Ethinylestradiol/Drospirenon STADA 0,02 mg/3 mg, 24+4 filmomhulde tabletten

1. What is and what it is used for

1. What is and what is used for

• • <invented name> is a contraceptive pill and is used to prevent pregnancy.
  • Each of the24 pink tablets contain a small quantity of two different female hormones, namely drospirenone and ethinylestradiol.
  • The 4 white tablets contain no active substances and are also called placebo tablets.
  • Contraceptive pills that contain two hormones are called “combination” pills.

2. What you need to know before you take

Do not take <invented name> Warnings and precautions

<invented name> and venous and arterial blood clots <invented name> and cancer

Bleeding between periods

What you must do if no bleeding occurs during the placebo days Other medicines and <invented name>

<invented name> with food, drink and alcohol Laboratory tests

Pregnancy, breast-feeding and fertility Driving and using machines <invented name> contains lactose

2. What you need to know before you take

General notes

Before you can begin taking <invented name>, 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, severalsituations are described whereyou should stop using <invented name>, or where the reliability of <invented name> may be decreased. In such situations you shouldeither not have sex or you shouldtake extra non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable as <invented name>alters the monthly changes of body temperature andof cervical mucus.

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

Do not take <invented name>

• if you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), of the lung (pulmonary embolism) or other organs
• if you have (or have ever had) a heart attack or stroke

1. a very high level of fat in the blood (cholesterol or triglycerides)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking <invented name>.

In some situations youneed to take special carewhile using <invented name> or any other combination pill, and your doctor may need to examine youregularly. If any of the following

conditions applies to you,you must informyour doctor beforestarting to use <invented name>. Also, if any of the following conditions develops or worsens while you are using <invented name> you must consult your doctor:

• if a close family has or has ever 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 inflammatory bowel disease (ulcerative colitis)
• if you havea blood disease calledHUS (haemolytic uremic syndrome) that causes kidney damage
• if you have a blood disease called sickle cell anaemia
• if you have epilepsy (see page 5 "<invented name> and using other medicines")
• if you have a disease of the immune system, called SLE (systemic lupus erythematosus)
• if you have adisease that firstappeared during pregnancy orearlier use of sex hormones(for

example, hearing loss, a blood diseasecalled porphyria, skinrash with blisters during pregnancy (gestational herpes), a nerve disease causing sudden movements of the body (Sydenham's chorea)

• if you have or haveever had golden brown pigment patches (chloasma), so called "pregnancy patches", especially on the face. If this is the cavoidse, direct exposure to sunlight or ultraviolet light.
• If you have hereditary angioedema, products containingoestrogens may cause or worsen the symptoms. 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.

<invented name> and venous and arterial blood clots

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

The risk of developing venous thrombosis when taking combination pills increases:

• with increasing age
• if you are overweight
• if one of your close relatives had a blood clot in the leg, lung (pulmonary embolism), or other organ at a young age

• if you must have surgery, if you have had a serious accidentor if you are immobilised for a long time. It is important to tell your doctor in advance that your are using<invented name> as the treatment may have to be stopped. Your doctor will tell you when to start<invented name> again. This is usually about two weeks after you are back on your feet.

Your chances of having a blood clot are increased by taking the pill.

• Of 100,000 women who are not on the pill and not pregnant, about 510- may have a blood clot in a year.

- Of 100,000 women taking a pill like <invented name>, 3040- may have a blood clot in a year, the exact number is unknown.

• Of 100,000 women who are pregnant, around 60 may have a blood clot in a year.

A blood clot in the veins may travel to the lungs and may block blood vessels (called a lung embolus). Formation of blood clots in the veins may be fatal in 1-2% of cases.

The level of risk may vary according to the type of pill you take. Discuss with your doctor the available options.

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

The risk of an arterial blood clot in users of combination pills increases:

• if you smoke. You are strongly advised to stop smoking when you use <invented name>, especially if you are older than 35 years.
• if you have high levels of blood cholesterol or triglycerides
• if you are overweight
• if one of your close relatives had a heart attack or stroke at a young age
• if you have high blood pressure
• if you suffer from migraine
• if you have a problem with your heart (valve disorder, a disturbance of the cardiac rhythm)

Stop taking <invented 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, sevre 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
• severe pain in the abdomen (known as acute abdomen)

<invented name> and cancer

Breast cancer has been observed slightly more often in women usingcombination pills, but it is not known whether this is caused by the treatment. For example itmay be that more tumours are detected in women on combination 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, in even fewer cases malignant liver tumours have been reported in pill users. Contact your doctor if you have unusually severe abdominal pain.

Bleeding between periods

During the firstfew months that you are taking<invented name>, you mayhave unexpected bleeding (bleeding outside the placebo days). If this bleeding occurs for more than a few months, or if it begins after some months, your doctor must find out what is wrong.

What you must do if no bleeding occurs during the placebo days

If you have taken all the pink active tablets correctly, you 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 insuccession, you may be pregnant. Contact your doctor immediately. Only start the next strip if you are sure that you are not pregnant.

Other medicines and <invented 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 <invented name>. They can tell you if you need to take additional contraceptives precautions (for example condoms) and if so, for how long.

Some medicines can make <invented name> less effective in preventing pregnancy, or can cause unexpected bleeding. These include:

• medicines used for the treatment of o epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) o tuberculosis (for example, rifampicin) o HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as grisoefulvin, penicillin, tetracyline) o high blood pressure in the blood vessels in the lungs (bosentan)
• the herbal remedy St. John’s wort

<invented name> may influence the effect of other medicines, e.g.

• medicines containing ciclosporin
• the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)

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

<invented name> with food, drink and alcohol

<invented 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 takingthe pill, because hormonal contraceptives can affect the results of some tests.

Pregnancy, breast-feeding and fertility

Pregnancy

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

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

Breast-feeding

Use of <invented 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 advise before taking any medicine.

Driving and using machines

There is no information suggesting that use of <invented name> affects driving or use of machines.

<invented name> contains lactose.

If you cannot tolerate certain sugars, contact your doctor before you take <invented name>.

3. How to take

Preparation of the strip

When can you start with the first strip?

If you take more <invented name> than you should If you forget to take <invented name>

What to do in the case of vomiting or severe diarrhoea Delaying your period: what you need to know

Changing the first day of your-period: what you need to know If you want to stop taking <invented name>

3. How to take

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

Each blister contains 24 active pink tablets and 4 white placebo tablets.

The two differently coloured tablets of <invented name> are arranged in order. A strip contains 28 tablets.

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

Do not confuse the tablets: take a pink tablet for the first 24 days and then a white tablet for the last 4 days. You must then start a new strip straight away (24 pink and then 4 white tablets). There is therefore no gap between two strips.

Because of the different composition of the tablets it is necessary to begin with the first tablet on the upper left and that you take the tablets every day. For the correct order, follow the direction of the arrows on the strip.

Preparation of the strip

To help you keep track, there are 7 stickers each with 7 days of the week for each strip of <invented name>. Choose the week sticker that starts with the day you begin taking the tabletsFor. example, if you start on a Wednesday, use the week sticker that starts with “WED”.

Stick the corresponding strip in the upper left hand corner of the pack, on the "Start" position.There is now a day indicated above every tablet and you can see whether you have taken acertain pill. The arrows show the order you are to take the pills.

During the 4 days when you are taking the white placebo tablets (the placebo days), bleeding should start (so-called withdrawal bleeding).This usually starts onthe 2nd or 3rd day after the last pink active tablet of <invented name>. Once you have taken the last white tablet, you should start with

the following strip, whether your bleeding has stopped or not. This means that you should start every strip on the same day of the week, and that the withdrawal bleed should occur on the same days each month.

If you use <invented name> in this manner, youare protected against pregnancy also during the 4 days when you are taking a placebo tablet.

• If you have not used a contraceptive in the previous month

Begin with <invented name> on the first day ofthe cycle (that is, the first day of yourperiod). If you start <invented name>on the first day of your menstruation youare 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 a combined hormonal contraceptive, or combined contraceptive vaginal ring or patch You can start <invented name> preferably on the day after the last active tablet (the last tablet

containing the active substances)of your previous pill,but at the latest onthe day after the tablet-free days of your previouspill finish (or after the lastinactive tablet of your previous pill). When changing from a combined contraceptive vaginal ring or patch, followthe 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 an 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 oftablet- taking.
• After a miscarriage Follow the advice of your doctor.
• After having a baby

You can start <invented name> between 21 and 28 days after havinga baby. If you start later than day 28, you must use a so-called barrier method (for example, a condom) during the first 7 days of <invented name> use.

If, after having ababy, you have had sex before starting <invented name>(again), you must first be sure that you are not pregnant or you must wait until your next period.

• If you are breast-feeding and you want to start <invented name> (again) after having a baby Read the section on "Breast-feeding", page 6.

Ask your doctor what to do if you are not sure when to start.

If you take more <invented name> than you should

There are no reports of serious harmful results of taking too may <invented name> tablets.

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

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

If you forget to take <invented name>

The last 4 tablets in the 4th row of the strip are placebo tablets. If you forget to take one of these tablets, this will have no effect on thereliability of <invented name>. Throw away the forgotten placebo tablet.

If you forget a pink, active tablet (tablets 1-24 of your blister-strip) you must do the following:

• If you areless than 24 hours late taking atablet, the protectionagainst pregnancy is not

reduced. Take the tablet as soon as youremember and then take the following tablets again at the usual time.

• If you are more than 24 hours late taking a tablet, the protection against pregnancy may be

reduced. The greater the number oftablets that you have forgotten, the greateris the risk of becoming pregnant.

The risk of incomplete protection against pregnancy isgreatest if you forgeta pink tablet at the beginning or at the end of the strip. Therefore, you should keep the following rules (see also the diagram on page 9):

• More than one tablet forgotten in this strip Contact your doctor.
• One tablet forgotten between days 1 – 7 (first row)

Take the forgotten tablet as soon as youremember, even if that means that you have to take

• One tablet forgotten between days 8 – 14 (second row)

Take the forgotten tablet as soon as youremember, even if that means that you have to take two tablets at the same time. Continue taking thetablets at the usual time. Theprotection against pregnancy is not reduced, and you do not need to take extra precautions.

• One tablet forgotten between days 15 – 24 (third or fourth row) 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 thetablets at the usual time. Insteadof taking the white placebo tablets on this strip, throw them away, and start the next strip (the starting day will be different).

Most likely, you will have a period at the end of the secondstrip - while taking the white placebo tablets - but you may have lightor menstruation-like bleeding during the second strip.

2. You can also stop theactive pink tablets and go directly to the 4white placebo tablets

(before taking the placebo tablets, record the day on which you forgot your tablet). If you want to start a newstrip on the day you always start, take the placebo tablets for less than 4 days.

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

• If you have forgottenany of thetablets in a strip, and you do not have ableeding during the placebo days, this may mean that you are pregnant.You must contact your doctor before you start the next strip.

More than 1 pink tablet forgotten in 1 strip

Only 1 pink tablet forgotten (taken more than 24 hours late)

5. How to store