LINELLE DIARIO 0.1mg/0.02mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Linelle Daily 0.1 mg/0.02 mg film-coated tablets EFG

Levonorgestrel / Ethinylestradiol

1. What is Linelle Daily 0.1 mg/0.02 mg film-coated tablets EFG and what is it used for.

1. What you need to know before you start taking Linelle Daily 0.1 mg/0.02 mg film-coated tablets EFG.

1. How to take Linelle Daily 0.1 mg/0.02 mg film-coated tablets EFG.

1. Possible side effects

1. Storage of Linelle Daily 0.1 mg/0.02 mg film-coated tablets EFG.

1. Package contents and additional information

1. What is Linelle Daily 0.1 mg/0.02 mg film-coated tablets EFG and what is it used for

• Each pink tablet contains a small amount of two different female hormones, called levonorgestrel and ethinylestradiol.

• The white tablets do not contain active ingredients and are also known as placebo tablets.

• Contraceptive pills that contain two hormones are known as “combined pills”. Linelle Daily is known as a “low-dose” contraceptive pill because it contains a small amount of hormones.

2. What you need to know before starting to take Linelle Daily 0.1 mg/0.02 mg film-coated tablets EFG

General notes

Before starting to take Linelle Daily, you should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before you can start taking Linelle Daily, your doctor will ask you some questions about your medical history and that of your close relatives. They will also measure your blood pressure and, depending on your personal situation, may perform other tests.

This prospectus describes several situations in which you should stop using Linelle Daily or in which the reliability of Linelle Daily may be reduced. In these situations, you should not have sexual intercourse or, if you do, you should take other non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These methods are unreliable, as Linelle Daily alters the monthly changes in body temperature and cervical mucus.

Like other hormonal contraceptives, Linelle Daily does not protect against HIV (AIDS) or any other sexually transmitted disease.

When you should not take Linelle Daily

You should not take Linelle Daily if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you what other form of contraception would be more suitable.

Do not take Linelle Daily film-coated tablets EFG

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or if you will be immobile for a long time (see section "Blood clots").
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• severe diabetes with blood vessel damage.
• very high blood pressure.
• very high levels of fat in the blood (cholesterol or triglycerides).
• a condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called "migraine with aura."
• • If you have (or have ever had) severe liver disease and if your liver function is still not normal.
  • If you have (or have ever had) a liver tumor.
  • If you have (or have ever had) or if there is a suspicion of breast cancer or cancer of the genital organs.
  • If you have vaginal bleeding of unknown cause.
  • If you have stopped having your periods, possibly due to exercise or diet.
  • If you are allergic (hypersensitive) to levonorgestrel or ethinylestradiol, or to any of the other components of Linelle Daily. This allergy may cause itching, skin rash, or inflammation.
  • Do not use Linelle Daily if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir (see also section "Use of Linelle Daily with medications").

Additional information in special populations

Use in children

Linelle Daily is not intended for use in women who have not started their period.

Use in elderly women

Linelle Daily is not intended for use after menopause.

Women with liver failure

DO NOT take Linelle Daily if you have liver disease. See also sections "Do not take Linelle Daily" and "Warnings and precautions".

Women with kidney failure

Consult your doctor. Available data do not suggest a need to change the use of Linelle Daily.

Warnings and precautions

Consult your doctor or pharmacist before taking Linelle Daily.

Tell your doctor if you are affected by any of the following situations

Consult your doctor before taking Linelle Daily. In some situations, you will need to take special precautions when using Linelle Daily or any other combined pill, and sometimes you will need to visit your doctor periodically. If the situation appears or worsens while you are using Linelle Daily, you should consult your doctor:

• If a close relative has had breast cancer.
• If you have a liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE - a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS - a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary disease of the red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• If you need an operation or are bedridden for a long time (see section 2 "Blood clots").
• If you have just given birth, you are at high risk of blood clots. You should consult your doctor about when you can start taking Linelle Daily after giving birth.
• If you have inflammation in the veins under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see "Taking Linelle Daily with other medications").
• If you have a disease that first appeared during pregnancy or with previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, a blistering skin rash that appears during pregnancy (gestational herpes), or a nerve disease in which the body produces sudden, jerky movements (Sydenham's chorea)).
• If you have ever had brownish-yellow patches on your skin (chloasma), which are known as "pregnancy patches", especially on your face. If so, avoid direct exposure to sunlight or ultraviolet light.
• If you have hereditary angioedema (rapid swelling of the skin, mucous membranes, internal organs, or brain); products containing estrogens may cause or worsen symptoms. If you notice symptoms of angioedema, such as swelling of the face, tongue, throat/neck area, or difficulty swallowing, or if you experience hives with difficulty breathing, you should see a doctor immediately.
• 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 the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Linelle Daily increases your risk of having a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to

Linelle Daily is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year that you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Linelle Daily, your risk of a blood clot returns to normal within a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Linelle Daily is small.

• Out of 10,000 women who do not take any combined hormonal contraceptive and are not pregnant, about 2 may have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, like Linelle Daily, between 5 and 7 women may have a blood clot in a year.
• The risk of having a blood clot will vary depending on your personal medical history (see "Factors that increase your risk of a blood clot" below).

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with Linelle Daily is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of about 50). In this case, you may have a hereditary blood clotting disorder.
• If you need an operation or if you will be immobile for a long time due to an injury or illness or if you have a leg in a cast. You may need to stop using Linelle Daily several weeks before surgery or while you have reduced mobility. If you need to stop using Linelle Daily, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have recently given birth.

The risk of a blood clot increases with the number of conditions you have.

Long-distance flights (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you have any of the conditions mentioned above, even if you are not sure. Your doctor may decide that you should stop using Linelle Daily.

If any of the conditions mentioned above change while you are using Linelle Daily, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

It is essential to note that the risk of a heart attack or stroke due to the use of Linelle Daily is very small, but it may increase:

• With age (above about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Linelle Daily, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, the risk of a blood clot may be increased further.

If any of the conditions mentioned above change while you are using Linelle Daily, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Linelle Daily 0.1 mg/0.02 mg film-coated tablets EFG and cancer

Cervical cancer has been reported in long-term users, but it is not clear if this is due to sexual behavior or other factors such as the human papillomavirus (HPV).

Cases of breast cancer have been observed with slightly higher frequency in women taking oral contraceptives, but it is not known if this is due to the treatment. The occurrence of breast tumors decreases after stopping the use of oral contraceptives.

Intermenstrual bleeding

During the first months of treatment with Linelle Daily, you may have unexpected bleeding (bleeding outside of the placebo week). If this bleeding occurs for more than three months, or if it starts after some months, your doctor should find out what is happening.

What to do if there is no bleeding during the placebo week

If you have taken all the active pink tablets correctly, have not vomited, or have not had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

However, if the expected bleeding does not appear on two consecutive occasions, you might be pregnant. Contact your doctor immediately. Since pregnancy must be ruled out before continuing with the pill, only start taking the next blister pack if you are sure you are not pregnant.

Psychiatric disorders:

Some women using hormonal contraceptives like Linelle Daily have reported depression or a depressed mood. Depression can be severe and sometimes can induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Use of Linelle Daily with medications

Always consult your doctor about other medications or herbal remedies you are using or have taken recently, including over-the-counter medications. Also, inform any other doctor or dentist who prescribes you other medications (or the pharmacist) that you are using Linelle Daily. They may tell you if you need to use other contraceptive measures (e.g., condoms) and, if so, for how long.

Some medications decrease the effectiveness of Linelle Daily in preventing pregnancy or may cause unexpected bleeding.

These include:

• medications used to treat:
• • intestinal motility (e.g., metoclopramide)
  • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, or felbamate)
  • tuberculosis (e.g., rifampicin)
  • HIV infections (ritonavir or nevirapine) or other infections (antibiotics such as griseofulvin, penicillin, or tetracycline),
  • the herbal remedy St. John's Wort.

The antibiotic troleandomycin may increase the risk of bile retention if taken with the pill.

Linelle Daily may influence the effect of other medications, such as:

• medications containing cyclosporin
• the antiepileptic lamotrigine (which may increase the frequency of seizures).

Do not use Linelle Daily if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir, as these medications may produce increases in liver test results (increase in liver enzyme ALT).

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

Linelle Daily can be resumed approximately 2 weeks after finishing this treatment. See section “Do not take Linelle Daily film-coated tablets EFG”

Taking Linelle Daily with food and drinks

Linelle Daily can be taken with or without food, if necessary with a small amount of water.

Lab tests

If you need a blood test, inform your doctor or laboratory staff that you are taking the pill because hormonal contraceptives affect the results of some tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

Do not take Linelle Daily if you are pregnant. If you become pregnant while taking Linelle Daily, stop taking Linelle Daily immediately and contact your doctor. If you want to become pregnant, you can stop taking Linelle Daily at any time (see also “If you want to stop taking Linelle Daily”)

Breastfeeding

It is not recommended to take Linelle Daily during breastfeeding unless advised by your doctor. You should consult your doctor if you wish to take the pill while breastfeeding.

Driving and using machines

There is no information that indicates the use of Linelle Daily affects the ability to drive or use machines.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Linelle Daily 0.1 mg/0.02 mg film-coated tablets EFG

Follow the administration instructions of the medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

If you were taking another contraceptive before starting Linelle Daily, you already know that most contraceptives contain 21 tablets. With those contraceptives, you take a pill for 21 days and then have a week where you do not take any tablets (medication-free interval).

The system to follow when using Linelle Daily is different. After taking the 21 colored pills, you must continue and take the 7 placebo tablets, i.e., there is no medication-free interval but a "placebo" week (the week you take the placebo pills from row 4). Since you have to take a tablet every day and there is no medication-free interval between two packs, taking the pills will become routine, and consequently, the risk of forgetting a tablet is lower.

The two distinct classes of colored pills of Linelle Daily are placed in order. A pack contains 28 tablets.

Take one Linelle Daily tablet every day, if necessary with a small amount of water. You must take the tablets every day, more or less at the same time.

Do not confuse the tablets: take one pink tablet once a day for the first 21 days, and then one white tablet every day for the last 7 days. Then, you should start a new pack (21 pink tablets and 7 white tablets). Consequently, there is no medication-free interval between packs.

The blister pack contains 28 tablets. Daily intake for 28 consecutive days is essential to maintain the contraceptive effect.

Along with the blister packs, adhesive labels with the days of the week are provided. Take the label for the day you start taking the pill. Place the label on the blister pack over the words "Place the label with the day here". Each day will align with a row of pills. It is essential that you take your pill every day. And take the first tablet from the first row where it says "START".

Follow the direction of the arrow indicated on the blister pack, take the pink tablets for 21 days, and then the white tablets for 7 days, until you have taken all 28 tablets. Then, you should start taking the next blister pack. This means there is no medication-free interval between packs.

During the 7 days of white tablets, you should start bleeding (usually on the 2nd or 3rd day). This is what is known as withdrawal bleeding and may continue when you start with the next blister pack.

You should start taking the next blister pack on the same day of the week, and the withdrawal bleeding should appear on the same days every month.

When can you start with the first blister pack

• If you have not used a hormonal contraceptive in the previous month.

Start taking Linelle Daily on the first day of your cycle (which is the first day of your period). If you start taking Linelle Daily on this day, you are immediately protected against pregnancy. You can also start on days 2-5 of your cycle, but you must use extra protection measures (e.g., a condom) during the first 7 days.

• Switching from another combined hormonal contraceptive or a vaginal ring or contraceptive patch

Start taking Linelle Daily the day after taking the last active tablet of your previous pill (or after removing the ring or patch) or, at the latest, the day after the usual medication-free interval (or the last placebo tablet of the previous hormonal contraceptive).

• Switching from a progestin-only method (oral pill, injection, implant, or intrauterine device/IUD).

You can switch to Linelle Daily on any day from the progestin-only pill (if you used an implant or IUD, on the day of its removal, and if you received the progestin by injection, on the date the next injection was due), but in all cases, you must apply additional protection measures (e.g., a condom) during the first 7 days of taking the new pills.

• After an abortion in the first trimester.

Follow your doctor's instructions.

• After having a child or an abortion in the second trimester.

Start taking Linelle Daily between 21 and 28 days after giving birth or the abortion in the second trimester. If you start after day 28, you must use an additional barrier method (e.g., a condom) during the first 7 days of using Linelle Daily.

If, after having a child, you have had sexual intercourse before starting to take Linelle Daily again, you must first check that you are not pregnant or wait until your next period before taking Linelle Daily.

• If you are breastfeeding and want to start taking Linelle Daily again after having a child

Read the section on “Breastfeeding”.

Ask your doctor for advice if you are not sure when to start.

If you take more Linelle Daily film-coated tablets EFG than you should

There are no publications on the harmful effects of taking too many Linelle Daily tablets. If you take several tablets at once, you may experience nausea or vomiting. Young girls may experience vaginal bleeding.

If you have taken too many Linelle Daily tablets, or if you discover that your child has taken some, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Linelle Daily film-coated tablets EFG

The tablets in the fourthrow of the pack are placebo tablets. If you forgot to take one of those tablets, it will not affect the effect of Linelle Daily. You should discard the forgotten placebo tablet to not prolong the placebo week, which could have a negative effect on the effectiveness of Linelle Daily.

If you forgot to take a tablet from row 1, 2, or 3, you should follow these instructions:

• If it has been less than 12 hourssince you forgot the tablet, the protection against pregnancy is not altered. Take the tablet as soon as you remember and then take the following tablets at the usual time.

• If it has been more than 12 hourssince you forgot the tablet, the protection against pregnancy may be reduced. The more tablets you forget, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is higher if you forget a tablet at the beginning of a blister pack (1st row) or at the end of the 3rd week (3rd row of the blister pack).

Therefore, you must follow these rules:

• tablet intake should never be interrupted.
• the effectiveness of Linelle Daily depends on the uninterrupted intake of the tablets.

If you are more than 12 hours late during days 1-7 (see also the diagram):

Take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then, continue taking the following tablets at the usual time. Additionally, you should use a barrier method such as a condom during the next 7 days. If you have had sexual intercourse in the 7 days prior to forgetting the tablet, the possibility of pregnancy should be considered. The more tablets you have forgotten and the closer they are to the usual medication-free interval, the higher the risk of pregnancy. Consult your doctor if this happens.

If you are late more than 12 hours during days 8-14 (see also the diagram):

Take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then, continue taking the following tablets at the usual time. If you have taken the tablets correctly in the 7 days prior to the first forgotten tablet, there is no need to use additional contraceptive precautions. If you have not taken the tablets correctly or have forgotten more than one tablet, you should use additional contraceptive precautions during the next 7 days.

If you are late more than 12 hours during days 15-21 (see also the diagram):

The risk of pregnancy increases the closer you are to the 7-day medication-free interval. However, pregnancy can still be prevented by adjusting the dosage.

If you follow the following advice, there is no need to use additional contraceptive precautions, provided you have taken all the tablets correctly in the 7 days before the first forgotten tablet.

If this is not the case, you should follow the first of these two options and also use additional contraceptive precautions during the next 7 days.

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then, take the rest of the tablets at the usual time.

Instead of taking the 7-day medication-free interval, continue immediately with the next pack of 21 tablets. You will probably not have withdrawal bleeding until the end of the second pack, but you may experience bleeding or intercurrent bleeding during the days of tablet intake.

1. You can stop taking the tablets from the current pack and take the 7-day medication-free interval, including the days you forgot the tablets, and then continue with the next pack.

If you forget several tablets and do not have withdrawal bleeding during the first normal medication-free interval, the possibility of pregnancy should be considered.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking the active pink tablet or if you have severe diarrhea, there is a risk that the active ingredients of the tablet will not be fully absorbed into your body. The situation is similar to when you forget to take a tablet. After vomiting or having diarrhea, take another tablet from another pack as soon as possible. If possible, take it within 12 hoursof the time you would normally take your tablet. If it is not possible, or if more than 12 hours have passed, follow the advice included in “If you forget to take Linelle Daily”.

Delayed period: what you need to know

Although it is not recommended, it is possible to delay your period if you do not take the 7 white placebo tablets and take a new Linelle Daily pack directly. You may experience spotting (drops or spots of blood) or intercurrent bleeding while using the next pack. After the 7 days of taking the placebo tablets from the second pack, continue with the next pack.

It is recommended to consult your doctor before deciding to delay your menstrual cycle.

Changing the first day of your menstrual period: what you need to know

If you want to change the day of the start of your period or have your period on another day of the week, you can shorten your next placebo period by as many days as you want. The shorter the placebo period, the higher the risk that you will not have withdrawal bleeding and that you will experience intercurrent bleeding and spotting during the second pack. Never extend the placebo period.

If you are not sure what to do, consult your doctor.

If you stop taking Linelle Daily film-coated tablets

You can stop taking Linelle Daily whenever you want. If you do not want to become pregnant, ask your doctor for advice on other reliable methods of birth control. If you want to become pregnant, stop taking Linelle Daily and wait for a menstrual period before trying to become pregnant. This way, you will be able to calculate the expected date of delivery more easily.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

If you experience any adverse effect, particularly if it is severe and persistent, or if you have any change in your health that you think may be due to Linelle Daily, consult your doctor.

Severe Adverse Effects

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also section "Warnings and Precautions").

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before taking Linelle Daily".

The following is a list of adverse effects that have been associated with the use of Linelle Daily:

Frequent:may affect up to 1 in 10 people

• mood changes, depression
• headache
• nausea, abdominal pain
• breast tenderness, breast sensitivity
• weight gain

Uncommon:may affect up to 1 in 100 people

• loss of sexual desire
• migraine
• vomiting, diarrhea
• skin rash
• itching or hives on the skin
• breast enlargement
• fluid retention

Rare:may affect up to 1 in 1,000 people

• intolerance to contact lenses
• allergic reactions
• increased libido
• vaginal or breast discharge
• redness or spots on the skin
• weight loss

• Harmful blood clots in a vein or artery, for example:
• • In a leg or foot (i.e., DVT).
  • In a lung (i.e., PE).
  • Heart attack.
  • Stroke.

• Mild stroke or temporary symptoms similar to those of a stroke, known as a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The possibility of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

The following serious adverse effects have been reported slightly more frequently in women using oral contraceptives, but it is not known if this is due to the treatment (see section 2: "Warnings and Precautions"):

• Increased blood pressure
• Liver tumors or breast cancer

The following conditions have also been associated with combined oral contraception:

Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, porphyria (a metabolic disorder that causes abdominal pain and mental disorders), systemic lupus erythematosus (where the body attacks and damages its own organs and tissues), herpes in the last stage of pregnancy, Sydenham's chorea (rapid involuntary spasms or spasmodic movements), hemolytic uremic syndrome (a condition that occurs after diarrhea caused by E. coli), liver problems shown by jaundice, gallbladder disorders, or bile stone formation.

In women with hereditary angioedema, exogenous estrogens in oral contraceptives may induce or exacerbate angioedema symptoms (see section 2: "Warnings and Precautions").

Linelle Daily contains lecithin (from soy) (E322). If you are allergic to peanuts or soy, do not take this medicine.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Linelle Daily 0.1 mg/0.02 mg Film-Coated Tablets EFG

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

Do not store above 30°C.

Do not use this medicine after the expiration date that appears on the outer packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Linelle Daily Film-Coated Tablets

The active ingredients are levonorgestrel and ethinylestradiol.

Linelle Daily film-coated tablets contain tablets of 2 colors:

• Each pink tablet contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol. The other components (excipients) are lactose, povidone K-30 (E1201), magnesium stearate (E572), and opadry II pink [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350, aluminum lake red (E129), lecithin (E322), iron oxide red (E172), and aluminum lake blue (E1329)].

• Each white tablet (inactive or placebo tablet) contains only excipients (without active ingredients), which are lactose, povidone K-30 (E1201), magnesium stearate (E572), and opadry II white [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), and polyethylene glycol 3350].

Appearance of Linelle Daily and Package Contents

• Each active film-coated tablet is round and pink.

• Each placebo film-coated tablet is round and white.

• Linelle Daily is marketed in blisters of 28 tablets: 21 active pink tablets and 7 white placebo tablets.

• The package sizes are 1, 3, or 6 blisters, and each blister contains 28 tablets. Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturer

Laboratorios León Farma, S.A.

Polígono Industrial Navatejera, La Vallina S/N

24193 Navatejera (León) - Spain

Local Representative

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.

28027 Madrid

Spain

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

Netherlands: Ethinylestradiol/Levonorgestrel 28 Theramex 0.02/0.10 mg, filmomhulde tabletten

Date of the last revision of this prospectus: March 2020

"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.es/"