ANAOMI 0.1 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Anaomi 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 symptoms are the same as yours.
• If you experience any side effects, talk to 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 see 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 and what it is used for
2. What you need to know before you start taking Anaomi
3. How to take Anaomi
4. Possible side effects
5. Storing Anaomi
6. Package contents and further information

1. What is Anaomi and what it is used for

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

It 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.

2. What you need to know before starting to take Anaomi

General considerations

Before starting to take Anaomi, 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, 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 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 rhythm or temperature methods. These methods are unreliable, as Anaomi alters the monthly changes in body temperature and cervical mucus.

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

Do not take Anaomi

• If you are allergic to levonorgestrel, ethinylestradiol, or any of the other components of this medication (including those 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 your 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, or 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 stroke 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 blood vessel damage,
  • 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) pancreatitis (inflammation of the pancreas).
• 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 liver tumor.
• 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, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Other medications and Anaomi").

Warnings and precautions

When should you consult your doctor?

Seek urgent medical attention

• If you notice possible signs of a blood clot that may indicate you are suffering from a blood clot in your leg (i.e., deep vein thrombosis), a blood clot in your 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. In some situations, you should take special precautions during the use of Anaomi 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. If any of the following situations develop or worsen while you are using Anaomi, 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 immobile for a long period (see "Blood clots").
• If you have just given birth, you have a higher risk of blood clots. You should ask your doctor how long after delivery you can start taking Anaomi.
• 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 (a hereditary 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., hearing loss, 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 may cause or worsen the symptoms of hereditary and acquired angioedema.

Psychiatric 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, such as 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 the veins (called "venous thrombosis," "venous thromboembolism," or VTE).
• In the arteries (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 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 medication 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, 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 is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, such as Anaomi, 5 to 7 will have 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 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).
• If you need surgery or are 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 several weeks before surgery or while you have reduced mobility. If you need to stop using Anaomi, ask your doctor when you can start using it again.
• As you get older (especially above 35 years).
• If you have recently given birth.

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

Long-distance flights (more than 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 not sure. 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 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 is very small, but it may increase:

• With age (above 35 years).
• If you smoke.When using a combined hormonal contraceptive like Anaomi, you are advised to quit smoking. If you are unable to quit 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 high levels 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, 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 and cancer

There have been reports of breast cancer with a slightly higher frequency in women taking oral contraceptives, but it is unknown whether 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 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 (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.

Examinations/medical consultations

Before starting or resuming 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 oral contraceptives.

Intermenstrual bleeding

During the first few months in which you are taking Anaomi, you may have unexpected bleeding (bleeding or spotting outside of the week without taking pills).

If this bleeding lasts for more than a few months or starts after some months, you should consult your doctor.

3. How to take Anaomi

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 contains 21 pills, each marked with a day of the week. Start by taking the pill marked with the correct day of the week (e.g., MON for Monday). Follow the direction of the arrows on the blister pack.

Take one Anaomi pill every day for 21 days, if necessary with a small amount of water.You should take the pills every day, more or less at the same time.

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

On the 8th day after taking the last Anaomi pill (i.e., after the week without treatment), start taking the next blister pack, even if bleeding has not stopped.

This means you should start the next blister pack on the same day of the week, and withdrawal bleeding should occur on the same days every month.

If you use Anaomi in this way, you will also be protected against pregnancy during the 7 days you are not taking pills.

When to start with the first blister pack

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

Start taking Anaomi on the first day of your 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 your cycle, but in that case, you must use additional protection measures, such as a condom, during the first 7 days of taking pills.

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

You can start taking Anaomi the day after taking the last active pill of the previous combined oral contraceptive (or after removing the ring or patch), but no later than the day after the usual pill-free interval (or the last pill of the previous contraceptive).

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

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

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

• After an abortion in the first trimester.

You can start taking Anaomi immediately. When you do, 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 before 21 to 28 days after childbirth or after an abortion in the second trimester of pregnancy, as this increases the risk of blood clots. If you start later, you should use a barrier method (e.g., a condom) during the first 7 days. However, if you have already had sexual intercourse, you should rule out pregnancy before starting to take Anaomi 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 after having a child,read the section on "Breastfeeding".

If you take more Anaomi than you should

No serious adverse reactions have been reported due to overdose.

If you take several pills at once, you may experience nausea and vomiting. 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

If it has been less than 12 hourssince you forgot to take the pill, the contraceptive action is not altered. You should take the pill as soon as you remember and then continue taking the following pills at the usual time (even if this means taking two pills 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 to take the pill, the contraceptive action may be reduced. The more pills 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 pill at the beginning or end of a blister pack.

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

1. You should never stop taking pills for more than 7 days.
2. You need to take pills continuously for 7 days to achieve 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 below):

• More than 1 forgotten pill from the same blister pack

Consult your doctor.

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

Take the forgotten pill as soon as you remember, even if this means taking two pills at the same time. Take the following pills 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 pill or if you forget to start a new blister pack after the pill-free period, there is a risk of pregnancy. In this case, consult your doctor.

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

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

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

The risk of reduced efficacy is imminent due to the proximity of the week without pills. However, by adjusting the pill-taking schedule, it is still possible to prevent the reduction in contraceptive protection. Therefore, if you follow one of the two options below, you will not need to take additional contraceptive precautions, provided you have taken all the pills correctly in the 7 days before the first forgotten pill. If this is not the case, you should follow the first of the two options below and take additional contraceptive precautions in the next 7 days.

1. Take the forgotten pill as soon as you remember, even if this means taking two pills at the same time. Continue taking the pills at the usual time. Instead of the pill-free period, start the next blister pack directly. It is likely that you will have a menstrual period (withdrawal bleeding) at the end of the second blister pack, but you may also experience spotting or intermenstrual bleeding while taking the second blister pack.
2. You can also stop taking the pills from the current blister pack and go directly to the 7-day pill-free period (note the day you forgot to take the pill). In this case, you must complete a pill-free interval of up to 7 days, including the days you forgot to take the pills, and then start the next blister pack. If you want to start a new blister pack on a specific day, you can shorten the pill-free period to less than 7 days.

If you forgot to take any of the pills from a blister pack and do not have bleeding during the first pill-free period, you should consider the possibility that you are 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 additional contraceptive measures should be taken.

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

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 it is not recommended, you can delay your period by continuing with the next Anaomi blister pack without taking the usual week off. You can continue for as long as you want until you finish the blister pack. During this time, you may experience bleeding or spotting. Afterward, you can take the usual 7-day pill-free period and resume regular Anaomi use.

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

If you take the pills correctly, your period will always start on the same day of the week without pills. If you need to change this day, you can do so by shortening the pill-free 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 pack 3 days earlier than usual. The shorter the break, the greater the risk that your period (menstruation) will not occur and that you will experience intermenstrual bleeding or spotting during the next blister pack (as occurs when delaying a period).

If you are unsure how to do this, consult your doctor.

If you interrupt treatment with Anaomi

You can stop taking Anaomi 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.

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 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".

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 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 stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA).
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk 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 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 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 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 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 Disorders

• Women with hypertriglyceridemia (increase in blood fats resulting in an increased risk of pancreatitis when using combined oral contraceptives).
• Hypertension.
• Appearance or worsening of disorders 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.
• Changes 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 does not appear 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

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

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

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

6. Package Contents and Additional Information

Composition of Anaomi

• The active ingredients are levonorgestrel and ethinylestradiol. Each tablet contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol.
• 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, aluminum lake red (E129), soy lecithin (E322), iron oxide red (E172), and aluminum lake blue (E1329)].

Appearance of Anaomi and Package Contents

Coated tablet, round, pink in color.

Anaomi is packaged in pressure-sensitive aluminum blister packs and PVC/PVDC film.

Package sizes are 1 or 3 blisters, and each blister contains 21 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, planta 3

28001 Madrid

Spain

Date of the Last Revision of this Prospectus: November 2022

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