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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 USER

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.
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
1. What Lestramyl® 150/30 micrograms tablets are 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 tablets are and what it is used
for
Lestramyl® 150/30 micrograms tablet 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. Also 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
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 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
Lestramyl® 150/30 micrograms tablets alters the monthly changes of
body temperature and of cervical mucus.
Lestramyl® 150/30 micrograms tablets, like other hormonal
contraceptives, does not protect against HIV infection (AIDS) or any
other sexually transmitted disease.
When you should not use Lestramyl® 150/30 micrograms tablets
You should not use Lestramyl® 150/30 micrograms tablets 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 embolism) 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 “Blood clots” (thrombosis and embolus)
• 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 vessel damage

• very high blood pressure

• 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) 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 to 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).
When to take special care with Lestramyl® 150/30 micrograms tablets
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” (thrombosis) section below.
For a description of the symptoms of these serious side effects please go to
“How to recognise a blood clot”.
Tell your doctor if any of the following conditions apply to you.
In some situations you need to take special care while using Lestramyl®
150/30 micrograms tablets or any other combination pill, and your doctor

may need to examine you regularly. If any of the following conditions
applies to you, tell your doctor before starting to use Lestramyl®
150/30 micrograms tablets. If the conditions develops, or gets worse
while you are using Lestramyl® 150/30 micrograms tablets, you should
tell your doctor:
• 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 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 epilepsy (see “The pill and using other medicines”)
• 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 “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.
• If you have hereditary angioedema, products 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.
• high blood pressure
BLOOD CLOTS
Using a combined hormonal contraceptive such as Lestramyl®
150/30 micrograms tablets, increases your risk of developing a blood clot
compared with not using one.
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 Lestramyl® 150 micrograms/ 30 micrograms tablet 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?
• swelling of one leg or along a vein in the leg or
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 breathlessness or rapid
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
• 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)

What are you
possibly suffering
from?
Deep vein
thrombosis

Pulmonary
embolism

Retinal vein
thrombosis (blood
clot in the eye)
Heart attack

Stroke

Blood clots
blocking other
blood vessels

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.

Date: 23 Oct 2014
Description Desogestrel/Ethinylestradiol 150/30mcg 21
Component Type Leaflet

Pharma Code 776

Affiliate Item Code 431844

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Vendor Job No. 231108

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Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Lestramyl® 150/30 micrograms tablets 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 using 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
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
Lestramyl® 150/30 micrograms tablets is very small but can increase:
• with increasing age (beyond about 35 years);
• if you smoke. When using a combined hormonal contraceptive
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). 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 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.
The pill 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 products

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• 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 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 Lestramyl® 150/30 micrograms tablets 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
Lestramyl® 150/30 micrograms tablets 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 with Lestramyl® 150/30 micrograms
tablets, between about 9 and 12 women 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”
below)
Risk of developing a
blood clot in a year
Women who are not using a combined
About 2 out of
hormonal pill/patch/ring and are not pregnant 10,000 women
Women using a combined hormonal
About 5-7 out of
contraceptive pill containing levonorgestrel,
10,000 women
norethisterone or norgestimate
Women using Lestramyl® 150/30 micrograms About 9-12 out of
10,000 women
tablets

Myriad Pro
270 x 390mm

Body Text Size 8.3 pt

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 Lestramyl® 150/30 tablets 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
Always tell the doctor which medicines or herbal products you are
already using. Also tell any other doctor or dentist who prescribes another
medicine (or the pharmacist) that you use Lestramyl® 150/30 micrograms
tablets. 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 Lestramyl® 150/30 micrograms tablets less
effective in preventing pregnancy, or can cause unexpected bleeding.
These include:
• Medicines used for the treatment of epilepsy (e.g. primidone, phenytoin,
barbiturates, carbamazepine, oxcarbamazepine, topiramate, felbamate)
• bosentan (a medicine for the treatment of hypertension in the lung
arterie or ulcers of the fingers)
• modafinil (a medicine for the treatment of narcolepsy)
• Medicines used for the treatment of tuberculosis (e.g. rifampicin),
• Medicines used for the treatment of HIV infections (ritonavir, nelfinavir,
nevirapine, efavirenz) or other infections (antibiotics such as griseofulvin,
penicillin, tetracycline, rifabutin)
• the herbal remedy St. John’s wort (Hypericum perforatum).
Lestramyl® 150/30 micrograms tablets may influence the effect of other
medicines, e.g.
• medicines containing cyclosporin,
• the anti-epileptic lamotrigine (this could lead to an increased frequency
of seizures).
Ask your doctor or pharmacist for advice before taking any medicine.
Lestramyl® 150/30 micrograms tablets with food and drink
Lestramyl® 150/30 micrograms tablets may be taken with or without food,
if necessary with a small amount of water.
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 effect the results of
some tests.
Pregnancy
If you are pregnant, do not take Lestramyl® 150/30 micrograms tablets.
If you become pregnant while taking Lestramyl® 150/30 micrograms
tablets stop immediately and contact your doctor. If you want to become
pregnant, you can stop taking the pill at any time.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Lestramyl® 150/30 micrograms tablets is generally not advisable
when a woman is breast-feeding. If you want to take the pill while you are
breast feeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no information suggesting that use of Lestramyl®
150/30 micrograms tablets affects driving or use of machines.
Lestramyl® 150/30 micrograms tablets contain lactose
This product contains 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 Lestramyl® 150/30 micrograms tablets
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 is socalled “ 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 (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 on the first day of the
cycle (that is the first day of your period). If you start Lestramyl®
150/30 micrograms 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 can start Lestramyl® 150/30 micrograms 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, follow
the advice of your doctor.
• 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 on the day of its removal, 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
Follow the advice of your doctor.
• After having a baby
You can start Lestramyl® 150/30 micrograms between 21 and 28 days
after having a baby,. If you start later than day 28, use a so-called
barrier method (for example, a condom) during the first seven days of
Lestramyl® 150/30 micrograms use. If, after having a baby, you have
had sex before starting Desogestrel 150 micrograms/ethinylestradiol
30 micrograms (again), be sure that you are not pregnant or wait until
your next period.
• If you are breastfeeding and want to start Lestramyl® 150/30 micrograms
Tablets (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.
Use in children and adolescents
No clinical data on efficacy and safety are available in adolescents below
18 years.

If you take more Lestramyl® 150/30 micrograms tablets than you should
There are no reports of serious harmful results of taking too many
Lestramyl® 150/30 micrograms tablets. If you take several tablets at
once then you may have symptoms of nausea or vomiting. Young girls
may have bleeding from the vagina. If you have taken too Lestramyl®
150/30 micrograms Tablets, or you discover that a child has taken some,
ask your doctor or pharmacist for advice.
What to do 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 (see the the diagram below):
• More than one tablet forgotten in this strip
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 may be pregnant. In that case, contact your doctor
• 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.
• One tablet forgotten in week 3
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 (record the day 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 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.

Several tablets forgotten
in 1 strip

Ask your doctor for advice
yes

in
week 1

Had sex in the previous week
before forgetting?
no
• Take the forgotten tablet
• Use a barrier method (condom)
for the following 7 days
• And finish strip

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

in
week 2

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

in
week 3

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

What to do in case of vomiting or severe diarrhoea
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
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 might 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.
If you want to stop taking Lestramyl® 150/30 micrograms Tablets
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.

Date: 23 Oct 2014
Description Desogestrel/Ethinylestradiol 150/30mcg 21
Component Type Leaflet

Pharma Code 776

Affiliate Item Code 431844

SAP No. N/A

Superceded Affiliate Item Code 10005117

Vendor Job No. 231108

TrackWise PR No. 431844

Proof No. 3

MA No. 04569/1342

Client Market UK

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Time: 15:48
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1

If you have any further questions on the use of this product,
ask your doctor or pharmacist
4. Possible side effects
Like all medicines, Lestramyl® 150/30 micrograms tablets
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 Lestramyl® 150/30 micrograms
tablets, please talk to your doctor.
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 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 take
Lestramyl® 150/30 micrograms tablets”.
Serious reactions
More serious reactions associated with combined hormonal contraceptive
pills are detailed above in section 2 under “Blood clots” and “The pill
and cancer”. Please read these subsections carefully, and if you have any
questions, ask your doctor.
The following serious side effects have been reported in women using the pill:
Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
systemic lupus erythematosus (SLE, a disease of the connective tissue),
epilepsy, the rash known as herpes gestationis, chorea (a movement
disease), a blood disorder called haemolytic uraemic syndrome - HUS
(a disorder where blood clots cause the kidneys to fail), brown patches
on the face and body (chloasma), movement disorder called Sydenham's
chorea, yellowing of the skin, gynaecological disorders (endometriosis,
uterine myoma)
Other possible side effects
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.
Very common (affects 1 in every 10 users): irregular bleeding and
weight gain.
Common (affects 1 to 10 users in 100): no bleeding, tender breasts, breast
pain, depression, headache, nervousness, dizziness, nausea, acne, high
blood pressure, stomach (abdominal) pain, spotting or break through
bleeding (metrorrhagia), change in your mood.
Uncommon (affects 1 to 10 users in 1,000): breast enlargement, decreased
sexual desire, migraine, vomiting, diarrhoea, rash, nettle-rash (urticaria),
fluid retention
Rare (affects 1 to 10 users in 10,000): 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, vaginal candidiasis (fungal infection), impaired
hearing (otosclerosis), thromboembolism, hypersensitivity, increased
sexual desire, eye irritation due to contact lens, loss of hair (alopecia),
itching, skin disorders (erythema nodosum – a skin disease associated
with joint pain, fever, hypersensitivity, or infection, and characterized by
small, painful, pink to blue nodules under the skin and on the shins that
tend to recur; erythema multiforme – a skin disease characterized 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.
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).
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.
If you get any side effects, talk to your doctor or pharmacist. This includes any
side effects not listed in this leaflet.
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 and store blisters in the original
pouches in order to protect from moisture and light.
Expiry date
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.
6. Contents of the pack and other information
What Lestramyl® 150/30 micrograms tablets contains
The active substances are desogestrel and ethinylestradiol.
The other ingredients are:
All-rac-alpha-tocopherol, potato starch, povidone (E1201), stearic acid
(E570), silica colloidal anhydrous (E551) and lactose anhydrous.
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 Lestramyl® 150/30 micrograms tablets contains
21 white tablets.
Each box of Lestramyl® 150/30 micrograms tablets contains 1, 3 or 6 strips
of 21 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Mylan
Potters Bar, Herts
EN6 1TL
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex
HA1 4HF,
United Kingdom
Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange State,
Dublin 13,
Ireland
Generics [UK] Limited,
Station Close,
Potters Bar,
Hertfordshire.
EN6 1TL
United Kingdom

Myriad Pro
270 x 390mm

Body Text Size 8.3 pt

431844

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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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