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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

• Keep this leaflet; 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Levonorgestrel/Ethinylestradiol Stada is and what it is used for
2. What you need to know before 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 there is no bleeding during the treatment-free week
• Taking Levonorgestrel/Ethinylestradiol Stada with other medicines
• Laboratory tests
• Pregnancy
• Breast-feeding
• Driving and use of machines
• Levonorgestrel/Ethinylestradiol Stada contains lactose

1. How to take Levonorgestrel/Ethinylestradiol Stada

   • When you can start the first 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 diarrhoea
   • Delayed menstrual period: what you should know
   • Change in the first day of your menstrual period: what you should know
   • If you wish to stop taking Levonorgestrel/Ethinylestradiol Stada

2. Possible side effects

3. How to store Levonorgestrel/Ethinylestradiol Stada

4. Contents of the pack and other information

1. What Levonorgestrel/Ethinylestradiol Stada is and what it is 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 containing two hormones are known as "combined pills".

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

General considerations

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

This leaflet describes various situations in which you must stop using levonorgestrel/ethinylestradiol or in which its effectiveness may be reduced. In these situations, you should not have sexual intercourse or, otherwise, must use additional non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These methods are unreliable because levonorgestrel/ethinylestradiol alters 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 transient ischemic attack without residual effects).

• If you have a disease that could increase the risk of arterial thrombosis. These warnings apply to the following situations:

  • diabetes with blood vessel damage
  • 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 neurological focal symptoms)

• If you have (or have had) inflammation of the pancreas (pancreatitis)

• If you have (or have had) liver disease in the past and 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 suspicion of breast cancer or cancer of the genital organs

• If you have unexplained vaginal bleeding

• If you have missed your period for several months without a known cause

• If you are allergic to levonorgestrel or ethinylestradiol, or to any of the other components of this medicine (listed in section 6). This allergy may manifest as itching, rash, or swelling.

• If you have Hepatitis C and are taking medications 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 certain situations, you must take special precautions when using Levonorgestrel / Ethinylestradiol STADA or any other combined hormonal contraceptive, and you may need to see your doctor regularly. If you are in any of the following situations, you must inform your doctor before starting to use levonorgestrel/ethinylestradiol. In addition, you must consult your doctor if any of the following conditions appear or worsen while you are using levonorgestrel/ethinylestradiol:

• If a close relative has or has had breast cancer.
• If you have 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 HUS (hemolytic uremic syndrome), a blood disorder causing kidney damage.
• If you have sickle cell anemia (an inherited red blood cell disorder).
• If you have epilepsy.
• If you have SLE (systemic lupus erythematosus, an immune system disorder).
• If you have a condition that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], herpes gestationis [a blistering skin rash during pregnancy], Sydenham's chorea [a nerve disorder causing sudden jerky movements]).
• If you have or have ever had chloasma (golden-brown pigmented spots, known as "pregnancy mask," especially on the face). If so, avoid direct exposure to sunlight or ultraviolet light.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with possible breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Levonorgestrel/Ethinylestradiol Stada and thrombosis

Venous thrombosis

The use of any combined oral contraceptive, including levonorgestrel/ethinylestradiol, increases a woman's risk of 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 overweight,
• If a close relative has had a blood clot (thrombosis) in the leg, lung, or another organ at a young age,
• If you are undergoing surgery, prolonged immobilization, or have suffered a serious accident. It is important to inform your doctor that you are taking levonorgestrel/ethinylestradiol, as you may need to stop treatment. Your doctor will tell you when to restart levonorgestrel/ethinylestradiol. Usually, this will be within two weeks after recovery.

Arterial thrombosis

The use of combined oral contraceptives has been associated with an increased risk of arterial thrombosis (blockage of an artery), for example, in 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 a close relative 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 irregular heartbeat).

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

• Severe pain or swelling in one of your legs
• Sudden severe chest pain, which may radiate to the left arm
• Sudden shortness of breath
• Sudden cough without an obvious cause
• 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, unusual sensation, or numbness in any part of the body

Levonorgestrel/Ethinylestradiol Stada and cancer

A slightly higher number of breast cancer cases have been observed in women taking oral contraceptives, but it is unknown whether this is due to the treatment. For example, more tumors may be detected in women taking combined pills because they are examined by their doctor more frequently. The occurrence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to examine your breasts regularly, and you should contact your doctor if you notice any lump.

Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in users of oral contraceptives. Contact your doctor if you experience unusual severe abdominal pain.

Psychiatric disorders

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

Bleeding between periods

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

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

If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medicines, it is very unlikely that you are pregnant.

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

Taking Levonorgestrel/Ethinylestradiol Stada with other medicines

Always consult the doctor who prescribed levonorgestrel/ethinylestradiol about any other medicines or herbal remedies you are already taking. Also, inform any other doctor or dentist who prescribes you medicines (or the pharmacist dispensing them) that you are using levonorgestrel/ethinylestradiol. They will advise you whether you need to use additional contraceptive measures (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 to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, or oxcarbazepine), tuberculosis (e.g., rifampicin), or HIV infections (ritonavir), other infectious diseases (such as griseofulvin, ampicillin, or tetracycline), those that increase intestinal motility (such as metoclopramide), and the herbal remedy St. John's wort.

If you wish to use herbal remedies containing St. John's wort while taking levonorgestrel/ethinylestradiol, you must first consult your doctor.

Levonorgestrel/ethinylestradiol may reduce the effectiveness of other medicines, such as those containing cyclosporine, or the antiepileptic lamotrigine (which could 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 (elevated 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 completion of this treatment. See section "Do not use Levonorgestrel/Ethinylestradiol Stada".

Consult your doctor or pharmacist before using any medicine.

Laboratory tests

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

Pregnancy

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

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

Breastfeeding

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

In general, levonorgestrel/ethinylestradiol is not recommended while breastfeeding. You should consult your doctor if you wish to take the pill while breastfeeding.

Driving and using machines

There is no information indicating 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 informed you that you have an intolerance to certain sugars, consult with him 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 must take the tablets every day, approximately 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. Take one tablet every day until you have finished all 21 tablets. After that, do not take any more tablets for 7 days.

During these 7 tablet-free days (known as the break or treatment-free week), you should experience bleeding. This is called "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the week.

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

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

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

Start taking levonorgestrel/ethinylestradiol on the first day of your cycle (i.e., the first day of your menstruation). If you start taking levonorgestrel/ethinylestradiol on the first day of your period, you are immediately protected against pregnancy. You may also start between days 2–5 of your cycle, but in this case, you must use additional contraceptive precautions (e.g., a condom) during the first 7 days.

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

You may start taking levonorgestrel/ethinylestradiol the day after the tablet-free interval of your previous pill ends (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, progestogen injection, implant, or progestogen-releasing IUD)

You may switch on any day from a progestogen-only pill (if you were using an implant or IUD, on the day of its removal; if you were receiving progestogen by injection, on the date when the next injection would have been due). However, in all these cases, you must use additional contraceptive precautions (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 giving birth

After giving birth, you may 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) during the first seven days of using levonorgestrel/ethinylestradiol. If you have had sexual intercourse after giving birth before starting levonorgestrel/ethinylestradiol (again), you must first confirm that you are not pregnant or wait until your next menstrual bleeding.

Ask your doctor for advice if you are unsure when to start.

• If you are breastfeeding and wish to start taking levonorgestrel/ethinylestradiol (again) after giving birth

Read the section on “Breast-feeding”.

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

There are no reports of harmful effects from taking too many levonorgestrel/ethinylestradiol tablets. If you take several tablets at once, you may experience symptoms such as 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Levonorgestrel/Ethinylestradiol Stada 0.1 mg/0.02 mg film-coated tablets EFG

• If less than 12 hours have passed since you missed the tablet, your protection against pregnancy remains intact. You can still take the missed tablet as soon as you remember, and then continue taking the following tablets at your usual time.

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

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

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

• More than 1 tablet missed from the pack

Consult your doctor.

• One tablet missed in week 1

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

• One tablet missed in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Your protection against pregnancy is not reduced, and you do not need to take additional precautions.

• One tablet missed in week 3

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Instead of the tablet-free interval, start the next blister pack immediately.

You are likely to have a period (withdrawal bleeding) after finishing the second blister pack, but you may also experience spotting or breakthrough bleeding during the second blister pack.

2. Alternatively, you may stop taking tablets from this blister pack and go directly to the 7-day tablet-free interval (note the day you missed your tablet). If you wish to start a new blister pack on a specific day, shorten the tablet-free interval to less than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you missed any tablets from a blister pack and do not have bleeding during the first tablet-free interval, this could mean you are pregnant. You must contact your doctor before starting 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 are not completely absorbed into your body. This situation is similar to missing a tablet. After vomiting or experiencing severe diarrhea, take another tablet from the reserve blister pack as soon as possible. If possible, take it within 12 hours of when you would normally take your tablet. If this is not possible, or if more than 12 hours have passed, follow the advice given under “If you forget 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 pack by continuing directly with a new blister pack of levonorgestrel/ethinylestradiol instead of taking the tablet-free interval, continuing until the end of the second blister pack rather than starting the break. You may experience spotting (drops or spots of blood) or breakthrough bleeding while using the second blister pack. After the usual 7-day tablet-free interval, continue with the next blister pack.

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

Changing 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 occur during the tablet-free week. If you wish to change this day, do so by shortening the tablet-free interval (but never by extending it). For example, if your tablet-free interval starts on a Friday and you wish to change it to Tuesday (3 days earlier), you should start the new blister pack 3 days earlier than usual. If you shorten the tablet-free interval significantly (e.g., 3 days or less), you may not have any bleeding during this interval. Afterwards, you may experience spotting (drops or spots of blood) or breakthrough bleeding.

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

If you wish to stop taking Levonorgestrel/Ethinylestradiol Stada

You may stop taking levonorgestrel/ethinylestradiol at any time. If you do not wish to become pregnant, consult your doctor about other reliable methods of contraception.

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

4. Possible adverse effects

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

Always inform your doctor if you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to the pill.

Serious adverse effects:

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with possible breathing difficulties (see also 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”. Please read these paragraphs for further information and consult your doctor immediately if necessary.

• Common side effects (may affect up to 1 in 10 women): headache, changes in mood (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, diarrhoea, fluid retention or oedema, migraine, loss of libido, breast enlargement, urticaria.

• Rare side effects (may affect up to 1 in 1,000 women): eye irritation when wearing contact lenses, hypersensitivity, weight loss, galactorrhoea, vaginal discharge, increased libido, erythema nodosum (nodules on the legs), erythema multiforme (skin lesions).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at the website: www.notificaRAM.es. By reporting adverse 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 after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Levonorgestrel/Ethinylestradiol Stada

• The active substances are levonorgestrel and ethinylestradiol.

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

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

Appearance of the medicine and contents of the pack

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

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

Pack sizes are 1, 3 or 6 blisters, each blister containing 21 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: September 2022

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