Levonorgestrel/Ethinylestradiol STADA 0,15 mg/0,03 mg, omhulde tabletten

1. What is and what it is used for

<Product Name> is a contraceptive pill and is used to prevent pregnancy.

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

Contraceptive pills that contain two hormones are called “combination” pills.

2. What you need to know before you take

General notes

Before you can begin taking this medicine, your doctor will ask you some questions about your personal health 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 this medicine, or where the reliability of this medicine 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 this medicine alters the monthly changes of the cervical mucus.

<Product Name>, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

DO NOT take <Product Name>

• if you have (or have had in the past) a blood clot (thrombosis) in a blood vessel of the leg, lung (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 diseases: o Diabetes mellitus 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 are allergic (hypersensitive) to levonorgestrel or ethinylestradiol or to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions

In some situations you need to take special care while using this medicine or any other combination pill, 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 this medicine. Also is any of the following conditions develops or worsens during the use of this medicine 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 uraemic syndrome; a blood disease that causes kidney damage)
• If you have a blood disease called sickle cell anaemia
• If you have epilepsy (see “Other medicines and <Product Name>”)
• If you have SLE (systemic lupus erythematosus; a disease 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.

<Product Name> and venous and arterial blood clots

The use of any combination pill, including <Product Name>, increases a woman’s risk of developing a venous blood clot (venous thrombosis) compared with a woman who does not take any contraceptive pill.

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

• with increasing age
• if you are overweight
• if one of your close relatives ever had a blood clot in the leg, lung (pulmonary embolism), or other organ at a young age
• if you have to have surgery, if you have had a serious accident or if you are immobilized for a long time. It is important to tell your doctor that you are using <Product Name> as you may have to stop taking it. Your doctor will tell you when to start again. This is usually about two weeks after you are back on your feet.

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

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

• with increasing age
• if you smoke. You are strongly advised to stop smoking when you use <Product Name>, 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 ever 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 <Product Name> and contact your doctor immediately if you notice possible signs of a blood clot, 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

<Product Name> 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 tumours, and in even fewer cases malignant liver tumours 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 this medicine, you may have unexpected bleeding (bleeding outside the gap week). If this bleeding lasts longer than a few months, or if it begins after some months, your doctor must find out what is wrong.

What to do if no bleeding occurs in the gap week

If you have taken all the 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 <Product Name>

Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you use <Product Name>. 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 this medicine less effective in preventing pregnancy, or can cause unexpected bleeding. These include medicines used for the treatment of: o epilepsy (e,g, primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine) o tuberculosis (e.g. rifampicin) o HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as griseofulvin, penicillin, tetracycline) o high blood pressure in the blood vessels in the lungs (bosentan) o the herbal remedy St. John’s wort

This medicine may influence the effect of other medicines, e.g. o medicines containing cyclosporin

1. the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)

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

<Product Name> with food and drink

<Product Name> may be taken with or without food, if necessary with a small amount of water.

Laboratory tests

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

Pregnancy

If you are pregnant, do not take <Product Name>. If you become pregnant while taking this medicine you must stop immediately and contact your doctor. If you want to become pregnant, you can stop taking this medicine at any time (see also “If you want to stop taking <Product Name>”).

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

Breast feeding

Use of <Product Name> is generally 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 any medicine.

Driving and using machines

There is no information suggesting that use of <Product Name> affects driving or use of machines.

<Product Name> contains lactose and sucrose

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

3. How to take

Take one tablet of <Product Name> every day, if necessary with a small amount of water. You may take the tablets with or without food, but you should take the tablets every day around the same time.

The strip contains 21 tablets. Next to each tablet is printed the day of the week that it should be taken. If, for example you start on a Wednesday, take a tablet with “WED” next to it. Follow the direction of the arrow on the strip until all 21 tablets have been taken.

Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwise called a stop

or gap week) bleeding should begin. This so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week.

On the 8th day after the last <Product Name> tablet (that is, after the 7-day gap week), start the following strip, even if the bleeding has not stopped. This means that 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.

If you use <Product Name> in this manner, you are also protected against pregnancy during the 7 days that you are not taking a tablet.

When can you start with the first strip?

• If you have not used a contraceptive with hormones in the previous month Begin with <Product Name> on the first day of the cycle (that is the first day of your menstruation). If you start this medicine 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 <Product Name> preferably on the day after the last active tablet (the last tablet containing the active substance) of your previous pill, but at the latest on the day after the tablet-free days of your previous pill finish (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. Follow the advice of your doctor.
• After having a baby After having a baby, you can start <Product Name> 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 <Product Name> use.

If, after having a baby, you have had intercourse before starting this medicine (again), you must first be sure that you are not pregnant or you must wait until the next menstrual bleed.

• If you are breastfeeding and want to start <Product Name> after having a baby Read the section on “Breast feeding”.

Let your doctor advice you in case you are not sure when to start.

If you take more <Product Name> than you should

There are no reports of serious harmful results of taking too many <Product name> tablets.

If you take several tablets at once then you may have symptoms of nausea or vomiting. Young girls may have bleeding from the vagina.

If you have taken too many <Product name> tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take <Product Name>

• If you are less than 12 hours late in taking your pill, the protection from pregnancy is not reduced. Take the tablet as soon as you remember, and further pills again at the usual time.
• If you are more than 12 hours late taking a tablet, the protection from pregnancy may be reduced. The greater the number of tablets that you have forgotten, the greater is the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or the end of the strip. Therefore, you should adhere to the following rules:

• More than one 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 sex in the week before forgetting the tablet you may be pregnant. 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 you have to take two tablets at the same time. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced, and you do not need to take extra precautions.

• One tablet forgotten in week 3

You can choose between two 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. Continue taking the tablets at the usual time. Instead of taking the tablet-free period start the next strip.

Most likely, you will have a period at the end of the second strip but you may have light or menstruation-like bleeding during the second strip.

2. You can also stop the strip and go directly to the tablet-free period of 7 days (record the day on which you forgot your tablet). If you want to start a new strip on the day you always start, make the tablet-free period less than 7 days.

If you follow one 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 during the first tablet-free period, you may be pregnant. Contact your doctor before you start the next strip.

What to do in the case of vomiting or severe diarrhoea

If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea, there is a risk that the active substances in the pill will not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, take another tablet from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your pill. If this is not possible or 12 hours have passed, you should follow the advice given under ‘If you forget to take <Product Name>’.

Delaying your period: what you need to know

Even though it is not recommended, you can delay your period by going straight on to a new strip of this medicine instead of the tablet-free period and finishing it. You may experience light or menstruation-like bleeding while using the second strip. After the usual tablet-free period of 7 days, start the next strip.

You might ask your doctor for advice before deciding to delay your menstrual period.

Changing the first day of your period: what you need to know

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

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

If you want to stop taking <Product Name>

You can stop taking this medicine 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 want to become pregnant, stop taking this medicine and wait for a period before trying to become pregnant. You will be able to calculate the expected delivery date more easily.

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

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

The following is a list of the side effects that have been linked with the use of <Product Name>.

Common side effects (affecting more than 1 in 100, but less than 1 in 10 women):

• mood swings
• headache
• abdominal pain (stomach ache)
• breast pain and tenderness
• weight gain
• nausea
• rash

Uncommon side effects (affecting more than 1 in 1,000 but less than 1 in 100 women):

• vomiting
• diarrhoea

• fluid retention,
• migraine
• decreased libido (interest in sex)
• breast enlargement
• hives

Rare side effects (affecting less than 1 in 1,000 women):

• contact lens intolerance
• allergic reactions
• weight loss
• increased libido (interest in sex)
• breast discharge
• vaginal discharge
• the skin conditions erythema nodosum (characterized by painful reddish skin nodules) or erythema multiforme (characterized by rash with target-shaped reddening or sores)

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

5. How to store

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

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton 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 to protect the environment.

What <Product Name> contains

- The active substances are Levonorgestrel (150 microgram) and Ethinylestradiol (30 microgram)

• The other ingredients are Lactose Monohydrate, Maize Starch, Povidone K-25, Sucrose, Talc, Calcium carbonate, Povidone K-90, Glycerin, Macrogol 6000, Titanium dioxide, Magnesium Stearate, Carnauba Wax.

What <Product Name> looks like and contents of the pack

<Product Name> tablets are white, circular, biconvex and sugar coated.

Each blister pack contains 21 tablets.

<Product Name> is sold in cartons of 3 or 13 blister packs. Not all pack sizes may be marketed.

Houder van de vergunning voor het in de handel brengen

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel, Duitsland

Fabrikant

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel, Duitsland

or

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harlow, Middlesex

HA1 4HF, Verenigd Koninkrijk

In het register ingeschreven onder:

RVG 109590

Dit geneesmiddel is geregistreerd in lidstaten van de EEA onder de volgende namen:

Denemarken:	Stadagyn
Nederland:	Levonorgestrel/Ethinylestradiol STADA 0,15 mg/0,03 mg, omhulde tabletten
Zweden:	Stadagyn

Deze bijsluiter is voor het laatst goedgekeurd in juli 2012.