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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Anaomi 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 you should not give it to others, even if they have the same symptoms as you, because it may 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 during the first year of use or when restarting a combined hormonal contraceptive 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”).

Leaflet contents:

1. What Anaomi Diario is and what it is used for
2. What you need to know before taking Anaomi Diario
3. How to take Anaomi Diario
4. Possible side effects
5. How to store Anaomi Diario

Pack contents and other information

1. What Anaomi Daily is and what it is used for

Anaomi Daily is a combined oral hormonal contraceptive used to prevent pregnancy.

Each pink tablet contains two different female hormones, levonorgestrel and ethinylestradiol. Each of the 21 round pink tablets contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol.

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

2. What you need to know before starting Anaomi Daily

General considerations

Before starting Anaomi Daily, 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 starting Anaomi Daily, your doctor will ask you some questions about your medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your personal situation, may carry out other tests.

This leaflet describes several situations in which you should stop taking Anaomi Daily or in which the reliability of Anaomi Daily may be reduced. In these situations, you should not have sexual intercourse or, otherwise, you must 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 Anaomi Daily alters the monthly changes in body temperature and cervical mucus.

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

Do not take Anaomi Daily

• If you are allergic to levonorgestrel, ethinylestradiol, or any of the other ingredients of this medicine (listed in section 6). This allergy may manifest as itching, rash, or swelling.
• If you have (or have had in the past) a blood clot (thrombosis) in a blood vessel of the leg, lungs (embolism), or other organs.
• Known hereditary or acquired predisposition to venous thromboembolism, such as protein C resistance (including factor V Leiden), antithrombin III deficiency, protein C deficiency, protein S deficiency.
• If you have (or have had in the past) a heart attack or stroke.
• If you have (or have had in the past) a condition that may predict a heart attack (e.g., angina pectoris, which causes severe chest pain) or a stroke (e.g., a transient ischemic attack without residual effects).
• If you have (or have had) a specific type of migraine (with so-called focal neurological symptoms).
• If you have a disease that may increase the risk of arterial thrombosis. These warnings apply in the following situations:
  • diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fat in the blood (cholesterol or triglycerides).
• Known hereditary or acquired predisposition to arterial thromboembolism, such as hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
• If you have inflammation of the pancreas (pancreatitis).
• If you currently have or have previously had a liver disease and your liver function is not yet normal.
• If you have or have had a tumor in the liver.
• If you have (or have 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 missed your period for several months without a known reason.
• If you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Anaomi Daily”).

Warnings and precautions

When should you consult your doctor?

Seek urgent medical attention

• If you notice possible signs of a blood clot, which may mean 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 clots” below).

For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

Consult your doctor or pharmacist before starting Anaomi Daily. In some situations, you must take special care when using Anaomi Daily or any other combined hormonal contraceptive, and your doctor may need to monitor you regularly. If you are in any of the following situations, you must inform your doctor before starting to use Anaomi Daily. If any of the following conditions develop or worsen while you are using Anaomi Daily, 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 have diabetes.
• If you need surgery or will be immobile for a long period (see “Blood clots”).
• If you have recently given birth, you have a higher risk of blood clots. Ask your doctor how long after delivery you can start taking Anaomi Daily.
• If you have Crohn's disease or ulcerative colitis (inflammatory bowel disease).
• If you have HUS (haemolytic uraemic syndrome), a blood disorder causing kidney damage.
• If you have sickle cell anemia (a hereditary disease of the red blood cells).
• If you have epilepsy.
• If you have SLE (systemic lupus erythematosus, an immune system disorder).
• If you have a condition that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], gestational herpes [a blistering skin rash occurring during pregnancy], Sydenham's chorea [a nerve disorder causing sudden jerky movements]).
• If you have or have ever had chloasma (golden-brown pigmented patches, known as “pregnancy mask,” 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 hives with possible breathing difficulty, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.

Psychiatric disorders

Some women using hormonal contraceptives such as Anaomi Daily have reported depression or 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 for medical advice as soon as possible.

BLOOD CLOTS

Using any combined hormonal contraceptive, such as Anaomi Daily, increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (called “venous thrombosis,” “venous thromboembolism,” or VTE).
• In arteries (called “arterial thrombosis,” “arterial thromboembolism,” or TEA).

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

It is important to remember that the overall risk of a harmful blood clot due to Anaomi Daily 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 along a vein in the leg or foot, especially when accompanied by: pain or tenderness in the leg, which may only be noticed when standing or walking. increased warmth in the affected leg. change in skin color of the leg, e.g., if it becomes pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp pain that may worsen when taking a deep breath. Severe chest pain or dizziness. Fast 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 such as 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, heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below 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. Fast 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 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 must 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 events are rare. They occur more 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 you take a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same medicine or a different one) 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 Anaomi Diario, the 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 developing 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 Anaomi Diario is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will experience a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, such as Anaomi Diario, between 5 and 7 will experience a blood clot in one year.
• The risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot in a vein” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 in 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel	5–7 in 10,000 women
Women who use Anaomi Diario	About 5–7 in 10,000 women

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

The risk of having a blood clot with Anaomi 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 approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or will be immobile for a long time due to injury or illness, or if your leg is in a cast. You may need to stop taking Anaomi Diario several weeks before surgery or while you are less mobile. If you need to stop taking Anaomi Diario, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years of age).
• If you have given birth within the last few weeks.

The risk of developing a blood clot increases the more 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 Anaomi Diario.

If any of the above conditions change while you are using Anaomi 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 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 from using Anaomi 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 Anaomi 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 any of your close relatives have 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 disorders, 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, your risk of developing a blood clot may be further increased.

If any of the above conditions change while you are using Anaomi 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.

Anaomi Diario and cancer

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. For example, more tumors may be detected in women taking combined pills because they are examined by their doctor more frequently. The occurrence of breast tumors has gradually decreased after stopping the use of combined hormonal contraceptives. After ten years, the chances of having breast tumors will be the same as for women who have never used contraceptive pills. It is important to regularly examine your breasts, and you should contact your doctor if you notice any lump.

Rarely, benign liver tumors and even more rarely, malignant liver tumors have been described in users of contraceptive pills. Contact your doctor if you experience unusual severe abdominal pain.

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 slight increase in the relative risk of cervical cancer and cervical intraepithelial neoplasia (serious conditions of the cervix) has been observed. Given the biological influence of combined oral contraceptives on these lesions, it is recommended that periodic cervical cytology tests be performed if you are prescribed a combined oral contraceptive.

Malignant tumors can be life-threatening or fatal.

Medical examinations/consultations

Before starting or resuming treatment with Anaomi Diario, your doctor must perform a complete medical history and physical examination to rule out contraindications and observe precautions, and these should be repeated at least once a year during the use of combined oral contraceptives.

Bleeding between periods

During the first few months of taking Anaomi Diario, you may experience unexpected bleeding (bleeding or spotting outside the week without tablet intake).

If this bleeding lasts more than a few months, or if it starts after several months, non-hormonal causes should be considered, and therefore you should see your doctor, who will take appropriate diagnostic measures to exclude malignancies, infections, or pregnancy.

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

In some women, withdrawal bleeding (period) may not occur during the placebo week (white tablets). If you have correctly taken all active tablets (pink tablets), have not vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

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

Other medicines and Anaomi Diario

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine, including herbal remedies.

Also, inform any other doctor or dentist who prescribes you other medicines (or the pharmacist dispensing them) that you are using Anaomi Diario. They will advise you whether you need to use additional contraceptive measures (e.g., condom) and, if so, for how long.

It is especially important that you inform your doctor if you are taking any of the following medicines:

• Intestinal motility treatment (e.g., metoclopramide).
• Treatment of HIV infection (e.g., ritonavir or nevirapine).
• Treatment of tuberculosis (e.g., rifampicin).
• Treatment of fungal infections (griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole).
• Treatment of bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin).
• Treatment of certain heart conditions and high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem).
• Treatment of arthritis and osteoarthritis (etoricoxib).
• Some antiepileptics (topiramate, barbiturates (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate).
• Grapefruit juice.
• Herbal preparations containing St. John's wort (Hypericum perforatum).

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

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

Anaomi Diario may be restarted approximately 2 weeks after completing this treatment. See section “Do not take Anaomi Diario.”

The antibiotic troleandomycin may increase the risk of bile retention when taken together with combined oral contraceptives.

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

• Medicines containing cyclosporine.
• The antiepileptic lamotrigine.

Laboratory tests

The use of oral contraceptives may affect the results of certain laboratory tests.

If you are scheduled for a blood test, inform your doctor or laboratory staff that you are using oral contraceptives.

Pregnancy and breastfeeding

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

Anaomi Diario is not indicated during pregnancy. If you become pregnant, you must stop taking Anaomi Diario immediately and consult your doctor.

While using combined oral contraceptives, small amounts of these contraceptives may be excreted in breast milk. These amounts may affect the infant, so combined oral contraceptives should generally not be used until breastfeeding has ended.

If you wish to use Anaomi Diario after childbirth or after a second-trimester abortion: see section 2 “How to take Anaomi Diario.”

Driving and using machines

There is no information indicating that the use of Anaomi Diario affects the ability to drive or use machines.

Anaomi Diario contains lactose and soy lecithin

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

Do not use this medicine if you are allergic to peanuts or soy.

3. How to take Anaomi Diario

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

Each Anaomi Diario blister contains 28 tablets: 21 pink tablets and 7 white tablets. The two different-colored tablets in Anaomi Diario are arranged in order.

Take one Anaomi Diario tablet daily, 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 each day for the last 7 days. Then, start a new blister pack (21 pink tablets and 7 white tablets), with no break between packs.

Due to the different composition of the tablets, you must start with the first tablet at the top left (near the label “START”) and take one tablet daily. For correct sequence, follow the direction of the arrows on the blister.

To help you remember to take the tablets, each Anaomi Diario package includes, for each blister, a sticker composed of 7 adhesive strips with the days of the week printed on them. Select the weekly sticker starting with the day you began taking the tablets. For example, if you started on a Wednesday, use the sticker beginning with “WED”. Place the weekly strip along the blister where it reads “Apply strip here”. Thus, each tablet will have a day indicated above it, allowing you to verify you are taking the correct tablet. The arrows indicate the order in which the tablets should be taken.

During the 7 days when you take the white placebo tablets (referred to as placebo days), menstruation should occur (this may also be called withdrawal bleeding). This usually begins on the 2nd or 3rd day after the last pink tablet of Anaomi Diario. Once you have taken the last white tablet, begin the next blister pack immediately, even if bleeding has not finished. This means you should start each pack on the same day of the week, and withdrawal bleeding should occur during the same days each month.

If you take Anaomi Diario in this way, you will also be protected against pregnancy during the 7 days when you take the white placebo tablets.

When to start the first blister of Anaomi Diario

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

Start taking Anaomi Diario on the first day of your cycle (i.e., the first day of your menstruation). If you start taking Anaomi Diario on the first day of your period, you are immediately protected against pregnancy. You may also start between days 2 and 5 of your cycle, but in this case, you must use additional contraceptive protection (e.g., a condom) for the first 7 days of tablet intake.

• Switching from another combined hormonal contraceptive (oral contraceptive, vaginal ring, or transdermal patch)

You may start taking Anaomi Diario the day after taking the last active tablet of your previous combined oral contraceptive (or after removing the vaginal ring or patch), but no later than the day after your usual tablet-free interval (ring-free or patch-free period) or after the last placebo tablet of your previous hormonal contraceptive.

This means that, at the latest, treatment with Anaomi Diario should begin on the same day you would have started a new pack of your previous hormonal contraceptive, vaginal ring, or transdermal patch.

• Switching from a progestogen-only method (progestogen-only pill or injection, implant, or progestogen-releasing IUD)

You may switch 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) for the first 7 days of taking Anaomi Diario.

• After a first-trimester abortion

You may start taking Anaomi Diario immediately. In this case, additional contraceptive measures are not necessary. Consult your doctor for advice.

• After childbirth or a second-trimester abortion

Do not start taking Anaomi Diario earlier than 21 to 28 days after childbirth or after a second-trimester abortion, as the risk of blood clots is increased. If you start later, you must use an additional barrier method (e.g., a condom) for the first 7 days. However, if sexual intercourse has already occurred, pregnancy must be ruled out before starting Anaomi Diario, or you must wait until your first menstrual bleed.

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

• If you are breastfeeding and wish to start taking Anaomi Diario after childbirth, read section 2 on “Breastfeeding”.

If you take more Anaomi Diario than you should

No serious adverse reactions have been reported due to overdose.

If you take several tablets at once, you may experience nausea and vomiting. Young girls may experience vaginal bleeding.

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 the amount ingested.

If you forget to take Anaomi Diario

The tablets in the fourth row of the blister are placebo tablets. If you forget to take one of these, it will not affect the effectiveness of Anaomi Diario. Discard the missed placebo tablet to avoid prolonging the placebo week, which could negatively affect the efficacy of Anaomi Diario.

If you forget to take an active tablet from rows 1, 2, or 3, follow the instructions below:

If less than 12 hours have passed since you missed the tablet, contraceptive protection is not reduced. Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time (even if this means taking two tablets on the same day). In this case, no additional contraceptive measures are necessary.

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 reduced protection against pregnancy.

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

Therefore, follow the rules below (see also the diagram below):

The recommended course of action in case of a missed tablet is governed by two basic rules:

1. Never extend the intake of placebo tablets beyond 7 days.
2. Active tablets must be taken continuously for 7 days to ensure adequate suppression of the hypothalamic-pituitary-ovarian axis.

Accordingly, and following the above guidelines, the following advice may be given in daily practice (see also the diagram below):

• More than 1 tablet missed from the same blister pack

Consult your doctor.

• One tablet missed in week 1 (days 1 to 7)

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time and use additional precautions for the next 7 days (e.g., a condom). If you had sexual intercourse in the week before the missed tablet or if you forget to start a new blister pack after the placebo tablet period, there is a risk of pregnancy. In this case, consult your doctor.

• One tablet missed in week 2 (days 8 to 14)

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. If you took all tablets correctly in the 7 days before the missed tablet, contraceptive protection is not reduced and no additional precautions are needed. However, if this is not the case or if you missed more than one tablet, use additional contraceptive measures for the next 7 days.

• One tablet missed in week 3 (days 15 to 21)

The risk of reduced efficacy is imminent due to the proximity of the break week. However, adjusting the tablet-taking schedule can still prevent reduced contraceptive protection. Therefore, if you follow one of the two options below, you will not need additional contraceptive precautions, provided you took all tablets correctly in the 7 days before the first missed tablet. If not, follow the first of the two options below and 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 tablets at your usual time. Instead of taking the 7 white placebo tablets, go directly to the next blister pack. You will most likely have a menstrual bleed (withdrawal bleeding) at the end of the second pack, but you may also experience spotting or intermenstrual bleeding during the second pack.
2. Alternatively, stop taking the active pink tablets from the current blister pack and immediately start taking the 7 white placebo tablets (note the day you missed the tablet). Then continue with the next blister pack. If you wish to start a new pack on a specific day, shorten the placebo tablet period to fewer than 7 days.

If you missed one or more active tablets from a blister pack and do not have bleeding during the week you take the placebo tablets, consider the possibility of pregnancy. Contact your doctor before continuing with the next blister pack.

Recommendations in case of gastrointestinal disturbances

In case of severe gastrointestinal disturbances, absorption may not be complete, and additional contraceptive measures should be used.

If you vomit within 3 to 4 hours after taking the pink tablet or have severe diarrhea, there is a risk that the active ingredients of the tablet may not be fully absorbed. This situation is similar to missing a tablet. After vomiting or diarrhea, take another pink tablet from the reserve blister as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or if more than 12 hours have passed, follow the advice under “If you forget to take Anaomi Diario”. If vomiting or diarrhea continues, consult your doctor. You may need to use an additional contraceptive method.

How to delay a menstrual period or change the first day of your period

Although not recommended, you can delay your period by continuing directly to the next Anaomi Diario blister pack without taking the placebo tablets. You may continue for as long as desired until the end of the blister pack. During this time, you may experience bleeding or spotting. Then take the placebo tablets as usual and start a new blister pack.

You may need to consult your doctor before deciding to delay your period.

If you take the tablets as instructed, your period will begin during the placebo days.

If you wish to change this day, reduce the number of placebo days (but never extend them; maximum 7 days). For example, if you usually start placebo tablets on Fridays and want to change to Tuesdays (3 days earlier), start the new blister pack 3 days earlier than usual. You may not bleed during these days or may experience light bleeding or period-like bleeding. If you are unsure how to do this, consult your doctor.

If you stop taking Anaomi Diario

You may stop taking Anaomi Diario at any time. If you do not wish to become pregnant, consult your doctor about other reliable methods of contraception.

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 will experience them.

Always inform your doctor if you experience any adverse effects, especially if they are severe or persistent, or if you notice any change in your health that you think may be due to Anaomi Diario.

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 the veins (venous thromboembolism (VTE)) or blood clots in the 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 Anaomi Diario”.

The adverse effects listed below are classified according to their frequency based on the following criteria:

Very common: may affect more than 1 in 10 women.

Common: may affect up to 1 in 10 women.

Uncommon: may affect up to 1 in 100 women.

Rare: may affect up to 1 in 1,000 women.

Very rare: may affect up to 1 in 10,000 women.

Frequency not known: (cannot be estimated from available data).

Common adverse effects (may affect up to 1 in 10 women):

• vaginitis (inflammation of the vagina), including candidiasis (fungal infection in the vagina),
• mood changes, including depression,
• headaches,
• nausea, abdominal pain,
• breast pain, breast tenderness,
• weight gain.

Uncommon adverse effects (may affect up to 1 in 100 women):

• fluid retention,
• decreased libido (sexual desire),
• migraine,
• vomiting, diarrhoea,
• skin rash, urticaria (itching),
• breast enlargement.

Rare adverse effects (may affect up to 1 in 1,000 women):

• hypersensitivity (abnormal increase in skin sensitivity),

• increased libido,

• intolerance to contact lenses,

• 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.

• transient ischaemic attack (TIA) or mild stroke-like symptoms.

• blood clots in the liver, stomach/intestines, 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 on conditions that increase the risk of blood clots and symptoms of a blood clot).

• nodular erythema (a type of skin inflammation causing nodules on the legs), erythema multiforme (a type of skin inflammation),
• vaginal discharge, breast discharge,
• weight loss.

Very rare adverse effects (may affect up to 1 in 10,000 women):

• worsening of porphyria (a disorder of haemoglobin metabolism),
• worsening of varicose veins.

Frequency not known (cannot be estimated from available data):

• angioedema (symptoms include: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with possible difficulty breathing (see also section “Warnings and precautions”).

Description of selected adverse reactions

Below are listed very rare or delayed-onset adverse reactions that may occur or worsen with the use of combined oral contraceptives (see sections “Do not take Anaomi Diario” and “Warnings and precautions”).

Tumours

• The frequency of breast cancer diagnosis among users of combined oral contraceptives is slightly increased. Since breast cancer is rare in women under 40 years of age, this increase is small in relation to the overall risk of breast cancer. Causality related to the use of combined oral contraceptives is unknown.
• Liver tumours (benign and malignant).
• Cervical cancer.

Other disorders

• Women with hypertriglyceridaemia (elevated blood fats, resulting in an increased risk of pancreatitis when using combined oral contraceptives).
• Hypertension.
• Onset or worsening of conditions whose association with the use of COCs is not conclusive: jaundice and/or pruritus related to cholestasis (blocked bile flow); gallstone formation; a metabolic disorder called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); haemolytic uraemic syndrome (a disease involving blood clot formation); a neurological disorder called Sydenham's chorea; gestational herpes (a type of skin disorder occurring during pregnancy); hearing loss related to otosclerosis.
• Changes in liver function.
• Changes in glucose tolerance or effects on peripheral insulin resistance.
• Crohn’s disease, ulcerative colitis.
• Chloasma.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Anaomi Diario

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 CAD/EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly discard medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anaomi Diario

• The active substances are levonorgestrel and ethinylestradiol. Each pink tablet contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol.

• The other components (excipients) are:

Pink tablets (active tablets)

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

White tablets (inactive tablets or placebo tablets, containing only excipients, no active substances)

anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E572) and Opadry II white [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350].

Appearance of Anaomi Diario and contents of the pack

Each active film-coated tablet is round and pink in colour.

Each placebo film-coated tablet is round and white in colour.

Anaomi Diario is packaged in press-through aluminium foil blisters with PVC/PVDC film.

Pack sizes are 1 or 3 blisters, each blister containing 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

Navatejera Industrial Estate;

La Vallina s/n;

24008-Villaquilambre, León

Spain

Local representative

SHIONOGI, S.L.U

C/ Serrano 45, 3rd floor

28001 Madrid

Spain

Date of latest revision of the package leaflet: November 2022

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