each blister contains 28 tablets. Take one tablet at the same time each day, for 28 days consecutively, following the direction indicated by the arrows, never missing, as follows: take one yellow-pale active tablet a day, for the first 24 days; then one white placebo tablet each day for the last 4 days.
• After taking the last tablet, continue taking Arianna the next day starting another blister without any interval between blisters. You must always start a new blister on the same day of the week. Since there are no breaks in intake, it is important that you have already obtained a new blister before finishing one.
• Your period usually starts two or three days after you have taken the last yellow-pale tablet of the blister and may not have ended before you start the next blister.

Method of administrationTake each tablet with a large 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 period. If you were using another contraceptive pill Finish the blister you are taking (if the pack of pills you are taking also contains the hormone-free (inactive) tablets, do not take them). Then start the ARIANNA blister the next day, without leaving any pill-free interval. If you were using a progestin-only method (progestin-only pill, an injectable method or an implant)

• Switching from a progestin-only pill: you can start ARIANNA at any time of your menstrual cycle, the day after you stop the progestin-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 your next injection was due.

In any case, you should use a barrier method of contraception (e.g. a condom) for the first 7 days of taking the pill. If you start ARIANNA after an abortion occurring in the first trimester You can start taking ARIANNA immediately, but you should follow your doctor's advice before starting. If you start ARIANNA after a miscarriage occurring during the second trimester As with any other contraceptive pill, ARIANNA should not be started before 21-28 days after the miscarriage, as the risk of blood clots is higher. If you start later, we recommend that you use a barrier method of contraception during the first 7 days of taking the pill. If you have had sexual intercourse before starting ARIANNA, make sure you are not pregnant or wait for your next period. Always ask your doctor for advice.

Duration of use
The doctor will tell you how long you should take this pill.
If you take more ARIANNA than you should
An overdose can cause gastrointestinal problems (e.g. nausea, vomiting, pain
abdominal), breast tenderness, dizziness, drowsiness/fatigue and irregular
menstrual cycle (vaginal bleeding). Even girls who have not yet had
menstruation, but who have accidentally taken this medicine may have such
bleeding.
Ask your doctor for advice.
If you forget to take ARIANNA
If you forget to take the pill there is a risk of becoming pregnant
If you notice that you have not taken a yellow-pale tablet within 12 hours of the time you
normally take the tablet, take the forgotten tablet immediately and continue
normally, taking the next tablet at the usual time until the end of the blister.
If you notice that you have not taken a yellow-pale tablet more than 12 hours after the time you
normally take it, there is a risk of becoming pregnant. In this case:

• take the forgotten tablet immediately, even if this means taking 2 tablets on the same day;
• continue to take the contraceptive until the end of the blister;
• also, use a barrier contraceptive method (condom, spermicide) for the next 7 days;
• if this 7-day period goes beyond the last yellow-pale tablet, discard the remaining tablets and start the next blister.

If you have forgotten yellow-pale tablets in a blister and do not have your expected menstruation,
which should start while taking the white tablets, you may be pregnant.
If you have forgotten one or more white tablets, you are still protected as long as no more than 4
days pass between the last yellow-pale tablet of the current blister and the first yellow-pale tablet of the
next blister.
Ask your doctor for advice.
In case of vomiting or severe diarrhea within 4 hours of taking the pill, the situation is similar to
what happens when you forget a tablet. Following vomiting or diarrhea, you must
take another tablet from a reserve blister as soon as possible. If possible, take it within
12 hours of the usual time of taking the pill. If this is not possible, or 12 hours have already passed,
you must follow the instructions provided in “If you forget to take ARIANNA”.
If these episodes of severe vomiting or diarrhea recur for several days, you should use a barrier
contraceptive method (condom, spermicide...) until the start of the next blister.
Ask your doctor for advice.

• 4. Possible side effects

Like all medicines, ARIANNA can cause side effects although not everybody gets them.
If you experience any side effect, especially if serious or persistent, or if any
change occurs in your health that you think could be due to ARIANNA, inform your
doctor.
A greater risk of developing blood clots in the veins (venous thromboembolism (VTE)) or
blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women who
take combined hormonal contraceptives.
For more detailed information on the different risks associated with taking combined hormonal
contraceptives, see section 2 “What you need to know before you use ARIANNA”.
The most frequently reported side effects (more than 10%) in women using ARIANNA
are infrequent or absent periods during the pill or after stopping it, breakthrough bleeding or headache, including migraine.
Common side effects (may affect up to 1 in 10 women):

• vaginal infection, including vaginal candidiasis
• mood changes, including depression or altered libido
• nervousness or dizziness
• nausea, vomiting or abdominal pain
• acne
• breast problems, such as pain, sensitivity, swelling or secretion
• painful periods or change in menstrual flow
• changes in vaginal discharge or change to the cervix (ectropion)
• fluid retention in the tissues or edema (marked fluid retention)
• weight loss or gain

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

• changes in appetite
• abdominal cramps or flatulence
• skin rash, excessive hair growth, hair loss or spots on the face (chloasma)
• changes in laboratory test results: increased levels of cholesterol, triglycerides or increased blood pressure

Rare side effects (may affect up to 1 in 10,000 women):

• allergic reactions (very rare cases of urticaria, angioedema or severe breathing or circulatory disorders)
• glucose intolerance
• intolerance to contact lenses
• jaundice
• a type of skin reaction called “erythema nodosum”
• harmful blood clots in a vein or in an artery, for example: in a leg or foot (DVT) or in a lung (PE) or heart attack or stroke or mini-stroke or temporary symptoms similar to those of a stroke, known as a transient ischemic attack (TIA) or blood clots in the liver, stomach/intestine, kidneys or eye. The possibility 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 the symptoms of a blood clot)

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

• benign liver tumor (called focal nodular hyperplasia or hepatic adenoma) or malignant liver tumor
• worsening of an autoimmune disease (lupus), a liver disease (porphyria) or a disease known as “chorea” characterized by irregular, sudden and involuntary movements
• some types of eye diseases, such as inflammation of the optic nerve, which can lead to partial or total loss of vision, or a blood clot in the retina
• pancreatic diseases
• increased risk of gallstones or obstruction of bile flow
• liver or biliary diseases (such as hepatitis or abnormal liver function)
• blood and urinary system diseases (hemolytic uremic syndrome)
• a type of skin reaction called “erythema multiforme”

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
. 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 which is stated on the pack and on the blister after
“EXP.:”. The expiry date refers to the last day of the month.
.
No special storage conditions are required.
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. Contents of the pack and other information

What ARIANNA contains
Yellow-pale tablet
The active ingredients are: 60 micrograms of gestodene and 15 micrograms of ethinylestradiol.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, potassium polacrilin,
Opadry yellow YS-1-6386-G [hypromellose, titanium dioxide (E171), yellow iron oxide
(E172), red iron oxide (E172)], macrogol 1450, E wax (montanglic wax).
White tablet
Does not contain active ingredients.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, potassium polacrilin,
Opadry Y-5-18024-A [hypromellose, hydroxypropylcellulose, titanium dioxide (E171),
macrogol 400], macrogol 1500, E wax (montanglic wax).
Description of ARIANNA and contents of the pack
ARIANNA is available as film-coated tablets.
Each pack contains 1, 3 or 6 blisters, each containing 28 tablets (24 active yellow-pale tablets and 4 placebo white tablets).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156 Milan
Manufacturer
Bayer Weimar GmbH und Co. KG
Doebereinerstrasse 20, 99427 Weimar
Germany
or
Delpharm Lille SAS,
PARC D’ACTIVITÉS Roubaix-Est 22, Rue de Toufflers, CS 50070
59452 Lys-Lez-Lannoy
France