Patient Information Leaflet

Loette Diario 100 /20 microgram film-coated tablets

levonorgestrel / etinilestradiol

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

2.What you need to know before you start taking Loette Diario

3.How to take Loette Diario

4.Possible side effects

5.Storage of Loette Diario

6.Contents of the pack and additional information

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

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

Do not take Loette Diario:

• If you are allergic to the active ingredients (levonorgestrel or ethinylestradiol) or to any of the other components of this medication (including those listed in section 6).
• If you have or have had heart problems or blood vessel problems, particularly:

• heart attack (myocardial infarction), alteration of heart rhythm or heart valve disorder
• blood clots in the legs (deep vein thrombosis), or in the lungs (pulmonary embolism) or rupture of brain blood vessels (apoplexy), mini-apoplexy 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 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.
• 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 Loette Diario until your liver has returned to normal.
• If you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section Taking Loette Diario with other medications).

Warnings and precautions

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

In some situations, special care may be needed when taking Loette 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 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 situations, inform your doctor before starting to take Loette Diario. If any of the situations related below develop or worsen while taking Loette Diario, you should consult with your doctor to decide if Loette Diario is suitable for you.

Inform your doctor if:

• You have high blood pressure.
• You have high cholesterol levels or abnormal lipid levels in the blood (hyperlipidemia) - these levels are detected in a blood test.
• You are obese.
• You are diabetic.
• You have heart valve problems or heart rhythm disorder (atrial fibrillation).
• You have had or a close relative (parents, brothers, or sisters) has had a disease with a tendency to develop blood clots in the blood vessels.
• You have varicose veins or have had inflammation of the superficial veins in the legs.
• You experience sudden and inexplicable changes in vision.
• You have gallstones, bile duct disorders, or problems caused by bile duct blockage (cholestasis) - may cause intense itching.
• You develop migraine for the first time or worsen an existing migraine.
• You have or develop liver disease, jaundice, or pancreatitis or kidney disorder.
• You have depression.
• You have hearing loss due to a known disorder called otosclerosis.
• You have had during pregnancy or while taking another contraceptive pill a skin problem that caused itching, red spots, or blisters (herpes gestationnis).
• You have had during pregnancy brownish skin spots (chloasma). The pill may cause this to recur, so you should avoid exposure to the sun or lying in the sun while taking Loette Diario.
• You have a disorder that affects your immune system (systemic lupus erythematosus).
• You have a disease known as Sydenham's chorea. Symptoms include irregular, sudden, and involuntary movements.
• You have had a blood disorder associated with kidney disease (hemolytic-uremic syndrome).
• You have had a blood disorder 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 disorder called sickle cell disease or anemia.

If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

Mental health disorders

Some women who use hormonal contraceptives like Loette 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.

Loette Diario and thrombosis (blood clots)

Deep vein thrombosis (blood clots)

The use of any combined pill, including Loette Diario, increases the risk in women of developing deep vein thrombosis (formation of blood clots in the veins) compared to women who do not take any pill (contraceptive).

The risk of deep vein thrombosis in patients taking combined pills increases:

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

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 heart (heart attack) or brain (apoplexy).

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

• if you smoke. It is strongly recommended to stop smoking when taking Loette Diario, especially if you are over 35 years old
• with age, although you do not smoke
• if you have high levels of fat in the blood (cholesterol or triglycerides)
• if you are overweight
• if one of your close relatives has had a heart attack or apoplexy at a young age
• if you have high blood pressure
• if you have migraines
• if you have any heart problem (valve disorder, heart rhythm disorder).

Loette 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 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 Loette 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 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 blister until you are sure you are not pregnant.

Taking Loette Diario with other medications

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 with Loette 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 taking Loette Diario as a contraceptive.

They may indicate if you need to take additional precautions (e.g., use condoms or other barrier contraceptives) while taking other medications with Loette Diario.

Some medications may make Loette Diario less effective in preventing pregnancy, or may cause unexpected bleeding. These include medications used to treat:

• HIV infections (ritonavir, nevirapina)
• Epilepsy (e.g., phenobarbital, phenytoin, primidone, felbamate, carbamazepine, oxcarbazepine, or topiramate)
• Infections (e.g., rifabutin, rifampicin, or griseofulvin)
• Sleep disorders (modafinilo)
• Gout (phenylbutazone)
• St. John's Wort (Hypericum perforatum) used to treat certain types of depression.

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 white pills in your current pack, do not take the white pills 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 medication.

Loette Diario may interact with the following medications:

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

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 take LOETTE DIARIO if you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver test results (elevated ALT enzyme levels).

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

LOETTE DIARIO can be used again 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 be pregnant while taking Loette Diario, consult your doctor immediately.

Breastfeeding

It is not recommended to take the combined pill while breastfeeding as the hormones may affect the 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 Loette 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.

Loette Diario contains lactose

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

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 of Loette Diario contains 21 pink tablets and 7 white tablets. Take the first pink tablet from the blister where the number “1”appears. You should take one pink tablet every day for 21 days, followed by the white tablets for 7 days. Take the tablets with water if necessary, and at the same time every day until the packaging is finished. Once you finish the last tablet, start the next day with a new package of tablets. You should always start the next package on the same day of the week.

During the week 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 package 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 2-7 of the cycle), you will need to use an additional barrier contraceptive method (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 package

Finish the package of the current pill, and start taking Loette Diario the next day, without interruption.

If you are taking “daily” pills that contain 28 tablets in the package

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

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

• If you change from a pill that only contains progestin, you can start with Loette Diario at any time of your menstrual cycle, the day after stopping the pill that only contains progestin.
• If you change from an implant, start using Loette Diario the day after the implant is removed.
• If you change from an injectable contraceptive, start with Loette Diario the day after the next injection would be due.

In all casesyou should use a barrier contraceptive method during the first 7 days of taking the pill.

If you start with Loette Diario after a first-trimester abortion (3 months) of pregnancy

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

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

Like any other combined oral contraceptive pill, Loette Diario should not be initiated before 28 days after giving birth, or after a second-trimester abortion, as the risk of blood clots increases. If you start later, you are recommended to use a barrier contraceptive method during the first 7 days you take the pill. If you have had sex before starting Loette Diario, make sure you are not pregnant or wait until your next period.

In case of doubt, consult your doctor always.

If you forget to take Loette Diario

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 decrease as your body adjusts to the excess hormones.

If you are concerned, consult your doctor.

Consult your doctor or pharmacist immediately, or the Toxicology Information Service. Phone: 91 562 04 20.

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.

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

• Severe allergic reaction:frequency unknown.

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

• Angioedema:frequency unknown.

The symptoms include: swelling of the face, tongue and/or throat and/or difficulty swallowing or urticaria with possible difficulty breathing (see also section “Warnings and precautions”).

• Blood clot in the eye:frequency unknown.

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

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

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

• Pancreatitis:frequency unknown.

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

• Erythema multiforme:frequency unknown.

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 ulcers in the mouth, eyes or genitals, and may have 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
• Feeling bloated in the abdomen
• Acne (pimples)
• Skin rash
• Amenorrhea (absence of period)
• Changes in the amount of bleeding and duration of periods
• Pain/sensitivity in the breasts, enlargement or discharge from the breasts
• Changes in the cervix 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 spots on the skin (may have been present from a previous pregnancy)
• Increased blood pressure
• Bile stones
• 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 an abnormal flow of bile in the liver)
• Boils under the skin that are painful and red (erythema nodosum)

Frequency not known:cannot be estimated from available data

• Benign or malignant liver tumor
• 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)
• Inflammation of the optic nerve: symptoms include blurred vision and may lead to total or partial loss of vision
• Intolerance to contact lenses
• Biliary tract 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 folate levels in the blood

If you are concerned about new symptoms or other aspects of your health while taking Loette Diario, consult your doctor.

Reporting of side effects:

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly to theSpanish System for Pharmacovigilance of Medicines for Human Use: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.

This medication does not require special storage conditions. Do not use this medication after the expiration date that appears on the blister pack and on the case after CAD. The expiration date is the last day of the month indicated.

If you stop taking Loette Daily:

Medicines should not be thrown down the drain or in the trash.Dispose of the containers and medicines you no longer need at the SIGREPoint of the pharmacy. Please ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Loette Diario

The active principles of the pink-colored tablets are 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol.

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

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

Appearance of the product and contents of the package

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

The blister packs are found inside a cardboard box or inside a carton that fits inside the cardboard box. Each blister is packaged in an aluminum bag containing a desiccant packet (silica gel). Once the aluminum bag is opened, the desiccant can be discarded.

Each package may contain:

1 x 28 tablets

3 x 28 tablets

6 x 28 tablets

13 x 28 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

For more information about this medication, 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 medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this prospectus: November 2023

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