Package Leaflet: Information for the User

Levonorgestrel/Ethinylestradiol Stada 0.1 mg/ 0.02 mg Film-Coated Tablets

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Do not use Levonorgestrel/Ethinylestradiol Stada
• Warnings and Precautions
• Levonorgestrel/Ethinylestradiol Stada and thrombosis
• Levonorgestrel/Ethinylestradiol Stada and cancer
• Spotting between periods
• What to do if there is no bleeding in the week without treatment
• Levonorgestrel/Ethinylestradiol Stada taken with other medicines
• Haematological tests
• Pregnancy
• Breast-feeding
• Driving and using machines
• Levonorgestrel/Ethinylestradiol Stada contains lactose

3.How to take Levonorgestrel/Ethinylestradiol Stada

• When you can start with the first pack
• What to do if you take more Levonorgestrel/Ethinylestradiol Stada than you should
• What to do if you forget to take Levonorgestrel/Ethinylestradiol Stada
• What to do in case of severe vomiting or diarrhoea
• Delay of menstrual period: what you should know
• Change of the first day of your menstrual period: what you should know
• How to stop taking Levonorgestrel/Ethinylestradiol Stada

4.Possible side effects

5.Storage of Levonorgestrel/Ethinylestradiol Stada

6.Contents of the pack and other information

• Levonorgestrel/ethinylestradiol is a contraceptive pill used to prevent pregnancy.
• Each pink tablet contains a small amount of two different female hormones, known as levonorgestrel and ethinylestradiol.
• Contraceptive pills containing two hormones are known as "combined pills".

General Considerations

Before you can start taking levonorgestrel/etinilestradiol, 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 using levonorgestrel/etinilestradiol or in which the reliability of levonorgestrel/etinilestradiol may be reduced. In these situations, you should not have sexual intercourse or, if you do, you should use other non-hormonal contraceptive precautions, such as a condom or other barrier method. Do not use the rhythm or temperature methods. These methods are unreliable because levonorgestrel/etinilestradiol alters the monthly changes in body temperature and cervical mucus.

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

Do Not Use Levonorgestrel/Etinilestradiol Stada

• If you have (or have had in the past) a blood clot (thrombosis) in a blood vessel in 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 intense chest pain) or stroke (e.g., a small transient ischemic attack with no residual effects).
• If you have a disease that may increase the risk of thrombosis in the arteries. These warnings apply to the following situations:
• • Diabetes with vascular damage
  • Very high blood pressure
  • Very high concentrations of fat in the blood (cholesterol or triglycerides)

• If you have a blood clotting disorder (e.g., protein C deficiency)
• If you have (or have had) a certain type of migraine (with focal neurological symptoms)
• If you have (or have had) pancreatitis (inflammation of the pancreas)
• If you have (or have had) liver disease and your liver function is not yet normal
• If you have (or have had) a liver tumor
• If you have (or have had) or if there is suspicion of breast cancer or cancer in genital organs
• If you have unexplained vaginal bleeding
• If you have not had a period for several months without a known cause
• If you are allergic to levonorgestrel or etinilestradiol, or to any of the other components of this medication (including those listed in section 6). This allergy can be recognized by the appearance of pruritus, skin rash, or inflammation.
• If you have Hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section Taking Levonorgestrel/Etinilestradiol Stada with other medications).

Warnings and Precautions

In some situations, you will need to take special precautions when using Levonorgestrel / Etinilestradiol STADA with any other combined hormonal contraceptive, and sometimes you will need to see your doctor periodically. If you are in any of the following situations, you should inform your doctor before starting to use levonorgestrel/etinilestradiol. In addition, you should consult your doctor if any of the following situations appear or worsen while using levonorgestrel/etinilestradiol:

• If a close relative has or has had breast cancer.
• If you have liver disease or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• If you have SUH (hemolytic-uremic syndrome), a blood disorder that causes kidney damage.
• If you have sickle cell anemia (a hereditary blood disorder).
• If you have epilepsy.
• If you have systemic lupus erythematosus (LES), a disorder of the immune system.
• If you have a disease that appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], gestational herpes [a skin rash with vesicles that appears during pregnancy], Sydenham's chorea [a nervous disorder that causes sudden body movements]).
• If you have or have had melasma (brownish patches on the skin, especially on the face). If so, avoid direct exposure to sunlight or ultraviolet light.
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

Levonorgestrel/Etinilestradiol Stada and Thrombosis

Deep Vein Thrombosis

The use of any combined pill, including levonorgestrel/etinilestradiol, increases the risk of a woman developing deep vein thrombosis (formation of a blood clot in a vein) compared to a woman who takes no contraceptive pill.

The risk of deep vein thrombosis increases in users of combined pills:

• With age,
• With obesity,
• If any of your relatives have had a blood clot (thrombosis) in the leg, lung, or other organ at a young age,
• If you are to undergo surgery (operation), prolonged immobilization, or have had a serious accident. It is essential to discuss with your doctor that you are using levonorgestrel/etinilestradiol, as you may need to stop treatment. Your doctor will tell you when to start taking levonorgestrel/etinilestradiol again. Normally, this will be within two weeks of your recovery.

Arterial Thrombosis

The use of combined pills has been associated with an increased risk of arterial thrombosis (blockage 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/etinilestradiol, especially if you are over 35 years old.
• If you have high concentrations of fat in your blood (cholesterol or triglycerides).
• If you are obese.
• If one of your close relatives has 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 valvular disorder or arrhythmia).

Stop taking levonorgestrel/etinilestradiol and contact your doctor immediately if you observe signs of possible thrombosis, such as:

• Intense pain or swelling of one of your legs
• Sudden intense chest pain that may radiate to the left arm
• Sudden shortness of breath
• Sudden cough without an apparent cause
• An unusual, intense, 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 the body

Levonorgestrel/Etinilestradiol Stada and Cancer

Cases of breast cancer have been observed with a slightly higher frequency in women taking contraceptive pills, but it is unknown whether this is due to treatment. For example, tumors may be detected more frequently in women taking combined pills because they are reviewed by their doctor more frequently. The appearance of breast tumors has gradually decreased after stopping the use of combined hormonal contraceptives. It is essential to have your breasts checked regularly, and you should contact your doctor if you notice any lump.

In rare cases, benign liver tumors and even more rare malignant liver tumors have been described in users of contraceptive pills. Contact your doctor if you notice intense abdominal pain.

Mental Disorders

Some women who use hormonal contraceptives like levonorgestrel/etinilestradiol 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.

Intermenstrual Bleeding

During the first months of treatment with levonorgestrel/etinilestradiol, you may experience unexpected bleeding (bleeding outside of the treatment-free week). If this bleeding lasts more than a few months or begins after several months, your doctor should investigate the cause.

What to Do If There Is No Bleeding in the Treatment-Free Week

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

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

Taking Levonorgestrel/Etinilestradiol Stada with Other Medications

Always consult your doctor who prescribed levonorgestrel/etinilestradiol about other medications or herbal medicines you are already using. In addition, inform any other doctor or dentist who prescribes other medications (or the pharmacist who dispenses them) that you are using levonorgestrel/etinilestradiol. They can tell you if you need to add other contraceptive measures (e.g., condoms) and, if so, for how long.

Some medications reduce the effectiveness of levonorgestrel/etinilestradiol in preventing pregnancy, or may cause unexpected bleeding.

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

If you want to use medicinal herbs containing St. John's Wort while taking levonorgestrel/etinilestradiol, you should consult your doctor first.

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

Do not take levonorgestrel/etinilestradiol if you have Hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver enzyme test results (elevated ALT levels).

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

Levonorgestrel/etinilestradiol can be reused approximately 2 weeks after the end of this treatment. See the section "Do Not Use Levonorgestrel/Etinilestradiol Stada."

Consult your doctor or pharmacist before using any medication.

Laboratory Tests

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

Pregnancy

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

If you are pregnant, do not take levonorgestrel/etinilestradiol. If you become pregnant while taking levonorgestrel/etinilestradiol, stop using it immediately and contact your doctor.

Lactation

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

Generally, it is not recommended to use levonorgestrel/etinilestradiol while breastfeeding. You should consult your doctor if you want to take the pill while breastfeeding.

Driving and Operating Machinery

There is no information to indicate that the use of levonorgestrel/etinilestradiol affects the ability to drive or operate machinery.

Levonorgestrel/Etinilestradiol Stada Contains Lactose

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

Take one Levonorgestrel/Ethinylestradiol Stada 0.1 mg/0.02 mg film-coated tablet every day, if necessary with a small amount of water. You should take the tablets every day, more or less at the same time.

The 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. Follow the direction of the arrows in the blister. Take one tablet every day until you have finished the 21 tablets. Then, do not take any more tablets for 7 days.

During those 7 days without tablets (known as the interruption or week without treatment) you should start bleeding. This is called "withdrawal bleeding" and starts on the 2nd or 3rd day of the week.

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

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

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

When can you start with the first blister

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

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

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

You can start taking Levonorgestrel/Ethinylestradiol the day after the pill-free period of the pill you just finished (or after the last inactive tablet of your previous pill). When you change from a vaginal ring or a combined contraceptive patch, follow your doctor's advice.

• Change from a method that contains only progestogen (pill or progestogen injection, implant or IUD releasing progestogen)

You can change any day from the pill that contains only progestogen (if you used an implant or IUD, on the day of its removal, and if you received progestogen by injection, on the date corresponding to the next injection), but in all cases, you should apply additional protection (e.g., a condom) during the first 7 days when you take the new pills.

• After an abortion or fetal loss

Follow your doctor's instructions.

• After having a child

After having a child, you can start taking Levonorgestrel/Ethinylestradiol between 21 and 28 days later. If you start after day 28, you should use a barrier method (e.g., a condom) during the first 7 days of Levonorgestrel/Ethinylestradiol use. If, after having a child, you have had sex before starting to take Levonorgestrel/Ethinylestradiol (again), you should first check if you are not pregnant or wait until your next menstrual bleeding.

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

• If you are breastfeeding and want to start taking Levonorgestrel/Ethinylestradiol again after having a child

Read the section on "Breastfeeding".

If you take more Levonorgestrel/Ethinylestradiol Stada 0.1 mg/0.02 mg film-coated tablets than you should

There are no publications on the harmful effects of taking too many Levonorgestrel/Ethinylestradiol tablets. If you take several tablets at once, you may have nausea and vomiting symptoms. Young girls may have vaginal bleeding.

If you have taken too many Levonorgestrel/Ethinylestradiol tablets, or if you discover that your child has taken some, consult your doctor or pharmacist.

For 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 Levonorgestrel/Ethinylestradiol Stada 0.1 mg/0.02 mg film-coated tablets

• If you makeless than 12 hoursof the forgotten tablet, the protection against pregnancy is not affected. You can still take the tablet as soon as you remember and then take the next tablets at the usual time.

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

The risk of incomplete protection against pregnancy is greater if you forgot to take a tablet at the beginning or end of a blister.

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

• More than 1 forgotten tablet from the blister

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 takeextra precautionsin the following 7 days, for example, usea condom. If you have had sex in the week before the oversight, or if you forgot to start a new blister after the pill-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 will not need to take extra precautions.

• One forgotten tablet in week 3

You can choose between 2 options:

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. Instead of the pill-free period, start directly the next blister.

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

1. You can also stop taking that blister and go directly to the 7-day pill-free period(note the day when you forgot to take your tablet). If you want to start a new blister on a specific day, shorten the pill-free period to less than 7 days.

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

• If you forgot to take one of the tablets from a blister and you do not have bleeding in the first pill-free period, it could mean that you are pregnant. You should contact your doctor before continuing with the next blister.

What to do in case of vomiting or intense diarrhea

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

Delayed menstrual period: what you should know

Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new blister if you continue to take directly a new blister of Levonorgestrel/Ethinylestradiol instead of the pill-free period, until the end of the second blister instead of starting the pill-free period. You may have spotting (drops or specks of blood) or intercurrent bleeding while taking the second blister. After the usual 7-day pill-free period,continue withthe next blister.

You may need to ask your doctor for advice before deciding whether to delay your menstrual cycle.

Change in the first day of your menstrual period: what you should know

If you take the tablets as instructed, your menstrual period or withdrawal bleeding will start in the pill-free period. If you need to change this day, do it by shortening the pill-free period (but never lengthening it). For example, if your pill-free period starts on a Friday and you want to change to a Tuesday (3 days earlier), you should start a new blister 3 days earlier than usual. If you shorten the pill-free period too much (e.g., 3 days or less), it is possible that you will not have any bleeding during this pill-free period. Afterwards, you may have spotting (drops or specks 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 Stada.

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

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

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

Severe Adverse Effects:

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

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

• Frequent Side Effects(may affect up to 1 in 10 women): headache, changes in mood (including depression), nausea, abdominal pain, breast pain, breast tenderness, weight gain, skin rash.

• Infrequent Side Effects(may affect up to 1 in 100 women): vomiting, diarrhea, fluid retention or edema, migraine, loss of libido, breast enlargement, urticaria.

• Rare Side Effects(may affect up to 1 in 1,000 women): eye irritation with contact lens use, hypersensitivity, weight loss, nipple secretion, vaginal discharge, increased libido, erythema nodosum (nodules on the legs), erythema multiforme (skin lesions).

Reporting Adverse Effects

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

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

Do not store at a temperature above 30 °C.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levonorgestrel/Ethinylestradiol Stada

-The active principles are levonorgestrel and ethinylestradiol.

Each tablet contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol.

• The other components (excipients) are lactose, povidone K-30 (E1201), magnesium stearate (E572) and opadry II pink [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350, red aluminum lake (E129), lecithin (E322), red iron oxide (E172) and blue aluminum lake (E1329)].

Appearance of the product and contents of the packaging

Each film-coated tablet is round and pink in color.

Levonorgestrel/Ethinylestradiol Stada is marketed in blisters of 21 tablets.

The packaging sizes are 1, 3 or 6 blisters, and each blister contains 21 tablets.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Responsible for manufacturing

León Farma Laboratories, S.A.

Navatejera Industrial Estate

La Vallina s/n

24193-Villaquilambre (León)

Spain

Last review date of this leaflet: September 2022

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

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