Linelle diario 0,1mg/0,02 mg comprimidos recubiertos con pelÍcula efg

PROSPECTO: INFORMATION FOR THE USER

Linelle Diario 0,1 mg/0,02 mg film-coated tablets

Levonorgestrel / Ethinylestradiol

1. What is Linelle Diario 0,1 mg/0,02 mg film-coated tablets and for what it is used.

1. What you need to know before starting to take Linelle Diario 0,1 mg/0,02 mg film-coated tablets.

1. How to take Linelle Diario 0,1 mg/0,02 mg film-coated tablets.

1. Possible adverse effects

1. Storage of Linelle Diario 0,1 mg/0,02 mg film-coated tablets.

1. Contents of the package and additional information

General Notes

Before starting to take Linelle Diario, read the information about blood clots in section 2. It is particularly important to read the symptoms of a blood clot (see section 2 “Blood Clots”).

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

This leaflet describes several situations in which you should stop using Linelle Diario or in which the reliability of Linelle Diario 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 the rhythm or temperature methods.These methods are unreliable because Linelle Diario alters the monthly changes in body temperature and cervical mucus.

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

When not to take Linelle Diario

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

Do not take Linelle Diario tablets with film-coated EFG

• If you have (or have ever had) a blood clot in a vein in your leg (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE) or in other organs.
• If you know that 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 spend a lot of time without standing up (see section “Blood Clots”).
• If you have ever had a heart attack or a 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, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in your arteries:

– severe diabetes with vascular damage.

– very high blood pressure.

– very high levels of fat in your 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) a severe liver disease and if your liver function is not yet normal
  • If you have (or have ever had) a tumor in the liver
  • If you have (or have ever had) or if there is suspicion of breast cancer or cancer in genital organs
  • If you have a vaginal bleeding of unknown cause
  • If you have stopped having periods, possibly due to exercise or diet
  • If you have an allergy (hypersensitivity) to levonorgestrel or ethinylestradiol, or to any of the other components of Linelle Diario. This allergy may cause the appearance of pruritus, skin rash or inflammation.
  • Do not use Linelle Diario if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir (see also in section “Use of Linelle Diario with medicines”).

Additional information for special populations

Use in children

Linelle Diario is not intended for use in women who have not yet started menstruating.

Use in elderly women

Linelle Diario is not intended for use after menopause.

Women with liver insufficiency

Do not take Linelle Diario if you have liver disease. See also sections “Do not take Linelle Diario” and “Warnings and precautions”.

Women with renal insufficiency

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

Warnings and precautions

Consult your doctor or pharmacist before taking Linelle Diario.

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

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

BLOOD CLOTS

The use of a combined hormonal contraceptive like Linelle Diario increases your risk of suffering 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 veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

The recovery from blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

It is essential to remember that the overall risk of a harmful blood clot due to Linelle Diario is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attentionif 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 a combined hormonal contraceptive has been associated with an increased risk of blood clots in 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 your leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from your leg and lodges in your lung, it may cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as your 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 in which you start taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medicine or a different medicine) after a break 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 Diario, your risk of a blood clot returns to normal in 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 your leg or lung (DVT or PE) with Linelle Diario is small.

• Of every 10,000 women who are not taking any combined hormonal contraceptive and are not pregnant, about 2 may develop a blood clot in a year.
• Of every 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimato like Linelle Diario, between 5 and 7 women may develop 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

Your risk of a blood clot is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30 kg/m2or more).
• If any of your close relatives have had a blood clot in their leg, lung, or other organ at a young age (i.e., before about 50 years). You may have an inherited disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to stop taking Linelle Diario for several weeks before the operation or while you have less mobility. If you need to stop taking Linelle Diario, ask your doctor when you can start using it again.
• As you get older (especially over about 35 years).
• If you have given birth recently.

Your risk of a blood clot increases the more conditions you have.

Long flights (over 4 hours) may temporarily increase your 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 listed above, even if you are unsure. Your doctor may decide that you should stop taking Linelle Diario.

If any of the conditions listed above change while you are using Linelle Diario, 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 a 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 Linelle Diario is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Linelle Diario, you are advised to stop smoking. If you cannot stop smoking and are over 35 years, 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). You may also be at higher risk of a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in your blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, abnormal heart rhythm called atrial fibrillation).
• If you have diabetes.

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

If any of the conditions listed above change while you are using Linelle Diario, 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 Diario 0.1 mg/0.02 mg tablets with film-coated EFG and cancer

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

Cases of breast cancer have been observed with a slightly higher frequency in women taking combined oral contraceptives, but it is unknown whether this is due to the treatment. The appearance of breast tumors decreases after stopping the use of the tablets. It is essential to check your breasts regularly, and you should contact your doctor if you notice any lumps.

Benign liver tumors (non-cancerous) have been described in rare cases, and malignant liver tumors (cancerous) have been reported in even rarer cases in users of combined oral contraceptives. Contact your doctor if you notice severe stomach pain.

Bleeding between periods

During the first few months of treatment with Linelle Diario, you may experience unexpected bleeding (bleeding outside the placebo week).If this bleeding occurs for more than three months or if it starts after some months, your doctor should investigate 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, and have not had severe diarrhea, and have not taken other medicines, it is very unlikely that you are pregnant.

However, if the expected bleeding does not appear on two consecutive occasions, you may be pregnant.Contact your doctor immediately.Only start taking the next pack if you are sure you are not pregnant.

Mental health disorders:

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

Use of Linelle Diario with medicines

Always consult your doctor about other medicines or herbal medicines you are already using or have recently taken, including those obtained without a prescription.Also, discuss any other medicines prescribed by another doctor or dentist that you are using Linelle Diario.They may tell you if you need to use other contraceptive measures (e.g., condoms) and, if so, for how long.

Some medicines reduce the effectiveness of Linelle Diario in preventing pregnancy, or may cause unexpected bleeding.

Examples include:

• Medicines used to treat:
• • Intestinal motility (e.g., metoclopramide)
  • Epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, or felbamate)
  • Tuberculosis (e.g., rifampicin)
  • HIV infection (ritonavir or nevirapina) or other infections (antibiotics such as griseofulvin, penicillin, or tetracycline),
  • The medicinal herb St. John's Wort.

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

Linelle Diario may influence the effect of other medicines, such as:

• Cyclosporine-containing medicines
• The antiepileptic lamotrigine (which may increase the frequency of seizures).

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

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

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

Taking Linelle Diario with food and drinks

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

Blood tests

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

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

It is not recommended to take Linelle Diario during breastfeeding, unless your doctor advises you to do so. You should consult your doctor if you want to take the pill while breastfeeding.

Driving and operating machinery

There is no information to indicate that the use of Linelle Diario affects your ability to drive or operate machinery.

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

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

If you were taking another contraceptive before starting to take Linelle Diario, you already know that most contraceptives contain 21 tablets.With those contraceptives, take a tablet for 21 days and then there is a week in which you do not take any tablets (medication-free interval).

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

The two different types of colored tablets in Linelle Diario are placed in order.One package contains 28 tablets.

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

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

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

Along with the blisters, adhesive labels with the days of the week are attached.Take the label of the day you start taking the pill.Put the label on the blister over the words "Stick the label with the day here."Each day will align with a row of tablets.It is essential to take your pill every day.And take the first tablet from the first row where the word "BEGINNING" is indicated.

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

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.

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

When can you start with the first blister

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

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

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

Start taking Linelle Diario on 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 7-day medication-free interval (free from the ring, or free from the patch) or the last placebo tablet of the previous hormonal contraceptive.

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

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

• After a first-trimester abortion

Follow your doctor's instructions.

• After having a child or a second-trimester abortion

Start taking Linelle Diario between 21 and 28 days after giving birth or after a second-trimester abortion.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 Diario.

If after having a child you have had sex again before starting to take Linelle Diario (again), you must first check if you are not pregnant or wait until your next period before taking Linelle Diario.

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

Read the section on "Lactation".

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

If you take more Linelle Diario tablets coated with EFG film than you should

There are no publications on the harmful effects of taking too many Linelle Diario 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 Diario 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 forgot to take Linelle Diario tablets

The tablets from thefourthrow of the package are placebo tablets. If you forgot to take one of those pills, it will not affect the effect of Linelle Diario. You should throw away the forgotten placebo tablet to avoid prolonging the placebo week, which could have a negative effect on the effectiveness of Linelle Diario.

If you forgot to take a tablet from the1st, 2nd, or 3rdrow, you should follow the following instructions:

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

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

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

Therefore, you must maintain the following rules:

• the intake of tablets must never be interrupted.
• the effectiveness of Linelle Diario depends on the non-interruption of the intake of the tablets.

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

Take the last forgotten tablet as soon as you remember it, even if this means taking two tablets at the same time. Then, continue taking the next tablets at the usual time. In addition, you must use a barrier method such as a condom during the next 7 days. If you have had sex during the 7 days before forgetting the tablet, you should consider the possibility of pregnancy. The more tablets you have forgotten and the closer they are to the usual 7-day medication-free interval, the higher the risk of pregnancy. Consult your doctor if this happens.

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

Take the last forgotten tablet as soon as you remember it, even if this means taking two tablets at the same time. Then, continue taking the next tablets at the usual time. If you have taken the tablets correctly during the 7 days before 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 must use additional contraceptive precautions during the next 7 days.

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

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

If you follow the following advice, there is no need to use additional contraceptive precautions, if you have taken all the tablets correctly during 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 it, 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 days of medication-free interval, continue immediately with the next package of 21 tablets. You will probably not have withdrawal bleeding until the end of the second package, but you may experience bleeding or intercurrent bleeding during the days of taking tablets.

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

If you forget several tablets and do not have withdrawal bleeding during the usual medication-free interval, you should consider the possibility of pregnancy.

What to do in case of vomiting or intense 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 principles of the tablet will not be fully absorbed by your body.This situation is similar to when you forget to take a tablet.After vomiting or diarrhea, take another tablet from another package as soon as possible.If possible, take itwithin 12 hoursof the time you would normally take your tablet.If not possible, or if more than 12 hours have passed, follow the advice included in "If you forgot to take Linelle Diario".

Delayed period: what you need to know

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

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

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

If you want to change the day of the start or have your period on a different 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 of not having withdrawal bleeding and experiencing spotting or intercurrent bleeding during the second package. Never lengthen the placebo period.

If you are unsure about what to do, consult your doctor.

If you stop taking Linelle Diario tablets

You can stop taking Linelle Diario when 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 Diario and wait for a menstrual period before trying to become pregnant. This way, you can calculate your expected date of delivery more easily.

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

Like all medicines, this medicine can have side effects, although not everyone will experience them.

If you have any side effects, particularly if they are severe and persistent, or if you have any change in your health that you think may be due to Linelle Diario, consult your doctor.

Severe side effects

Seek immediate medical attention if you experience any of the following angioedema symptoms: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also section “Warnings and precautions”).

All women taking 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 starting to take Linelle Diario”.

Following is a list of side effects that have been associated with the use of Linelle Diario:

Common:may affect up to 1 in 10 people

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

Uncommon:may affect up to 1 in 100 people

• loss of libido
• migraines
• vomiting, diarrhea
• skin rash
• pruritus or skin nodules
• breast enlargement
• fluid retention

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

• contact lens intolerance
• allergic reactions
• increased libido
• vaginal or mammary discharge
• skin redness or patches
• 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 a stroke, known as a transient ischemic attack (TIA)
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances 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 severe side effects have been reported slightly more frequently in women using combined oral contraceptives but it is not known if this is due to the treatment (see section 2: “Warnings and precautions”):

• Increased blood pressure
• Hepatic tumors or breast cancer

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

Crohn's disease, ulcerative colitis, epilepsy, migraines, 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 late stages of pregnancy, Sydenham's chorea (rapid involuntary spasms or movements), hemolytic-uremic syndrome (a condition that appears after diarrhea caused by E. coli), liver problems shown by jaundice, gallbladder disorders or formation of gallstones.

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

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

Reporting side effects

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

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

Do not store at a temperature above30°C.

Do not use this medication 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 through the drains or in the trash. Dispose of the packaging and medicines you no longer need at your local SIGRE collection pointat your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Linelle Diario coated tablets

The active principles are levonorgestrel and etinilestradiol.

Linelle Diario coated tablets contain tablets of 2 colors:

• Eachtablet of pink color contains 0.1 mg of levonorgestrel and 0.02 mg of etinilestradiol.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, red aluminum lake (E129), lecithin (E322), red iron oxide (E172) and blue aluminum lake (E1329)].

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

Appearance of Linelle Diario and contents of the package

• Each active coated tablet is a round pink tablet.

• Each placebo coated tablet is a round white tablet.

• Linelle Diario 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. Some package sizes may only be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturer

Laboratorios León Farma, S.A.

Navatejera Industrial Estate, La Vallina S/N

24193 Navatejera (León) - Spain

Local Representative

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, 2nd floor left.

28027 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

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

Last review date of this leaflet: March 2020

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/”