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LESTRAMYL 150 MICROGRAM/30 MICROGRAM TABLETS

Active substance(s): DESOGESTREL / ETHINYL ESTRADIOL

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Package leaflet: Information for the patient

Lestramyl®
150/30 micrograms
Tablets
(desogestrel/ethinylestradiol)

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
Important things to know about combined hormonal
contraceptives (CHCs):
• 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
“Blood clots”).

What is in this leaflet

Lestramyl®
150 microgram/30 microgram
Tablets

BARCODE

1. What Lestramyl® 150/30 micrograms tablets is and
what it is used for
2. What you need to know before you take Lestramyl®
150/30 micrograms tablets
3. How to take Lestramyl® 150/30 micrograms tablets
4. Possible side effects
5. How to store Lestramyl® 150/30 micrograms tablets
6. Contents of the pack and other information

1. What Lestramyl® 150/30 micrograms
tablet is and what it is used for
Lestramyl® 150/30 micrograms tablets is a combined oral
contraceptive, also called ‘the pill’. Each tablet contains
a small amount of two types of female hormones,
namely, a progestogen, desogestrel and an oestrogen,
ethinylestradiol.
These help to stop you from getting pregnant, just as
your natural hormones would stop you conceiving again
when you are already pregnant.
The combined contraceptive pill protects you against
getting pregnant in three ways. These hormones:
1. stop the ovary from releasing an egg each month
(ovulation).
2. thicken the fluid at the neck of the womb making it
more difficult for the sperm to reach the egg.
3. alter the lining of the womb to make it less likely to
accept a fertilised egg.

2. What you need to know before you take
Lestramyl® 150/30 micrograms tablets
General notes

measure your blood pressure, and depending upon
your personal situation, may also carry out some
other tests.
In this leaflet, several situations are described where
you should stop using Lestramyl® 150/30 micrograms
tablets, or where the reliability of the pill may be
decreased. In such situations you should either not
have sex, or you should take extra non-hormonal
contraceptive precautions (e.g. use a condom or
another barrier method). Do not use rhythm or
temperature methods. These methods can be
unreliable because desogestrel/ethinylestradiol alters
the monthly changes of body temperature and of
cervical mucus.
Desogestrel/ethinylestradiol, like other hormonal
contraceptives, does not protect against HIV infection
(AIDS) or any other sexually transmitted disease.

Do not take Lestramyl® 150/30 micrograms
tablets
You should not use desogestrel/ethinylestradiol
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.
• 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 have (or 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 the risk of a clot in the arteries:
* severe diabetes with blood vessels damage
* very high blood pressure
* a very high level of fat in the blood (cholesterol or
triglycerides)
* a condition known as hyperhomocysteinaemia
• 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 ‘Blood clots (thrombosis and
embolus)
• if you have (or have ever had) a type of migraine called
‘migraine with aura’
• if you have (or have ever had) an inflammation of the
pancreas (pancreatitis)
• if you have (or have ever had) a liver disease and your
liver function is still not normal.
• if you have (or have ever had) a tumour in the liver.
• if you have (or have ever had) or if you are suspected of
having breast cancer or cancer of the genital organs.
• if you have any unexplained bleeding from the vagina.
• overgrowth of the lining of the uterus (womb)
• if you are allergic to ethinylestradiol or desogestrel, or
any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions

Before you start using Lestramyl 150/30 micrograms
tablets you should read the information on blood clots
(thrombosis) in section 2. It is particularly important
to read the symptoms of a blood clot – see Section 2
“Blood clots”).
Before you can begin taking Lestramyl®
150/30 micrograms tablets, your doctor will ask you
some questions about your personal health history and
that of your close relatives. The doctor will also
®

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

Talk to your doctor or pharmacist before taking
desogestrel/ethinylestradiol if any of the following
conditions apply to you.
If any of the conditions develop, or get worse while you
are using Lestramyl® 150/30 micrograms tablets, you
should tell your doctor. In some situations you need to
take special care while using desogestrel/ethinylestradiol
or any other combination pill, and your doctor may need
to examine you regularly.
Talk to your doctor or pharmacist before taking
Lestramyl® 150/30 micrograms tablets:
• if a close relative has or has ever had breast cancer
• if you have a disease of the liver or the gallbladder
• if you have diabetes
• if you have depression
• if you have Crohn’s disease or ulcerative colitis (chronic
inflammatory bowel disease)
• 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 epilepsy (see Other medicines and
Lestramyl® 150/30 micrograms tablets)
• if you have systemic lupus erythematosus (SLE - a
disease affecting your natural defence system)
• if you have elevated levels of fat in the blood
(hypertriglyceridaemia) or a positive family history
of 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 “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
Lestramyl® 150/30 micrograms tablets;
• if you have an inflammation in the veins under the skin
(superficial thrombophlebitis)
• if you have varicose veins
• if you have a disease that first appeared during
pregnancy or earlier use of sex hormones (for example,
hearing loss, a blood disease called porphyria, skin rash
with blisters during pregnancy (gestational herpes) a
nerve disease causing sudden movements of the body
(Sydenham’s chorea)
• if you have or have ever had chloasma (a discoloration
of the skin especially of the face or neck known as
“pregnancy patches”,) If so, avoid direct sunlight or
ultraviolet light while taking this medicine.
• if you have hereditary angioedema, medicines
containing oestrogens may cause or worsen
symptoms. You should see your doctor immediately
if you experience symptoms of angioedema such as
swollen face, tongue and/or throat and/or difficulty
swallowing or hives together with difficulty breathing.
• if you have high blood pressure (hypertension) which is
not controlled by treatment with medicine.

BLOOD CLOTS
Using a combined hormonal contraceptive such as
desogestrel/ethinylestradiol increases your risk of
developing a blood clot compared with not using one. In
rare cases a blood clot can block blood 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 a
harmful blood clot due to desogestrel/ethinylestradiol
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
these signs?

• 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
occur in one eye:
• immediate loss of vision or
• painless blurring of vision
which can progress to loss
of vision

Date: 03 OCT 2016

Pharma Code N/A

No. of colours

Affiliate Item Code 964079

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• swelling and slight blue
discolouration of an extremity;
• severe pain in your stomach
(acute abdomen)

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1

• 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).

Retinal vein
thrombosis (blood
clot in the eye)

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 medicine or a different
medicine) 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 desogestrel/ethinylestradiolyour 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 desogestrel/ethinylestradiol 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,
norethisterone, or norgestimate about 5-7 will develop
a blood clot in a year.
• Out of 10,000 women who are using a combined
hormonal contraceptive that contains desogestrel,
such as Lestramyl® 150/30 micrograms tablets,
between about 9 and 12 women will develop a blood
clot in a year.

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Blood clots blocking
other blood vessels

Blood clots in a vein
What can happen if a blood clot forms in a vein?

• chest pain, discomfort,
Heart attack
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

Component Type Leaflet

TrackWise PR No. 964079

What are you
possibly suffering
from?

• swelling of one leg or along a
Deep vein
vein in the leg or foot especially thrombosis
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

Description Desogestrel Ethinylestradiol 0.15 mg / 0.03 mg 63

Superceded Affiliate Item Code 549036

• sudden weakness or numbness Stroke
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.

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v1/May 2015

• 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” below)
Risk of developing a
blood clot in a year
Women who are not using a
About 2 out of
combined hormonal pill/patch/ 10,000 women
ring and are not pregnant
Women using a combined
hormonal contraceptive pill
containing levonorgestrel,
norethisterone or
norgestimate

About 5-7 out of
10,000 women

Women using desogestrel/
ethinylestradiol

About 9-12 out of
10,000 women

If you take Desogestrel/ethinylestradiol, you have a
higher risk of developing a venous thrombosis than
women using other combined pills containing the
progestogen levonorgestrel.

Factors that increase your risk of a blood clot in a
vein

The risk of a blood clot with desogestrel/ethinylestradiol
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
Lestramyl® 150/30 micrograms tablets may need
to be stopped several weeks before surgery or
while you are less mobile. If you need to stop
Lestramyl® 150/30 micrograms tablets: 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 Lestramyl® 150/30 micrograms
tablets needs to be stopped.
If any of the above conditions change while you
are taking Lestramyl® 150/30 micrograms tablets,
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 (arterial thrombosis)
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 desogestrel/ethinylestradiol is very
small but can increase:
• with increasing age (beyond about 35 years);

• if you smoke. When using a combined hormonal
contraceptive like Lestramyl® 150/30 micrograms
tablets 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 years). 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
taking Lestramyl® 150/30 micrograms tablets 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.

Stop taking Lestramyl® 150/30 micrograms tablets
and contact your doctor or go to the nearest
hospital casualty department immediately if you
notice possible signs of blood clot, such as:

• severe pain and/or swelling in one of your legs
• sudden severe pain in the chest which may reach the
left arm
• sudden breathlessness
• sudden cough without an obvious cause
• any unusual, severe or long-lasting headache or
worsening of migraine
• partial or complete blindness or double vision
• difficulty in speaking or inability to speak
• spinning sensation
• giddiness or fainting
• weakness, strange feeling, or numbness in any part of
the body
• problems when you move
• sudden, severe stomach pain (abdominal pain)
without a clear cause

Lestramyl® 150/30 micrograms tablets and cancer
Cervical cancer has been found more often in women
taking oral contraceptives. However, this may be due to
other causes including less frequent use of a condom.
Breast cancer has been observed slightly more often
in women using combination pills, but it is not known
whether this is caused by the treatment. For example it
may be that more tumours are detected in women on
combination pills because they are examined by their
doctor more often. The occurrence of breast tumours
becomes gradually less after stopping the combination
hormonal contraceptives. It is important to regularly
check your breasts and you should contact your doctor if
you feel any lump.
In rare cases, benign liver tumours, and in even fewer
cases malignant liver tumours have been reported in pill
users. Contact your doctor if you have unusually severe
abdominal pain.

Bleeding between periods
During the first few months that you are taking
Lestramyl® 150/30 micrograms tablets, you may have
unexpected bleeding (bleeding outside the gap week).
If this bleeding occurs for more than a few months, or if
it begins after some months, your doctor must find out
what is wrong.

What you must do if no bleeding occurs in the
gap week

If you have taken all the tablets correctly, have not had
vomiting or severe diarrhoea and you have not taken
any other medicines or any medicinal products which
contain the herbal remedy St. John’s wort (Hypericum
perforatum), it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in
succession, you may be pregnant. Contact your doctor
immediately. Do not start the next strip until you are sure
that you are not pregnant.

Children and adolescents

The use of desogestrel/ethinylestradiol is not
recommended as there are no clinical data on efficacy
and safety in adolescents under 18 years of age.

Other medicines and Lestramyl®
150/30 micrograms tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines or
herbal products. Also tell any other doctor or dentist
who prescribes another medicine (or the pharmacist)
that you use Desogestrel/ethinylestradiol. They can
tell you if you need to take additional contraceptive
precautions (for example condoms) and if so, for
how long.
Some medicines can make desogestrel/ethinylestradiol
less effective in preventing pregnancy, or can cause
unexpected bleeding/spotting. These include:
• medicines used for the treatment of epilepsy (e.g.
primidone, phenytoin, barbiturates, carbamazepine,
oxcarbazepine, topiramate, felbamate)
• bosentan (a medicine for the treatment of
hypertension in the lung arteriesor ulcers of the
fingers)
• modafinil (a medicine for the treatment of narcolepsy)
• medicines used for the treatment of tuberculosis (e.g.
rifampicin, rifabutin),
• medicines used for the treatment of HIV infections
(ritonavir, nelfinavir, nevirapine, efavirenz)
• Griseofulvin (a medicine used for the treatment of
fungal infections)
• The herbal remedy St. John’s wort (Hypericum
perforatum).
Desogestrel/ethinylestradiol may influence the effect of
other medicines, e.g.
• medicines containing ciclosporin,
• the anti-epileptic lamotrigine (this could lead to an
increased frequency of seizures).
Ask your doctor or pharmacist for advice before taking
any medicine.

Laboratory tests:

If you need a blood test, tell your doctor or the laboratory
staff that you are taking the pill, because hormone
contraceptives can affect the results of some tests.

Pregnancy and breast-feeding
Pregnancy

If you are pregnant, do not take Lestramyl®
150/30 micrograms tablets. If you think you may be
pregnant while taking Lestramyl® 150/30 micrograms
tablets stop immediately and contact your doctor. If you
are planning to have a baby, you can stop taking the pill
at any time.

Breast-feeding

Use of desogestrel/ethinylestradiol is generally not
advisable if you are breast-feeding. If you want to take
the pill while you are breast-feeding, ask your doctor for
advice before taking this medicine.

Driving and using machines

There is no information suggesting that use of
desogestrel/ethinylestradiol affects driving or use
of machines.

Lestramyl® 150/30 micrograms tablets
contain lactose

If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Desogestrel/ethinylestradiol
Take one tablet of Lestramyl® 150/30 micrograms tablets
every day, if necessary with a small amount of water.
You may take the tablets with or without food, but you
should take the tablets every day around the same time.
The strip contains 21 tablets. Next to each tablet is
printed the day of the week that it should be taken. If,
for example you start on a Wednesday, take a tablet with
“WED” next to it. Follow the direction of the arrow on the
strip until all 21 tablets have been taken.
Then take no tablets for 7 days. In the course of these
7 tablet-free days (otherwise called a stop or gap week)
bleeding should begin. This so-called “withdrawal
bleeding” usually starts on the 2nd or 3rd day of the
gap week.
On the 8th day after the last tablet of Lestramyl®
150/30 micrograms tablets (that is, after the 7-day gap
week), you should start with the following strip, whether
your bleeding has stopped or not. This means that you
should start every strip on the same day of the week and
that the withdrawal bleed should occur on the same
days each month.
If you use Lestramyl® 150/30 micrograms tablets in
this manner, you are also protected against pregnancy
during the 7 days when you are not taking a tablet.

When can you start with the first strip?

• If you have not used a contraceptive with hormones in the
previous month
Begin with Lestramyl® 150/30 micrograms tablets on
the first day of your usual cycle (that is the first day of
your period). If you start Lestramyl® 150/30 micrograms
tablets on the first day of your period you are
immediately protected against pregnancy. You may
also begin on day 2-5 of the cycle, but then you must
use extra protective measures (for example, a condom)
for the first 7 days.
• Changing from a combination hormonal contraceptive,
or combination contraceptive vaginal ring or patch
You should start taking Lestramyl® 150/30 micrograms
tablets preferably on the day after the last active
tablet (the last tablet containing active substances)
of your previous pill, but at the latest on the day after
the tablet-free days of your previous pill (or after
the last inactive tablet of your previous pill). When
changing from a combination contraceptive vaginal
ring or patch, you should start taking Lestramyl®
150/30 micrograms tablets on the day of removal,
but at the latest when the next application would
have been.
• Changing from a progestogen-only-method
(progestogen-only pill, injection, implant or a
progestogen-releasing IUD)
You may switch any day from the progestogen-only
pill (from an implant or an IUD you should switch on
the day of its removal, and from an injectable when the
next injection would be due) but in all of these cases
use extra protective measures (for example, a condom)
for the first 7 days of tablet-taking.
• After a miscarriage or termination
Follow the advice of your doctor.
• After having a baby
You can start Lestramyl® 150/30 micrograms tablets
between 21 and 28 days after having a baby. If
you start later than day 28, use a so-called barrier
method of contraception (for example, a condom)

during the first seven days of taking Lestramyl®
150/30 micrograms tablets. If, after having a baby,
you have had sex before starting Lestramyl®
150/30 micrograms tablets (again), be sure that you are
not pregnant or wait until your next period.
• If you are breastfeeding and want to start desogestrel/
ethinylestradiol (again) after having a baby.
Read the section on “Breast-feeding”.
Ask your doctor what to do if you are not sure when
to start.

If you have forgotten any of the tablets in a strip, and you
do not have bleeding in the first tablet-free period, you
may be pregnant. Contact your doctor before you start
the next strip.
The following diagram describes how to proceed if you
forget to take your tablet(s):
Several tablets forgotten
in 1 strip

Ask your doctor for advice
yes

Use in children and adolescents

No clinical data on efficacy and safety are available in
adolescents below 18 years.

in
week 1

If you take more Lestramyl® 150/30 micrograms
tablets than you should

If you forget to take Lestramyl®
150/30 micrograms tablets

• If you are less than 12 hours late taking a tablet, the
protection against pregnancy is not reduced. Take the
tablet as soon as you remember and then take the
following tablets again at the usual time.
• If you are more than 12 hours late taking a tablet, the
protection against pregnancy may be reduced. The
greater the number of tablets that you have forgotten,
the greater is the risk of becoming pregnant.
The risk of incomplete protection against pregnancy is
greatest if you forget a tablet at the beginning or the end
of the strip. Therefore, you should keep to the following
rules (also see the diagram below):

More than one tablet forgotten in this strip

only
1 tablet
forgotten
(taken
more than
12 hours
late)

• Take the forgotten tablet
• Use a barrier method (condom)
for the following 7 days
• And finish strip
in
week 2

• Take the forgotten tablet and
• Finish the strip

or

What to do in case of vomiting or severe diarrhoea

Contact your doctor.

One tablet forgotten in week 1

Take the forgotten tablet as soon as you remember, even
if that means that you have to take two tablets at the
same time. Continue taking the tablets at the usual time
and use extra precautions for the next 7 days, for example,
a condom. If you have had sex in the week before
forgetting the tablet you should contact your doctor as
there is a chance you may have become pregnant.

One tablet forgotten in week 2

Take the forgotten tablet as soon as you remember, even
if that means that you have to take two tablets at the
same time. Continue taking the tablets at the usual time.
The protection against pregnancy is not reduced, and
you do not need to take extra precautions.
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember,
even if that means that you have to take two tablets
at the same time. Continue taking the tablets at the
usual time. Instead of taking the tablet-free period
start next strip.
Most likely, you will have a period at the end of the
second strip but you may also have light or menstruation
–like bleeding during the second strip.
2. You can also stop the strip and go directly to the
tablet-free period of 7 days (include the days on
which you forgot your tablet). If you want to start
a new strip on the day you always start, make the
tablet-free period less than 7 days.
If you follow one of these two recommendations, you will
remain protected against pregnancy.

If you vomit within 3-4 hours of taking a tablet or you
have severe diarrhoea, there is a risk that the active
substances in the tablet are not fully absorbed into your
body. The situation is almost the same as forgetting a
tablet. After vomiting or diarrhoea, take another tablet
from a reserve strip as soon as possible. If possible take
it within 12 hours of when you normally take your pill. If
this is not possible or 12 hours have passed, you should
follow the advice given under “If you forget to take
Lestramyl® 150/30 micrograms tablets”.

Delay of menstrual period: what you need to know

Even though it is not recommended, you can delay your
menstrual period in exceptional cases by going straight
to a new strip of Lestramyl® 150/30 micrograms tablets
instead of the tablet-free period, and finishing it. You may
experience light or menstruation-like bleeding while
using this second strip. After the usual tablet-free period
of 7 days, start the next strip.

You should ask your doctor for advice before
deciding to delay your menstrual period.
Changing of the first day of your menstrual
period: what you must know

If you take the tablets according to the instructions,
then your period will begin during the tablet-free week.
If you have to change this day, reduce the number of
the tablet-free days (but never increase them – 7 is the
maximum). For example, if your tablet-free days normally
begin on a Friday, and you want to change this to a
Tuesday (3 days earlier) start a new strip 3 days earlier
than usual. If you make the tablet-free interval very
short (for example, 3 days or less) you may not have any
bleeding during these days. You may then experience
light or menstruation-like bleeding.
If you are not sure what to do, consult your doctor.

Description Desogestrel Ethinylestradiol 0.15 mg / 0.03 mg 63

Other possible side effects

Serious reactions

• no bleeding (amenorrhea),
• tender breasts, breast pain,
• depression,
• headache,
• nervousness,
• dizziness,
• feeling sick (nausea),
• acne,
• high blood pressure,
• stomach (abdominal) pain,
• spotting or breakthrough bleeding (metrorrhagia),
• change in your mood.

The following serious side effects have been
reported in women using the pill. If you notice
any of the following, stop taking this medicine
and contact your doctor or go to the nearest
hospital casualty department straight away:

• Stop the strip immediately
• Begin the gap week (not
longer than 7 days, including
the forgotten tablet)
• Then go on to the next strip

Rare (may affect up to 1 in 1,000 people):
• hypersensitivity, (itchy red rash with swelling of the
face, lips and/or tongue and difficulty breathing)
• 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 for more information on the conditions that
increase risk for blood clots and the symptoms of a
blood clot).

Some conditions may occur or worsen during
pregnancy or use of the pill. Contact your doctor
immediately if you notice any of the following:
Rare (may affect up to 1 in 1,000 people):
• Breast cancer. You may notice a lump in your breast
or in the armpit or a change of size or shape of
your breast.
• Liver tumours (benign and malignant). You may have
upper stomach pain, loss of appetite, weight loss or
yellowing of the skin or whites of the eyes (jaundice).
Not known (cannot be estimated from the available data):
• Crohn's disease or ulcerative colitis (chronic
inflammatory bowel diseases) You may experience
symptoms such as bloody diarrhoea, pain when
passing stools, and pain in the stomach.
• systemic lupus erythematosus (SLE, a disease affecting
your natural defence system),
• epilepsy,

Date: 03 OCT 2016

Pharma Code N/A

No. of colours

Affiliate Item Code 964079

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Colours

TrackWise PR No. 964079
MA No. 04569/1342
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Vendor Job No. 288375
Trackwise Proof No. 3
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Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

5. How to store Lestramyl®
150/30 micrograms tablets
Keep this medicine out of the sight and reach of children.
Do not store this medicine above 25°C. Store blisters in
the original package in order to protect from moisture
and light.
Do not use this medicine after the expiry date which is
stated on the package after “EXP”. The expiry date refers
to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

The following side effects have been reported in women
using the pill, which can occur in the first few months
after starting Lestramyl® 150/30 micrograms tablets, but
they usually stop once your body has adjusted to the pill.

6. Contents of the pack and other
information

Very common (may affect more than 1 in
10 people):

The active substances are desogestrel and
ethinylestradiol. Each tablet contains 150 micrograms of
desogestrel and 30 micrograms of ethinylestradiol.
The other ingredients are:
all-rac-alpha-Tocopherol, potato starch, povidone
(E1201), stearic acid (E570), silica colloidal anhydrous
(E551) and lactose anhydrous.

• irregular bleeding
• weight gain.

Common (may affect up to 1 in 10 people):

Uncommon (may affect up to 1 in 100 people):
• breast enlargement,
• decreased sexual desire,
• migraine,
• being sick (vomiting), diarrhoea,
• rash, nettle-rash (urticaria),
• fluid retention

Rare (may affect up to 1 in 1,000 people):

• vaginal candidiasis (fungal infection of the vagina),
• impaired hearing or loss of hearing (otosclerosis),
• increased sexual desire,
• eye irritation due to contact lens,
• loss of hair (alopecia),
• itching,
• other skin disorders, such as:
• erythema nodosum – a skin disease associated with
joint pain, fever, hypersensitivity, or infection, and
characterised by small, painful, pink to blue nodules
under the skin and on the shins that tend to recur,
• erythema multiforme – a skin disease characterised
by solid raised spots on the skin or fluid-filled blisters/
lesions and reddening or discoloration of the skin often
in concentric zones about the lesions,
• vaginal discharge, breast discharge,
• loss of weight.

Before you have any blood tests

Tell your doctor or the laboratory staff that you are taking
the pill, because oral contraceptives can affect the results
of some tests.
Reporting of side effects If you get any side effects, talk
to your doctor or pharmacist. 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.

What Lestramyl® 150/30 micrograms tablets
contains

What Lestramyl® 150/30 micrograms tablets look
like and contents of the pack

Each tablet is round, white to off-white, uncoated,
biconvex, debossed with ‘142’ on one side and other
side plain.
Each strip of desogestrel 150 micrograms/
ethinylestradiol 30 micrograms tablets contains 21 white
tablets. Each strip is packed in trilaminated pouch.
Each box of desogestrel 150 micrograms/ethinylestradiol
30 micrograms tablets contains 1, 3 or 6 strips of
21 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan
Station Close,
Potters Bar, Hertfordshire,
EN61TL,
United Kingdom

Manufacturers

Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex
HA1 4HF,
United Kingdom
McDermott Laboratories Limited trading as
Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange State,
Dublin 13,
Ireland
Generics [UK] Limited,
Station Close,
Potters Bar,
Hertfordshire.
EN6 1TL
United Kingdom
This leaflet was last revised in 10/2016

964079

Component Type Leaflet

Superceded Affiliate Item Code 549036

• a blood disorder called haemolytic uraemic syndrome
- HUS (a disorder of blood clotting causing failure of
the kidneys),
• hereditary angioedema (an inherited blood disorder
that can cause occasional attacks of swelling that may
affect the face, hands, feet, genitals, gastrointestinal
tract and upper airways)
• Cervical cancer. You may notice bleeding or discharge
from the vagina that is not normal, pain or discomfort
during sex. Cervical cancer. You may notice bleeding or
discharge from the vagina that is not normal, pain or
discomfort during sex. Cervical cancer. You may notice
bleeding or discharge from the vagina that is not
normal, pain or discomfort during sex.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
An increased risk of blood clots in your veins (venous
thromboembolism (VTE)) or blood clots in your arteries
(arterial thromboembolism (ATE)) is present for all
women taking combined oral contraceptives. For more
detailed information on the different risks from taking
combined oral contraceptives please see section 2
“What you need to know before you take Lestramyl®
150/30 micrograms tablets”.
More serious reactions associated with combined
hormonal contraceptive pills are detailed above
in section 2 under “Blood clots”” and “Lestramyl®
150/30 micrograms tablets and cancer”. Please read these
subsections carefully, and if you have any questions, ask
your doctor.

• Take the forgotten tablet and
• Finish the strip
• Instead of the gap week
• Go straight on to the next strip
in
week 3

You can stop taking Lestramyl® 150/30 micrograms
tablets whenever you want. If you do not want to
become pregnant, ask your doctor for advice about other
reliable methods of birth control. If you want to become
pregnant, stop taking Lestramyl® 150/30 micrograms
tablets and wait for a period before trying to become
pregnant. You will be able to calculate the expected
delivery date more easily.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects

no

There are no reports of serious harmful results of taking
too many desogestrel/ethinylestradiol tablets. If you
take several tablets at once then you may experience
nausea or vomiting. Young girls may have bleeding from
the vagina. If you have taken too many desogestrel/
ethinylestradiol tablets, or you discover that a child has
taken some, ask your doctor or pharmacist for advice.

One tablet forgotten in week 3

Had sex in the previous
week before forgetting?

If you stop taking Lestramyl® 150/30 micrograms
tablets

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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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