Desogestrel 150 microgram en Ethinylestradiol 20 microgram betapharm tabletten

used for

Desogestrel 150 micrograms/ethinylestradiol 20 microgramstablet is a combined oral contraceptive, also called the pill. Each ta blet contains a s mallountamof t wo types of female hormones, namely, a progestogen, desogestrel and an oestrogen, ethinylestradiol.

These help to stop you from getting pregnant, just as your natural hormones would stop you conceiving again when you are already pregnant.

The combined contraceptive pill protects you against getting pregnant in three ways. These hormones

1. stop the ovary from releasing an egg each month (ovulation).
2. also thicken the fluid (at the neck of the womb making it more difficult for the sperm to reach the egg.
3. alter the lining of the womb to make it less likely to accept a fertilised egg.

General notes

Before you can begin taking Desogestrel 150 micrograms/ethinylestradiol 20 m icrograms tablets, 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets, or where the reliability of the pill 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms

tablets alters the monthly changes of body temperature and of cervical mucus.

Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets

• if you have (or have ever had) a bl ood clot in a bl ood 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 canbe an indicator of a heart attack in the fut ure (for example, angina pectoris, which causes severe pain in the chest) or ofa stroke (for example, a passing slight stroke with no residual effects).

• if you ha ve a disease t hat mayincrease the risk of a cl ot in et harteries. Th is 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 m igraine (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 you have (or have ever had) a tumour in the liver.
• if you have (or have ever 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 al lergic to ethinylestradiol or desogestrel, or any of t he other ingredients of t his medicine (listed in section 6).

Warnings and precautions

In some situations you need to take special care while using Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets or any other combination pill, and your doctor may need to examine you regularly. If

any of the following conditions applies to you, tell yo ur doctor before starting to use Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets. Also if any of the following applies or if any of the conditions develops or worsens while you are u sing Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets 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 “The pill 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 nerve disease causing sudden movements of the body (Sydenham’s chorea)
• if you have or have ever had chloasma (a discoloration 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 oestrogens may cause or worsen symptoms. You should see your doctor immediatelyif you expe rience symptoms of angioe dema such as s wollen face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing.

The pill and venous and arterial blood clots (thrombosis)

Venous thrombosis

The use of any co mbination pill, including Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets, increases a woman’s risk of developing avenous blood clot (venous thrombosis) compared with women who do not take any contraceptive pill.

If you take Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets, you have a higher risk of developing a venous thrombosis than women using other combined pills containing the progestogen levonorgestrel.

The risk of venous blood clots in users of combined 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 an serious accident or if you are immobilized for a long time.

It is i mportant to tell yo ur doctor that you are using Desogestrel 150 micr ograms/ethinylestradiol 20 micrograms tablets as you may have to stop taking it. Your doctor will tell you when to start Desogestrel

150 micrograms/ethinylestradiol 20 micrograms tablets 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 150micrograms/ethinylestradiol 20 micrograms tablets, 20-40 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 riskarterialof 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 y ou smoke. You are strongly advised to stop smoking when you use Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets, 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 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets and contact your doctor immediately if you notice possible signs of 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

The pill and cancer

Breast cancer has been observed slightly more oftenin 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 m onths that you are	taking Desogestrel 150 micrograms/ethinylestradiol 20
micrograms tablets, 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 you must do if no bleeding occurs in the gap week

If you have taken all the tablets correctly, have nothad 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets

Always tell the 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets. They can t ell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long.

• Some medicines can make Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets 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)
  • tuberculosis (e.g. rifampicin),

HIV infections (ritonavir, nevirapin) or other infections (antibiotics such as g riseofulvin, penicillin, tetracycline)

 the herbal remedy St. John’s wort.

• Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets may influence the effect of other medicines, e.g.

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

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

Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets with food and drink

Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets 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 doct or or the rlabotory staff that you aretaking the pill, because hormone contraceptives can effect the results of some tests.

Pregnancy

If you are pregnant, do not take Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets. If you become pregnant while taking Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets 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 micrograms/ethinylestradiol 20 micrograms tablets affects driving or use of machines.

Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets contain 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 you take this product.

Take one tablet of Des ogestrel 150 m icrograms/ethinylestradiol 20 micrograms tablets 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 ofthese 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 of Desogestrel 150 micrograms/ethinylestradiol 20 micrograms (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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets in this manner, you are also protected against pregnancy during the 7 days when 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms on the first day of the cycle (that is t he first day of your period). If youart stDesogestrel 150 micrograms/ethinylestradiol 20 micrograms 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 youmust use extra protect ive 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms preferably on the day after the last active tablet (the last tablet 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 th e	last in active tablet of	you r
previous pill). When	changing	from	a c ombination 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 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms use. If, after having a baby, you have had sex before starting Desogestrel 150 micrograms/ethinylestradiol 20 micrograms (again), be sure that you are not pregnant or wait until your next period.
• If you are breastfeeding and want to start Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets (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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets than you should

There are no reports of serious harmful results of taking too many Desogestrel 1 micrograms/ethinylestradiol 20 micrograms 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 Desogestrel 150 microgram and Ethinylestradiol 20 microgram 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets

• If you are less than 12 hours late 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 aremore than 12 hours late 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 the end of the strip. Therefore, you should keep to the following rules (see the 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. Continue taking the tablets at the usual time and useextra 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 p rotection 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 next strip. Most likely, you will have a period at the end theof second strip but youmay 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 daysrecord( 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 in the first tablet-free period, you may be pregnant . Contact your doctor before you start the next strip.

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, take another tablet from a reserve strip as soon as possible. If possible

take it within 12 hours of when you normally take yourpill. If this is not possible or 12 hours have passed,

you

should

follow

the

advice

given

under

“If

you

forget

to

take

Desogestrel

micrograms/ethinylestradiol 20 micrograms tablets”.

Delay of menstrual period: what you need to know

Even though it is not recommended, you can delay your menstrual period by going straight to a new strip of

Desogestrel 150 microgram and Ethinylestradiol 20 microgram Tablets instead of the tablet-free period,

and

finishing

it. You may

experience light

or m enstruation-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.

Changing of the first day of your menstrual period: what you must 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 the tablet-free daysbut( 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 strip3 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms Tablets

You can stop taking Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets 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, Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets can cause side effects, although not everybody gets them.

Serious reactions

More serious reactions associated with combined hormonal contraceptive pills are detailed above in section 2 under “The pill and venous and arterial blood clots (thrombosis)” and “The pill and cancer”. Please read these subsections carefully, and if you have any questions, ask your doctor.

The following serious side effects have been reported in women using the pill: Crohn's disease or ulcerative

colitis (chronic inflammatory bowel diseases), systemic lupus erythematosus (SLE, a d isease	of th e
connective tissue), epilepsy, the rash known as herpes gestationis,chorea (a movement disease), a blood
disorder called haemolytic uraemic syndrome	- HUS (a disorder where blood clots cause the kidneys	to
fail), brown patches on the face and body	(chloasma), movement disorder called Sydenham' s chorea,
yellowing of the skin, gynaecological disorders (endometriosis, uterine myoma)

Other possible side effects

The following side effects have been reported in women using the pill, which can occur in the first few months after starting Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets, but they usually stop once your body has adjusted to the pill. The most commonly reported side effects (more than 1 in every 10 users may be affected) are irregular bleeding and weight gain.

Common or uncommon (between 1 and 100 in every 1,000 users may be affected): none or reduced bleeding, tender breasts, breast enlargement, breast pain, decreased sexual desire, depression, headache, nervousness, migraine, dizziness, nausea, vomiting, acne,rash, nettle-rash (urticaria), fluid retention, high blood pressure.

Rare (between 1 and 10 in every 10,000 users may be affected):, vaginal candidiasis (fungal infection), impaired hearing (otosclerosis), thromboembolism, hypersensitivity, increased sexual desire, eye irritatio n

due to contact lens, loss of hair (alopecia), itching, skin disorders (erythema nodosum – a ski n disease associated with joint pain, fever, hypersensitivity, or infection, and characterized by small, painful, pink to

blue nodules under the skin and on the shins that tend to recur; erythema multiforme – a sk in disease characterized by solid raised spots on the skin or fluid-filled blisters lesions and reddening or discoloration

of the skin often in concentric zones about the lesions), vaginal discharge, breast discharge.

Before you have any blood tests

Tell your doctor or the laboratory staff that you aretaking the pill, because oral contraceptives can affect the results of some tests.

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 25°C. Store in original package in order to protect from moisture and light.

Expiry date

Do not use this medicine after the expiry date which is stated on the package 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 Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets contains

The active substances are desogestrel and ethinylestradiol. The other ingredients are:

All-rac-alpha-tocopherol, potato starch, povidone (E1201), stearic acid (E570), silica colloidal anhydrous (E551) and lactose anhydrous.

What Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets look like and contents of the pack

Each tablet is round, white to off-white, uncoated, biconvex, debossed with ‘141’ on one side and other side plain.

Each strip of Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets contains 21 white tablets.

Each box of Desogestrel 150 micrograms/ethinylestradiol 20 micrograms tablets contains 1, 3 or 6 strips of 21 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Duitsland

Manufacturer

Betapharm Arzneimittel GmbH

Kobelweg 95, 86156 Augsburg, Germany

In het register ingeschreven onder:

Desogestrel 150 microgram en Ethinylestradiol 20 microgram betapharm tabletten: RVG 110149

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

Netherlands: Desogestrel 150 microgram and Ethinylestradiol 20 microgram betapharm tabletten Germany: Aricia beta

Deze bijsluiter is vastgesteld op februari 2012