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

Patient Information Leaflet

Introduction

PATIENT INFORMATION LEAFLET

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

Levonorgestrel / Ethinylestradiol

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you. Keep this leaflet as you may need to read it again. If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them. If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4. Important things you should know about combined hormonal contraceptives (CHCs): •They are one of the most reliable reversible contraceptive methods if used correctly. •They slightly increase the risk of developing blood clots in veins and arteries, especially after a break of 4 weeks or more. •Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”). Contents of the leaflet

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

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

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

4. Possible side effects.

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

6. Contents of the pack and other information.

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

• Linelle Diario is a contraceptive pill used to prevent pregnancy.

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

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

• Contraceptive pills containing two hormones are known as "combined pills". Linelle Diario is referred to 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 Diario 0.1 mg/0.02 mg film-coated tablets EFG

General notes

Before starting Linelle Diario, you must read the information about blood clots in section 2. It is particularly important that you read about 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 personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out other tests.

This leaflet describes several situations in which you should stop using Linelle Diario or in which its effectiveness may be reduced. In these situations, you should not have sexual intercourse or, otherwise, should use additional non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use 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 infections.

When you must not take Linelle Diario

Do not take Linelle Diario if you have any of the conditions listed below. If you have any of the conditions listed below, you must inform your doctor. Your doctor will discuss with you which alternative form of contraception would be most suitable.

Do not take Linelle Diario 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), in your lungs (pulmonary embolism, PE), or in other organs.

• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you need surgery or 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 causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of developing a 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 your liver function has not returned to normal.
    • If you have (or have ever had) a liver tumour.
    • If you have (or have ever had) or if there is suspicion of breast cancer or cancer of the genital organs.
    • If you have vaginal bleeding of unknown cause.
    • If you have stopped menstruating, possibly due to exercise or diet.
    • If you are allergic (hypersensitive) to levonorgestrel or ethinylestradiol, or to any of the other components of Linelle Diario. This allergy may cause itching, rash, or swelling.
    • Do not use Linelle Diario if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Use of Linelle Diario with other medicines”)

Additional information in special populations

Use in children

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

Use in older women

Linelle Diario is not intended for use after menopause.

Women with hepatic impairment

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 impairment

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

Warnings and precautions

Consult your doctor or pharmacist before taking Linelle Diario.

When should you consult your doctor? Seek urgent medical attention if you notice possible signs of a blood clot which may indicate you are experiencing a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see section “Blood clot (thrombosis)” below). For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

Inform your doctor if any of the following situations apply to you

Talk to your doctor before taking Linelle Diario. In certain situations, you will need to take special precautions when using Linelle Diario or any other combined oral contraceptive pill, and sometimes you will need regular medical check-ups. If any of the following conditions develop or worsen while you are using Linelle Diario, you must consult your doctor:

• If a close relative has had breast cancer.
• If you have liver or gallbladder disease.
• If you have diabetes.
• If you suffer from depression.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE – a disease affecting your body's natural defense system).
• If you have hemolytic uremic syndrome (HUS – a blood clotting disorder causing kidney failure).
• If you have sickle cell anemia (an inherited red blood cell disorder).
• 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 require surgery, or will be immobile for a prolonged period (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. You should consult your doctor about when you can start taking Linelle Diario after childbirth.
• If you have inflammation in the veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see “Taking Linelle Diario with other medicines”).
• If you have ever had a condition that first occurred during pregnancy or with previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, a blistering skin rash occurring during pregnancy (herpes gestationis), or a nerve disorder involving sudden jerky movements of the body (Sydenham's chorea)).
• If you have ever had brownish pigmented patches (chloasma), commonly known as “melasma of pregnancy,” 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 hives appear with difficulty breathing, seek medical attention 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 breathing difficulty, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive like Linelle Diario increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious complications.

Blood clots may form:

• In the veins (known as “venous thrombosis”, “venous thromboembolism” or VTE).
• In the arteries (known as “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, there may be long-term serious effects, and very rarely, they may be fatal.

It is important 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 attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, possibly producing blood. Sharp chest pain that may worsen when breathing deeply. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or congestion in the chest, arm, or beneath the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance, or coordination. Sudden, severe, or prolonged headache without a known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels.

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 veins (venous thrombosis). However, these adverse effects are rare. They occur most frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of developing a blood clot in a vein is higher during the first year of first-time use of a combined hormonal contraceptive. The risk may also be increased if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

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

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

What is the risk of developing a blood clot?

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

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

• Among 10,000 women who do not take any combined hormonal contraceptive and are not pregnant, about 2 may develop a blood clot within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, such as Linelle Diario, between 5 and 7 women will develop a blood clot within one year.
• Your risk of developing a blood clot may vary depending on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5 – 7 out of 10,000 women
Women who use Linelle 0.1 mg/0.02 mg	About 5 – 7 out of 10,000 women

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

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

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before the age of approximately 50). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or if you are immobile for a long time due to injury or illness, or if your leg is in a cast. You may need to stop taking Linelle Diario several weeks before surgery or while you are less mobile. If you need to stop taking Linelle Diario, ask your doctor when you can start taking it again.
• With increasing age (especially over about 35 years).
• If you have given birth within the last few weeks.

The risk of developing a blood clot increases the more of these conditions you have.

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you need to stop taking Linelle Diario.

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

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive such as Linelle Diario, 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 a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of 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 suffer from migraines, especially migraines with aura.
• If you have a heart condition (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 developing a blood clot may be further increased.

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

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

A slightly increased incidence of breast cancer has been observed in women taking contraceptive pills, but it is unknown whether this is due to the treatment. The occurrence of breast tumors decreases after stopping the use of the pills. It is important to examine your breasts regularly and you should contact your doctor if you notice any lumps.

Rare cases of benign liver tumors (non-cancerous) and even rarer cases of malignant liver tumors (cancerous) have been reported in users of combined oral contraceptives. Contact your doctor if you experience unusual, severe stomach pain.

Bleeding between periods

During the first 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 several 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 pink active tablets correctly, have not vomited or had severe diarrhoea, and have not taken any other medicines, it is very unlikely that you are pregnant.

However, if the expected bleeding does not occur in two consecutive cycles, you may be pregnant. Contact your doctor immediately. Since pregnancy must be ruled out before continuing the pill, only start taking the next blister pack if you are certain you are not pregnant.

Psychiatric disorders:

Some women using hormonal contraceptives such as Linelle Diario have reported depression or a depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor as soon as possible for further medical advice.

Use of Linelle Diario with other medicines

Always consult your doctor about any other medicines or herbal supplements you are currently using or have recently taken, including those obtained without a prescription. Also, inform any other doctor or dentist who prescribes medication for you (or your pharmacist) that you are taking Linelle Diario. They will advise you whether you need to use additional contraceptive methods (e.g., condoms), and if so, for how long.

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

These include:

• medicines used to treat:
  • gastrointestinal motility (e.g., metoclopramide)
  • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine, topiramate, or felbamate)
  • tuberculosis (e.g., rifampicin)
  • HIV infection (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 together with the pill.

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

• medicines containing cyclosporine
• the antiepileptic lamotrigine (which could increase the frequency of seizures).

Do not use Linelle Diario if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function tests (elevated liver enzyme ALT).

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

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

Taking Linelle Diario with food and drinks

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

Analytical tests

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning 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 Linelle Diario immediately and contact your doctor. If you wish to become pregnant, you may stop taking Linelle Diario at any time (see also “If you wish to stop taking Linelle Diario”).

Breastfeeding

Taking Linelle Diario during breastfeeding is not recommended 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 indicating that the use of Linelle Diario affects the ability to drive or operate machinery.

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

Follow exactly the instructions for use provided by your doctor. In case of doubt, consult your doctor or pharmacist.

If you were previously taking another contraceptive before starting Linelle Diario, you are already aware that most contraceptives contain 21 tablets. With these contraceptives, you take one pill for 21 days and then have a week during which no tablets are taken (a tablet-free interval).

The regimen for Linelle Diario is different. After taking the 21 colored tablets, you must continue with the 7 placebo tablets; that is, there is no tablet-free interval, but rather a week of "placebo" (the week during which you take the placebo tablets from row 4). Since you must take one tablet every day and there is no tablet-free interval between packs, taking the pills becomes a routine, thereby reducing the risk of forgetting a dose.

The two different types of colored tablets in Linelle Diario are arranged in order. One pack 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, approximately at the same time.

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

The blister contains 28 tablets. Daily intake over 28 consecutive days is important to maintain contraceptive effectiveness.

Adhesive labels with the days of the week are included alongside the blisters. Select the label corresponding to the day you start taking the pill. Apply the label to the blister over the words “Pegar aquí la etiqueta con el día” (“Attach the day label here”). Each day will align with a row of tablets. It is important that you take your pill every day. Take the first tablet from the first row where the word “INICIO” (“START”) is indicated.

Follow the direction of the arrow shown on the blister: first take the pink tablets for 21 days, then the white tablets for 7 days, until all 28 tablets are taken. After this, you must start the next blister. This means there is no tablet-free interval between packs.

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

You should start the next blister on the same day of the week, and withdrawal bleeding should occur on the same days each month.

When to start the first pack

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

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

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

Start taking Linelle Diario 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 your usual tablet-free break (ring-free or patch-free break), or after the last placebo tablet of your previous hormonal contraceptive.

• Switching from a progestogen-only method (oral pill, injection, implant, or intrauterine device [IUD])

You may switch to Linelle Diario on any day from the progestogen-only pill (if using an implant or IUD, on the day of removal; if receiving progestogen by injection, on the date the next injection would have been due), but in all cases, you must use additional contraceptive protection (e.g., a condom) during the first 7 days of taking the new pills.

• After a first-trimester abortion

Follow your doctor’s instructions.

• After childbirth or second-trimester abortion

Start taking Linelle Diario between 21 and 28 days after childbirth or 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 Linelle Diario use.

If you have had sexual intercourse after childbirth before starting Linelle Diario (again), you must first confirm you are not pregnant or wait until your next period before starting Linelle Diario.

• If you are breastfeeding and wish to start taking Linelle Diario (again) after childbirth

Read the section on “Breastfeeding”.

Consult your doctor if you are unsure about when to start.

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

There are no reports of harmful effects from taking too many Linelle Diario tablets. If you take several tablets at once, you may experience symptoms such as nausea or vomiting. Young girls may experience vaginal bleeding.

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

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

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

The tablets in the fourth row of the pack are placebo tablets. If you forget to take one of these tablets, it will not affect the effectiveness of Linelle Diario. You should discard the forgotten placebo tablet to avoid prolonging the placebo week, which could negatively affect the efficacy of Linelle Diario.

If you forget to take a tablet from row 1, 2, or 3, follow the instructions below:

• If less than 12 hours have passed since you missed the tablet, protection against pregnancy remains intact. Take the missed tablet as soon as you remember, then continue taking the following tablets at your usual time.

• If more than 12 hours have passed since you missed the tablet, protection against pregnancy may be reduced. The more tablets you miss, the greater the risk of becoming pregnant.

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

Therefore, observe the following rules:

• Tablet intake must never be interrupted.
• The effectiveness of Linelle Diario depends on uninterrupted tablet intake.

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

Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the following tablets at your usual time. In addition, you must use a barrier method such as a condom for the next 7 days. If you had sexual intercourse in the 7 days prior to missing the tablet, consider the possibility of pregnancy. The more tablets you have missed and the closer they are to the usual tablet-free break, the higher the risk of pregnancy. Contact your doctor if this occurs.

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

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

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

The risk of pregnancy increases the closer you are to the 7-day tablet-free break. However, pregnancy can still be prevented by adjusting the dosing regimen.

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

If this is not the case, follow the first of the two options below and also use additional contraceptive precautions for the next 7 days.

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the remaining tablets at your usual time.

Instead of taking the 7-day tablet-free break, immediately start the next pack of 21 tablets. You will likely not have withdrawal bleeding until the end of the second pack, but you may experience breakthrough bleeding or spotting during tablet intake.

1. You may stop taking tablets from the current pack and take the 7-day tablet-free break (including the days you missed tablets), then continue with the next pack.

If you miss several tablets and do not have withdrawal bleeding during the first usual tablet-free break, consider the possibility of pregnancy.

What to do in case of vomiting or severe diarrhea

If you vomit within 3–4 hours after taking the active pink tablet or have severe diarrhea, there is a risk that the active ingredients of the tablet are not fully absorbed into your body. This situation is similar to forgetting to take a tablet. After vomiting or experiencing diarrhea, take another tablet from a different pack as soon as possible. If possible, take it within 12 hours of when you would normally take your tablet. If this is not possible, or if more than 12 hours have passed, follow the advice in the section “If you forget to take Linelle Diario”.

Delaying your period: what you need to know

Although not recommended, it is possible to delay your period by skipping the 7 white placebo tablets and immediately starting a new Linelle Diario blister. You may experience spotting (drops or blood stains) or breakthrough bleeding while using the next blister. After taking the 7 placebo tablets of the second blister, continue with the next blister.

It is advisable 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 wish to change the starting day or have your period on a different day of the week, you may shorten your next placebo period by as many days as desired. The shorter the placebo period, the higher the risk of no withdrawal bleeding and the greater the likelihood of breakthrough bleeding and spotting during the second blister. Never extend the placebo period.

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

If you stop taking Linelle Diario film-coated tablets

You may stop taking Linelle Diario at any time. If you do not wish to become pregnant, consult your doctor about other reliable methods of contraception. If you wish to become pregnant, stop taking Linelle Diario and wait for a menstrual period before trying to conceive. This will make it easier to calculate your expected due date.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

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

Serious 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 hives with possible difficulty breathing (see also section “Warnings and precautions”).

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting Linelle Diario”.

Below is a list of adverse effects that have been associated with the use of Linelle Diario:

Frequent: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• loss of sexual desire
• migraine
• vomiting, diarrhoea
• skin rash
• 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

• vaginal or breast discharge

• redness or skin spots

• 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 stroke-like symptoms, known as transient ischaemic attack (TIA)

• blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about 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 contraceptive pills, but it is not known whether this is due to the treatment (see section 2: “Warnings and precautions”):

• Increased blood pressure
• Liver tumours 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 causing abdominal pain and mental disturbances), systemic lupus erythematosus (a condition in which the body attacks and damages its own organs and tissues), herpes in the late stages of pregnancy, Sydenham's chorea (involuntary rapid spasms or spasmodic movements), haemolytic uraemic syndrome (a condition occurring after diarrhoea caused by E. coli), liver problems shown by jaundice, gallbladder disorders or gallstone formation.

In women with hereditary angioedema, exogenous oestrogens in contraceptive pills may induce or exacerbate angioedema symptoms (see section 2: “Warnings and precautions”).

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Linelle Diario 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 expiry date stated on the outer packaging and blister after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Linelle Diario film-coated tablets

The active substances are levonorgestrel and ethinylestradiol.

Linelle Diario film-coated tablets contain tablets of 2 colours:

• 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, red aluminium lake (E129), lecithin (E322), iron oxide red (E172) and blue aluminium lake (E1329)].

• Each white tablet (inactive tablets or placebo tablets) contains only excipients (no active substances), 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 pack

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

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

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

• Pack sizes are 1, 3 or 6 blisters, each blister containing 28 tablets. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised 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 most recent revision of this leaflet: March 2020

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/”