TRIADENE

Active substance: GESTODENE

View full screen / Print PDF » Download PDF ⇩

Transcript
81559716_04.indd 1

09.04.2013 09:51:09

!

The Pill is a reliable contraceptive and
may reduce your risk of cancer of the
ovary and womb if used in the long
term.
The Pill will not protect you against
sexually transmitted diseases.
This medicine can increase your risk of
problems such as blood clots and breast
cancer.
Some women should not take the Pill
because of current medical problems
or illnesses. Please read this leaflet to
make sure Triadene is right for you.
To prevent pregnancy it is important
to take Triadene as instructed and
start each pack on time. Please make
sure that you understand what to do
if you miss a pill or if you think you are
pregnant.
Read all of this leaflet carefully before
you start taking this medicine.
Keep this leaflet. You may need to read
it again.
If you have any questions or need more
advice, ask your doctor, family planning
nurse or pharmacist.
This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them.
If any of the side effects gets severe,
or if you notice any not listed in this
leaflet, please tell your doctor, family
planning nurse or pharmacist.

Five important things to know about
the Pill.

Gestodene
Ethinylestradiol

Triadene®

Package leaflet: Information for the user

Triadene is a combined oral contraceptive
pill (‘the Pill’). You take it to stop you
getting pregnant.
This contraceptive contains two types
of female sex hormones, oestrogen and
progestogen. These hormones stop you
getting pregnant by working in three
ways: by preventing an egg being released
from your ovaries; by making the fluid
(mucus) in your cervix thicker, which makes
it more difficult for sperm to enter the
womb; and by preventing the lining of your
womb thickening enough for an egg to
grow in it.
Triadene is a 21-day Pill – you take one
each day for 21 days, followed by 7 days
when you take no pills.
The benefits of taking the Pill include:
it is one of the most reliable reversible
methods of contraception if used
correctly
it doesn’t interrupt sex
it usually makes your periods regular,
lighter and less painful
it may help with pre-menstrual
symptoms.
Triadene will not protect you against sexually
transmitted infections, such as Chlamydia or
HIV. Only condoms can help to do this.
Triadene needs to be taken as directed
to prevent pregnancy.

1. What Triadene does

In this leaflet:
1. What Triadene does
2. Make sure Triadene is OK for you
3. Taking Triadene
3.3 A missed pill
4. Possible side effects
5. How to store Triadene
6. What is in Triadene and who makes it

It’s important that you understand the
benefits and risks of taking the Pill before
you start taking it, or when deciding
whether to carry on taking it. Although the
Pill is suitable for most healthy women it
isn’t suitable for everyone.
 Tell your doctor if you have any of the
illnesses or risk factors mentioned in
this leaflet.
Before you start taking the Pill
Your doctor will ask about you and
your family’s medical problems, check
your blood pressure and exclude the
likelihood of you being pregnant. You
may also need other checks, such as a
breast examination, but only if these
examinations are necessary for you, or
if you have any special concerns.
While you’re on the Pill
You will need regular check-ups
with your doctor or family planning
nurse, usually when you need another
prescription of the Pill.
You should go for regular cervical
smear tests.
Check your breasts and nipples every
month for changes – tell your doctor if
you can see or feel anything odd, such
as lumps or dimpling of the skin.
If you need a blood test tell your
doctor that you are taking the Pill,
because the Pill can affect the results of
some tests.
If you’re going to have an operation,
make sure your doctor knows about
it. You may need to stop taking the Pill
about 4–6 weeks before the operation.
This is to reduce the risk of a blood clot
(see section 2.1). Your doctor will tell
you when you can start taking the Pill
again.

2. Make sure Triadene
is OK for you

The Pill may slightly increase your
risk of having a blood clot (called a
thrombosis), especially in the first year
of taking it.
A clot in a leg vein – a deep vein thrombosis
(or DVT) – is not always serious. However,
if it moves up the veins and blocks an
artery in the lungs, it can cause chest pain,
breathlessness, collapse or even death.
This is called a pulmonary embolism and is
very rare.
Your chances of having a blood clot
are only increased slightly by taking
the Pill.
Of 100,000 women who are not on the
Pill and not pregnant, about 5 will have
a blood clot in a year.
Of 100,000 women taking a Pill such
as Triadene, about 25 will have a blood
clot in a year.
Of 100,000 women who are pregnant,
around 60 will have a blood clot in a
year.
Very rarely, blood clots can also form in the
blood vessels of the heart (causing a heart
attack) or the brain (causing a stroke). In
healthy young women the chance of having
a heart attack or stroke is extremely small.
You are more at risk of having a blood
clot:
as you get older
if you smoke
if you or any of your close family have
had blood clots
if you are seriously overweight
if you have a disorder of blood fat
(lipid) metabolism, or some other very
rare blood disorders
if you have high blood pressure
if you suffer from migraines
if you have a heart valve disorder or a
particular type of irregular heartbeat
(atrial fibrillation)
if you have recently had a baby
if you have diabetes
if you have certain rare medical
conditions such as systemic lupus

2.1 The Pill and blood clots

erythematosus, sickle cell disease,
Crohn’s disease or ulcerative colitis
if you’re off your feet for a long time
because of major surgery, injury or
illness.
 Tell your doctor if any of these apply
to you. Taking the Pill may add to this
risk so Triadene may not be suitable
for you.
Signs of a blood clot include:
a migraine for the first time, a
migraine that is worse than normal
or unusually frequent or severe
headaches
any sudden changes to your eyesight
(such as loss of vision or blurred vision)
any sudden changes to your hearing,
speech, sense of smell, taste or
touch
pain or swelling in your leg
stabbing pain when you breathe
coughing for no apparent reason
pain and tightness in the chest
sudden weakness or numbness in one
side or part of your body
dizziness or fainting.
 See a doctor as soon as possible. Do
not take any more Triadene until
your doctor says you can. Use another
method of contraception, such as
condoms, in the meantime.

While high dose Pills reduces your risk
of cancer of the ovary and womb if used
in the long term, it is not clear whether
lower dose Pills like Triadene also provide
the same protective effects. However, it
also seems that taking the Pill slightly
increases your risk of cancer of the cervix
– although this may be due to having sex
without a condom, rather than the Pill. All
women should have regular smear tests.
If you have breast cancer, or have had it in
the past, you should not take the Pill. The
Pill slightly increases your risk of breast
cancer. This risk goes up the longer you’re
on the Pill, but returns to normal within
about 10 years of stopping it. Because
breast cancer is rare in women under the
age of 40, the extra cases of breast cancer
in current and recent Pill users is small.
For example:
Of 10,000 women who have never
taken the Pill, about 16 will have
breast cancer by the time they are 35
years old.
Of 10,000 women who take the Pill for
5 years in their early twenties, about
17–18 will have breast cancer by the
time they are 35 years old.
Of 10,000 women who have never
taken the Pill, about 100 will have
breast cancer by the time they are 45
years old.
Of 10,000 women who take the Pill for
5 years in their early thirties, about
110 will have breast cancer by the time
they are 45 years old.
Your risk of breast cancer is higher:
if you have a close relative (mother,
sister or grandmother) who has had
breast cancer
if you are seriously overweight.
 See a doctor as soon as possible
if you notice any changes in your
breasts, such as dimpling of the skin,
changes in the nipple or any lumps you
can see or feel.
Taking the Pill has also been linked to liver
diseases, such as jaundice and non-cancer
liver tumours, but this is rare. Very rarely,

2.2 The Pill and cancer

 Tell your doctor or family planning
nurse if you have any medical
problems or illnesses.
Do not take Triadene if any of the
following apply to you. Taking Triadene
would put your health at risk.
If you have or have ever had breast
cancer
If you have ever had a problem with
your blood circulation. This includes a
blood clot (thrombosis) in the legs (deep
vein thrombosis), lungs (pulmonary
embolism), heart (heart attack), brain
(stroke) or any other parts of the body
If you have any condition which makes
you more at risk of a blood clot
(thrombosis – see section 2.1, The Pill
and blood clots)
If you have very high or uncontrolled
blood pressure
If you have any symptoms of a blood
clot, such as chest pain (angina
pectoris) or ‘mini-stroke’ (transient
ischaemic attack)
If you have ever suffered from
migraine with visual disturbances
If you have ever had a severe liver
disease, and you have been told by
your doctor that your liver function test
results are not yet back to normal
If you have ever had liver tumours
If you have severe diabetes affecting
your blood vessels
If you are allergic (hypersensitive) to
any of the ingredients in Triadene.
 If you suffer from any of these, or
get them for the first time while taking
Triadene, contact your doctor as soon
as possible. Do not take Triadene.

2.3 Triadene should not be taken
by some women

the Pill has also been linked with some
forms of liver cancer in women who have
taken it for a long time.
 See a doctor as soon as possible if
you get severe pain in your stomach,
or yellow skin or eyes ( jaundice). You
may need to stop taking Triadene.

 Tell your doctor or family planning
nurse if any of these apply to you.
Also tell them if you get any of these
for the first time while taking the
Pill, or if any get worse or come back,
because you may need to stop taking
Triadene.

Some of the conditions listed below can be
made worse by taking the Pill. Or they may
mean it is less suitable for you. You may
still be able to take Triadene but you need
to take special care and have check-ups
more often.
If you have diabetes
If you or your close family have ever had
problems with your heart, or circulation
such as high blood pressure
If you or your close family have ever had
problems with blood clotting
If you have the inherited disease called
porphyria
If you are overweight (obese)
If you have migraines
If you have inflammation of the
pancreas (pancreatitis) or a history
or family history of high levels of fat
in your blood (hypertriglyceridemia),
as you may be at risk of developing
pancreatitis
If you have any illness that worsened
during pregnancy or previous use of
the Pill (see section 4.2)

2.4 Triadene can make some
illnesses worse
If you ever need to take another medicine
at the same time as being on the Pill,
always tell your doctor, pharmacist or
dentist that you’re taking Triadene. Also
check the leaflets that come with all your
medicines to see if they can be taken with
hormonal contraceptives.
Some medicines can stop Triadene from
working properly – for example:
some medicines used to treat
epilepsy
some medicines used to treat HIV
griseofulvin (an anti-fungal medicine)
certain antibiotics
certain sedatives (called barbiturates)
St. John’s Wort (a herbal remedy).
If you do need to take one of these
medicines, Triadene may not be suitable
for you or you may need to use extra
contraception for a while. Your doctor,
pharmacist or dentist can tell you if this is
necessary and for how long.
Triadene can also affect how well other
medicines work. Your doctor may need to
adjust the dose of your other medicine.
In addition, Triadene can also interfere
with the results of some blood tests, so
always tell your doctor that you are taking
Triadene if you have a blood test.

2.5 Taking other medicines

If you have been told by your doctor that
you have intolerance to some sugars,
contact your doctor before using Triadene.

2.9 Triadene contains lactose and
sucrose

Triadene has no known effect on the ability
to drive or use machines.

2.8 Driving and using machines

Do not use Triadene if you are pregnant.
If you think you might be pregnant, do a
pregnancy test to confirm that you are before
you stop taking Triadene.
If you are breast-feeding, your doctor
or family planning nurse may advise you
not to take Triadene. They will be able
to suggest alternative contraception.
Breast-feeding may not stop you getting
pregnant.

2.7 Pregnancy and breast-feeding

There are no special instructions about
food and drink while on Triadene.

2.6 Taking Triadene with food and
drink

81559716_04.indd 2

09.04.2013 09:51:32

As long as you take Triadene correctly, you will
always start each new strip on the same day of
the week.

Start taking your next strip of Triadene after the
seven pill-free days – even if you are still bleeding.
Always start the new strip on time.

Within a few days of taking the last pill from the
strip, you should have a withdrawal bleed like a
period. This bleed may not have finished when it
is time to start your next strip of pills.
You don’t need to use extra contraception during
these seven pill-free days – as long as you have
taken your pills correctly and start the next
strip of pills on time.
Then start your next strip

take the last pill of one pack on a Friday, you will take
the first pill of your next pack on the Saturday of the
following week.

To prevent pregnancy, always take Triadene
as described below. Check with your doctor or
family planning nurse if you are not sure.
Take Triadene every day for 21 days
Triadene comes in strips of 21 pills (6 beige, 5
dark brown and 10 white tablets), each marked
with a number.
Take your pill at the same time every day.
Start by taking pill number 1 and mark
that day of the week under the heading “I
took my first pill on” by piercing the small
unnumbered foil disc. This will remind you
on which day you started taking the course
of pills.
Follow the direction of the arrows on the
strip. Take one pill each day, until you have
finished all 21 pills.
Swallow each pill whole, with water if
necessary. Do not chew the pill.
Then have seven pill-free days
After you have taken all 21 pills in the strip, you
have seven days when you take no pills. So if you

3.1 How to take it

3. Taking Triadene

As a new user or starting the Pill again after
a break
It is best to take your first Triadene pill on the
first day of your next period. By starting in this
way, you will have contraceptive protection with
your first pill.
Changing to Triadene from another
contraceptive Pill
If you are currently taking a 21-day
Pill: start Triadene the next day after the
end of the previous strip. You will have
contraceptive protection with your first pill.
You will not have a bleed until after your first
strip of Triadene.
If you are taking a 28-day Pill: start taking
Triadene the day after your last active pill.
You will have contraceptive protection with
your first pill. You will not have a bleed until
after your first strip of Triadene.
Or, if you are taking a progestogen-only
Pill (POP or ‘mini Pill’): start Triadene on the
first day of bleeding, even if you have already
taken the progestogen-only Pill for that day.
You will have contraceptive cover straight
away.
Starting Triadene after a miscarriage
or abortion
If you have had a miscarriage or an abortion
during the first three months of pregnancy,
your doctor may tell you to start taking
Triadene straight away. This means that you will
have contraceptive protection with your first pill.
If you have had a miscarriage or an abortion
after the third month of pregnancy, ask your
doctor for advice. You may need to use extra
contraception, such as condoms, for a short
time.
Contraception after having a baby
If you have just had a baby, your doctor may
advise you that Triadene should be started
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
Triadene and for the first 7 days of pill taking.

3.2 Starting Triadene

If you have missed any of the pills in a strip,
and you do not bleed in the first pill-free
break, you may be pregnant. Contact your
doctor or family planning clinic, or do a
pregnancy test yourself.

next 7 days.
R When you have finished the strip, leave the
usual 7-day break before starting the next strip.
R If you have missed one or more pills from the
first week of your strip (days 1 to 7) and you
had sex in that week, you could become
pregnant. Contact your doctor, family planning
nurse or pharmacist for advice as soon as
possible. They may recommend you use
emergency contraception.

R Don’t forget to use extra precautions for the

7 or more pills left in the pack

as usual. This may mean taking two pills in one day.
R Don’t worry, your contraceptive protection should
not be reduced.

R Take the delayed pill straight away and further pills

Less than 12 hours ago

If you start a new strip of pills late, you may
not be protected from pregnancy. If you had sex
in the last seven days, ask your doctor, family
planning nurse or pharmacist for advice. You
may need to consider emergency contraception.
You should also use extra contraception, such as
a condom, for seven days.

have finished the second strip, do a pregnancy
test before starting another strip.
R If you have missed one or more pills from the
first week of your strip (days 1 to 7) and you
had sex in that week, you could become
pregnant. Contact your doctor, family planning
nurse or pharmacist for advice as soon as
possible.

R If you do not have a withdrawal bleed after you

strip the next day without a break.

R When you finish the strip of pills, start the next

7 days.

R Don’t forget to use extra precautions for the next

Fewer than 7 pills left in the pack

taking two pills in one day.
R Use extra precautions (condoms, for instance) for
the next 7 days.
R Check how many pills are left in the strip after
the most recently missed pill.

R Take the most recently missed pill straight away.
R Leave any earlier missed pills in the strip.
R Take your further pills as usual. This may mean

More than 12 hours ago, or you
have missed more than one pill.

When were you due to take the missed pill?

If you miss a pill, follow these instructions:

3.3 A missed pill

It is unlikely that taking more than one pill will
do you any harm, but you may feel sick, vomit or
have some vaginal bleeding. Talk to your doctor

3.7 Taking more than one pill should
not cause harm

Occasionally, you may miss a withdrawal bleed.
This could mean that you are pregnant, but
that is very unlikely if you have taken your pills
correctly. Start your next strip at the normal
time. If you think that you might have put
yourself at risk of pregnancy (for example, by
missing pills or taking other medicines), or if you
miss a second bleed, you should do a pregnancy
test. You can buy these from the chemist or
get a free test at your family planning clinic or
doctors surgery. If you are pregnant, stop taking
Triadene and see your doctor.

3.6 Missed a period – could you be
pregnant?

If you are sick (vomit) or have very bad diarrhoea
within 4 hours of taking the Pill, your body
may not get its usual dose of hormones from
that pill. If you are better within 12 hours of
taking Triadene, follow the instructions in
section 3.4 A lost pill, which describes how to
take another pill.
If you are still sick or have diarrhoea more than
12 hours after taking Triadene, see section
3.3, A missed pill.
 Talk to your doctor if your stomach upset
carries on or gets worse. He or she may
recommend another form of contraception.

3.5 If you are sick or have diarrhoea

If you lose a pill,
Either take the last pill of the strip 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 your contraceptive protection
won’t be affected. After your seven pill-free
days you will have a new starting day, one day
earlier than before.
Or if you do not want to change the starting
day of your cycle, take a pill from a spare strip
if you have one. Then take all the other pills
from your current strip as usual. You can then
keep the opened spare strip in case you lose any
more pills.

3.4 A lost pill

Signs of a blood clot:
a migraine for the first time, a migraine that
is worse than normal, or unusually frequent
or severe headaches
any sudden changes to your eyesight (such
as loss of vision or blurred vision)
any sudden changes to your hearing,
speech, sense of smell, taste or touch
pain or swelling in your leg
stabbing pain when you breathe
coughing for no apparent reason
pain and tightness in the chest
sudden weakness or numbness in one side
or part of your body
dizziness or fainting.
Signs of a severe allergic reaction or
worsening of hereditary angioedema:
swelling of the hands, face, lips, mouth,
tongue or throat. A swollen tongue/throat
may lead to difficulty swallowing and
breathing
a red bumpy rash (hives) and itching.
Signs of breast cancer include:
dimpling of the skin
changes in the nipple
any lumps you can see or feel.
Signs of cancer of the cervix include:
vaginal discharge that smells and/or
contains blood
unusual vaginal bleeding

4.1 Serious side effects – see a doctor
straight away

Like all medicines, Triadene can cause side
effects, although not everybody gets them.
 Tell your doctor, pharmacist or family
planning nurse if you are worried about
any side effects which you think may be due
to Triadene.

4. Possible side effects

If you are planning a baby, it’s best to use
another method of contraception after stopping
Triadene until you have had a proper period.
Your doctor or midwife relies on the date of your
last natural period to tell you when your baby is
due. However, it will not cause you or the baby
any harm if you get pregnant straight away.

3.8 When you want to get pregnant

if you have any of these symptoms.

Common side effects (between 100 and 1000
in every 10,000 users may be affected)
feeling sick
stomach ache
putting on weight
headaches
depressive moods or mood swings
sore or painful breasts
Uncommon side effects (between 10 and 100
in every 10,000 users may be affected)
being sick and stomach upsets
fluid retention
migraine
loss of interest in sex
breast enlargement
skin rash, which may be itchy
Rare side effects (between 1 and 10 in every
10,000 users may be affected)
poor tolerance of contact lenses
losing weight
increase of interest in sex
vaginal or breast discharge
Other side effects reported
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 (see section 4.3).
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 and/or UV lamps
Occurrence or deterioration of the movement
disorder chorea

4.2 Less serious side effects

pelvic pain
painful sex.
Signs of severe liver problems include:
severe pain in your upper abdomen
yellow skin or eyes ( jaundice)
inflammation of the liver (hepatitis)
your whole body starts itching.
 If you think you may have any of these,
see a doctor straight away. You may need
to stop taking Triadene.

A few women have a little unexpected bleeding
or spotting while they are taking Triadene,
especially during the first few months.
Normally, this bleeding is nothing to worry
about and will stop after a day or two. Keep
taking Triadene as usual. The problem should
disappear after the first few strips.
You may also have unexpected bleeding if you
are not taking your pills regularly, so try to
take your pill at the same time every day. Also,
unexpected bleeding can sometimes be caused
by other medicines.
 Make an appointment to see your doctor
if you get breakthrough bleeding or spotting
that:
 carries on for more than the first few
months
 starts after you’ve been taking Triadene
for a while

4.3 Bleeding between periods
should not last long

Conditions that may worsen during
pregnancy or previous use of the Pill:
 yellowing of the skin ( jaundice)
 persistent itching (pruritus)
 kidney or liver problems
 gall stones
 certain rare medical conditions such as
systemic lupus erythematosus
 occurrence or deterioration of the
movement disorder chorea
 blister-like rash (herpes gestationis)
whilst pregnant
 an inherited form of deafness
(otosclerosis)
 Crohn’s disease
 ulcerative colitis
 a personal or family history of a form of
sickle cell disease
 swelling of body parts (hereditary
angioedema)
 an inherited disease called porphyria
 cancer of the cervix
 Tell your doctor, pharmacist or family
planning nurse if you are worried about
any side effects which you think may be due
to Triadene. Also tell them if any existing
conditions get worse while you are taking
Triadene.

Each box of Triadene contains six beige tablets,
five dark brown tablets, and ten white tablets.
In addition to the pills, the Triadene box contains
3 self-adhesive stickers marked with days of the
week.
Each beige tablet contains 30 micrograms
of ethinylestradiol and 50 micrograms of
gestodene.
Each dark brown tablet contains 40 micrograms
ethinylestradiol and 70 micrograms of
gestodene.
Each white tablet contains 30 micrograms
of ethinylestradiol and 100 micrograms of
gestodene.
Gestodene is a progestogen and ethinylestradiol
is an oestrogen.
Triadene also contains the inactive ingredients:
Lactose, maize starch, povidone 700 000,
calcium disodium edetate, magnesium stearate
(E572), sucrose, macrogol 6000, calcium
carbonate (E170), talc, montan glycol wax,
titanium dioxide (E171), ferric oxide pigment
(brown and yellow) (E172), glycerol (E422).
The company that holds the product licence
for Triadene is:
Bayer plc, Bayer House, Strawberry Hill,
Newbury, Berkshire, RG14 1JA.
Triadene is made by:
Bayer Pharma AG, Berlin, Germany
or Bayer Weimar GmbH & Co KG, Weimar,
Germany.
This leaflet was last updated
in January 2013.

What is in Triadene

6. What is in Triadene
and who makes it

Keep all medicines out of the reach and sight of
children.
Do not use Triadene after the expiry date shown
on the strip.
Do not throw away any medicines down a drain
or into a bin. Ask your pharmacist what to do
with any medicines you do not want. This will
help to protect the environment.

5. How to store Triadene

 carries on even after you’ve stopped
taking Triadene.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)