LEVONORGESTREL/ETHINYLESTRADIOL DAILY DURBAN 0.1 mg/0.02 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Levonorgestrel/Ethinylestradiol Daily Durban 0.1 mg/0.02 mg

film-coated tablets EFG

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 "Blood clots").

Contents of the leaflet

1. What is Levonorgestrel/Ethinylestradiol Daily Durban and what is it used for
2. What you need to know before starting to take Levonorgestrel/Ethinylestradiol Daily Durban
3. How to take Levonorgestrel/Ethinylestradiol Daily Durban
4. Possible side effects
5. Storage of Levonorgestrel/Ethinylestradiol Daily Durban
6. Packaging contents and additional information

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

Levonorgestrel/Ethinylestradiol Daily Durban is a combined oral contraceptive pill for the prevention of pregnancy. It contains two different female hormones, levonorgestrel and ethinylestradiol.

Each of the 21 round white tablets contains 0.1 milligrams of levonorgestrel and 0.02 milligrams of ethinylestradiol. The pack also includes 7 inactive light brown tablets (placebo).

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

General considerations

Before starting to use this medication, you should read the information about blood clots in section 2. It is especially important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before you start taking Levonorgestrel/Ethinylestradiol Daily Durban, your doctor will ask you some questions about your medical history and your personal relationships. Your doctor will also measure your blood pressure and may perform some other tests.

In this prospectus, some situations are described in which you should stop taking Levonorgestrel/Ethinylestradiol Daily Durban or where the reliability of Levonorgestrel/Ethinylestradiol Daily Durban may decrease, with a risk of pregnancy. In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions (e.g., use condoms or another barrier method). Do not use the rhythm or temperature method. These methods may not be reliable since Levonorgestrel/Ethinylestradiol Daily Durban alters the monthly changes in body temperature and cervical mucus.

Levonorgestrel/Ethinylestradiol Daily Durban, like other oral contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Do not take Levonorgestrel/Ethinylestradiol Daily Durban:

• If you are allergic to the active substances (levonorgestrel or ethinylestradiol) or to any of the other components of this medication (included in section 6).
• If you have any of the conditions listed below.

Tell your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable:

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or spend a lot of time without getting up (see section 2 "Blood clots").
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you have breast cancer or uterine cancer, or a type of cancer that is sensitive to female hormones, or if you suspect you may have one of these cancers.
• If you have vaginal bleeding of unknown cause.
• If you have high blood sugar levels (diabetes) associated with blood vessel problems.
• If you are pregnant or suspect you may be pregnant.
• If you have or have had a benign or malignant tumor in the liver, or if you have recently had liver disease. In these cases, your doctor will ask you to stop taking Levonorgestrel/Ethinylestradiol Daily Durban until your liver has returned to normal.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir (see also the section "Taking Levonorgestrel/Ethinylestradiol Daily Durban with other medications").

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Levonorgestrel/Ethinylestradiol Daily Durban.

Psychiatric disorders:

Some women who use hormonal contraceptives like Levonorgestrel/Ethinylestradiol Daily Durban have reported depression or a depressed mood. Depression can be severe and sometimes can induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Tell your doctor if you suffer from any of the following conditions.

Consult your doctor or pharmacist before starting to take Levonorgestrel/Ethinylestradiol Daily Durban. In some situations, you should be particularly careful while using Levonorgestrel/Ethinylestradiol Durban or any other combined contraceptive, and your doctor may need to examine you periodically. If the condition develops or worsens while you are using Levonorgestrel/Ethinylestradiol Daily Durban, you should also inform your doctor.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (an inherited disease of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of developing blood clots. You should ask your doctor when you can start taking this medication after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you are diabetic.
• If you experience any sudden and unexplained change in vision.
• If you have gallstones, gallbladder disease, or problems caused by blockage of the bile ducts (cholestasis) – it can cause intense itching.
• If you develop migraine for the first time or if your existing migraine worsens.
• If you have or develop liver disease, jaundice, or inflammation of the pancreas or kidney disorder.
• If you have depression.
• If you have hearing loss due to a condition known as otosclerosis.
• If you have had a skin problem during pregnancy or when taking another contraceptive pill that caused itching, red spots, or blisters (herpes gestationis).
• If you have had brown spots on your skin during pregnancy (chloasma). The pill may cause this to happen again, so you should avoid exposure to the sun or sunbathing while taking this medication.
• If you have a disease known as Sydenham's chorea. The symptoms include irregular, sudden, and involuntary movements.
• If you have ever had a blood disease called porphyria.

• 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 that contain estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive, such as Levonorgestrel/Ethinylestradiol Daily Durban, increases your risk of developing a blood clot compared to not using it.

Blood clots can form:

• In the veins (which is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (which is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to Levonorgestrel/Ethinylestradiol Daily Durban is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Levonorgestrel/Ethinylestradiol Daily Durban, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Levonorgestrel/Ethinylestradiol Daily Durban is small.

• Out of 10,000 women who do not take a combined hormonal contraceptive and are not pregnant, about 2 may develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, such as Levonorgestrel/Ethinylestradiol Daily Durban, norethisterone, or norgestimate, between 5 and 7 may develop a blood clot in a year.
• The risk of developing a blood clot will depend on your personal medical history (see "Factors that increase your risk of a blood clot" below).

Factors that increase your risk of a blood clot in a vein

The risk of developing a blood clot with Levonorgestrel/Ethinylestradiol Daily Durban is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50).
• If you need an operation or spend a lot of time without getting up due to an injury or illness or if you have your leg in a cast. You may need to stop using Levonorgestrel/Ethinylestradiol Daily Durban several weeks before surgery or while you have reduced mobility. If you need to stop using Levonorgestrel/Ethinylestradiol Daily Durban, ask your doctor when you can start using it again.
• As you get older (especially above 35 years).
• If you have recently given birth.

The risk of developing a blood clot increases with the number of conditions you have.

Long-distance flights (more than 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Levonorgestrel/Ethinylestradiol Daily Durban.

If any of the above conditions change while you are using Levonorgestrel/Ethinylestradiol Daily Durban, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

It is essential to note that the risk of a heart attack or stroke due to Levonorgestrel/Ethinylestradiol Daily Durban is very small, but it can increase:

• With age (above 35 years).
• If you smoke. When using a combined hormonal contraceptive like Levonorgestrel/Ethinylestradiol Daily Durban, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valvular disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, the risk of developing a blood clot may be increased further.

If any of the above conditions change while you are using Levonorgestrel/Ethinylestradiol Daily Durban, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight, inform your doctor.

Levonorgestrel/Ethinylestradiol Daily Durban

3. How to take Levonorgestrel/Ethinylestradiol Daily Durban

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

Each blister pack of Levonorgestrel/Ethinylestradiol Daily Durban contains 21 white tablets and 7 light brown tablets. Take the first white tablet from the blister pack where the number "1" appears. You should take one white tablet every day for 21 days, followed by the light brown tablets for 7 days. Take the tablets with water if necessary, and at the same time every day until the pack is finished. Once you finish the last tablet, start a new pack the next day. You should always start the next pack on the same day of the week.

During the week you are taking the light brown tablets, you will have a bleeding similar to your period. This bleeding usually starts after 2 or 3 days and may not have finished before starting the next pack of tablets.

If this is the first time you start with the pill or have not used any hormonal contraceptive in the previous month

Take the first tablet on the first day of your period.

If you start after the first day of your period (on days 2-7 of the cycle), you will need to use an additional barrier contraceptive method (e.g., condoms) for the first 7 days.

If you are changing from a combined contraceptive pill

If you are taking pills that contain 21 tablets in the pack

Finish the current pill pack and start taking Levonorgestrel/Ethinylestradiol Daily Durban the next day without a break.

If you are taking "daily" pills that contain 28 tablets in the pack

If your current pill pack contains inactive tablets (placebo), do not take these tablets and start with Levonorgestrel/Ethinylestradiol Daily Durban immediately the next day.

If you are changing from a progestogen-only pill, injection, or implant

• If you change from a progestogen-only pill, you can start with Levonorgestrel/Ethinylestradiol Daily Durban at any time during the menstrual cycle, the day after stopping the progestogen-only pill.

• If you change from an implant, start using Levonorgestrel/Ethinylestradiol Daily Durban on the same day the implant is removed.
• If you change from an injectable contraceptive, start with Levonorgestrel/Ethinylestradiol Daily Durban on the day you would have had your next injection.

In all cases, you should use a barrier contraceptive method during the first 7 days of taking the pill.

If you start with Levonorgestrel/Ethinylestradiol Daily Durban after an abortion during the first trimester (3 months) of pregnancy

You can start taking Levonorgestrel/Ethinylestradiol Daily Durban immediately, but you should follow your doctor's advice before doing so. No additional barrier contraceptive method is needed.

If you start with Levonorgestrel/Ethinylestradiol Daily Durban after having a baby or after an abortion during the second trimester

Like any other contraceptive pill, Levonorgestrel/Ethinylestradiol Daily Durban should not be started before 28 days after giving birth or after an abortion in the second trimester of pregnancy, as the risk of blood clots increases. If you start later, you are advised to use a barrier contraceptive method during the first 7 days you take the pill. If you have had sexual intercourse before starting with Levonorgestrel/Ethinylestradiol Daily Durban, make sure you are not pregnant or wait until your next period.

In case of doubt, always consult your doctor.

If you forget to take Levonorgestrel/Ethinylestradiol Daily Durban

If you take more Levonorgestrel/Ethinylestradiol Daily Durban than you should

If you accidentally take more Levonorgestrel/Ethinylestradiol Daily Durban than you should, you may have symptoms that include gastrointestinal problems (e.g., nausea, vomiting, abdominal pain), breast tenderness, dizziness, numbness/fatigue, and vaginal bleeding. These symptoms will naturally decrease as your body manages the excess hormones.

If you are concerned, consult your doctor.

Consult your doctor or pharmacist immediately, or the Toxicology Information Service. Telephone: 91 562 04 20.

4. Possible Adverse Effects

“Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to Levonorgestrel/Ethinylestradiol Daily Durban, consult your doctor.

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before taking Levonorgestrel/Ethinylestradiol Daily Durban”.

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 section “Warnings and Precautions”).

If you experience any of the following serious adverse effects,you may need urgent medical attention. Stop taking this medicine and consult your doctor or go immediately to the nearest hospital:

Rare(may affect up to 1 in 1,000 people):

• Severe allergic reactions such as skin rash, itching, urticaria or swelling of the face, lips, mouth, tongue, neck or throat, causing difficulty breathing or swallowing.

• Harmful blood clots in a vein or artery, for example:

• In a leg or foot (i.e., DVT).
• In a lung (i.e., PE).
• Heart attack.
• Stroke.
• Mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys or eye.

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

The following serious adverse effects have been reported with a slightly higher frequency in women using oral contraceptives, but it is not known if this is caused by the treatment. (see section 2: “What you need to know before taking Levonorgestrel/Ethinylestradiol Daily Durban”):

• Increased blood pressure
• Liver tumors or breast cancer

If you suffer from hereditary angioedema (sudden inflammation of the skin, mucous tissues (mouth, nose, intestine, genitals), internal organs or brain), medicines containing estrogens may induce or exacerbate the symptoms of angioedema (see section 2 “Warnings and Precautions”)

Other adverse effects include:

Frequent(may affect up to 1 in 10 people)

• mood changes, including depression
• headache
• nausea, abdominal pain
• breast pain/tenderness
• weight gain

Uncommon(may affect up to 1 in 100 people)

• fluid retention (e.g., swollen ankles)
• decreased sexual desire
• migraine
• vomiting, diarrhea
• skin rash
• hives (urticaria) increased breast size

Rare(may affect up to 1 in 1,000 people)

• increased sexual desire
• intolerance to contact lenses
• painful and reddened lumps under the skin (erythema nodosum) or spots on the skin, especially on the palms or soles of the feet, which may blister. You may also have ulcers in the mouth, eyes or genitals, and may have a fever (erythema multiforme).
• breast secretion, vaginal discharge
• weight loss

The following conditions have also been associated with the use of combined oral contraceptives.

• Crohn's disease, ulcerative colitis (inflammation of the colon or other parts of the intestine with signs such as bloody diarrhea, pain when passing stools, stomach pain).
• porphyria (metabolic disorder that causes abdominal pain and mental disorder)
• systemic lupus erythematosus (the body attacks and damages its own organs and tissues).
• gestational herpes (skin rash with blisters that appears during pregnancy)
• Sydenham's chorea (uncontrolled or spasmodic body movements).
• hemolytic uremic syndrome (a condition that occurs after the onset of diarrhea caused by E. coli)
• liver disorders, such as jaundice, stones,
• changes in glucose tolerance or peripheral insulin resistance
• hearing loss related to otosclerosis
• chloasma (dark spots on the skin, also called pregnancy spots, especially on the face.)
• Increased risk of pancreatitis in women with hypertriglyceridemia.

If you are concerned about new symptoms or other aspects related to your health while taking Levonorgestrel/Ethinylestradiol Daily Durban, consult your doctor.

Reporting of adverse effects:

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

5. Conservation of Levonorgestrel/Ethinylestradiol Daily Durban

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30 °C.

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

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofLevonorgestrel/Ethinylestradiol Daily Durban

The active ingredients of the white tablets are 0.1 milligrams of levonorgestrel and 0.020 milligrams of ethinylestradiol.

The other components are: lactose monohydrate; cornstarch; povidone; talc; magnesium stearate, sucrose; povidone; macrogol 6000; calcium carbonate; talc; montanglicol wax.

The inactive light brown tablets contain: lactose monohydrate; cornstarch; magnesium stearate; sucrose; calcium carbonate; talc; macrogol 6000; titanium dioxide (E171); povidone; glycerol 85%; yellow iron oxide (E172); red iron oxide (E172), montanglicol wax.

Appearance of the Product and Package Contents

Levonorgestrel/Ethinylestradiol Daily Durban is packaged in aluminum/PVC blister packs containing 21 coated tablets, white, shiny, odorless and with a smooth surface, and additionally, 7 coated tablets of light brown color, with a smooth surface.

The blisters are inside a cardboard box or inside a case that is inserted into the cardboard box. Each package may contain:

1 x 28 tablets

3 x 28 tablets

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Date of the Last Revision of this Prospectus: March 2020

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