Femodene® This Booklet Tells You About Oral Contraceptives In

femodene® this booklet tells you about oral contraceptives in general and about femodene in detail. please read it carefully to get the bes

Femodene®
This booklet tells you about oral contraceptives in general and about
Femodene in detail. Please read it carefully to get the best from
Femodene. If you are in any doubt about these instructions contact
your doctor, pharmacist or Family Planning clinic.
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 a sperm
reaches it, you can become pregnant. This is called 'conception'.
A fertilised egg gets embedded in the lining of your womb and takes 9
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 changes
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 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 the next section of this booklet.
Product information
The name of your medicine is: Femodene
What does Femodene contain?
Each memo strip of Femodene contains 21 white sugar‑coated tablets
containing 75 micrograms of the progestogen gestodene and 30
micrograms of the
oestrogen ethinyloestradiol(ethinylestradiol}.Progestogen and
oestrogen are both female types of hormone.
Femodene also contains the following inactive ingredients: lactose,
maize starch, povidone, magnesium stearate (E572), sodium calcium
edetate, sucrose, macrogol 6000, calcium carbonate (E170), talc,
montan glycol wax.
Each pack of Femodene contains 3 memo strips of 21 tablets. Packs
containing 1 memo strip of 21 tablets are also available to doctors.
Femodene is a combined oral contraceptive pill. Combined oral
contraceptives contain two female types of hormone, oestrogen and
progestogen.
The product licence is held by
Schering Health Care Ltd
The Brow, Burgess Hill, West Sussex, RH15 9NE
Product licence number 0053/0179
Femodene is manufactured by: Schering AG, Berlin, Germany.
Uses
Femodene is a low dose combined oral contraceptive. When used as
instructed you are very unlikely to become pregnant.
Reasons for not taking Femodene
Before taking Femodene, tell your doctor if you have any of these:
1.
you are pregnant or think you may be pregnant.
2.
blood clots in the legs, lungs, eyes, or anywhere else or have
ever had these. If you have had a heart attack or if you have any
medical condition which makes you more at risk of developing blood
clots.
3.
abnormal red blood cells (sickle‑cell anaemia).
4.
disorders of blood fat (lipid) metabolism.
5.
cancer of the breast or of the lining of the womb (mammary or
endometrial carcinoma) or have ever had either of these
conditions.
6.
abnormal bleeding from your vagina of unknown cause.
7.
certain types of jaundice (Dubin‑Johnson or Rotor syndromes).
8.
severe diabetes with changes to the blood vessels.
9.
liver tumours or have ever had these.
10.
any other long or short‑term liver disease.
11.
allergy to any of the ingredients of Femodene.
Do not take Femodene if you have had any of these conditions when you
were pregnant:
12.
itching of your whole body (pruritus of pregnancy.
13.
the rash known as herpes gestationis.
14.
worsening of inherited deafness (otosclerosis).
15.
yellowing of the skin ( jaundice).
What you should know before taking Femodene
Before you start taking Femodene your pelvic organs, breasts and blood
pressure should be checked by your doctor and these checks should be
repeated regularly. The doctor will also make sure you are not
pregnant.
If anyone in your family has had any illness caused by blood clots, or
a heart attack, or a stroke at a young age, tell your doctor.
The following conditions need watching carefully while you are taking
the pill:
If you have:
16.
severe depressive states, past or present. ‑ varicose veins.
17.
diabetes (diabetes mellitus) or a tendency towards diabetes.
18.
high blood pressure (hypertension).
19.
20.
fits (epilepsy).
21.
the inherited form of deafness known as otosclerosis.
22.
the disease of the nervous system called multiple sclerosis.
23.
the inherited disease called porphyria.
24.
calcium deficiency with cramps (tetany).
25.
the movement disorder called Sydenham's chorea.
26.
breast problems, past or present.
27.
diseases of the heart and blood vessels (cardio­ vascular
diseases).
1.
kidney diseases.
2.
disturbed liver function.
3.
you are very overweight (obese).
4.
an intolerance of contact lenses.
5.
systemic lupus erythematosus‑SLE (inflammation of connective
tissue).
6.
asthma.
7.
uterine fibroids (benign tumour of the womb).
8.
gallstones.
9.
migraine.
10.
brown patches on the face and body (chloasma). This may be reduced
by avoiding too much sunlight.
11.
any disease that is prone to worsen during pregnancy.
or, if:
12.
you have had inflamed veins (phlebitis).
13.
anyone in your family has had breast cancer.
14.
anyone in your family has had any illness caused by blood clots,
or a heart attack or stroke at a young age.
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.
When you stop taking Femodene it may take some
time for your regular periods to return.
Taking other medicines with Femodene
Some medicines may stop Femodene from working
Properly.
If you are taking any other medicine while you are
taking Femodene, 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 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, 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 your present pack
ends before these 7 days, start the next pack the next day without a
break. This means taking a pill every day during your normal 7
pill‑free days.
If you run two packs together 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. 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.
If you are in doubt check with your doctor, pharmacist or Family
Planning clinic.
Stomach upsets
Being sick or having very bad diarrhoea may stop Femodene from working
properly and make it less effective. Carry on taking Femodene 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 you finish your pack before these 7 days, start the
next pack the next day without a break. This means taking a pill every
day during your normal 7 pill-free days. If you run two packs together
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 starting the next pack. If your stomach
upset continues for some time, consult your
doctor who may consider another form of contraception.
Warnings
It has been suggested, on the basis of statistical evidence, 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, for example, deep vein thrombosis (blood
clot in the leg), strokes (blood clots and haemorrhages from the blood
vessels of the brain), heart attacks or pulmonary embolism (blood
clots blocking the arteries of the lungs). People do not always fully
recover from these disorders, and, very rarely, they are fatal.
Studies suggest that these disorders occur less often with modern
low‑dose oral contraceptives than with older pills.
Certain conditions increase the risk of thrombosis. They include:
1.
smoking.
2.
obesity.
3.
some diseases of the heart and blood vessels.
4.
diabetes.
5.
migraine.
6.
a major operation or period of immobilisation (e.g. you are in bed
after an accident or operation or you have a plaster cast on a
broken leg).
7.
if any members of your family have suffered from thromboembolic
diseases {e.g. deep vein thrombosis, stroke or heart attack) at a
young age.
8.
varicose veins.
If any of these conditions apply to you before you decide to take
Femodene or while you are taking Femodene you must discuss them with
your doctor.
The risk of arterial thrombosis (e.g. heart attack and stroke)
associated with the pill increases with age and this risk is increased
by cigarette smoking. For this reason, the use of combined pills by
women in the older age-group, especially those who also smoke, is
discouraged.
Signs and symptoms of blood clots are given in the section Reasons for
stopping Femodene immedi­ately .
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.
The evidence linking use of the pill and breast cancer is unclear.
Some studies suggest an increased risk of breast cancer in women below
the age of 35, the risk increasing the longer the pill is used. Any
possible increased risk of breast cancer with combined pills is,
however, likely to be small.
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.
If you think you might be pregnant, stop taking Femodene and consult
your doctor immediately. Use another method of contraception such as a
condom until you see your doctor.
Certain conditions may sometimes get worse during use of the pill. The
diseases are those listed under “What you should know before taking
Femodene”.
Reasons for stopping Femodene immediately
If you experience any of the following conditions, take no further
tablets of Femodene and consult your
continued
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
open 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 six weeks before
a planned major operation (e.g. 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 (e.g. 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 again.
How to take Femodene
This pack is designed to help you remember to take your pills.
When to start
If you are new to the pill or are starting the pill again after a
break, take your first Femodene tablet 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 after
having a baby" or "Starting Femodene after a miscar­riage or an
abortion".
Start with a pill marked with the correct day of the week. For
instance, if your period starts on a Wednesday, start with a pill
marked "Wed".
Taking your first pack of Femodene
After taking your first pill, take one pill each day, following the
direction of the arrows, until you have finished all 21 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.
Your seven pill-free days
After you have taken all 21 tablets, you have 7 days when you take no
tablets. A few days after you have taken the last pill from each pack,
you will have a period. Your periods will be regular, probably lighter
than before and almost always painless. The feelings that open make
the last days before a period unpleasant (called premenstrual
syndrome) usually disappear. You will not have to take extra
contraceptive precautions during the 7-day break from taking the
pill as long as you have taken your pills correctly and start the next
pack on time.
Taking your next pack of Femodene
Start taking your next pack of Femodene after 7 pill-free days. Each
new pack will begin on the same day of the week as the one before, so
it is easy to remember when to start again. You should start taking
your next pack of Femodene after 7 days, even if you are still
bleeding. The table "How to take Femodene" should help you to take the
pills properly (see figure).
Changing from another type of oral contraceptive
21-day combined pill
If you are taking a 21-day contraceptive pill, finish that pack and
then start taking Femodene the next day. Do not leave a gap between
packs. Start with a pill marked with the correct day of the week. Then
follow the instructions as described before. (see "Taking your first
pack of Femodene"). 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 pack, but this is not harmful. You may have
some bleeding on pill‑taking days, but do not worry.
Every‑Day (ED) combined pill {28-day pill)
Femodene should be started after taking the last active tablet from
the Every‑Day pill pack. If you are not sure which tablets are the
active ones, ask your doctor or pharmacist. The first Femodene tablet
is taken the next day which means that you do not leave a gap between
packs. Start with a pill marked with the correct day of the week.
Return to your pharmacist any remaining inactive tablets from your old
Every-Day pack. Then follow the instructions as before (see "Taking
your first pack of Femodene"). 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 pack, but this is not harmful. You may have
some bleeding on pill‑taking days, but do not worry.
Mini pill (progestogen‑only pill)
The first Femodene 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 led in your old pack. Start with a
pill marked with the correct day of the week. Follow the instructions
as before (see "Taking your first pack of Femodene"). By starting in
this way you will have contraceptive protection at once.
Starting Femodene after having a baby
If you have just had a baby, your doctor may advise you to start
taking Femodene 21 days after delivery. 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 and for the first 7 days of
pill‑taking. Follow the instructions as before (see "Taking your first
pack of Femodene").
The use of Femodene during breast feeding may reduce the amount of
milk that you produce.
Very small amounts of the active ingredients of Femodene are found in
breast milk. If you are breast feeding and want to take Femodene, you
should discuss this with your doctor. Your doctor may decide to give
you the mini pill instead.
Starting Femodene 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 immediately. Follow the
instructions as before (see "Taking your first pack of Femodene").
While you are taking Femodene
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 forget to take a pill
If you forget to take a pill please follow these instructions:
1.
If you are more than 12 hours late in taking a pill, or have
missed more than one pill
Contraceptive protection may be lower, so you must use extra
protection. Follow the instructions for the 7-day rule.
7‑day rule
2.
take the most recent 'late' pill and continue to take your next
pills at your normal times and
3.
use an extra contraceptive method (condoms or cap plus spermicide)
for the next 7 days and
4.
if your present pack ends before the 7 days do, start the next
pack the next day, without a break. Do not leave a gap between
packs. You will not have a period until you have finished the next
pack, but this is not harmful. You may see some bleeding on
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
5.
If one 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.
What should you do if you lose a pill?
If you lose a pill, the easiest thing to do is take the last pill of
the pack in place of the lost pill. Then take all the other pills on
their proper days. Your cycle will be one day shorter than normal, but
contraceptive protection is not affected. After your 7 pill‑free days
you will have a new starting‑day, one day earlier than before. Should
you lose a pack of pills halfway through, ask your doctor or
pharmacist what to do.
What if you have bleeding between periods?
A small number of women may have a little break­through bleeding or
spotting while taking Femodene, 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 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 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.
Overdosage
Overdosage may cause nausea, vomiting and, in females withdrawal
bleeding. You should consult your doctor who will be able to advise
you what action, if any, is necessary.
Possible side‑effects
Sometimes unwanted effects occur with Femodene. These can be mild or
serious.
Mild reactions
Sometimes mild unwanted effects can occur in the first few months
after starting Femodene.
*
bleeding and spotting between your periods can sometimes occur for
the first few months but this usually stops once your body has
adjusted to Femodene. 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 for a number of months. Chloasma
may be reduced by avoiding too much sunlight.
*
poor tolerance of contact lenses.
Serious reactions
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 explained more fully in the "Warnings"
section.
If you think that you have a serious adverse reaction to Femodene stop
taking your tablets and consult your doctor as soon as possible.
If you think you have an unwanted effect due to Femodene which is not
included in this leaflet, tell your doctor or a pharmacist about it.
Effect on blood tests: The use of oral contraceptives may affect the
results of certain laboratory tests. Always tell your doctor or the
laboratory staff that you are using an oral contraceptive.
Expire date: The expire date is printed on the pack. Do not use after
this date.
Storage: Store all medicines out of the reach of children.
Date of last revision of this leaflet: 12 April 1996
® Femodene is a registered trade‑mark of Schering AG.