Label: information for the user

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

levonorgestrel/etiniliestradiol

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. 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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”)

Contents of the package and additional information

Anaomi Diario is a combined oral 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.

General Considerations

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

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

This leaflet describes several situations in which you should stop taking Anaomi Diario or in which the reliability of Anaomi Diario may be reduced.Do not have sexual intercourse or, if you do, use non-hormonal contraceptive methods, such as a condom or other barrier method.Do not use the rhythm or temperature methods.These methods are unreliable because Anaomi Diario alters the monthly changes in body temperature and cervical mucus.

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

Do not take Anaomi Diario

• If you are allergic to levonorgestrel, ethinylestradiol, or any of the other components of this medication (listed in section 6).
  This allergy may 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 of the leg, lungs (embolism), or other organs.
• Known hereditary or acquired predisposition to venous thromboembolism, such as resistance to protein C (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 stroke (e.g., a small transient ischemic attack without residual effects).
• If you have (or have had at any time) a certain type of migraine (with 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 vascular damage,
  • Very high blood pressure,
  • Very high concentrations of fat in the blood (cholesterol or triglycerides).
• Known hereditary or acquired predisposition to arterial thromboembolism, such as hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, anticoagulant of lupus).
• If you have (or have had) pancreatitis.
• If you have or have had liver disease and your liver function is not yet normal.
• If you have or have had a liver tumor.
• If you have (or have had) or if there is suspicion of breast cancer or cancer in genital organs.
• If you have unexplained vaginal bleeding.
• If you have not had a period for several months without a known cause.
• 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 Medications and Anaomi Diario”).

Warnings and Precautions

Consult your doctor or pharmacist before starting Anaomi Diario. In some situations, you should be particularly careful when using Anaomi Diario or any other combined hormonal contraceptive, and your doctor may need to monitor you regularly. If you are in any of the following situations, inform your doctor before starting Anaomi Diario. If any of the following situations develop or worsen while you are using Anaomi Diario, also inform your doctor:

• If a close relative has had breast cancer.
• If you have liver disease or gallbladder disease.
• If you have diabetes.
• If you need surgery, or are 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 you can start taking Anaomi Diario after giving birth.
• If you have Crohn's disease or ulcerative colitis (inflammatory bowel disease).
• If you have hemolytic-uremic syndrome (a blood disorder that causes kidney damage).
• If you have sickle cell anemia (a genetic disorder of red blood cells).
• If you have epilepsy.
• If you have systemic lupus erythematosus (a disorder of the immune system).
• If you have a disease that appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], gestational herpes [a skin rash with blisters that appears during pregnancy], Sydenham's chorea [a nervous disorder that causes sudden, involuntary movements of the body]).
• If you have or have had melasma (brown or gray patches on the skin, 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 estrogen can cause or worsen symptoms of hereditary and acquired angioedema.

Mental Health Disorders

Some women who use hormonal contraceptives like Anaomi Diario have reported

depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

BLOOD CLOTS

The use of any combined hormonal contraceptive, like Anaomi Diario, increases your risk of blood clots compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate 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 veins (venous thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
• In very rare cases, a blood clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may be higher 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 is always slightly higher than if you were not taking a combined hormonal contraceptive.

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

What is the risk of a blood clot?

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

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

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel like Anaomi Diario, 5-7 will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal factors (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

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

• If you are overweight (body mass index or BMI greater than 30 kg/m2).
• If a close relative has had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years old). In this case, you may have a hereditary disorder of blood clotting.
• If you need surgery or are immobile for a long period due to an injury or illness, or if you have a leg cast. You may need to stop using Anaomi Diario for several weeks before surgery or while you are less mobile. If you need to stop using Anaomi Diario, ask your doctor when you can start taking it again.
• With increasing age (especially over about 35 years).
• If you have given birth recently.

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

Long flights (over 4 hours) may 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 have any of the above conditions, even if you are unsure. Your doctor may decide that you should stop using Anaomi Diario.

If any of the above conditions change while you are using Anaomi Diario, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it may 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 Diario is very small, but it may increase:

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 even further.

If any of the above conditions change while you are using Anaomi Diario, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Anaomi Diario and Cancer

Cases of breast cancer have been observed with a slightly higher frequency in women taking combined oral contraceptives, but it is unclear whether this is due to the treatment. For example, tumors may be detected more frequently in women taking combined oral contraceptives because they are reviewed by their doctor more frequently. The appearance of breast tumors has gradually decreased after stopping the use of combined hormonal contraceptives. After 10 years, the chances of having breast tumors will be the same as for women who have never used oral contraceptives. It is essential to have regular breast checks, and you should contact your doctor if you notice any lumps.

In rare cases, benign liver tumors and even more rare malignant liver tumors have been described in users of oral contraceptives. Contact your doctor if you notice unusual 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 the human papillomavirus (HPV).

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

Malignant tumors can pose a threat to life or have a fatal outcome.

Examinations/Consultations

Before starting or restarting treatment with Anaomi Diario, your doctor should 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.

Intermenstrual Bleeding

During the first few months of taking Anaomi Diario, you may experience unexpected bleeding (bleeding or spotting outside of the pill-free week).

If this bleeding lasts for more than a few months or starts after a few months, possible non-hormonal causes should be considered, and you should consult your doctor to take appropriate diagnostic measures to rule out malignant processes, infections, or pregnancy.

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

In some women, bleeding may not occur during the pill-free week. If you have taken all the active pills correctly, have not vomited, and have not had severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.

If you have missed bleeding twice in a row, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other Medications and Anaomi Diario

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

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

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

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 liver function parameters in the blood (elevated liver enzyme ALT).

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

Anaomi Diario can 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 if taken with combined oral contraceptives.

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

• Cyclosporin-containing medications.
• The antiepileptic medication lamotrigine.

Blood Tests

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

Inform your doctor or laboratory personnel that you are using combined oral contraceptives if you are scheduled for a blood test.

Pregnancy and Breastfeeding

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

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

During the use of combined oral contraceptives, small amounts of these contraceptives may be eliminated through breast milk. These amounts may affect the baby, so combined oral contraceptives are generally not recommended until the end of breastfeeding.

If you want to use Anaomi Diario after giving birth or after an abortion in the second trimester: see section 2 “How to take Anaomi Diario.”

Driving and Operating Machinery

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

Anaomi Diario contains lactose and soy lecithin

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

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 of Anaomi Diario are placed in order.

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

Do not confuse the tablets:take one pink tablet once a day for the first 21 days and then one white tablet every day for the last 7 days.After that, you must start a new blister (21 pink tablets and 7 white tablets).Do not leave a break between the blisters.

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

To help you remember to take the tablets, each Anaomi Diario package comes with a sticker for each blister, which consists of 7 adhesive strips with the days of the week printed on them. Take the sticker of 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 strip of the week along the blister where you can read "Stick here the adhesive strip". In this way, 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 must take the tablets.

During the 7 days when you take the white placebo tablets of Anaomi Diario, you must have menstruation (also called withdrawal bleeding). This usually starts on the 2nd or 3rd day after the last pink Anaomi Diario tablet. Once you have taken the last white tablet, you must start with the next blister, even if you have not finished bleeding. This means that you must start each strip on the same day of the week and that withdrawal bleeding must occur on 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 can you start with the first Anaomi Diario blister

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

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

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

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

This means that you must start the treatment with Anaomi Diario on the same day that you should start a new package of the previous combined oral contraceptive, vaginal ring, or transdermal patch.

• Switching from a method that contains only progestogen (progestogen pills or injections, implant, or IUD releasing progestogen)

You can switch any day from the progestogen-only pill (if you used an implant or IUD, on the day of its removal, and if you received progestogen by injection, on the date of the next scheduled injection), but in all cases, you must use additional protective measures (e.g., a condom) during the first 7 days when you take Anaomi Diario.

• After a first-trimester abortion

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

• After a second-trimester abortion or childbirth

You must not start taking Anaomi Diario before 21 to 28 days after childbirth or a second-trimester abortion, as the risk of blood clots increases. If you do so later, you must use an additional barrier method (e.g., a condom) during the first 7 days. However, if sexual intercourse has already taken place, you must rule out the possibility of pregnancy before starting Anaomi Diario or wait for your first menstrual bleeding.

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

• If you are breastfeeding and want to start taking Anaomi Diario after having a child,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 symptoms. Young girls may experience 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 forget to take Anaomi Diario

The tablets in thefourthrow of the blister are placebo tablets. If you forget to take one of these tablets, it will not affect the effect of Anaomi Diario. You must throw away the forgotten placebo tablet to avoid prolonging the placebo week, which could have a negative effect on the effectiveness of Anaomi Diario.

If you forget to take an active tablet from the rows1, 2, or 3, follow the instructions below:

If you makeless than 12 hoursof the forgotten tablet, the contraceptive action does not decrease. Take the forgotten tablet as soon as you remember it and then take the next tablets at the usual time (although this may mean taking two tablets at the same time). In this case, you do not need to take any additional contraceptive measures.

If you makemore than 12 hoursof the forgotten tablet, the protection against pregnancy may decrease. The more tablets you forget to take, the greater the risk of reduced protection against pregnancy.

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

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

1. Never extend the placebo tablet week more than 7 days.
2. You must take the active tablets in an uninterrupted manner for 7 days to achieve an adequate suppression of the hypothalamic-pituitary-ovarian axis.

Consequently, and following the above indications, in daily practice, you can be advised as follows (see also the diagram, later):

• More than 1 tablet forgotten from the same blister

Consult your doctor.

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

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

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

Take the forgotten tablet as soon as you remember it, 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 will not decrease and you will not need to take additional precautions. However, if not or if you have forgotten more than 1 tablet, you must take additional contraceptive measures during the next 7 days.

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

The risk of reduced effectiveness is imminent due to the proximity of the rest week. However, adjusting the tablet-taking program still allows you to prevent the contraceptive effectiveness from decreasing. Therefore, if you follow one of the two options below, you will not need to take additional contraceptive measures, provided that in the 7 days before the first forgotten tablet, you have taken all the tablets correctly. If not, you must follow the first of the two options indicated below and take additional contraceptive measures during the next 7 days.

1. Take the forgotten tablet as soon as you remember it, even if this means taking two tablets at the same time. Then continue taking the tablets at the usual time. Instead of taking the 7 white placebo tablets, go directly to the next blister.You are likely to have menstruation (withdrawal bleeding) at the end of the second strip, but you may also have spotting or bleeding between periods when you take the second blister.
2. You can also leave taking the active tablets from the current blister, the pink ones, and go directly to taking the 7 white placebo tablets, the ones with the day marked on them.(Note the day on which you forgot to take the tablet).Then continue with the next blister.If you want to start a new blister on a specific day, shorten the placebo tablet period to less than 7 days.

If you forgot to take one of the active tablets from a blister and you do not have bleeding during the week when you take the placebo tablets,you must consider the possibility of being pregnant.You must contact your doctor before continuing withthe next blister.

Recommendations in case of gastrointestinal disorders

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

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

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

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

If you take the tablets as instructed, your period will start during the placebo tablet week.

If you need to change that day, shorten the number of placebo tablet days (but never increase it; 7 at most!). For example, if you start taking the placebo tablets on Friday and want to change to Tuesday (3 days earlier), start a new blister 3 days earlier than usual. You may not experience bleeding during these days, but you may experience light bleeding or spotting.
Ask your doctor for advice if you are unsure how to do it.

If you interrupt the treatment with Anaomi Diario

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

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

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

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

Severe side effects

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

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

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

Side effects are listed below, classified according to their frequency based on the following criteria:

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

Common: can affect up to 1 in 10 women.

Uncommon: can affect up to 1 in 100 women.

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

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

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

Common side effects(can affect up to 1 in 10 women):

• vaginitis (vaginal inflammation), including candidiasis (vaginal yeast infection),
• mood changes, including depression,
• headaches,
• nausea, abdominal pain,
• mammalian pain, breast tension,
• weight gain.

Uncommon side effects(can affect up to 1 in 100 women):

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

Rare side effects(can affect up to 1 in 1,000 women):

• hypersensitivity (abnormal skin sensitivity),
• increased libido,

• contact lens intolerance,
• 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 ischemic attack (TIA) or mild symptoms similar to a stroke.
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot)

• 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 side effects(can affect up to 1 in 10,000 women):

• exacerbation of porphyria (a metabolic disorder of hemoglobin),
• exacerbation of varicose veins,

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

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

Description of selected adverse reactions

Below are listed rare or delayed adverse reactions that may occur or worsen with the group 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 old, this increase is low compared to the overall risk of breast cancer. The causal relationship with the use of combined oral contraceptives is unknown.
• Benign and malignant liver tumors.
• Cervical cancer.

Other alterations

• Women with hypertriglyceridemia (increased blood fats resulting in an increased risk of pancreatitis when using combined oral contraceptives).
• Hypertension.
• Appearance or worsening of alterations whose association with the use of AOC is not conclusive: jaundice and/or pruritus related to cholestasis (bile flow blocked); formation of gallstones; 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 alteration that occurs during pregnancy); hearing loss related to otosclerosis.
• Liver function alterations.
• Changes in glucose tolerance or effect on peripheral insulin resistance.
• Crohn's disease, ulcerative colitis.
• Melasma

Reporting of adverse reactions

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

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

Do not store at a temperature above 86°F (30°C).

Do not use this medication 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 disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Anaomi Diario

• The active principles are levonorgestrel and etinilestradiol. Each pink tablet contains 0.1 mg of levonorgestrel and 0.02 mg of etinilestradiol.

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

White tablets (inactive tablets or placebo, contain only excipients, without active principles)

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 content of the container

Each active tablet coated with a film is a round pink tablet.

Each placebo tablet coated with a film is a round white tablet.

Anaomi Diariois packaged in blisters of aluminum foil that can be broken under pressure and PVC/PVDC film.

The container sizes are 1 or 3 blisters, and eachblister contains 28 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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, planta 3

28001 Madrid

Spain

Last review date of thisprospectus: November 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.