Label: information for the user

aileva Diario 0.1mg/0.02mg film-coated tablets

levonorgestrel/etinilestradiol

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist
• This medication has been prescribed only for you, and you should not give it to others as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this label. See section 4.

Contents of the package and additional information

Aileva Diario is a combined oral contraceptive for pregnancy prevention.

It contains two different female hormones, levonorgestrel and ethinyl estradiol.

Each of the 21 round pink pills contains 0.1 milligrams of levonorgestrel and 0.02 milligrams of ethinyl estradiol. The package also includes 7 inactive white pills (placebo).

Do not take aileva Diario:

• if you are allergic to levonorgestrel, ethinylestradiol, or any of the other components of this medication (listed in section 6)
• if you have (or have had) heart problems or blood vessel problems, particularly:
• heart attack (myocardial infarction), arrhythmia, or heart valve disorder
• blood clot in the legs (deep vein thrombosis), or in the lungs (pulmonary embolism) or rupture of brain blood vessels (stroke), "mini-stroke" or 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 uterine cancer, or a type of cancer that is sensitive to female sex hormones, or if you suspect that you may have any 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 suspect that you may be pregnant
• if you have or have had a benign or malignant liver tumor, or if you have recently had liver disease. In these cases, your doctor will ask you to stop taking aileva Diario until your liver has returned to normal
• if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medications and aileva Diario").

Warnings and precautions

Consult your doctor or pharmacist before starting to take aileva Diario.

In some situations, special care may be needed when taking aileva Diario or any combined oral contraceptive. Your doctor will monitor you regularly. Smoking cigarettes increases the risk of serious heart and blood vessel reactions due to the use of oral contraceptives. This risk increases with age and the amount of tobacco and is quite relevant 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 starting to take aileva Diario. If any of the following conditions develop or worsen while you are taking aileva Diario, you must consult your doctor to decide if aileva Diario is suitable for you.

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

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

Mental health disorders

Some women who use hormonal contraceptives like aileva Diario 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 Diario and blood clots (blood clots)

Blood clots (venous thromboembolism)

The use of any combined pill, including aileva Diario, increases the risk in women of developing a blood clot (venous thromboembolism) compared to women who do not take any pill (contraceptive).

The risk of blood clots in patients taking combined pills increases:

Arterial blood clots (blood clots)

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

The risk of arterial blood clots in patients taking combined pills increases:

aileva Diario and cancer

Breast cancer has been diagnosed at a slightly higher frequency in women who use the combined pill, but it is unknown whether the cancer is caused by the pill. It is possible that these women are simply examined more rigorously and more frequently, so there would be a greater chance of detecting breast cancer before.

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 unknown whether this is caused by the pill or is related to sexual behavior (e.g., more frequent changes of partner) 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 and unusual abdominal pain.

Intermenstrual bleeding

During the first few months of taking aileva Diario, you may experience unexpected bleeding (bleeding or spotting outside the week in which you are taking the inactive pills (placebo) of white color). 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 there is no bleeding in the last week of taking pills (white color)

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

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

Other medications and aileva Diario

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

There are medications that may interact withaileva Diario.

Medications 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 takingaileva Diarioas a contraceptive.

They may advise you to take additional precautions (e.g., use condoms or other barrier contraceptives) while taking other medications withaileva Diario.

Some medications may makeaileva Diarioless effective in preventing pregnancy, or may cause unexpected bleeding. These include medications used to treat:

If you have been told to take additional contraceptive precautions while taking one of the medications mentioned above, follow your doctor's instructions carefully. If you need to continue taking the medication after finishing the pink pills in your current pack, do not take the white pills and start with a new pack immediately.

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

aileva Diariomay interact with the following medications:

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

Taking a medication called flunarizine used to prevent migraines may increase the risk of galactorrhea. This is an alteration in which the breasts secrete milk spontaneously without breastfeeding or having recently given birth.

Do not takeaileva Diarioif you have Hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver test results (elevated ALT enzyme).

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

aileva Diario can be taken again approximately 2 weeks after completing this treatment. See the section "Do not take aileva Diario".

Pregnancy and breastfeeding

Pregnancy

Do not take aileva Diario if you are pregnant. If you think you may be pregnant while taking aileva Diario, 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 suitable contraceptive methods.

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

Driving and operating machinery

No studies have been conducted on the effect of aileva Diario on the ability to drive or operate machinery. Dizziness has been reported as an adverse effect. If you experience dizziness, do not drive or operate machinery until it has resolved.

aileva Diario contains lactose

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

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

Each blister pack of Aileva Diario 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 in 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 when you start taking the contraceptives. For example, if you start taking the tablets on a Tuesday, you should select the adhesive strip that starts with "MAR" and stick it on the first row where it is written: "Place the adhesive strip that matches the start date here". Take the tablets with water if necessary, and at the same time every day until the packaging is finished. Once you have finished the last tablet, start the next day with a new pack of tablets. You should always start the next pack on the same day of the week.

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

If this is the first time you start with the pill or you have not used any hormonal contraceptive the previous month

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

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

If you are changing from a combined oral contraceptive pill

If you are taking pills that contain 21 tablets in the pack

Finish the pack of the current pill, and start taking Aileva Diario the next day, without interruption.

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

If your current pack of pills contains inactive tablets (placebo), do not take these tablets, and start with Aileva Diario immediately the next day.

If you are changing from a pill that only contains a progestogen, an injection, or an implant

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

If you start with Aileva Diario after a first-trimester abortion (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 method of contraception is needed.

If you start with Aileva Diario after having a baby or after a second-trimester abortion

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

Always consult your doctor in case of doubt.

If you forgot to take Aileva Diario

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 normal, taking the next tablets at the usual time until the pack is finished.Take the missed tablet as soon as possible, and continue with the rest of the pack as usual.

If you realize you have forgotten to take a pink tablet more than 12 hours after the usual time, there is a risk of pregnancy. In this case:Take the last missed tablet as soon as possible, even if this means taking two tablets on the same day.

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

If you forget to take a white tablet, no further action is needed, apart from starting the next pack on the usual day.

If you experience vomiting or diarrhea

If you vomit or experience severe diarrhea within 4 hours of taking the tablet, it is as if you have forgotten to take the pink tablet. After vomiting or diarrhea, you should take another pink tablet from the reserve pack as soon as possible. If possible, take it within the next 12 hours or at the usual time for taking the pill. If 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, a barrier method of contraception (e.g., condoms) should be used until the start of the next pack. Consult your doctor in case of doubt.

If you vomit or experience diarrhea while taking the white tablets, no action is needed as long as the vomiting and diarrhea have stopped by the time you start the next pack.

How to delay your period

You can delay your period by starting another pack of Aileva Diario immediately without taking any of the white inactive tablets. You may experience spotting or bleeding while taking the second pack, but do not worry about this. You should have a normal bleeding after finishing the pink tablets of the second pack.

If you take more Aileva Diario than you should

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

Consult your doctor if you are concerned.

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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you consider that any of the side effects you are experiencing are severe 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 angioedema symptoms: facial, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also "Warnings and precautions").

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

• A severe allergic reaction - unknown frequency.

The symptoms consist of sudden wheezing, difficulty breathing, or dizziness, eyelid, face, lip, or throat swelling, skin rash, hives.

• Blood clot in the eye - unknown frequency.

The symptoms consist of vision loss, eye pain, and swelling, especially if sudden.

• Uremic hemolytic syndrome (a condition that affects the blood and kidneys) - unknown frequency.

The symptoms consist of vomiting, diarrhea (which may be bloody), fever, feeling weak, and urinating less than usual.

• Pancreatitis - unknown frequency.

The symptoms consist of intense upper abdominal pain that may radiate to the back.

• Erythema multiforme - unknown frequency.

The symptoms consist of a skin rash with pink-red patches, especially on the palms or soles of the feet, which may have blisters. It may also present with mouth, eye, or genital ulcers, and 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
• Changes in mood, including depression
• Decreased libido
• Feeling nervous
• Dizziness
• Vomiting
• Diarrhea
• Abdominal bloating
• Acne (pimples)
• Skin rash
• Amenorrhea (absence of period)
• Changes in menstrual bleeding and duration
• Breast tenderness, enlargement, or discharge
• Changes in cervical mucus that can be observed in a Pap smear
• Fluid retention (e.g., swollen ankles)
• Weight gain or loss
• Changes in blood lipid levels (observed 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 skin patches (may be from a previous pregnancy)
• Increased blood pressure
• Gallstones
• Glucose intolerance
• Worsening of varicose veins

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

• Yellowing of the skin and eyes (jaundice caused by an abnormal bile flow in the liver)
• Painful and inflamed skin nodules (erythema nodosum)

Unknown frequency:cannot be estimated from available data

• Benign or malignant liver tumor
• Worsening of a systemic autoimmune disease called lupus erythematosus
• Worsening of a hereditary blood disorder called porphyria
• Worsening of uncontrolled or spasmodic body movements (chorea)
• Optic nerve inflammation: symptoms consist of blurred vision and may lead to total or partial vision loss
• Lens intolerance
• Biliary tract disease or worsening of this condition
• Inflammatory or ischemic bowel disease: symptoms consist of abdominal pain and cramps, diarrhea (which may be bloody), weight loss
• Stomach cramps
• Vaginal discharge
• Decreased folate levels in the blood

Reporting of side effects

If you experience any type of side effect, 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 System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGREEpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of aileva Diario

Coated tablets with active film of pink color:

• The active principles are levonorgestrel and etinilestradiol.
• Each coated tablet of pink active film contains0.1mgof levonorgestrel and0.02mgof etinilestradiol.
• The other excipients are:

• Tablet core: lactose monohydrate, potassium polacrilex, 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).

Coated tablets with placebo film of white color:

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

Appearance of the product and contents of the package

Active tablets:

Pink, cylindrical, biconvex, coated tablet with a diameter of approximately 6 mm.

Placebo tablets:

White, cylindrical, biconvex, coated tablet with a diameter of approximately 6 mm.

aileva Diariois packaged in a PVC/PVDC/Aluminum blister of 28 tablets, containing 21 active tablets and 7 placebo tablets.

aileva Diariois available in packages of 28 and 84 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra)-Spain

Responsible manufacturer

CYNDEA PHARMA S.L.

Emiliano Revilla Sanz Industrial Estate, Av. de Agreda 31

42110, Olvega, Soria (Soria)

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Italy:Jadiza 100/20 microgrammi compresse rivestite con film

Spain:aileva Diario comprimidos recubiertos con película

Last review date of this leaflet: September 2023

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

You can access detailed and updated information on this medicinal product 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

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