ANAOMI DIARIO 0.1 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

levonorgestrel/ethinylestradiol

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Important things to 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 having a blood clot in the veins and arteries, especially in the first year 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 might have symptoms of a blood clot (see section 2 “Blood clots”)

Contents of the package leaflet:

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

Package contents and additional information

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

Anaomi Daily is a combined oral hormonal contraceptive and is 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 to take Anaomi Daily

General considerations

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

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

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

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

Do not take Anaomi Daily

• If you are allergic to levonorgestrel, ethinylestradiol, or any of the other components of this medicine (listed in section 6). This allergy can be recognized by the appearance of itching, skin rash, or inflammation.
• If you have (or have had in the past) a blood clot (thrombosis) in a blood vessel in the leg, lungs (embolism), or other organs.
• Known inherited or acquired predisposition to venous thromboembolism, such as resistance to PCA (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 disease that may predict a heart attack (e.g., angina pectoris, which causes intense chest pain) or a stroke (e.g., a small transient cerebral vascular accident without residual effects).
• If you have (or have ever had) a certain type of migraine (with so-called focal neurological symptoms).
• If you have a disease that could increase the risk of thrombosis in the arteries. These warnings apply in the following situations:
• • diabetes with damage to blood vessels,
  • very high blood pressure,
  • very high levels of fat in the blood (cholesterol or triglycerides).
• Known inherited or acquired predisposition to arterial thromboembolism, such as hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
• If you have (or have had) inflammation of the pancreas (pancreatitis).
• If you have or have had liver disease in the past and if your liver function is still not 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 in the genital organs.
• If you have vaginal bleeding of unknown cause.
• If you have not had your period for several months without a known cause.
• If you have hepatitis C and are taking medications that contain 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 that may mean you are suffering from 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).

To obtain a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

Consult your doctor or pharmacist before starting to take Anaomi Daily. In some situations, you should take special precautions during the use of Anaomi Daily or any other combined hormonal contraceptive, and it may be necessary for your doctor to monitor you regularly. If you are in any of the following situations, you should inform your doctor before starting to use Anaomi Daily. If any of the following situations 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 are going to be immobile for a long period (see "Blood clots").
• If you have just given birth, you have a higher risk of suffering from blood clots. You should ask your doctor how long after giving birth you can start taking Anaomi Daily.
• If you have Crohn's disease or ulcerative colitis (inflammatory bowel disease).
• If you have hemolytic uremic syndrome (HUS), a blood disorder that causes kidney damage.
• If you have sickle cell anemia (an inherited disease of the red blood cells).
• If you have epilepsy.
• If you have systemic lupus erythematosus (SLE, an immune system disorder).
• If you have a disease that first appeared during pregnancy or during previous use of sex hormones (e.g., loss of hearing, porphyria [a blood disease], gestational herpes [a skin rash with blisters that appears during pregnancy], Sydenham's chorea [a nerve disease in which sudden movements of the body occur]).
• If you have or have had chloasma (brownish-yellow pigmented patches, known as "pregnancy patches," especially on the face). If so, avoid direct exposure to sunlight or ultraviolet light.
• If you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

Psychiatric disorders

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

BLOOD CLOTS

The use of any combined hormonal contraceptive, such as Anaomi Daily, increases your risk of suffering from a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

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

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

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

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

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

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

What is the risk of a blood clot?

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

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

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, such as Anaomi Daily, 5 to 7 will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot in a vein" below).

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

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

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

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

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

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

If any of the above conditions change while you are using Anaomi Daily, 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 essential to note that the risk of a heart attack or stroke due to Anaomi Daily is very small, but it can increase:

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

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

If any of the above conditions change while you are using Anaomi Daily, 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 Daily and cancer

There have been reports of breast cancer with a slightly higher frequency in women taking oral contraceptives, but it is not known if this is due to the treatment. For example, it could be that more tumors are detected in women taking combined pills because they are examined by their doctor more frequently. The occurrence of breast tumors has been gradually lower after stopping the use of combined hormonal contraceptives. After ten years, the chances of having breast tumors will be the same as for women who have never used oral contraceptives. It is essential to regularly check your breasts, and you should contact your doctor if you notice any lump.

In rare cases, benign liver tumors and even rarer cases of malignant liver tumors have been reported in users of oral contraceptives. Contact your doctor if you notice any unusual severe abdominal pain.

There have been reports of cervical cancer in long-term users, but it is not clear if this is due to sexual behavior or other factors, such as the human papillomavirus (HPV).

A slight increase in the relative risk of cervical cancer and cervical intraepithelial neoplasia (severe diseases of the cervix) has been observed. Given the biological influence of combined oral contraceptives on these lesions, it is recommended that, if you are prescribed a combined oral contraceptive, you have regular cervical smears.

Malignant tumors can be life-threatening or have a fatal outcome.

Exams/medical consultations

Before starting or resuming treatment with Anaomi Daily, it is necessary for your doctor to perform a complete medical history and physical examination, aimed at ruling out contraindications and observing precautions, and these should be repeated at least once a year during the use of combined oral contraceptives.

Intermenstrual bleeding

During the first few months of use, you may experience intermenstrual bleeding or spotting. If this persists or is heavy, you should consult your doctor.

During the months you are taking Anaomi Daily, you may have unexpected bleeding (bleeding or bleeding outside of the pill-free week).

If this bleeding lasts for more than a few months, or if it starts after a few months, possible non-hormonal causes should be considered and, therefore, you should see your doctor so that he or she can take appropriate diagnostic measures to rule out malignant processes, 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 pill week (white pills). If you have taken all the active pills (pink pills) correctly, have not vomited, and have not had severe diarrhea, and have not taken any other medications, it is very unlikely that you are pregnant.

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

Other medications and Anaomi Daily

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including herbal remedies.

Also, inform any other doctor or dentist who prescribes you other medications (or the pharmacist who dispenses them) that you are using Anaomi Daily. They may tell you if you need to add other contraceptive measures (e.g., condom) and, if so, for how long.

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

• Intestinal motility treatment (e.g., metoclopramide).
• HIV infection treatment (e.g., ritonavir or nevirapine).
• Tuberculosis treatment (e.g., rifampicin).
• Fungal infection treatment (griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole).
• Bacterial infection treatment (macrolide antibiotics, e.g., clarithromycin, erythromycin).
• Treatment of certain heart diseases and high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem).
• Treatment of arthritis and osteoarthritis (etoricoxib).
• Certain antiepileptics (topiramate, barbiturates (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate).
• Grapefruit juice.
• Preparations based on St. John's Wort (Hypericum perforatum).

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

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

Anaomi Daily can be restarted approximately 2 weeks after completing this treatment. See section "Do not take Anaomi Daily".

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

Anaomi Daily may affect the effect of other medications, such as:

• Medications containing cyclosporine.
• The antiepileptic lamotrigine.

Laboratory tests

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

If you are prescribed a blood test, inform your doctor or laboratory personnel 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 medication.

Anaomi Daily is not indicated during pregnancy. In case of pregnancy, you should stop taking Anaomi Daily immediately and consult your doctor.

During the use of combined oral contraceptives, small amounts of these contraceptives may be excreted in breast milk. The amounts may affect the child, so combined oral contraceptives should not be used until the end of the breastfeeding period.

If you want to use Anaomi Daily after childbirth or abortion in the 2nd trimester: see section 2 "How to take Anaomi Daily".

Driving and using machines

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

Anaomi Daily 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 medication.

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

3. How to Take Anaomi Daily

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Each blister pack of Anaomi Daily contains 28 tablets: 21 pink tablets and 7 white tablets. The two types of differently colored Anaomi Daily tablets are placed in order.

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

Do not confuse the tablets: take one pinktablet once a day for the first 21 days and then one whitetablet every day for the last 7 days. Afterward, you should start a new blister pack (21 pink tablets and 7 white tablets). Thus, not leaving a break between blister packs.

Due to the different composition of the tablets, it is necessary that you start with the first tablet from the top left (near the "START" label) and take one tablet per day. For the correct order, follow the direction of the arrows on the blister pack.

To help you remember to take the tablets, each Anaomi Daily package comes with a sticker for each blister pack, which consists of 7 adhesive strips with the days of the week printed on them. Take the sticker for the week that starts with the day you started taking the tablets. For example, if you started on a Wednesday, use the sticker that starts with "WED". Place the weekly strip along the blister pack where you can read "Stick the strip here". Thus, for each tablet, there is a day indicated at the top, and you can check that you are taking the correct tablet. The arrows show the order in which you should take the tablets.

During the 7 days when you take the white placebo tablets (called placebo days), menstruation (also known as withdrawal bleeding) should occur. This normally begins on the 2nd or 3rd day after the last pink Anaomi Daily tablet. Once you have taken the last white tablet, you should start with the next blister pack, even if you have not finished bleeding. This means that you should start each strip on the same day of the week, and the withdrawal bleeding should occur on the same days every month.

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

When can you start with the first Anaomi Daily blister pack

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

Start taking Anaomi Daily on the first day of your cycle (which is the first day of your menstruation). If you start taking Anaomi Daily on the first day of your menstruation, you are immediately protected against pregnancy. You can also start on days 2 to 5 of your cycle, but in that case, you should use additional protective measures, such as a condom, during the first 7 days of taking the tablets.

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

You can start taking Anaomi Daily the day after taking the last active tablet of the previously used combined oral contraceptive (or after removing the ring or patch), but no later than the day after the usual break without tablets (without a ring or patch) or the last placebo tablet of the previous hormonal oral contraceptive.

This means that, at the latest, you should start treatment with Anaomi Daily on the same day you would start a new package of the previous hormonal oral contraceptive, vaginal ring, or transdermal patch.

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

You can switch any day from the progestogen-only pill (if you use an implant or IUD, on the day of its removal, and if you receive progestogen by injection, on the date the next injection is due), but in all cases, you should use additional protective measures (e.g., a condom) during the first 7 days of taking Anaomi Daily.

• After an abortion in the first trimester

You can start taking Anaomi Daily immediately. When you do so, you do not need to take additional contraceptive measures.Ask your doctor for advice.

• After childbirth or an abortion in the second trimester

You should not start taking Anaomi Daily before 21 to 28 days after childbirth or after an abortion in the second trimester of pregnancy, as the risk of blood clots increases. If you do so later, you should use an additional barrier method (e.g., a condom) during the first 7 days. However, if you have already had sexual intercourse, you should rule out the possibility of pregnancy before starting to take Anaomi Daily or wait until you have your first menstrual period.

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

• If you are breastfeeding and want to start taking Anaomi Daily after having a child,read the section 2 on "Breastfeeding".

If you take more Anaomi Daily 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 have vaginal bleeding.

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 Anaomi Daily

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

If you forgot to take an active tablet from rows 1, 2, or 3, you should follow the following instructions:

If it has been less than 12 hourssince you forgot the tablet, the contraceptive action is not reduced. You should take the tablet as soon as you remember and then continue taking the following tablets at the usual time (even if this means taking two tablets on the same day). In this case, you do not need to take any additional contraceptive measures.

If it has been more than 12 hourssince you forgot the tablet, the protection against pregnancy may be reduced. The more tablets you forget to take, the greater the risk that the protection against pregnancy will be reduced.

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

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

The procedure to follow in case of forgetfulness is governed by two basic rules:

1. Never extend the intake of placebo tablets for more than 7 days.
2. It is necessary to take the active tablets continuously for 7 days to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.

Consequently, and following the above instructions, in daily practice, the following can be advised (see also the diagram below):

• More than 1 forgotten tablet from the same blister pack

Consult your doctor.

• One forgotten tablet in week 1(day 1 to 7)

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Take the subsequent tablets at the usual time and take additional precautionsfor the next 7 days, for example, a condom. If you have had sexual intercourse in the week before the forgotten tablet or if you forget to start a new blister pack after the placebo period, there is a risk of pregnancy. In that case, consult your doctor.

• One forgotten tablet in week 2(day 8 to 14)

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time. If you have taken the tablets correctly in the 7 days before the forgotten tablet, the protection against pregnancy is not reduced, and you do not need to take additional precautions. But if not, or if you have forgotten more than 1 tablet, you should take additional contraceptive measures for the next 7 days.

• One forgotten tablet in week 3(day 15 to 21)

The risk of reduced efficacy is imminent due to the proximity of the placebo week. Nevertheless, by adjusting the tablet intake schedule, it is still possible to prevent the reduction of contraceptive protection. Therefore, if you follow one of the two options below, you will not need to take additional contraceptive precautions, provided that you have taken all the tablets correctly in the 7 days before the first forgotten tablet. If not, you should follow the first of the two options below and take additional contraceptive precautions in the next 7 days.

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at the usual time. Instead of taking the 7 white placebo tablets, go directly to the next blister pack. It is likely that you will have a menstrual period (withdrawal bleeding) at the end of the second strip, but you may also experience spotting or intermenstrual bleeding when taking the second blister pack.
2. You can also stop taking the active tablets of the current blister pack, the pink ones, and go directly to taking the 7 white placebo tablets (note the day you forgot to take the tablet). Then continue with the next blister pack. If you want to start a new blister pack on a specific day, shorten the placebo tablet intake period to less than 7 days.

If you forgot to take any of the active tablets from a blister pack and do not have bleeding during the placebo tablet week, you should consider the possibility that you may be pregnant. You should contact your doctor before continuing with the next blister pack.

Recommendations in case of gastrointestinal disorders

In case of severe gastrointestinal disorders, absorption may not be complete, and you should take additional contraceptive measures.

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

Although it is not recommended, you can delay your period by continuing with the next Anaomi Daily blister pack without taking the placebo tablets. You can continue for as long as you want until you finish the blister pack. During this time, you may experience bleeding or spotting. Then take the placebo tablets as usual. Start with a new blister pack afterward.

You may need to ask your doctor for advice before deciding whether to delay your period.

If you take the tablets according to the instructions, your period will begin during the placebo days.

If you need to change that day, reduce the number of placebo days (but never increase them; 7 at most!). For example, if you start taking the placebo tablets on Fridays and want to change to Tuesdays (3 days earlier), start a new blister pack 3 days earlier than usual. You may not experience bleeding during these days, or you may experience light or period-like bleeding. If you are unsure how to do this, ask your doctor for advice.

If you interrupt treatment with Anaomi Daily

You can stop taking Anaomi Daily whenever you want. If you do not want to become pregnant, ask your doctor for advice on other reliable methods of birth control.

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

4. Possible Adverse Effects

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

Always inform your doctor if you experience any adverse effect, especially if it is intense or persistent, or if you notice any change in your state of health that you think may be due to Anaomi Diario.

Severe Adverse Effects

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

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)).

To obtain more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before taking Anaomi Diario".

Adverse effects are listed below, 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 the 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 tension,
• weight gain.

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

• fluid retention,
• decreased libido (sexual desire),
• migraine,
• vomiting, diarrhea,
• 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.
• mild or temporary stroke-like symptoms, called transient ischemic attack (TIA).
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood 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)

• erythema nodosum (a type of skin inflammation with the appearance of 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 disease of hemoglobin metabolism),
• aggravation of varices,

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

• angioedema (symptoms include: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also the section "Warnings and Precautions").

Description of Selected Adverse Reactions

The following are very rare or delayed 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").

Tumors

• 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 low in relation to the overall risk of breast cancer. The causality related to the use of combined oral contraceptives is unknown.
• Liver tumors (benign and malignant).
• Cervical cancer.

Other Alterations

• Women with hypertriglyceridemia (increased fat in the blood resulting in an increased risk of pancreatitis when using combined oral contraceptives).
• Hypertension.
• Appearance or worsening of alterations whose association with the use of COCs is not conclusive: jaundice and/or pruritus related to cholestasis (bile flow blocked); formation of bile stones; a metabolic disorder called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic uremic syndrome (a disease with the appearance of blood clots); a neurological disorder called Sydenham's chorea; gestational herpes (a type of skin disorder that occurs during pregnancy); hearing loss related to otosclerosis.
• Alterations in liver function.
• Changes in glucose tolerance or effect 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 it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Anaomi Diario

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

Do not store at a temperature above 30°C.

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

Medicines should not be thrown away through the sewage system or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Anaomi Diario

• The active ingredients 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, aluminum lake red (E129), soy lecithin (E322), iron oxide red (E172), and aluminum lake blue (E1329)].

White tablets (inactive or placebo tablets, containing only excipients, without active ingredients)

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 Package Contents

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

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

Anaomi Diario is packaged in pressure-sensitive aluminum laminate blisters and PVC/PVDC film.

The package sizes are 1 or 3 blisters, and each blister contains 28 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera;

La Vallina s/n;

24008-Villaquilambre, León

Spain

Local Representative

SHIONOGI, S.L.U

C/ Serrano 45, 3rd floor

28001 Madrid

Spain

Date of the Last Revision of thisProspectus: November 2022

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