Femodene, Femodene Pill, Femodene Birth Control

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Femodene

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Femodene

If Femodene is used in the presence of any of the conditions listed below or they appear for the first time or recur or worsen during treatment, you may need to be kept under close observation. Your doctor can explain this to you.

You should tell your doctor if:

you smoke
you have diabetes
you are overweight
you have high blood pressure
you have a heart valve disorder or a certain heart rhythm disorder
you have an inflammation of your veins (superficial phlebitis)
you have varicose veins
anyone in your immediate family has had thrombosis, a heart attack or a stroke
you suffer from headaches
you suffer from epilepsy
anyone in your immediate family has had breast cancer
you have liver, kidney or gallbladder disease
you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)
you have systemic lupus erythematosus (SLE; a disease affecting the skin all over the body)
you have haemolytic uraemic syndrome (HUS; a disorder of blood coagulation causing failure of the kidneys)
you have sickle cell disease
you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation
What else you should know
Femodene does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
In this leaflet, several situations are described where you should stop taking Femodene, or where the reliability of Femodene may be decreased. In such situations you should 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 Femodene alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

Femodene and thrombosis

Thrombosis is the formation of a blood clot which may block a blood vessel.
Thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "pulmonary embolism". Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you become pregnant. The risk is higher in Pill users than in non-users but not as high as during pregnancy.
Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely, blood clots can occur in the liver, gut, kidney or eye.
Very occasionally a thrombosis may cause serious permanent disabilities or may even be fatal.
The risk of having a heart attack or stroke increases as you get older. It also increases the more you smoke.

When using Femodene you should stop smoking, especially if you are older than about 35 years of age.
If you develop high blood pressure while using Femodene, you may be told to stop using it.
The risk of having deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example, when you have your leg or legs in plaster or splints). In women who use Femodene the risk may be even higher. Tell your doctor you are using Femodene well in advance of any expected hospitalisation or surgery. Your doctor may tell you to stop taking Femodene several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking Femodene again after you are back on your feet.

Femodene and cancer

Breast cancer has been diagnosed slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the ten years after stopping use of the Pill. It is not known whether the difference is caused by the Pill. It may be that the women were examined more often, so that the breast cancer was noticed earlier.
In rare cases, benign, and even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding. Contact your doctor immediately if you have severe pain in your abdomen.
Cervical cancer has been reported to occur more often in women using the Pill for a long time. This finding may not be caused by the Pill but may be related to sexual behaviour and other factors.

Femodene and other medicines

Some oral medicines may stop Femodene from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates) and tuberculosis (e.g. rifampicin); and antibiotics (e.g. ampicillin, tetracyclines, griseofulvin) for some other infectious diseases. Always tell the doctor who prescribes Femodene which medicines you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use Femodene. They can tell you if you need to take additional contraceptive precautions and if so, for how long.

Femodene and breast-feeding

Femodene is generally not recommended for use during breast-feeding. If you wish to take the Femodene while breast-feeding, please seek the advice of your doctor.

Femodene and pregnancy

Femodene must not be used by women who are pregnant, or who think they may be pregnant.

Femodene and ability to drive

There are no observed effects.

How to use Femodene properly

The contraceptive protection provided by Femodene is continuous. Additional contraceptive precautions are only required when special circumstances (e.g. forgetting tablets) reduce the reliability of the preparation.
Remember that Femodene has been prescribed for you personally. Do not share it with others.

When and how to take Femodene

The Femodene pack contains 21 small round beige tablets. On the pack each tablet is marked with the day of the week on which it is to be taken. Take your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days you take no tablets. A period should begin during these 7 days (the withdrawal bleed). Usually it will start on day 2 - 3 after the last Femodene tablet. Start taking your next pack on the 8th day even if your period continues. This means that you will always start new packs on the same day of the week, and also that you will have your withdrawal bleed on about the same day each month.

Starting your first pack of Femodene
When no hormonal contraceptive has been used in the past month
Start taking Femodene on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if your period starts on a Monday, take a tablet marked Monday. Then follow the days in order of the directional arrows. When you start taking Femodene your very first cycle may be shorter than usual.

When changing from a combined Pill

You can start taking Femodene the day after you take the last tablet from your present Pill pack (this means no tablet-free break). If your present Pill pack also contains non-hormonal tablets you can start Femodene on the day after taking the last hormonal tablet (if you are not sure which this is, ask your doctor or pharmacist).

When changing from a progestogen-only Pill (minipill)

You can stop taking the minipill any day and start taking Femodene the next day, at the same time. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet taking when having intercourse.

When changing from an injectable or implant

Start using Femodene when your next injection is due or on the day that your implant is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet taking when having intercourse.

After having a baby with Femodene

If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking Femodene. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take Femodene, you should discuss this first with your doctor.

After a miscarriage or an abortion

Your doctor will advise you.

Special circumstances with Femodene

The following describes special circumstances that could alter the way you take Femodene. In all situations where the reliability of Femodene is reduced (such as missing tablets) additional contraceptive precautions are required following the advice given below. This advice should also be followed in situations where other medicines may stop Femodene from working properly and in the case of vomiting after taking Femodene.

If you forget to take your Femodene tablets

If you forget to take your Femodene tablets, follow the instructions below. This is often called the "7 day rule". The more tablets you have missed, the higher the risk that the contraceptive effect is decreased. There is a particularly high risk of becoming pregnant if you miss tablets at the beginning or at the end of the pack.

If you are less than 12 hours late in taking one of your Femodene tablets, you are still protected against pregnancy. Take the tablet as soon as you remember and take the next one at your usual time. This may mean that you are taking 2 tablets in one day.

If you are more than 12 hours late in taking one of your Femodene tablets, you will not be protected. Take the last tablet as soon as you remember and take the next one at your normal time.

This may mean taking 2 tablets in one day. You must take extra contraceptive precautions and you must follow the 7 day rule.

Read the section on "Extra contraceptive precautions" and "The 7 day rule" carefully.

If you forgot tablets in the first week of taking the tablets in your pack and had intercourse in the seven days before, consult your doctor as the possibility of pregnancy should be considered.

If you have forgotten to take your tablets for a few days, consult your doctor to be sure you are not pregnant, then discard the missed tablets and follow the 7 day rule.

Extra contraceptive precautionsç
When you need extra contraceptive precautions, either:

don't have sex; or
use a cap plus spermicide; or
use a condom
Do not use the rhythm or temperature methods as extra contraceptive precautions. This is because oral contraceptives alter the usual menstrual cycle changes, such as changes in temperature and cervical mucus.

The 7 day rule

Continue taking your Femodene Pills
You will not be protected from pregnancy until you have taken your daily hormone Pill for the next 7 days in a row.
Use another method of contraception (Extra contraceptive precautions) such as condoms or do not have sexual intercourse for the next 7 days while taking the next 7 hormone Pills.
If there are fewer than 7 hormone Pills left in the pack, finish the hormone Pills and go straight on to the hormone Pills of the next pack. This means that you do not leave a gap between the hormone Pills. You may not have a period until the end of the next pack. This is not harmful.
If you vomit after taking Femodene
If you vomit within 3 to 4 hours after taking your Femodene, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets.

If you are taking medicines that affect Femodene

Some oral medicines may stop Femodene from working properly. These medicines are listed in an earlier section. For the time that you are taking the medicine and for the next 7 days follow the advice for missed tablets. If you are taking rifampicin, or you are taking these medicines continuously, your doctor will advise you on the length of time you need to take extra contraceptive precautions.

If you want to delay a period

You can delay your period if you start your next pack of Femodene immediately after finishing your current pack. You can continue with this pack for as long as you wish, until this pack is empty. When you wish your period to begin, just stop tablet taking. While using the second pack, you may have some breakthrough bleeding or spotting on tablet-taking days. Start your following pack after the usual 7 day tablet-free break.

If you want to change the starting day of your period
If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten, (never lengthen) the next tablet-free break. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now start your next pack 3 days sooner than you usually do. If you make your tablet-free break very short (e.g. 3 days or less), you may not have a bleeding during the break. You may have some breakthrough bleeding or spotting during the use of the next pack.

If you have unexpected bleeding

As with other Pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) with Femodene between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to Femodene (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.

If you have missed a period

If you have taken all of your tablets at the right time, and you have not vomited or used other medicines, then you are very unlikely to be pregnant. Continue to take Femodene as usual.
If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of Femodene until your doctor has checked you are not pregnant.

Overdosage with Femodene

There have been no reports of serious harmful effects from taking too many Femodene tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken Femodene, ask your doctor for advice.

When using Femodene

Tell your doctor immediately if:

You should stop treatment and see your doctor immediately if you get a blood clot while you are taking Femodene.

Warning signs to look out for are:
an unusual cough
severe pain in the chest which may reach the left arm
breathlessness
any unusual, severe, or prolonged headache or migraine attack
partial or complete loss of vision, or double vision
slurring or speech disability
sudden changes to your hearing, sense of smell, or taste
dizziness or fainting
weakness or numbness in any part of your body
severe pain in your abdomen
severe pain or swelling in either of your legs

Tell your doctor if:
Contact your doctor as soon as possible if:
you notice any changes in your own health, especially involving any of the items mentioned in this leaflet; do not forget about the items related to your immediate family
you feel a lump in your breast
you are going to use other medications
you are to be immobilised or are to have surgery (consult your doctor at least four weeks in advance)
you have unusual, heavy vaginal bleeding
you forgot tablets in the first week of the pack and had intercourse in the seven days before
you miss your period twice in a row or suspect you are pregnant (do not start the next pack until told to by your doctor)
Regular check-ups
When you are using Femodene, your doctor will tell you to return for regular check-ups. In general, you should have a check-up every year.

Side effects of Femodene

Tell your doctor if you notice any unwanted effect, especially if severe or persistent, or if there is a change in your health that you think might be caused by Femodene.

Serious side effects with Femodene

Serious reactions associated with the use of combined oral contraceptives such as Femodene, as well as the related symptoms, are described in the section "Before you use Femodene". Please read this section carefully and consult your doctor where appropriate.

Other possible side effects with Femodene

The following have been reported in users of combined oral contraceptives such as Femodene, although they may not be caused by the contraceptive Pill. Such undesirable effects that occur in the first few months that you are using Femodene will probably lessen with time.

breast tenderness, pain and secretion
headache
changes in sexual drive; depressive moods
contact lens intolerance
nausea, vomiting and feeling sick
changes in vaginal secretion
various skin reactions
fluid retention
changes in body weight
hypersensitivity reactions

Storage of Femodene

Do not use after the expiry date stated on the package.

Store all drugs properly and keep them out of reach of children.

Further information on Femodene

Like other combined oral contraceptive Pills, Femodene may also have non-contraceptive health benefits.

Your period may be lighter and shorter. As a result, the risk of anaemia may be lower. Your period pains may become less severe or may completely disappear.
Some serious disorders have been reported to occur less frequently in users of "high-dose" oral contraceptive Pills. These are benign breast disease, ovarian cysts, pelvic infections (pelvic inflammatory disease or PID), ectopic pregnancy (pregnancy in which the embryo implants outside of the womb) and cancer of the endometrium (lining of the womb) and ovaries. This may also be the case for "low-dose" Pills such as Femodene.

Femodene tablets contain:

active substances (per tablet)

gestodene (0.075mg) and ethinylestradiol (0.03mg)

other substances

lactose monohydrate, maize starch, polyvidone 25 000, sodium calcium edetate, magnesium stearate, sucrose, polyvidone 700 000, macrogol 6000, calcium carbonate, talc, montanglycol wax

If you have any further questions please consult your doctor or pharmacist.

Femodene