LOETTE 100/20 micrograms FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Loette 100/20 micrograms film-coated tablets

levonorgestrel / ethinylestradiol

Contents of the pack

1. What is Loette and what is it used for
2. What you need to know before you start taking Loette
3. How to take Loette
4. Possible side effects
5. Storing Loette
6. Contents of the pack and other information

1. What is Loette and what is it used for

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 tablets contains 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol.

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

Do not take Loette:

• 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).
• If you have or have had heart or blood vessel problems, in particular:

• heart attack (myocardial infarction), irregular heartbeat, or heart valve disorders.
• blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism), or a stroke (cerebral haemorrhage), transient stroke, or a tendency to form blood clots (venous or arterial thrombosis).
• chest pain caused by angina.
• If you have uncontrolled high blood pressure.
• If you have certain types of migraine (migraine with neurological symptoms).
• If you have breast cancer or cancer of the uterus, or a type of cancer that is sensitive to female hormones, or if you suspect you may have one 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 think you may be pregnant.
• If you have or have had a benign or malignant tumor in the liver, 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 medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Taking Loette with other medicines").

Warnings and precautions

Consult your doctor, pharmacist, or nurse before you start taking Loette.

In some situations, you may need special care when taking Loette or any other combined oral contraceptive. Your doctor will check you regularly. Smoking cigarettes increases the risk of serious heart and blood vessel problems 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 conditions, tell your doctor before you start taking Loette. If any of the following conditions occur or worsen while you are taking Loette, you should consult your doctor to decide whether Loette is suitable for you.

Tell your doctor if:

• You have high blood pressure.
• You have high cholesterol or abnormal blood lipid levels (dislipidemia) - these levels can be detected in a blood test.
• You are obese.
• You have diabetes.
• You have heart valve problems or irregular heartbeat (atrial fibrillation).
• You have or have had a blood clotting disorder (in the legs, lungs, or any other part of the body) or have a family history of blood clots.
• You have varicose veins or have had inflammation of the superficial veins of the legs.
• You experience sudden and unexplained changes in vision.
• You have gallstones, gallbladder disorders, or problems caused by blockage of the bile ducts (cholestasis) - this can cause intense itching.
• You develop migraine for the first time or experience worsening of existing migraine.
• You have or develop liver disease, jaundice, or pancreatitis, or kidney disorder.
• You have depression.
• You have hearing loss due to a condition known as otosclerosis.
• You have had a skin problem during pregnancy or while taking another oral contraceptive that caused itching, red spots, or blisters (herpes gestationis).
• You have had temporary brown spots on the skin during pregnancy (chloasma). The pill may cause this to happen again, so you should avoid exposure to the sun or sunlamps while taking Loette.
• You have a condition that affects your immune system (systemic lupus erythematosus).
• You have a condition known as Sydenham's chorea. The symptoms include irregular, sudden, and involuntary movements.
• You have had a blood disorder associated with kidney disease (haemolytic uraemic 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).
• If 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 urticaria with possible difficulty breathing, contact a doctor immediately. Products that contain estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

Psychiatric 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 blood clots

Venous thrombosis (blood clots)

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

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

• with age
• if you are overweight
• if a close relative has had a disease with a tendency to form blood clots at a young age
• with prolonged immobilization (for example, with one or both legs in plaster or splints), major surgery, any type of surgery on the legs, serious injury. In these situations, it is best to stop taking Loette (if surgery is planned, you should stop taking it at least four weeks in advance) and not start again until two weeks after you can get up 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 after childbirth.

Arterial thrombosis (blood clots)

The use of combined pills 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 patients taking combined pills increases:

• if you smoke. It is strongly recommended that you stop smoking when taking Loette, especially if you are over 35 years old.
• with age, even if you do not smoke
• if you have high blood fat levels (cholesterol or triglycerides)
• if you are overweight
• if a close relative has 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 (heart valve disorders, irregular heartbeat).

Loette and cancer

Breast cancer has been diagnosed slightly more frequently in women who use the combined pill, but it is not known whether the cancer is caused by the pill. It is possible that these women are simply examined more thoroughly and more frequently, so that there is a greater chance of breast cancer being detected earlier.

There have been reports of cervical cancer in women who have taken combined pills for a relatively long period. It is currently not known 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 liver cancer, have been reported in patients taking the pill. Contact your doctor if you have severe unusual abdominal pain.

Irregular bleeding

During the first few months that you are taking Loette, you may have irregular bleeding (bleeding or spotting outside of the pill-free week). If these bleeding episodes last more than a few months, or if they start after some months, your doctor should investigate the cause.

What to do if you do not have a withdrawal bleed during the pill-free week

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

If your period does not occur for the second consecutive time, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Taking Loette with other medicines

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

There are medicines that can interact with Loette.

Medicines can sometimes interfere with each other. If you are receiving treatment from another doctor, nurse, or qualified healthcare professional, make sure they know that you are taking Loette as a contraceptive.

They may tell you that you need to take extra precautions (e.g., use a condom or another barrier method) while you are taking other medicines with Loette.

Some medicines may make Loette less effective in preventing pregnancy or may cause irregular bleeding. These include medicines used to treat:

• HIV infections (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 told to take extra contraceptive precautions while taking any of the above medicines, follow your doctor's instructions carefully. If you need to continue taking the medicine after the current pack is finished, do not take the pill-free week and start a new pack immediately.

In some cases, you may need to continue using a barrier contraceptive for several weeks after stopping the medicine.

Loette may interfere with the following medicines:

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

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

Taking a medicine called flunarizine used to prevent migraines may increase the risk of galactorrhoea. This is a condition where the breasts produce milk spontaneously without breastfeeding or having recently given birth.

Do not take LOETTE if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver test results (increase in liver enzyme ALT).

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

LOETTE can be used again approximately 2 weeks after the end of 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 have become pregnant while taking Loette, consult your doctor immediately.

Breastfeeding

It is not recommended that you 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 contraceptive methods.

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

Driving and using machines

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

Loette contains lactose

Loette contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking Loette.

3. How to take Loette

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

Each Loette blister pack contains 21 tablets. Take the first tablet from the blister pack where the correct day of the week appears. You should take one tablet every day, with water if necessary, and at the same time every day until the pack is finished. Then you will have a week without taking tablets before starting the next pack of tablets. You should always start the next pack on the same day of the week.

During the week without taking tablets, you will have a bleed similar to a period. This bleed usually starts after 2-3 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 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 will need to use an additional barrier contraceptive method (e.g., condoms) for the first 7 days.

If you are changing from a combined contraceptive pill

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

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

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

If your current pill pack contains inactive tablets (placebo), do not take these tablets and start Loette immediately the next day without leaving any break.

If you are changing from a progestogen-only pill, injection, or implant

• If you are changing from a progestogen-only pill, you can start Loette at any time during your menstrual cycle, the day after you stop taking the progestogen-only pill.
• If you are changing from an implant, start using Loette the day after the implant is removed.
• If you are changing from an injectable contraceptive, start Loette the day after you would have had your next injection.

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

If you start Loette after an abortion during the first trimester (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 Loette after having a baby or after an abortion during the second trimester

Like any other contraceptive pill, Loette should not be started before 28 days after giving birth or after an abortion in the second trimester of pregnancy, as this increases the risk of blood clots. If you start later, it is recommended that you use a barrier contraceptive method during the first 7 days you take the pill. If you have had sex before starting Loette, make sure you are not pregnant or wait until your next period.

In case of doubt, always consult your doctor.

If you forget to take Loette

If you take more Loette than you should

If you accidentally take more Loette 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 handles the excess hormones.

If you are concerned, consult your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience side effects, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet.

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

• A severe allergic reaction: frequency not known.

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

• Angioedema: frequency not known.

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").

• A blood clot in the eye: frequency not known.

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

• Hemolytic uremic syndrome (a condition that affects the blood and kidneys): frequency not known.

Symptoms include vomiting, diarrhea (which may be bloody), fever, feeling weak, decreased urine output.

• Pancreatitis: frequency not known.

Symptoms include severe pain in the upper abdomen, which may radiate to the back.

• Erythema multiforme: frequency not known.

Symptoms include a skin rash with pink-red patches, especially on the palms or soles of the feet, which may blister. You may also have ulcers in the mouth, eyes, or genitals, and may have a 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
• mood changes, including depression
• decreased sex drive
• feeling nervous
• feeling dizzy
• vomiting
• diarrhea
• feeling bloated in the abdomen
• acne (pimples)
• skin rash
• absence of period (amenorrhea)
• changes in the amount of blood loss and duration of periods
• breast pain or tenderness, enlargement, or discharge
• changes in the cervix that can be seen on a Pap smear
• fluid retention (e.g., swollen ankles)
• weight gain or loss
• changes in blood lipid levels (seen on blood tests)

Uncommon(may affect up to 1 in 100 people)

• increased appetite
• decreased appetite
• hives (urticaria)
• abnormal hair growth (hirsutism)
• hair loss
• dark skin patches (which 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 the 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 can lead to total or partial loss of vision
• intolerance to contact lenses
• gallbladder disease or worsening of this condition
• inflammatory or ischemic intestinal disease: symptoms include abdominal pain and cramps, diarrhea (which may be bloody), weight loss.
• stomach cramps
• vaginal discharge
• decreased blood folate levels

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 think any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Loette

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date that appears on the blister pack and carton after EXP. The expiry date is the last day of the month indicated.

If you stop taking Loette:

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Loette

The active ingredients are 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol.

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

Appearance and packaging of the product

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

The blister packs are inside a cardboard box or inside a wallet that is inserted into the cardboard box. Each blister pack is packaged in an aluminum bag containing a desiccant sachet (silica gel). Once the aluminum bag is opened, the desiccant can be discarded.

Each pack may contain:

1 x 21 tablets

3 x 21 tablets

6 x 21 tablets

13 x 21 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: November 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/