Wanneer mag u dit middel niet gebruiken of moet u er extra voorzichtig mee zijn?
2. What you need to know before you take 150microgram/20microgram
(150microgram/30microgram)
- How to take <Product name>150microgram/20microgram (150microgram/30microgram)
2. What you need to know before you take 150microgram/20microgram (150microgram/30microgram)
General notes
Before you can begin taking <Product 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 <Product name>, or where the reliability of <Productname> 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 <Product name> alters the monthly changes of body temperature and of the cervical mucus.
<Productname>, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
.
When you should not use <Product name>150microgram/20microgram
( 150microgram/30microgram)
- 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 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 (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.
Version: 3.1
Date: 11.11.2011
| <Product name> 150 microgram / 20 microgram tablets | Module 1.3.1.1 | |
| <Product name> | 150 microgram / 30 microgram tablets | |
| d210 | Package Leaflet |
• if you are allergic to ethinylestradiol or desogestrel, or any of the other ingredients of <Product name>150microgram/20microgram (150microgram/30microgram) (listed in section 6). This can be recognised by itching, rash or swelling.
Warnings and precautions
Talk to your doctor or pharmacist before taking <Product Name> 150microgram/20microgram (150microgram/30microgram)
In some situations you need to take special care while using <Product name>150microgram/20microgram (150microgram/30microgram) 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 <Product name>150microgram/20microgram (150microgram/30microgram). Also if any of the following conditions develops or worsens during the use of <Product name>150microgram/20microgram (150microgram/30microgram) 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 sickle cell anaemia (an inherited disease of the red blood cells)
- if you have epilepsy (see “Taking other medicines”)
- 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.
The pill and blood clots (thrombosis)
Venous thrombosis
The use of any combination pill, including <Product name>150microgram/20microgram (150microgram/30microgram), increases a woman’s risk of developing a venous thrombosis (formation of a blood clot in vessels) compared with women who does not take any (contraceptive) pill.
Version: 3.1
Date: 11.11.2011
| <Product name> 150 microgram / 20 microgram tablets | Module 1.3.1.1 | |
| <Product name> | 150 microgram / 30 microgram tablets | |
| d210 | Package Leaflet |
If you take <Product name>150microgram/20microgram (150microgram/30microgram), you have a higher risk of developing a venous thrombosis than women using other combination pills containing the progestogen levonorgestrel.
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 <Product name>150microgram/20microgram (150microgram/30microgram) as the treatment may have to be stopped. Your doctor will tell you when to start <Product name>150microgram/20microgram (150microgram/30microgram) 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 Desogestrel 150 microgram and Ethinylestradiol 20/30 microgram Tablets, 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.
Arterial thrombosis
The use of combination pills has been connected with an increase of the risk of arterial blood clot (arterial thrombosis), for example, in the blood vessels of the heart (heart attack) or the brain (stroke).
The risk of arterial blood clot in users of combined pills increases:
- If you smoke. You are strongly advised to stop smoking when you use <Product name>150microgram/20microgram (150microgram/30microgram), especially if you are older than 35 years.
- with increasing age
- if you are overweight
- if one of your close relatives has had a heart attack or stroke at a young age
- if the fat content of your blood is increased (cholesterol or triglycerides)
- 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)
Version: 3.1
Date: 11.11.2011
| <Product name> 150 microgram / 20 microgram tablets | Module 1.3.1.1 | |
| <Product name> | 150 microgram / 30 microgram tablets | |
| d210 | Package Leaflet |
Stop taking <Product name>150microgram/20microgram ( 150microgram/30microgram) and
contact your doctor immediately if you notice possible signs of blood clot (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
The pill 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, notice any changes in the nipple or dimpling of the skin.
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 <Product name>150microgram/20microgram (150microgram/30microgram), 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 investigate the cause.
What you must 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>150microgram/20microgram ( 150microgram/30microgram)
Always tell the doctor, who prescribes <Product name>150microgram/20microgram (150microgram/30microgram), which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use <Product name>150microgram/20microgram (150microgram/30microgram). They can tell you if you
Version: 3.1
Date: 11.11.2011
| <Product name> 150 microgram / 20 microgram tablets | Module 1.3.1.1 | |
| <Product name> | 150 microgram / 30 microgram tablets | |
| d210 |
Package Leaflet need to take additional contraceptive precautions (for example condoms) and if so, for how long.
- Some medicines can make <Product name>150microgram/20microgram (150microgram/30microgram) 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, topiramate, hydantoins, felbamat) and tuberculosis (e.g. rifampicin), or HIV infections (ritonavir, nevirapin), or for treatment of high blood pressure in the blood vessels in the lungs (bosentan) or other infectious diseases (antibiotics such as griseofulvin, penicillin, tetracycline), and the herbal remedy St. John’s wort.
- <Product name>150microgram/20microgram (150microgram/30microgram) may influence the effect 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 any medicine.
<Product name>150microgram/20microgram (150microgram/30microgram)with food and drink
<Product name>150microgram/20microgram (150microgram/30microgram) 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
If you are pregnant, do not take <Product name>150microgram/20microgram (150microgram/30microgram).
If you become pregnant while taking <Product name>150microgram/20microgram
(150microgram/30microgram) stop immediately and contact your doctor. If you want to become pregnant, you can stop taking the pill at any time.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of <Product name>150microgram/20microgram (150microgram/30microgram) 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 Desogestrel 150 microgram and Ethinylestradiol 30 microgram Tablets affects driving or use of machines.
Version: 3.1
Date: 11.11.2011
| <Product name> 150 microgram / 20 microgram tablets | Module 1.3.1.1 | |
| <Product name> | 150 microgram / 30 microgram tablets | |
| d210 | Package Leaflet |
<Product name>150microgram/20microgram ( 150microgram/30microgram) contains lactose
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
3 How to take <PRODUCT NAME>150microgram/20microgram ( 150microgram/30microgram)
Take one tablet of <Product name>150microgram/20microgram (150microgram/30microgram) 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 is so-called “ withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week.
On the 8th day after the last tablet <Product name>150microgram/20microgram
(150microgram/30microgram) (that is, after the 7-day gap week), 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 <Product name>150microgram/20microgram (150microgram/30microgram) in this manner, you are also protected against pregnancy also during the 7 days when you are not taking a tablet.
When can you start with the first strip?
If you are a new pill user or if no oral contraception has been used during the last month
Begin with <Product name>150microgram/20microgram (150microgram/30microgram) on the first day of your period. This is the first day of your cycle - the day when bleeding starts. Take a tablet marked for that day of the week (for example, if it is Tuesday when your period starts, take the tablet marked Tuesday on the pack). Follow the direction of the arrow and continue taking one tablet each day until the strip is empty. If you start <Product name>150microgram/20microgram (150microgram/30microgram) on the first day of your period you are immediately protected against pregnancy. If you start on day 2-5 of your period, you should use another method of contraception as well, such as the condom, for the first seven tablet-taking days, but this is only for the first pack.
Changing to <Product name>150microgram/20microgram ( 150microgram/30microgram) from another combined hormonal contraceptive, or combined contraceptive vaginal ring or patch
- You can start <Product name>150microgram/20microgram (150microgram/30microgram) preferably on the day after the last active tablet (the last containing 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.
Version: 3.1 Date: 11.11.2011
| <Product name> 150 microgram / 20 microgram tablets | Module 1.3.1.1 | |
| <Product name> | 150 microgram / 30 microgram tablets | |
| d210 | Package Leaflet |
Changing to <Product name>150microgram/20microgram ( 150microgram/30microgram) from a progestogen- product (progestogen-only-pills, injection, implant or progestogen releasing IUD)
You may switch any day from the progestogen-only tablet (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>150microgram/20microgram (150microgram/30microgram) 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>150microgram/20microgram (150microgram/30microgram) use. If, after having a baby, you have had intercourse before starting <Product name>150microgram/20microgram (150microgram/30microgram) (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>150microgram/20microgram
( 150microgram/30microgram) (again) after having a baby.
Read the section on “Breast feeding”.
Ask your doctor what to do if you are not sure when to start.
If you take more <Product name>150microgram/20microgram ( 150microgram/30microgram) than you should
There are no reports of serious harmful results of taking too many <Product name>150microgram/20microgram (150microgram/30microgram) 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>150microgram/20microgram (150microgram/30microgram) tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.
What to do if you forget to take <Product name>150microgram/20microgram
( 150microgram/30microgram)
- If you are less than 12 hours late taking a tablet, the protection from pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual
time.
Version: 3.1 Date: 11.11.2011
| <Product name> 150 microgram / 20 microgram tablets | Module 1.3.1.1 | |
| <Product name> | 150 microgram / 30 microgram tablets | |
| d210 | Package Leaflet |
- 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 that the protection
from pregnancy is reduced.
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 (see also the diagram below):
- 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 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 you 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 need to take extra precautions.
• One tablet forgotten in week 3
You can choose between two possibilities:
- 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. Instead of the tablet-free period 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.
- 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 your fixed start day, make the tablet-free period 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 first tablet-free period, this may mean that you are pregnant. You must contact your doctor before you start the next strip.
Version: 3.1
Date: 11.11.2011
| <Product name> 150 microgram / 20 microgram tablets | Module 1.3.1.1 | |
| <Product name> | 150 microgram / 30 microgram tablets | |
| d210 | Package Leaflet |
What to do in 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 tablet are not fully absorbed into your body. The situation is almost the same as forgetting 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 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>150microgram/20microgram (150microgram/30microgram)”.
Delay of menstrual period: what you must know
Even though it is not recommended, you can delay your menstrual period (withdrawal bleed) by going straight on to a new strip of <Product name>150microgram/20microgram (150microgram/30microgram) instead of the tablet-free period, and finishing it. You may experience light or menstruation-like bleeding while using this 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.
Version: 3.1
Date: 11.11.2011
| <Product name> 150 microgram / 20 microgram tablets | Module 1.3.1.1 | |
| <Product name> | 150 microgram / 30 microgram tablets | |
| d210 | Package Leaflet |
Change of the first day of your menstrual period: what you must know
If you take the tablets according to the instructions, then your period/withdrawal bleed will begin in the tablet-free week. If you have to change this day, you do this by making the tablet-free period shorter (but never longer!). For example, if your tablet-free period begins on a Friday, and you want to change this to a Tuesday (3 days earlier) you must start a new strip 3 days earlier than usual. If you make the tablet-free period very short (for example, 3 days or less) then it may be that you do not have any bleeding during this tablet-free period. You may then experience spotting (droplets or flecks or blood) or breakthrough bleeding.
If you are not sure how to proceed, consult your doctor for advice.
If you want to stop taking <Product name>150microgram/20microgram
( 150microgram/30microgram)
You can stop taking <Product name>150microgram/20microgram (150microgram/30microgram) 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 <Product name>150microgram/20microgram (150microgram/30microgram) 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.
Advertentie
