You and the pill

How your body gets ready for pregnancy (the menstrual cycle)

You can usually become pregnant (conceive) from when you start to have periods, up until you are in your late 40s. Every menstrual cycle takes about 28 days. About halfway through this cycle an egg is released from one of your ovaries into a Fallopian tube. This is called ovulation.

The egg travels down the Fallopian tube towards your womb. When you make love, your partner's penis releases millions of sperm into your vagina. Some of these sperm travel up through your womb into your Fallopian tubes. If there is an egg in one of these tubes, and sperm reaches it, you can become pregnant. This is called "conception".

A fertilised egg gets embedded in the lining of your womb and takes nine months to grow into a baby. As an egg can live for up to 2 days, and sperm for up to 5 days, you can become pregnant if you have made love up to 5 days before ovulation and for some time afterwards. If a sperm does not fertilise an egg, the egg is lost at the end of the menstrual cycle with the lining of your womb. This is called a "period".

How do natural hormones work?

Your menstrual cycle is controlled by two sex hormones made by your ovaries: one called oestrogen, the other progesterone (a progestogen). Oestrogen increases during the first half of your menstrual cycle, and makes your womb develop a thick lining, ready to receive the egg if conception happens. Progesterone comes later in the cycle and thickens the lining of the womb still further to prepare it for pregnancy.

If you do not become pregnant, you make less of these hormones and this causes the lining of your womb to break down and the lining leaves your body as a period. But during pregnancy, your ovaries, and then the placenta (this attaches the growing baby to the womb and gives it food), carry on making progesterone and oestrogen to stop any more eggs being released.

How does the pill work?

A pill such as Femodene ED contains hormones which are like those your body produces (oestrogen and progestogen). These help 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 3 ways:

• No egg is released to be fertilised by sperm
• The fluid in the neck of your womb thickens so it is more difficult for sperm to enter it
• The lining of your womb does not thicken enough for an egg to grow in it.

How effective is the pill?

The pill is one of the most effective contraceptives apart from sterilisation. But this can only be true when it is taken correctly. So you must follow your doctor's instructions and take the tablets exactly as it says in this leaflet.

The name of your medicine is: Femodene ED

What does Femodene ED contain?

Each memo strip of Femodene ED contains 21 white sugar-coated tablets containing 75 micrograms of the progestogen gestodene and 30 micrograms of the oestrogen ethinyloestradiol (ethinylestradiol) and 7 larger, white, inactive tablets. Progestogen and oestrogen are both female types of hormone.

An active ingredient in this medicine is ethinylestradiol. This is the new name for ethinyloestradiol. The ingredient itself has not changed.

Femodene ED also contains the following inactive ingredients:

lactose
maize starch
povidone
magnesium stearate (E572)
sucrose
macrogol 6000
sodium calcium edetate
calcium carbonate (E 170)
talc
montan glycol wax.

Regular check-ups

Before you start taking Femodene ED, your doctor should take a medical history by asking you some questions about yourself and also about other members of your family. Your doctor should also ask you these questions on a regular basis, for example, when you come back to see your doctor for more pills. Your doctor will also take your blood pressure and may check your breasts, abdomen and pelvic organs if this is considered necessary. You may also need to have a cervical smear test. Your doctor will also make sure you are not pregnant.

Tell your doctor immediately if:

If you experience any of the following conditions take no further tablets of Femodene ED and consult your doctor immediately. In the meantime use another method of contraception such as a condom.

• Migraine for the first time, or if existing migraine occurs more often than before.
• unusually bad headaches or if you have headaches more often than before.
• sudden changes to your eyesight, hearing, speech, sense of smell, taste or touch.
• unusual pains in your leg or unusual swelling of your arms or legs, sharp pains in your chest or sudden shortness of breath, crushing pains or feelings of heaviness in your chest, coughing for no apparent reason, dizziness or fainting, or if one side of your body suddenly becomes very weak or numb. These may be symptoms of blood clot formation or symptoms of an inflammation of veins combined with the formation of blood clots (thrombophlebitis).
• your skin becomes yellow (jaundice), you develop hepatitis (inflammation of the liver) or if your whole body starts itching.
• an increase in the number of fits (epileptic seizures).
• a large increase in your blood pressure.
• severe depression
• severe upper abdominal pains or unusual swelling of your abdomen.
• definite worsening of conditions which had got worse during a previous pregnancy or while taking the pill in the past.
• pregnancy
• surgery or immobilisation. You must stop Femodene ED six weeks before a planned major operation (eg stomach surgery), if you are having any surgery to the legs, or medical treatment for varicose veins. Also if you are immobilised for a long time (eg you are in bed after an accident or operation or you have a plaster cast on a broken leg). Your doctor will advise you when to start taking Femodene ED again.

Tell your doctor as soon as you can if:

If you know you suffer from the following conditions be sure to tell your doctor as these conditions may get worse while you are taking the pill. If the condition does get worse tell your doctor as soon as you can.

• Severe depression, or have ever had this
• varicose veins
• diabetes (diabetes mellitus) or a tendency towards diabetes
• high blood pressure (hypertension)
• fits (epilepsy)
• the inherited form of deafness known as otosclerosis
• the disease of the nervous system called multiple sclerosis
• the inherited disease called porphyria
• calcium deficiency with cramps (tetany)
• the movement disorder called Sydenham's chorea
• breast problems, past or present
• diseases of the heart and blood vessels (cardiovascular diseases)
• kidney diseases
• disturbed liver function
• you are very overweight (obese)
• an intolerance of contact lenses
• systemic lupus erythematosus-SLE (a disease affecting the skin all over the body)
• asthma
• uterine fibroids (benign tumour of the womb)
• gallstones
• migraine
• brown patches on the face and body (chloasma). This may be reduced by avoiding too much sunlight
• any disease that is prone to worsen during pregnancy
  
  or, if:
• you have had inflamed veins (phlebitis)
• anyone in your family has had breast cancer.

If any of these conditions gets worse or you have them for the first time, this may be a sign that you should stop taking Femodene ED.

When you stop taking Femodene ED it may take some time for your regular periods to return.

Taking other medicines with Femodene ED

Some medicines may stop Femodene ED from working properly.
If you are taking any other medicine while you are taking Femodene ED, be sure to tell your doctor (or dentist). Your doctor (or dentist) can tell you whether you should use extra contraceptive precautions and for how long.

Medicines which can sometimes stop Femodene ED from working properly are antibiotics (such as ampicillin and rifampicin); griseofulvin (which is used to treat fungal infections); phenylbutazone (which is used as an anti-inflammatory drug to treat some types of joint diseases); phenytoin, primidone, phenobarbitone and some other medicines used in people with epilepsy, and carbamazepine (which can be used to treat epilepsy or other illnesses).

If you are taking any of these medicines you might still be able to use Femodene ED, but you will also need to use an extra contraceptive method (condoms or cap plus spermicide) while you are taking the other medicine and for 7 days after you stop taking it. If these 7 days extend beyond the last active (small) tablet, finish taking the small active tablets, throw away the large white inactive tablets and start a new pack of Femodene ED the next day. Start with the tablet marked 'start' and use the self-adhesive strips to help you to see on which day you have to take each tablet (see “How to take Femodene ED”).

If you have to miss the large white inactive tablets you may not have a period until the end of two packs, but this is not harmful. If you do not have a period after the second pack, you must talk to your doctor before you start the next pack.

If you are taking rifampicin you will need to use another method of contraception as well as Femodene ED. You should do this while you are taking the rifampicin and for 4 weeks after you stop.

If you are diabetic your doctor may alter the dose of medicine required to treat your diabetes.

The herbal remedy St John's wort (Hypericum perforatum) should not be taken at the same time as Femodene ED. If you already take a St John's wort preparation, stop taking the St John's wort and mention it to your doctor at your next visit.

If you are in doubt, please check with your doctor, pharmacist or Family Planning clinic.

Before you have any blood tests

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

 

What else you need to know

Risks associated with taking medicines are varied but largely depend on the individual taking the medicine. These differences in risk are explained more fully here.

The pill and thrombosis

Some studies have suggested that the risk of developing various disorders of the circulation of the blood is slightly greater in women who take the combined pill than in those who do not.
This can lead to a thrombosis. A thrombosis is when you have a blood clot which may block a blood vessel. It may form in the veins (venous thrombosis) or in the arteries (arterial thrombosis). Most blood clots can be treated, with no long-term danger. However, a thrombosis may cause serious permanent disabilities or could even kill you. This is very rare.

A thrombosis sometimes happens 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 “pulmonary embolism”. Deep venous thrombosis is a rare condition.

Blood clots can also happen very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke).

In extremely rare cases blood clots can happen in other places such as the liver, gut, kidney or eye.

A thrombosis can develop whether or not you are taking the pill. It can also happen if you become pregnant. The risk is higher in people who take the pill than in people who don't take the pill, but is not as high as the risk during pregnancy. A thrombosis is most likely in the first year of taking any combined pill.

In healthy non-pregnant women not taking the pill:
about 5 cases of thrombosis occur per 100,000 women per year.

In women taking combined oral contraceptive pills which contain the progestogen levonorgestrel:
about 15 cases of thrombosis occur per 100,000 women per year.

In women taking combined oral contraceptive pills which contain the progestogens gestodene or desogestrel:
about 25 cases of thrombosis occur per 100,000 women per year.

In pregnant women:
about 60 cases of thrombosis occur per 100,000 pregnancies per year. That is 2 to 4 times the risk of being on the pill.

Remember the differences between the risks for the type of pills mentioned here are very small (0.01%) and your doctor will have chosen the pill that most suits your needs.

You should also remember that certain conditions increase the risk of thrombosis. They include:

• age (the risk of having a heart attack or stroke increases as you get older)
• smoking (with heavier smoking and increasing age the risk further increases). When using the pill stop smoking, especially if you are older than 35 years
• if any member of your close family has had any illness caused by blood clots, or a heart attack, or a stroke, you may have a higher risk of thrombosis
• if you are very overweight
• if you have a disorder of blood fat (lipid) metabolism, or other very rare blood disorders that may increase your risk of thrombosis
• if you have high blood pressure
• if you have a heart valve disorder or a certain heart rhythm disorder
• if you gave birth recently (you will have an increased risk of thrombosis for up to 6 weeks after giving birth)
• if you have diabetes mellitus
• if you have systemic lupus erythematosus (SLE - a disease affecting the skin all over the body)
• if you have haemolytic uraemic syndrome (HUS - a disorder where the blood clots cause the kidneys to fail)
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases)
• if you have sickle cell disease
• if you have had a subarachnoid haemorrhage (haemorrhage from the blood vessels of the brain)
• if you have an operation or can't move around as normal.

The risk of having a deep venous thrombosis temporarily increases after an operation or during a period when you can't move around as normal (for example, when you have your leg or legs in plaster or splints). In women who use the pill, the risk could be higher. Tell your doctor you are using the pill well before you expect to be admitted into hospital or have surgery. Your doctor may tell you to stop taking the pill several weeks before surgery or after an operation. Your doctor will also tell you when you can start taking the pill again after you are back on your feet.

If any of these conditions of increased risk apply to you before you decide to take Femodene ED, or while you are taking it, you must discuss them with your doctor straight away.

If you notice possible signs of a thrombosis, stop taking the pill and consult your doctor immediately (see “Tell your doctor immediately if”). In the meantime use another method of contraception such as a condom.

The pill and cancer

The pill does give a substantial degree of protection against cancers of the ovary and the lining of the womb. An increased risk of cervical cancer in long-term users of the pill has been reported in some studies. It is uncertain whether this increased risk is caused by the pill, as it could be due to the effects of sexual behaviour and other factors.

Every woman is at risk of breast cancer whether or not she takes the Pill. Breast cancer is rare under the age of 40 years, but the risk increases as a woman gets older. Breast cancer has been found slightly more often in women who take the Pill than in women of the same age who do not take the Pill. If women stop taking the Pill this reduces the risk so that 10 years after stopping the Pill, the risk of finding breast cancer is the same as for women who have never taken the Pill. Breast cancer seems less likely to have spread when found in women who take the Pill than in women who do not take the Pill.

It is not certain whether the Pill causes the increased risk of breast cancer. It may be that women taking the Pill are examined more often, so that breast cancer is noticed earlier. The risk of finding breast cancer is not affected by how long a woman takes the Pill but by the age at which she stops. This is because the risk of breast cancer strongly increases as a woman gets older.

The chart below shows the background chances of breast cancer at various ages for 10,000 women who have never taken the Pill (black bars) and for 10,000 women whilst taking the Pill and during the 10 years after stopping it (grey bars). The small extra risk of finding breast cancer can be seen for each age group. This small possible additional risk in women who take the Pill has to be balanced against the fact that the Pill is a very effective contraceptive and it may also help prevent cancer of the womb or ovary.

The combination of ethinyloestradiol and gestodene, like other contraceptives, has been linked with an increased incidence of abnormal growths in the rat liver, but it is unclear whether this could happen in humans. On rare occasions, the use of the pill has led to liver diseases such as jaundice and benign liver tumours, and, very rarely, it has been associated with some forms of malignant liver tumours (cancer) in long-term users. Liver tumours may lead to life-threatening intra-abdominal haemorrhage (bleeding in the abdomen). Therefore, if you have pain in the upper abdomen that does not soon clear up, tell your doctor. Also, if your skin becomes yellow (jaundice) you must tell your doctor.

The pill and pregnancy

If you think you might be pregnant, stop taking Femodene ED and consult your doctor immediately. Use another method of contraception such as a condom until you see your doctor.

Remember

Certain conditions may sometimes get worse during use of the pill. The diseases are those listed under “Take special care with Femodene ED”.

When to start

• If you are new to the pill or are starting the pill again after a break, take your first Femodene ED pill on the first day of bleeding of your next period. For other users, follow instructions for “Changing from another type of oral contraceptive”, “Starting Femodene ED after having a baby” or “Starting Femodene ED after a miscarriage or an abortion”.
• Find the set of self-adhesive strips. Each strip starts with a different day of the week. Peel off a strip that starts with your starting day.
• For instance, if you start the tablets on a Wednesday, use a strip that starts with 'Wed'.
• Stick the strip along the top of the foil memo-strip so that the first day is above the pill marked 'start'.
• You can now see on which day you have to take each tablet.

Taking your first pack of Femodene ED

• After taking your first pill which is marked 'start', take one pill each day, following the direction of the arrows, until you have finished all 28 pills in the pack.
• You should try to take the pill at the same time every day, for example, after breakfast.
• Swallow each pill, whole, with water if necessary.
• By starting in this way you will have contraceptive protection at once.

Taking your next pack of Femodene ED

When you have finished the first pack, start a new pack (or memo strip) the next day. Do not leave a gap between packs. You will always start each new pack on the same day of the week. The first pill you will take will be the one marked 'start'. For example, if you finish a pack on Tuesday, take the pill marked ' start' on Wednesday and use the self-adhesive strip that starts with a 'Wed' to help you to see on which day you have to take each tablet.

A few days after you have taken the last active tablet from each pack, you will have a period. Your periods will be regular, probably lighter than before and almost always painless. The feelings that often make the last days before a period unpleasant (called premenstrual syndrome) usually disappear.

Changing from another type of oral contraceptive

21 day combined pill
If you are already taking a 21 day contraceptive pill, finish that pack and then start taking Femodene ED the next day - for example Tuesday if you finished your other contraceptive pill on Monday. Start the Femodene ED with the pill marked 'start', then follow the instructions as described under "Taking your first pack of Femodene ED". Do not leave a gap between packs.

By starting in this way, you will have contraceptive protection at once. You may not have a period until the end of the first Femodene ED pack, but this is not harmful.

Every Day (ED) combined pill (28 day pill)
If you are already taking a 28 day (ED) contraceptive pill, finish the pack by taking all the small active tablets. Throw away the remaining larger white inactive tablets.
Start the Femodene ED pack, the next day, by taking the tablet marked 'start', then follow the instructions as described under “How to take Femodene ED”. By starting in this way you will have contraceptive protection at once. You may not have a period until the end of the first Femodene ED pack, but this is not harmful.

Mini pill (progestogen-only pill)

The first Femodene ED tablet should be taken on the first day of the period, even if you have already taken a mini pill on that day. Return to your pharmacist any mini pills left in your old pack. Start with the pill marked 'start', then follow the instructions as described under "Taking your first pack of Femodene ED". By starting in this way you will have contraceptive protection at once.

Starting Femodene ED after having a baby

Very small amounts of the active ingredients of Femodene ED are found in breast milk. If you are breast feeding and want to take Femodene ED, you should discuss this with your doctor. Your doctor may decide to give you the mini pill instead.
If you have just had a baby, your doctor may advise you to start taking Femodene ED 21 days after delivery provided that you are fully mobile. You do not have to wait for a period. You will need to use another method of contraception, such as a condom, until you start Femodene ED and for the first 7 days of tablet taking. Follow the instructions as described under “Taking your first pack of Femodene ED” but remember you will need additional contraceptive precautions for the first 7 days.

The use of Femodene ED during breast feeding may reduce the amount of milk that you produce.

Starting Femodene ED after a miscarriage or an abortion

If you have just had a miscarriage or an abortion your doctor may advise you to start using Femodene ED immediately. Follow the instruction as described under “Taking your first pack of Femodene ED”.

While you are taking Femodene ED

What to do if you miss a period

Occasionally, you may miss a period. While this can mean you are pregnant, it is most unlikely if you have taken your pills correctly. Take your next pack as normal. If you think that you might have put yourself at risk (e.g. missed pills, taking other medicines) or if you miss a second period, see your doctor at once.

What to do if you take more Femodene ED than you should
An accidental overdose is unlikely to be harmful but may cause nausea, vomiting and in females, withdrawal bleeding. You should consult your doctor who will be able to tell you what action, if any, is necessary.

What to do if you forget to take an active pill (one of the 21 small tablets)

Look at your pill packet which contains 21 active tablets and 7 inactive tablets.

If you forget to take an active pill please follow these instructions:

1. If you are more than 12 hours late in taking an active pill, or have missed more than one active pill

Contraceptive protection may be lower, so you must use extra protection. Follow the instructions for the 7-day rule.

7-day rule

• take the most recent 'late' pill and continue to take your next pills at your normal times and
• use an extra contraceptive method (condoms or cap plus spermicide) for the next 7 days and
• if these 7 days go beyond the last active (small) tablet, take the small active tablets, throw away the large white inactive tablets and start a new pack of Femodene ED the next day. Start with the tablet marked 'start' and use the self-adhesive strips to help you to see on which day you have to take each tablet (see “How to take Femodene ED”). If you have to miss the large white inactive tablets you may see some bleeding on active pill-taking days, but do not worry. If you do not have a period after the second pack, you must talk to your doctor before you start the next pack.

2. If one active pill is 12 hours late or less

Don't worry. Contraceptive protection should not be affected if you take the late pill at once, and keep taking your next pills at the usual time. This may mean taking two pills in one day.

Stomach upsets
Being sick or having very bad diarrhoea may stop Femodene ED from working properly and make it less effective. Carry on taking Femodene ED as usual, and also use another method of contraception, (condom or cap plus spermicide) until 7 days after you have recovered from the stomach upset. If these 7 days extend beyond the last active (small) tablet, finish taking the active tablets, throw away the large white inactive tablets and start a new pack of Femodene ED the next day. Start with the tablet marked 'start' and use the self-adhesive strips to help you to see on which day you have to take each tablet (see "How to take Femodene ED"). If you have to miss the large inactive tablets you may not have a period until the end of two packs. If you do not have a period after the second pack, you must talk to your doctor before starting the next pack. If your stomach upset continues for some time, consult your doctor who may consider another form of contraception.

What to do if you forget to take one of the large white inactive pills

Don't worry. Take the tablet as soon as you can and then keep taking your next pills at the usual time. This may mean taking two pills in one day.

What should you do if you lose one of the small white active pills?

Contact your doctor or pharmacist for advice as soon as possible.

What if you have bleeding between periods?

A small number of women may have a little breakthrough bleeding or spotting while taking Femodene ED, especially during the first few months. Normally, this bleeding is nothing to worry about, and will stop in a day or two. Keep taking the pills as usual, and the problem should disappear after the first few packs.

If the bleeding keeps on returning, is annoying or long-lasting, talk to your doctor. Also, if you start to have breakthrough bleeding for the first time after being on Femodene ED for a long time, you should see your doctor.

Unexpected bleeding may also be a sign of irregular pill-taking, so try to take your pill at the same time every day.

Will you put on weight?

Unless you usually have trouble keeping your weight down this is unlikely. But you may find you have a bigger appetite while you are taking the pill, so it is wise to watch what you eat.

What if you want to have a baby?

The bleeding you have after each pack (including the last pack) is not a true period. Your doctor relies on the date of your last true period before you get pregnant to tell you when your baby will be born. So, if you stop taking Femodene ED to have a baby, use another method of contraception until you have had a true period. However, it will not be harmful if you become pregnant straight away.

Are there any extra benefits of the pill?

Your periods may become shorter, more regular and less painful. Heavy periods may become lighter. The symptoms that often make the last few days before a period so unpleasant (known as premenstrual syndrome) usually disappear. Long-term use of the pill reduces your risk of cancers of the ovaries and of the lining of the womb.

Serious reactions

Like all medicines Femodene ED can have side-effects. More serious reactions have sometimes been associated with contraceptive pills that contain oestrogen and progestogen, for example thrombosis (the formation of a clot in blood vessels) or liver disease. These are listed in Section 3 under “Tell your doctor immediately if”.

If you think that you have a serious adverse reaction to Femodene ED, stop taking your tablets and consult your doctor immediately. In the meantime use another method of contraception such as a condom.

Mild reactions

Sometimes mild unwanted effects can occur in the first few months after starting Femodene ED.

• Bleeding and spotting between your first periods can sometimes occur for the first few months but this usually stops once your body has adjusted to Femodene ED. If it continues, becomes heavy or starts again, contact your doctor
• headaches
• feeling sick, being sick and stomach upsets
• sore breasts
• depressive moods, loss of interest in sex
• changes in weight
• chloasma (yellow brown patches on the skin). This may happen even if you have been using Femodene ED for a number of months. Chloasma may be reduced by avoiding too much sunlight
• poor tolerance of contact lenses.

If you think you have an unwanted effect due to Femodene ED even if it is not included in this leaflet, tell your doctor or a pharmacist about it.