Yvette

Patient information leaflet

Yvette 60 micrograms/15 micrograms film-coated tablets

gestodene/ethinylestradiol
Equivalent medicine
Please 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, consult 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, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception 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”).

1. What Yvette is and what it is used for

• Yvette is a contraceptive "pill" used to prevent pregnancy.
• Each light yellow tablet contains a small amount of two different female hormones, namely gestodene and ethinylestradiol.
• The white tablets do not contain any active ingredients and are also called placebo tablets.
• Contraceptive pills containing the two hormones are also referred to as "combined pills".

2. WHAT YOU SHOULD KNOW BEFORE TAKING YVETTE

General Notes
Before starting Yvette, 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”).
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Before starting treatment with Gestodene/Ethinylestradiol, your doctor will ask you some questions about your medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your condition, may carry out additional examinations. During treatment with Gestodene/Ethinylestradiol, periodic medical check-ups may be necessary in certain situations.
This patient leaflet describes circumstances under which you must stop using Gestodene/Ethinylestradiol, or when the effectiveness of Gestodene/Ethinylestradiol may be reduced. In these cases, you must avoid sexual intercourse or use other non-hormonal contraceptive methods, such as condoms. Do not use fertility awareness-based methods or temperature-based methods: these may fail because Gestodene/Ethinylestradiol alters the monthly fluctuations in body temperature and cervical mucus.
Like other hormonal contraceptives, Gestodene/Ethinylestradiol does not protect against HIV (AIDS) or other sexually transmitted infections.

Do not use Yvette
Do not use Yvette 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 to ethinylestradiol, gestodene, or any of the other ingredients of this medicine (listed in section 6);
• if you have (or have ever had) a blood clot in a vein of your 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 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 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 ischemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which could increase the risk of developing clots in the arteries:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fats (cholesterol or triglycerides) in the blood,
  • a condition known as hyperhomocysteinemia;
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have ever had) a benign liver tumor (called focal nodular hyperplasia or hepatic adenoma) or a malignant liver tumor, or if you have recently had liver disease. In such cases, your doctor will ask you to stop taking the tablets until your liver functions normally;
• if you have vaginal bleeding of unknown cause;
• if you have breast cancer, uterine cancer, or any cancer sensitive to female sex hormones, or if such cancers are suspected;
• if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other Medicines and Yvette”).

Warnings and Precautions
Inform your doctor or pharmacist before taking Yvette.

When should you contact a doctor?
Contact a doctor urgently:

• if you notice signs suggestive of a blood clot, which may indicate you are suffering from a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), heart attack, or stroke (see the following section “Blood Clot (Thrombosis)”).

For a description of the symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions appear or worsen while you are using Yvette, inform your doctor.

• If blood tests show 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 tumor or a close relative who has had breast cancer;
• if you have 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 defense system);
• if you have hemolytic uremic syndrome (HUS – a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disorder);
• if you have high levels of fat 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 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 Yvette;
• 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 suffered from a condition with a tendency to develop blood clots (in 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 pregnancy or while using another contraceptive pill, you developed a skin condition causing itching, red spots, and blisters (herpes gestationis);
• if during pregnancy or while using another contraceptive pill, you developed facial skin discoloration (chloasma). In this case, avoid direct sun exposure while using Gestodene/Ethinylestradiol;
• if you have 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 condition known as “chorea”, characterized by irregular, sudden, and involuntary movements;
• if you suffer from hereditary angioedema, estrogen-containing products may trigger or worsen angioedema symptoms. You must consult 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 breathing difficulties.

Do not hesitate to ask your doctor or pharmacist for advice if you have any doubts about using Yvette.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Yvette 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, such effects can be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with Yvette is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.

Do you have any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or 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 color of the leg, such as paleness, redness, or bluish discoloration;
• sudden and 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

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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 the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.

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• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of
taking a combined hormonal contraceptive for the first time. The risk may also
be higher if you restart taking a combined hormonal contraceptive (the same drug
or a different one) 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 Yvette, 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 (venous thromboembolism) 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
Yvette 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 gestodene, such as Yvette, approximately 9 to 12 women will develop a blood clot in one year.
• The likelihood 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 Yvette is low, but certain conditions can increase it. 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 (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Yvette several weeks before surgery or during periods of reduced mobility. If you stop taking Yvette, 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.

Your risk of developing a blood clot increases if you have more than one of these conditions. Air travel (lasting >4 hours) may temporarily increase the risk of blood clots, 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 uncertain. Your doctor may decide to have you stop taking Yvette. If any of the above conditions change while you are using Yvette—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 Yvette is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Yvette, 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 Yvette—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.
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Gestodene/Ethinylestradiol and cancer
Breast cancer is diagnosed slightly more frequently in women taking "the pill" compared to women of the same age using other contraceptive methods. It is not known whether this is due to "the pill." The difference may also be due to the fact that women taking "the pill" undergo more frequent and thorough medical check-ups, leading to earlier diagnosis of breast cancer.
In women who use combined oral contraceptives for a relatively long time, studies have reported cases of cervical cancer. Currently, it is not known whether this is caused by the pill or due to sexual behavior (e.g., more frequent partner changes) and other factors.
In rare cases, benign liver tumors have been reported in women using the pill, and even more rarely, malignant liver tumors. If you experience unusually severe abdominal pain, contact your doctor.

Psychiatric disorders
Depression or depressed mood has been reported in some women using hormonal contraceptives, including Yvette. 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 Yvette, unexpected bleeding (bleeding outside the days when you take the placebo tablets) may occur. If this 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 active pale-yellow tablets correctly, have not vomited or had severe diarrhea, and have not taken any other medicines, 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 Yvette
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal products. They will advise you whether you need to use additional contraceptive measures (e.g., condoms) and, if so, for how long.
Some medicines:

• may affect blood levels of Gestodene/Ethinylestradiol;
• may make the pill less effective in preventing pregnancy;
• may cause unexpected bleeding.

These include medicines used to treat:

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o epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine,
topiramate, felbamate)
o tuberculosis (e.g., rifampicin)
o HIV and hepatitis C infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, indinavir)
o fungal infections (e.g., griseofulvin)
o arthritis, osteoarthritis (etoricoxib)
o St. John’s wort, a herbal remedy used to treat certain types of depression

Yvette may affect the effect of other medicines, for example:

• cyclosporine
• theophylline
• tizanidine
• lamotrigine

Troleandomycin may increase the risk of intrahepatic cholestasis (bile retention in the liver) during concomitant administration with COCs.

Do not use Yvette if you have hepatitis C and are taking medications containing
ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause an increase in liver function blood test results (elevated transaminases, ALT, liver enzymes).
Your doctor will prescribe another type of contraceptive before you start treatment with these medications.
Yvette may be restarted approximately 2 weeks after completion of treatment.
See section “Do not use Yvette.”
Ask your doctor or pharmacist for advice before taking any medicine.

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

Pregnancy and breastfeeding
If you are pregnant or think you might be, if you are breastfeeding, or if you are planning a pregnancy, consult your doctor or pharmacist before taking this medicine. You must not use Gestodene/Ethinylestradiol if you are pregnant or suspect you may be pregnant. If pregnancy occurs while taking Yvette, you must stop taking the medicine immediately and consult your doctor.

Driving and using machines
Yvette has no or negligible effect on the ability to drive or use machinery.

Yvette contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Yvette

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Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Take the tablets at the same time each day. Take one light yellow tablet for each of the first 24 days, followed by one white tablet for each of the last 4 days. There is no break between two blister packs. To ensure correct sequence, follow the direction indicated by the arrows on the blister.
Your withdrawal bleed usually occurs on the 2nd or 3rd day after taking the last light yellow tablet.
Start taking the light yellow tablets from the next blister pack immediately after taking the last white tablet, regardless of whether your menstrual period has ended.
This means you will always start the new blister pack on the same day of the week and have your period approximately on the same days each month.

Starting with the first blister pack

• If you have not taken any contraceptive pill in the previous month: start taking Yvette on the first day of your cycle, i.e. the first day of menstrual bleeding.
• Switching from another combined hormonal contraceptive (combined oral contraceptive pill, vaginal ring, or transdermal patch): start taking Yvette the day after taking the last active tablet of your previous contraceptive, but in any case no later than the day after the end of the pill-free interval of the previous contraceptive (or after the last inactive tablet of the previous contraceptive). When switching from a vaginal ring or transdermal patch, it is preferable to start on the day of removal, but in any case no later than the day the next application would have been due.
• Switching from a progestogen-only contraceptive (progestogen-only pill, injection, implant, or intrauterine system releasing progesterone [IUS]): you may switch to Yvette on any day from a progestogen-only contraceptive (from an implant or IUD on the day of removal, from an injectable system on the day the next injection would have been due). However, in all these cases, you must use additional contraceptive precautions (e.g. condoms) for the first 7 days of tablet intake.
• After childbirth: you may start Yvette between day 21 and 28 after delivery. If you start later than day 28, you must use a so-called “barrier method” (e.g. condoms) during the first 7 days of taking Yvette. If you have had sexual intercourse after childbirth before starting (again) Yvette, you must first ensure that you are not pregnant or wait for your next menstrual cycle.
• After an abortion: consult your doctor.

If you take more Yvette than you should
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The following symptoms may occur: nausea, vomiting, breast tenderness, vaginal bleeding. Girls who have not yet had their first menstruation and who have accidentally taken this medicine may also experience similar bleeding. If you have taken an excessive amount, consult a doctor who can treat the symptoms.

If you forget to take Yvette
White tablets
The last 4 tablets in the blister are placebo tablets. Forgetting one of these white tablets does not affect the efficacy of Yvette. However, the interval between the last light yellow tablet of the current blister pack and the first light yellow tablet of the next blister pack must not exceed 4 days.

Light yellow tablets
If you forget a light yellow tablet (numbered 1 to 24 on the blister), do the following:

• If you remember within 12 hours of your usual intake time: the contraceptive effect of Yvette is still reliable. Take the missed tablet immediately and continue taking the next tablet at your usual time.
• If you remember more than 12 hours after your usual intake time: the contraceptive effect can no longer be guaranteed. Take the missed tablet immediately, even if this means taking two tablets at once. You may continue taking the next tablet at your usual time, but you must use a supplementary contraceptive method (e.g. condoms) for the next 7 days. If this 7-day period extends beyond the last light yellow tablet, skip the white tablets and start the new blister pack the day after taking the last light yellow tablet of the current pack. You may not have your usual withdrawal bleed, but spotting or breakthrough bleeding may occur during intake of the tablets from the next blister pack. If you miss a tablet during the first week of the current pack and have had sexual intercourse in the 7 days before the missed tablet, there is a risk of pregnancy. If this is the case, inform your doctor immediately.

If your regular menstrual period does not occur after completion of the second blister pack, you may be pregnant.
Consult your doctor before starting tablets from a new blister pack.

In case of vomiting or severe diarrhoea
Vomiting or severe diarrhoea within 4 hours after taking a tablet is equivalent to missing a tablet. In this case, take another tablet immediately from a reserve pack. If you are unable to take the replacement tablet within 12 hours of your usual intake time, follow the instructions in section 3, “If you forget to take Yvette”.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Yvette can cause side effects, although not everybody gets them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think may be due to Yvette, 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 Yvette”.

Other serious side effects

Signs of a severe allergic reaction or worsening of hereditary angioedema:

• swelling of the hands, face, lips, mouth, tongue or throat. Swelling of the tongue/throat may lead to difficulty swallowing and breathing
• skin rash with hives (urticaria) and itching.

Signs of breast cancer include:

• bumpy skin
• changes in the nipple
• any lumps that can be seen or felt.

Signs of cervical cancer include:

• vaginal discharge that smells and/or contains blood
• unusual vaginal bleeding
• pelvic pain
• painful intercourse. Signs of serious liver problems include:
• severe pain in the upper abdomen
• yellowing of the skin or eyes (jaundice)
• inflammation of the liver (hepatitis)
• itching throughout the body.

If you think you have any of these signs, seek medical advice immediately.
You may need to stop taking Yvette.

Other potential side effects

Very common, may affect more than 1 in 10 people

• headache, including migraine
• spotting and intermenstrual bleeding

Common, may affect up to 1 in 10 people

• vaginal inflammation, including fungal infection (candidiasis)
• mood changes, including depression and changes in sexual desire (libido)
• nervousness, dizziness

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• nausea, vomiting, abdominal pain
• acne
• breast pain
• breast tenderness
• breast enlargement
• breast discharge
• menstrual cramps
• changes in the intensity of menstrual bleeding
• changes in vaginal discharge
• abnormal eversion of the cervical mucosa (ectropion)
• absence of menstrual bleeding during treatment or after discontinuation
• fluid retention in tissues
• weight changes

Uncommon, may affect up to 1 in 100 people

• changes in appetite
• abdominal cramps, flatulence
• skin rash, pigmented brownish-yellow spots on the face (chloasma)
• hair loss
• increased body hair
• high blood pressure
• changes in blood lipid values

Rare, may affect up to 1 in 1,000 people

• increased blood glucose level (glucose intolerance)
• eye irritation when wearing contact lenses
• 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 symptoms similar to stroke, known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestines, kidneys or eye. The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot)
• cholestatic jaundice (abnormal bile flow in the liver causing yellowing of the skin)
• erythema nodosum
• decreased vitamin levels in the blood (folate)

Very rare, may affect up to 1 in 10,000 users

• hepatic adenomas (benign liver tumours)
• hepatocellular carcinomas (liver cancer)
• worsening of a certain autoimmune disease (systemic lupus erythematosus)
• worsening of a metabolic disease porphyria affecting blood pigments
• visual disturbances

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• worsening of varicose veins (enlarged and twisted veins)
• pancreatic disorders
• inflammation of the large intestine due to insufficient blood supply (ischaemic colitis)
• skin redness with blister and nodule formation (erythema multiforme)
• specific blood disorder causing kidney damage (haemolytic-uraemic syndrome)
• worsening of Sydenham's chorea (St. Vitus' dance)

Not known: frequency cannot be estimated from the available data

• inflammation of the intestine (inflammatory bowel disease)
• liver problems (inflammation or abnormal function)

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/segnalazione-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Yvette

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister,
after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
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 Yvette contains
Light yellow film-coated tablets (containing the active substances)
The active substances are ethinylestradiol and gestodene.
Each tablet contains:
0.015 milligrams (15 micrograms) of ethinylestradiol and
0.06 milligrams (60 micrograms) of gestodene.
The excipients are the following:
monohydrate lactose, magnesium stearate, maize starch, povidone K 25,
hypromellose, polyethylene glycol, titanium dioxide (E171), yellow iron oxide (E172).

White film-coated tablets (placebo)
The excipients are:
monohydrate lactose, magnesium stearate, maize starch, povidone K 25,
hypromellose, polyethylene glycol, titanium dioxide (E171).
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Description of the appearance of Yvette and the package contents
The active film-coated tablets are light yellow, round, film-coated and rounded on both upper and lower sides.
The placebo tablets are white, round, film-coated and rounded on both upper and lower sides.
The film-coated tablets are packaged in PVDC (PVC/PE/PVDC)/aluminum blisters and placed in a cardboard box.

Pack sizes:
1 x 28, 3 x 28 and 6 x 28 film-coated tablets.
One blister contains 24 light yellow film-coated tablets (active tablets) and 4 white film-coated tablets (placebo tablets).
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers
Salutas Pharma GmbH, Otto-von-Guericke Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names:
France: Gestodene Etinilestradiolo Sandoz 60 microgrammes/15 microgrammes comprimé pelliculé
Germany: Alessia HEXA 0.06 mg/0.015 mg filmtabletten
Italy: Yvette
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