Aileva Diario 0.1 mg/0.02 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

levonorgestrel/ethinylestradiol

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

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

Leaflet contents

What aileva Diario is and what it is used for
What you need to know before taking aileva Diario
How to take aileva Diario
Possible adverse effects
How to store aileva Diario

Pack contents and additional information

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

aileva Diario 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 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 starting to take aileva Diario

Before you start taking aileva Diario, your doctor will ask you some questions about your medical history and that of your close relatives. Your doctor will also measure your blood pressure and may carry out other tests.

This leaflet describes some situations in which you should stop taking aileva Diario or where the effectiveness of aileva Diario may be reduced, with a risk of pregnancy. In these situations, you should abstain from sexual intercourse or use additional non-hormonal contraceptive precautions (for example, use condoms or another barrier method). Do not use rhythm or temperature methods. These methods may not be reliable since aileva Diario alters the monthly changes in body temperature and cervical mucus.

aileva Diario, like other oral contraceptives, does not protect against HIV (AIDS) infection or against other sexually transmitted diseases.

Do not take aileva Diario:

if you are allergic to levonorgestrel, ethinylestradiol, or any of the other components of this medicine (listed in section 6)
if you have (or have had) heart problems or blood vessel disorders, particularly:
heart attack (myocardial infarction), irregular heartbeat, or heart valve disorders
blood clot in the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or rupture of blood vessels in the brain (stroke), "mini-stroke" (transient ischemic attack), or a general tendency to form blood clots (venous or arterial thrombosis)
chest pain caused by angina pectoris
if you have uncontrolled high blood pressure despite treatment
if you suffer from certain types of migraine (migraine with focal neurological symptoms)
if you have breast cancer or uterine cancer, or a type of cancer sensitive to female sex hormones, or if you suspect 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 you might 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 function returns to normal
if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and aileva Diario”).

Warnings and precautions

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

Special care may be needed when taking aileva Diario or any combined oral contraceptive. Your doctor will routinely monitor you. Smoking increases the risk of serious adverse effects on the heart and blood vessels associated with the use of oral contraceptives. This risk increases with age and the number of cigarettes smoked, and is particularly significant in women over 35 years of age. Women who use combined oral contraceptives should not smoke. Women over 35 who smoke should consider using alternative contraceptive methods.

If you have any of the following conditions, inform your doctor before starting to take aileva Diario. If any of the conditions listed below develop or worsen while you are taking aileva Diario, you must consult your doctor to determine whether aileva Diario remains suitable for you.

Inform your doctor if you have any of the following conditions

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

You have high blood pressure.
You have high cholesterol levels or abnormal levels of lipids (fats) in the blood (dyslipidemia) – these are detected by a blood test.
You are obese.
You are diabetic.
You have heart valve problems or an irregular heartbeat (atrial fibrillation).
You or a close relative (parent, sibling) have had a condition with a tendency to develop blood clots (in the legs, lungs, or elsewhere in the body), or have a history of heart attacks or strokes.
You have varicose veins or have previously had inflammation in the superficial veins of the legs (phlebitis).
You experience a sudden and unexplained change in vision.
You have gallstones, gallbladder disorders, or problems caused by blockage of the bile ducts (cholestasis) – this may cause intense itching.
You develop migraine for the first time or experience worsening of an existing migraine.
You have or develop liver disease, jaundice, pancreatitis, or kidney disorder.
You have depression.
You have hearing loss due to a condition known as otosclerosis.
You previously experienced a skin condition during pregnancy or while taking another contraceptive pill that caused itching, red patches, or blisters (herpes gestationis).
You had temporary brown patches on the skin during pregnancy (chloasma). The pill may cause this to recur, so you should avoid sun exposure or sunbathing while taking aileva Diario.
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, sudden, and involuntary movements.
You have ever had a blood disorder associated with kidney disease (hemolytic uremic syndrome).
You have ever had a blood disorder called porphyria.
You have had ulcerative colitis or Crohn's disease (inflammation of the intestine causing abdominal pain, frequent diarrhea, and fatigue).
You have a blood disorder 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 hives with possible breathing difficulties, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Psychiatric disorders

Some women using hormonal contraceptives such as aileva Diario 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, contact your doctor for further medical advice as soon as possible.

aileva Diario and thrombosis (blood clots)

Venous thrombosis (blood clots)

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

The risk of venous thrombosis in women taking combined oral contraceptives increases:

with age;
if you are overweight;
if a close relative has had a condition with a tendency to form blood clots at a young age;
with prolonged immobilization (e.g., with one or both legs in casts or splints), major surgery, any type of leg surgery, or major trauma. In these situations, it is advisable to stop taking aileva Diario (if surgery is planned, stop at least four weeks beforehand) and not restart until two weeks after you are able to walk normally again;
immediately after childbirth, women have an increased risk of developing blood clots; therefore, consult your doctor about when it is safe to start taking the combined pill again after delivery.

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 women taking combined oral contraceptives increases:

if you smoke. It is strongly recommended that you stop smoking while taking aileva Diario, especially if you are over 35 years of age
with age, even if you do not smoke
if you have elevated levels of fat in the blood (cholesterol or triglycerides)
if you are overweight
if a close relative 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 (valve disorders, irregular heart rhythms)

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

unusual, severe or prolonged headache, or more frequent or severe migraine attacks
increase in blood pressure
severe and/or swelling in one of your legs
sudden, severe chest pain that may spread to the left arm
sudden difficulty breathing, or sudden shortness of breath
sudden, unexplained cough
changes in vision, partial or complete blindness, or double vision
difficulty speaking, or inability to speak
sudden changes in hearing, sense of smell, or taste
dizziness or fainting
weakness, unusual sensations, or numbness in any part of the body
sudden, severe stomach pain

aileva Daily and cancer

Breast cancer has been diagnosed slightly more frequently in women using the combined oral contraceptive pill, but it is unknown whether the cancer is caused by the pill. It is possible that these women simply undergo more thorough and frequent examinations, making it more likely that breast cancer will be detected earlier.

There have been studies reporting cases of cervical cancer in women who have taken combined oral contraceptives for a relatively long period of time. It is currently unknown whether this is caused by the pill or is related to sexual behavior (e.g., more frequent partner changes) and other factors.

Rarely, 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 experience unusual, severe abdominal pain.

Breakthrough bleeding

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

What to do if there is no bleeding during the last week of taking the tablets (white tablets)

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

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

Other medicines and aileva Daily

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

Some medicines may interact with aileva Daily.

Medicines can sometimes interfere with each other. If you are being treated by 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 whether additional precautions are needed (e.g., using condoms or other barrier methods) while you are 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 infection (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 advised to take additional contraceptive precautions while taking any of the medicines listed above, 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 interacting medicine.

aileva Daily may interfere with the following medicines:

Cyclosporine (used to reduce 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 oral contraceptive.

Taking a medicine called flunarizine, used for migraine prevention, may increase the risk of galactorrhea. This is a condition in which the breasts secrete milk spontaneously without breastfeeding or recent childbirth.

Do not take aileva Daily if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function test results (elevated liver enzyme ALT).

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

aileva Daily can be restarted approximately 2 weeks after completion 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

The use of the combined oral contraceptive is not recommended while breastfeeding, as hormones may affect breast milk. If you wish to breastfeed, your doctor will advise you on appropriate alternative contraceptive methods.

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

Driving and use of machines

The effect of aileva Daily on the ability to drive or operate machinery has not been studied. Dizziness has been reported as an adverse effect. If you experience dizziness, do not drive or operate machinery until symptoms resolve.

aileva Daily contains lactose

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

3. How to take aileva Diario

Follow exactly the dosing instructions for this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Each aileva Diario blister contains 28 tablets (21 pink and 7 white). Take the first pink tablet from the blister marked with the number “1”. Follow the direction of the arrows on the blister to take the tablets in the correct order. You must take one pink tablet daily 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 applied on the day you start taking the contraceptive. For example, if you start taking the tablets on a Tuesday, select the adhesive strip starting with “TUE” and apply it to the first row labeled: “Place the adhesive strip matching your start date here”. Take the tablets with water if necessary, at the same time each day, until the pack is finished. After taking the last tablet, start a new pack the next day. You must always start the next pack on the same day of the week.

During the week you take the white tablets, you will experience a withdrawal bleed similar to a 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 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 must use an additional barrier contraceptive method (e.g., condoms) for the first 7 days.

If switching from a combined oral contraceptive pill

If you are currently taking 21-tablet packs

Finish the current pack of your current pill and start taking aileva Diario the next day, without a break.

If you are currently taking “daily” pills containing 28 tablets per pack

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

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

When switching from a progestogen-only pill, you may start aileva Diario at any time during your menstrual cycle, beginning the day after stopping the progestogen-only pill.
When switching from an implant, start using aileva Diario on the day of its removal.
When switching from a contraceptive injection, start aileva Diario on the day your next injection would have been due.

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

If starting aileva Diario after a first-trimester abortion (within the first 3 months of pregnancy)

You may start taking this medicine immediately, but you should follow your doctor’s advice before doing so. An additional barrier contraceptive method is not required.

If starting aileva Diario after childbirth or after a second-trimester abortion

Like any other oral contraceptive, this medicine should not be started earlier than 28 days after giving birth or after a second-trimester abortion, as the risk of blood clots is increased. You must use a barrier contraceptive method (e.g., condom) during the first 7 days of taking levonorgestrel/ethinylestradiol. If you have had sexual intercourse before starting levonorgestrel/ethinylestradiol, ensure you are not pregnant or wait until your next period.

If in doubt, always consult your doctor.

If you forget to take aileva Diario

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

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

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

take the most recently missed tablet immediately, even if this means taking two tablets in one day
continue taking the tablets at your usual times until the end of the pack
additionally, use a barrier contraceptive method (e.g., condoms) for the next 7 days
if this 7-day period extends beyond the last pink tablet in the pack, start the next pack immediately without taking any of the inactive white tablets. You may experience spotting or bleeding while taking the second pack, but this is not a cause for concern.

If you have missed one or more pink tablets in a pack and do not have any 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 additional action is required other than starting the next pack on your usual day.

If you vomit or have diarrhea

If you vomit or have severe diarrhea within 4 hours of taking a tablet, it is as if you had missed a pink tablet. After vomiting or having diarrhea, take another pink tablet from your reserve pack as soon as possible. If possible, take it within the next 12 hours or at your usual time of taking the pill. If this is not possible or more than 12 hours have passed, follow the instructions given under “If you realize you have forgotten to take a pink tablet more than 12 hours after your usual time.”

If episodes of vomiting or severe diarrhea recur over several days, a barrier contraceptive method (e.g., condoms) should be used until the start of the next pack. Consult your doctor if you have any doubts.

If you vomit or have diarrhea while taking the white tablets, no action is required, provided the vomiting and diarrhea have stopped by the time you start the next pack and you begin it on your usual day.

How to delay your period

You can delay your period by immediately starting another pack of aileva Diario without taking any of the white tablets. You may experience some spotting or bleeding while taking the second pack, but this is not a cause for concern. You should have a normal withdrawal bleed 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 recommended, you may experience symptoms such as gastrointestinal problems (e.g., nausea, vomiting, abdominal pain), breast tenderness, dizziness, drowsiness/fatigue, and vaginal bleeding. These symptoms will gradually subside as your body processes the excess hormones.

If you are concerned, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed 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 hives with possible difficulty breathing (see also section “Warnings and precautions”).

If you experience any of the following serious adverse effects, consult your doctor immediately:

A severe allergic reaction – frequency is unknown.

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 is unknown.

Symptoms include sudden loss of vision, eye pain and swelling, especially if sudden.

Haemolytic uraemic syndrome (a condition affecting the blood and kidneys) – frequency is unknown.

Symptoms include vomiting, diarrhoea (which may be bloody), fever, feeling weak, urinating less than usual.

Pancreatitis – frequency is unknown.

Symptoms include severe upper abdominal pain, which may spread to the back.

Erythema multiforme – frequency is unknown.

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

Other adverse effects include:

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

headache, including migraines
bleeding and spotting between periods
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
dizziness
vomiting
diarrhoea
feeling of bloating in the abdomen
acne (spots)
skin rash
absence of periods (amenorrhoea)
changes in the amount of menstrual bleeding and in the duration of periods
breast pain/tenderness, breast enlargement or breast discharge
changes in the cervix that may be seen on a smear test
fluid retention (e.g. swollen ankles)
weight gain or weight 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)
abnormal hair growth (hirsutism)
hair loss
dark patches on the skin (may have occurred during 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 available data

benign or malignant liver tumour
worsening of an autoimmune disease called systemic lupus erythematosus
worsening of a hereditary blood disorder called porphyria
worsening of uncontrolled or spasmodic body movements (chorea)
optic neuritis: symptoms include blurred vision and may lead to partial or complete vision loss
intolerance to contact lenses
gallbladder disease or worsening of this condition
inflammatory or ischaemic bowel disease: symptoms include abdominal pain and cramps, diarrhoea (which may be bloody), weight loss
stomach cramps
vaginal discharge
decreased levels of folate in blood

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of aileva Diario

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of aileva Diario

Active film-coated pink tablets:

The active ingredients are levonorgestrel and ethinylestradiol.
Each pink film-coated active tablet contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol.
Other excipients are:
Tablet core: monohydrate lactose, potassium polacrilin, microcrystalline cellulose, magnesium stearate.
Coating: Opadry II pink, containing macrogol 3350, titanium dioxide (E171), poly (vinyl alcohol), talc (E553b), red iron oxide (E172), yellow iron oxide (E172).

Placebo film-coated white tablets:

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

Appearance of the product and contents of the pack

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 Diario is packaged in PVC/PVDC/aluminum blisters containing 28 tablets, comprising 21 active tablets and 7 placebo tablets.

aileva Diario 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 medicinal product is authorized in the European Economic Area Member States under the following names:

Italy: Jadiza 100/20 micrograms film-coated tablets

Spain: aileva Diario film-coated tablets

Date of the most recent review of this leaflet: September 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. 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