YVETTE 60 MICROGRAMS/15 MICROGRAMS Film-coated tablets

Содержание инструкции

1. Yvette 60 micrograms/15 micrograms film-coated tablets
   1. What is Yvette and what is it 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. Package contents and other information

Yvette 60 micrograms/15 micrograms film-coated tablets

gestodene/ethinylestradiol
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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.

Contents of this leaflet:

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

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 a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”)

1. What is Yvette and what is it used for

• Yvette is a contraceptive “pill” and is 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 active ingredients and are also called placebo tablets.
• Contraceptive pills that contain the two hormones are also called “combined pills”.

2. WHAT YOU NEED TO KNOW BEFORE TAKING YVETTE

General notes
Before starting to use Yvette, read the information on blood clots in paragraph 2.
It is particularly important that you read the symptoms of a blood clot (see paragraph 2
“Blood clots”).
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Before starting treatment with Gestodene/Ethinylestradiol, your doctor will ask you some
questions about the medical history of your health and that of your close relatives. The doctor will
also measure your blood pressure and, depending on your condition, may also
perform some other tests. In some situations, during treatment
with Gestodene/Ethinylestradiol, periodic medical check-ups may be necessary.
Gestodene/Ethinylestradiol, or when the reliability of Gestodene/Ethinylestradiol may be reduced
In these cases, you should avoid sexual intercourse or use other non-hormonal methods of
contraception, such as condoms. Do not use methods based on the cycle or on
temperature: these can fail, due to the fact that Gestodene/Ethinylestradiol alters the
monthly variations in body temperature and cervical mucus.
Like other hormonal contraceptives, Gestodene/Ethinylestradiol does not protect in any way
from HIV (AIDS) infections or other sexually transmitted diseases.

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, see 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 to ethinylestradiol, gestodene or any of the other ingredients of this medicine (listed in paragraph 6).
• if you have (or have ever had) a blood clot in a leg vessel (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or 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 an operation or if you will be bedridden for a long period (see paragraph “Blood clots”);
• if you have ever had a heart attack or a 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 blood clots forming in the arteries: severe diabetes with damage to blood vessels or very high blood pressure or very high levels of fats (cholesterol or triglycerides) in the blood or 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) a benign tumor (called focal nodular hyperplasia or hepatic adenoma) or a malignant liver tumor or if you have recently had a 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 hormone-sensitive cancers of the female reproductive system or if you are suspected of having one of these types of cancer.

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• if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also paragraph Other medicines and Yvette).

Warnings and Precautions
Tell your doctor or pharmacist before taking Yvette
When should you see a doctor?
Seek medical attention urgently

• if you notice possible signs of a blood clot that may indicate you have a blood clot in your leg (deep vein thrombosis), a blood clot in your lung (pulmonary embolism), a heart attack or a stroke (see the following paragraph "Blood clot (thromboembolism)").

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

Tell your doctor if any of the following conditions apply to you.
If this condition appears or worsens while you are using Yvette, you should tell your doctor.

• If the blood test shows that you have a high level of sugar, a high level of cholesterol or a high level of prolactin (a hormone that stimulates the production of milk).
• If you are obese.
• If you have a benign breast tumor or 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 natural 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 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 going to have an operation or if you will be bedridden for a long period (see paragraph 2 "Blood clots").
• If you have just 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 the veins located under 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 birth control pill, you have had a skin disease that has caused itching, red spots and blisters (herpes gestationis).
• If during pregnancy or during the use of another birth control pill, you have had patches of discoloration on your face (chloasma). In this case, avoid direct exposure to the sun while using Gestodene/Ethinylestradiol.

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• 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 disease known as “chorea” characterized by irregular, sudden and involuntary movements. If you suffer from hereditary angioedema, products containing estrogens may induce or worsen the symptoms of angioedema. You should immediately consult a doctor 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 Yvette.

BLOOD CLOTS
The use of a combined hormonal contraceptive like Yvette 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 ATE). Healing from blood clots is not always complete. Rarely, serious long-term effects can occur or, 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
See a doctor immediately if you notice any of the following signs or symptoms.

Do you have any of these signs?What are you likely to 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 that may be felt Deep vein thrombosis

only when standing or walking

• increased warmth in the affected leg
• change in skin color of the leg, such as paleness, redness or bluishness
• sudden shortness of breath or rapid breathing;
• sudden cough without a clear cause, with possible blood emission;
• sharp chest pain that may increase when breathing deeply;
• severe dizziness or lightheadedness;
• fast or irregular heartbeat;
• severe stomach pain Pulmonary embolism

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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 linked to an increased risk of blood clots in the veins (venous thromboembolism). However, these side effects are rare. In most cases, they occur in the first year of use of a combined hormonal contraceptive.

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• 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
start taking 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 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 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.

• 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 Yvette, about 9-12 women will develop a blood clot in a year.
• The risk of forming a blood clot depends on your medical history (see “Factors that increase the risk of forming 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 some conditions increase it.
Your risk is higher:

• if you are strongly overweight (body mass index or BMI greater than 30 kg/m²);

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• if a close relative has had a blood clot in a leg, in the lung or in another 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 have to lie down for a long period due to an injury or illness or if you have a leg in plaster. It may be necessary to stop taking Yvette a few weeks before the operation or during the time when you are less mobile. If you need to stop taking Yvette, 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. Air travel (duration >4 hours) can temporarily increase the risk of blood clot formation, 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 Yvette. If any of the above conditions change while you are using Yvette, for example if a close relative develops thrombosis for no known reason or if you gain a lot of 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 a 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 can increase:

• as you get older (over 35 years);
• if you smoke.When using a combined hormonal contraceptive like Yvette 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 Yvette, for example if
you start smoking, if a close relative develops thrombosis for no known reason or if you gain
a lot of weight, contact your doctor.
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Gestodene/Ethinylestradiol and cancer
Breast cancer is diagnosed slightly more frequently in women who
take "the pill" compared to women of the same age who use other contraceptive systems.
It is not known whether this is attributable to "the pill". The difference may also be due to the fact
that women who take "the pill" undergo more frequent and
thorough medical examinations, and therefore breast cancer is diagnosed earlier.
In women who use combined pills 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 is due 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 disorders
In some women who use hormonal contraceptives including Yvette have reported depression or
low mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you
experience changes in mood and depressive symptoms, seek medical advice as soon as possible
for further medical advice.

Breakthrough bleeding
During the first few months of taking Yvette, unexpected bleeding may occur
(bleeding outside the days you take the placebo tablets). If this
bleeding persists for more than a few months, or if it 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 light yellow-pale active tablets correctly, you have not had vomiting or severe diarrhea
and you have not taken any other medicines, 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 Yvette
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines including herbal products,. They will tell you if you need to
take additional contraceptive measures (for example condoms) and, if so, for
how long.
Some medicines

• may have an influence on the blood levels of Gestodene/Ethinylestradiol
• may make the pill less effective in preventing pregnancy
• may cause unexpected bleeding.

These include:

• medicines for the treatment of:

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or epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine,
topiramate, felbamate)
or tuberculosis (e.g. rifampicin)
or HIV and Hepatitis C infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, indinavir)
fungal infections (e.g. griseofulvin)
or arthritis, osteoarthritis (etoricoxib)
or the herbal remedy of St John's wort, which is used to treat some types of
depression
Yvette can affect the effectof other medicines, e.g.:

• cyclosporine
• theophylline
• tizanidine
• lamotrigine. Troleandomycin may increase the risk of cholestasis (retention of bile in the liver) during concomitant administration with COCs.

Do not use Yvette if you have Hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause an increase in blood test results of liver function (increased transaminases, ALT, liver enzymes).
Your doctor will prescribe you another type of contraceptive before starting treatment with
these medicines.
Yvette can be restarted about 2 weeks after the end of treatment.
See section “Do not use Yvette”.

Ask your doctor or pharmacist for advice before taking any medicine.

Laboratory tests
If you need a blood test, tell your doctor or laboratory staff that you
are taking the pill, as hormonal contraceptives can affect the results of some tests.

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

Driving and operating machinery
Yvette has no or negligible effect on the ability to drive or operate machinery.

Yvette contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine

3. How to take Yvette

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Always take this medicine exactly as your doctor has told you. If you are unsure
ask your doctor or pharmacist.
Always take the tablets at the same time of day. Take one light yellow tablet
on each of the first 24 days. Then continue with one white tablet on each of the
last 4 days. There is no interval between two blisters. To respect the correct sequence, follow the
direction indicated by the arrows on the blister.
Your withdrawal bleeding (period) usually occurs on the 2nd or 3rd day after you have taken
the last light yellow tablet.
Start taking the light yellow tablets from the next blister immediately after you have taken
the last white tablet, regardless of whether your monthly period has finished or not.
This means you will always start the new blister on the same day of the week and have your
period around the same day each month.

Starting to take Yvette from the first blister

• If you have not taken any contraceptive “pill” in the last month: start taking Yvette on the first day of your period, that is, the first day of your monthly bleeding.
• Switching from another combined hormonal contraceptive (contraceptive “pill”, vaginal ring or transdermal patch): start taking Yvette the day after you have taken the last tablet containing the active ingredient of the previous contraceptive, in any case within 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 a transdermal patch, it is preferable to start on the day of removal, in any case within the day for which the next application would have been scheduled.
• Switching from a progestin-only contraceptive (“progestin-only pill”, injection, implant or a progesterone-releasing intrauterine system [IUS]): you can switch from a progestin-only contraceptive (from an implant or coil on the day of its removal, from an injectable system on the day for which the next injection would have been scheduled) to Yvette at any time, but in all these cases you must use additional protective measures (e.g. condoms) for the first 7 days of taking the tablet.
• After childbirth: you can start Yvette between 21 and 28 days after delivery. If you start after 28 days, you must use a so-called “barrier” method (e.g. condoms) during the first 7 days of using Yvette. If you have had intercourse after delivery before starting (again) Yvette, you must first make sure you are not pregnant or wait for your next menstrual period.
• 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. Even girls who have not had their first period and have
accidentally taken this medicine may experience similar bleeding. If you have
taken too much, consult a doctor who is able to 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 has no effect on the effectiveness of Yvette. However, the interval between the last
light yellow tablet of the blister in use and the first light yellow tablet
of the next blister must not exceed 4 days.
Light yellow tablets
If you forget a light yellow tablet (numbered 1 to 24 on the blister), you must do
the following:

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

If your regular period does not occur at the end of the second blister, you may be pregnant.
Consult your doctor before starting to take the tablets from a new blister.

In case of severe vomiting or diarrhoea
Vomiting or severe diarrhoea within the first 4 hours after taking the tablet is
comparable to forgetting a tablet. In this case, take another
tablet from a reserve pack immediately. If you are unable to take the reserve tablet
within 12 hours of the usual time of taking, follow the instructions given in
paragraph 3, “If you forget to take Yvette”.
If you have any questions about using this medicine, ask 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 severe or persistent, or
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if any change in your health occurs that you think could be due to Yvette,
inform your doctor.
A higher 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 using Yvette”

Other serious side effects
Signs of a serious allergic reaction or worsening of hereditary angioedema:

• swellingof the hands, face, lips, mouth, tongue or throat. Swollen tongue/throat can lead to difficulty swallowing and breathing
• a skin rash with wheals (urticaria) and itching.

The signs of breast cancer include:

• lumpin the skin
• changes in the nipple
• any lumpsthat can be seen or felt.

The signs of cervical cancer include:

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

If you think you have any of these signs, seek medical attention 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 breakthrough bleeding

Common,may affect up to 1 in 10 people

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

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• nausea, vomiting, abdominal pain
• acne
• breast pain
• breast tension
• breast enlargement
• breast secretion
• menstrual pain
• changes in the intensity of menstrual bleeding
• changes in vaginal secretions
• eversion (prolapse) of the cervical mucosa
• absence of menstrual bleeding during treatment or when it is stopped
• fluid retention in the tissues
• weight changes

Uncommon,may affect up to 1 in 100 people

• changes in appetite
• abdominal cramps, flatulence
• skin rash, pigmented spots of brownish-yellow color on the face (chloasma)
• hair loss
• increased body hair
• elevated 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 an artery, for example: in a leg or foot (DVT) or in the 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 chance 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)
• colestatic jaundice (abnormal bile flow in the liver causing yellowing of the skin) erythema nodosum
• reduction of vitamin in the blood (folate)

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

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

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• worsening of varicose veins enlarged and twisted veins (varicose veins)
• pancreas disorders
• inflammation of the large intestine due to insufficient blood supply (ischemic colitis)
• skin redness with blisters and nodules (erythema multiforme)
• specific blood disorder that causes kidney damage (hemolytic uremic syndrome)
• worsening of St. Vitus' dance (Sydenham's chorea)

Not known:frequency cannot be estimated based on available data

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the package and on the blister,
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient)
The active ingredientsare ethinylestradioland gestodene.
Each tablet contains:
0.015 milligrams (15 micrograms) of ethinylestradiol and
0.06 milligrams (60 micrograms) of gestodene
The excipients are as follows.
lactose monohydrate, magnesium stearate corn starch, povidone K 25.
hypromellose, polyethylene glycol, titanium dioxide (E171), yellow iron oxide (E172).
White film-coated tablets (placebo)
The excipients are:
lactose monohydrate, magnesium stearate corn starch, povidone K 25.
hypromellose, polyethylene glycol, titanium dioxide (E171).
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Description of the appearance of Yvette and package contents
The active film-coated tablets are light yellow in color, round, film-coated and
rounded on the upper and lower sides.
The placebo tablets are white in color, round, film-coated and rounded on the upper
and lower sides.
The film-coated tablets are packaged in PVDC (PVC / PE / PVDC) /
aluminum blisters and inserted into a carton.
Packs:
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).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturers

Marketing authorization holder
Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturer
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 Member States of the European Economic Area with the
following denominations:
France Gestodene Ethinylestradiol Sandoz 60 micrograms/15 micrograms coated tablet
Germany Alessia HEXA 0.06 mg/0.015 mg filmtablets
Italy Yvette
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