Prospect: information for the patient

Levonorgestrel/Ethinylestradiol Durban 0.1 mg/0.02 mg coated tablets EFG

Important things you should 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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause 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”).

1.What isLevonorgestrel/Ethinylestradiol Durbanand what is it used for

2.What you need to know before starting to takeLevonorgestrel/Ethinylestradiol Durban

3.How to takeLevonorgestrel/Ethinylestradiol Durban

4.Possible side effects

5.Storage ofLevonorgestrel/Ethinylestradiol Durban

6. Contents of the package and additional information

Levonorgestrel/Ethinylestradiol Durban is an oral combined contraceptive pill for the prevention of pregnancy. Each of the 21 round white tablets contains a small amount of two different female hormones, levonorgestrel and ethinylestradiol.

General Considerations

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

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

This leaflet describes some situations in which you should stop takingLevonorgestrel/Ethinylestradiol Durbanor where the reliability ofLevonorgestrel/Ethinylestradiol Durbanmay be reduced, with a risk of pregnancy. In these situations, you should not have sexual intercourse or 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 sinceLevonorgestrel/Ethinylestradiol Durbanalters the monthly changes in body temperature and cervical mucus.

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

Do not take Levonorgestrel/Ethinylestradiol Durban:

• if you are allergic tolevonorgestrel or ethinylestradiol or to any of the other components of this medication (listed in section 6).
• if you have any of the conditions listed below.

Inform 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 leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• if you know that 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 if you spend a lot of time without standing up (see section “Blood Clots”).
• if you have ever had a heart attack or a 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 vascular 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 that you may have any of these cancers.
• if you have unexplained vaginal bleeding.
• if you have high blood sugar levels (diabetes) associated with vascular problems.
• if you are pregnant or suspect that you may be pregnant.
• if you have or have had a benign or malignant liver tumor, or if you have recently had liver disease. In these cases, your doctor will ask you to stop taking Levonorgestrel/Ethinylestradiol 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 Durban with other medications”).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to takeLevonorgestrel/Ethinylestradiol Durban.

Psychiatric disorders:

Some women who use hormonal contraceptives like Levonorgestrel/Ethinylestradiol Durban 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.

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

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

• if you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• if you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• if you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney failure).
• if you have sickle cell anemia (a hereditary disorder 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 pancreatitis (inflammation of the pancreas).
• if you need an operation or spend a lot of time without standing up (see section 2 “Blood Clots”).
• if you are recently postpartum, you are at increased risk of blood clots. Ask your doctor when you can start taking this medication after childbirth.
• if you have superficial thrombophlebitis (inflammation of veins under the skin).
• if you have varicose veins.

• if you are diabetic
• if you experience sudden and inexplicable changes in vision
• if you have gallstones, bile duct problems, or liver problems – may cause intense itching
• if you develop migraines for the first time or worsen an existing migraine
• if you have liver disease, jaundice, or pancreatitis or kidney problems
• if you have depression
• if you have hearing loss due to a condition known as otosclerosis
• if you have had during pregnancy or while taking another contraceptive pill a skin problem that caused itching, red patches, or blisters (herpes gestationnis).
• if you have had during pregnancy brownish skin patches (melasma). The pill may cause this to recur, so you should avoid exposure to the sun or lie in the sun while taking this medication.
• if you have a disease known as Sydenham's chorea. Symptoms include irregular, sudden, and involuntary movements.
• if you have ever had a blood disorder called porphyria.

• 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.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Levonorgestrel/Ethinylestradiol Durban increases your risk of suffering a blood clot compared to not using it.In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• in veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• in arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

The recovery of blood clots is not always complete. In rare cases, there may be lasting or, very rarely, fatal effects.

It is essential to remember that the overall risk of a harmful blood clot due toLevonorgestrel/Ethinylestradiol Durbanis small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif 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 veins (venous thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may 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 a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may be higher also if you start taking a combined hormonal contraceptive again (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 takingLevonorgestrel/Ethinylestradiol Durban, your risk of a blood clot returns to normal in a few weeks.

What is the risk of 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 a blood clot in the leg or lung (DVT or PE) withLevonorgestrel/Ethinylestradiol Durbanis small.

• Of every 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.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel likeLevonorgestrel/Ethinylestradiol Durban, norethisterone, or norgestimato, between 5 and 7 will develop a blood clot in a year.
• The risk of 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 a blood clot is higher:

• if you are overweight (BMI of 30 kg/m2or higher).
• if one of your close relatives has had a blood clot in a leg, lung, or other organ at a young age (i.e., before about 50 years). In this case, you may have an inherited disorder of blood clotting.
• if you need surgery or spend a lot of time without standing up due to an injury or illness or if you have a leg cast. You may need to stop takingLevonorgestrel/Ethinylestradiol Durbanfor several weeks before the operation or while you have less mobility. If you need to stop takingLevonorgestrel/Ethinylestradiol Durban, ask your doctor when you can start taking it again.
• if you are over 35 years old.
• if you have recently given birth. You are at increased risk of blood clots. Ask your doctor when you can start taking this medication after childbirth.

The risk of a blood clot increases the more conditions you have.

Long flights (over 4 hours) may 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 have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop takingLevonorgestrel/Ethinylestradiol Durban.

If any of the conditions listed above change while you are usingLevonorgestrel/Ethinylestradiol Durban, for example, a close relative experiences a blood clot 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 a 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 toLevonorgestrel/Ethinylestradiol Durbanis very small, but it may increase:

• with age (over 35 years).
• if you smokeWhen using a combined hormonal contraceptive like Levonorgestrel/Ethinylestradiol 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 one of your close relatives has had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at increased risk of a heart attack or stroke.
• if you or one of your close relatives has high levels of fat in the blood (cholesterol or triglycerides).
• if you have migraines, especially migraines with aura.
• if you have a heart problem (valve disorder, arrhythmia 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 a blood clot may be increased even further.

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

Levonorgestrel/Ethinylestradiol Durbanand cancer

Breast cancer has been diagnosed slightly more frequently in women who use combined oral contraceptives. However, it is unclear whether the cancer is caused by the pill. These women may simply be examined more rigorously and frequently, so there would be a greater chance of detecting breast cancer before it becomes serious.

The increased risk disappears gradually after 10 years of stopping the use of combined hormonal contraceptives. It is essential to have regular breast checks and to contact your doctor if you notice any lumps.

There have been studies in which cases of cervical cancer have been reported in women who take combined oral contraceptives for a relatively long period. Currently, it is unclear whether this is caused by the pill or is related to sexual behavior (e.g., more frequent changes of partner) and other factors such as the human papillomavirus (HPV).

In rare cases, benign liver tumors and even malignant liver tumors have been described in patients taking the pill. Contact your doctor if you have severe and unusual abdominal pain.

Menstrual bleeding

During the first few months of taking Levonorgestrel/Ethinylestradiol Durban, you may experience unexpected bleeding (bleeding or spotting outside of the pill-free week). If this bleeding persists for more than a few months or starts after several months, your doctor will investigate the cause.

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

Some women do not have bleeding during the pill-free week.

If you have taken all the pills correctly,(following the instructions provided),you have not had severe vomiting or diarrhea, and you have not taken any other medication, it is unlikely that you are pregnant.

If your period does not appear for the second time in a row,or if you have not taken the pills correctly before the first missed period, or if a second missed period occurs, you should consult your doctor immediatelyas you may be pregnant. Do not start a new pack until you are sure you are not pregnant.

Taking Levonorgestrel/Ethinylestradiol Durban with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications can interact with Levonorgestrel/Ethinylestradiol Durban.

Medications can sometimes interfere with each other. If you are receiving treatment from another doctor, nurse, or healthcare professional, ensure that they are aware that you are taking Levonorgestrel/Ethinylestradiol Durban as a contraceptive.

They may advise you to take additional precautions (e.g., use condoms or other barrier methods) while taking other medications with Levonorgestrel/Ethinylestradiol Durban.

Some medications can make Levonorgestrel/Ethinylestradiol Durban less effective in preventing pregnancy, or may cause unexpected bleeding. These include medications used to treat:

• infections caused by the HIV virus (ritonavir, nevirapina)
• epilepsy (e.g., phenobarbital, phenytoin, primidone, felbamate, carbamazepine, oxcarbazepine, or topiramate)
• infections (e.g., rifabutin, rifampicin, griseofulvin, ampicillin, or other penicillins or tetracyclines)
• sleep disorders (modafinilo)
• gout (phenylbutazone)
• St. John's Wort (Hypericum perforatum) used to treat certain types of depression.

If you have been advised to take additional contraceptive precautions while taking one of the medications listed above, follow your doctor's instructions carefullyas you may need to use a non-hormonal backup method of contraception.If you need to continue taking the medication after finishing your current pack, do not skip the pill-free week and start a new pack immediately.

In some cases, you may need to continue using a barrier contraceptive method for several weeks after stopping the medication.

Levonorgestrel/Ethinylestradiol Durban may interact with the following medications:

• ciclosporin (used to reduce the immune response)
• lamotrigine (used to treat epilepsy)

Taking a medication called troleandomycin may increase the risk of intrahepatic cholestasis (retention of bile in the liver) during treatment with the combined pill.

Taking a medication called flunarizine used to prevent migraines may increase the risk of galactorrhea. This is a condition in which the breasts secrete milk spontaneously without breastfeeding or having recently given birth.

Do not takeLevonorgestrel/Ethinylestradiol Durbanif you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir, as these medications can cause increases in liver enzyme test results (elevated ALT levels).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications. You can start takingLevonorgestrel/Ethinylestradiol Durbanagain approximately 2 weeks after completing this treatment. See the section “Do not takeLevonorgestrel/Ethinylestradiol Durban”.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or suspect that you may be pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

It is not recommended to take the combined pill while breastfeeding, as the hormones may affect the milk. If you wish to breastfeed, your doctor will advise you on suitable alternative contraceptive methods.

Consult your doctor, nurse, or healthcare professional before using any medication.

Driving and operating machinery

No studies have been conducted on the effect of Levonorgestrel/Ethinylestradiol Durban on the ability to drive or operate machinery. Dizziness has been reported as a side effect. If you experience dizziness, do not drive or operate machinery until the symptoms have resolved.

Levonorgestrel/Ethinylestradiol Durban contains lactose and saccharose

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

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

Each blister of Levonorgestrel/Ethinylestradiol Durban contains 21 tablets. Take the first tablet of the blister where the correct day of the week appears. You should take one tablet every day, with water if necessary, and at the same time every day until the package is finished.

You will have a week of tablet-free time before starting the next package of tablets. You must always start the next package on the same day of the week.

During the tablet-free week, you will have a bleeding similar to your period. This bleeding usually starts after two or three days, and it may not have ended before starting the next package of tablets.

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

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

If you start after the first day of your period (in 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 oral contraceptive

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

Finish the package of the current pill, and start taking Levonorgestrel/Ethinylestradiol Durban the next day, without interruption.

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

If your current package of pills contains inactive tablets (placebo), do not take these tablets, and start with Levonorgestrel/Ethinylestradiol Durban immediately the next day without leaving any interruption.

If you are changing from a pill that only contains a progestogen, an injection, an implant, or an intrauterine system with progestogens:

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

• If you change from an implant or an intrauterine system with progestogens, start using Levonorgestrel/Ethinylestradiol Durban on the same day of the implant removal.
• If you change from an injectable contraceptive, start with Levonorgestrel/Ethinylestradiol Durban on the day when you would have had the next injection.

In all casesyou must use a barrier contraceptive method during the first 7 days of taking the pill.

If you start with Levonorgestrel/Ethinylestradiol Durban after a first-trimester abortion (3 months) of pregnancy.

You can start taking Levonorgestrel/Ethinylestradiol 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 Durban after having a baby or after a second-trimester abortion

Like any other oral contraceptive, Levonorgestrel/Ethinylestradiol Durban should not be initiated before 28 days after giving birth, or after a second-trimester abortion, as the risk of blood clots increases. If you start later, it is recommended to use a barrier contraceptive method during the first 7 days you take the pill. If you have had sex before starting Levonorgestrel/Ethinylestradiol Durban, make sure you are not pregnant or wait until your next period.

In case of doubt, always consult your doctor.

Use in children and adolescents

Levonorgestrel/Ethinylestradiol Durban is not indicated in girls who have not yet had their first period.

Use in elderly women

Levonorgestrel/Ethinylestradiol Durban is contraindicated after menopause.

If you take more Levonorgestrel/Ethinylestradiol Durban than you should

It is unlikely that taking more than one tablet will harm you, but you may feel dizzy or vomit. Young women may experience vaginal bleeding. Consult your doctor if you experience these symptoms.

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 takeLevonorgestrel/Ethinylestradiol Durban

• If you forget to take a tabletless than 12 hoursbefore the usual time, the protection against pregnancy is not affected. You can still take the tablet as soon as you remember and then take the next tablets at the usual time.
• If you forget to take a tabletmore than 12 hoursbefore the usual time, 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 maximum if you forget to take the first tablet of the blister (1st row) or the last tablet of the 3rd week (3rd row of the blister). Therefore, you should follow the recommendations given below (see also the diagram):

•Never interrupt the tablet-taking for more than 7 days.

•The effectiveness of Levonorgestrel/Ethinylestradiol Durban depends on the non-interruption of tablet-taking for 7 days.

• More than 1 tablet forgotten in this blister

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 take extra precautions for the next 7 days, for example, a condom. If you have had sex in the week before the mistake, or if you forgot to start a new blister after the tablet-free period, you should 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.If you have taken the tablets correctly in the 7 days before the first forgotten tablet, no additional contraceptive measures are necessary. If you have not taken the tablets correctly or if you have forgotten to take more than one tablet, you should take additional contraceptive measures for the next 7 days.

• 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.

Take the next tablets at the usual time. Instead of the tablet-free period, start the next blister directly.

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

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

If you experience vomiting or diarrhea

If you vomit or have severe diarrhea in the 3-4 hours after taking the tablet, it is as ifyou had forgotten to take the tablet. After vomiting or diarrhea, you should take anothertablet from the reserve package as soon as possible. If possible, take it in thenext 12hoursor when you take the pill normally. If not possible or more than 12hours have passed, you should follow the recommendations given in “If you realize you have forgotten to take atablet more than 12 hours after the usual time”.

If the episodes of vomiting or diarrhea are repeated over several days, a barrier contraceptive method (e.g., condoms) should be used until the start of the next package. Consult your doctor in case of doubt.

How to delay your period or change the first day of a period

You can delay your period by starting another package ofLevonorgestrel/Ethinylestradiol Durbanimmediately without interruption.You may experience spotting or bleeding while taking the second package, but you do not need to worry about this. You should have a normal bleeding after finishing the second package.

The usual taking of Levonorgestrel/Ethinylestradiol Durban will then resume after the usual 7-day tablet-free period. 4 of 18

If you want to change the start date of your period to another day of the week, you can shorten the next tablet-free period by as many days as you want. The shorter the period, the greater the risk of not having withdrawal bleeding and having spotting or intermenstrual bleeding with the second package (just like when delaying a period).

If you take moreLevonorgestrel/Ethinylestradiol Durbanthan you should

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

If you are concerned, consult your doctor.

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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

All women taking 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 starting to take Levonorgestrel/Ethinylestradiol Durbán”

Contact a doctor immediately if you experience any of the following angioedema symptoms: 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 severe side effects,you may need urgent medical attention. Stop taking this medicine and see 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.

• Deleterious 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 or transient stroke-like symptoms, known as 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 severe side effects have been reported with a slightly higher frequency in women using combined oral contraceptives but it is not known if this is caused by the treatment. (see section 2: “What you need to know before starting to take Levonorgestrel/Ethinylestradiol Durbán”):

• Increased blood pressure
• Hepatic tumors or breast cancer

If you have hereditary angioedema (sudden inflammation of the skin, mucous membranes (mouth, nose, intestine, genitals), internal organs, or brain), medications containing estrogen may induce or exacerbate angioedema symptoms (see section 2 “Warnings and precautions”)

Other side effects include:

Frequent(may affect up to 1 in 10 people)

• Mood changes, including depression
• Headache
• Nausea, abdominal pain
• Breast tenderness
• Weight gain

Occasional(may affect up to 1 in 100 people)

• Fluid retention (e.g., swollen ankles)
• Decreased libido
• Migraine
• Vomiting, diarrhea
• Skin rash
• Hives (urticaria)Increased breast size

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

• Increased libido
• Intolerance to contact lenses
• Boils under the skin that are painful and red (erythema nodosum)or skin spotsespecially on the palms or soles of the feet, which may present blisters. You may also have ulcers in the mouth, eyes, or genitals, and may have a fever (erythema multiforme).
• Breast secretion, vaginal secretion
• 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 symptoms such as bloody diarrhea, abdominal pain, stomach pain).
• Porphyria (metabolic disorder causing abdominal pain and mental disorder)
• SLE (the body attacks and damages its own organs and tissues).
• Herpes gestationalis (skin rash with blisters that appears during pregnancy)
• Sydenham's chorea (uncontrolled or spasmodic body movements).
• Sickle cell disease (a condition that occurs after the appearance of diarrhea caused by E. coli)
• Changes in the liver, such as jaundice, gallstones,
• Changes in glucose tolerance or peripheral insulin resistance
• Loss of hearing related to otosclerosis
• Melasma (dark spots on the skin, also known as pregnancy spots, especially on the face.)
• Increased risk of pancreatitis in women with hypertriglyceridemia.

If you are concerned about new symptoms or other aspects of your health while taking this medicine, consult your doctor.

Reporting of side effects:

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.You can also report them directly to theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 blister pack and on the case after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGREpoint of the pharmacy. Please ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Levonorgestrel/Ethinylestradiol Durban

The active principles are 0.1 milligrams of levonorgestrel and 0.02 milligrams of ethinylestradiol.

The other components are: lactose monohydrate, a corn starch, povidone 30, talc, magnesium stearate, saccharose, povidone 90, macrogol 6000, calcium carbonate, talc, and montan wax.

Appearance of the product and contents of the packaging

Levonorgestrel/Ethinylestradiol Durban is packaged in aluminum/PVC blister packs containing 21 coated white, shiny, odorless, and smooth surface .

The blister packs are located inside a cardboard box or inside a carton that is placed inside the cardboard box.

Each package may contain:

1 x 21 tablets

3 x 21 tablets

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Responsible manufacturer:

Haupt Pharma Munster GmbH

Schleebrüggenkamp 15

D-48159 Münster

Germany

Last review date of this leaflet: March 2020

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/ .