LINELLE 0.1mg/0.02mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Linelle 0.1 mg/0.02 mg film-coated tablets EFG

Levonorgestrel / Ethinylestradiol

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

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

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

1. Possible side effects

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

1. Package contents and additional information

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

• Linelle 0.1 mg/0.02 mg is a contraceptive pill used to prevent pregnancy.
• Each pink tablet contains a small amount of two different female hormones, called levonorgestrel and ethinylestradiol.
• Contraceptive pills that contain two hormones are known as “combined pills”.

Linelle 0.1 mg/0.02 mg contains only a small amount of hormones, it is called a “low-dose” contraceptive pill.

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

General considerations

Before starting to use Linelle 0.1 mg/0.02 mg, 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 0.1 mg/0.02 mg, 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 0.1 mg/0.02 mg or in which the reliability of Linelle 0.1 mg/0.02 mg 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 0.1 mg/0.02 mg alters the monthly changes in body temperature and cervical mucus.

Like other hormonal contraceptives, Linelle 0.1 mg/0.02 mg does not protect against HIV (AIDS) or any other sexually transmitted disease.

When not to use Linelle 0.1 mg/0.02 mg film-coated tablets EFG:

You should not use Linelle 0.1 mg/0.02 mg if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

Do not use Linelle 0.1 mg/0.02 mg film-coated tablets EFG:

• If you have (or have had in the past) a blood clot (deep vein thrombosis, DVT) in a blood vessel of the leg, lungs (pulmonary embolism, PE) or other organs
• If you have (or have had in the past) 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 symptoms of a stroke)
• If you have (or have had) a certain type of migraine called "migraine with aura"
• If you have a disease that could increase the risk of thrombosis in the arteries:

• severe diabetes with damage to blood vessels
• very high blood pressure
• very high levels of fat in the blood (cholesterol or triglycerides)
• a condition known as hyperhomocysteinemia
• • If you have or have had liver disease and if your liver function is still not normal.
  • If you have or have had a liver tumor
  • If you have (or have 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 not had a period for several months without a known cause
  • If you are allergic to levonorgestrel or ethinylestradiol, or to any of the other components of this medicine (listed in section 6). This may cause itching, rash, or swelling.
  • If you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also in section "Taking Linelle 0.1 mg/0.02 mg with other medicines")

Additional information on special populations

Use in children

Linelle 0.1 mg/0.02 mg is not indicated for use in women who have not started their period.

Use in elderly women

Linelle 0.1 mg/0.02 mg is not intended for use after menopause.

Women with liver insufficiency

Do not take Linelle 0.1 mg/0.02 mg if you have liver disease. See also sections "Do not use Linelle 0.1 mg/0.02 mg" and "Warnings and precautions".

Women with renal insufficiency

Consult your doctor. Available data do not suggest a need to change the use of Linelle 0.1 mg/0.02 mg.

Tell your doctor if you suffer from any of the following conditions

In some situations, you should have special precautions during the use of Linelle 0.1 mg/0.02 mg or any other combined hormonal contraceptive, and it may be necessary for your doctor to monitor you regularly. If the condition develops or worsens while you are using Linelle 0.1 mg/0.02 mg, you should also inform your doctor.

• If a close relative has or has had breast cancer.
• If you have a liver or gallbladder disease.
• If you suffer from diabetes.
• If you have depression. Some women who use hormonal contraceptives like Linelle 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.
• If you have Crohn's disease or ulcerative colitis (inflammatory bowel disease).
• If you have SLE (systemic lupus erythematosus, an immune system disorder).
• If you have HUS (hemolytic uremic syndrome), a blood disorder that causes kidney damage.
• If you have sickle cell anemia (an inherited disease of the red blood cells).
• if you have high levels of fat in the blood (hypertriglyceridemia) or a family history of this disease. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• if you need surgery or if you are not standing for a long time (see in section 2 "Blood clots")
• if you have just given birth, you have a higher risk of blood clots forming. You should ask your doctor when you can start taking Linelle 0.1 mg/0.02 mg after childbirth.
• if you have inflammation in the veins under the skin (superficial thrombophlebitis)
• if you have varicose veins
• If you have epilepsy (see "Taking Linelle 0.1 mg/0.02 mg with other medicines")
• If you have a disease that appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, porphyria [a blood disease], gestational herpes [a skin rash with blisters that appears during pregnancy], Sydenham's chorea [a nerve disease in which sudden movements of the body occur]).
• If you have or have had chloasma (brownish-yellow pigmented patches, known as "pregnancy patches", especially on the face). If so, avoid direct exposure to sunlight or ultraviolet light.
• 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 containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Linelle 0.1 mg/0.02 mg 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 lasting effects or, very rarely, they can be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Linelle 0.1 mg/0.02 mg 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 of 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 of another organ, such as the eye (retinal vein thrombosis).

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

The risk of having a blood clot in a vein is higher during the first year in which 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 medicine 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 0.1 mg/0.02 mg, your risk of having a blood clot returns to normal within a few weeks.

What is the risk of having 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 having a blood clot in the leg or lung (DVT or PE) with Linelle 0.1 mg/0.02 mg is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
  • Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 will have a blood clot in a year.
  • The risk of having a blood clot will depend on your personal 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 0.1 mg/0.02 mg 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).
• If you need to have surgery or if you are not standing for a long time due to an injury or illness or if you have your leg in a cast. You may need to stop using Linelle 0.1 mg/0.02 mg several weeks before the surgery or while you have less mobility. If you need to stop using Linelle 0.1 mg/0.02 mg, 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 having a blood clot increases the more conditions you have.

Long-haul 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 important to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Linelle 0.1 mg/0.02 mg.

If any of the above conditions change while you are using Linelle 0.1 mg/0.02 mg, for example, a close relative experiences a thrombosis 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 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 important to note that the risk of a heart attack or stroke due to Linelle 0.1 mg/0.02 mg is very small, but it can increase:

• With age (above about 35 years);
• If you smoke.When you use a combined hormonal contraceptive like Linelle 0.1 mg/0.02 mg, 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 a high level 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 disturbance 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 having a blood clot may be increased even further.

If any of the above conditions change while you are using Linelle 0.1 mg/0.02 mg, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight, inform your doctor.

Linelle 0.1 mg/0.02 mg tablets and cancer

Cancer of the cervix has been reported in long-term users, but the effect of sexual behavior or other factors such as the human papillomavirus (HPV) is unclear.

Cases of breast cancer have been observed with slightly higher frequency in women taking combined oral contraceptives, but it is not known if this is due to the treatment. For example, it could be that more tumors are detected in women taking combined oral contraceptives because they are examined by their doctor more frequently. The occurrence of breast tumors has been gradually lower after stopping the use of combined hormonal contraceptives. It is important to regularly check your breasts, and you should contact your doctor if you notice any lump.

In rare cases, benign liver tumors and even rarer cases of malignant liver tumors have been described in users of oral contraceptives

Bleeding between periods

During the first months of treatment with Linelle 0.1 mg/0.02 mg, you may have unexpected bleeding (bleeding outside of the treatment-free week). If this bleeding occurs for more than three months, or if it starts after some months, your doctor should investigate the cause.

What to do if there is no bleeding during the treatment-free week

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

If the expected bleeding does not occur on two consecutive occasions, you may be pregnant. Contact your doctor immediately. Do not start taking the next blister pack until you are sure you are not pregnant.

Taking Linelle 0.1 mg/0.02 mg with other medications

Do not use Linelle if you have Hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications can 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.

You can restart treatment with Linelle approximately 2 weeks after finishing this treatment. See section "Do not use Linelle"

Some medications may affect the blood levels of Linelle and may make it less effective in preventing pregnancy or may cause unexpected bleeding. This includes:

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• stomach and intestine mobility (e.g., metoclopramide);

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, or felbamate);
• • tuberculosis (e.g., rifampicin);
  • HIV and hepatitis C infection (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
  • fungal infections (griseofulvin);
  • arthritis, arthrosis (etoricoxib);
  • high blood pressure in the blood vessels of the lungs (bosentan);

• the herbal remedy called St. John's Wort.

Linelle may affect the effect of other medications, for example:

• medications that contain cyclosporine.
• the antiepileptic lamotrigine (this could lead to an increased frequency of seizures).
• theophylline (used to treat respiratory problems).
• tizanidine (used to treat muscle pain and/or muscle cramps).

Taking Linelle 0.1 mg/0.02 mg with food and drink

Linelle 0.1 mg/0.02 mg 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

Pregnancy

If you are pregnant, you should not take Linelle 0.1 mg/0.02 mg. If you become pregnant while taking Linelle 0.1 mg/0.02 mg, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Linelle 0.1 mg/0.02 mg at any time (see also "If you stop taking Linelle 0.1 mg/0.02 mg").

Consult your doctor or pharmacist before taking any medication.

Breastfeeding

Generally, it is not recommended to use Linelle 0.1 mg/0.02 mg when the woman is breastfeeding. You should consult your doctor if you want to take the pill while breastfeeding.

Driving and using machines

There is no information to indicate that the use of Linelle 0.1 mg/0.02 mg affects the ability to drive or use machines.

Linelle 0.1 mg/0.02 mg contains lactose

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 0.1 mg/0.02 mg film-coated tablets EFG

Follow the administration instructions exactly as stated in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Each blister pack contains 21 tablets. Each tablet is marked with the day of the week on which it should be taken. For example, if you start taking the tablets on a Tuesday, press the tablet through the aluminum foil, in a blister pack marked with "TUE". Take the tablets every day in the order indicated by the arrows.

Take one Linelle 0.1 mg/0.02 mg tablet every day for 21 days, if necessary with a small amount of water. You should take the tablets with or without food, but you should take them every day at approximately the same time.

Once you have finished the 21 tablets, you will not take any tablets for the next 7 days. Your period (withdrawal bleeding) will start during these 7 days, usually 2-3 days after taking the last Linelle 0.1 mg/0.02 mg tablet.

Start the next blister pack on the 8th day, even if your period is still ongoing. This way, you will always start a new pack on the same day of the week, and withdrawal bleeding will occur approximately 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 with Linelle 0.1 mg/0.02 mg on the first day of your cycle (which is the first day of your menstruation). If you start taking Linelle 0.1 mg/0.02 mg on the first day of your menstruation, you are immediately protected against pregnancy. You can also start on days 2-5 of your cycle, but in that case, you must use extra protection measures (e.g., a condom) for the first 7 days.

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

Start taking Linelle 0.1 mg/0.02 mg the day after the last active tablet of your previous pill or, at the latest, the day after the usual pill-free interval or the last placebo tablet of the previous hormonal contraceptive. In the case of a vaginal ring or patch, start taking Linelle 0.1 mg/0.02 mg the day the last ring or patch is removed from a cycle pack or, at the latest, when the next application should be done.

• Switching from a progestin-only method (progestin-only pill or injection, implant, or IUD that releases progestin).

You can switch any day from the progestin-only pill (if you used an implant or IUD, on the day of its removal, and if you received 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) for the first 7 days you take the new pills.

• After a spontaneous abortion or termination of pregnancy in the first trimester.

Follow your doctor's instructions.

• After having a child or after a spontaneous abortion or termination of pregnancy in the second trimester.

Start with Linelle 0.1 mg/0.02 mg between 21 and 28 days after childbirth or the abortion or termination of pregnancy in the second trimester. If you start later than day 28, you must use a barrier method (e.g., a condom) for the first 7 days of taking Linelle 0.1 mg/0.02 mg.

If, after having a child, you have had sexual intercourse before starting to take Linelle 0.1 mg/0.02 mg again, you must first check that you are not pregnant or wait until your next menstrual period.

Ask your doctor for advice if you are unsure when to start.

• If you are breastfeeding and want to start taking Linelle 0.1 mg/0.02 mg again after having a child

Read the section on "Breastfeeding".

If you take more Linelle 0.1 mg/0.02 mg tablets than you should

There are no publications on the harmful effects of taking too many Linelle 0.1 mg/0.02 mg tablets. If you take several tablets at once, you may experience nausea and vomiting. Young girls may experience vaginal bleeding.

If you have taken too many Linelle 0.1 mg/0.02 mg 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 0.1 mg/0.02 mg tablets

• If it has been less than 12 hourssince you forgot the tablet, your protection against pregnancy is not reduced. 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, your protection against pregnancy may be reduced. The more tablets you forget, the higher the risk of pregnancy.

• Therefore, you must follow these rules:
• you must never interrupt tablet-taking for more than 7 days.
• the effectiveness of Linelle 0.1 mg/0.02 mg depends on taking tablets for 7 days without interruption.

• If it has been more than 12 hours since you forgot the tablet during days 1-7 (see also the diagram)

Take the last forgotten tablet as soon as you remember, even if it 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, for the next 7 days. If you have had sexual intercourse in the 7 days before forgetting the tablet, you should consider the possibility of pregnancy. The more tablets you have forgotten and the closer you are to the usual pill-free interval, the higher the risk of pregnancy. Consult your doctor if this happens to you.

• If it has been more than 12 hours since you forgot the tablet during days 8-14 (see also the diagram)

Take the last forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Then continue taking the following tablets at the usual time. As long as you have taken the tablets correctly in the 7 days before the first forgotten tablet, you do not need to take additional contraceptive precautions. If you have not taken the tablets correctly or have forgotten more than one tablet, you should use additional contraceptive precautions for the next 7 days.

• If it has been more than 12 hours since you forgot the tablet during days 15-21 (see also the diagram)

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

If you follow these guidelines, you do not need to take additional contraceptive precautions, as long as 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 use additional contraceptive precautions for the next 7 days as well.

• Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Then take the rest of the tablets at the usual time. Instead of taking the usual 7-day pill-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 spotting or intermenstrual bleeding during the days of tablet-taking.

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

• If you forgot to take any of the tablets from a blister pack and do not have bleeding during the first pill-free interval, it may mean that you are pregnant.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking the 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, you should take another tablet from a reserve blister 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, you should follow the advice included in "If you forget to take Linelle 0.1 mg/0.02 mg."

If you do not want to change your usual tablet-taking routine, you can take the extra tablet from another pack.

If the vomiting or diarrhea continues, contact your doctor. You will need to use additional contraceptive precautions.

Delayed menstrual period: what you should know

Although it is not recommended, it is possible to delay your menstrual period (withdrawal bleeding) by taking a new Linelle 0.1 mg/0.02 mg blister pack directly instead of the pill-free interval, until the end of the second blister pack. You may experience spotting (drops or spots of blood) or intermenstrual bleeding while using the second blister pack. After the usual 7-day pill-free interval, continue with the next blister pack.

You may need to ask your doctor for advice before deciding to delay your menstrual cycle.

Changing the first day of your period: what you should know

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

If you are unsure what to do, ask your doctor for advice.

If you stop taking Linelle 0.1 mg/0.02 mg

You can stop taking Linelle 0.1 mg/0.02 mg 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 0.1 mg/0.02 mg and wait for your menstrual period before trying to become pregnant. You will be able to calculate the expected date of birth 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 cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to Linelle 0.1 mg/0.02 mg, 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 0.1 mg/0.02 mg".

The following is a list of adverse effects that have been associated with the use of Linelle 0.1 mg/0.02 mg.

Frequent:may affect up to 1 in 10 people

• headache
• mood changes (including depression)

nausea, abdominal pain

• breast pain or breast tenderness

• weight gain

Uncommon: may affect up to 1 in 100 people

• loss of sexual desire
• rash
• migraine
• vomiting, diarrhea
• itching or lumps 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
• breast or vaginal discharge
• red lesions on the skin or nodules
• 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 risk 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 with a slightly higher frequency 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 hormonal contraceptives:

Crohn's disease, ulcerative colitis, epilepsy, migraine, cervical cancer, 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 at the end of pregnancy, Sydenham's chorea (rapid involuntary movements or spasmodic movements), hemolytic uremic syndrome (a condition that occurs after diarrhea caused by E. coli), liver problems presented with jaundice, gallbladder disorders, or kidney stone formation.

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. 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 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.

Expiry Date

Do not use this medicine after the expiry date stated on the outer packaging of Linelle 0.1 mg/0.02 mg and on the blister after CAD. The expiry 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 0.1 mg/0.02 mg Film-Coated Tablets

The active ingredients are levonorgestrel and ethinylestradiol.

Each 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), soy lecithin (E322), red iron oxide (E172), and aluminum lake blue (E132)].

Appearance of Linelle 0.1 mg/0.02 mg Film-Coated Tablets and Package Contents

• Each film-coated tablet is pink and round.

• Linelles 0.1 mg/0.02 mg are marketed in blisters of 21 tablets.

• Packages of 1, 3, 6, or 13 blisters, each blister containing 21 tablets.

Only some pack sizes may be marketed.

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.

Calle La Vallina s/n, Polígono Industrial Navatejera;

Villaquilambre – 24193 - 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:

Belgium: Lavinia

Germany: Asumate 20 0.10 mg/0.02 mg Filmtabletten

Ireland: Vonodiol 100 mcg/20 mcg Film-coated tablets

Netherlands: Ethinylestradiol/Levonorgestrel 0.02 mg/0.10 mg Focus, filmomhulde tabletten

Spain: Linelle 0.1 mg/0.02 mg film-coated tablets EFG

Date of the last revision of this leaflet: November 2022

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