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

Introduction

Package Leaflet: Information for the User

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

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Levonorgestrel/Ethinylestradiol Stada and what is it used for
2. What you need to know before you start taking Levonorgestrel/Ethinylestradiol Stada

• Do not use Levonorgestrel/Ethinylestradiol Stada
• Warnings and precautions
• Levonorgestrel/Ethinylestradiol Stada and thrombosis
• Levonorgestrel/Ethinylestradiol Stada and cancer
• Bleeding between periods
• What to do if you do not have bleeding during the week without treatment
• Taking Levonorgestrel/Ethinylestradiol Stada with other medicines
• Lab tests
• Pregnancy
• Breast-feeding
• Driving and using machines
• Levonorgestrel/Ethinylestradiol Stada contains lactose

1. How to take Levonorgestrel/Ethinylestradiol Stada
   • When can you start with the first blister pack
   • If you take more Levonorgestrel/Ethinylestradiol Stada than you should
   • If you forget to take Levonorgestrel/Ethinylestradiol Stada
   • What to do in case of vomiting or severe diarrhea
   • Delayed menstrual period: what you should know
   • Change of the first day of your menstrual period: what you should know
   • If you want to stop taking Levonorgestrel/Ethinylestradiol Stada

1. Possible side effects
2. Storage of Levonorgestrel/Ethinylestradiol Stada
3. Contents of the pack and other information

1. What is Levonorgestrel/Ethinylestradiol Stada and what is it used for

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

2. What you need to know before you start taking Levonorgestrel/Ethinylestradiol Stada

General considerations

Before you can start taking levonorgestrel/ethinylestradiol, your doctor will ask you some questions about your medical history and that of your close relatives. He/She 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/ethinylestradiol or in which the reliability of levonorgestrel/ethinylestradiol may be decreased. In such situations, you should either not have sex or take extra non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use the rhythm or temperature methods. These methods can be unreliable because levonorgestrel/ethinylestradiol affects the monthly changes in body temperature and cervical mucus.

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

Do not use Levonorgestrel/Ethinylestradiol Stada

• 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, temporary stroke without any lasting 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 damage to blood vessels
  • very high blood pressure
  • very high levels 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 so-called focal neurological symptoms)
• If you have (or have had) inflammation of the pancreas (pancreatitis)
• If you have (or have had) liver disease in the past and if your liver function is still not normal
• If you have (or have had) a liver tumor
• If you have (or have had) or if there is a 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 are allergic to levonorgestrel or ethinylestradiol, or to any of the other ingredients of this medicine (listed in section 6). This allergy may be recognized by itching, rash or hives.
• If you have Hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section "Taking Levonorgestrel/Ethinylestradiol Stada with other medicines").

Warnings and precautions

In some situations, you will need to take special precautions while using Levonorgestrel/Ethinylestradiol Stada or any other combined hormonal contraceptive, and sometimes you will need to visit your doctor regularly. If you are in any of the following situations, you should tell your doctor before starting to use levonorgestrel/ethinylestradiol. You should also tell your doctor if any of the following conditions appear or worsen while you are using levonorgestrel/ethinylestradiol:

• If a close relative 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, a disease of the immune system).
• If you have a disease that first appeared during pregnancy or previous use of sex hormones (e.g. loss of hearing, porphyria [a blood disorder], gestational herpes [a skin rash with blisters that appears during pregnancy], Sydenham's chorea [a nerve disease in which sudden movements of the body occur]).
• If you have or have had chloasma (brownish discoloration of the skin, especially on the face, known as "pregnancy patches"). If so, avoid direct exposure to sunlight or UV 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 can cause or worsen the symptoms of hereditary and acquired angioedema.

Levonorgestrel/Ethinylestradiol Stada and thrombosis

Venous thrombosis

The use of any combined pill, including levonorgestrel/ethinylestradiol, increases the risk of a woman developing a venous thrombosis (formation of a blood clot in a vein) 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 have an operation (surgery), a period of prolonged immobilization or if you have had a serious accident. It is important that you discuss with your doctor that you are using levonorgestrel/ethinylestradiol, as you may need to stop treatment. Your doctor will tell you when you can start taking levonorgestrel/ethinylestradiol again. This is usually after 2 weeks of 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, 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 heart valve disorder or a heart rhythm disorder).

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

• Severe pain or swelling of one leg
• Sudden severe chest pain, which may radiate to the left arm
• Sudden shortness of breath
• Sudden cough without an obvious cause
• An unusual, severe or prolonged headache, or worsening of a migraine
• Partial or complete loss of vision, or double vision
• Difficulty or inability to speak
• Dizziness or fainting
• Weakness, feeling or numbness in any part of the body

Levonorgestrel/Ethinylestradiol Stada and cancer

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

Psychiatric disorders

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

Bleeding between periods

During the first few months of treatment with levonorgestrel/ethinylestradiol, you may have unexpected bleeding (bleeding outside of the week without treatment). If this bleeding lasts for more than a few months, or if it starts after a few months, your doctor should investigate the cause.

What to do if you do not have bleeding during the week without treatment

If you have taken all the tablets correctly, have not vomited, and have not had severe diarrhea, and have not taken any other medicines, 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 blister pack until you are sure you are not pregnant.

Taking Levonorgestrel/Ethinylestradiol Stada with other medicines

Always consult the doctor who prescribed levonorgestrel/ethinylestradiol about other medicines or herbal remedies you are already using. Also, inform any other doctor or dentist who prescribes you other medicines (or the pharmacist who dispenses them) that you are using levonorgestrel/ethinylestradiol. They may tell you if you need to use additional contraceptive precautions (e.g. condoms) and, if so, for how long.

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

These include medicines used for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine or oxcarbazepine) and tuberculosis (e.g. rifampicin) or HIV infections (e.g. 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 containing hypericum while taking levonorgestrel/ethinylestradiol, you should first consult your doctor.

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

Do not take levonorgestrel/ethinylestradiol 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 liver test results (increase in liver enzyme ALT).

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

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

Consult your doctor or pharmacist before using any medicine.

Lab tests

If you need to have 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 breast-feeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Breast-feeding

If you are pregnant or breast-feeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Generally, it is not recommended to use levonorgestrel/ethinylestradiol when you are breast-feeding. You should consult your doctor if you wish to take the pill while you are breast-feeding.

Driving and using machines

There is no information that suggests that the use of levonorgestrel/ethinylestradiol affects the ability to drive or use machines.

Levonorgestrel/Ethinylestradiol Stada contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to Take Levonorgestrel/Ethinylestradiol Stada

Take one Levonorgestrel/Ethinylestradiol 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 pack 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 on the blister pack. Take one tablet every day until you have finished all 21 tablets. After that, do not take any more tablets for 7 days.

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

On the 8th day after taking the last Levonorgestrel/Ethinylestradiol tablet (i.e., after the 7-day treatment-free week), start taking the next blister pack, even if bleeding has not stopped.

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

When to Start with the First Blister Pack

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

Start with Levonorgestrel/Ethinylestradiol on the first day of your 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 your cycle, but in that case, you must use extra protective measures (e.g., a condom) for 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 on the day after the tablet-free period of your previous pill (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-only pill, injection, implant, or 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 the next injection was due), but in all cases, you must use extra protective measures (e.g., a condom) for the first 7 days of taking the new tablets.

• After an abortion or miscarriage.

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 must use a barrier method (e.g., a condom) for the first 7 days of taking Levonorgestrel/Ethinylestradiol. If, after having a child, you have had sexual intercourse before starting to take Levonorgestrel/Ethinylestradiol 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 unsure 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 reports of serious harmful effects from taking too many Levonorgestrel/Ethinylestradiol tablets. If you take several tablets at once, you may experience nausea and vomiting. Young girls may experience 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.

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

If You Forget to Take Levonorgestrel/Ethinylestradiol Stada 0.1 mg/0.02 mg Film-Coated Tablets

• If it has been less than 12 hourssince you forgot to take the tablet, your protection against pregnancy is not affected. 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 to take the tablet, your protection against pregnancy may be reduced. The more tablets you forget to take, the greater the risk that your protection against pregnancy will be reduced.

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

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

• More than 1 forgotten tablet in the blister pack

Consult your doctor.

• 1 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 following tablets at the usual time and take extra precautionsfor the next 7 days, for example, use a condom. If you have had sexual intercourse in the week before the missed tablet, or if you forgot to start a new blister pack after the tablet-free period, you should be aware that there is a risk of pregnancy. In this case, consult your doctor.

• 1 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 following tablets at the usual time. Your protection against pregnancy is not reduced, and you do not need to take extra precautions.

• 1 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 following tablets at the usual time. Instead of the tablet-free period, start the next blister pack directly.

It is likely that you will have a menstrual period (withdrawal bleeding) after finishing the second blister pack, but you may also experience spotting or intermenstrual bleeding when taking the second blister pack.

1. You can also stop taking the current blister pack and go directly to the 7-day tablet-free period (note the day you forgot to take your tablet). If you want to start a new blister pack on a specific day, you can shorten the tablet-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 any of the tablets in a blister pack and do not have bleeding during the first tablet-free period, it could mean that you are pregnant. You should contact your doctor before continuing with the next blister pack.

What to Do in Case of Vomiting or Severe Diarrhea

If you vomit within 3-4 hours after taking the tablet or if you have severe 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 blister pack as soon as possible. If possible, take it within 12 hoursof the time you would normally take your tablet. If this is not possible, or if more than 12 hours have passed, you should follow the advice given in "If you forget to take Levonorgestrel/Ethinylestradiol Stada".

Delayed Menstrual Period: What You Should Know

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

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

Changing the First Day of Your Menstrual Period: What You Should Know

If you take the tablets according to the instructions, your menstrual period or withdrawal bleeding will begin during the tablet-free week. If you need to change this day, do so by shortening the tablet-free period (but never lengthening it). For example, if your tablet-free period starts on a Friday and you want to change it to a Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. If you shorten the tablet-free period significantly (e.g., to 3 days or less), you may not have any bleeding during this period. Afterward, you may experience spotting (drops or spots of blood) or intermenstrual bleeding.

If you are unsure what to do, consult your doctor.

If You Want to Stop Taking Levonorgestrel/Ethinylestradiol Stada

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Severe side effects:

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

• 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).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are 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 help provide more information on the safety of this medicine.

5. Storage of Levonorgestrel/Ethinylestradiol Stada

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 pack after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Additional Information

Composition of Levonorgestrel/Ethinylestradiol Stada

• The active ingredients are levonorgestrel and ethinylestradiol.

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

• The other ingredients (excipients) are 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)].

Appearance of the Product and Contents of the Pack

Each film-coated tablet is pink and round.

Levonorgestrel/Ethinylestradiol Stada is available in blister packs of 21 tablets.

The pack sizes are 1, 3, or 6 blister packs, and each blister pack contains 21 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

La Vallina s/n

24193-Villaquilambre (León)

Spain

Date of the Last Revision of this Leaflet: September 2022

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

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