Medication Guide App

TRIADENE

Active substance: GESTODENE

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R They are one of the most reliable reversible
methods of contraception if used correctly.
R They slightly increase the risk of having a blood
clot in the veins and arteries, especially in the
first year or when restarting a combined
hormonal contraceptive following a break of 4 or
more weeks.
R Please be alert and see your doctor if you think
you may have symptoms of a blood clot (see
section 2 “Blood clots”).
R The Pill may reduce your risk of cancer of the
ovary and womb if used in the long term.
R The Pill will not protect you against sexually
transmitted diseases.
R This medicine can increase your risk of problems
such as blood clots and breast cancer.
R 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.
R 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.
R Keep this leaflet. You may need to read it again.
R If you have any questions or need more advice,
ask your doctor, family planning nurse or
pharmacist.
R This medicine has been prescribed for you. Do not
pass it on to others. It may harm them.
R 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.

Gestodene
Ethinylestradiol
Important things to know about
! combined hormonal contraceptives
(CHCs):

Triadene®

Package leaflet: Information for the user

Taking Triadene

3.

How to store Triadene

Possible side effects

6.

General notes
Before you start using Triadene you should read the
information on blood clots in section 2. It is
particularly important to read the symptoms of a
blood clot – see Section 2 “Blood clots”.
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.
M Tell your doctor if you have any of the illnesses
or risk factors mentioned in this leaflet.
Before you start taking the Pill
R 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

2. What you need to know
before you use Triadene

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:
R it is one of the most reliable reversible methods
of contraception if used correctly
R it doesn’t interrupt sex
R it usually makes your periods regular, lighter and
less painful
R 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

What is in Triadene and who makes it

5.

4.

What you need to know before you use
Triadene

2.

3.3 A missed pill

What Triadene does

1.

In this leaflet:

You should not use Triadene if you have any of the
conditions listed below. If you do have any of the
conditions listed below, you must tell your doctor.
Your doctor will discuss with you what other form of
birth control would be more appropriate.
Do not take Triadene:
R If you have (or have ever had) a blood clot in a
blood vessel of your legs (deep vein thrombosis,
DVT), your lungs (pulmonary embolus, PE) or
other organs
R If you know you have a disorder affecting your
blood clotting – for instance, protein C deficiency,
protein S deficiency, antithrombin-III deficiency,
Factor V Leiden or antiphospholipid antibodies
R If you need an operation or if you are off your feet
for a long time (see section ‘Blood clots’)
R If you have ever had a heart attack or stroke
R If you have (or have ever had) angina pectoris (a
condition that causes severe chest pain and may
be a first sign of a heart attack) or transient
ischaemic attack (TIA – temporary stroke
symptoms)
R If you have any of the following diseases that
may increase your risk of a clot in the arteries:
R severe diabetes with blood vessel damage
R very high blood pressure
R a very high level of fat in the blood
(cholesterol or triglycerides)
R a condition known as
hyperhomocysteinaemia
R If you have (or have ever had) a type of migraine
called ‘migraine with aura’
R If you have or have ever had breast cancer
R 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

2.1 When you should not use Triadene

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
R You will need regular check-ups with your
doctor or family planning nurse, usually when
you need another prescription of the Pill.
R You should go for regular cervical smear tests.
R 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.
R 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.
R 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 2.3). Your doctor will tell you when
you can start taking the Pill again.
Using a combined hormonal contraceptive such as
Triadene increases your risk of developing a blood clot
compared with not using one. In rare cases a blood
clot can block vessels and cause serious problems.
Blood clots can develop:
R in veins (referred to as a ‘venous thrombosis’,
‘venous thromboembolism’ or VTE);
R in the arteries (referred to as an ‘arterial
thrombosis’, ‘arterial thromboembolism’ or ATE).
Recovery from blood clots is not always complete.
Rarely, there may be serious lasting effects or, very
rarely, they may be fatal.
It is important to remember that the overall risk
of having a harmful blood clot due to Triadene is
small.

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.
Tell your doctor if any of the following conditions
apply to you.
If the condition develops, or gets worse while you are
using Triadene, you should also tell your doctor.
R If you have Crohn’s disease or ulcerative colitis
(chronic inflammatory bowel disease)
R If you have systemic lupus erythematosus (SLE –
a disease affecting your natural defence system)
R If you have haemolytic uraemic syndrome (HUS –
a disorder of blood clotting causing failure of the
kidneys)
R If you have sickle cell anaemia (an inherited
disease of the red blood cells)
R If you have inflammation of the pancreas
(pancreatitis)
R If you have elevated levels of fat in the blood
(hypertriglyceridaemia) or a positive family
history for this condition. Hypertriglyceridaemia
has been associated with an increased risk of
developing pancreatitis (inflammation of the
pancreas)
R If you need an operation, or you are off your feet
for a long time (see in section 2 ‘Blood clots’)
R If you have just given birth you are at an
increased risk of blood clots. You should ask your
doctor how soon after delivery you can start
taking Triadene
R If you have an inflammation in the veins under
the skin (superficial thrombophlebitis)
R If you have varicose veins
R If you have diabetes
R If you or your close family have ever had
problems with your heart, or circulation such as
high blood pressure

For a description of the symptoms of these serious
side effects please go to “How to recognise a blood
clot”.

2.3 Blood clots

R if you notice possible signs of a blood clot that
may mean you are suffering from a blood clot
in the leg (i.e. deep vein thrombosis), a blood
clot in the lung (i.e. pulmonary embolism), a
heart attack or a stroke (see ‘Blood clots`
section below).

R If you or your close family have ever had
problems with blood clotting
R If you have the inherited disease called porphyria
R If you are overweight (obese)
R If you have migraines
R If you have any illness that worsened during
pregnancy or previous use of the Pill (see section
4.2)

Seek urgent medical attention

When should you contact your doctor?

2.2 When to take special care with Triadene

R If you have ever had liver tumours
R If you are allergic (hypersensitive) to any of the
ingredients in Triadene.
M Tell your doctor or family planning nurse if
you have any medical problems or illnesses.

R severe pain in your stomach (acute abdomen)

R swelling and slight blue discolouration of an extremity

Sometimes the symptoms of stroke can be brief with an almost immediate
and full recovery, but you should still seek urgent medical attention as you
may be at risk of another stroke.

R loss of consciousness or fainting with or without seizure

R sudden, severe or prolonged headache with no known cause

R sudden trouble walking, dizziness, loss of balance or coordination

R sudden trouble seeing in one or both eyes

R sudden confusion, trouble speaking or understanding

R sudden weakness or numbness of the face, arm or leg, especially on
one side of the body

R rapid or irregular heartbeats

R extreme weakness, anxiety, or shortness of breath

R sweating, nausea, vomiting or dizziness

R upper body discomfort radiating to the back, jaw, throat, arm and
stomach

R fullness, indigestion or choking feeling

R sensation of squeezing or fullness in the chest, arm or below the
breastbone

R chest pain, discomfort, pressure, heaviness

R painless blurring of vision which can progress to loss of vision

R immediate loss of vision or

Symptoms most commonly occur in one eye:

If you are unsure, talk to a doctor as some of these symptoms such as
coughing or being short of breath may be mistaken for a milder condition
such as a respiratory tract infection (e.g. a ‘common cold’).

R severe pain in your stomach

R rapid or irregular heartbeat

R severe light headedness or dizziness

R sharp chest pain which may increase with deep breathing

R sudden cough without an obvious cause, which may bring up blood

R sudden unexplained breathlessness or rapid breathing

R change in colour of the skin on the leg e.g. turning pale, red or blue

R increased warmth in the affected leg

Blood clots blocking other blood
vessels

Stroke

Heart attack

Retinal vein thrombosis (blood
clot in the eye)

Pulmonary embolism

Deep vein thrombosis

R swelling of one leg or along a vein in the leg or foot especially when
accompanied by:
R pain or tenderness in the leg which may be felt only when standing
or walking

What are you possibly
suffering from?

Are you experiencing any of these signs?

HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.

M 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.
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
R The use of combined hormonal contraceptives
has been connected with an increase in the risk of
blood clots in the vein (venous thrombosis).
However, these side effects are rare. Most
frequently, they occur in the first year of use of a
combined hormonal contraceptive.
R If a blood clot forms in a vein in the leg or foot it
can cause a deep vein thrombosis (DVT).
R If a blood clot travels from the leg and lodges in
the lung it can cause a pulmonary embolism.
R Very rarely a clot may form in a vein in another
organ such as the eye (retinal vein thrombosis).
When is the risk of developing a blood clot in a
vein highest?
The risk of developing a blood clot in a vein is highest
during the first year of taking a combined hormonal
contraceptive for the first time. The risk may also be
higher if you restart taking a combined hormonal
contraceptive (the same product or a different
product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always
slightly higher than if you were not using a combined
hormonal contraceptive.
When you stop Triadene your risk of a blood clot
returns to normal within a few weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the
type of combined hormonal contraceptive you are
taking.
The overall risk of a blood clot in the leg or lung (DVT
or PE) with Triadene is small.
R Out of 10,000 women who are not using any
combined hormonal contraceptive and are not
pregnant, about 2 will develop a blood clot in a
year.
R Out of 10,000 women who are using a combined
hormonal contraceptive that contains
levonorgestrel, norethisterone, or norgestimate
about 5-7 will develop a blood clot in a year.
R Out of 10,000 women who are using a combined
hormonal contraceptive that contains gestodene
such as Triadene, between about 9 and 12 women
will develop a blood clot in a year.
R The risk of having a blood clot will vary according
to your personal medical history (see “Factors
that increase your risk of a blood clot in a vein”
below).

About 9-12 out of
10,000 women

About 5-7 out of
10,000 women

About 2 out of
10,000 women

Factors that increase your risk of a blood clot in a
vein
The risk of a blood clot with Triadene is small but
some conditions will increase the risk. Your risk is
higher:
R if you are very overweight (body mass index or
BMI over 30kg/m2)
R if one of your immediate family has had a blood
clot in the leg, lung or other organ at a young age
(e.g. below the age of about 50). In this case you
could have a hereditary blood clotting disorder
R if you need to have an operation, or if you are off
your feet for a long time because of an injury or
illness, or you have your leg in a cast. The use of
Triadene may need to be stopped several weeks
before surgery or while you are less mobile. If you
need to stop Triadene ask your doctor when you
can start using it again.
R as you get older (particularly above about 35
years)
R if you gave birth less than a few weeks ago.
The risk of developing a blood clot increases the more
conditions you have.
Air travel (>4 hours) may temporarily increase your
risk of a blood clot, particularly if you have some of
the other factors listed.
It is important to tell your doctor if any of these
conditions apply to you, even if you are unsure. Your
doctor may decide that Triadene needs to be stopped.
If any of the above conditions change while you are
using Triadene, for example a close family member
experiences a thrombosis for no known reason, or you
gain a lot of weight, tell your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an
artery?
Like a blood clot in a vein, a clot in an artery can cause
serious problems. For example, it can cause a heart
attack or a stroke.

Women using Triadene

Women using a combined
hormonal contraceptive pill
containing levonorgestrel,
norethisterone or
norgestimate

Women who are not using a
combined hormonal pill and
are not pregnant

Risk of developing
a blood clot in a
year

J

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:
R Of 10,000 women who have never taken the
Pill, about 16 will have breast cancer by the time
they are 35 years old.
R 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.

2.4 The Pill and cancer

Factors that increase your risk of a blood clot in an
artery
It is important to note that the risk of a heart attack
or stroke from using Triadene is very small but can
increase:
R with increasing age (beyond about 35 years)
R if you smoke. When using a combined hormonal
contraceptive like Triadene, you are advised to
stop smoking. If you are unable to stop smoking
and are older than 35 your doctor may advise you
to use a different type of contraceptive
R if you are overweight
R if you have high blood pressure
R if a member of your immediate family has had a
heart attack or stroke at a young age (less than
about 50). In this case you could also have a
higher risk of having a heart attack or stroke
R if you, or someone in your immediate family, have
a high level of fat in the blood (cholesterol or
triglycerides)
R if you get migraines, especially migraines with
aura
R if you have a problem with your heart (valve
disorder, disturbance of the rhythm called atrial
fibrillation)
R if you have diabetes.
If you have more than one of these conditions or if
any of them are particularly severe the risk of
developing a blood clot may be increased even more.
If any of the above conditions change while you are
using Triadene, for example you start smoking, a close
family member experiences a thrombosis for no
known reason, or you gain a lot of weight, tell your
doctor.

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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

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 have an influence on the blood levels of
Triadene and can stop it from working properly – for
example:
R some medicines used to treat epilepsy
R some medicines used to treat HIV and Hepatitis C
Virus infections (so-called protease inhibitors and
non-nucleoside reverse transcriptase inhibitors)
R griseofulvin (an anti-fungal medicine)
R certain antibiotics
R certain sedatives (called barbiturates)
R 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

R Of 10,000 women who have never taken the Pill, about
100 will have breast cancer by the time they are 45
years old.
R 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:
R if you have a close relative (mother, sister or
grandmother) who has had breast cancer
R if you are seriously overweight.
M 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, the Pill has also been linked with some forms of liver
cancer in women who have taken it for a long time.
M 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.

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
R 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.
R 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.

3.2 Starting Triadene

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.
R Take your pill at the same time every day.
R 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.
R Follow the direction of the arrows on the strip. Take one
pill each day, until you have finished all 21 pills.
R 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 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.
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
Start taking your next strip of Triadene after the seven pillfree days – even if you are still bleeding. Always start the
new strip on time.
As long as you take Triadene correctly, you will always start
each new strip on the same day of the week.

3.1 How to take it

3. Taking Triadene

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

as usual. This may mean taking two pills in one day.

R Don’t worry, your contraceptive protection should

R Take the delayed pill straight away and further pills

Less than 12 hours ago

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 have missed one or more pills from the

have finished the second strip, do a pregnancy
test before starting another strip.

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

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.

next 7 days.

R When you have finished the strip, leave the

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.

R Don’t forget to use extra precautions for the

7 or more pills left in the pack

not be reduced.

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.

When were you due to take the missed pill?

If you miss a pill, follow these instructions:

3.3 A missed pill

R 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 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

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 if you have any of these
symptoms.

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.
M 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

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.
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.

4. Possible side effects

R harmful blood clots in a vein or artery for example:
R in a leg or foot (i.e. DVT)
R in a lung (i.e. PE)
R heart attack
R stroke
R mini-stroke or temporary stroke-like symptoms,
known as a transient ischaemic attack (TIA)
R blood clots in the liver, stomach/intestine, kidneys
or eye.
The chance of having a blood clot may be higher if you have
any other conditions that increase this risk (see section 2 for
more information on the conditions that increase risk for
blood clots and the symptoms of a blood clot).
Signs of a blood clot (see section 2 “Blood clots”)
Signs of a severe allergic reaction or worsening of
hereditary angioedema:
R swelling of the hands, face, lips, mouth, tongue or
throat. A swollen tongue/throat may lead to difficulty
swallowing and breathing
R a red bumpy rash (hives) and itching.
Signs of breast cancer include:
R dimpling of the skin
R changes in the nipple
R any lumps you can see or feel.
Signs of cancer of the cervix include:
R vaginal discharge that smells and/or contains blood
R unusual vaginal bleeding
R pelvic pain
R painful sex.
Signs of severe liver problems include:
R severe pain in your upper abdomen
R yellow skin or eyes (jaundice)
R inflammation of the liver (hepatitis)
R your whole body starts itching.
M If you think you may have any of these, see a doctor
straight away. You may need to stop taking Triadene.

4.1 Serious side effects – see a doctor straight away
Rare side effects (between 1 and 10 in every 10,000
users may be affected)

Like all medicines, Triadene can cause side effects, although
not everybody gets them. If you get any side effect,
particularly if severe and persistent, or have any change to
your health that you think may be due to Triadene, please
talk to your doctor.
An increased risk of blood clots in the veins (venous
thromboembolism (VTE)) or blood clots in the arteries
(arterial thromboembolism (ATE)) is present for all women
using combined hormonal contraceptives. For more detailed
information on the different risks from taking combined
hormonal contraceptives please see section 2 “What you
need to know before you use Triadene”.
M Tell your doctor, pharmacist or family planning
nurse if you are worried about any side effects which
you think may be due to Triadene.

Common side effects (between 100 and 1000 in every
10,000 users may be affected)
R feeling sick
R stomach ache
R putting on weight
R headaches
R depressive moods or mood swings
R sore or painful breasts
Uncommon side effects (between 10 and 100 in every
10,000 users may be affected)
R being sick and stomach upsets
R fluid retention
R migraine
R loss of interest in sex
R breast enlargement
R skin rash, which may be itchy
Rare side effects (between 1 and 10 in every 10,000 users
may be affected)
R poor tolerance of contact lenses
R losing weight
R increase of interest in sex
R vaginal or breast discharge
Other side effects reported
R Bleeding and spotting between your periods can
sometimes occur for the first few months but this
usually stops once your body has adjusted to Triadene.
If it continues, becomes heavy or starts again, contact
your doctor (see section 4.3).
R Chloasma (yellow brown patches on the skin). This
may happen even if you have been using Triadene for a
number of months. Chloasma may be reduced by
avoiding too much sunlight and/or UV lamps
R Occurrence or deterioration of the movement disorder
chorea
R Conditions that may worsen during pregnancy or
previous use of the Pill:
R yellowing of the skin (jaundice)
R persistent itching (pruritus)
R kidney or liver problems
R gall stones
R certain rare medical conditions such as systemic
lupus erythematosus
R occurrence or deterioration of the movement
disorder chorea
R blister-like rash (herpes gestationis) whilst
pregnant
R an inherited form of deafness (otosclerosis)
R Crohn’s disease
R ulcerative colitis
R a personal or family history of a form of sickle cell
disease
R swelling of body parts (hereditary angioedema)
R an inherited disease called porphyria
R cancer of the cervix

4.2 Less serious side effects

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.
M Make an appointment to see your doctor if you get
breakthrough bleeding or spotting that:
R carries on for more than the first few months
R starts after you’ve been taking Triadene for a while
R carries on even after you’ve stopped taking Triadene.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

4.3 Bleeding between periods should not last long

M 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.

5. How to store Triadene

83935235

What is in 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 June 2014.

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.

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.

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