0.15 mg / 0.03 mg film-coated tablets 
levonorgestrel / ethinyl estradiol

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can hurt them.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Erlibelle is and what it is used for 
2. What you need to know before using Erlibelle 
3. How to use Erlibelle 
4. Possible side effects 
5. How to store Erlibelle 
6. Contents of the packaging and other information 

1. What Erlibelle is and what it is used for

  • Erlibelle is a contraceptive ( birth control pill ) and it is used to prevent pregnancy.
  • Each tablet contains a small amount of two different female hormones, namely levonorgestrel and Ethinylestradiol.
  • Birth control pills that contain two hormones are called combination pills.

Levonorgestrel and Ethinylestradiol contained in Erlibelle may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Erlibelle

General remarks

Before you can start using Erlibelle, your doctor will ask you some questions about your personal medical history and the medical history of your close relatives. The doctor will also measure your blood pressure and depending on your personal situation, the doctor may perform other tests.
This leaflet describes several situations in which you must stop using Erlibelle or where the reliability of Erlibelle may be impaired. In such situations, you should either refrain from intercourse or use additional non-hormonal contraceptives, e.g. use a condom or other barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because Erlibelle affects the monthly changes in body temperature and cervical secretions.
Erlibelle, like other hormonal contraceptives, does not protect you against HIV – infection ( AIDS ) or other sexually transmitted diseases.

Do not take Erlibelle:

  • if you have (or have ever had) a blood clot in a blood vessel in your bones ( thrombosis ), lung ( pulmonary embolism ), or other organs
  • if you have (or have ever had) a heart attack or stroke
  • if you have (or have ever had) a disease that may be a sign of a heart attack (eg angina pectoris, which causes severe chest pain) or a stroke (eg a small stroke from which you have recovered)
  • if you have a disease that may increase the risk of a blood clot in the artery. This applies to the following diseases:
    • diabetes with vascular damage
    • very high blood pressure
    • very high blood fat levels ( cholesterol or triglycerides )
  • if you have blood clotting disorders (eg protein C deficiency)
  • if you have (or ever had) liver disease and your liver function is still not normal
  • if you have (or ever had) a liver tumor
  • if you have (or ever had) or are suspected of having breast or genital cancer
  • if you have vaginal bleeding for unknown reasons
  • if you have (or have ever had) a certain type of migraine (with so-called focal neurological symptoms)
  • if you are allergic to Ethinyl estradiol, levonorgestrel, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can cause itching, rash, and swelling
  • Do not use Erlibelle if you have hepatitis C and are taking medicines containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glekaprevir / pibrentasvir and sofosbuvir / velpatasvir / voxilaprevir (see also section “Other medicines and Erlibelle”).

Warnings and cautions

In some situations, you need to be especially careful when using Erlibelle or any other combination pill and it may be necessary to check with your doctor regularly. If any of the following conditions apply to you, tell your doctor before taking Erlibelle.

Even if any of the following conditions develop or worsen when you use Erlibelle, you must consult a doctor:

  • if a close relative has or has ever had breast cancer
  • if you have liver disease or biliary tract disease
  • if you have diabetes
  • if you have depression
  • if you have Crohn’s disease or inflammatory bowel disease ( ulcerative colitis )
  • if you have a blood disorder called HYY (hemolytic-uremic syndrome) that causes kidney damage
  • if you have a blood disorder called sickle cell anemia
  • if you have epilepsy (see section “Other medicines and Erlibelle”)
  • if you have a central nervous system disease called SLE (systematic lupus erythematosus)
  • if you have a condition that first appeared during pregnancy or with previous use of sex hormones (eg hearing loss), a blood disease called porphyria, skin rash with blisters during pregnancy ( herpes gestationis), a nerve disease that causes sudden body movements (Sydenhams Korea)
  • if you have or have ever had chloasma (discoloration of the skin especially on the face or neck called “pregnancy spots”). If so, you should avoid exposing yourself to direct sunlight or ultraviolet radiation.
  • Contact a doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives, possibly with difficulty breathing. Products containing estrogen can cause or worsen the symptoms of hereditary or acquired angioedema.

Talk to your doctor or pharmacist before taking Erlibelle.

Erlibelle and venous and arterial blood clots

The use of any combination pill, including Erlibelle, increases the risk of women developing venous thrombosis (venous thrombosis ) compared to women who do not use the pill. The increased risk is greatest during the first year a woman begins using the contraceptive pill or when she resumes use after a break of at least one month.

The risk of venous thrombosis increases in users of the contraceptive pill:

  • with increasing age
  • if you are overweight
  • if one of your close relatives has ever had a blood clot at a young age in bone, lung ( pulmonary embolism ), or other organs
  • if you have to undergo surgery, if you have been in a serious accident or if you have been immobile for a long time. You must tell your doctor that you are using Erlibelle because you may need to stop taking it. Your doctor will tell you when you can start taking it again. This is usually about two weeks after you get back on your feet.

The risk of you getting a blood clot increases when you use birth control pills 

  • Of 100,000 women who do not use birth control pills and are not pregnant, about 5-10 can get a blood clot in a year.
  • Of 100,000 women who use birth control pills such as Erlibelle, 30-40 can get a blood clot in a year. The exact number is unknown.
  • Of 100,000 women who are pregnant, about 60 can get a blood clot in a year.

A blood clot in the veins can be transported to the lungs and can block blood vessels there (called pulmonary embolism ). Blood clot formation in the veins can be fatal in 1-2% of cases.

The risk level can vary with the type of birth control pill you use. Discuss with your doctor about available options.

The use of the contraceptive pill has been associated with an increased risk of an arterial blood clot ( arterial thrombosis ) e.g. in the blood vessels of the heart (heart attack) or the blood vessels of the brain ( stroke ).

The risk of arterial blood clots increases in users of birth control pills:

  • if you smoke. You are strongly advised to stop smoking when using Erlibelle, especially if you are over 35 years old.
  • if the fat content of your blood increases ( cholesterol or triglycerides )
  • if you are overweight
  • if any of your close relatives have ever had a heart attack or stroke at a young age
  • if you have high blood pressure
  • if you suffer from migraines
  • if you have heart problems (heart valve disease, heart rhythm disorders)
Stop taking Erlibelle and contact your doctor immediately if you notice any signs of a blood clot, such as severe pain and/or swelling of one leg sudden severe pain in the chest that may radiate to the left arm sudden shortness of breath sudden cough for no apparent reason unusual, severe or prolonged headache or worsening of migrainepartial or complete vision loss or double vision speech difficulties or speech loss dizziness or faintingweakness, strange feeling or numbness in any part of the body. severe pain in the abdomen ( acute abdomen)

Erlibelle and cancer

Breast cancer has been observed slightly more often in women using birth control pills, but it is not known if this is due to the treatment. For example, it may be that women who use birth control pills visit doctors more often and thus more tumors are detected.

The incidence of breast tumors gradually decreases after stopping treatment with the contraceptive pill. It is important to see a doctor regularly if you feel a lump.

Cervical cancer has been reported in long-term users, but it is not certain whether it is sexual behavior or human papillomavirus (HPV) that is contributing.

In rare cases, benign liver tumors and in even fewer cases, malignant liver tumors have been reported in users of birth control pills. Contact a doctor if you experience unusually severe abdominal pain.

Bleeding between periods (loss of bleeding)

During the first months of using Erlibelle, you may experience unexpected bleeding (bleeding between the weeks of the break). If these bleedings occur for more than a few months or if they occur after a few months, talk to your doctor who will find out what is wrong.

What should you do if the bleeding does not occur during the break week?

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

If the expected bleeding (loss of bleeding) does not occur twice in a row, you may be pregnant. Contact a doctor immediately. Do not start on the following tablet chart until you are sure you are not pregnant.

Other medicines and Erlibelle

Always tell your doctor who prescribes Erlibelle if you are taking, have recently taken, or might take any other medicines, including herbal medicines. Also, tell other doctors or dentists who prescribe other medicines (or pharmacists) that you are using Erlibelle. They can tell you if you need to use additional contraceptives (eg condoms) and if this is the case for how long.

Some medicines may reduce the effect of Erlibelle on preventing pregnancy or causing unexpected bleeding. These include

  • medicines used to treat:
    • epilepsy (eg primidone, phenytoin , barbiturates , carbamazepines, oxcarbazepine, topimarate, felbamate)
    • tuberculosis (eg rifampicin)
    • HIV infection (ritonavir, nevirapine) or other infection (griseofulvin)
    • high blood pressure in the pulmonary blood vessels ( bosentan )
  • herbal medicine that contains St. John’s wort.

Erlibelle can affect the effectiveness of other medicines, for example:

  • medicines containing ciclosporin
  • the epilepsy drug lamotrigine (this may lead to an increased number of epileptic seizures).

Do not use Erlibelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glekaprevir / pibrentasvir, and sofosbuvir / velpatasvir / voxilaprevir, as treatment with these products may lead to increased liver function levels in the blood (an increase in ALAT ).

Your doctor will prescribe another type of contraceptive before you start treatment with these drugs.

Erlibelle can be used about 2 weeks after the end of this treatment. See section “Do not use Erlibelle”.

Erlibelle with food and drink

Erlibelle can be taken with or without food, if necessary with a small amount of water.

Laboratory tests

If a blood sample needs to be taken, tell your doctor or laboratory staff that you are taking birth control pills, as hormonal contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are pregnant do not take Erlibelle. If you become pregnant while using Erlibelle, stop using the contraceptive pill immediately and consult a doctor. If you want to get pregnant, you can stop using the contraceptive pill at any time (see also “If you want to stop using Erlibelle”).

Breast-feeding

The use of Erlibelle is generally not recommended for breastfeeding women. If you want to take birth control pills while breastfeeding, consult a doctor.

Driving and using machines

There is no information to suggest that the use of Erlibelle affects the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Erlibelle contains lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Erlibelle.

3. How to use Erlibelle

Use for children and adolescents

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Remember to take Erlibelle according to the instructions as forgotten tablets can reduce the effect of the medicine.

How and when to take Erlibelle

Each tablet map contains 21 tablets.

Take one tablet of Erlibelle daily, if necessary with a small amount of water. You should take the tablets at about the same time each day.

The day of the week when the tablet is to be taken is printed next to each tablet. Start by taking a tablet from the first row marked with the correct day of the week. If you e.g. start on a Wednesday take a tablet with the marking “Wed” next to it. Follow the direction of the arrows on the tablet map until you have taken all 21 tablets. Then do not take tablets for 7 days. During these 7 tablet-free days (also called the break week), you should experience bleeding. This so-called “dropout bleeding” usually begins on the 2nd or 3rd day of the break week.

On the 8th day after the last tablet of Erlibelle (that is, after the 7-day break week), you should start on the next tablet chart regardless of whether the bleeding has stopped or not. This means that you should start each tablet chart on the same day of the week and that the dropout bleeding occurs on the same days each month.

If you use Erlibelle in this way, you will also be protected against pregnancy during the 7 days when you are not taking tablets.

When to start taking Erlibelle

  • You have not used any hormonal contraceptives in the last month started taking Erlibelle on the first day of your menstrual cycle (ie on the first day of your period). If you start using Erlibelle on the first day of your period, you are immediately protected against pregnancy. You can also start on days 2-5 of the menstrual cycle, but then you must use an additional method of contraception (eg condoms) for the first 7 days.
  • If you are switching from a combination pill, vaginal ring, or patch you can start taking Erlibelle preferably on the following day after the last active tablet (the last tablet containing the active substances) of the previous pill but no later than the day after the tablet-free days of the previous pill. When changing from a vaginal ring or patch, follow your doctor’s instructions.
  • If you are switching from a progestagen-only contraceptive (mini-pills, injection, implants, or progestagen-releasing intrauterine insert)You can change any day from the mini-pill (from an implant or progestagen-releasing intrauterine insert on the day it is removed, from injection when the next injection should be given) but in any case, an additional method of contraception (eg condom) used during the first 7 days you take tablets.
  • After miscarriage follows your doctor’s advice.
  • After childbirth, you can start taking Erlibelle between 21 and 28 days after delivery. If you start later than day 28, use a barrier method (eg condom) for the first 7 days. If you have had intercourse after giving birth and before taking Erlibelle (again), be sure that you are not pregnant or waiting for your next period before using this medicine.
  • When breastfeeding you are breast-feeding and want to start using Erlibelle (again) after giving birth, read the section “Pregnancy and breast-feeding”.

Ask your doctor if you are not sure when to start using Erlibelle.

If you use more Erlibelle then you should 

There are no reports of serious harmful effects from taking too many Erlibelle tablets. If you take several tablets at once, you may experience symptoms of nausea and vomiting. Young girls may experience vaginal bleeding.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Erlibelle

  • If less than 12 hours have passed since you should have taken your tablet, you are still protected against pregnancy. Take the tablet as soon as you remember and take the following tablet at the usual time (even if this means taking two tablets on the same day). In this case, you do not need to use an additional method of contraception.
  • If it has been more than 12 hours since you should have taken your tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk that you may become pregnant. The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or end of the tablet chart

If you forgot to take a tablet, follow the instructions below:

– If you have forgotten more than one tablet on this tablet map.

Contact a doctor.

– If you have forgotten a tablet during week 1

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue to take the tablets at the usual time and use the additional method of contraception for the following 7 days, e.g. condom. If you have had intercourse during the week before you forgot the tablet, you may be pregnant. In this case, consult a doctor.

– If you have forgotten a tablet during week 2

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue to take the tablets at the usual time. The drug’s protective effect against pregnancy is not reduced and you do not need to use an additional method of contraception.

– If you forget a tablet during week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue to take the tablets at the usual time. Start with the following tablet chart instead of the tablet-free period.

You will probably experience bleeding after the second tablet chart is over, but you may also have light or menstrual-like bleeding while taking tablets from the other tablet chart.

You can also stop taking the tablets in the tablet map and immediately start the tablet-free period of 7 days ( write down the day you forgot to take your tablet ). If you want to start a new tablet map on the day you always start, you must have a shorter tablet-free period than 7 days.

If you follow the above recommendations, you are still protected against pregnancy.

– If you have forgotten a tablet in the tablet map and you do not have bleeding during the first tablet-free days, this may mean that you are pregnant. Contact a doctor before starting the next tablet chart.

If you have forgotten a tablet / tablets

What to do if you vomit or have severe diarrhea

If you vomit within 3-4 hours after taking a tablet or if you have severe diarrhea, there is a risk that the active substance in the tablet will not be completely absorbed by your body. The situation is almost the same as if you were forgetting a tablet. After vomiting or when you have diarrhea, take another tablet from a spare tablet card as soon as possible. If possible, take it within 12 hours of when you usually take the tablets. If not possible or 12 hours have elapsed, follow the advice given under “If you have forgotten to take Erlibelle”.

Postponement of your menstruation (bleeding): what you need to know

Although not recommended, you can postpone your period by continuing directly with a new tablet map by Erlibelle (and completing it) instead of the tablet-free period. You may experience light or menstrual-like bleeding while taking the tablets from the other tablet chart. Start on the next tablet chart, after the usual tablet-free period of 7 days.

You can ask your doctor for advice before you decide to postpone your period.

Change of start date for your period (loss of bleeding): what you need to know

If you take the tablets according to the instructions, your menstruation will begin during the tablet-free week. If you want to change this day, reduce the tablet-free days (but never increase them – 7 days is the maximum!). For example, if the tablet-free days usually start on a Friday and you want to change it to a Tuesday (3 days earlier), you should start on a new tablet map 3 days earlier than usual. If the tablet-free interval becomes very short (eg 3 days or less), you may not experience any bleeding during these days. You may then experience light or menstrual-like bleeding.

If you are not sure what to do, talk to your doctor.

If you stop using Erlibelle

You can stop taking Erlibelle at any time. If you do not want to get pregnant, ask your doctor for advice on other reliable contraceptive methods. If you want to get pregnant stop taking Erlibelle and wait a period before you try to get pregnant. This facilitates the calculation of when the birth is to take place.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Below is a list of the side effects that have been linked to the use of Erlibelle.

Serious side effects are

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, hives, possibly with difficulty breathing (see also section “Warnings and precautions”).

Common (may affect up to 1 in 10 people):

  • nausea
  • abdominal pain
  • weight gain
  • headache
  • Depression
  • mood swings
  • chest tightness
  • chest pain

Uncommon (may affect up to 1 in 100 people):

  • vomiting
  • diarrhea
  • fluid retention (accumulation of fluid in the body)
  • migraine
  • decreased sexual desire
  • breast augmentation
  • rash
  • hives ( urticaria )

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

  • contact lens intolerance (difficulty wearing contact lenses)
  • hypersensitivity
  • weight loss
  • increased sexual desire
  • fluid secretion from the breasts
  • vaginal discharge
  • a type of skin inflammation that results in reddish, painful, sensitive lumps (erythema nodosum)
  • a skin disease that causes red spots or sores that resemble targets (erythema multiforme)

Birth control pills have been associated with:

  • Increased risk of bloproppar the artery you and veins and the condition caused by a blood clot that detaches including heart attack, blood clot in a vein, and a blood clot in the lung (see section “Warnings and Precautions”).
  • Increased risk of changes in the walls of the cervix (neoplasia of the epithelium ) and cervical cancer.
  • Increased risk of breast cancer (see section “Warnings and precautions”.

5. How to store Erlibelle

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

Do not store above 30 ° C.

Do not use this medicine after the expiry date which is stated on the carton and tablet carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are levonorgestrel and Ethinylestradiol. Each tablet contains 0.15 mg levonorgestrel and 0.03 mg Ethinylestradiol.
  • Other ingredients are Tablet core: lactose monohydrate, povidone K30, crospovidone type A and magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b), and yellow iron oxide (E172).

What the medicine looks like and the contents of the pack

  • Each tablet of Erlibelle contains 21 yellow film-coated tablets.
  • The Erlibelle tablets are film-coated. The tablets are yellow, round, with a diameter of about 6 mm and a thickness of less than 4 mm.
  • Erlibelle is available in packs of 1, 3, 6, and 13 tablet tablets, each containing 21 tablets. Not all pack sizes may be marketed. A blister case is supplied with the tablet charts.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjordur

Iceland

Manufacturer

Laboratories León Farma, SA

Poligono Industrial Navatejera, La Vallina S / N

24008 Navatejera (Leon)

Spain

Muhammad Nadeem

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