Package Leaflet: Information for the User

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

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes very rare side effects. See section 4.

2.What you need to know before you take Levonorgestrel/Ethinylestradiol Daily Stada

• Do not use Levonorgestrel/Ethinylestradiol Daily Stada
• Warnings and precautions
• Levonorgestrel/Ethinylestradiol Daily Stada and thrombosis
• Levonorgestrel/Ethinylestradiol Daily Stada and cancer
• Bleeding between periods
• What to do if there is no bleeding in the placebo week
• Combination with other medicines
• Haematological tests
• Pregnancy
• Breast-feeding
• Driving and using machines
• Levonorgestrel/Ethinylestradiol Daily Stada contains lactose

3.How to take Levonorgestrel/Ethinylestradiol Daily Stada

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

4.Possible side effects

5.Storage of Levonorgestrel/Ethinylestradiol Daily Stada

6.Contents of the pack and additional information

• Levonorgestrel/ethinylestradiolis a contraceptive pill used to prevent pregnancy.
• Each pink tablet contains a small amount of two different female hormones, known as levonorgestrel and ethinylestradiol.
• The white tablets do not contain active ingredients and are also known as placebo tablets.
• Contraceptive pills containing two hormones are known as "combined pills".

General Notes

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 leaflet 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 basal body 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 Diario Stada

• If you have (or have had in the past) a blood clot (thrombosis) in a blood vessel in the leg, lungs (pulmonary 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 in the past) 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 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 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 Diario Stada with other medications).

Warnings and Precautions

In some situations, you will need to take special precautions when using levonorgestrel/etinilestradiol or any other combined hormonal contraceptive, and sometimes you will need to see your doctor regularly. If you are in any of the following situations, you should inform your doctor before starting to use levonorgestrel/etinilestradiol. You should also consult your doctor if any of the following situations appear or worsen while you are 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 Crohn's disease or ulcerative colitis (inflammatory bowel disease).
• If you have SUH (hemolytic-uremic syndrome), a blood disorder that causes kidney damage.
• If you have sickle cell anemia (a hereditary blood disorder).
• If you have epilepsy.
• If you have systemic lupus erythematosus (a disorder of the immune system).
• If you have a disease that appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], herpes gestational [a skin rash with blisters that appears during pregnancy], Sydenham's chorea [a nervous disorder that causes sudden body movements]).
• If you have or have had melasma (brownish-yellow skin patches, especially on the face). If so, avoid direct exposure to sunlight or ultraviolet light.
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

Levonorgestrel/Etinilestradiol Diario 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 one of your relatives has had a blood clot (thrombosis) in the leg, lungs, or other organs at a young age
• If you are to undergo surgery (operation), prolonged immobilization, or have had a serious accident. It is essential that you inform 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. This is usually 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 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 an arrhythmia).

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

• Intense pain or swelling in one of your legs
• Sudden intense chest pain that may radiate to the left arm
• Sudden shortness of breath
• Unusual, sudden, or prolonged coughing
• 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 Diario Stada and Cancer

Cases of breast cancer have been observed with a slightly higher frequency in women taking combined oral contraceptives, 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 incidence of breast tumors has gradually decreased 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 more rare malignant liver tumors have been described in users of oral contraceptives. 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.

Spotting

During the first few months of treatment with levonorgestrel/etinilestradiol, you may experience unexpected bleeding (bleeding outside the placebo week). If this bleeding persists for more than a few months or starts after a few months, your doctor should investigate the cause.

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

If you have taken all the active pink-colored 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 pack until you are sure you are not pregnant.

Taking Levonorgestrel/Etinilestradiol Diario Stada with Other Medications

Always consult your doctor who prescribed levonorgestrel/etinilestradiol about other medications or herbal supplements you are already using. Additionally, 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 herbal supplements containing St. John's Wort while taking levonorgestrel/etinilestradiol, you must first consult your doctor.

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 test results (elevated ALT enzyme).

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

Levonorgestrel/etinilestradiol can be used again approximately 2 weeks after the end of this treatment. See the section "Do not use Levonorgestrel/Etinilestradiol Diario 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 oral 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 when the woman is 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 Diario Stada contains lactose

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

If you were taking another contraceptive before starting to take levonorgestrel/etinilestradiol, you already know that most contraceptives contain 21 tablets. With those contraceptives, you take a tablet for 21 days and then there is a week in which you do not take any tablets (drug-free interval).

The system to follow when using levonorgestrel/etinilestradiol is different. After taking the 21 pink tablets, you must continue and take the 7 placebo tablets, that is, there is no drug-free interval but there is a week of "placebo" (the week in which you take the placebo tablets from row 4). Since you have to take a tablet every day and there is no drug-free interval between two packs, taking the tablets will become a routine and, as a result, the risk of forgetting a tablet is lower.

The two different types of pink tablets of levonorgestrel/etinilestradiol are placed in order. One pack contains 28 tablets.

Take a levonorgestrel/etinilestradiol tablet every day, if necessary with a small amount of water. You must take the tablets every day, more or less at the same hour.

Do not confuse the tablets: take a pink tablet once a day for the first 21 days, and then take a white tablet every day for the last 7 days. Then, you should start a new pack (21 pink tablets and 7 white tablets). As a result, there is no drug-free interval between packs.

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

Along with the blisters, adhesive labels with the days of the week are attached. Take the label of the day you start taking the pill. Put the label on the blister over the words "Stick the label with the day here". Each day will align with a row of tablets. It is essential that you take your pill every day.And take the first tablet from the first row where it indicates the word "BEGINNING".

Follow the direction of the arrow indicated in the blister, take the pink tablets first for 21 days and then the white tablets for 7 days, until you have taken the 28 tablets. Then, you should start taking the next blister. This means that there is no drug-free interval between packs.

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 blister.

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

When can you start with the first blister

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

Start with levonorgestrel/etinilestradiol on the first day of the cycle (which is the first day of your menstruation). If you start taking levonorgestrel/etinilestradiol 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 must use extra protection measures (e.g., a condom) for the first 7 days.

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

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

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

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

You can change any day from the progestin-only pill (if you used an implant or IUD, on the day of its removal, and if you received progestin by injection, on the date corresponding to the next injection), but in all cases, you must apply additional protection measures (e.g., a condom) for the first 7 days while taking 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/etinilestradiol between 21 and 28 days later. If you start after day 28, you must use a barrier method (e.g., a condom) for the first 7 days of levonorgestrel/etinilestradiol use.

If after having a child you have had sex again before starting to take levonorgestrel/etinilestradiol (again), you must first check if 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/etinilestradiol (again) after having a child

Read the section on "Breastfeeding".

If you take more Levonorgestrel/Etinilestradiol Diario Stadatablets coated with EFG film than you should

There are no publications on the harmful effects of taking too many levonorgestrel/etinilestradiol 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/etinilestradiol 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Levonorgestrel/Etinilestradiol Diario Stadatablets coated with EFG film

The tablets in thefourthrow of the pack are placebo tablets. If you forgot to take one of those pills, it will not affect the effect of levonorgestrel/etinilestradiol. You should remove the forgotten placebo tablet to avoid prolonging the placebo week, which could have a negative effect on the effectiveness of levonorgestrel/etinilestradiol.

If you forgot to take a tablet from rows1, 2, or 3, you should follow the following instructions:

• If you makeless than 12 hoursof the forgotten tablet, the protection against pregnancy is not altered. 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 forget to take a tablet at the beginning of a pack (1st row) or at the end of week 3 (3rd row of the pack).

Therefore, you should observe the following rules (see also the diagram, later):

• More than 1 tablet forgotten from the pack

Consult your doctor.

• One tablet forgotten 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 next tablets at the usual time and takeextra precautionsfor the next 7 days, for example, use a condom. If you have had sex in the week before the oversight, or if you forgot to start a new pack after the inactive tablet-free period, you must be aware that there is a risk of pregnancy. In that case, consult your doctor.

• One tablet forgotten 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 next tablets at the usual time. The protection against pregnancy is not reduced and you will not need to take extra precautions.

• One tablet forgotten 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.

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

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

1. Take the active tablets, the pink ones, and pass directly to the 7 white placebo tablets, from row 4(note the day you forgot to take the tablet). Then, continue withthe next pack. If you want to start a new pack 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 one of the tablets from a pack and you do not have bleeding in the placebo week, it could mean that you are pregnant. You must contact your doctor before continuing with the next pack.

What to do in case of vomiting or intense diarrhea

If you vomit in the 3-4 hours after taking the active pink 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 pack 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/Etinilestradiol DiarioStada."

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 pack if you do not take the white placebo tablets and start taking a second pack oflevonorgestrel/etinilestradiol . You may have spotting (drops or specks of blood) or intercurrent bleeding while usingthesecond pack. After taking the placebo tablets from the second pack for 7 days,continue withthe next pack.

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

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

If you take the pills according to the instructions, your menstrual period or withdrawal bleeding will start in the week of the placebo tablets. If you need to change this day, do it by shortening the placebo period, that is, 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 pack 3 days earlier than usual. If you shorten the placebo period too much (e.g., 3 days or less), it is possible that you will not have any bleeding during this placebo period. Then, 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/Etinilestradiol Diario Stadatablets coated with EFG film

You can stop taking levonorgestrel/etinilestradiol when you want. If you do not want to get 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 medication may 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 observe 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" section).

Several side effects related to the use of the pill are described in the sections "Levonorgestrel/Ethinylestradiol Daily Stada" and "Levonorgestrel/Ethinylestradiol Daily 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 sexual desire, 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 an adverse effect not listed 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 Daily Stada

-The active principles are levonorgestrel and ethinylestradiol.

Levonorgestrel/Ethinylestradiol Daily Stada contains colored tablets:

• Each pink tabletcontains 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)
• Each white tablet (inactive tablets or placebo tablets)contains only excipients (without active principles), which are lactose, povidone K-30 (E1201), magnesium stearate (E572) and opadry II white [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350].

Appearance of the product and content of the packaging

Each active tablet coated with a film is round and pink.

Each placebo tablet coated with a film is round and white.

Levonorgestrel/Ethinylestradiol Daily Stada is marketed in blisters of 28 tablets: 21 active pink tablets and 7 white placebo tablets.

The packaging sizes are 1, 3 or 6 blisters, and each blister contains 28 tablets.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Stada Laboratorios, 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/.