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LOGYNON ED TABLETS

Active substance(s): ETHINYLESTRADIOL / ETHINYLOESTRADIOL / LEVONORGESTREL / NO ACTIVES PRESENT

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1.3.2.1

84330914_03.indd 1

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19.05.2015 13:59:38

In this leaflet:
1. What Logynon ED does
2. What you need to know before you use
Logynon ED
3. Taking Logynon ED
3.3 A missed pill
4. Possible side effects
5. How to store Logynon ED
6. What is in Logynon ED and who makes it

Levonorgestrel
Ethinylestradiol

 They are one of the most reliable reversible
methods of contraception if used correctly.
 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.
 Please be alert and see your doctor if you
think you may have symptoms of a blood
clot (see section 2.3 ‘Blood clots’).
 The Pill 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 Logynon ED is right for you.
 To prevent pregnancy it is important to take
Logynon ED 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.

!

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

Logynon ED 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.
Logynon ED is taken every day without a break.
You take an ‘active pill’ each day for 21 days,
followed by an ‘inactive pill’ each day for 7
days.
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.
Logynon ED will not protect you against sexually
transmitted infections, such as Chlamydia or HIV.
Only condoms can help to do this.
Logynon ED needs to be taken as directed to
prevent pregnancy.

1. What Logynon ED does

 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.

Logynon® ED

Package leaet: Information for the user

2. What you need to know
before you use Logynon ED
General notes
Before you start using Logynon ED you should
read the information on blood clots in section
2.3. It is particularly important to read the
symptoms of a blood clot – see Section
2.3 ‘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.
 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
2.3). Your doctor will tell you when you can
start taking the Pill again.
2.1 When you should not use Logynon ED
You should not use Logynon ED 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 Logynon ED:
 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
 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
 If you need an operation or if you are off
your feet for a long time (see section
2.3 ‘Blood clots’)
 If you have ever had a heart attack or stroke
 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)
 If you have any of the following diseases
that may increase your risk of a clot in the
arteries:
 severe diabetes with blood vessel
damage
 very high blood pressure


When should you contact your doctor?
Seek urgent medical attention
 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).
For a description of the symptoms of these
serious side effects please go to “How to
recognise a blood clot”.
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 Logynon ED 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 Logynon ED, you should also tell
your doctor.
 If you have Crohn’s disease or ulcerative
colitis (chronic inflammatory bowel disease)
 If you have systemic lupus erythematosus
(SLE – a disease affecting your natural
defence system)
 If you have haemolytic uraemic syndrome
(HUS – a disorder of blood clotting causing
failure of the kidneys)
 If you have sickle cell anaemia (an inherited
disease of the red blood cells)
 If you have inflammation of the pancreas
(pancreatitis)
 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)
 If you need an operation, or you are off your
feet for a long time (see in section 2.3 ‘Blood
clots’)
 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 Logynon ED
 If you have an inflammation in the veins
under the skin (superficial thrombophlebitis)
 If you have varicose veins
 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

2.2









 a very high level of fat in the blood
(cholesterol or triglycerides)
 a condition known as
hyperhomocysteinaemia
If you have (or have ever had) a type of
migraine called ‘migraine with aura’
If you have or have ever had breast cancer
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 are allergic (hypersensitive) to any of
the ingredients in Logynon ED.
Tell your doctor or family planning nurse
if you have any medical problems or
illnesses.
When to take special care with
Logynon ED

 painless blurring of vision
which can progress to
loss of vision

 If you are overweight (obese)
 If you have migraines
 If you have any illness that worsened during
pregnancy or previous use of the Pill (see
section 4.2)
2.3 Blood clots
Using a combined hormonal contraceptive such
as Logynon ED 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:
 in veins (referred to as a ‘venous
thrombosis’, ‘venous thromboembolism’ or
VTE);
 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
Logynon ED is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any
of the following signs or symptoms.
Are you experiencing any of
What are you
these signs?
possibly
suffering
from?
 swelling of one leg or
Deep vein
along a vein in the leg or thrombosis
foot especially when
accompanied by:
 pain or tenderness in
the leg which may be
felt only when
standing or walking
 increased warmth in
the affected leg
 change in colour of
the skin on the leg
e.g. turning pale, red
or blue
 sudden unexplained
Pulmonary
breathlessness or rapid
embolism
breathing
 sudden cough without an
obvious cause, which may
bring up blood
 sharp chest pain which
may increase with deep
breathing
 severe light headedness
or dizziness
 rapid or irregular
heartbeat
 severe pain in your
stomach
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’).
Symptoms most commonly
Retinal vein
occur in one eye:
thrombosis
 immediate loss of vision (blood clot in
the eye)
or
Blood clots
blocking
other blood
vessels

Stroke

Heart attack

 See a doctor as soon as possible. Do not
take any more Logynon ED 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?
 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.
 If a blood clot forms in a vein in the leg or
foot it can cause a deep vein thrombosis
(DVT).
 If a blood clot travels from the leg and
lodges in the lung it can cause a pulmonary
embolism.
 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

 chest pain, discomfort,
pressure, heaviness
 sensation of squeezing or
fullness in the chest, arm
or below the breastbone
 fullness, indigestion or
choking feeling
 upper body discomfort
radiating to the back, jaw,
throat, arm and stomach
 sweating, nausea,
vomiting or dizziness
 extreme weakness,
anxiety, or shortness of
breath
 rapid or irregular
heartbeats
 sudden weakness or
numbness of the face,
arm or leg, especially on
one side of the body
 sudden confusion, trouble
speaking or
understanding
 sudden trouble seeing in
one or both eyes
 sudden trouble walking,
dizziness, loss of balance
or coordination
 sudden, severe or
prolonged headache with
no known cause
 loss of consciousness or
fainting with or without
seizure
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.
 swelling and slight blue
discolouration of an
extremity
 severe pain in your
stomach (acute abdomen)
About 5-7 out of
10,000 women

About 5-7 out of
10,000 women

Risk of developing a
blood clot in a year
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 Logynon ED is small
but some conditions will increase the risk. Your
risk is higher:
 if you are very overweight (body mass index
or BMI over 30kg/m2)
 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
 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 Logynon ED may need to be
stopped several weeks before surgery or
while you are less mobile. If you need to
stop Logynon ED ask your doctor when you
can start using it again.
 as you get older (particularly above about
35 years)
 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 Logynon ED needs
to be stopped.
If any of the above conditions change while you
are using Logynon ED, for example a close
family member experiences a thrombosis for no
known reason, or you gain a lot of weight, tell
your doctor.

Women who are not
using a combined
hormonal pill and are
not pregnant
Women using a
combined hormonal
contraceptive pill
containing
levonorgestrel
Women using
Logynon ED

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 Logynon ED 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 Logynon ED is small.
 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.
 Out of 10,000 women who are using a
combined hormonal contraceptive that
contains levonorgestrel, such as Logynon
ED, about 5-7 will develop a blood clot in a
year.
 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).

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.
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 Logynon ED is very
small but can increase:
 with increasing age (beyond about 35 years)
 if you smoke. When using a combined
hormonal contraceptive like Logynon ED,
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
 if you are overweight
 if you have high blood pressure
 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
 if you, or someone in your immediate
family, have a high level of fat in the blood
(cholesterol or triglycerides)
 if you get migraines, especially migraines
with aura
 if you have a problem with your heart (valve
disorder, disturbance of the rhythm called
atrial fibrillation)
 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 Logynon ED, 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.
2.4 The Pill and cancer
While high dose Pills reduce your risk of cancer
of the ovary and womb if used in the long term,
it is not clear whether lower dose Pills like
Logynon ED 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.



3.1 How to take it
To prevent pregnancy, always take Logynon ED
as described below. Check with your doctor or
family planning nurse if you are not sure.
This pack is designed to help you remember
to take your pills. Your pack contains 3 foil
memo strips with 3 sets of 7 self-adhesive
strips showing the days of the week. Each foil
memo strip contains 28 tablets: 21 small active
tablets in 3 rows (6 red, 5 white and 10 ochrecoloured tablets) and 7 larger, white, inactive
tablets in the last row.
Take Logynon ED every day for 28 days
 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.
 Take your pill at the same time every day.
 Follow the direction of the arrows on the
strip. Take one pill each day, until you have
finished all 28 pills.
 Swallow each pill whole, with water if
necessary. Do not chew the pill.
Then start your next strip
Start taking your next strip of Logynon ED the
next day. Do not leave a gap between packs.
As long as you take Logynon ED correctly, you
will always start each new strip on the same
day of the week.
3.2 Starting Logynon ED
As a new user or starting the Pill again after a
break
It is best to take your first Logynon ED 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 Logynon ED from another
contraceptive Pill
 If you are currently taking a 21-day Pill:
start Logynon ED 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 Logynon ED.
 If you are taking a 28-day Pill: start taking
Logynon ED 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 Logynon ED.
 Or, if you are taking a progestogen-only
Pill (POP or ‘mini Pill’): start Logynon ED 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 Logynon ED 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 Logynon
ED straight away. This means that you will have
contraceptive protection with your first pill.

3. Taking Logynon ED

2.9 Logynon ED contains lactose and
sucrose
If you have been told by your doctor that you
have intolerance to some sugars, contact your
doctor before using Logynon ED.

Packaging Technology Berlin sgmgj
page 1
Bayer Pharma AG
client: 0021
item-no.: 84330914
PZ: 2688A-3
code-no.: 180
name: LF-OUTS-Logynon ED SCT 28
country: GB/-/BPH
colors: Black
version: 19.05.2015/03
approval:
dimension: 355 x 594 mm

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, 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 Logynon ED.
2.5 Taking other medicines
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
Logynon ED. 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 Logynon ED and can stop it from
working properly – for example:
 some medicines used to treat epilepsy
 some medicines used to treat HIV
and Hepatitis C Virus infections (so-called
protease inhibitors and non-nucleoside
reverse transcriptase inhibitors)
 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,
Logynon ED 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.
Logynon ED can also affect how well other
medicines work. Your doctor may need to
adjust the dose of your other medicine.
In addition, Logynon ED can also interfere with
the results of some blood tests, so always tell
your doctor that you are taking Logynon ED if
you have a blood test.
2.6 Taking Logynon ED with food and
drink
There are no special instructions about food and
drink while on Logynon ED.
2.7 Pregnancy and breast-feeding
Do not use Logynon ED if you are pregnant.
If you think you might be pregnant, do a
pregnancy test to confirm that you are before you
stop taking Logynon ED.
If you are breast-feeding, your doctor or
family planning nurse may advise you not to
take Logynon ED. They will be able to suggest
alternative contraception. Breast-feeding may
not stop you getting pregnant.
2.8 Driving and using machines
Logynon ED has no known effect on the ability
to drive or use machines.

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Logynon® ED

1.3.2.1

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19.05.2015 14:00:21

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 Logynon ED 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 Logynon ED and for the
first 7 days of pill taking.

A missed pill

Less than 12 hours ago

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

 When you finish the active pills, throw away the large

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.

 If you have missed one or more pills from the first week of

talk to your doctor before you start the next pack.

 If you do not have a period after the second pack, you must

pills, but do not worry.

 You may see some bleeding on the days you take the active

inactive tablets and start the next strip the next day.

Fewer than 7 active pills left

before starting the next one
 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.

 Complete your pack as usual

protection should not be reduced.

 Don’t worry, your contraceptive

7 or more active pills left

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

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

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

Inactive (large)

 Take the delayed pill straight away and

What kind of pill did you miss?

When were you due to take the missed pill?

Active (small)

If you miss a pill, follow these instructions:

3.3

If you have missed any of the pills in a strip, and
you do not bleed while taking the large inactive
pills, 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
condoms, for seven days.
3.4 A lost pill
If you lose an active pill,
Either take the last active 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 taking the large white inactive pills
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.
If you lose an inactive pill, don’t worry, just
continue taking the remaining tablets at the
correct time. Your contraceptive protection won’t
be affected.
3.5 If you are sick or have diarrhoea
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 Logynon ED,
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 Logynon ED, 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.
3.6 Missed a period – could you be pregnant?
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 Logynon ED and see your
doctor.
Like all medicines, Logynon ED 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 Logynon ED, 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 Logynon ED”.
 Tell your doctor, pharmacist or family
planning nurse if you are worried about any
side effects which you think may be due to
Logynon ED.
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)
 harmful blood clots in a vein or artery for
example:
 in a leg or foot (i.e. DVT)
 in a lung (i.e. PE)
 heart attack
 stroke
 mini-stroke or temporary stroke-like
symptoms, known as a transient ischaemic
attack (TIA)
 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 2.3 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 2.3 ‘Blood clots’)

4. Possible side effects

3.7 Taking more than one pill should not cause
harm
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.
3.8 When you want to get pregnant
If you are planning a baby, it’s best to use another
method of contraception after stopping Logynon
ED 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.
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
 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 Logynon ED.
4.2 Less serious side effects
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

84330914

What is in Logynon ED
Each box of Logynon ED contains three strips of 28
tablets (21 active tablets and 7 larger inactive
tablets).
Each memo strip of Logynon ED contains:
6 red tablets containing 50 micrograms
levonorgestrel and 30 micrograms ethinylestradiol
5 white tablets containing 75 micrograms
levonorgestrel and 40 micrograms ethinylestradiol
10 ochre tablets containing 125 micrograms
levonorgestrel and 30 micrograms ethinylestradiol
7 larger, white, inactive tablets. All tablets are
sugar-coated. Levonorgestrel is a progestogen and
ethinylestradiol is an oestrogen.
Logynon ED also contains the inactive ingredients:
Lactose, maize starch, povidone, magnesium
stearate (E572), sucrose, polyethylene glycol 6000,
calcium carbonate (E170), talc, montan glycol wax,
glycerin (E422), titanium dioxide (E171), ferric
oxide pigment (red and yellow) (E172).
The company that holds the product licence for
Logynon ED is:
Bayer plc, Bayer House, Strawberry Hill, Newbury,
Berkshire, RG14 1JA
Logynon ED is made by:
Bayer Pharma AG, Berlin, Germany
or
Bayer Weimar GmbH & Co KG, Weimar, Germany
This leaflet was last revised in
May 2015.

6. What is in Logynon ED and
who makes it

Keep all medicines out of the sight and reach of
children.
Do not use Logynon ED 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 Logynon ED

 starts after you’ve been taking Logynon ED for
a while
 carries on even after you’ve stopped taking
Logynon ED.
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.

Packaging Technology Berlin sgmgj
page 2
Bayer Pharma AG
client: 0021
item-no.: 84330914
PZ: 2688A-3
code-no.: 180
name: LF-OUTS-Logynon ED SCT 28
country: GB/-/BPH
colors: Black
version: 19.05.2015/03
approval:
dimension: 355 x 594 mm

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 Logynon ED. 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
Logynon ED 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
 Crohn’s disease or ulcerative colitis
 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
 blister-like rash (herpes gestationis) whilst
pregnant
 an inherited form of deafness (otosclerosis)
 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
Logynon ED. Also tell them if any existing
conditions get worse while you are taking
Logynon ED.
4.3 Bleeding between periods should not last
long
A few women have a little unexpected bleeding or
spotting while they are taking Logynon ED,
especially during the first few months. Normally,
this bleeding is nothing to worry about and will
stop after a day or two. Keep taking Logynon ED 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

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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