LEVONORGESTREL/ETHINYLESTRADIOL CINFALAB 0.1 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levonorgestrel/Ethinylestradiol Daily Cinfalab 0.1 mg/0.02 mg Film-Coated Tablets EFG

Contents of the Package Leaflet:

1. What is Levonorgestrel/Ethinylestradiol Daily Cinfalab 0.1 mg/0.02 mg Film-Coated Tablets EFG and what is it used for.
2. What you need to know before taking Levonorgestrel/Ethinylestradiol Daily Cinfalab 0.1 mg/0.02 mg Film-Coated Tablets EFG.

• Do not use Levonorgestrel/Ethinylestradiol Daily Cinfalab
• Warnings and precautions.
• Levonorgestrel/Ethinylestradiol Daily Cinfalab and thrombosis
• Levonorgestrel/Ethinylestradiol Daily Cinfalab and cancer
• Bleeding between periods
• What to do if there is no bleeding during the placebo week
• Use of other medications
• Lab tests

• Pregnancy, breastfeeding, and fertility

• Driving and using machines
• Important information about some of the ingredients of Levonorgestrel/Ethinylestradiol Daily Cinfalab

1. How to take Levonorgestrel/Ethinylestradiol Daily Cinfalab 0.1 mg/0.02 mg Film-Coated Tablets EFG.

• When can you start with the first strip
• If you take more Levonorgestrel/Ethinylestradiol Daily Cinfalab than you should
• If you forget to take Levonorgestrel/Ethinylestradiol Daily Cinfalab
• What to do in case of vomiting or severe diarrhea
• Delayed menstrual period: what you need to know
• Change of the first day of your menstrual period: what you need to know
• If you want to stop taking Levonorgestrel/Ethinylestradiol Daily Cinfalab

1. Possible side effects.
2. Storage of Levonorgestrel/Ethinylestradiol Daily Cinfalab 0.1 mg/0.02 mg Film-Coated Tablets EFG.

Package contents and additional information.

1. What is Levonorgestrel/Ethinylestradiol Daily Cinfalab 0.1 mg/0.02 mg Film-Coated Tablets EFG and what is it used for

• Levonorgestrel/Ethinylestradiol Daily Cinfalab is a contraceptive pill used to prevent pregnancy.

• Each pink tablet contains a small amount of two different female hormones, called levonorgestrel and ethinylestradiol.
• The white tablets do not contain active ingredients and are also known as placebo tablets.
• Contraceptive pills that contain two hormones are known as "combined pills".

2. What you need to know before taking Levonorgestrel/Ethinylestradiol Daily Cinfalab 0.1 mg/0.02 mg Film-Coated Tablets EFG

General notes

Before you can start taking Levonorgestrel/Ethinylestradiol Daily Cinfalab, 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 perform other tests.

This package leaflet describes several situations in which you should stop using Levonorgestrel/Ethinylestradiol Daily Cinfalab or in which the reliability of Levonorgestrel/Ethinylestradiol Daily Cinfalab may be decreased. In these situations, you should not have sexual intercourse or, if you do, you should use other non-hormonal contraceptive methods (e.g., a condom or another barrier method). Do not use the rhythm or temperature methods. These methods are unreliable, as Levonorgestrel/Ethinylestradiol Daily Cinfalab alters the monthly changes in body temperature and cervical mucus.

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

Do not use Levonorgestrel/Ethinylestradiol Daily Cinfalab Film-Coated Tablets EFG

Do not use Levonorgestrel/Ethinylestradiol Daily Cinfalab if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Taking Levonorgestrel/Ethinylestradiol Daily Cinfalab with other medications").

• If you are allergic to levonorgestrel or ethinylestradiol, or to any of the other ingredients of Levonorgestrel/Ethinylestradiol Daily Cinfalab 0.1 mg/0.02 mg (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 of the leg, lungs (embolism), or other organs.
• 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 severe chest pain) or a stroke (e.g., a small, transient stroke without residual effects).
• If you have a disease that could increase the risk of thrombosis in the arteries. These warnings apply to the following situations:

• diabetes with damage to blood vessels
• very high blood pressure
• very high levels of fat in the blood (cholesterol or triglycerides)

• If you have a blood coagulation disorder (e.g., protein C deficiency).
• If you have (or have had) a certain type of migraine (with so-called focal neurological symptoms).
• 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 tumor in the liver
• If you have (or have had) or if there is a suspicion of breast cancer or cancer of 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 are allergic to levonorgestrel or ethinylestradiol, or to any of the other ingredients of Levonorgestrel/Ethinylestradiol Daily Cinfalab. This allergy can be recognized by the appearance of itching, skin rash, or inflammation.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levonorgestrel/Ethinylestradiol Daily Cinfalab.

In some situations, you will need to take special precautions when using Levonorgestrel/Ethinylestradiol Daily Cinfalab or any other combined hormonal contraceptive, and sometimes you will need to visit your doctor periodically. If you are in any of the following situations, you should inform your doctor before starting to use Levonorgestrel/Ethinylestradiol Daily Cinfalab. Additionally, you should consult your doctor if any of the following situations occur or worsen while using Levonorgestrel/Ethinylestradiol Daily Cinfalab:

• If a close relative has or has had breast cancer.
• If you have a liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• 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 while using sex hormones (e.g., loss of hearing, porphyria [a blood disease], gestational herpes [a skin rash with blisters that appears during pregnancy], Sydenham's chorea [a nerve disease in which the body makes sudden movements]).
• If you have or have had chloasma (brownish-yellow skin 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 Levonorgestrel/Ethinylestradiol Daily Cinfalab 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.

Levonorgestrel/Ethinylestradiol Daily Cinfalab Film-Coated Tablets EFG and thrombosis

Venous thrombosis

The use of any combined pill, including Levonorgestrel/Ethinylestradiol Daily Cinfalab, increases the risk of a woman developing venous thrombosis (formation of a blood clot in a blood vessel) compared to a woman who does not take any contraceptive pill.

The risk of venous thrombosis increases in users of combined pills:

• With age,
• If you are overweight,
• If any of your close relatives have had a blood clot (thrombosis) in the leg, lung, or other organ at a young age,
• If you need to undergo surgery (surgery), a prolonged period of immobilization, or if you have had a serious accident. It is essential that you discuss with your doctor that you are using Levonorgestrel/Ethinylestradiol Daily Cinfalab, as you may need to interrupt treatment. Your doctor will tell you when you can start taking Levonorgestrel/Ethinylestradiol Daily Cinfalab again. This is usually within two weeks after your recovery.

Arterial thrombosis

The use of combined pills has been associated with an increased risk of arterial thrombosis (obstruction of an artery), for example, in the blood vessels of the heart (heart attack) or brain (stroke).

The risk of arterial thrombosis increases in users of combined pills:

• If you smoke. You are strongly advised to stop smoking when using Levonorgestrel/Ethinylestradiol Daily Cinfalab, especially if you are over 35 years old.
• If you have high levels of fat in your blood (cholesterol or triglycerides).
• If you are overweight.
• If any of your close relatives have had a heart attack or stroke at a young age.
• If you have high blood pressure.
• If you have migraines.
• If you have heart problems (a valve disorder or a heart rhythm disorder).

Stop taking Levonorgestrel/Ethinylestradiol Daily Cinfalab and contact your doctor immediately if you notice any of the following possible signs of thrombosis:

• Severe pain or swelling in one of your legs
• Sudden, severe chest pain, which may radiate to your left arm
• Sudden shortness of breath
• Sudden, unexplained cough
• An unusual, severe, or prolonged headache, or worsening of a migraine
• Partial or complete blindness, or double vision
• Difficulty or inability to speak
• Dizziness or fainting
• Weakness, strange sensation, or numbness in any part of your body

Levonorgestrel/Ethinylestradiol Daily Cinfalab 0.1 mg/0.02 mg Film-Coated Tablets EFG and cancer

There have been cases of breast cancer with a slightly higher frequency in women taking contraceptive pills, but it is not known if this is due to the treatment.For example, it could be that more tumors are detected in women taking combined pills because they are examined by their doctor more frequently. The occurrence of breast tumors has been gradually lower after stopping the use of combined hormonal contraceptives. 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 contraceptive pills. Contact your doctor if you notice any unusual, severe abdominal pain.

Bleeding between periods

During the first few months of treatment with Levonorgestrel/Ethinylestradiol Daily Cinfalab, you may experience unexpected bleeding (bleeding outside of the placebo week). If this bleeding lasts for more than a few months or starts after some months, your doctor should investigate the cause.

What to do if there is no bleeding during the placebo week

If you have taken all the active pink tablets correctly, have not vomited, and have not had severe diarrhea, and have not taken any other medications, it is very unlikely that you are pregnant.

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

Using Levonorgestrel/Ethinylestradiol Daily Cinfalab with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications or herbal remedies.

Do not take Levonorgestrel/Ethinylestradiol Daily Cinfalab if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may produce increases in liver test results (increase in liver enzyme ALT).

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

Levonorgestrel/Ethinylestradiol Daily Cinfalab can be used again approximately 2 weeks after the end of this treatment. See the section "Do not use Levonorgestrel/Ethinylestradiol Daily Cinfalab".

Additionally, inform any other doctor or dentist who prescribes you other medications (or the pharmacist who dispenses them) that you are using Levonorgestrel/Ethinylestradiol Daily Cinfalab.They may tell you if you need to use additional contraceptive measures (e.g., condoms) and, if so, for how long.

Some medications reduce the effectiveness of Levonorgestrel/Ethinylestradiol Daily Cinfalab in preventing pregnancy or may cause unexpected bleeding.

These include medications used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, or oxcarbazepine) and tuberculosis (e.g., rifampicin) or HIV infection (ritonavir) or other infectious diseases (such as griseofulvin, ampicillin, or tetracycline), which increase intestinal motility (such as metoclopramide), and the herbal remedy St. John's Wort.

If you want to use herbal remedies that contain hypericum while taking Levonorgestrel/Ethinylestradiol Daily Cinfalab, you should consult your doctor first.

Levonorgestrel/Ethinylestradiol Daily Cinfalab reduces the effectiveness of other medications, such as those containing cyclosporin, or the antiepileptic lamotrigine (which may increase the frequency of seizures).

Consult your doctor or pharmacist before using any medication.

Lab tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking the pill, as oral contraceptives affect the results of some tests.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, you should not take Levonorgestrel/Ethinylestradiol Daily Cinfalab.If you become pregnant while taking Levonorgestrel/Ethinylestradiol Daily Cinfalab, you should stop taking it immediately and contact your doctor.

Consult your doctor or pharmacist before using any medication.

Breastfeeding

It is generally not recommended to use Levonorgestrel/Ethinylestradiol Daily Cinfalab when breastfeeding.You should consult your doctor if you want to take the pill while breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

There is no information to suggest that the use of Levonorgestrel/Ethinylestradiol Daily Cinfalab affects the ability to drive or use machines.

Levonorgestrel/Ethinylestradiol Daily Cinfalab Film-Coated Tablets EFG contains lactose.

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

3. How to take levonorgestrel/ethinylestradiol daily cinfalab 0.1 mg/0.02 mg film-coated tablets EFG

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

If you were taking another contraceptive before starting to take levonorgestrel/ethinylestradiol daily cinfalab, you will already know that most contraceptives contain 21 tablets. With those contraceptives, you take a pill for 21 days and then there is a week when you do not take any tablets (medication-free interval).

The system to follow when using levonorgestrel/ethinylestradiol daily cinfalab is different. After taking the 21 colored pills, you must continue and take the 7 placebo tablets, i.e., there is no medication-free interval but a week of "placebo" (the week when you take the placebo pills from row 4). Since you have to take one tablet every day and there is no medication-free interval between two packages, taking the pills will become routine and, consequently, the risk of forgetting a tablet is lower.

The two distinct classes of colored pills of levonorgestrel/ethinylestradiol daily cinfalab are placed in order. One package contains 28 tablets.

Take one levonorgestrel/ethinylestradiol daily cinfalab tablet every day, if necessary with a small amount of water.You must take the tablets every day, more or less at the same time.

Do not confuse the tablets: take one pink-colored tablet once a day for the first 21 days, and then one white-colored tablet every day for the last 7 days. After that, you will have to start a new package (21 pink-colored tablets and 7 white-colored tablets). Consequently, there is no medication-free interval between packages.

The strip contains 28 tablets.Daily intake for 28 consecutive days is important to maintain the contraceptive effect.

Along with the blisters, labels with the days of the week are attached. Take the label of the day you start taking the pill. Place the strip on the blister card over the words "Stick the label with the day here". Each day will align with a row of pills. It is essential that you take your pill every day. And take the first tablet of the first row where the word "START" is indicated.

Follow the direction of the arrow indicated on the strip, take the pink-colored tablets first for 21 days and then the white-colored tablets for 7 days, until you have taken all 28 tablets.After that, you will have to start taking the next strip.This means that there is no medication-free interval between packages.

During the 7 days of white tablets, you should start bleeding (usually on the 2nd or 3rd day).This is what is known as withdrawal bleeding and may continue when you start with the next strip.

You should start taking the next strip on the same day of the week, and the withdrawal bleeding should appear on the same days every month.

When can you start with the first strip

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

Start with levonorgestrel/ethinylestradiol daily cinfalab on the first day of your cycle (which is the first day of your menstruation). If you start taking levonorgestrel/ethinylestradiol daily cinfalab on the first day of your menstruation, you are immediately protected against pregnancy. You can also start on days 2-5 of your cycle, but in that case, you must use extra protection measures (e.g., a condom) during the first 7 days.

• Switching from another combined hormonal contraceptive or a vaginal ring or a combined contraceptive patch

You can start taking levonorgestrel/ethinylestradiol daily cinfalab the day after the tablet-free period of the pill you just finished (or after the last inactive tablet of your previous pill).

When switching from a vaginal ring or a combined contraceptive patch, follow your doctor's advice.

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

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 the progestogen by injection, on the date when the next injection would be due), but in all cases, you must apply additional protection measures (e.g., a condom) during the first 7 days of taking the new pills.

• After an abortion or miscarriage.

Follow your doctor's instructions.

• After having a child.

After having a child,you can start taking levonorgestrel/ethinylestradiol daily cinfalab between 21 and 28 days later. If you start after day 28, you must use a barrier method (e.g., a condom) during the first 7 days of using levonorgestrel/ethinylestradiol daily cinfalab.

If after having a child you have had sexual intercourse before starting to take levonorgestrel/ethinylestradiol daily cinfalab (again), you must first check that you are not pregnant or wait until your next menstrual period.

Ask your doctor for advice if you are not sure when to start.

• If you are breastfeeding and want to start taking levonorgestrel/ethinylestradiol daily cinfalab (again) after having a child

Read the section on "Breastfeeding".

If you take more levonorgestrel/ethinylestradiol daily cinfalab tablets than you should

There are no reports on the harmful effects of taking too many levonorgestrel/ethinylestradiol daily cinfalab tablets. If you take several tablets at once, you may have symptoms of nausea and vomiting. Little girls may have vaginal bleeding.

If you have taken too many levonorgestrel/ethinylestradiol daily cinfalab tablets, or if you discover that your child has taken some, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take levonorgestrel/ethinylestradiol daily cinfalab film-coated tablets

The tablets in the fourthrow of the package are placebo tablets. If you forgot to take one of those pills, it will not affect the effect of levonorgestrel/ethinylestradiol daily cinfalab. You should discard the forgotten placebo tablet so as not to prolong the placebo week, which could have a negative effect on the effectiveness of levonorgestrel/ethinylestradiol daily cinfalab.

If you forgot to take a tablet from rows 1, 2, or 3, you should follow these instructions:

• If it has been less than 12 hourssince you forgot the tablet, the protection against pregnancy is not altered. You can still take the tablet as soon as you remember and then take the following tablets at the usual time.
• If it has been more than 12 hourssince you forgot the tablet, the protection against pregnancy may be reduced. The more tablets you forget to take, the greater the risk that the protection against pregnancy will be reduced.

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

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

• More than 1 forgotten tablet in this strip

Consult your doctor.

• One forgotten tablet in week 1

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Take the tablets afterwards at the usual time and take extra precautionsfor the next 7 days, for example, a condom. If you have had sexual intercourse in the week before the forgetfulness, or if you forgot to start a new strip after the tablet-free period, you should be aware that there is a risk of pregnancy. In that case, consult your doctor.

• One forgotten tablet in week 2

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Take the tablets afterwards at the usual time. The protection against pregnancy is not reduced, and you do not need to take extra precautions.

• One forgotten tablet in week 3

You can choose between 2 possibilities:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time.

Instead of taking the 7 white placebo tablets, go directly to the next strip.

It is likely that you will have a menstrual period (withdrawal bleeding) at the end of the second strip, but you may also have spotting or intercurrent bleeding when taking the second strip.

1. You can also stop taking the active tablets, the pink-colored ones, and go directly to taking the 7 white placebo tablets (note the day you forgot to take the tablet). Then, continue with the next strip. If you want to start a new strip on a specific day, take the placebo tablets for less than 7 days.

If you follow one of these two recommendations, you will still be protected against pregnancy.

• If you forgot to take any of the tablets in a strip and do not have bleeding during the placebo week, it could mean that you are pregnant. You should contact your doctor before continuing with the next strip.

What to do in case of vomiting or severe diarrhea

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

Delayed menstrual period: what you should know

Although it is not recommended, it is possible to delay your menstrual period (withdrawal bleeding) if you do not take the 7 white placebo tablets and take a new strip of levonorgestrel/ethinylestradiol daily cinfalab, from the end of the second strip. You may have spotting (drops or spots of blood) or intercurrent bleeding while using the second strip. After the 7 days of taking the placebo tablets of the second strip, continue with the next strip.

It is possible that you will have to ask your doctor for advice before deciding whether to delay your menstrual cycle.

Changing the first day of your period: what you should know

If you take the tablets according to the instructions, your menstrual period or withdrawal bleeding will start during the week of the placebo tablets. If you need to change this day, do so by shortening the placebo period, i.e., when you take the white placebo tablets (but never lengthening it). For example, if your placebo period starts on a Friday and you want to change to a Tuesday (3 days earlier), you should start a new strip 3 days earlier than usual. If you shorten the placebo interval too much (e.g., 3 days or less), you may not have any bleeding during this placebo period. After that, you may have spotting (drops or spots of blood) or intercurrent bleeding.

If you are not sure what to do, ask your doctor for advice.

If you want to stop taking levonorgestrel/ethinylestradiol daily cinfalab film-coated tablets

You can stop taking levonorgestrel/ethinylestradiol daily cinfalab 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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, levonorgestrel/ethinylestradiol daily cinfalab can have side effects, although not everyone will experience them.

Always inform your doctor if you experience any side effects, especially if the side effect is intense or persistent, or if you notice any change in your health that you consider possibly due to the pill.

Several side effects related to the use of the pill are described in the sections "levonorgestrel/ethinylestradiol daily cinfalab and thrombosis" and "levonorgestrel/ethinylestradiol daily cinfalab and cancer". Read those paragraphs for more information and consult your doctor immediately if necessary.

• Common side effects (may affect up to 1 in 10 women): headache, mood changes (including depression), nausea, abdominal pain, breast tenderness, breast sensitivity, weight gain, skin rash.
• Uncommon side effects (may affect up to 1 in 100 women): vomiting, diarrhea, fluid retention or edema, migraine, loss of libido, breast enlargement, hives.
• Rare side effects (may affect up to 1 in 1,000 women): eye irritation with contact lens use, hypersensitivity, weight loss, breast secretion, vaginal discharge, increased libido, erythema nodosum (nodules on the legs), erythema multiforme (skin lesions).

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").

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of levonorgestrel/ethinylestradiol daily cinfalab 0.1 mg/0.02 mg film-coated tablets EFG

Keep this medication out of sight and reach of children.

Do not store above 30°C.

Do not use levonorgestrel/ethinylestradiol daily cinfalab after the expiration date stated on the outer packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE point of your usual pharmacy. Ask your pharmacist how to dispose of the packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of levonorgestrel/ethinylestradiol daily cinfalab film-coated tablets

The active ingredients are levonorgestrel and ethinylestradiol.

Levonorgestrel/ethinylestradiol daily cinfalab film-coated tablets contain tablets of 2 colors:

• Each pink-colored 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), lecithin (E322), iron oxide red (E172), and aluminum lake blue (E1329)].
• Each white-colored tablet (inactive or placebo tablet) contains only excipients (without active ingredients), which are anhydrous lactose, Povidone K-30 (E1201), magnesium stearate (E572), and Opadry II white [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350].
• Each active film-coated tablet is round and pink in color.
• Each placebo film-coated tablet is round and white in color.
• Levonorgestrel/ethinylestradiol daily cinfalab is marketed in strips (blisters) of 28 tablets: 21 active pink-colored tablets and 7 white-colored placebo tablets.
• The package sizes are 1, 3, or 6 strips, and each strip contains 28 tablets. Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera;

La Vallina s/n;

24008-Villaquilambre, León

Spain

This leaflet was revised in October 2022

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