Package leaflet: Information for the patient

Jadiza 100 micrograms/20 micrograms film-coated tablets
levonorgestrel/ethinylestradiol
Equivalent medicine
Please read all of 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others; it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Jadiza is and what it is used for
What you need to know before taking Jadiza
How to take Jadiza
Possible side effects
How to store Jadiza
Contents of the pack and other information

1. What Jadiza is and what it is used for

Jadiza is a combined oral contraceptive used to prevent 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 pack also contains 7 inactive white placebo tablets.

2. What you should know before taking Jadiza

Before starting Jadiza, your doctor will ask you some questions about your personal medical history and
that of your close relatives. Your doctor will also measure your blood pressure and may carry out some
examinations.
This leaflet describes certain situations in which you must 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 must not
have sexual intercourse or must take additional non-hormonal contraceptive precautions (e.g. use of
condom 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.
Like 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 to any of the other ingredients of this medicine (listed in section 6)
if you have or have ever had heart disease or blood vessel disorders, particularly: heart attack (myocardial infarction), a heart rhythm disorder or a heart valve disorder
a blood clot including in the legs (deep vein thrombosis) or in the lung (pulmonary embolism), or a rupture of a blood vessel in the brain (stroke), a “mini-stroke” (transient ischaemic attack), or a general tendency to form blood clots (venous or arterial thrombosis)
chest pain caused by angina pectoris
if you have high blood pressure that is not stabilized by treatment
if you suffer from certain types of migraine (migraine with focal 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 may 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 blood vessel disease
if you are pregnant or suspect you may be pregnant
if you have or have had a benign or malignant liver tumour, or if you have recently had liver disease. In these cases, your doctor will ask you to stop taking Jadiza until your liver functions properly again
if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also 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 using Jadiza or other oral contraceptives. Your doctor will perform regular check-ups. Smoking increases the risk of serious adverse effects on the heart and blood vessels when using oral contraceptives. The risk increases with age and the number of cigarettes smoked, and is particularly pronounced in women over 35 years of age. Women who use combined oral contraceptives must not smoke. For women over 35 who smoke, alternative contraceptive methods should be considered.
If you have any of the following conditions, inform your doctor before starting Jadiza.
If any of the conditions listed below develop or worsen while taking Jadiza, consult your doctor so that they can decide whether 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 develop or worsen while taking Jadiza, consult a doctor

If you have high blood pressure
If you have high cholesterol levels or abnormal lipid (fat) levels in the blood (dyslipoproteinaemia) – this is seen in blood tests
You are obese
You have diabetes
You have a heart valve disorder or a heart rhythm disorder (atrial fibrillation)
You or a close relative (parent, brother or sister) have suffered from a condition involving a tendency to form 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, gallbladder disease or problems caused by blockage of the bile ducts (cholestasis) – this can cause intense itching
You develop migraine for the first time or experience worsening of existing migraine headaches
You have or develop liver disease, jaundice, inflamed pancreas, or kidney disease
You suffer from depression
You have hearing loss due to a disorder known as otosclerosis
You experienced a skin condition during pregnancy or while using another contraceptive pill that causes itching, red spots and blisters (herpes gestationis)
If you developed temporary brown patches on the skin during pregnancy (chloasma). The pill may cause these to reappear, so you should avoid strong sunlight or sunbeds while taking Jadiza.
You suffer from a disorder affecting your immune system (systemic lupus erythematosus)
You suffer from a condition known as Sydenham's chorea. Symptoms include irregular and sudden involuntary movements
If you have had a blood disorder associated with kidney disease (haemolytic uraemic syndrome)
If you have had a blood disorder called porphyria
If you have ulcerative colitis or Crohn’s disease (inflammation of the intestine causing abdominal pain, frequent diarrhoea and fatigue)
If you have a disease called sickle cell anaemia
If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with potential breathing difficulties, contact your doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary and acquired angioedema.

Psychiatric disorders
Some women using hormonal contraceptives, including Jadiza, have reported depression or depressed mood.
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.
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Jadiza and thrombosis (blood clots)
Venous thrombosis (blood clots)
The use of any combined oral contraceptive, including Jadiza, increases the risk of venous thrombosis (formation of a blood clot in blood vessels) in women compared to women who do not take oral contraceptives.
The risk of venous thrombosis in users of combined oral contraceptives increases:

with increasing age
if you are overweight
if one of your close relatives developed a blood clot in a blood vessel at a young age
with prolonged immobilisation (e.g. if you have had a cast or splint on one or both legs), major surgery, any type of leg surgery, or major trauma. In these situations, it is better to stop taking Jadiza (if the surgery is planned, stop at least 4 weeks beforehand) and not restart until two weeks after you resume normal mobility
immediately after childbirth, women are at increased risk of blood clots, so ask your doctor how long after delivery you can start taking the combined pill

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

if you smoke. It is strongly advised to stop smoking when using Jadiza, especially if you are over 35 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 one of your close relatives 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 (valvular disorders or a heart rhythm disorder)

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

Any unusual, severe or prolonged headache, or an increase in frequency or severity of migraine attacks
An increase in blood pressure
Severe pain and/or swelling in one leg
Sudden severe chest pain that may radiate to the left arm
Difficulty breathing, sudden shortness of breath 4/12
Sudden unusual cough without any obvious cause
Changes in vision, partial or complete blindness, or double vision
Difficulty or inability to speak
Sudden changes in hearing, smell or taste
Dizziness or fainting
Weakness, unusual sensations or numbness in any part of the body
Sudden severe stomach pain

Jadiza and cancer
Breast cancer has been found slightly more often in women using combined oral contraceptives, but it is not known whether this is caused by the pill. It is possible that these women are simply examined more thoroughly and more frequently, and therefore cancer is detected earlier.
In women who use combined oral contraceptives for a relatively long time, studies have reported cases of cervical cancer. It is currently not known whether this is caused by the pill or related to sexual behaviour (e.g. more frequent partner changes) and other factors.
In rare cases, benign liver tumours have been reported in users of the pill, and even more rarely, malignant liver tumours. Contact your doctor if you have unusually severe abdominal pain.
Bleeding between periods
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 during the last week of taking the tablets
(white tablets)
If you have taken all tablets correctly, have not vomited or had severe diarrhoea, and have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive cycles, 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There are some medicines that can interact with Jadiza.
Medicines can sometimes interfere with each other. If you receive treatment from any other doctor, nurse or qualified healthcare professional, ensure they are informed that you are using Jadiza as a contraceptive. They may advise you whether additional precautions (e.g. using a condom or another barrier contraceptive) are needed when taking other medicines while on Jadiza.
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Some medicines can make Jadiza less effective in preventing pregnancy or can cause unexpected bleeding. These include medicines used to treat:

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) used to treat certain types of depression

If you have been advised 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 in the current pack, skip the white tablets and start the next pack immediately.
In some cases, you may need to continue using an additional barrier contraceptive 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 called troleandomycin may increase the risk of intrahepatic cholestasis (bile retention in the liver) while taking the combined pill.
Taking a medicine called flunarizine used to prevent migraine may increase the risk of galactorrhoea. This is a condition in which the breast spontaneously secretes milk when not breastfeeding or having recently given birth.
Do not use Jadiza if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function blood tests (increase in liver enzyme ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
Jadiza can be resumed approximately 2 weeks after completing this treatment. See section “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, inform your doctor immediately.
Breastfeeding
It is not recommended to take combined oral contraceptives during breastfeeding, as the hormones may affect
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breast milk. If you wish to breastfeed, your doctor can advise you on suitable alternative contraceptive methods.
Always consult your doctor, pharmacist or healthcare professional before taking any medicine.
Driving and using machines
The effects of Jadiza on the ability to drive or operate machinery have not been studied. Dizziness has been reported as an adverse effect. If you experience dizziness, do not drive or operate machinery until it resolves.
Jadiza contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Jadiza

Take this medicine exactly as instructed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

The Jadiza blister pack contains 28 tablets (21 pink tablets and 7 white tablets). Take the first pink tablet from the first blister pack under the number "1". Take the tablets every day in the order indicated by the arrows. You must take one pink tablet daily for 21 days, followed by the white tablets for 7 days.

Inside the package, there is a sticker showing the days of the week. This can be applied to indicate the day of the week on which you started the blister pack. For example, if you start taking the tablets on Thursday, select the adhesive strip starting from "THU" and apply it to the top of the first row of the blister pack where it says: "Apply the adhesive strip aligning it with the starting date".

Take the tablets with water if needed, at the same time each day, until the pack is finished. Then start the next pack the day after finishing the last tablet. Always start the next pack on the same day of the week.

During the week of taking the white tablets, you will experience a bleed similar to a menstrual period. This bleeding usually starts after two or three days and may not have finished before you start the next pack of tablets.

If this is the first time you are starting the pill, or you have not used a hormonal contraceptive in the previous month

Take the first tablet on the first day of your menstrual cycle.

Starting after the first day of the cycle (from day 2 to day 5) means you must use an additional barrier method of contraception (e.g. a condom) for the first 7 days.

If switching from another combined oral contraceptive

Switching from 21-tablet packs

Finish the current pack of your current pill and start Jadiza the next day without a break.

Switching from 28-tablet "daily" packs

If your current pill contains inactive (placebo) tablets, do not take them and start Jadiza immediately the next day.

If switching from a progestogen-only pill, an injectable method, or an implant

When switching from a progestogen-only pill, you may start Jadiza at any time during your menstrual cycle, the day after stopping the progestogen-only pill.
When switching from an implant, start Jadiza on the day the implant is removed.
When switching from a contraceptive injection, start Jadiza on the day the next injection would have been due.

In all cases, you must use a barrier method of contraception during the first 7 days of taking the pill.

If starting Jadiza after an abortion in the first trimester (first three months) of pregnancy

You may start taking Jadiza immediately, but you must follow your doctor's advice before doing so. No additional barrier contraception is required.

If starting Jadiza after childbirth or after an abortion in the second trimester of pregnancy

As with any other oral contraceptive, Jadiza must not be started earlier than 28 days after childbirth or after a second-trimester abortion, because your risk of blood clots is higher during this time. If you start later than this, it is recommended to use a barrier method of contraception (such as a condom) 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 consult your doctor if you are unsure.

If you forget to take Jadiza

If you forget to take a pink tablet, there is a risk you could become pregnant

If you realize you have missed a pink tablet within 12 hours of your usual time, take the missed dose immediately and continue taking the tablets as usual, at your regular time, until the end of the blister pack.

If you realize you have missed a pink tablet more than 12 hours after your usual time, there is a risk you could become pregnant.

In this case:

Take the missed tablet as soon as possible, even if this means taking two tablets on the same day
Continue taking the tablets as usual 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 immediately without taking the inactive white tablets. You may experience some spotting or bleeding during the second pack, but this is not a cause for concern.

If you have missed one or more pink tablets in a blister pack and do not have any bleeding during the week you take the white tablets, you may be pregnant and should consult your doctor.

If you miss a white tablet, you do not need to do anything, provided 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 tablet is similar to missing a pink tablet. After vomiting or diarrhoea, take another pink tablet from a spare blister pack as soon as possible. If possible, take it within 12 hours of your usual pill-taking time. If this is not possible or if more than 12 hours have passed, follow the advice given above in the section "If you realize you have missed a pink tablet more than 12 hours after your usual time".

If episodes of severe vomiting or diarrhoea continue over several days, use a barrier method of contraception (e.g. a condom) until you start the next blister pack. Consult your doctor.

If you vomit or have diarrhoea while taking the white tablets, you do not need to do anything, provided 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 a new pack of Jadiza immediately, without taking the white tablets. You may experience some spotting or bleeding during the second pack, but this is not a cause for concern. You should 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 symptoms including gastrointestinal problems (e.g. nausea, vomiting, abdominal pain), breast tenderness, dizziness, drowsiness/fatigue, and vaginal bleeding. These symptoms will gradually resolve as your body processes the excess hormones.

If you are concerned, consult your doctor.

4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, talk to your doctor or pharmacist.
Contact your doctor immediately if you experience any of the following symptoms of angioedema:
swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with possible breathing difficulties (see also “Warnings and precautions”).
If you experience any of the following side effects, seek immediate medical help:

A severe allergic reaction – frequency not known
Symptoms include sudden breathlessness, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat, skin rash, hives.
A blood clot in the eye – frequency not known
Symptoms include loss of vision, eye pain and swelling, especially if sudden.
Haemolytic uraemic syndrome (a condition affecting the blood and kidneys) – frequency not known
Symptoms include vomiting, diarrhoea (which may contain blood), fever, feeling weak, urinating less than usual.
Pancreatitis – frequency not known
Symptoms include severe upper abdominal pain that may spread to the back.
Erythema multiforme – frequency not known
Symptoms include a skin rash with red-pink spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters. You may also have mouth ulcers, eye or genital ulcers, and fever.

Other side effects include:
Very common (may affect more than 1 in 10 people)

Headache, including migraine
Bleeding between periods 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 desire
Feeling nervous
Dizziness
Vomiting 10/12
Diarrhoea
Feeling bloated
Acne (blackheads)
Rash
Absent periods (amenorrhoea)
Changes in the amount of bleeding and length of menstrual cycles
Breast pain, tenderness or enlargement, or nipple discharge
Changes in your cervix, which may be detected on a Pap test
Fluid retention (e.g. swollen ankles)
Weight gain or loss
Changes in blood fat levels (detected by blood tests)

Uncommon (may affect up to 1 in 100 people)

Increased appetite
Decreased appetite
Hives (urticaria)
Unusual hair growth (hirsutism)
Hair loss
Dark patches on the skin (you may have had these 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 1,000 people)

Yellowing of the skin or eyes (jaundice due to abnormal bile flow in the liver)
Red, tender lumps (erythema nodosum)

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

Benign or malignant liver tumour
Worsening of an autoimmune condition called systemic lupus erythematosus
Worsening of an inherited blood disorder called porphyria
Worsening of uncontrollable or jerky body movements (chorea)
Optic neuritis (inflammation of the optic nerve); symptoms include blurred vision and may lead to partial or complete vision loss
Intolerance to contact lenses
Gallbladder disease or worsening of this condition
Ischaemic intestinal inflammatory disease – symptoms include abdominal cramps and pain, diarrhoea (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 symptoms or other aspects of your health while taking Jadiza, speak to your doctor.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avvers e
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 stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C.

Do not dispose of any medicine 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 Jadiza contains
Active film-coated tablets

The active substances are: levonorgestrel and ethinylestradiol.
Each film-coated tablet contains 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol.
Other components are:
- Tablet core: monohydrate lactose, polacrilin potassium, 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).

Placebo film-coated tablets

Tablet core: monohydrate lactose, polacrilin potassium, 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 the appearance of Jadiza and contents of the pack
Active tablets:
Pink, cylindrical, biconvex film-coated tablet, approximately 6 mm in diameter.
Placebo tablets:
White, cylindrical, biconvex film-coated tablet, approximately 6 mm in diameter.
Jadiza is packaged in PVC/PVDC/Aluminum blisters containing 28 tablets, consisting of 21 active tablets and 7 placebo tablets per blister.
Jadiza is available in the following pack sizes: 28 and 84 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
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 authorized in the European Economic Area Member States under the following
names:
Spain: Levonorgestrel/ethinylestradiol diario cinfa.
Italy: Jadiza
This leaflet was last updated on
13/12