Anaomi 0.1 mg/0.02 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Anaomi 0.1 mg/0.02 mg film-coated tablets EFG

levonorgestrel/ethinylestradiol

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Important things you should know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of developing a blood clot in veins and arteries, especially during the first year or when restarting use of a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Leaflet contents:

1. What Anaomi is and what it is used for
2. What you need to know before taking Anaomi
3. How to take Anaomi
4. Possible side effects
5. How to store Anaomi
6. Contents of the pack and other information

1. What Anaomi is and what it is used for

Anaomi is a combined oral hormonal contraceptive 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 you start taking Anaomi

General considerations

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

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

This leaflet describes several situations in which you should stop taking Anaomi or in which Anaomi may become less effective. In these situations, you must not have sexual intercourse or, alternatively, you must use 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 because Anaomi alters the monthly changes in body temperature and cervical mucus.

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

Do not take Anaomi

• If you are allergic to levonorgestrel, ethinylestradiol, or any of the other ingredients of this medicine (listed in section 6). This allergy may manifest as itching, rash, or swelling.
• If you have (or have had in the past) a blood clot (thrombosis) in a blood vessel of the leg, lungs (embolism), or other organs.
• Known hereditary or acquired predisposition to venous thromboembolism, such as APC resistance (including factor V Leiden), antithrombin III deficiency, protein C deficiency, protein S deficiency.
• If you have (or have had in the past) a heart attack or stroke.
• If you have (or have had in the past) a condition that may predict a heart attack (e.g., angina pectoris, which causes severe chest pain) or stroke (e.g., transient ischemic attack 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 arterial thrombosis. These warnings apply in the following situations:
  • diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fat in the blood (cholesterol or triglycerides).
• Known hereditary or acquired predisposition to arterial thromboembolism, such as hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
• If you have or have had inflammation of the pancreas (pancreatitis).
• If you currently have or have previously had liver disease and your liver function is still abnormal.
• If you have a liver tumor or have had one in the past.
• If you have (or have had) or if there is suspicion of breast cancer or cancer of the 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, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Anaomi”).

Warnings and precautions

When should you consult your doctor?

Seek urgent medical help

• If you notice possible signs of a blood clot, which may indicate that you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below).

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

Consult your doctor or pharmacist before starting to take Anaomi. In certain situations, you must take special care when using 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 conditions 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 liver or gallbladder disease.
• If you have diabetes.
• If you need surgery or will be immobile for a long period (see “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. 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 HUS (hemolytic uremic syndrome), a blood disorder causing kidney damage.
• If you have sickle cell anemia (an inherited disorder of the red blood cells).
• If you have epilepsy.
• If you have SLE (systemic lupus erythematosus, an immune system disorder).
• If you have a condition that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], herpes gestationis [a blistering skin rash occurring during pregnancy], Sydenham’s chorea [a nerve disorder causing sudden jerky movements]).
• If you have or have ever had chloasma (brownish golden pigmentation spots, known as “pregnancy mask,” especially on the face). If so, avoid direct exposure to sunlight or ultraviolet light.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with possible breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.

Psychiatric disorders

Some women using hormonal contraceptives such as Anaomi have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for further medical advice as soon as possible.

BLOOD CLOTS

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

Blood clots can form:

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

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

It is important 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 help if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot along a vein, especially when accompanied by: pain or tenderness in the leg, which may only be noticeable when standing or walking, increased warmth in the affected leg, change in skin color of the leg, e.g., if it becomes pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing, Sudden cough without clear cause, which may produce blood, Sharp pain that may worsen upon deep breathing, Severe chest tightness or dizziness, Rapid or irregular heartbeat, Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: sudden loss of vision, or painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye)
Pain, discomfort, pressure, or heaviness in the chest, Feeling of tightness or fullness in the chest, arm, or below the sternum, Feeling of fullness, indigestion, or suffocation, Upper body discomfort radiating to the back, jaw, throat, arm, or stomach, Sweating, nausea, vomiting, or dizziness, Extreme weakness, anxiety, or shortness of breath, Rapid or irregular heartbeat.	Heart attack
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body, Sudden confusion, difficulty speaking or understanding speech, Sudden vision problems in one or both eyes, Sudden difficulty walking, dizziness, loss of balance or coordination, Sudden, severe, or prolonged headache without known cause, Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you must still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb, Severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels

BLOOD CLOTS IN A VEIN

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

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

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

The risk of developing a blood clot in a vein is higher during the first year of first-time use of a combined hormonal contraceptive. The risk may also be higher if you restart 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 remains somewhat higher than if you were not taking a combined hormonal contraceptive.

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

What is the risk of developing a blood clot?

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

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

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

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

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

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

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If a close relative has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). In this case, you may have an inherited blood clotting disorder.
• If you need surgery or are immobile for a long time due to illness or injury, or if your leg is in a cast. You may need to stop taking Anaomi several weeks before surgery or while you are less mobile. If you need to stop taking Anaomi, ask your doctor when you can start again.
• As you get older (especially above about 35 years of age).
• If you have given birth within the last few weeks.

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

Air travel (over 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide that you need to stop taking 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 lead to a heart attack or stroke.

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

It is important to note that the risk of heart attack or stroke while using Anaomi is very small, but it may increase:

• With age (above about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Anaomi, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, heart rhythm disorders such as atrial fibrillation).
• If you have diabetes.

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

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

A slightly increased incidence of breast cancer has been observed in women taking oral contraceptives, but it is unknown whether this is due to the treatment. For example, it may be that more tumors are detected in women taking combined pills because they are examined by their doctor more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. After ten years, the risk of breast cancer is the same as in women who have never used oral contraceptives. It is important to regularly examine your breasts, and you should contact your doctor if you notice a 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 experience unusual severe abdominal pain.

Cervical cancer has been reported in long-term users, but it is unclear whether this is due to sexual behavior or other factors such as human papillomavirus (HPV).

A slight increase in the relative risk of cervical cancer and cervical intraepithelial neoplasia (serious cervical abnormalities) has been observed. Given the biological influence of combined oral contraceptives on these lesions, it is recommended that periodic cervical cytology (Pap smears) be performed when a combined oral contraceptive is prescribed.

Malignant tumors can be life-threatening or fatal.

Medical examinations/consultations

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

Bleeding between periods

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

If this bleeding lasts for more than a few months, or if it starts after several months, non-hormonal causes should be considered, and you should consult your doctor so appropriate diagnostic measures can be taken to exclude malignancies, infections, or pregnancy.

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

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

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

Other medicines and Anaomi

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal remedies.

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

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

• Medicines for intestinal motility (e.g., metoclopramide).
• HIV infection treatments (e.g., ritonavir or nevirapine).
• Tuberculosis treatments (e.g., rifampicin).
• Antifungal treatments (griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole).
• Bacterial infection treatments (macrolide antibiotics, e.g., clarithromycin, erythromycin).
• Treatments for certain heart conditions and high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem).
• Treatments for arthritis and osteoarthritis (etoricoxib).
• Some antiepileptic medicines (topiramate, barbiturates (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate).
• Grapefruit juice.
• Herbal remedies containing St. John's wort (Hypericum perforatum).

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

Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.

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 cholestasis when taken with combined oral contraceptives.

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

• Medicines containing cyclosporine.
• The antiepileptic lamotrigine.

Laboratory tests

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

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

Pregnancy and breastfeeding

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

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

Small amounts of these contraceptives may pass into breast milk during the use of combined oral contraceptives. These amounts may affect the infant, so combined oral contraceptives should generally not be used until breastfeeding has ended.

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

Driving and using machines

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

Anaomi contains lactose and soybean lecithin

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

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

3. How to take Anaomi

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in 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 Anaomi tablet every day for 21 days, if necessary with a small amount of water. You must take the tablets every day, roughly at the same time.

After taking the 21 tablets, do not take any more tablets for the following 7 days. During these 7 days without tablets (known as the break or treatment-free week), you should experience bleeding. This is called "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the week.

On the 8th day after taking the last Anaomi tablet (i.e., after the seven-day treatment-free period), start taking the next blister, even if the bleeding has not stopped.

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

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

When to start the first blister

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

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

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

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

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

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

You may switch on any day from the progestogen-only pill (if you used an implant or IUD, on the day of its removal; if you received progestogen by injection, on the date when the next injection would have been due), but in all cases you must use additional contraceptive precautions (e.g., a condom) during the first 7 days of taking Anaomi.

• After a first-trimester abortion.

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

• After childbirth or a second-trimester abortion.

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

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

• If you are breastfeeding and wish to start taking Anaomi after having a child, please read section 2 on "Breast-feeding".

If you take more Anaomi than you should

No serious adverse reactions have been reported with overdose.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Anaomi

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

If more than 12 hours have passed since you missed the tablet, contraceptive protection may be reduced. The more tablets you miss, the greater the risk of reduced protection against pregnancy.

The risk of incomplete protection against pregnancy is higher if you miss a tablet at the beginning or end of a blister pack.

The following two basic rules apply when a tablet is missed:

1. You should never stop taking tablets for more than 7 days.
2. It is necessary to take tablets continuously for 7 days to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.

Accordingly, and following the above guidelines, the following practical advice applies (see also the diagram below):

- More than 1 tablet missed from the same blister pack

Consult your doctor.

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

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

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

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

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

The risk of reduced efficacy is imminent due to the proximity of the break week. However, by adjusting the tablet-taking schedule, contraceptive protection can still be maintained. Therefore, if you follow one of the two options below, you do not need to take additional contraceptive precautions, provided you took all tablets correctly in the 7 days before the first missed tablet. If this is not the case, follow the first of the two options below and use additional contraceptive precautions for the next 7 days.

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Instead of the tablet-free interval, start the next blister pack immediately. You will most likely have a period (withdrawal bleeding) at the end of the second blister pack, but you may also experience spotting or intermenstrual bleeding during the second blister pack.
2. You may also stop taking tablets from the current blister pack and go directly to the 7-day tablet-free interval (note the day you missed the tablet). In this case, complete a total of up to 7 days without tablets, including the days when you missed tablets, and then start the next blister pack. If you wish to start a new blister pack on a specific day, shorten the tablet-free interval to less than 7 days.

If you missed any tablets from a blister pack and do not have bleeding during the first tablet-free interval, consider the possibility of pregnancy. You should contact your doctor before continuing with the next blister pack.

Recommendations in case of gastrointestinal disorders

In case of severe gastrointestinal disturbances, absorption may not be complete, and you should use additional contraceptive precautions.

If you vomit within 3 to 4 hours after taking a tablet or have severe diarrhea, there is a risk that the active ingredients in the tablet may not be fully absorbed. This situation is similar to missing a tablet. After vomiting or diarrhea, take another tablet from a spare blister pack as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or if more than 12 hours have passed, follow the advice given under "If you forget 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 your period

Although not recommended, you may delay your period by continuing with the next Anaomi blister pack without taking the usual 7-day break. You may continue as long as desired until the end of the blister pack. During this time, you may experience bleeding or spotting. After this, take the usual 7-day tablet-free interval and then resume regular Anaomi intake.

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

If you take the tablets correctly, your period will always start on the same day of the week during the tablet-free interval. If you wish to change this day, you may do so by shortening the tablet-free interval (but never extending it) by as many days as desired. For example, if your period starts on a Friday and you wish to change it to Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. The shorter the break, the higher the risk that your period (menstruation) may not occur and that you may 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 stop taking Anaomi

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

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

4. Possible adverse effects

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

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

Serious adverse effects

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

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in arteries (arterial thromboembolism (ATE)).

For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take 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 the available data).

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

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

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

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

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

• hypersensitivity (abnormal increase in skin sensitivity),
• increased libido,
• intolerance to contact lenses.
• harmful blood clots in a vein or artery, for example:
• in a leg or foot (i.e., DVT).
• in a lung (i.e., PE).
• heart attack.
• stroke.
• transient ischaemic attack (TIA) or mild stroke-like symptoms.
• blood clots in the liver, stomach/intestine, kidneys or eye.

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

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

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

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

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

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

Description of selected adverse reactions

Listed below are very rare or delayed-onset adverse reactions that may occur or worsen with combined oral contraceptives (see sections “Do not take Anaomi” and “Warnings and precautions”).

Tumours

• The frequency of breast cancer diagnosis among users of combined oral contraceptives is slightly increased. As breast cancer is rare in women under 40 years of age, this increase is small in relation to the overall risk of breast cancer. A causal relationship with the use of combined oral contraceptives is not known.
• Liver tumours (benign and malignant).
• Cervical cancer.

Other disorders

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anaomi

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the outer packaging and on the blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Anaomi

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

Appearance of Anaomi and contents of the pack

Film-coated tablet, round, pink in colour.

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

Pack sizes are 1 or 3 blisters, each blister containing 21 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera;

La Vallina s/n;

24008-Villaquilambre, León

Spain

Local representative

SHIONOGI, S.L.U

C/ Serrano 45, 3rd floor

28001 Madrid

Spain

Date of the most recent revision of this leaflet: 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/