Loette Diario 100/20 micrograms film-coated tablets: detailed information

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Loette Diario 100/20 micrograms film-coated tablets

levonorgestrel / ethinylestradiol

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Package leaflet

What Loette Diario is and what it is used for
What you need to know before starting to take Loette Diario
How to take Loette Diario
Possible side effects
Storage of Loette Diario
Contents of the pack and other information

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

Loette Diario is a combined oral contraceptive tablet for the prevention of pregnancy. It contains two different female hormones, levonorgestrel and ethinylestradiol.

Each of the 21 round pink tablets contains 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol. The pack also includes 7 inactive white tablets (placebo).

2. What you need to know before starting to take Loette Diario

Before you start taking Loette Daily, your doctor will ask you some questions about your medical history and personal relationships. Your doctor will also measure your blood pressure and may carry out other examinations.

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

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

Do not take Loette Diario if:

You are allergic to the active substances (levonorgestrel or ethinylestradiol) or to any of the other ingredients of this medicine (listed in section 6).
You have or have had heart problems or blood vessel disorders, particularly:
heart attack (myocardial infarction), irregular heartbeat, or heart valve disorders
blood clots 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.
You have uncontrolled high blood pressure despite treatment.
You suffer from certain types of migraine (migraine with focal neurological symptoms).
You have breast cancer, uterine cancer, or a type of cancer sensitive to female hormones, or if you suspect you may have any of these cancers.
You have vaginal bleeding of unknown cause.
You have high blood sugar levels (diabetes) associated with blood vessel complications.
You are pregnant or suspect you might be pregnant.
You have or have had a benign or malignant liver tumor, or if you have recently had liver disease. In such cases, your doctor will ask you to stop taking Loette Diario until your liver function returns to normal.
You have hepatitis C and are taking medications containing ombitasvir / paritaprevir / ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Taking Loette Diario with other medicines").

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Loette Diario.

Special care may be needed when taking Loette Diario or any combined oral contraceptive. Your doctor will monitor you routinely. 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 using oral contraceptives should not smoke. Women over 35 who smoke should consider using other contraceptive methods.

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

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 have diabetes.
You have heart valve problems or an irregular heartbeat (atrial fibrillation).
You or a close relative (parent, sibling) have had a condition associated 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 had inflammation in the superficial leg veins (superficial thrombophlebitis).
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 severe itching.
You develop migraine for the first time or experience worsening of an existing migraine.
You have or develop liver disease, jaundice, inflammation of the pancreas, or kidney disorder.
You have depression.
You have hearing loss due to a condition known as otosclerosis.
You had a skin condition during pregnancy or while taking another contraceptive pill that caused itching, red spots, or blisters (herpes gestationis).
You developed temporary brown patches on your skin during pregnancy (chloasma). The pill may cause this to recur, so you should avoid sun exposure or sunbathing while taking Loette Diario.
You have a disorder affecting your immune system (systemic lupus erythematosus).
You have a disease 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 difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Psychiatric disorders

Some women using hormonal contraceptives such as Loette Diario have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor for medical advice as soon as possible.

Loette Diario and thrombosis (blood clots)

Venous thrombosis (blood clots)

Using any combined oral contraceptive pill, including Loette 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 had a condition involving a tendency to form blood clots at a young age
during prolonged immobilization (e.g., with one or both legs in casts or splints), major surgery, any type of leg surgery, or major trauma. In such cases, it is advisable to stop taking Loette 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 forming blood clots, so you should consult your doctor about when you can 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 Loette 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 heart problems (valve disorders, irregular heart rhythms).

Stop taking Loette 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 shortness of breath, or suffocation
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.

Loette Diario and cancer

Breast cancer has been diagnosed slightly more frequently in women using combined oral contraceptives, but it is unknown whether the pill causes this increase. It is possible that these women are simply examined more thoroughly and frequently, making it more likely that breast cancer will be detected earlier.

Studies have reported 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 change of partners) 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 Loette Diario, 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 tablet intake (white tablets)

If you have taken all tablets correctly, have not experienced vomiting or severe diarrhea, and have not taken any other medications, it is very unlikely that you are pregnant.

If you miss your period for a second consecutive cycle, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you have confirmed that you are not pregnant.

Taking Loette Diario with other medicines

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

Some medicines may interact with Loette Diario.

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 Loette Diario as a contraceptive.

They may advise you whether additional contraceptive precautions are needed (e.g., using condoms or other barrier methods) while taking other medicines with Loette Diario.

Some medicines may make Loette Diario 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 method for several weeks after stopping the interacting medicine.

Loette Diario 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 LOETTE DIARIO if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and 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.

LOETTE DIARIO can be restarted approximately 2 weeks after completing this treatment. See the section “Do not take LOETTE DIARIO”.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

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

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

Driving and using machines

The effect of Loette Diario on the ability to drive or use machines has not been studied. Dizziness has been reported as an adverse effect. If you experience dizziness, do not drive or use machines until the symptoms have resolved.

Loette Diario contains lactose

Loette Diario contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking Loette Diario.

3. How to take Loette Diario

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

Each Loette Diario blister pack contains 21 pink tablets and 7 white tablets. Take the first pink tablet from the blister pack marked with the number “1”. You must take one pink tablet daily for 21 days, followed by the white tablets for 7 days. Take the tablets with water if necessary, at the same time each day, until the pack is finished. Once you have taken 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 usually 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 2–7 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 using a 21-tablet pack

Finish the current pack and start taking Loette Diario the next day, without a break.

If you are currently using a 28-tablet “daily” pack

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

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

If switching from a progestogen-only pill, you may start Loette Diario at any time during your menstrual cycle, starting the day after stopping the progestogen-only pill.
If switching from an implant, start using Loette Diario the day after removal of the implant.
If switching from a contraceptive injection, start Loette Diario the day after the date you would have received your next injection.

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

If starting Loette Diario after a first-trimester (3-month) abortion

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

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

Like any other contraceptive pill, Loette Diario 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. If you start later, you are advised to use a barrier contraceptive method during the first 7 days of taking the pill. If you have had sexual intercourse before starting Loette Diario, make sure you are not pregnant or wait until your next period.

If in doubt, always consult your doctor.

If you forget to take Loette Diario

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

If you realize that 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 the end of the pack.

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

take the last missed tablet immediately, even if this means taking two tablets on the same day
continue taking the tablets at your usual times until the end of the pack
in addition, use a barrier contraceptive method (e.g., condoms) for the next 7 days

if this 7-day period extends beyond the last pink tablet of 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 needed other than starting the next pack on the usual day.

If you experience vomiting or 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, you should take another pink tablet from a spare pack as soon as possible. If possible, take it within the next 12 hours or at your usual pill-taking time. If this is not possible or more than 12 hours have passed, you should follow the advice given under “If you realize that 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 are unsure.

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

How to delay your period

You can delay your period by immediately starting another pack of Loette 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 Loette Diario than you should

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

If you are concerned, consult your doctor.

Contact your doctor or pharmacist immediately, or contact the Toxicology Information Service. Telephone: 91 562 04 20.

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 serious, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

If you experience any of the following serious adverse effects, seek immediate medical advice:

A severe allergic reaction: frequency unknown

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

Angioedema: frequency unknown

Symptoms include swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives possibly with difficulty breathing (see also section “Warnings and precautions”).

A blood clot in the eye: frequency unknown

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

Haemolytic uraemic syndrome (a condition affecting the blood and kidneys): frequency unknown

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

Pancreatitis: frequency unknown

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

Erythema multiforme: frequency 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 a fever.

Other adverse effects include:

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

headache, including migraine
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 sexual desire
feeling nervous
dizziness
vomiting
diarrhoea
bloating sensation in the abdomen
acne (spots)
skin rash
absence of periods (amenorrhoea)
changes in the amount of menstrual blood loss and in the duration of periods
breast pain/tenderness, breast enlargement or breast discharge
changes in the cervix that may be seen on a Pap smear
fluid retention (e.g. swollen ankles)
weight gain or weight loss
changes in blood fat 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 patches on the skin (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 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 blood folate levels

If you are concerned about new symptoms or other health-related issues while taking Loette Diario, consult your doctor.

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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Loette Daily

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

This medicine does not require any special storage conditions. Do not use this medicine after the expiry date stated on the blister and the carton, following EXP. The expiry date is the last day of the month indicated.

If you stop taking Loette Daily:

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Loette Diario

The active substances in the pink tablets are 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol.

The other components are: monohydrate lactose, microcrystalline cellulose, potassium polacrilin, magnesium stearate, hypromellose (E464), macrogol 1450, titanium dioxide (E171), iron oxide red (E172), glycolized montan wax.

The inactive white tablets contain: monohydrate lactose, microcrystalline cellulose, magnesium stearate, potassium polacrilin, hypromellose 2910 (E464), hydroxypropyl cellulose, titanium dioxide (E171), macrogol, macrogol 1500, glycolized montan wax.

Appearance of the product and pack contents

Loette Diario is packaged in aluminum/PVC blister packs containing 21 film-coated, round, biconvex pink tablets marked with a "W" on one side and 912 on the other side, and additionally 7 biconvex film-coated white tablets.

The blisters are contained within a cardboard box or a wallet placed inside a cardboard box. Each blister is packed in an aluminum pouch containing a desiccant sachet (silica gel). Once the aluminum pouch is opened, the desiccant may be discarded.

Each pack may contain:

1 x 28 tablets

3 x 28 tablets

6 x 28 tablets

13 x 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Wyeth Farma S.A.

Ctra. Burgos, km 23

28700 San Sebastián de los Reyes (Madrid)

Spain

Manufacturer Responsible:

Pfizer Ireland Pharmaceuticals Unlimited Company,

Little Connell,

Newbridge,

Co. Kildare,

W12 HX57,

Ireland

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain	Loette Daily 100/20 micrograms film-coated tablets
Denmark	LOETTE

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

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