AILEVA DIARIO 0.1 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

aileva Daily 0.1mg/0.02mg film-coated tablets EFG

levonorgestrel/ethinylestradiol

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is aileva Daily and what is it used for
2. What you need to know before you start taking aileva Daily
3. How to take aileva Daily
4. Possible side effects
5. Storage of aileva Daily

Contents of the pack and other information

1. What is aileva Daily and what is it used for

aileva Daily 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 0.1 milligrams of levonorgestrel and 0.02 milligrams of ethinylestradiol. The pack also includes 7 inactive white tablets (placebo).

2. What you need to know before you start taking aileva Daily

Do not take aileva Daily:

• 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 had) heart or blood vessel problems, in particular:
• heart attack (myocardial infarction), irregular heartbeat or heart valve disorders
• blood clots in the legs (deep vein thrombosis), or in the lungs (pulmonary embolism) or rupture of blood vessels in the brain (stroke), "mini-stroke" or general tendency to form blood clots (venous or arterial thrombosis)
• chest pain caused by angina pectoris
• if you have uncontrolled high blood pressure
• if you have certain types of migraine (migraine with focal neurological symptoms)
• if you have breast cancer or cancer of the uterus, or a type of cancer that is sensitive to female sex hormones, or if you suspect you may have one of these cancers
• if you have vaginal bleeding of unknown cause
• if you have high blood sugar levels (diabetes) associated with blood vessel problems
• if you are pregnant or think you may be pregnant
• if you have or have had a benign or malignant tumor in the liver, or if you have recently had liver disease. In these cases, your doctor will ask you to stop taking aileva Daily until the liver has returned to normal
• if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir (see also section "Other medicines and aileva Daily").

Warnings and precautions

Consult your doctor or pharmacist before you start taking aileva Daily.

In some situations, you may need special care when taking aileva Daily or any combined oral contraceptive. Your doctor will routinely monitor you. Smoking cigarettes increases the risk of serious adverse reactions in the heart and blood vessels due to the use of oral contraceptives. This risk increases with age and the amount of tobacco and is quite significant in women over 35 years of age. Women who use combined oral contraceptives should not smoke. Women over 35 years of age who smoke should consider using other contraceptive methods.

If you have any of the following conditions, inform your doctor before you start taking aileva Daily. If any of the following conditions develop or worsen while you are taking aileva Daily, you should consult your doctor to determine if aileva Daily is suitable for you.

Tell your doctor if you suffer from any of the following conditions

If the condition develops or worsens while you are using aileva Daily, you should also inform your doctor if:

• You have high blood pressure.
• You have high cholesterol or abnormal lipid levels in the blood (dislipidemia) - these levels are detected in a blood test.
• You are obese.
• You are diabetic.
• You have heart valve problems or irregular heartbeat (atrial fibrillation).
• You or a close relative have had a disease with a tendency to develop blood clots (in the legs, lungs, or any other part of the body) or have had a heart attack or stroke.
• You have varicose veins or have had inflammation in the superficial veins of the legs.
• You experience sudden and unexplained changes in vision.
• You have gallstones, gallbladder disorders, or problems caused by blockage of the bile ducts (cholestasis) - this can cause intense itching.
• You develop migraine for the first time or worsening of existing migraine.
• You have or develop liver disease, jaundice, or inflammation of the pancreas or kidney disorder.
• You have depression.
• You have hearing loss due to a condition known as otosclerosis.
• You have had a skin problem during pregnancy or while taking another contraceptive pill that caused itching, red spots, or blisters (herpes gestationis).
• You have had brown spots on the skin during pregnancy (chloasma). The pill may cause this to recur, so you should avoid exposure to the sun or sunlamps while taking aileva Daily.
• You have a disorder that affects your immune system (systemic lupus erythematosus).
• You have a disease known as Sydenham's chorea. The symptoms include irregular, sudden, and involuntary movements.
• You have had a blood disease associated with kidney disease (hemolytic uremic syndrome).
• You have had a blood disease called porphyria.
• You have had ulcerative colitis or Crohn's disease (inflammation of the intestine that causes abdominal pain, frequent diarrhea, and fatigue).
• You have a blood disease called sickle cell disease, also known as sickle cell anemia.
• If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products that contain estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

Psychiatric disorders

Some women who use hormonal contraceptives like aileva Daily have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

aileva Daily and thrombosis (blood clots)

Venous thrombosis (blood clots)

The use of any combined pill, including aileva Daily, increases the risk in women of developing a venous thrombosis (formation of blood clots in the veins) compared to women who do not take any pill (contraceptive).

The risk of venous thrombosis in patients taking combined pills increases:

• with age;
• if you are overweight;
• if a close relative has had a disease with a tendency to develop blood clots in the veins at a young age;
• with prolonged immobilization (e.g., with one or both legs in a cast or splint), major surgery, any type of surgery on the legs, significant trauma. In these situations, it is best to stop taking aileva Daily (if surgery is planned, you should stop taking it at least 4 weeks before) and not start again until 2 weeks after you can stand up again;
• immediately after childbirth, women have an increased risk of forming blood clots, so you should consult your doctor when you can start taking the combined pill after childbirth.

Arterial thrombosis (blood clots)

The use of combined pills has been associated with an increased risk of arterial thrombosis (obstruction of an artery), for example, in the blood vessels of the heart (heart attack) or brain (stroke).

The risk of arterial thrombosis in patients taking combined pills increases:

• if you smoke. It is strongly recommended that you stop smoking when taking aileva Daily, especially if you are over 35 years old
• with age, even if you do not smoke
• if you have high levels of fat 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 have migraines
• if you have any heart problems (heart valve disorders, irregular heartbeat)

aileva Daily and cancer

Breast cancer has been diagnosed slightly more frequently in women who use the combined pill, but it is not known if the cancer is caused by the pill. It is possible that these women are simply examined more rigorously and frequently, so there is a greater likelihood that breast cancer will be detected earlier.

There have been studies in which cases of cervical cancer have been reported in women who take combined pills for a relatively long period. Currently, it is not known if this fact may be caused by the pill or is related to sexual behavior (e.g., more frequent changes of partners) and other factors.

In rare cases, benign liver tumors, and even a few cases of malignant liver tumors, have been reported in patients taking the pill. Contact your doctor if you have severe unusual abdominal pain.

Irregular bleeding

During the first few months that you are taking aileva Daily, you may have unexpected bleeding (bleeding or spotting outside of the week when you are taking the inactive white tablets (placebo)). If this bleeding lasts for more than a few months, or if it starts after some months, your doctor should investigate the cause.

What to do if you do not have bleeding during the last week of taking tablets (white tablets)

If you have taken all the tablets correctly, have not had vomiting or severe diarrhea, and have not taken any other medicine, it is unlikely that you are pregnant.

If your period does not appear for the second consecutive time, you may be pregnant. Consult your doctor immediately. Do not start with the next blister pack until you are sure you are not pregnant.

Other medicines and aileva Daily

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

There are medicines that can interact with aileva Daily.

Medicines can sometimes interfere with each other. If you are receiving treatment from another doctor, nurse, or qualified healthcare professional, make sure they are aware that you are taking aileva Daily as a contraceptive.

They may advise you to take extra precautions (e.g., use condoms or other barrier contraceptives) while taking other medicines with aileva Daily.

Some medicines may make aileva Daily less effective in preventing pregnancy or may 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)
• St. John's Wort (Hypericum perforatum) used to treat certain types of depression.

If you have been told to take extra contraceptive precautions while taking any of the above medicines, follow your doctor's instructions carefully. If you need to continue taking the medicine after finishing the pink tablets in your current pack, do not take the white tablets and start a new pack immediately.

In some cases, you may need to continue using an additional barrier contraceptive for several weeks after stopping the medicine.

aileva Daily may interfere with the following medicines:

• Cyclosporin (used to reduce the immune response)
• Lamotrigine (used to treat epilepsy)

Taking an antibiotic called troleandomycin may increase the risk of intrahepatic cholestasis (bile retention in the liver) during treatment with the combined pill.

Taking a medicine called flunarizine used for the prevention of migraines may increase the risk of galactorrhea. This is a condition in which the breasts secrete milk spontaneously without breastfeeding or having recently given birth.

Do not take aileva Daily if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver test results (increase in liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.

aileva Daily can be taken again approximately 2 weeks after the end of this treatment. See the section "Do not take aileva Daily".

Pregnancy and breastfeeding

Pregnancy

Do not take aileva Daily if you are pregnant. If you think you may have become pregnant while taking aileva Daily, consult your doctor immediately.

Breastfeeding

It is not recommended to take the combined pill while breastfeeding, as the hormones may affect the breast milk. If you want to breastfeed, your doctor will advise you on alternative contraceptive methods.

Always consult your doctor, nurse, or healthcare professional before using any medicine.

Driving and using machines

The effect of aileva Daily on the ability to drive or use machines has not been studied. Dizziness has been reported as a side effect. If you experience dizziness, do not drive or use machines until it has resolved.

aileva Daily contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Aileva Daily

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Each Aileva Daily blister pack contains 28 tablets (21 pink and 7 white). Take the first pink tablet from the blister pack where the number "1" appears. Follow the direction of the arrows on the blister pack to take the tablets in the correct order. You should take one pink tablet every day for 21 days, followed by the white tablets for 7 days.

Inside each box, there are 7 adhesive strips with the days of the week. This adhesive strip should be stuck on the day you start taking the contraceptive. For example, if you start taking the tablets on a Tuesday, you should select the strip that starts with "TUE" and stick it in the first row where it says: "Place the strip that matches the start date here". Take the tablets with water if necessary, and at the same time every day until the pack is finished. Once you finish the last tablet, start a new pack the next day. You should always start the next pack on the same day of the week.

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

If it's the first time you're starting with the pill or you haven't used any hormonal contraceptive in the previous month

Take the first tablet on the first day of your period.

If you start after the first day of your period (on days 2-5 of the cycle), you will need to use an additional barrier contraceptive method (e.g., condoms) for the first 7 days.

If you're switching from a combined contraceptive pill

If you're taking pills that contain 21 tablets in the pack

Finish the current pill pack, and start taking Aileva Daily the next day, without a break.

If you're taking "daily" pills that contain 28 tablets in the pack

If your current pill pack contains inactive tablets (placebo), do not take these tablets, and start Aileva Daily immediately the next day.

If you're switching from a progestogen-only pill, injection, or implant

• When switching from a progestogen-only pill, you can start Aileva Daily at any time during your menstrual cycle, the day after you stop taking the progestogen-only pill.
• When switching from an implant, start using Aileva Daily on the day of its removal.
• When switching from an injectable contraceptive, start Aileva Daily when your next injection is due.

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

If you start Aileva Daily after an abortion during the first trimester (3 months) of pregnancy

You can start taking this medication immediately, but you should follow your doctor's advice before doing so. No additional barrier contraceptive method is needed.

If you start Aileva Daily after having a baby or after an abortion during the second trimester

Like any other contraceptive pill, this medication should not be started before 28 days after giving birth, or after an abortion in the second trimester of pregnancy, as this increases the risk of blood clots. You should use a barrier contraceptive method (e.g., condoms) during the first 7 days of taking levonorgestrel/ethinylestradiol. If you have had sex before starting levonorgestrel/ethinylestradiol, make sure you are not pregnant or wait until your next period.

In case of doubt, always consult your doctor.

If you forget to take Aileva Daily

If you realize you have forgotten to take a pink tablet within 12 hours of the usual time,take the missed tablet immediately and continue as usual, taking the following tablets at the usual times until the pack is finished.

If you realize you have forgotten to take a pink tablet more than 12 hours after the usual time,there is a risk that you may become pregnant. In this case:

• take the last missed tablet immediately, even if it means taking two tablets on the same day
• continue taking the tablets until the end of the pack
• also use a barrier contraceptive method (e.g., condoms) for the next 7 days

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

If you forget to take a white tablet, you don't need to take any other action, apart from starting the next pack on the usual day.

If you have vomiting or diarrhea

If you vomit or have severe diarrhea within 4 hours of taking the tablet, it is as if you had forgotten to take the pink tablet. After vomiting or having diarrhea, you should take another pink tablet from the reserve pack as soon as possible. If possible, take it within the next 12 hoursor when you would normally take the pill. If it is not possible or more than 12 hours have passed, you should follow the recommendations given in "If you realize you have forgotten to take a pink tablet more than 12 hours after the usual time".

If episodes of vomiting or severe diarrhea recur over several days, you should use a barrier contraceptive method (e.g., condoms) until the start of the next pack. Consult your doctor in case of doubt.

If you vomit or have diarrhea while taking the white tablets, you don't need to take any action as long as the vomiting and diarrhea have disappeared by the time you start the next pack on the usual day.

How to delay your period

You can delay your period by starting another pack of Aileva Daily immediately without taking any of the white tablets. You may experience some spotting or bleeding while taking the second pack, but you don't need to worry about this. You should have a normal bleed after finishing the pink tablets of the second pack.

If you take more Aileva Daily than you should

If you accidentally take more Aileva Daily than you should, you may experience symptoms that include gastrointestinal problems (e.g., nausea, vomiting, abdominal pain), breast tenderness, dizziness, numbness/fatigue, and vaginal bleeding. These symptoms will decrease naturally as your body deals with the excess hormones.

If you are concerned, consult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contact a 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 urticaria with possible difficulty breathing (see also section "Warnings and precautions").

If you experience any of the following serious side effects, consult a doctor immediately:

• A severe allergic reaction - frequency not known.

The symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat, skin rash, hives.

• A blood clot in the eye - frequency not known.

The symptoms include loss of vision, pain, and swelling of the eye, especially if they are sudden.

• Hemolytic uremic syndrome (a condition that affects the blood and kidneys) - frequency not known.

The symptoms include vomiting, diarrhea (which may be bloody), fever, feeling of weakness, decreased urination.

• Pancreatitis - frequency not known.

The symptoms include severe pain in the upper abdomen, which may radiate to the back.

• ERYTHEMA MULTIFORME - frequency not known.

The symptoms include a skin rash with red-pink spots, especially on the palms or soles of the feet, which may blister. You may also have ulcers in the mouth, eyes, or genitals, and may have a fever.

Other side effects include:

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

• headache, including migraines
• bleeding and spotting outside of period
• nausea
• abdominal pain
• painful periods

Common(may affect up to 1 in 10 people)

• vaginal irritation and infection, including candidiasis
• mood changes, including depression
• decreased sex drive
• feeling nervous
• feeling dizzy
• vomiting
• diarrhea
• feeling bloated in the abdomen
• acne (pimples)
• skin rash
• absence of period (amenorrhea)
• changes in the amount of blood loss and duration of periods
• breast pain or tenderness, enlargement, or discharge
• changes in the cervix that can be seen in a Pap smear
• fluid retention (e.g., swollen ankles)
• weight gain or loss
• changes in blood lipid levels (seen through blood tests)

Uncommon(may affect up to 1 in 100 people)

• increased appetite
• decreased appetite
• hives (urticaria)
• abnormal hair growth (hirsutism)
• hair loss
• dark spots on the skin (which may be from 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 and eyes (jaundice caused by abnormal bile flow in the liver)
• painful red lumps under the skin (erythema nodosum)

Frequency not known:cannot be estimated from the available data

• benign or malignant liver tumor
• worsening of an autoimmune disease called systemic lupus erythematosus
• worsening of a hereditary blood disease called porphyria
• worsening of uncontrolled or spasmodic body movements (chorea)
• inflammation of the optic nerve: symptoms include blurred vision and can lead to total or partial loss of vision
• intolerance to contact lenses
• gallbladder disease or worsening of this condition
• inflammatory or ischemic intestinal disease: symptoms include abdominal pain and cramps, diarrhea (which may be bloody), weight loss
• abdominal cramps
• vaginal discharge
• decreased blood folate levels

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Aileva Daily

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Aileva Daily

Active film-coated tablets are pink:

• The active ingredients are levonorgestrel and ethinylestradiol.
• Each active film-coated pink tablet contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol.
• The other excipients are:

• Tablet core: lactose monohydrate, potassium polacrylate, microcrystalline cellulose, magnesium stearate.
• Coating: Opadry II pink, contains macrogol 3350, titanium dioxide (E171), poly(vinyl alcohol), talc (E553b), iron oxide red (E172), iron oxide yellow (E172).

Placebo film-coated tablets are white:

• Tablet core: lactose monohydrate, potassium polacrylate, microcrystalline cellulose, magnesium stearate.
• Coating: Opadry II white, contains macrogol 3350, titanium dioxide (E171), poly(vinyl alcohol), talc (E553b).

Appearance and packaging of the product

Active tablets:

Pink, cylindrical, biconvex, film-coated tablet with an approximate diameter of 6 mm.

Placebo tablets:

White, cylindrical, biconvex, film-coated tablet with an approximate diameter of 6 mm.

Aileva Daily is packaged in PVC/PVDC/Aluminum blisters of 28 tablets, containing 21 active tablets and 7 placebo tablets.

Aileva Daily is available in packs of 28 and 84 tablets.

Only certain pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra)-Spain

Manufacturer

CYNDEA PHARMA S.L.

Polígono Industrial Emiliano Revilla Sanz, Av. de Agreda 31

42110, Olvega, Soria (Soria)

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Italy:Jadiza 100/20 micrograms film-coated tablets

Spain:Aileva Daily film-coated tablets

Date of last revision of this leaflet: September 2023

Detailed and up-to-date information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and up-to-date information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78777/P_78777.html

QR code to: https://cima.aemps.es/cima/dochtml/p/78777/P_78777.html