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ERLIBELLE 30 MICROGRAMS/150 MICROGRAMS FILM-COATED TABLETS

Active substance(s): ETHINYLESTRADIOL / LEVONORGESTREL

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Package leaflet: Information for the user

Erlibelle 30micrograms/150micrograms film-coated tablets
Ethinylestradiol / Levonorgestrel
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 further questions, ask your doctor or your
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
What is in this leaflet
1. What Erlibelle is and what it is used for
2. What you need to know before you take Erlibelle
3. How to take Erlibelle
4. Possible side effects
5. How to store Erlibelle
6. Contents of the pack and other information
1. What Erlibelle is and what it is used for
• Erlibelle is a contraceptive pill and it is used to prevent
pregnancy.
• Each tablet contains a small amount of two different female
hormones, namely ethinylestradiol and Levonorgestrel.
• Contraceptive pills that contain two hormones are called
“combination” pills.
2. What you need to know before you take Erlibelle
General notes
Before you can begin taking Erlibelle, 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 Erlibelle, or where the reliability of Erlibelle
may be decreased. In such situations you should either not
have intercourse or you should take extra non-hormonal
contraceptive precautions, for example use a condom or
another barrier method. Do not use rhythm or temperature
methods. These methods can be unreliable because Erlibelle
alters the monthly changes of the body temperature and of
the cervical mucus.
Erlibelle , like other hormonal contraceptives, does not
protect you against HIV infection (AIDS) or any other
sexually transmitted disease.
Do not take Erlibelle
• 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 an indicator
of a heart attack (for example, angina pectoris, which causes
severe pain in the chest) or of a stroke (for example, a passing
slight stroke with no residual effects)
• if you have a disease that may increase the risk of a clot in the
arteries. This applies to the following diseases:
- diabetes 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 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
• if you have (or have ever had) a certain form of migraine (with
so-called focal neurological symptoms)
• if you are allergic to ethinylestradiol, levonorgestrel or any of
the other ingredients of this medicine (listed in section 6). An
allergic reaction may cause itching, rash or swelling.
Warnings and precautions
In some situations you need to take special care while using
Erlibelle or any other combination pill, and it may be necessary
that you are regularly checked by your doctor. If any of the
following conditions applies to you, inform your doctor before
starting to take Erlibelle.
Also if any of the following conditions develops or worsens
while you are using Erlibelle, you must consult 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 inflammatory bowel disease
(ulcerative colitis)
• if you have a blood disease called HUS (haemolytic uraemic
syndrome) which causes kidney damage)
• if you have a blood disease called sickle cell anaemia
• if you have epilepsy (see section “Other medicines and
Erlibelle”)
• if you have a disease of the immune system called SLE
(systemic lupus erythematosus)
• 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 exposure to sunlight or ultraviolet
light
• if you have hereditary angioedema, products containing
estrogens may cause or worsen symptoms. Talk to 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.

The risk of arterial blood clot in users of combination pills
increases:
• i f you smoke. You are strongly advised to stop smoking when
you use Erlibelle, especially if you are older than 35 years
• if the fat content of your blood is increased (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 suffer from migraine
• if you have a problem with your heart (valve disorder, a
disturbance of the cardiac rhythm).
Stop taking Erlibelle and contact your doctor immediately if
notice possible signs of a 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
• giddiness or fainting
• weakness, strange feeling, or numbness in any part of the
body.
Erlibelle and cancer
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 using the pill because they see
the doctor more often.
The occurrence of breast tumours becomes gradually less
after stopping the combination hormonal contraceptives. It is
important to regularly check 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 Erlibelle, 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, 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.
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 Erlibelle
Always tell your doctor, who prescribes Erlibelle, if you are
using, have recently used or might use any other medicines,
including herbal products. Also tell any other doctor or dentist
who prescribes another medicine (or the pharmacist) that you
take Erlibelle. 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 Erlibelle less effective in preventing
pregnancy, or can cause unexpected bleeding. These include
• medicines used for the treatment of:
- epilepsy (for example primidone, phenytoin, barbiturates,
carbamazepine, oxcarbazepine)
- tuberculosis (for example rifampicin)
- HIV infections (ritonavir, nevirapin) or other infections
(antibiotics such as griseofulvin, penicillin, tetracycline)
- high blood pressure in the blood vessels in the lungs
(bosentan)
• the herbal remedy St. John’s wort.
Erlibelle may influence the effect of other medicines, for
example:
• medicines containing cyclosporine
• the anti-epileptic lamotrigine (this could lead to an increased
frequency of seizures).
Erlibelle with food and drink
Erlibelle 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 affect the results of some tests.
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.
Pregnancy
If you are pregnant, do not take Erlibelle. If you become
pregnant while taking Erlibelle stop using the pill immediately
and contact your doctor. If you want to become pregnant, you
can stop taking the pill at any time (see also “If you want to stop
taking Erlibelle”).
Breast-feeding
Use of Erlibelle is generally not advisable when a woman is
breast-feeding. If you want to take the pill while you are breastfeeding, contact your doctor.
Driving and using machines
There is no information suggesting that the use of Erlibelle
affects driving or use of machines.
Erlibelle contains lactose
This medicine contains lactose. If you cannot tolerate certain
sugars, contact your doctor before you take Erlibelle.

Talk to your doctor or pharmacist before taking Erlibelle.

3. How to take Erlibelle

Erlibelle and venous and arterial blood clots
The use of any combination pill, including Erlibelle, increases
a woman’s risk of developing a venous blood clot (venous
thrombosis) compared with women who do not take any
contraceptive pill.

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

The risk of venous blood clots in users of combination pills
increases:
• with increasing age
• if you are overweight
• if one of your close relatives ever had a blood clot in the leg,
lung (pulmonary embolism), or other organ at a young age
• if you have to have surgery, if you have had a serious accident
or if you are immobilised for a long time. It is important to tell
your doctor that you are using Erlibelle as you may have to
stop taking it. Your doctor will tell you when to start using it
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 Erlibelle, 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.
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 level of risk may vary according to the type of pill you take.
Discuss with your doctor the available options.
The use of the combination pill has been connected with
an increase of the risk of an arterial blood clot (arterial
thrombosis), for example, in the blood vessels of the heart
(heart attack) or the brain (stroke).

How and when should Erlibelle be used:
Each strip contains 21 tablets.
Take one Erlibelle tablet every day, if necessary with a small
amount of water. You should take the tablets every day around
the same time.
Next to each tablet is printed the day of the week when it
should be taken. Start by taking a tablet from the first row
marked with the correct day of the week. If, for example, you
start on a Wednesday, take a tablet with “WED” next to it. Follow
the direction of the arrows on the strip until you have taken
all 21 tablets. 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 Erlibelle tablet (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 Erlibelle in this manner, you are also protected against
pregnancy during the 7 days when you are not taking tablets.
When can you start taking Erlibelle
• I f you have not used any contraceptive with hormones in the
previous month
Start taking Erlibelle on the first day of the cycle (that is, on the
first day of your menstrual period). If you start Erlibelle on the
first day of your menstruation, you are immediately protected
against pregnancy. You may also begin on days 2-5 of the cycle,
but then you must use extra protective measures (for example,
a condom) for the first 7 days.

Levonorgestrel/Ethinylestradiol 150mcg / 30mcg, PIL, United Kingdom

colours/plates:
1. black

item no:

AAAF8235

dimensions: 222 x 680

print proof no:

5

pharmacode:

origination date: 20.8.13
approved for print/date

min pt size:

2.
3.
4.

10.5 pt

originated by:

db

revision date:

21.8.13

Technical Approval

revised by:

db

date sent:

supplier:

León Farma

approved:

5.
6.

20.8.13

Non Printing Colours
1.
2.
3.

• I f you are changing from a combination hormonal
contraceptive, vaginal ring or a patch
You can start Erlibelle 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). When changing from a combination
contraceptive vaginal ring or patch, follow the advice of your
doctor.
• I f you are changing from a progestogen-only-method
(progestogen-only–pill, injection, implant or progestogen
releasing intrauterine device - 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 the
cases use extra protective measures (for example, a condom)
for the first 7 days of tablet-taking.
• I f you had a miscarriage
Follow the advice of your doctor.
•A
 fter having a baby
You can start taking Erlibelle between 21 and 28 days after
having a baby. If you start later than day 28, use a barrier
contraceptive method (for example, a condom) during the first
seven days. If, after having a baby, you have had sex before
starting to take Erlibelle (again), be sure that you are not
pregnant or wait until the next menstrual period before taking
this medicine.
•W
 hile breast-feeding
If you are breast-feeding and want to start taking Erlibelle
(again) after having a baby, read the section “Pregnancy and
breast-feeding”.
Ask your doctor what to do if you are not sure when to start
taking Erlibelle.
If you take more Erlibelle than you should
There are no reports of serious harmful results of taking too
many Erlibelle 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 Erlibelle tablets, or you discover that
a child has taken some, ask your doctor or pharmacist for advice.
If you forget to take Erlibelle
• If you are less than 12 hours late taking a tablet, the protection
from pregnancy is not reduced. Take the tablet as soon as you
remember and then continue to take the following tablets
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 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.
Follow the instructions below if you have forgotten to take a
tablet:
• I f you forgot more than one tablet in this strip
Contact your doctor.
• I f you forgot one tablet in week 1
Take the forgotten tablet as soon as you remember, even if that
means taking two tablets at the same time. Continue taking
the tablets at the usual time and use extra contraceptive
barrier methods 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.
• I f you forgot one tablet in week 2
Take the forgotten tablet as soon as you remember, even if that
means taking two tablets at the same time. Continue taking
the tablets at the usual time. The contraceptive effect of the
medicine is not reduced, and you do not need to take extra
precautions.
• I f 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 taking two tablets at the same time. Continue taking
the tablets at the usual time. Instead of the tablet-free period,
start the 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 taking the tablets in the strip and
immediately start 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 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 days, this may mean
that you are pregnant. Contact your doctor before you start the
next strip.
More than
1 tablet
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

Changing the first day of your period: what you need to know
If you take the tablets according to the instructions, then your
period will begin during the tablet-free week. If you want to
change this day, reduce the number of 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 Erlibelle
You can stop taking Erlibelle 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 Erlibelle 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 Erlibelle:
Common (may affect up to 1 in 10 people):
• nausea
• abdominal pain
• increased weight
• headache
• depressed mood
• altered mood
• breast tenderness
• breast pain
Uncommon (may affect up to 1 in 100 people):
• vomiting
• diarrhoea
• fluid retention
• migraine
• decreased libido
• breast enlargement
• rash
• hives (urticaria)
Rare (may affect up to 1 in 1,000 people):
• contact lens intolerance
• hypersensitivity
• decreased weight
• increased libido
• breast discharge
• vaginal discharge
• a type of skin inflammation resulting in reddish, painful, tender
lumps (erythema nodosum)
• a skin disorder that causes red, target-shaped or ”bulls-eye”
patches or sores (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
“Warnings and precautions” section).
- 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 “Warnings and
precautions” section).
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 Erlibelle
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on
the carton and strip 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 Erlibelle contains
• The active ingredients are ethinylestradiol and levonorgestrel.
Each tablet contains 0.03mg of ethinylestradiol and 0.15mg of
levonorgestrel.
• The other ingredients are:
Tablet core: lactose monohydrate, povidone K30, crospovidone
type A and magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol
3350, talc (E553b) and iron oxide yellow (E172)
What Erlibelle looks like and contents of the pack
• Each strip of Erlibelle contains 21 yellow film-coated tablets.
• Erlibelle tablets are film-coated tablets. The tablets are yellow,
round, with a diameter of 6mm and thickness less than 4mm
approximately.
• Erlibelle is available in packs of 3 strips, each strip with 21
tablets.
Marketing Authorisation Holder
Laboratorios León Farma, S.A.
Polígono Industrial Navatejera, La Vallina S/N
24008 Navatejera (Leon) - Spain
Manufacturer
Laboratorios León Farma, S.A.
Polígono Industrial Navatejera, La Vallina S/N
24008 Navatejera (Leon) - Spain
This leaflet was last revised in August 2013

If you would like a
leaflet with larger text,
please contact
01271 385257.

• Take the forgotten
tablet and
• Finish the strip
• Take the forgotten
tablet and
• Finish the strip
• Instead of the gap
week
• Start 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 start the next
strip
What to do if you vomit or have severe diarrhoea
If you vomit within 3-4 hours after taking a tablet or you have
severe diarrhoea, there is a risk that the active substances in
the tablet are not fully absorbed in your body. The situation
is almost the same as forgetting a tablet. After vomiting or
having 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 tablets. If this is not possible or 12 hours
have passed, follow the advice given under “If you forget to take
Erlibelle”.
Delaying your period: what you need to know
Even though it is not recommended, you can delay your period
by going straight to a new strip of Erlibelle (and finishing it)
instead of the tablet-free period. You may experience light or
menstruation-like bleeding while taking the tablets from 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.
Actavis, Barnstaple, EX32 8NS, UK

AAAF8235

Levonorgestrel/Ethinylestradiol 150mcg / 30mcg, PIL, United Kingdom

colours/plates:
1. black

item no:

AAAF8235

dimensions: 222 x 680

print proof no:

5

pharmacode:

origination date: 20.8.13
approved for print/date

min pt size:

2.
3.
4.

10.5 pt

originated by:

db

revision date:

21.8.13

Technical Approval

revised by:

db

date sent:

supplier:

León Farma

approved:

5.
6.

20.8.13

Non Printing Colours
1.
2.
3.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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