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

Introduction

Package Leaflet: Information for the Patient

Levonorgestrel/Ethinylestradiol Durban 0.1 mg/0.02 mg film-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 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 Package Leaflet

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

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

Levonorgestrel/Ethinylestradiol Durban is a combined oral 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.

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

General considerations

Before you start using 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 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.

This leaflet describes some situations where you should stop taking Levonorgestrel/Ethinylestradiol Durban or where the reliability of Levonorgestrel/Ethinylestradiol Durban may be decreased, 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 Durban alters the monthly changes in body temperature and cervical mucus.

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

Do not take Levonorgestrel/Ethinylestradiol Durban:

• If you are allergic to levonorgestrel or ethinylestradiol or any of the other components of this medication (listed 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 if you spend a long time without getting 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 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 cancer of the uterus, 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 think 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 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 take Levonorgestrel/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.

Tell 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 be 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 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 (a hereditary 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 pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a long time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of 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 disorders, 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 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 had a skin problem during pregnancy or when taking another contraceptive pill that caused itching, red spots, or blisters (herpes gestationis).
• If you had brown spots on your skin during pregnancy (chloasma). The pill may make this come back, 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 may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (this 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 important to remember that the overall risk of a harmful blood clot due to Levonorgestrel/Ethinylestradiol 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 use of 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 of 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 that 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 Durban, your risk of a blood clot returns to normal within 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) with Levonorgestrel/Ethinylestradiol Durban is small.

• Out of 10,000 women who do not take a combined hormonal contraceptive and are not pregnant, about 2 may have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, such as Levonorgestrel/Ethinylestradiol Durban, norethisterone, or norgestimate, between 5 and 7 may have 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 with Levonorgestrel/Ethinylestradiol 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 about 50).
• If you need an operation or if you spend a long 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 Durban several weeks before the operation or while you have less mobility. If you need to stop using Levonorgestrel/Ethinylestradiol Durban, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have recently given birth.

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

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

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

If any of the conditions above change while you are using Levonorgestrel/Ethinylestradiol 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 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 important to note that the risk of a heart attack or stroke due to Levonorgestrel/Ethinylestradiol Durban is very small, but it may increase:

• with age (above about 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 any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also have a higher risk of having a heart attack or stroke.
• if you or any of your close relatives have a high level 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 a blood clot may be increased further.

If any of the conditions above change while you are using Levonorgestrel/Ethinylestradiol 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 Durban and cancer

Breast cancer has been diagnosed slightly more frequently in women who use combined hormonal contraceptives, but it is not known whether this is caused by the medication, as the risk of breast cancer also increases with age.

3. How to take Levonorgestrel/Ethinylestradiol Durban

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

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

Then you will have a week without taking pills before starting with the next pack of pills. You should always start the next pack on the same day of the week.

During the week without taking pills, 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 pills.

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

Take the first pill 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 pills in the pack

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

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

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

If you are changing from a progestin-only pill, injection, implant, or intrauterine system with progestins:

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

• If you change from an implant or an intrauterine system with progestins, 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 you would have had the 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 Durban after an abortion during the first trimester (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 an abortion during the second trimester

Like any other contraceptive pill, Levonorgestrel/Ethinylestradiol 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, it is recommended 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 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 had their first period yet.

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 pill will harm you, but you may feel dizzy or vomit. Young women may have 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 take Levonorgestrel/Ethinylestradiol Durban

• If it has been less than 12 hourssince you forgot the pill, the protection against pregnancy is not altered. You can still take the pill as soon as you remember and then take the following pills at the usual time.
• If it has been more than 12 hourssince you forgot the pill, the protection against pregnancy may be reduced. The more pills you forget to take, the greater the risk that the protection against pregnancy will be reduced.

The risk of incomplete protection against pregnancy is maximum if you forget to take the pill at the beginning of the blister pack (1st row) or at the end of the 3rd week (3rd row of the blister pack). Therefore, you should follow the recommendations outlined below (see also the diagram):

• You should never stop taking pills for more than 7 days.
• The effectiveness of Levonorgestrel/Ethinylestradiol Durban depends on the uninterrupted intake of pills during the 7 days.

• More than 1 forgotten pill in this blister pack

Consult your doctor.

• 1 forgotten pill in week 1

Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Take the following pills at the usual time and take extra precautions for the next 7 days, for example, a condom. If you have had sexual intercourse in the week before the missed pill, or if you forgot to start a new blister pack after the pill-free week, you should be aware that there is a risk of pregnancy. In this case, consult your doctor.

• 1 forgotten pill in week 2

Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Take the following pills at the usual time. As long as you have taken the pills correctly in the 7 days before the first forgotten pill, you do not need to use additional contraceptive measures. If you have not taken the pills correctly or if you have forgotten to take more than one pill, you should take extra contraceptive precautions for the next 7 days.

• 1 forgotten pill in week 3

You can choose between 2 options:

1. Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time.

Take the following pills at the usual time. Instead of the pill-free week, start the next blister pack immediately.

It is likely that you will have a withdrawal bleeding (menstruation) after finishing the second blister pack, but you may also have 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 pill-free period (note the day you forgot to take your pill) including the days you forgot the pills, and continue with the next pack. If you want to start a new blister pack on a specific day, you can shorten the pill-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 pills from a blister pack and do not have bleeding during the first pill-free week, it could mean that you are pregnant. You should contact your doctor before continuing with the next blister pack.

If you have vomiting or diarrhea

If you vomit or have severe diarrhea within 3-4 hours after taking the pill, it is as if you had forgotten to take the pill. After vomiting or having diarrhea, you should take another pill from the reserve pack as soon as possible. If possible, take it within the next 12hoursor when you normally take the pill. If it is not possible or more than 12 hours have passed, you should follow the recommendations given in "If you realize you have forgotten to take a pill after 12 hours from the usual time".

If episodes of vomiting or severe diarrhea recur over several days, you should use a barrier contraceptive method (e.g., condoms) until the start of the next pack. 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 pack of Levonorgestrel/Ethinylestradiol Durban immediately without leaving a break. You may have some spotting or bleeding while taking the second pack, but you do not need to worry about this. You should have a normal menstrual period after finishing the second pack.

The usual intake of Levonorgestrel/Ethinylestradiol Durban will then be resumed after the normal 7-day break without taking pills.

If you want to change the start day of your period to another day of the week, you can shorten the next pill-free week as many days as you want. The shorter the break, the greater the risk that you will not have withdrawal bleeding and that you will have intermenstrual bleeding or spotting with the second pack (just like when you delay a period).

If you take more Levonorgestrel/Ethinylestradiol Durban than you should

If you accidentally take more Levonorgestrel/Ethinylestradiol Durban than you should, you may experience 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.

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.

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 if you have any change in health that you think may be due to Levonorgestrel/Ethinylestradiol Durbán, 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 Durbán"

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 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), medications 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, painful bowel movements, 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).
• Herpes gestationis (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 this medicine, consult your doctor.

Reporting of adverse effects:

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist. 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. Storage of Levonorgestrel/Ethinylestradiol Durban

Keep this medicine out of the sight and reach of children.

Do not store above 30 ºC.

Do not use this medicine after the expiry date stated on the blister and carton after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofLevonorgestrel/Ethinylestradiol Durban

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

The other ingredients are: lactose monohydrate, cornstarch, povidone 30, talc, magnesium stearate, sucrose, povidone 90, macrogol 6000, calcium carbonate, talc, and montanglicol wax.

Appearance of the Product and Package Contents

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

The blisters are inside a cardboard box or inside a wallet that is inserted into the cardboard box.

Each package may contain:

1 x 21 tablets

3 x 21 tablets

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer:

Haupt Pharma Munster GmbH

Schleebrüggenkamp 15

D-48159 Münster

Germany

Date of the Last Revision of this Leaflet: 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/.