Patient Information Leaflet

Loette 100 /20 microgram film-coated tablets

levonorgestrel / etinilestradiol

1.What Loette is and what it is used for

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

3.How to take Loette

4.Possible side effects

5.Storage of Loette

6. Contents of the pack and additional information

Loette 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.

Do not take Loette:

• 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), arrhythmia, or heart valve disorder.
• Deep vein thrombosis, pulmonary embolism, or rupture of blood vessels in the brain (apoplexy), mini-apoplexy, or a tendency to form blood clots (venous or arterial thrombosis).
• Chest pain caused by angina pectoris.
• Uncontrolled high blood pressure.
• 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 unexplained vaginal bleeding.
• 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 Loette 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 with other medications").

Advertencias and precautions

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

In some situations, special care may be needed when taking Loette 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 significant 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. If any of the situations related below develop or worsen while taking Loette, you should consult your doctor to decide if Loette 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 arrhythmia (atrial fibrillation).
• You have a family history (parents, siblings, or children) of a disease that tends to develop blood clots (in the legs, lungs, or any other part of the body) or have had heart attacks or apoplexies.
• You have varicose veins or have had superficial venous inflammation 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 condition 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 lie in the sun while taking Loette.
• You have a systemic lupus erythematosus disorder that affects your immune system.
• You have a condition 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 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 known as 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 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 and thrombosis (blood clots)

Deep vein thrombosis (blood clots)

The use of any combined pill, including Loette, 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 (parents, siblings, or children) has had a disease that tends to develop blood clots in the veins
• with prolonged immobilization (for example, with one or both legs in a cast or splint), major surgery, any type of surgery in the legs, or significant trauma. In these situations, it is better to stop taking Loette (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 related to an increased risk of arterial thrombosis (obstruction of an artery), for example, in the blood vessels of the heart (heart attack) or the 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, especially if you are over 35 years old.
• with age, although you do not smoke
• if you have high cholesterol levels or triglycerides
• if you are overweight
• if a close relative 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, arrhythmia).

Loette and cancer

Cancer of the breast 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 abdominal pain.

Intermenstrual bleeding

During the first few months of taking Loette, you may experience unexpected bleeding (bleeding or spotting outside of the pill-free week). If this bleeding lasts more than a few months or starts after some months, your doctor should investigate the cause.

What to do if there is no bleeding in the pill-free week

If you have taken all the pills correctly, have not had severe vomiting or diarrhea, and 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 a new pack until you are sure you are not pregnant.

Taking Loette 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 can interact with Loette.

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 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.

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

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

If you have been told to take 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 your current pack, do not skip the pill-free week 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 may interfere with the following medications:

• Ciclosporin (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 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 can be used again approximately 2 weeks after completing this treatment. See the section "Do not take LOETTE."

Pregnancy and breastfeeding

Pregnancy

Do not take Loette if you are pregnant. If you think you may be pregnant while taking Loette, 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

There is no study on the effect of Loette 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 contains lactose

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

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 Loette blister contains 21 tablets. Take the first tablet from the blister where the correct day of the week appears. You must take one tablet every day, with water if necessary, and at the same time every day until the package is finished. You will then have a week off from taking tablets before starting the next package of tablets. You must always start the next package on the same day of the week.

During the week off from taking 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 you are starting with the pill for the first time or 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 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 immediately the next day without leaving any gap.

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

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

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

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

You can start taking Loette 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 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, it is recommended to use a barrier contraceptive method during the first 7 days you take the pill. If you have had sex before starting with Loette, make sure you are not pregnant or wait until your next period.

Consult your doctor in case of doubt.

If you forgot to take Loette

If you take more Loette than you should

If you accidentally take more Loette 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.

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 experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

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

• A 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.

Thesymptoms include: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also "Warnings and precautions").

• A 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, and 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 have 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 or tenderness in the breasts, enlargement or discharge from the breasts
• Changes in the cervix that can be seen in a Pap smear
• Fluid retention (e.g. swollen ankles)
• Weight gain or loss
• Changes in blood lipid levels (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 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 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 bowel disease: symptoms include abdominal pain and cramps, diarrhea (which may be bloody), weight loss.
• Stomach 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, consult your doctor.

Reporting of side effects:

If you consider that any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.You can also report them directly to theSpanish System for the 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:

Do not dispose of medications through drains or trash.Deposit the containers and medications you no longer need at the SIGREpoint of the pharmacy. Please ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Loette

The active principles 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), iron oxide red (E172), and montan wax glicolate.

Appearance of the product and contents of the package

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

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 (silica gel) package. Once the aluminum bag is opened, the desiccant can be discarded.

Each package may contain:

1 x 21 tablets

3 x 21 tablets

6 x 21 tablets

13 x 21 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

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 leaflet: 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/