Label: information for the user

Anaomi 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 do not appear 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”)

Anaomi is a combined oral contraceptive hormone and is used to prevent pregnancy.

It contains two different female hormones, levonorgestrel and ethinyl estradiol.

Each of the 21 round pink tablets contains 0.1 mg of levonorgestrel and 0.02 mg of ethinyl estradiol.

General Considerations

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

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

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

Do not take Anaomi

• If you are allergic to levonorgestrel, ethinylestradiol, or to any of the other components of this medication (including 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 of the leg, in the lungs (embolism), or in 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 a 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 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 in the past liver disease and if 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 a vaginal hemorrhage of unknown cause.
• If you have not had a period for several months without a known cause.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other Medications and Anaomi”).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Anaomi. In some situations, you should take special precautions during the use of Anaomi 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 to use Anaomi. If any of the following situations develop or worsen while you are using Anaomi, also inform your doctor:

• If a close relative has or 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 of time (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 after giving birth.
• If you have Crohn's disease or ulcerative colitis (inflammatory bowel disease).
• If you have SUH (hemolytic uremic syndrome), a blood disorder that causes kidney damage.
• If you have sickle cell anemia (a hereditary blood disorder).
• If you have epilepsy.
• If you have SLE (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 body movements]).
• If you have or have had melasma (brownish-yellow skin patches, especially on the face). If so, avoid direct exposure to sunlight or ultraviolet light.
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

Mental Disorders

Some women who use hormonal contraceptives like Anaomi 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, 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 (which is called “deep vein thrombosis,” “venous thromboembolism,” or DVT).
• In arteries (which is called “arterial thrombosis,” “arterial thromboembolism,” or ATE).

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

It is essential to remember that the overall risk of a harmful blood clot due to Anaomi 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 can 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 in which you take 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 medication) 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, 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 DVT 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 is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, such as Anaomi, 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

The risk of having a blood clot with Anaomi 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 any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years). In this case, you may have a hereditary blood clotting disorder.
• 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 for several weeks before surgery or while you have limited mobility. If you need to stop using Anaomi, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years).
• If you have given birth recently.

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

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.

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

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

It is essential to note that the risk of a heart attack or stroke due to Anaomi 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, for example, you start smoking, a close relative experiences a blood clot without a cause, or you gain a lot of weight, inform your doctor.

Anaomi and Cancer

Cases of breast cancer have been observed with a slightly higher frequency in women taking combined hormonal contraceptives, but it is unclear whether this is due to the treatment. For example, tumors may be detected more frequently in women taking combined hormonal 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 combined hormonal contraceptives. It is essential to have your breasts checked regularly, 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 combined hormonal contraceptives. Contact your doctor if you notice 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 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, 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 hormonal contraceptives.

Menstrual Bleeding

During the first few months of taking Anaomi, 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 pills correctly, have not vomited, and have not had severe diarrhea, it is highly unlikely that you are pregnant.

If the expected bleeding does not appear for two consecutive times, you may be pregnant. Contact your doctor immediately. Do not start taking the next pack until you are sure you are not pregnant.

Other Medications and Anaomi

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

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

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

Do not use Anaomi 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 can cause increases in liver function tests in the blood (elevated ALT levels).

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

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

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

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

• Medications containing cyclosporine.
• The antiepileptic medication lamotrigine.

Blood Tests

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

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

Pregnancy and Breastfeeding

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

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

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

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

Driving and Operating Machinery

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

Anaomi 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 blister contains 21 tablets, each marked with a day of the week. You should start by taking the tablet marked with the correct day of the week (e.g., MON for Monday). Follow the direction of the arrows on the blister.

Take one tablet ofAnaomieach day, for 21 days, if necessary with a small amount of water.You should take the tablets every day, more or less at the same hour.

Once you have taken the 21 tablets, do not take any more tablets for the next 7 days. During those 7 days without tablets (known as interruption or week without treatment) you should start bleeding.This is called "withdrawal bleeding" and starts on the 2nd or 3rd day of the week.

On the 8th day after taking the last tablet ofAnaomi(i.e., after the 7-day week without treatment), start taking the next blister, even if the bleeding has not stopped.

This means that you should start thenext blister on the same day of the week and the withdrawal bleeding should appear on the same days every month.

By usingAnaomiin this way, you will also be protected against pregnancy during the 7 days that you are not taking the tablets.

When can you start with the first blister

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

Start taking Anaomi on the first day of the cycle (which is the first day of your menstruation). If you start taking Anaomi on the first day of your menstruation, you are immediately protected against pregnancy. You can also start on days 2 to 5 of the cycle, but in that case, you should use additional barrier 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 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 pause without tablets (without ring or patch) or the last placebo tablet (without hormones) of the previous combined oral contraceptive.

This means that, no later than, you should start the treatment with Anaomi 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-only pill or injection, 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 corresponding to the next injection), but in all cases, you should use additional barrier measures (e.g., a condom) during the first 7 days while taking Anaomi.

• After a first-trimester abortion.

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

• After a delivery or second-trimester abortion.

You should not start taking Anaomi before 21 to 28 days after delivery or after a second-trimester abortion, 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 sexual intercourse has already taken place, you should rule out the possibility of pregnancy before starting Anaomi 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 after having a child,read the section 2 on "Breastfeeding".

If you take more Anaomi 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Anaomi

If you makeless than 12 hoursof the forgotten tablet, the contraceptive action is not altered. You should take the tablet as soon as you remember and then continue taking the next tablets at the usual hour (although this means 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 contraceptive action may be reduced. 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 or end of a blister.

The guidelines to follow in case of forgetting are based on two basic rules:

1. You should never suspend taking tablets for more than 7 days.
2. You need to take the tablets uninterruptedly for 7 days to achieve an adequate suppression of the hypothalamic-pituitary-ovarian axis.

Consequently, and following the above indications, in daily practice, the following can be advised (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, even if this means taking two tablets at the same time. Then continue taking the tablets at the usual hour and takeadditional precautionsin the next 7 days, for example, a condom. If you have had sexual intercourse in the week before forgetting or if you forget to start a new blister after the period without 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, even if this means taking two tablets at the same time. Continue taking the tablets at the usual hour.If in the 7 days before the forgotten tablet you have taken the tablets correctly,the protection against pregnancy is not reduced and you do not need to take additional precautions. However, if not, or if you have forgotten more than 1 tablet, you should take additional contraceptive measures during the next 7 days.

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

The risk of reduced efficacy is imminent due to the proximity of the rest period. However, by adjusting the tablet-taking program, you can still prevent the contraceptive efficacy from being reduced. 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 forgetting you have taken all the tablets correctly. If not, you should follow the first of the two options indicated below and take additional contraceptive measures 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 hour. Instead of the rest period, start the next blister directly. It is likely that you will have a menstrual period (withdrawal bleeding) at the end of the second blister, but you may also experience spotting or intermenstrual bleeding while taking the second blister.
2. You can also stop taking the tablets from the current blister and go directly to the 7-day rest period(note the day you forgot to take the tablet).Then you should complete a period of up to 7 days without taking tablets, including the days when you forgot to take the tablets, and then start with the next blister. If you want to start a new blister on a specific day, shorten the rest period to less than 7 days.

If you forgot to take one of the tablets from a blister and you do not have bleeding in the first rest period, you should consider the possibility that you may be pregnant. You should contact your doctor before continuing with the next blister.

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 in the 3 or 4 first hours after taking the 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 should take another tablet from another blister of reserve 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, you should follow the advice included in "If you forgot to takeAnaomi".

If vomiting or diarrhea continue, 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 blister without leaving the usual 7-day rest period. You can continue for as long as you want until you finish the blister. During that time, you may experience bleeding or spotting. Then, you should follow the usual 7-day rest period without tablets and resume regular Anaomi tablet-taking.

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

If you take the tablets correctly, your period will always start on the same day of the week without tablets. If you need to change this day, you can do so by shortening the rest period (but never lengthening it) by as many days as you want. For example, if your period starts on a Friday and you want to change it to a Tuesday (3 days earlier), you should start a new blister 3 days earlier than usual. The shorter the pause, the greater the risk that your period will not appear and that you will experience intermenstrual bleeding or spotting while taking the next blister (as when delaying a period).

If you are unsure how to do it, ask your doctor for advice.

If you interrupt treatment with Anaomi

You can stop taking Anaomi 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 medicinecan cause side effects, although not everyone will experience them.

Always inform your doctor if you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health status that you think may be related to Anaomi.

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 (see also 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".

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 fungal infection),
• mood changes, including depression,
• headaches,
• nausea,
• abdominal pain,
• mammalian pain,
• mammalian 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),
• mammalian growth.

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).
• 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 (see also the "Warnings and precautions" section).

Description of selected adverse reactions

The following list includes rare or delayed adverse reactions that may occur or worsen with the group of combined oral contraceptives (see sections "Do not take Anaomi" 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, 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 Vigilance of Medicinal Products for Human Use:https://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 the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Anaomi

• The active principles are levonorgestrel and etinilestradiol. Each tablet contains 0.1 mg of levonorgestrel and 0.02 mg of etinilestradiol.
• The other components (excipients) are 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)].

Appearance of Anaomi and content of the container

Pink-coated round tablet.

Anaomi is packaged in breakable aluminum foil blisters with PVC/PVDC film.

The container sizes are 1 or 3 blisters, and each blister contains 21 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, 3rd floor

28001 Madrid

Spain

Last review date of this leaflet: November 2022

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