JADIZA 100 MICROGRAMMI/20 MICROGRAMMI Film-coated tablets

Содержание инструкции

1. Cos'è Jadiza e a cosa serve
2. Cosa deve sapere prima di prendere Jadiza
3. How to take Jadiza
4. Possible side effects
5. How to store Jadiza
6. Package Contents and Other Information

Jadiza 100 micrograms/20 micrograms film-coated tablets
levonorgestrel/ethinylestradiol
Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. Cos'è Jadiza e a cosa serve

Jadiza is a combined oral contraceptive for the prevention of pregnancy. It contains two different female hormones
levonorgestrel and ethinylestradiol.
Each of the 21 round, pink tablets contains 100 micrograms of levonorgestrel and 20
micrograms of ethinylestradiol. The package also contains 7 inactive (placebo) white tablets.

2. Cosa deve sapere prima di prendere Jadiza

Before starting to take Jadiza, your doctor will ask you some questions about your personal medical history and
that of your close relatives. The doctor will also measure your blood pressure and may perform some
tests.
This leaflet describes some situations in which you should stop using Jadiza or in which
the reliability of Jadiza may be reduced and there is an increased risk of pregnancy. In these situations you should not
have sexual intercourse or you should take additional non-hormonal contraceptive precautions (e.g. use of
condoms or other barrier method). Do not use rhythm or temperature methods. These methods may
become unreliable because Jadiza alters the monthly changes in body temperature and cervical mucus.

As with other oral contraceptives, Jadiza does not protect against infection with HIV (AIDS) or any other
sexually transmitted disease.
Do not take Jadiza:

• if you are allergic to levonorgestrel, ethinylestradiol or any of the other ingredients of this medicine (listed in section 6)
• if you have or have ever had heart disease or blood vessel disease, in particular: a heart attack (myocardial infarction), an irregular heartbeat or a heart valve disorder
• a blood clot, including in the legs (deep vein thrombosis) or in the lung (pulmonary embolism) or a ruptured blood vessel in the brain (stroke), a “mini-stroke” or a general tendency to develop blood clots (venous or arterial thrombosis)
• chest pain caused by angina pectoris
• if you have high blood pressure that is not controlled by treatment
• if you suffer from certain types of migraine (migraine with neurological symptoms)
• if you have breast cancer, uterine cancer or a type of cancer that is sensitive to female hormones, or if you suspect you have any of these types of cancer
• if you have vaginal bleeding for unknown reasons
• if you have high blood sugar levels (diabetes) associated with a blood vessel disease
• if you are pregnant or suspect you may be pregnant
• if you have or have had a benign or malignant liver tumor, or if you have recently had a liver disease. In these cases, your doctor will ask you to stop taking Jadiza until your liver returns to functioning properly
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasavir and sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other medicines and Jadiza”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Jadiza.
In some situations, you may need to take special care when taking Jadiza or other
oral contraceptives. Your doctor will perform regular check-ups. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels with the use of oral contraceptives. The risk increases with age and depending on how much you smoke, and is quite pronounced in women over 35 years of age. Women who use combined oral contraceptives should not smoke. For women over 35 who smoke, other methods of contraception should be considered.
If you have any of the following conditions, you should tell your doctor before starting to take Jadiza.
If any of the conditions listed below develops or worsens while you are taking Jadiza, you should
consult your doctor so that they can decide if Jadiza is suitable for you.
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Talk to your doctor if you have any of the following conditions
If any of the following conditions develops or worsens while you are taking Jadiza you should consult a doctor

• If you have high blood pressure
• If you have high cholesterol levels or abnormal lipid (fat) levels in the blood (dyslipoproteinemia) - this is seen in blood tests
• You are obese
• You have diabetes
• You have a heart valve disease or an irregular heartbeat (atrial fibrillation)
• You or a close relative (parent, brother or sister) have suffered from a disease with a tendency to develop blood clots (in the legs, lungs or other parts of the body) or have a history of heart attack or stroke
• You have varicose veins or have suffered from inflammation of the superficial veins in the legs
• You experience any unexplained changes in vision
• You have gallstones, a gallbladder disease or have problems caused by a blockage of the bile ducts (cholestasis) - this can cause intense itching
• You develop migraine for the first time or suffer from a worsening of existing headache migraines
• You have or develop a liver disease, jaundice, inflamed pancreas or kidney disease
• You suffer from depression
• You have hearing loss due to a condition known as otosclerosis
• You have had during pregnancy or during the use of another contraceptive pill a skin condition that causes itching, red spots and blisters (herpes gestationis)
• If you have had temporary brown spots on the skin during pregnancy (chloasma). The pill can cause them to return, so you should avoid strong sunlight or tanning beds while taking Jadiza.
• You suffer from a disorder that affects your immune system (systemic lupus erythematosus)
• You suffer from a disease known as Sydenham's chorea. Symptoms include involuntary, irregular and sudden movements
• If you have had a blood disease associated with kidney disease (hemolytic uremic syndrome)
• If you have had a blood disease called porphyria
• If you have ulcerative colitis or Crohn's disease (inflammation of the intestine that causes abdominal pain, frequent diarrhea and fatigue)
• If you have sickle cell anemia
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficultyswallowing or hives with potential breathing difficulties, contact your doctor immediately.Products containing estrogens can cause or worsen the symptoms of hereditary andacquired angioedema.

Psychiatric disorders
Some women using hormonal contraceptives including Jadiza have reported depression or depressed mood.
Depression can be severe and sometimes can lead to suicidal thoughts. If you experience mood changes
and depressive symptoms, see your doctor as soon as possible for further medical advice.
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Jadiza and thrombosis (blood clots)
Venous thrombosis (blood clots)
The use of any combined pill, including Jadiza, increases the risk for the woman of developing a venous thrombosis (formation of a blood clot in the blood vessels) compared to a woman who does not take pills
(contraceptives).
The risk of venous thrombosis in users of combined pills increases:

• With increasing age
• If you are overweight
• If a close relative has developed a blood clot in a blood vessel at a young age
• With prolonged immobilization (e.g. if you have a cast or splint on one or both legs), major surgery, any type of leg surgery, major trauma. In these situations it is best to stop taking Jadiza (if the surgery is planned you should stop at least 4 weeks before) and you should not restart taking it until two weeks after resuming normal walking
• Immediately after childbirth, women are at increased risk of blood clots, so you should ask your doctor how long after childbirth you can start taking the combined pill

Arterial thrombosis (blood clots)
The use of combined pills has been linked to an increased risk of arterial thrombosis (blockage of
an artery), for example in the blood vessels of the heart (heart attack) or the brain (stroke).
The risk of arterial thrombosis in users of combined pills increases:

• If you smoke. It is strongly recommended to stop smoking when using Jadiza, especially if you are over35 years old
• With increasing age even if you do not smoke
• If you have increased fat levels in the blood (cholesterol or triglycerides).
• If you are overweight.
• If a close relative has had a heart attack or stroke at a young age
• If you have high blood pressure
• If you suffer from migraine.
• If you have heart problems (valve disorders, or an irregular heartbeat).

Stop taking Jadiza and contact your doctor immediately or go to the nearest hospital emergency room
if you experience possible signs of thrombosis, such as:

• Any unusual, severe or prolonged headache or a more frequent or severe migraine
• An increase in blood pressure
• Severe pain and/or swelling in a leg
• Sudden severe chest pain that may radiate to the left arm
• Difficulty breathing, sudden shortness of breath 4/12
• Sudden unusual cough with no apparent cause
• Changes in vision, partial or total blindness or double vision
• Difficulty or inability to speak
• Sudden changes in hearing, smell or taste
• Dizziness or fainting
• Weakness, unusual sensations or numbness of any part of the body
• Severe and sudden abdominal pain

Jadiza and cancer
Breast cancer has been found slightly more often in women who use combined pills, but it is not known if
this is caused by the pill. It is possible that these women are simply visited more carefully and more
frequently, and that therefore cancer is found earlier.
In women who use combined pills for a relatively long period, studies have reported cases of
cervical cancer. It is currently not known whether this is caused by the pill or related to sexual behavior
(e.g. more frequent partner changes) and other factors.
In rare cases, benign liver tumors have been reported, and even rarer cases of malignant liver tumors in
users of the pill. Contact your doctor if you have unusually severe abdominal pain.

Bleeding between two cycles
During the first two months of taking Jadiza, you may experience unexpected bleeding (bleeding or
spotting outside the week of taking the inactive (placebo) tablets). If this bleeding
lasts longer than a few months, or starts after a few months, your doctor should investigate the cause.

What to do if no bleeding occurs in the last week of taking the tablets
(white tablets)
If you have taken all the tablets correctly, you have not had vomiting or severe diarrhea and you have not taken other
medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive times, you may be pregnant. Contact
your doctor immediately. Do not start the next blister pack until you are sure you are not pregnant.

Other medicines and Jadiza
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
There are some medicines that can interact with Jadiza.
Medicines can sometimes interfere with each other. If you are receiving treatment from any other doctor, nurse or qualified healthcare professional, make sure they are informed that you are using Jadiza as a contraceptive. They can advise you if you need to take additional precautions (e.g. using a condom or another barrier contraceptive) when taking other medicines while taking Jadiza.
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Some medicines can make Jadiza less effective at preventing pregnancy or can cause unexpected bleeding. These include medicines used for the treatment of:

• HIV infections (ritonavir, nevirapine)
• Epilepsy (e.g. phenobarbital, phenytoin, primidone, felbamate, carbamazepine, oxcarbazepine or topiramate)
• Infections (e.g. rifabutin, rifampicin or griseofulvin)
• Sleep disorders (modafinil)
• Gout (phenylbutazone)
• The herbal remedy St John's Wort ( Hypericum perforatum) which is used to treat certain types of depression

If you have been told to take additional contraceptive precautions while taking any of the following medicines, follow your doctor's instructions carefully. If you need to take the medicine beyond the end of the pink tablets of the current pack, skip the white tablets and start the next pack directly.
In some cases, you may need to continue using additional barrier contraception for several weeks after stopping the medicine.
Jadiza can interfere with the following medicines:

• Cyclosporine (to reduce the body's immune response)
• Lamotrigine (for epilepsy)

Taking an antibiotic medicine called troleandomycin can increase the risk of cholestasis (bile retention in the liver) while taking the combined pill.
Taking a medicine called flunarizine used for the prevention of migraine can increase the risk of galactorrhea. This is a condition in which the breasts spontaneously secrete milk when you are not breastfeeding or have not recently had a baby.
Do not use Jadiza if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir, as these products can cause increases in blood test results on liver function (increased liver enzyme ALT).
Your doctor will prescribe you another type of contraception before starting treatment with these medicines.
Jadiza can be resumed approximately 2 weeks after completion of this treatment. See the paragraph “Do not use Jadiza”.

Pregnancy and breastfeeding
Pregnancy
Do not take Jadiza if you are pregnant. If you suspect you are pregnant while taking Jadiza, tell your doctor immediately.
Breastfeeding
The combined pill is not recommended during breastfeeding as hormones can have effects on breast milk. If you wish to breastfeed, your doctor will be able to advise you on suitable alternative methods of contraception.
Always ask your doctor, pharmacist or healthcare professional for advice before taking any medicine.

Driving and using machines
The effects of Jadiza on the ability to drive or operate machines have not been studied. Dizziness has been reported as an undesirable effect. If you experience dizziness, do not drive or operate machines until it has resolved.

Jadiza contains lactose.
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Jadiza

Take this medicine always exactly as your doctor or pharmacist has told you. If you have doubts
consult your doctor or pharmacist.
The Jadiza blister contains 28 tablets (21 pink tablets and 7 white tablets). Take the first
pink tablet from the first blister under the number “1”. Take the tablets every day, following the order
shown by the arrows. You must take one pink tablet every day for 21 days followed by the white
tablets for 7 days.
Inside the package there is an adhesive sheet containing the days of the week. This can be
applied on the day of the week on which the blister started. For example, if you start taking the tablets
on Thursday, then select the adhesive strip starting from “THU” and apply it on the top of the first
row of the blister where it is written: “Position the adhesive strip so that it coincides with the start date”.
Take the tablets with water if necessary, at the same time each day until the package is finished.
Then you will start the next package of tablets the day after finishing the last one. Start the next
package always on the same day of the week.
During the week of taking the white tablets you will have bleeding similar to a period. This
bleeding will usually last for two or three days and may not have finished before starting the next
package of tablets.

If this is the first time you start the pill or you have not used a hormonal contraceptive in the month
preceding
Take the first tablet on the first day of your period.
Starting after the first day of your period (from the 2nd to the 5th day of your period) will mean you have to use an additional barrier contraceptive (e.g. a condom) for the first 7 days.

If you are switching from another combined contraceptive pill
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Switching from pills in 21-tablet packs
Finish the current pill pack before starting Jadiza the next day without a break.

Switching from “everyday” pills in 28-tablet packs
If your current pill contains inactive tablets (placebo tablets), do not take them and start Jadiza immediately
the next day.

If you are switching from a progestin-only pill, an injectable method or an implant

• When switching from a progestin-only pill, you can start Jadiza at any time during your menstrual cycle, the day after stopping the progestin-only pill.
• When switching from an implant, start Jadiza on the day the implant is removed
• When switching from an injectable contraceptive start Jadiza on the day your injection was due.

In all cases you must use a barrier contraceptive method for the first 7 days of taking the
pill.
If you are starting Jadiza after an abortion that occurred during the first trimester (three months) of
pregnancy
You can start taking Jadiza immediately but you must follow your doctor's advice before doing so. No
additional barrier contraception is necessary.

If you are starting Jadiza after childbirth or after an abortion that occurred during the second trimester.
As with any other contraceptive pill, Jadiza should not be started less than 28 days after childbirth or
after a second trimester abortion, as you are at a higher risk of blood clots. If you start
later, the use of a barrier contraceptive method (such as a condom) is recommended during the first seven
days of taking Jadiza. If you have had sexual intercourse before starting Jadiza, make sure you are not
pregnant and wait until your next period.
Always ask your doctor for advice if you are unsure.

If you forget to take Jadiza
If you forget to take a pink tablet there is a risk that you may become pregnant
If you realise you have missed a pink tablet within 12 hours of the time you usually take the tablet,
take the missed dose immediately and continue normally, taking the next tablet at the usual
time until the end of the blister pack.

If you realise you have missed the pink tablet more than 12 hours after the time you usually take it, there is
a risk that you may become pregnant.
In this case:

• Take the last missed tablet immediately, even if this means taking 2 tablets on the 8/12

same day

• Continue taking the tablets until the end of the blister pack
• In addition, use a barrier method of contraception (e.g. a condom) for the next 7 days
• If this 7-day period extends beyond the last pink tablet, start the next blister pack without taking the inactive white tablets. You may have some spotting or bleeding during the second pack, but there is no need to worry.

If you have forgotten one or more pink tablets in a blister pack and have no bleeding in the
week when you take the white tablets, you may be pregnant and should ask your doctor for advice.
If you skip a whitetablet, you do not need to do anything as long as you start the next pack on the
usual day.

If you vomit or have diarrhoea
Severe vomiting or diarrhoea within 4 hours of taking the pill is similar to when you forget a
pink tablet. After vomiting or diarrhoea, you must take another pink tablet from the reserve blister pack
as soon as possible. If possible, take it within 12 hours of when you usually take the pill. If this is not possible or
more than 12 hours have passed, you must follow the advice given above in the paragraph “ If you realise you have skipped the
pink tablet more than 12 hours after the time you usually take it”
If these episodes of severe vomiting or diarrhoea recur over several days, you should use a barrier method of
contraception (e.g. a condom) until the start of the next blister pack. Ask
your doctor for advice.
If you vomit or have diarrhoea while taking the whitetablets, you do not need to do anything as long as the vomiting
or diarrhoea has stopped by the time you start the next pack and you start the next
pack on the usual day.

How to delay your period
You can delay your period by starting another pack of Jadiza directly without taking the white
tablets. You may have some spotting or bleeding during the second pack,
but there is no need to worry. You will have a normal bleed after finishing the
pink tablets of the second pack.

If you take more Jadiza than you should
If you accidentally take more Jadiza than you should, you may experience some symptoms including
gastrointestinal problems (e.g. nausea, vomiting, abdominal pain), breast tenderness, dizziness,
sleepiness/fatigue and vaginal bleeding. These symptoms will naturally decrease as your
body processes the excess hormones.
If you are worried, ask your doctor for advice.

4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects gets serious or if you notice any side effect not listed in
this leaflet, please tell your doctor or pharmacist.

Contact your doctor immediately if you notice any of the following symptoms of angioedema:
swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with possible difficulty
breathing (see also “Warnings and precautions”).
If you experience any of the following side effects, seek immediate medical attention:

• A severe allergic reaction - the frequency of which is not known
• Symptoms include sudden shortness of breath, difficulty breathing or dizziness, swelling of the eyelids, face, lips or tongue, skin rash, hives.
• A blood clot in the eye - the frequency of which is not known
• Symptoms include loss of vision, pain and swelling of the eye, especially if sudden.
• Hemolytic uremic syndrome (a condition that affects the blood and kidneys) - the frequency of which is not known
• Symptoms include vomiting, diarrhea (which may contain blood), fever, feeling weak, urinating less than usual.
• Pancreatitis - the frequency of which is not known
• Symptoms include severe upper abdominal pain that may spread to the back.
• Erythema multiforme - the frequency of which is not known
• Symptoms include a skin rash with pink-red patches especially on the palms of the hands or soles of the feet that may become blisters. It may also have ulcers in the mouth, eyes or genitals and have a fever.

Other side effects include:

Very common(may affect more than 1 in 10 people)

• Headache, including migraines
• Bleeding through breakthrough and spotting
• Nausea
• Abdominal pain
• Painful menstrual periods

Common(may affect up to 1 in 10 people)

• Vaginal irritation and infection, including candidiasis
• Mood changes, including feeling depressed
• Reduced sexual sensation
• Feeling nervous
• Dizziness
• Vomiting 10/12
• Diarrhea
• Feeling swollen
• Acne (blackheads)
• Skin rash
• Absent period (amenorrhea)
• Changes in the amount of blood loss and the length of menstrual cycles
• Pain, tension or enlargement of the breasts or nipple discharge
• Changes in your cervix, which may be detected with a Pap test
• Fluid retention (e.g. swollen ankles) Weight gain or loss Change in blood fat levels (detected through blood tests).

Uncommon(may affect up to 1 in 100 people)

• Increased appetite
• Decreased appetite
• Hives (urticaria)
• Unusual hair growth (hirsutism)
• Hair loss
• Dark spots on the skin (may have had them in a previous pregnancy)
• Increased blood pressure
• Gallstones
• Intolerance to a sugar called glucose
• Worsening of varicose veins.

Rare(may affect up to 1 in 1000 people)

• Yellowing of the skin or eyes (jaundice caused by abnormal bile flow in the liver)
• Soft, red nodules (erythema nodosum).

Not known(the frequency cannot be estimated from the available data)

• Benign or malignant tumor in the liver
• Worsening of an autoimmune condition called systemic lupus erythematosus
• Worsening of an inherited blood condition called porphyria
• Worsening of uncontrolled or jerky movements of the body (chorea)
• •Inflammation of the optic nerve the symptoms include blurred vision and can lead to partial or total loss of vision
• Intolerance to contact lenses
• Gallbladder disease or worsening of this condition
• Ischemic inflammatory bowel disease - symptoms include abdominal cramps and pain, diarrhea (which may contain blood), weight loss
• Stomach cramps
• Vaginal discharge
• Decreased levels of folate in the blood.

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If you are concerned about any new symptom or other aspect of your health while taking Jadiza, please
consult your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 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/segnalazioni-reazioni-avvers and
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Jadiza

• 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 after “Exp.”. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.

Do not dispose of any medicine in waste water 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 Jadiza contains
Film-coated active tablets

• The active ingredients are: levonorgestrel and ethinylestradiol
• Each film-coated tablet contains 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol.
• The other ingredients are:
• Tablet core: lactose monohydrate, potassium polyacrilin, microcrystalline cellulose, magnesium stearate.
• Tablet coating: Opadry II pink containing: macrogol 3350, titanium dioxide (E171), polyvinyl alcohol, talc (E553b), red iron oxide (E172), yellow iron oxide (E172).

Film-coated placebo tablets

• Tablet core: lactose monohydrate, potassium polyacrilin, microcrystalline cellulose, magnesium stearate.
• Tablet coating: Opadry II white containing: macrogol 3350, titanium dioxide (E171), polyvinyl alcohol, talc (E553b).

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Description of Jadiza and package contents
Active tablets:
Film-coated tablet, pink in color, cylindrical, biconvex, approximately 6 mm in diameter.
Placebo tablets:
Film-coated tablet, white in color, cylindrical, biconvex, approximately 6 mm in diameter.
Jadiza is packaged in PVC/PVDC/Aluminum blisters containing 28 tablets, including 21 active tablets and 7
placebo tablets per blister.
Jadiza is available in the following pack sizes: 28 and 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

MAH
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

Manufacturer
Cyndea Pharma, S.L.
Polígono Industrial Emiliano Revilla Sanz
Av. de Ágreda 31, 42110 Ólvega (Soria)
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Spain: Levonorgestrel/etinilestradiol diario cinfa.
Italy: Jadiza

This leaflet was last updated on
13/12