Levonorgestrel/ethinylestradiol diario Durban 0,1 mg/0,02 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

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

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of developing a blood clot in the veins and arteries, especially during 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").

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you. Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor, pharmacist, or nurse. This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it may harm them. If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

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

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

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

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

General considerations

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

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

This leaflet describes some situations in which you should stop taking Levonorgestrel/Ethinylestradiol Daily Durban or where the effectiveness of Levonorgestrel/Ethinylestradiol Daily Durban may decrease, with a risk of pregnancy. In these situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions (for example, use condoms or another barrier method). Do not use the rhythm or temperature method. These methods may not be reliable because Levonorgestrel/Ethinylestradiol Daily Durban alters the monthly changes in body temperature and cervical mucus.

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

Do not take Levonorgestrel/Ethinylestradiol Daily Durban:

• If you are allergic to the active substances (levonorgestrel or ethinylestradiol) or to any of the other ingredients of this medicine (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 which 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 affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you require surgery or will be immobile for a long time (see section “Blood clots”).
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following conditions that may increase your risk of forming a blood clot in the arteries:
  • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have breast cancer or uterine cancer, or a type of cancer sensitive to female hormones, or if you suspect 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 blood vessel problems.
• If you are pregnant or suspect you might be pregnant.
• If you have or have had a benign or malignant liver tumour, or if you have recently had liver disease. In these cases, your doctor will ask you to stop taking Levonorgestrel/Ethinylestradiol Daily Durban until your liver has returned to normal.
• If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Taking Levonorgestrel/Ethinylestradiol Daily Durban with other medicines”).

Warnings and precautions

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

When should you consult your doctor? Seek urgent medical attention If you notice possible signs of a blood clot, which may indicate you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clot (thrombosis)” below). For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

Psychiatric disorders:

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

Inform your doctor if you have any of the following conditions.

Consult your doctor or pharmacist before starting Levonorgestrel/Ethinylestradiol Diario Durban. In certain situations, you should take special care while using Levonorgestrel/Ethinylestradiol Diario Durban or any other combined contraceptive, and your doctor may need to examine you periodically. If any of these conditions develop or worsen while you are using Levonorgestrel/Ethinylestradiol Diario Durban, you must 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 affecting your body's natural defense system).

• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure).

• If you have sickle cell anemia (an inherited red blood cell disorder).

• 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 require surgery or will be immobile for prolonged periods (see section 2 “Blood clots”).

• If you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you may start taking this medicine after childbirth.

• If you have inflammation of veins beneath the skin (superficial thrombophlebitis).

• If you have varicose veins.

• If you are diabetic.

• If you experience a sudden, unexplained change in vision.

• If you have gallstones, gallbladder disorders, or problems caused by blockage of the bile ducts (cholestasis) – this may cause intense itching.

• If you develop migraine for the first time or experience worsening of an existing migraine.

• If you have or develop liver disease, jaundice, pancreatitis, or kidney disorder.

• If you have depression.

• If you have hearing loss due to a condition known as otosclerosis.

• If you previously experienced a skin condition during pregnancy or while taking another contraceptive pill that caused itching, red rash, or blisters (herpes gestationis).

• If you had temporary brown patches on the skin during pregnancy (melasma). The pill may cause this to recur, so you should avoid sun exposure or sunbathing while taking this medicine.

• If you have or develop a condition known as Sydenham's chorea. Symptoms include irregular, sudden, involuntary movements.

• If you have ever had a blood disorder called porphyria.

• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with possible breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Levonorgestrel/Ethinylestradiol Diario Durban increases your risk of developing a blood clot compared to not using one.

Blood clots may form:

• In veins (known as “venous thrombosis”, “venous thromboembolism” or VTE).
• In arteries (known as “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects, and very rarely, they may be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

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

Are you experiencing any of these signs?	What could you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Skin discoloration of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough with no clear cause, possibly bringing up blood. Sharp chest pain that may worsen when taking a deep breath. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to vision loss. Double vision.	Retinal vein thrombosis (blood clot in the eye).
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below the sternum. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without a known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels.

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 adverse effects are rare. They occur most frequently during the first year of using 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 travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may 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 developing a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases but remains somewhat higher than if you were not taking a combined hormonal contraceptive.

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

What is the risk of developing a blood clot?

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

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

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

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women using a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5–7 out of 10,000 women
Women using Levonorgestrel/Ethinylestradiol Daily Durban	About 5–7 out of 10,000 women

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

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

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or will be immobile for a long time due to injury or illness, or if your leg is in a cast. You may need to stop using Levonorgestrel/Ethinylestradiol Daily Durban several weeks before surgery or while you are less mobile. If you need to stop using Levonorgestrel/Ethinylestradiol Daily Durban, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years).
• If you have given birth within the last few weeks.

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

Air travel (over 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other listed risk factors.

It is important to inform your doctor if you have any of the above conditions, even if you are uncertain. Your doctor may decide that you should stop using Levonorgestrel/Ethinylestradiol Daily Durban.

If any of the above conditions change while you are using Levonorgestrel/Ethinylestradiol Daily Durban—for example, a close relative experiences a thrombosis without a known cause, or you gain significant 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 may cause a heart attack or 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 while using Levonorgestrel/Ethinylestradiol Daily Durban is very small, but it may increase:

• With age (especially over about 35 years).
• If you smoke You are advised to stop smoking when using a combined hormonal contraceptive such as Levonorgestrel/Ethinylestradiol. 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 (under about 50 years). In this case, you may also have a higher risk of heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, heart rhythm disturbances known as atrial fibrillation).
• If you have diabetes.

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

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

Levonorgestrel/Ethinylestradiol Daily Durban and cancer

Breast cancer has been diagnosed slightly more frequently in women using the combined pill, but it is unknown whether the pill causes cancer. It is possible that these women were simply examined more thoroughly and more frequently, making it more likely that breast cancer would be detected earlier.

The increased risk gradually disappears after 10 years of stopping combined hormonal contraceptives. It is important to regularly check your breasts and you should contact your doctor if you notice any lump.

Studies have reported cases of cervical cancer in women who have taken combined pills for a relatively long period. It is currently unknown whether this is caused by the pill or related to sexual behavior (e.g., more frequent partner changes) and other factors such as human papillomavirus (HPV).

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

Bleeding between periods

During the first few months of taking Levonorgestrel/Ethinylestradiol Daily Durban, you may experience unexpected bleeding (bleeding or spotting outside the week when you are taking the inactive (placebo) light brown tablets). If this bleeding lasts for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if there is no bleeding during the last week of taking tablets (light brown color)

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

If your period does not occur for a second consecutive time, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Taking Levonorgestrel/Ethinylestradiol Daily Durban with other medicines

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

Some medicines may interact with Levonorgestrel/Ethinylestradiol Daily Durban.

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

They may advise you whether additional precautions are needed (e.g., using condoms or other barrier contraceptives) while taking other medicines with Levonorgestrel/Ethinylestradiol Daily Durban.

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

• HIV infections (ritonavir, nevirapine)
• 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 (modafinil)
• Gout (phenylbutazone)
• St. John's wort (Hypericum perforatum) used to treat certain types of depression.

If you are advised to take additional contraceptive precautions while taking any of the medicines listed above, follow your doctor's instructions carefully. If you need to continue taking the medicine after finishing the pink tablets in your current pack, do not take the white tablets 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 medicine.

Levonorgestrel/Ethinylestradiol Daily Durban may interfere with the following medicines:

• Cyclosporine (used to reduce immune response)
• Lamotrigine (used to treat epilepsy)

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

Taking a medicine 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 Durban if you have Hepatitis C and are taking medicines containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function test results (elevation of liver enzyme ALT).

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

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

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

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

Driving and using machines

The effect of Levonorgestrel/Ethinylestradiol Daily Durban on the ability to drive or use machines has not been studied. Dizziness has been reported as an adverse effect. If you experience dizziness, do not drive or use machines until symptoms resolve.

Levonorgestrel/Ethinylestradiol Daily Durban contains lactose and sucrose

This medicine contains lactose and sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Levonorgestrel/Ethinylestradiol Daily Durban

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

During the week you are taking the light brown tablets, you will have a withdrawal bleed similar to a period. This bleeding usually starts after two or three days and may not have finished before you start the next pack of tablets.

If you are starting the pill for the first time or have not used any hormonal contraceptive in the previous month

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

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

If switching from a combined oral contraceptive pill

If you are taking 21-tablet packs

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

If you are taking "daily" pills containing 28 tablets per pack

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

If switching from a progestogen-only pill, injection, or implant

• If switching from a progestogen-only pill, you may start Levonorgestrel/Ethinylestradiol Daily Durban at any time during the menstrual cycle, starting the day after stopping the progestogen-only pill.
• If switching from an implant, start using Levonorgestrel/Ethinylestradiol Daily Durban on the same day the implant is removed.
• If switching from a contraceptive injection, start Levonorgestrel/Ethinylestradiol Daily Durban on the day the next injection would have been due.

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

If starting Levonorgestrel/Ethinylestradiol Daily Durban after a first-trimester abortion (within the first 3 months of pregnancy)

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

If starting Levonorgestrel/Ethinylestradiol Daily Durban after childbirth or after a second-trimester abortion

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

If in doubt, always consult your doctor.

If you forget to take Levonorgestrel/Ethinylestradiol Daily Durban

If you forget to take a white tablet, there is a risk you could become pregnant

If you realize you have forgotten to take a white tablet within 12 hours of your usual time, take the missed tablet immediately and continue taking your tablets at the usual times until the end of the pack. If you realize you have forgotten to take a white tablet more than 12 hours after your usual time, there is a risk you could become pregnant. In this case: take the missed tablet as soon as you remember, even if this means taking two tablets on the same day continue taking your tablets as normal until the end of the pack in addition, use a barrier contraceptive method (e.g., condoms) for the next 7 days if this 7-day period extends beyond the last white tablet in the pack, start the next pack immediately without taking any of the light brown inactive tablets. You may experience spotting or bleeding while taking the second pack, but this is not a cause for concern. If you have missed one or more white tablets in a pack and do not have any bleeding during the week you are taking the light brown tablets, you may be pregnant and should consult your doctor. If you forget to take a light brown tablet, no additional action is needed other than starting the next pack on the usual day. If you vomit or have diarrhea If you vomit or have severe diarrhea within 4 hours of taking a tablet, it is as if you had missed a white tablet. After vomiting or having diarrhea, you should take another white tablet from a reserve pack as soon as possible. Ideally, take it within the next 12 hours or at your usual tablet-taking time. If this is not possible or more than 12 hours have passed, you should follow the advice given under “If you realize you have forgotten to take a white tablet more than 12 hours after your usual time”. If episodes of vomiting or severe diarrhea recur over several days, a barrier contraceptive method (e.g., condoms) should be used until the start of the next pack. Consult your doctor if you are unsure. If you vomit or have diarrhea while taking the light brown tablets, no action is needed provided the vomiting and diarrhea have stopped by the time you start the next pack, allowing you to begin it on the usual day. How to delay your period You can delay your period by immediately starting a new pack of Levonorgestrel/Ethinylestradiol Daily Durban without taking any of the light brown tablets. You may experience some spotting or bleeding while taking the second pack, but this is not a cause for concern. You should have a normal withdrawal bleed after finishing the white tablets in the second pack.

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

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

If you are concerned, consult your doctor.

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

4. Possible adverse effects

“Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives 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 contact 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, hives, 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.

• Mini-stroke or temporary stroke-like symptoms, known as transient ischemic attack (TIA).

• Blood clots in the liver, stomach/intestines, kidneys, or eye.

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

The following serious adverse effects have been reported slightly more frequently in women using contraceptive pills, but it is not known whether this is caused by the treatment (see section 2: “What you need to know before starting Levonorgestrel/Ethinylestradiol Daily Durban”):

• Increased blood pressure
• Liver tumours or breast cancer

If you have hereditary angioedema (sudden swelling of the skin, mucous membranes (mouth, nose, intestines, genitals), internal organs, or brain), medicines containing oestrogens may trigger or worsen symptoms of angioedema (see section 2: “Warnings and precautions”).

Other adverse effects include:

Common (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 sex drive
• Migraine
• Vomiting, diarrhoea
• Skin rash
• Hives (urticaria), breast enlargement

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

• Increased sex drive
• Intolerance to contact lenses
• Painful, red lumps under the skin (nodular erythema) or skin lesions, especially on the palms or soles of the feet, which may blister. You may also develop mouth, eye, or genital ulcers, and may have a fever (erythema multiforme).
• Breast discharge, 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 diarrhoea, pain during bowel movements, stomach pain).
• Porphyria (a metabolic disorder causing abdominal pain and mental disturbances).
• Systemic lupus erythematosus (a condition in which the body attacks and damages its own organs and tissues).
• Gestational herpes (a blistering skin rash occurring during pregnancy).
• Sydenham's chorea (uncontrolled or spasmodic body movements).
• Haemolytic uraemic syndrome (a condition occurring after diarrhoea caused by E. coli).
• Liver disorders, such as jaundice, gallstones.
• Changes in glucose tolerance or peripheral insulin resistance.
• Hearing loss related to otosclerosis.
• Chloasma (dark patches on the skin, also known as pregnancy mask, especially on the face).
• Increased risk of pancreatitis in women with hypertriglyceridemia.

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

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levonorgestrel/Ethinylestradiol Diario Durban

Keep this medicine out of sight and reach of children.

Do not store above 30 °C.

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

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Levonorgestrel/Ethinylestradiol Diario Durban

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

The other components are: monohydrate lactose; corn starch; povidone; talc; magnesium stearate; sucrose; povidone; macrogol 6000; calcium carbonate; talc; montanglycol wax.

The inactive brownish-light coloured tablets contain: monohydrate lactose; corn starch; magnesium stearate; sucrose; calcium carbonate; talc; macrogol 6000; titanium dioxide (E171); povidone; glycerol 85%; yellow iron oxide (E171); red iron oxide (E171); montanglycol wax.

Appearance of the product and contents of the pack

Levonorgestrel/Ethinylestradiol Diario Durban is packaged in aluminum/PVC blister packs containing 21 coated tablets, white, shiny, odourless and with a smooth surface, plus 7 coated tablets, light brown in colour, with a smooth surface.

The blisters are contained within a cardboard box or within a wallet inserted into the cardboard box. Each package may contain:

1 x 28 tablets

3 x 28 tablets

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Laboratorios Francisco Durbán S.A. Polígono Ind. La Redonda, c/ IX, nº 2 04710 El Ejido (Almería) Manufacturer Responsible: Haupt Pharma Münster GmbH Schleebrüggenkamp 15, 48159, Münster, Germany

Date of the last review of this leaflet: March 2020

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