Levonorgestrel/ethinylestradiol Durban 0.1 mg/0.02 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Levonorgestrel/Ethinylestradiol 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 veins and arteries, especially during the first year of use 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 be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Read the entire leaflet carefully before you start taking 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.

Package leaflet

1. What Levonorgestrel/Ethinylestradiol Durban is and what it is used for
2. What you need to know before taking Levonorgestrel/Ethinylestradiol Durban
3. How to take Levonorgestrel/Ethinylestradiol Durban
4. Possible side effects
5. How to store Levonorgestrel/Ethinylestradiol Durban
6. Contents of the pack and other information

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

Levonorgestrel/Ethinylestradiol Durban is a combined oral contraceptive tablet 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 Levonorgestrel/Ethinylestradiol Durban

General considerations

Before starting 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 Durban, your doctor will ask you some questions about your medical history and personal circumstances. Your doctor will also measure your blood pressure and may carry out other tests.

This leaflet describes certain situations in which you should stop taking Levonorgestrel/Ethinylestradiol Durban or when its effectiveness may be reduced, increasing the risk of pregnancy. In these situations, you should either abstain from sexual intercourse or use additional non-hormonal contraceptive precautions (for example, use condoms or another barrier method). Do not use rhythm or temperature methods. These methods may not be reliable, as 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 infections.

Do not take Levonorgestrel/Ethinylestradiol Durban:

• If you are allergic to 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 alternative contraceptive method may be more suitable:

• If you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the 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 prolonged period (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 transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of developing a clot in an artery:

  • 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 sex hormones, or if you suspect you may have such 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 might be pregnant.

• If you have or have had a benign or malignant liver tumour, or if you have recently had liver disease. In such cases, your doctor will ask you to stop taking Levonorgestrel/Ethinylestradiol Durban until your liver function has returned to normal.

• If you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Taking Levonorgestrel/Ethinylestradiol Durban with other medicines”).

Warnings and precautions

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

When should you consult your doctor? Seek urgent medical attention if you notice possible signs of a blood clot which may mean 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 side effects, see “How to recognize a blood clot”.

Psychiatric disorders:

Some women who use hormonal contraceptives such as Levonorgestrel/Ethinylestradiol 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 symptoms of depression, contact your doctor for further medical advice as soon as possible.

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

Consult your doctor or pharmacist before starting to take Levonorgestrel/Ethinylestradiol Durban. In certain situations, you should take special care while using Levonorgestrel/Ethinylestradiol Durban or any other combined contraceptive, and your doctor may need to examine you periodically. If any condition develops or worsens while you are using Levonorgestrel/Ethinylestradiol 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 haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure).

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

• If you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).

• If you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots").

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

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

• If you have varicose veins.

• You are diabetic.

• You experience a sudden and unexplained change in vision.

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

• You develop migraine for the first time, or experience worsening of an existing migraine.

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

• You have depression.

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

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

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

• You have or develop Sydenham's chorea. Symptoms include irregular, sudden, involuntary movements.

• 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 Durban increases your risk of developing blood clots compared to not using it. Rarely, a blood clot may block blood vessels and cause serious problems.

Blood clots may form:

• In the veins (called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (called "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 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 might 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. Change in skin color of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. 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 such as 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 beneath 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 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 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 (PE).
• Very rarely, a blood clot may form in a vein of another organ such as the eye (retinal vein thrombosis).

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

The risk of developing a blood clot in a vein is higher during the first year of first-time use of a combined hormonal contraceptive. 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 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 Durban is low.

• Among 10,000 women who do not take a combined hormonal contraceptive and who 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 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 not using 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 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 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 Durban several weeks before surgery or while you are less mobile. If you need to stop using Levonorgestrel/Ethinylestradiol 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 risk factors listed.

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

If any of the above conditions change while you are using Levonorgestrel/Ethinylestradiol Durban—for example, a close relative experiences 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 can 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 from using Levonorgestrel/Ethinylestradiol Durban is very small, but it may increase:

• With age (over about 35 years).
• If you smoke When using a combined hormonal contraceptive such as 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 a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative has 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 called 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 Durban—for example, you start smoking, a close relative experiences thrombosis without a known cause, or you gain significant weight—inform your doctor.

Levonorgestrel/Ethinylestradiol Durban and cancer

Breast cancer has been diagnosed slightly more frequently in women using the combined pill, but it is unknown whether the cancer is caused by the pill. 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 contact your doctor if you notice any lump.

Studies have reported cases of cervical cancer in women who take combined pills for a relatively long time. It is currently unknown whether this may be caused by the pill or is 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 Durban, you may experience unexpected bleeding (bleeding or spotting outside the pill-free week). If this bleeding lasts longer 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 pill-free week

Some women do not have bleeding during the rest week.

If you have taken all the tablets correctly (following the instructions provided), 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, or if you have not taken the tablets as instructed, you should consult your doctor immediately before the first missed period or if a second period is missed, as you may be pregnant. Do not start the next pack until you are sure you are not pregnant.

Taking Levonorgestrel/Ethinylestradiol 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 Durban.

Medicines can sometimes interfere with each other. If you are being treated by another doctor, nurse, or qualified healthcare professional, make sure they are aware that you are taking Levonorgestrel/Ethinylestradiol 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 Durban.

Some medicines may make Levonorgestrel/Ethinylestradiol 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 have been advised to take additional contraceptive precautions while taking any of the medicines listed above, follow your doctor’s instructions carefully, as you may need a non-hormonal backup method of birth control. If you need to continue taking the medicine after finishing your current pack, do not take the pill-free week 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 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 Durban if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir/dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications can cause increases in liver function tests (elevated liver enzyme ALT).

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

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

Driving and using machines

The effect of Levonorgestrel/Ethinylestradiol 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 Durban contains lactose and sucrose

This medicine contains lactose and sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Levonorgestrel/Ethinylestradiol Durban

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

Each Levonorgestrel/Ethinylestradiol Durban blister pack contains 21 tablets. Take the first tablet from the blister on the day corresponding to the correct day of the week. You must take one tablet every day, with water if necessary, at the same time each day, until the pack is finished.

Afterwards, you will have a tablet-free week before starting the next pack. You must always start the next pack on the same day of the week.

During the tablet-free week, you will experience a withdrawal bleed similar to a period. This bleeding usually starts two or three days after stopping the tablets and may not have finished before you start the next pack.

If this is the first time you are starting the pill or you 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) during the first 7 days.

If switching from a combined oral contraceptive pill

If you are currently taking 21-tablet packs

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

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

If your current pack contains inactive (placebo) tablets, do not take these tablets and start Levonorgestrel/Ethinylestradiol Durban immediately the next day, without a break.

If switching from a progestogen-only pill, injection, implant, or intrauterine system containing progestogen:

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

• If switching from an implant or a progestogen-releasing intrauterine system, start using Levonorgestrel/Ethinylestradiol Durban on the same day the implant or device is removed.

• If switching from a contraceptive injection, start Levonorgestrel/Ethinylestradiol Durban on the day your next injection would have been due.

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

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

You may 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 starting Levonorgestrel/Ethinylestradiol Durban after childbirth or after a second-trimester abortion

Like any other oral contraceptive, Levonorgestrel/Ethinylestradiol 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 during the first 7 days of taking the pill. If you have had sexual intercourse before starting Levonorgestrel/Ethinylestradiol Durban, make sure you are not pregnant or wait until your next period.

If in doubt, always consult your doctor.

Use in children and adolescents

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

Use in older women

Levonorgestrel/Ethinylestradiol Durban is contraindicated after menopause.

If you take more Levonorgestrel/Ethinylestradiol Durban than you should

Taking more than one tablet is unlikely to cause harm, but you may feel dizzy or vomit. Young women may experience vaginal bleeding. Consult your doctor if you experience these symptoms.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Levonorgestrel/Ethinylestradiol Durban

If you forget to take a tablet, there is a risk that you may become pregnant

• If less than 12 hours have passed since you missed the tablet, protection against pregnancy is not affected. You can still take the tablet as soon as you remember, and then continue taking the following tablets at your usual time.

• If more than 12 hours have passed since you missed the tablet, protection against pregnancy may be reduced. The more tablets you miss, the greater the risk that protection against pregnancy will decrease.

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

• You should never stop taking tablets for more than 7 days.

• The effectiveness of Levonorgestrel/Ethinylestradiol Durban depends on continuous intake of the tablets without interruption for 7 days.

• More than 1 tablet missed in this blister pack

Consult your doctor.

• One tablet missed in week 1

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time and use additional contraceptive precautions for the next 7 days (e.g., a condom). If you had sexual intercourse during the week before the missed tablet, or if you forgot to start a new blister pack after the tablet-free interval, be aware that there is a risk of pregnancy. In such a case, consult your doctor.

• One tablet missed in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. If you have taken all the tablets correctly in the 7 days prior to the missed tablet, no additional contraceptive measures are necessary. However, if you did not take the tablets correctly or if you missed more than one tablet, you must use additional contraceptive precautions for the next 7 days.

• One tablet missed in week 3

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time.

Then continue taking the tablets at your usual time. Instead of the tablet-free interval, start the next blister pack immediately.

You are likely to have a menstrual period (withdrawal bleeding) after finishing the second blister pack, but you may also experience spotting or breakthrough bleeding during the second pack.

2. You may also stop taking the current blister pack and go directly to the 7-day tablet-free interval (note the day you missed the tablet), including the days when you missed tablets, and then continue with the next pack. If you wish to start a new blister pack on a specific day, shorten the tablet-free interval to less than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

If you missed any tablets in a pack and do not have bleeding during the first tablet-free interval, this could indicate that you are pregnant. You must contact your doctor before starting the next blister pack.

If you experience vomiting or diarrhea

If you vomit or have severe diarrhea within 3–4 hours after taking a tablet, it is as if you had missed taking the tablet. After vomiting or having diarrhea, you should take another tablet from your reserve pack as soon as possible. If possible, take it within the next 12 hours or at your usual tablet-taking time. If this is not possible or if more than 12 hours have passed, you should follow the recommendations given under "If you realize you have missed a tablet more than 12 hours after your usual dosing time".

If episodes of vomiting or severe diarrhea continue 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 have any doubts.

How to delay your period or change the start day of your period

You can delay your period by immediately starting another pack of Levonorgestrel/Ethinylestradiol Durban without a break. 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 second pack.

Regular use of Levonorgestrel/Ethinylestradiol Durban will then resume after the usual 7-day tablet-free interval. 4 of 18

If you wish to change the start day of your period to another day of the week, you can shorten the next tablet-free interval by as many days as desired. The shorter the interval, the greater the risk that withdrawal bleeding will not occur and that intermenstrual bleeding or spotting may occur during the second pack (as also happens when delaying a period).

If you take more Levonorgestrel/Ethinylestradiol Durban than you should

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

If you are concerned, consult your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 everyone will experience them.

If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think may be due to Levonorgestrel/Ethinylestradiol Durbán, 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 to take 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 hives with possible difficulty breathing (see also section “Warnings and precautions”).

If you experience any of the following serious adverse effects, you may require 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 ischaemic 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 to take Levonorgestrel/Ethinylestradiol Durbán”):

• 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 angioedema symptoms (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 libido
• Migraine
• Vomiting, diarrhoea
• Skin rash
• Hives (urticaria), breast enlargement

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

• Increased libido
• Intolerance to contact lenses
• Painful red lumps under the skin (erythema nodosum) 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).
• Herpes gestationis (a blistering skin rash that appears during pregnancy).
• Sydenham’s chorea (uncontrolled or spasmodic body movements).
• Haemolytic uraemic syndrome (a condition occurring after E. coli-induced diarrhoea).
• Liver disorders, such as jaundice, gallstones.
• Changes in glucose tolerance or peripheral insulin resistance.
• Hearing loss related to otosclerosis.
• Chloasma (dark skin patches, also known as pregnancy mask, especially on the face).
• Increased risk of pancreatitis in women with hypertriglyceridaemia.

If you are concerned about new symptoms or other health-related issues while taking this medicine, consult your doctor.

Reporting of adverse effects:

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist. 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 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 or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levonorgestrel/Ethinylestradiol Durban

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

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

Appearance of the product and contents of the pack

Levonorgestrel/Ethinylestradiol Durban is supplied in aluminum/PVC blister packs containing 21 white, shiny, odourless coated tablets with a smooth surface.

The blisters are contained within a cardboard box or within a wallet which is placed inside the cardboard box.

Each pack may contain:

1 x 21 tablets

3 x 21 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:

Haupt Pharma Munster GmbH
Schleebrüggenkamp 15
D-48159 Münster
Germany

Date of the most recent 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/.