Levonorgestrel/Ethinylestradiol 100/20 microgram 28 Actavis, filmomhulde tabletten

/…/ is a contraceptive pill used to prevent pregnancy.

Each pink tablet contains a small amount of two different female hormones, namely levonorgestrel and ethinylestradiol.

The white tablets do not contain active substances and are also called placebo tablets.

Contraceptive pills that contain two hormones are called ‘combination pills.’

General notes

Before you can begin taking /…/, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure, and depending upon your personal situation, may also carry out some other tests.

In this leaflet, several situations are described where you should stop using /…/, or where the reliability of the /…/ may be decreased. In such situations you should either not have intercourse or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because /…/ alters the monthly changes of the body temperature and of the cervical mucus.

/…/, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take /…/:

• If you have (or have had in the past) a blood clot (thrombosis) in a blood vessel of the leg, lungs (embolus) or other organs
• If you have (or have had in the past) a heart attack or stroke
• If you have (or have had in the past) a disease that can be a predictor of a heart attack (for example, angina pectoris, which causes severe pain in the chest) or of a stroke (for example, a transient slight stroke with no residual effects).
• If you have a disease that may increase the risk of a thrombosis in the arteries. This applies to the following situations: o diabetes with damaged blood vessels o very high blood pressure o a very high level of fat in the blood (cholesterol or triglycerides)
• If you have a disturbance of blood clotting (for example, protein C deficiency)
• If you have (had) a certain form of migraine (with so-called focal neurological symptoms)
• If you have (had) an inflammation of the pancreas (pancreatitis)
• If you have or have had in the past a liver disease and your liver function is still not normal.
• If you have or have had a tumour in the liver
• If you have (had) or if you are suspected to having breast cancer or cancer of the genital organs.
• If you have any unexplained bleeding from the vagina
• If you have unexplained absence of your period for several months
• If you are allergic to levonorgestrel or ethinylestradiol, or any of the other ingredients of this medicine (listed in section 6). This can be recognized by itching, rash or swelling.

Warnings and precautions

In some situations you need to take special care while using /…/ or any other combined hormonal contraceptive, and it may be necessary that you are regularly checked by your doctor. If any of the following conditions applies to you, you must inform your doctor before starting to use /…/. Also if any of the following conditions develops or worsens during the use of /…/ you must consult your doctor:

• If a close relative has or has had breast cancer
• If you have a disease of the liver or the gallbladder
• If you have diabetes
• If you have depression
• If you have Crohn’s disease or ulcerative colitis (inflammatory bowel disease)
• If you have HUS (haemolytic uremic syndrome); a blood disorder that causes kidney damage
• If you have sickle cell anaemia (an inherited disease of the red blood cells)
• If you have epilepsy
• If you have SLE (systemic lupus erythematosus; a disorder of the immune system)
• If you have a disease that first appeared during pregnancy or earlier use of sex hormones (for example, hearing loss, porphyria (a disease of the blood), gestational herpes (skin rash with vesicles during pregnancy), Sydenham’s chorea (a disease of the nerves in which sudden movements of the body occur)
• If you have or have ever had chloasma (golden brown pigment patches, so called “pregnancy patches”, especially on the face). If this is the case, avoid direct exposure to sunlight or ultraviolet light
• If you have hereditary angioedema, products containing estrogens may induce or worsen symptoms of angioedema. You should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or pharynx and/or difficulty swallowing or hives together with difficulty breathing.

/…/ and thrombosis

Venous thrombosis

The use of any combination pill, including /…/, increases a woman’s risk of developing a venous thrombosis (formation of a blood clot in vessels) compared with a woman who does not take any (contraceptive) pill.

The risk of venous thrombosis in users of combined pills increases:

• With increasing age
• If you are overweight,
• If one of your close relatives has had a blood clot (thrombosis) in the leg, lung, or other organ at a young age,
• If you must have an operation (surgery), any prolonged period of immobilization, or if you have had an serious accident. It is important to tell your doctor in advance that you are using /…/ as the treatment may have to be stopped. Your doctor will tell you when to start /…/ again. This is usually about two weeks after you are back on your feet.

Arterial thrombosis

The use of combinations pills has been connected with an increase of the risk of arterial thrombosis (obstruction of an artery), for example, in the blood vessels of the heart (heart attack) or the brain (stroke).

The risk of arterial thrombosis in users of combines pills increases:

• If you smoke. You are strongly advised to stop smoking when you use /…/, especially if you are older than 35 years.
• If you have an increased fat content in your blood (cholesterol or triglycerides)
• If you are overweight
• If one of your close relatives has had a heart attack or stroke at a young age
• If you have high blood pressure .
• If you have migraine
• If you have a problem with your heart (valve disorder, a disturbance of the heart rhythm)

Stop taking /…/ and contact your doctor immediately if you notice possible signs of thrombosis, such as:

• Severe pain and/or swelling in one of your legs
• Sudden severe pain in the chest which may reach the left arm
• Sudden breathlessness
• Sudden cough without an obvious cause
• Any unusual, severe or long-lasting headache or worsening of migraine
• Partial or complete blindness or double vision
• Difficulty in speaking or inability to speak
• Giddiness or fainting
• Weakness, strange feeling, or numbness in any part of the body

/…/ and cancer

Breast cancer has been observed slightly more often in women using combined pills, but it is not known whether this is caused by the treatment. For example it may be that more tumours are detected in women on combined pills because they are examined by their doctor more often. The occurrence of breast tumours becomes gradually less after stopping the combination hormonal contraceptives. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.

In rare cases, benign liver tumors, and in even fewer cases malignant liver tumors have been reported in pill users. Contact your doctor if you have unusual severe abdominal pain.

Bleeding between periods

During the first few months that you are taking /…/, you may have unexpected bleeding (bleeding outside the placebo week). If this bleeding lasts longer than a few months, or if it begins after some months, your doctor must investigate the cause.

What you must do if no bleeding occurs in the placebo week

If you have taken all the pink active tablets correctly, have not had vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant.

If the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor immediately. Do not start the next strip until you are sure that you are not pregnant.

Other medicines and /…/

Tell your doctor if you are taking, have recently taken or might take any other medicines. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use /…/. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long.

Some medicines can make /…/ less effective in preventing pregnancy, or can cause unexpected bleeding.

These include medicines used for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine) and tuberculosis (e.g. rifampicin), or HIV infections (ritonavir) or other infectious diseases (such griseofulvin, ampicillin, tetracycline) ), to increase intestinal motility (e.g. metoclopramide) and the herbal remedy St. John’s wort.

• If you want to use herbal products containing St. John’s wort while you are already using /…/ you should consult your doctor first.
• /…/ may decrease the efficacy of other medicines, e.g. medicines containing cyclosporin,

or the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures) Ask your doctor or pharmacist for advice before taking this medicine.

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because oral contraceptives can affect the results of some tests.

Pregnancy and breast-feeding

If you are pregnant, you must not take /…/. If you become pregnant while taking /…/ you must stop immediately and contact your doctor.

Use of /…/ is general not advisable when a woman is breast-feeding. If you want to take the pill while you are breast-feeding you should contact your doctor.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

There is no information suggesting that the use of /…/ affects driving or use of machines.

/…/ contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you were taking another contraceptive before starting /…/ 28 tablets, you know that the majority of contraceptives contain 21 tablets. With these contraceptives, you take a tablet for 21 days and then there is a week of not taking any tablets (drug-free interval).

The system to follow when using /…/ 28 tablets is different. After taking the 21 pink tablets, you must continue and take the 7 placebo tablets; consequently there is no drug-free interval, but a "placebo" week (the week you take the placebo tablets in row 4). As you have to take a tablet every day and there is no drug-free interval between two packs, taking the tablets becomes routine and there is consequently less risk of forgetting to take a tablet.

The two different kinds of coloured /…/ 28 tablets are placed in order. One pack contains 28 tablets.

Take one tablet of /…/ every day, if necessary with a small amount of water. You should take the tablets every day around the same time.

Do not confuse the tablets: take a pink tablet once per day for the first 21 days, and then one white tablet per day for the last 7 days. Then you should start a new pack (21 pink tablets and 7 white tablets). Consequently there is no drug-free interval between packs.

The strip contains 28 tablets. The daily intake during 28 consecutive days is important to keep the contraceptive effect.

Along with blisters, there are enclosed stickers with the days of the week. Pick the day label that starts with the first day of your pill intake. Place the strip on the blister card over the words “Place day label here”. Each day will line up with a row of pills. It is important to take your pill every day. And take the first tablet of the first row where the word “START” is indicated.

Follow the direction of the arrow indicated on the strip, first take the pink tablets for 21 days and then, the white ones for 7 days, until you have taken all 28 tablets. Then you should start with the next strip. This means that there is no drug-free interval between packs.

In the course of the 7 days of white tablets (usually the 2nd or 3rd day) bleeding should begin. This so-called withdrawal bleeding and may continue when you start with the next strip.

You should start the following strip on the same day of the week and that the withdrawal bleed should occur on the same days each month.

When can you start with the first strip

• If you have not used a contraceptive with hormones in the previous month. Begin with /…/ on the first day of the cycle (that is the first day of your menstruation). If you start /…/ on the first day of your menstruation you are immediately protected against pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.
• Changing from another combined hormonal contraceptive, or combined contraceptive vaginal ring or patch You can start /…/ on the day after the tablet-free period of your previous pill finished (or after the last inactive tablet of your previous pill). When changing from a combined contraceptive vaginal ring or patch, follow the advice of your doctor.
• Changing from a progestogen-only-method (progestogen-only pill, injection, implant or a progestogen-releasing IUD). You may switch any day from the progestogen-only pill (from an implant or the IUD on the day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.
• After a miscarriage or an abortion Follow your doctor’s advice.
• After having a baby After having a baby, you can start /…/ between 21 and 28 days later. If you start later than day 28, you must use a so-called barrier method (for example, a condom) during the first seven days of /…/ use. If, after having a baby, you have had intercourse before starting /…/ (again), you must first be sure that you are not pregnant or you must wait until the next menstrual bleed. Let your doctor advise you in case you are not sure when to start
• If you are breastfeeding and want to start /…/ (again) after having a baby Read the section on “Pregnancy and breast-feeding”.

If you take more /…/ than you should

There are no reports of serious harmful results of taking too many /…/ tablets. If you take several tablets at once then you may have symptoms of nausea vomiting. Young girls may have bleeding from the vagina.

If you have taken too many /…/ tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take /…/

The tablets in the fourth row of the pack are placebo tablets. If you forget to take one of these tablets, this will have no effect on the effect of /…/. You should throw the forgotten placebo tablet away, so that you do not prolong the placebo week, which could have a negative effect on the effectiveness of /…/ 28 tablet.

If you forget to a tablet in the 1st, 2nd or 3rd rows, you should follow these instructions:

• If you are less than 12 hours late taking a tablet, the protection from pregnancy is not reduced. Then still take the tablet as soon as you remember and then take the following tablets again at the usual time.
• If you are more than 12 hours late taking a tablet, the protection from pregnancy may be reduced. The great the number of the tablets that you have forgotten, the greater is the risk that the protection from pregnancy is reduced. The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning of a strip (1st row) or the end of week 3 (3rd row in the strip). Therefore, you should adhere to the following rules (see also the diagram below):
  • More than 1 tablet forgotten in this strip Contact your doctor
  • One tablet forgotten in week 1 Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Take the tablets again at the usual time and use extra precautions for the next 7 days, for example, a condom. If you have had sexual intercourse in the week before the oversight or you have forgotten to start a new strip after the tablet-free period, you must realize that there is a risk of pregnancy. In that case, contact your doctor.
  • One tablet forgotten in week 2 Take the forgotten tablet as soon as you remember, even if that means that have to take two tablets at the same time. Take the tablets again at the usual time. The protection from pregnancy is not reduced, and you do not to take extra precautions.
  • One tablet forgotten in week 3 You can choose between 2 possibilities:

1. Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Instead of taking the 7 placebo white tablets go straight on to the next strip. Most likely, you will have a period (withdrawal bleed) at the end of the second strip but you may also have spotting or breakthrough bleeding during the second strip.
2. You can also stop the active tablets, pink in colour and go directly to the 7 placebo tablets, white in colour (record the day on which you forgot your tablet). Then just continue with the next strip. If you want to start a new strip on your fixed start day, make the placebo tablets for less than 7 days.

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

• If you have forgotten any of the tablets in a strip and you do not have bleeding in the placebo week, this may mean that you are pregnant. You must contact your doctor before you go on to the next strip.

Forgotten to take more than one pink tablet in a strip

Forgetting to take one pink tablet only (taken more than 12 hours late)

In week 1

In week 2

In week 3

Consult your doctor

Yes

Did you have sex in the previous week?

No

-Take the tablet you have forgotten

-Use a barrier method (condom) for the next 7 days

-Finish the pack

-Take the pill you have forgotten and -Finish the strip

-Take the tablet you have forgotten -Finish taking the pink tablets -Throw away the 7 white tablets -Start the next strip

Or

-Stop the pink tablets immediately -Go directly to the 7 white tablets -Then, start the next strip

What you must do in case of vomiting or severe diarrhoea

If you vomit within 3-4 hours of taking a pink active tablet or you have severe diarrhoea, there is a risk that the active substances in the tablet are not fully absorbed into your body. The situation is similar to if you forget a tablet. After vomiting or diarrhoea, you must take another tablet from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your tablet. If this is not possible or 12 hours have passed, you should follow the advice given under “If you forget to take /…/.

Delaying of menstrual period: what you must know

Even if not recommended, delay of your menstrual period (withdrawal bleed) is possible by not taking the 7 white placebo tablets and going straight on to a new strip of /…/ instead of, to the end of the second strip. You may experience spotting (drops or flecks of blood) or breakthrough bleeding while using this second strip. After the 7 days of placebo tablets of the second strip, continue with the following strip.

You might ask your doctor for advice before deciding to delay your menstrual period Change of the first day of your menstrual period: what you must know

If you take the tablets according to the instructions, then your menstrual period/withdrawal bleed will begin in the placebo-tablet week. If you have to change this day, you do this by making the placebo period - when you take the white placebotablets - shorter (but never longer!). For example, if your placebo period begins on a Friday and you want to change this to Tuesday (3 days earlier), you must start a new strip 3 days earlier than usual. If you make the placebo tablet interval very short (for example, 3 days or less) then it may be that you do not have any bleeding during this placebo period. You may then experience spotting (droplets or flecks or blood) or breakthrough bleeding.

If you are not sure how to proceed, contact your doctor for advice.

If you want to stop taking /…/

You can stop taking /…/ whenever you want. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control.

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

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

Always inform your doctor if you suffer from a side effect, especially if this side effect is severe or persistent, of if you notice a change in your health that you think could possibly be caused by the pill.

Severe side effects connected to the use of the pill are described in the sections “/…/ and thrombosis”, “/…/ and cancer.” Read these paragraphs to obtain more information and immediately consult your doctor if necessary.

• Common side effects (may affect up to 1 in 10 10 women): headache, mood changes (including depression), nausea, abdominal ache, painful breasts, tender breast, weight increase, rash.
• Uncommon side effects (may affect up to 1 in 100 women): vomiting, diarrhoea, water retention or oedema, migraine, less desire in sex, breast enlarged, urticaria.

• Rare side effects (may affect up to 1 in 1,000 women): irritation of the eyes during the use of contact lenses, hypersensitivity, weight decreased, breast discharge, vaginal discharge, libido increased, erythema nodosus (nodules on the legs), erythema multiforme (skin lesions).

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

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

Do not store above 30ºC.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP:”. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What /…/ contains

The active substances are levonorgestrel and ethinylestradiol.

/…/ has tablets of 2 colours:

• Each pink tablet contains 0.10 mg of levonorgestrel and 0.02 mg of ethinylestradiol. The other ingredients (excipients) are anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E572) and opadry II pink [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350, red aluminium lake (E129), lecithin (E322), iron oxide red (E172) and blue aluminium lake (E1329)].
• Each white tablet (inactive tablet or placebo tablet) contains only excipients (no active substances) which are anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E572) and opadry II white [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350].

What /…/ looks like and contents of the pack

• Each active film-coated tablet is pink and rounded.
• Each placebo film-coated tablet is white and rounded.
• /…/ is available in strips (blisters) of 28 tablets: 21 pink active tablets and 7 white placebo tablets.
• Pack sizes are of 1, 3 or 6 strips, each strip with 28 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf. Reykjavíkurvegur 76-78 220 Hafnarfjörður IJsland

Manufacturer

Laboratorios León Farma, S.A.

Polígono Industrial Navatejera, La Vallina S/N

24008 Navatejera (Leon) - Spanje

Marketing Authorisation Number

RVG 102389

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Erlidona 20 Mikrogramm/100 Mikrogramm Filmtabletten

The Netherlands: Levonorgestrel/Ethinylestradiol 100/20 microgram 28 Actavis, filmomhulde tabletten Spain: Erlidona Diario 0,1 mg/0,02 mg comprimidos recubiertos con película EFG

This leaflet was last revised in November 2013.