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LEVEST 150/30 MICROGRAM COATED TABLETS

Active substance(s): ETHINYLESTRADIOL / LEVONORGESTREL / ETHINYLESTRADIOL / LEVONORGESTREL / ETHINYLESTRADIOL / LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Levest 150/30 microgram Coated Tablets

!

Levonorgestrel/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.
! If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Levest is and what it is used for
2. What you need to know before you take Levest
3. How to take Levest
4. Possible side effects
5. How to store Levest
6. Contents of the pack and other information
1. What Levest is and what it is used for
Levest coated tablets are a combined oral contraceptive and belongs to
a group of products often referred to as “the Pill”. Levest contains two
hormones: oestrogen (Ethinylestradiol) and progestogen
(Levonorgestrel). These hormones prevent you from getting pregnant,
just as your natural hormones would prevent you from conceiving again
when you are already pregnant.
2. What you need to know before you take Levest
General notes
Before you can begin taking Levest, your doctor will ask you some
questions about your personal health 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
taking Levest, or where the reliability of Levest may be decreased. In
such situations you should either not have intercourse 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 Levest alters the monthly
changes of the body temperature and of the cervical mucus.
Levest, like other hormonal contraceptives, does not protect against HIV
infection (AIDS) or any other sexually transmitted disease.
Do not take Levest
! If you are allergic ethinylestradiol or levonorgestrel or any of the
other ingredients of this medicine (listed in section 6).
! If you have (or have ever had) a blood clot in a blood vessel of the
leg (thrombosis), lung (pulmonary embolism) or other organs.
! If you have (or have ever had) a heart attack or stroke.
! If you have (or have ever had) a disease that can be a predictor of
a heart attack (for example, angina pectoris, which causes severe
pain in the chest) or of a stroke (for example, a transient slight
stroke with no residual effects).
! If you have a disease that may increase the risk of a thrombosis in
the arteries. This applies to the following diseases:
, Diabetes mellitus with damaged blood vessels.
, Very high blood pressure.
, A very high level of fat in the blood (cholesterol or triglycerides).
! If you have a disturbance of blood clotting (for example, protein C
deficiency).
! If you have (or have ever had) a certain form of migraine (with socalled focal neurological symptoms).
! 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.
! If you have hepatitis C and are taking the medicinal products
containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also
in section “Other medicines and Levest”).
Warnings and precautions
In some situations you need to take special care while taking Levest or
any other combined hormonal contraceptive, and it may be necessary
that you are regularly checked by your doctor. If any of the following
conditions apply to you, you must inform your doctor before starting to
use Levest. Also if any of the following conditions develops or worsens
during the use of Levest you must consult your doctor.
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If a close relative has or has 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 (inflammatory
bowel disease).
If you have HUS (haemolytic uraemic syndrome; a blood disease
that causes kidney damage).
If you have epilepsy (see section “Other medicines and Levest”).
If you have SLE (systemic lupus erythematosus; a disease of the
immune system).
If you have a disease that first appeared during pregnancy or earlier
use of sex hormones (for example hearing loss), porphyria (a
disease of the blood), gestational herpes (skin rash with vesicles

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during pregnancy), Sydenham's chorea (a disease of the nerves in
which sudden movements of the body occur).
If you have or have ever had chloasma (golden brown pigment
patches, so called “pregnancy patches”, especially on the face). If
this is the case, avoid direct exposure to sunlight or ultraviolet light.
If you have hereditary angioedema, products containing oestrogens
may induce or worsen symptoms of angioedema. 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 a blood disease called sickle cell anaemia.
If a pre-existing high blood pressure condition worsens.
If a pre-existing high level of fat in blood worsens.

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 unusual severe abdominal pain.
Bleeding between periods
During the first few months that you are taking Levest, you may have
unexpected bleeding (bleeding outside the gap week). If this bleeding
lasts longer than a few months, or if it begins after some months, talk to
your doctor, who will find out what is wrong.
What to do if no bleeding occurs during 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, it is
highly unlikely that you are pregnant.

Talk to your doctor or pharmacist before taking Levest.
Levest and venous and arterial blood clots
Venous blood clots
The use of any combination pill, including Levest increases a woman's
risk of developing a venous blood clot or venous thrombosis
(formation of a blood clot in vessels) compared with a woman who does
not take any (contraceptive) pill. The excess risk is highest during the
first year a woman initially starts using a combination pill or when she
restarts use after a pill-free interval of at least a month.
The risk of venous thrombosis in users of combined pills increases:
! With increasing age.
! If you are overweight.
! If one of your close relatives has had a blood clot (thrombosis) in
the leg, lung, or other organ at a young age.
! If you must have an operation (surgery), any prolonged period of
immobilisation, or if you have had a serious accident. It is important
to tell your doctor in advance that you are using Levest as the
treatment may have to be stopped. Your doctor will tell you when to
start again. This is usually about two weeks after you are back on
your feet.
Your chances of having a blood clot are increased by taking the pill.
! Of 100,000 women who are not on the pill and not pregnant, about
5-10 may have a blood clot in a year.
! Of 100,000 women taking a pill like Levest, 30-40 may have a blood
clot in a year, the exact number is unknown.
! Of 100,000 women who are pregnant, around 60 may have a blood
clot in a year.

If the expected bleeding does not happen twice in a row, you may be
pregnant. Contact your doctor immediately. Do not start the next strip
until you are sure that you are not pregnant.
Other medicines and Levest
Always tell the doctor, who prescribes Levest, if you are taking, have
recently taken or might take any other medicines, including herbal
products. Also tell any other doctor or dentist who prescribes another
medicine (or the pharmacist) that you take Levest. 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 Levest less effective in preventing
pregnancy, or can cause unexpected bleeding. They include medicines
used for the treatment of:
! epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine,
oxcarbazepine, topiramate and felbamate),
! tuberculosis (e.g. rifampicin),
! HIV infections (ritonavir, nevirapine) or other infectious diseases
(griseofulvin),
! high blood pressure in the blood vessels in the lungs (bosentan),
! the herbal remedy St. John's wort.
Levest may influence the effect of other medicines, for example:
! medicines containing cyclosporin,
! the anti-epileptic lamotrigine (this could lead to an increased
frequency of seizures).
Do not take Levest if you have Hepatitis C and are taking the medicinal
products containing ombitasvir/paritaprevir/ritonavir and dasabuvir as
this may cause increases in liver function blood test results (increase in
ALT liver enzyme).

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 socalled “withdrawal bleeding” usually starts on the 2nd or 3rd day of the
gap week.

If you have not used any contraceptive with hormones in the
previous month
Begin with Levest on the first day of the cycle (that is the first day of
your menstruation). If you start Levest on the first day of your
menstruation 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 another combined hormonal contraceptive, or
combined contraceptive, vaginal ring or patch
You can start Levest preferably on the day after the last active tablet
(the last tablet containing the active substance) of your previous pill, but
at the latest on the day after the tablet-free days of your previous pill
finish (or after the last inactive tablet of your previous pill). When
changing from a combined 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 the IUD on the day of its removal, from an injectable when the next
injection would be due) but in all of these cases you must 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.
After having a baby, you can start Levest between 21 and 28 days later.
If you start later than day 28, you must use a so-called barrier method
(for example, a condom) during the first seven days of Levest use.
If, after having a baby, you have had intercourse before starting Levest
(again), you must first be sure that you are not pregnant or you must
wait until the next menstrual bleed.

Levest can be restarted approximately 2 weeks after completion of this
treatment. See section “Do not take Levest”.

! While breast-feeding
If you are breast-feeding and want to start taking Levest (again) after
having a baby, read the section “Pregnancy and breast feeding”.

Arterial blood clots
The use of combination pills has been connected with an increase of
the risk of arterial blood clot or arterial thrombosis (obstruction of an
artery), for example, in the blood vessels of the heart (heart attack) or
the brain (stroke).

Levest with food and drink
Levest may be taken with or without food, if necessary with a small
amount of water.

Ask your doctor what to do if you are not sure when to start taking
Levest.

Effect on laboratory tests
If you need a blood test, 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 take more Levest than you should
There are no reports of serious harmful results of taking too many
Levest 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 many Levest tablets, or you discover that a child
has taken some, ask your doctor or pharmacist for advice.

Stop taking Levest and contact your doctor immediately if after
taking Levest you notice possible signs of a blood clot, such as:
! any unusual, severe or long-lasting headache or worsening of
migraine.
! partial or complete blindness or double vision.
! severe pain and/or swelling in one of your legs.
! sudden breathlessness.
! sudden cough without an obvious cause.
! sudden severe pain in the chest which may reach the left arm.
! difficulty in speaking or inability to speak.
! weakness, strange feeling, or numbness in any part of the body.
! a feeling of dizziness or spinning.
! collapse with or without focal seizure.
! weakness, strange feeling, or numbness in any part of the body.
! sudden severe abdominal pain.

Breast-feeding
Use of Levest is generally not advisable when a woman is breastfeeding. If you want to take the pill while you are breast-feeding you
should contact your doctor.

Levest and cancer
Breast cancer has been observed slightly more often in women using
combined 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 combined 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 lumps.

Always take Levest exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure. Remember to
take Levest as prescribed because missing tablets could reduce the
effectiveness of the medicine.

Cervical cancer in long-term users has been reported, but it is not clear
if it is contributed by sexual behaviour or other factors such as human
papilloma virus (HPV).

Driving and using machines
Levest does not have any known effect on your ability to drive or use
machines.
Levest contains lactose and sucrose
Levest contains lactose and sucrose. 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 Levest

Take one tablet of Levest every day, if necessary with a small amount of
water. 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.

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)

If you forget to take Levest
If you are less than 12 hours late in taking your pill, the protection from
pregnancy is not reduced. Take the tablet as soon as you remember,
and then continue to take following pills at the usual time (even if this
means taking two tablets the same day). In this case you do not need to
use any additional method of contraception.
If you are more than 12 hours late taking a tablet, the protection from
pregnancy may be reduced. The greater the number of tablets that you
have forgotten, the greater is the risk that the protection from pregnancy
is reduced.
The risk of incomplete protection against pregnancy is greatest if you
forget a tablet at the beginning or the end of the strip.
Follow the instructions below if you have forgotten to take a tablet:
! If you forgot more than one tablet in this strip
Contact your doctor.
! If you forgot one tablet 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. Take the tablets
again at the usual time and use extra precautions for the next 7 days,
for example, a condom. If you have had intercourse in the week before
the oversight or you have forgotten to start a new strip after the tabletfree period, you must realise that there is a risk of pregnancy. In that
case, contact your doctor.
! If you forgot one tablet 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. Take the tablets
again at the usual time. The protection from pregnancy is not reduced,
given that you have taken the tablets correctly in the previous 7 days,
otherwise extra precaution should be used for the next 7 days.
! If you forgot one tablet in week 3
You can choose between two options:
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. Take the

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

!

!

Had sex in the previous week before forgetting?

No

Starting the first pack of Levest

The level of risk may vary according to the type of pill you take. Discuss
with your doctor the available options.

Pregnancy
If you are pregnant, do not take Levest. If you become pregnant while
taking Levest you must stop immediately and contact your doctor. If you
want to become pregnant, you can stop taking the pill at any time (see
also section “If you want to stop taking Levest”).

in week 1

If you take Levest in this manner, you are also protected against
pregnancy during the 7 days that you are not taking a tablet.

Your doctor will prescribe another type of contraceptive prior to start of
the treatment with these medicinal products.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.

Ask your doctor for advice

Yes

On the 8th day after the last Levest tablet (that is, after the 7-day gap
week), start the following strip, even if the bleeding has not stopped.
This means that you should start the following strip on the same day of
the week and that the withdrawal bleed should occur on the same days
each month.

A blood clot in the veins may travel to the lungs and may block blood
vessels (called a lung embolus). Formation of blood clots in the veins
may be fatal in 1-2% of cases.

The risk of arterial thrombosis in users of combined pills increases:
! With increasing age.
! If you smoke you are strongly advised to stop smoking when
you use Levest, especially if you are older than 35 years.
! If you have an increased fat content in your blood (cholesterol or
triglycerides).
! If you are overweight.
! If one of your close relatives ever had a heart attack or stroke at a
young age.
! If you have high blood pressure.
! If you have migraine.
! If you have a problem with your heart (valve disorder, a disturbance
of the heart rhythm).

Several tablets
forgotten in 1 strip

tablets again at the usual time. Instead of the tablet-free period go
straight on to the next strip.
Most likely, you will have a period (withdrawal bleed) at the end of the
second strip but you may also have spotting or breakthrough 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 your fixed start day, make the tablet-free
period less than 7 days.
If you follow any of the above 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, this may mean that you are
pregnant. You must contact your doctor before you go on to the next
strip.
What to do if you vomit or have 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 pill are not
fully adsorbed into your body. The situation is almost similar to if you
forget a tablet. After vomiting or diarrhoea, you must 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 Levest.'

Uncommon (may affect up to 1 in 100 people):
Vomiting, diarrhoea, fluid retention, migraine, decreased libido (interest
in sex), breast enlargement, itchy red rash of the skin (urticaria).
Rare (may affect up to 1 in 1,000 people):
Contact lens intolerance, allergic reactions, weight loss, increased libido
(interest in sex), breast discharge, vaginal discharge, allergic reactions
which can sometimes be severe with swelling of the skin and/or mucous
membranes (erythema nodosum & erythema multiforme).
Oral contraceptive use has been associated with:
! Increased risk of blood clots in arteries and veins and disorders
caused by a blood clot that breaks loose, including heart attack,
blood clot in a vein and blood clot in the lung (see section
“Warnings and precautions”).
! Increased risk of changes in the surface of the neck of the uterus
(intraepithelial neoplasia) and cancer of the neck of the uterus.
! Increased risk of breast cancer diagnosis (see section “Warnings
and precautions”).
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,
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Levest

Delaying your period: what you need to know
Even if not recommended, delay of your menstrual period (withdrawal
bleed) is possible by going straight on to a new strip of Levest instead of
the tablet-free period, to the end of the second strip. You may
experience spotting (drops or flecks of blood) or breakthrough bleeding
while using the second strip. After the usual tablet-free period of 7 days,
continue with the following strip.
You might ask your doctor for advice before deciding to delay your
menstrual period.

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use Levest after the expiry date which is stated on the carton
after 'EXP'. The expiry date refers to the last day of that month.
Do not throw away the 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

Change of the first day of your menstrual period: what you must
know
If you take the tablets according to the instructions, then your menstrual
period/withdrawal bleed will begin in the tablet-free week. If you have to
change this day, do this by making the tablet- free period shorter (but
never longer!) For example, if your tablet-free period begins on a Friday,
and you want to change this to a Tuesday (3 days earlier) you must
start a new strip 3 days earlier than usual. If you make the tablet-free
period very short (for example, 3 days or less) then it may be that you
do not have any bleeding during this tablet-free period. You may then
experience spotting (droplets or flecks of blood) or breakthrough
bleeding.

What Levest contains
! The active substances are levonorgestrel (150µg) and
ethinylestradiol (30µg).
! The other ingredients are lactose monohydrate, maize starch,
povidone k-25, sucrose, talc, calcium carbonate, povidone k-90,
glycerin, macrogol 6000, titanium dioxide, magnesium stearate and
carnauba wax.
What Levest looks like and contents of the pack
Levest tablets are white, circular, biconvex and sugar coated.
Each blister pack contains 21 tablets.

If you are not sure how to proceed, contact your doctor for advice.
If you want to stop taking Levest
You can stop taking Levest 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
Levest and wait for a menstrual 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
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following is a list of the side effects that have been linked with the
use of Levest:
Common (may affect up to 1 in 10 people):
Mood swings, headache, abdominal pain (stomach ache), acne, breast
pain, weight gain, nausea.

Levest is sold in cartons of 1, 3, 6 or 13 blister packs. Not all pack sizes
may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd.
115 Narborough Road
Leicester
LE3 0PA
UK
Manufacturer
Morningside Pharmaceuticals Ltd.
5 Pavilion Way, Castle Business Park,
Loughborough, Leicestershire,
LE11 5GW, UK
This leaflet was last revised in May 2017.

Expand Transcript

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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