Loette 100/20 micrograms film-coated tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Loette 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, since it could harm them. If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Package leaflet

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

1. What Loette is and what it is used for

Loette is a combined oral contraceptive tablet used to prevent 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 starting to take Loette

Before you start taking Loette, 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 some other tests. This leaflet describes certain situations in which you should stop taking Loette or where the effectiveness of Loette may be reduced, resulting in a 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 or temperature methods. These methods may not be reliable since Loette alters the monthly changes in body temperature and cervical mucus. Loette, like other oral contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Do not take Loette:

• If you are allergic to the active substances (levonorgestrel or ethinylestradiol) or to any of the other components of this medicine (listed in section 6).

• If you have or have had heart problems or blood vessel disorders, particularly:

• heart attack (myocardial infarction), irregular heartbeat, or heart valve disorders.

• blood clots in the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or rupture of blood vessels in the brain (stroke), mini-stroke, or a general tendency to form blood clots (venous or arterial thrombosis).

• chest pain caused by angina pectoris.

• If you have uncontrolled high blood pressure despite treatment.

• If you suffer from certain types of migraine (migraine with focal neurological symptoms).

• If you have breast cancer or uterine cancer, or a type of cancer sensitive to female hormones, or if you suspect you may have any of these cancers.

• If you have vaginal bleeding of unknown cause.

• If you have high blood sugar levels (diabetes) associated with blood vessel problems.

• If you are pregnant or suspect you might be pregnant.

• If you have or have had a benign or malignant liver tumor, or if you have recently had liver disease. In these cases, your doctor will ask you to stop taking Loette until your liver has returned to normal.

• If 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 with other medicines").

Warnings and precautions

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

Special care may be needed when taking Loette or any combined oral contraceptive. Your doctor will routinely monitor you. Smoking increases the risk of serious adverse effects on the heart and blood vessels associated with the use of oral contraceptives. This risk increases with age and the number of cigarettes smoked and is particularly significant in women over 35 years of age. Women who use 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 to take Loette. If any of the conditions listed below develop or worsen while you are taking Loette, you must consult your doctor to determine whether Loette is still 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 levels are detected in a blood test.
• You are obese.
• You are diabetic.
• You have heart valve problems or irregular heartbeat (atrial fibrillation).
• You or a close relative (parent, sibling) have had a condition that predisposes to blood clots (in the legs, lungs, or any other part of the body), or have a history of heart attacks or strokes.
• You have varicose veins or have had inflammation in the superficial veins of the legs.
• You experience a sudden and unexplained change in vision.
• You have gallstones, gallbladder disorders, or problems caused by blockage of the bile ducts (cholestasis) – this may cause intense itching.
• You develop migraine for the first time or experience worsening of an existing migraine.
• You have or develop liver disease, jaundice, pancreatitis, or kidney disorder.
• You have depression.
• You have hearing loss due to a disorder known as otosclerosis.
• You have had a skin condition during pregnancy or while taking another contraceptive pill that caused itching, red spots, or blisters (herpes gestationis).
• You had temporary brown patches on the skin during pregnancy (chloasma). The pill may cause this to recur, so you should avoid exposure to sunlight or sunbathing while taking Loette.
• 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 have reported depression or a depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for medical advice as soon as possible.

Loette and thrombosis (blood clots)

Venous thrombosis (blood clots)

Using any combined pill, including Loette, 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 pills increases:

• with age
• if you are overweight
• if a close relative has had a condition that predisposes to blood clots at an early age
• with prolonged immobilization (e.g., with one or both legs in casts or splints), major surgery, any type of leg surgery, or major trauma. In these situations, it is better to stop taking Loette (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 after delivery.

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 women taking combined pills increases:

• if you smoke. It is strongly recommended that you stop smoking while taking Loette, especially if you are over 35 years old.
• with age, even if you do not smoke
• if you have elevated fat levels in the blood (cholesterol or triglycerides)
• if you are overweight
• if one of your close relatives 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 heartbeat).

Stop taking Loette 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 increased blood pressure severe pain and/or swelling in one of your legs sudden, severe chest pain that may spread to the left arm difficulty breathing, or sudden shortness of breath sudden, unusual cough without obvious cause 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 and cancer

Breast cancer has been diagnosed with a slightly higher frequency in women who use combined oral contraceptives, but it is unknown whether the cancer is caused by the pill. It is possible that these women were simply examined more thoroughly and more frequently, thus increasing the likelihood that breast cancer would 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 partner changes) and other factors.

Rarely, benign liver tumors, and even a few cases of malignant liver tumors, have been reported in patients taking oral contraceptives. Contact your doctor if you experience unusual, severe abdominal pain.

Breakthrough bleeding

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

What to do if there is no 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 medication, it is highly unlikely that you are pregnant.

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

Taking Loette 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.

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 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.

Some medicines may make Loette 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 are 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 your current pack, do not take 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 interacting medicine.

Loette may interfere with the following medicines:

• Cyclosporine (used to suppress the 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 combined oral contraceptives.

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 having recently given birth.

Do not take LOETTE 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 (elevation of the liver enzyme ALT).

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

LOETTE may be used again approximately 2 weeks after completion 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 to take combined oral contraceptives while breastfeeding, as the 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 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 operate machinery until symptoms have resolved.

Loette contains lactose

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

3. How to take Loette

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

Each Loette blister pack contains 21 tablets. Take the first tablet from the blister on the day corresponding to the correct day of the week. You must take one tablet daily, with water if necessary, at the same time each day, until the pack is finished. After that, you will have a tablet-free week before starting the next pack of tablets. You should always start the next pack on the same day of the week.

During the tablet-free week, you will experience a withdrawal bleed similar to a period. This bleeding usually starts two or three days after stopping the tablets and may not have finished before you start the next pack.

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 the next day, without a break.

If you are currently using a 28-tablet "daily" pack

If your current pack contains inactive (placebo) tablets, do not take these tablets; instead, start Loette the next day immediately, without a break.

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

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

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

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

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

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

Like any other oral contraceptive, Loette should not be started earlier than 28 days after childbirth 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 for the first 7 days of taking the pill. If you have had sexual intercourse before starting Loette, 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

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

If you realize you have forgotten to take a tablet within 12 hours of your usual time, take the missed tablet immediately and continue taking the following tablets at the usual times until the end of the pack. If you realize you have forgotten to take a 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 in one day continue taking the tablets 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 tablet of the pack, start the next pack immediately without a break. 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 tablets in a pack and do not have any bleeding during the week off, you may be pregnant and should consult your doctor. 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 dose. After vomiting or having diarrhea, you should take another tablet from your reserve 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 if more than 12 hours have passed, you should follow the instructions given under “If you realize you have forgotten to take a 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 in doubt. How to delay your period You can delay your period by starting the next pack of Loette immediately without a break. 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 second pack.

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 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 experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

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 with possible 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, which 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. Mouth, eye or genital ulcers may also occur, and fever may be present.

Other adverse effects include:

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

• headache, including migraines
• bleeding and spotting between periods
• nausea
• abdominal pain
• painful periods

Common (may affect up to 1 in 10 people)

• vaginal irritation and infection, including candidiasis
• mood changes, including depression
• decreased 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 duration of periods
• breast pain/tenderness, breast enlargement or breast discharge
• changes in the cervix that may be seen on a smear test
• fluid retention (e.g. swollen ankles)
• weight gain or weight loss
• changes in blood fat levels (detected by blood tests)

Uncommon (may affect up to 1 in 100 people)

• increased appetite
• decreased appetite
• hives (urticaria)
• abnormal hair growth (hirsutism)
• hair loss
• dark patches on the skin (may 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 nerve inflammation: symptoms include blurred vision and may lead to partial or complete vision loss
• intolerance to contact lenses
• gallbladder disease or worsening of this condition
• inflammatory or ischaemic bowel disease: symptoms include abdominal pain and cramps, diarrhoea (which may be bloody), weight loss
• stomach cramps
• vaginal discharge
• decreased levels of folate in blood

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

Reporting of adverse effects:

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist. You may 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

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 after EXP. The expiry date is the last day of the month indicated.

If you stop taking Loette:

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in 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

The active substances 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), red iron oxide (E172), and glycolized montan wax.

Appearance of the medicine and contents of the pack

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

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

Each pack may contain:

1 x 21 tablets

3 x 21 tablets

6 x 21 tablets

13 x 21 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: Pfizer Ireland Pharmaceuticals Unlimited Company, Little Connell, Newbridge, Co. Kildare, W12 HX57, Ireland

You can request further information about this medicinal product 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 medicinal product is authorized in the European Economic Area member states under the following names:

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

Date of the last revision 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 Health Products (AEMPS) http://www.aemps.gob.es/