Ethinylestradiol/Drospirenon ELC-Group 0,03 mg/3 mg filmomhulde tabletten

1. What is and what it is used for

1. What is and what it is used for

<invented name> is a contraceptive pill and is used to prevent pregnancy.

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

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

2. What you need to know before you take

• When you should not use <invented name>
• Warnings and precautions
• <invented name> and venous and arterial blood clots
• <invented name> and cancer
• Bleeding between periods
• What to do if no bleeding occurs during the gap week
• Other medicines and <invented name>
• Taking <invented name> with food, drink and alcohol
• Laboratory tests
• Pregnancy, reast-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, several situations are described where you should stop using <invented name>, or where the reliability of <invented name> may be decreased.

In such situations you should either not have sex 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 <invented name> alters the monthly changes of body temperature and of the cervical mucus.

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

When you should not use <invented name>

Do no take <invented name>:

• if you have (or have ever had) a blood clot in a blood vessel of the leg (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 can be an indicator of a heart attack in the future (for example, angina pectoris, which causes severe pain in the chest) or of a stroke (for example, a passing slight stroke with no residual effects)
• if you have a disease that may increase the risk of a blood clot in the arteries. This applies to the following diseases:
  • diabetes with damaged blood vessels
  • very high blood pressure
  • 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 (or have ever had) a certain form of migraine (with so-called focal neurological symptoms)
• if you have (or have ever had) an inflammation of the pancreas (pancreatitis)
• if you have (or have ever had) a liver disease and your liver function is still not normal
• if your kidneys are not working well (renal failure)

• if you have (or have ever had) a tumour in the liver
• if you have (or have ever had) or if you are suspected of having breast cancer or cancer of the genital organs
• if you have any unexplained bleeding from the vagina
• if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash or swelling.

Warnings and precautions

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

In some situations you need to take special care while using <invented name> or any other combination pill, and your doctor may need to examine you regularly. If any of the following conditions applies to you, tell your doctor before starting to use <invented name>. Also if any of the following applies or if any of the conditions develops or worsens while you are using <invented name> consult your doctor:

• if a close relative 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 have a blood disease called HUS (haemolytic uraemic syndrome) which 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 a disease that first appeared during pregnancy or earlier use of sex hormones (for example, hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (gestational herpes), a disease of the nerves in which sudden movements of the body occur (Sydenham’s chorea))

• if you have or have ever had chloasma (a discolouration of the skin especially of the face or neck known as “pregnancy patches”). If so, avoid direct sunlight or ultraviolet light.

• if you have hereditary angioedema, products containing estrogens 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 throat 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 a venous blood clot in users of combiantion pills increases:

• with increasing age
• if you are overweight
• if one of your close relatives has 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 <invented 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.

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 5-10 may have a blood clot in a year.
• Of 100,000 women taking a Pill like <invented name>, 30-40 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 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 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 the fat content of your blood is increased (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 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, 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
• severe pain in the abdomen (known as acute abdomen)

<invented name> and cancer

Breast cancer has been observed slightly more often in women using combination 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 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, and 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 first few months that you are taking <invented name>, you may have unexpected bleeding (bleeding outside the gap week). 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 to do if no bleeding occurs during 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 <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 contraceptive 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 (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) o tuberculosis (e.g. rifampicin)

1. 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)

<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 medicine.

Taking <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 taking the pill, because hormone contraceptives can affect the results of some tests.

Pregnancy, breast-feeding and fertility

Pregnancy

If you are pregnant do not take <invented name>. If you become pregnant while taking <invented name> 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 advice 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 advice 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 have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

• If you have not used a contraceptive with hormones in the previous month Begin with <invented name> on the first day of the cycle (that is, the first day of your period). If you start <invented name> on the first day of your period 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 a combination hormonal contraceptive, or combination 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 on the day after the tablet-free days of your previous pill (or after the last inactive tablet of your previous pill). When changing from a combination contraceptive vaginal ring or patch, follow the advice of your doctor.
• Changing from a progestogen-only-method (progestogen-only pill, injection, implant or 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 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 You can start <invented name> between 21 and 28 days after having a baby. If you start later than day 28, use a so-called barrier method (for example, a condom) during the first seven days of <invented name> use. If, after having a baby, you have had sex before starting <invented name> (again), be sure that you are not pregnant or wait until your next period.
• If you are breastfeeding and want to start <invented name> (again) after having a baby. Read the section "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 many <invented 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 <invented name> tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take <invented name>

• If you are less than 12 h ourslate taking a tablet, the protection against pregnancy is not reduced. 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 hourslate taking a tablet, the protection against 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 at the end of the strip. Therefore, you should keep to the following rules (see the diagram on page 9):

• 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. Continue taking the tablets 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 or you may also 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 whichyou 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 a bleeding during the first tablet-free period, you may be pregnant. Contact your doctor before you start the next strip.

More than 1 tablet forgotten in 1 strip

Only 1 tablet forgotten

(taken more than 12 hours late)

5. How to store