Package Insert: Information for the Patient

Levonorgestrel/Ethinylestradiol Daily Durban 0.1 mg/0.02 mg

Coated Tablets EFG

Important Information 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 Daily Durbanand for what it is used

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

3.How to takeLevonorgestrel/Ethinylestradiol Daily Durban

4.Possible adverse effects

5.Storage ofLevonorgestrel/Ethinylestradiol Daily Durban

6.Contents of the package and additional information

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

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

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 starting to take Levonorgestrel/Ethinylestradiol Daily, 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.

In this prospectus, some situations are described in which you should stop taking Levonorgestrel/Ethinylestradiol Daily or where the reliability of Levonorgestrel/Ethinylestradiol Daily 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 alters the monthly changes in body temperature and cervical mucus.

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

Do not take Levonorgestrel/Ethinylestradiol Daily:

• If you are allergic to the active ingredients (levonorgestrel or ethinylestradiol) or to any of the other components of this medication (including those 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 had at any time) 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 condition that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need surgery 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 had at any time) 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, 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 had at any time) 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 vaginal bleeding of unknown cause.
• 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 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 until the 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 with other medications).

Warnings and Precautions

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

Mental Health Disorders:

Some women who use hormonal contraceptives like Levonorgestrel/Ethinylestradiol Daily 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 Daily. In some situations, you should have special care while using Levonorgestrel/Ethinylestradiol Daily or any other combined contraceptive, and you may need to have regular check-ups with your doctor. If the condition develops or worsens while you are using Levonorgestrel/Ethinylestradiol Daily, 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 a higher risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at a higher risk of blood clots. Ask your doctor when you can start taking this medication after childbirth.
• If you have superficial vein inflammation under the skin (thrombophlebitis).
• If you have varicose veins.
• If you are diabetic.
• If you experience sudden and inexplicable changes in vision.
• If you have gallstones, bile duct disorders, or problems caused by bile duct blockage (cholestasis) – may cause intense itching.
• If you develop migraines for the first time or worsen an existing migraine.
• If you have or develop liver disease, jaundice, or pancreatitis or kidney disorder.
• If you have depression.
• If you have hearing loss due to a known condition called 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 disease 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, such as Levonorgestrel/Ethinylestradiol Daily, increases your risk of suffering a blood clot compared to not using it.

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 serious and lasting effects, or very rarely, they may be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to Levonorgestrel/Ethinylestradiol Daily is 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 thrombosis). 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 may 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 a combined hormonal contraceptive is taken for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same medication or a different medication) after a break 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, 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) with Levonorgestrel/Ethinylestradiol Daily is 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, noretisterone, or norgestimato, such as Levonorgestrel/Ethinylestradiol Daily, 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 small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI greater than 30 kg/m2).
• If one of your close relatives has had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of about 50). In this case, you may have an inherited blood clotting disorder.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to stop taking Levonorgestrel/Ethinylestradiol Daily for several weeks before the operation or while you have less mobility. If you need to stop taking Levonorgestrel/Ethinylestradiol Daily, ask your doctor when you can start taking it again.
• As you get older (especially over the age of about 35).
• If you have given birth recently.

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 taking Levonorgestrel/Ethinylestradiol Daily.

If any of the conditions listed above change while you are using Levonorgestrel/Ethinylestradiol Daily, 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, an artery clot can cause serious problems. For example, it may 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 to Levonorgestrel/Ethinylestradiol Daily is very small, but it may increase:

• with age(over the age of about 35).
• if you smokeWhen using a combined hormonal contraceptive like Levonorgestrel/Ethinylestradiol Daily, you are advised to quit smoking. If you are unable to quit smoking and are over 35, your doctor may advise you to use a different type of contraceptive.
• if you are overweight
• if you have high blood pressure
• if a close relative has had a heart attack or stroke at a young age (less than about 50). In this case, you may also be at a higher risk of a heart attack or stroke.
• if you 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 (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 using Levonorgestrel/Ethinylestradiol Daily, 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 Daily and Cancer

Breast cancer has been diagnosed at a slightly higher frequency in women who use the combined pill. However, it is unknown 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 taking combined pills for a relatively long period. Currently, it is unknown whether this is caused by the pill or is related to sexual behavior (e.g., more frequent partner changes) 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 experience severe and unusual abdominal pain.

BLEEDING BETWEEN PERIODS

During the first few months of taking Levonorgestrel/Ethinylestradiol Daily, you may experience unexpected bleeding (bleeding or spotting outside the week in which you take the inactive pills (placebo) of brown color). If this bleeding persists for more than a few months or starts after a few months, your doctor should investigate the cause.

What to do if there is no bleeding in the last week of taking pills (brown color)

If you have taken all the pills correctly, have not had severe vomiting or diarrhea, and 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, you may be pregnant. Consult your doctor immediately. Do not start a new pack until you are sure you are not pregnant.

Taking Levonorgestrel/Ethinylestradiol Daily with other medications

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

Medications can sometimes interact 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 Daily 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 Daily.

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

• HIV infections (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 carefully. If you need to continue taking the medication after finishing the pink pills in your current pack, do not take the white pills and start a new pack immediately.

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

Levonorgestrel/Ethinylestradiol Daily 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 (bile retention 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 take Levonorgestrel/Ethinylestradiol Daily if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increased liver enzyme levels (elevated ALT levels).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications. You can start taking Levonorgestrel/Ethinylestradiol Daily again approximately 2 weeks after completing this treatment. See the section “Do not take Levonorgestrel/Ethinylestradiol Daily”.

Pregnancy and Breastfeeding

If you are pregnant 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 milk production. If you wish to breastfeed, your doctor will advise you on suitable alternative contraceptive methods.

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

Driving and Operating Machines

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

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

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

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 pill 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 pills in the package

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

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

If your current package of pills contains inactive pills (placebo), do not take these pills, and start with Levonorgestrel/Ethinylestradiol Daily the next day.

If you are changing from a pill that only contains a progestogen, an injection, or an implant

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

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

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

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

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

Like any other oral contraceptive, Levonorgestrel/Ethinylestradiol Daily 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, you are 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 Daily, make sure you are not pregnant or wait until your next period.

In case of doubt, always consult your doctor.

If you forgot to takeLevonorgestrel/Ethinylestradiol Daily

If you take moreLevonorgestrel/Ethinylestradiol Dailythan you should

If you accidentally take more Levonorgestrel/Ethinylestradiol Daily 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 handles the excess hormones.

If you are concerned, consult your doctor.

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

“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 changes that you think may be related to Levonorgestrel/Ethinylestradiol Daily Tablet, 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 Daily Tablet”.

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 serious 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 symptoms similar to a stroke, 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 serious 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 Daily Tablet”):

• Increased blood pressure
• Hepatic tumors or breast cancer

If you have hereditary angioedema (sudden inflammation of the skin, mucous membranes (mouth, nose, intestines, 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)breast enlargement

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

• Increased libido
• Intolerance to contact lenses
• Boils under the skin that are painful and inflamed (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 that causes 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 byE.coli)
• Liver changes, such as jaundice, gallstones,
• Changes in glucose tolerance or peripheral insulin resistance
• Age-related hearing loss
• 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 takingLevonorgestrel/Ethinylestradiol Daily Tablet, consult your doctor.

Reporting of side effects:

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through 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.

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

Composition ofLevonorgestrel/Ethinylestradiol Daily Durban

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

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

The inactive brownish-colored tablets contain:monohydrate lactose; cornstarch; magnesium stearate; saccharose; calcium carbonate; talc; macrogol 6000; titanium dioxide (E171); povidone; 85% glycerol; yellow iron oxide (E171); red iron oxide (E171), montan wax.

Appearance of the product and contents of the packaging

Levonorgestrel/Ethinylestradiol Daily Durbanis packaged in aluminum/PVC blister packs containing 21 coated tablets,white, shiny, odorless, and smooth on the surface, and additionally, 7 coated tabletsof brownish color, with a smooth surface.

The blister packs are found inside a cardboard box or inside a carton that is placed in the cardboard box. Each package may contain:

1 x 28 tablets

3 x 28 tablets

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

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/.