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JULIPERLA 75MICROGRAMS/20MICROGRAMS TABLETS

Active substance(s): ETHINYLESTRADIOL / GESTODENE

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Are you experiencing any of these signs?

Package leaflet: Information for the user

Juliperla 75micrograms/20micrograms Tablets
Gestodene/Ethinylestradiol
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”).
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 or need more advice, ask your doctor,
family planning nurse 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 possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Juliperla is and what it is used for
2. What you need to know before you take Juliperla
3. How to take Juliperla
4. Possible side effects
5. How to store Juliperla
6. Contents of the pack and other information
1. What Juliperla is and what it is used for
• J
 uliperla is a contraceptive tablet and is used to prevent pregnancy.
• E
 ach tablet contains a small amount of two different female hormones,
namely ethinylestradiol and gestodene.
• Contraceptive tablets as Juliperla that contain two hormones are called
“combination” contraceptives.
2. What you need to know before you take Juliperla
General notes
Before you start using Juliperla you should read the information on blood
clots in section 2. It is particularly important to read the symptoms of a
blood clot – see Section 2 “Blood clots”.

• 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

What are
you possibly
suffering
from?

Pulmonary
embolism

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.

Retinal vein
thrombosis
(blood clot in
the eye)

• 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.

Heart attack

• 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.

Stroke

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.

Before you can begin taking Juliperla, your doctor will ask you some
questions about your personal health history and that of your close
Blood clots
• swelling and slight blue discolouration of an
relatives. The doctor will also measure your blood pressure, and
blocking
extremity
depending upon your personal situation, may also carry out some other
other blood
• severe pain in your stomach (acute abdomen).
tests. In this leaflet, several situations are described where you should
vessels
stop using Juliperla, or where the reliability of Juliperla may be decreased.
In such situations you should either not have intercourse or you should
BLOOD CLOTS IN A VEIN
take extra non-hormonal contraceptive precautions, e.g., a condom or
What can happen if a blood clot forms in a vein?
another barrier method. Do not use rhythm or temperature methods.
• The use of combined hormonal contraceptives has been connected
These methods can be unreliable because Juliperla alters the monthly
with an increase in the risk of blood clots in the vein (venous
changes of the body temperature and of the cervical mucus.
thrombosis). However, these side effects are rare. Most frequently,
they occur in the first year of use of a combined hormonal
Juliperla, like other hormonal contraceptives, does not protect against
contraceptive.
HIV infection (AIDS) or any other sexually transmitted disease.
• If a blood clot forms in a vein in the leg or foot it can cause a deep vein
thrombosis (DVT).
When you should not use Juliperla
• If a blood clot travels from the leg and lodges in the lung it can cause a
You should not use Juliperla if you have any of the conditions listed
pulmonary embolism.
below. If you do have any of the conditions listed below, you must tell
• Very rarely a clot may form in a vein in another organ such as the eye
your doctor. Your doctor will discuss with you what other form of birth
(retinal vein thrombosis).
control would be more appropriate.
• if you have (or have ever had) a blood clot in a blood vessel of your legs
When is the risk of developing a blood clot in a vein highest?
(deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or
The risk of developing a blood clot in a vein is highest during the first
other organs
year of taking a combined hormonal contraceptive for the first time.
• if you know you have a disorder affecting your blood clotting – for
The risk may also be higher if you restart taking a combined hormonal
instance, protein C deficiency, protein S deficiency, antithrombin-III
contraceptive (the same product or a different product) after a break of 4
deficiency, Factor V Leiden or antiphospholipid antibodies
• if you need an operation or if you are off your feet for a long time (see weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if
section ‘Blood clots’)
you were not using a combined hormonal contraceptive.
• if you have ever had a heart attack or a stroke
• if you have (or have ever had) angina pectoris (a condition that causes When you stop Juliperla your risk of a blood clot returns to normal within
a few weeks.
severe chest pain and may be a first sign of a heart attack) or transient
ischaemic attack (TIA – temporary stroke symptoms)
• if you have any of the following diseases that may increase your risk of What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined
a clot in the arteries:
hormonal contraceptive you are taking.
– severe diabetes with blood vessel damage
The overall risk of a blood clot in the leg or lung (DVT or PE) with Juliperla
– very high blood pressure
is small.
– a very high level of fat in the blood (cholesterol or triglycerides)
- Out of 10,000 women who are not using any combined hormonal
– a condition known as hyperhomocysteinaemia
contraceptive and are not pregnant, about 2 will develop a blood clot
• if you have (or have ever had) a type of migraine called ‘migraine with
in a year.
aura’
- Out of 10,000 women who are using a combined hormonal
• if you have (had) an inflammation of the pancreas (pancreatitis)
contraceptive that contains levonorgestrel, norethisterone, or
• if you have or have had a liver disease and your liver function is still not
norgestimate about 5-7 will develop a blood clot in a year.
normal
- Out of 10,000 women who are using a combined hormonal
• if you have or have had a tumour in the liver
contraceptive that contains gestodene such as Juliperla between about
• if you have (had) or if you are suspected of having breast cancer or
9 and 12 women will develop a blood clot in a year.
cancer of the genital organs
- The risk of having a blood clot will vary according to your personal
• if you have any unexplained bleeding from the vagina
medical history (see “Factors that increase your risk of a blood clot”
• if you are pregnant or think you may be pregnant
below).
• if you are allergic to ethinylestradiol or gestodene, or any of the other
ingredients of Juliperla (listed in section 6). This can be recognised by
Risk of developing a blood clot in a year
itching, rash or swelling.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine.
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”.

Women who are not using a
combined hormonal pill/patch/
ring and are not pregnant

About 2 out of 10,000 women

Women using a combined
hormonal contraceptive pill
containing levonorgestrel,
norethisterone or
norgestimate

About 5-7 out of 10,000 women

Women using Juliperla

About 9-12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Juliperla 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)
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Juliperla, you • 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
should also tell your doctor.
case you could have a hereditary blood clotting disorder
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory
• 
if you need to have an operation, or if you are off your feet for a long
bowel disease)
time because of an injury or illness, or you have your leg in a cast. The
• if you have systemic lupus erythematosus (SLE – a disease affecting
use of Juliperla may need to be stopped several weeks before surgery
your natural defence system)
or while you are less mobile. If you need to stop Juliperla ask your
• if you have haemolytic uraemic syndrome (HUS - a disorder of blood
doctor when you can start using it again
clotting causing failure of the kidneys)
• 
as you get older (particularly above about 35 years)
• if you have sickle cell anaemia (an inherited disease of the red blood
• 
if you gave birth less than a few weeks ago.
cells)
• if you have elevated levels of fat in the blood (hypertriglyceridaemia)
The risk of developing a blood clot increases the more conditions you
or a positive family history for this condition. Hypertriglyceridaemia
have.
has been associated with an increased risk of developing pancreatitis
Air travel (>4 hours) may temporarily increase your risk of a blood clot,
(inflammation of the pancreas)
• if you need an operation, or you are off your feet for a long time (see in particularly if you have some of the other factors listed.
section 2 ‘Blood clots’)
It is important to tell your doctor if any of these conditions apply to you,
• if you have just given birth you are at an increased risk of blood clots.
even if you are unsure. Your doctor may decide that Juliperla needs to be
You should ask your doctor how soon after delivery you can start
stopped.
taking Juliperla
If any of the above conditions change while you are using Juliperla, for
• if you have an inflammation in the veins under the skin (superficial
example a close family member experiences a thrombosis for no known
thrombophlebitis)
reason; or you gain a lot of weight, tell your doctor.
• if you have varicose veins

• if a close relative has (had) breast cancer or breast cancer was
diagnosed
• if you have a disease of the liver or the gallbladder
• if you have diabetes
• if you have depression
• if you have epilepsy (see section “Other medicines and Juliperla”)
• 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 during pregnancy),
Sydenham’s chorea (a disease of the nerves in which sudden
movements of the body occur)
• if you have (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 (severe allergic reaction),
products containing estrogens 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 pharynx and/or difficulty swallowing or hives together with
difficulty breathing.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Juliperla 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.

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
Juliperla is very small but can increase:
• with increasing age (beyond about 35 years)
• if you smoke. When using a combined hormonal contraceptive like
Juliperla 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 then 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 Juliperla,
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.

Juliperla and cancer
It is important to remember that the overall risk of a harmful blood clot Breast cancer has been observed slightly more often in women using
combined contraceptives, but it is not known whether this is caused by
due to Juliperla is small.
the treatment. For example it may be that more tumours are detected
in women on combined contraceptives because they are examined by
HOW TO RECOGNISE A BLOOD CLOT
their doctor more often. The occurrence of breast tumours becomes
Seek urgent medical attention if you notice any of the following signs or
gradually less after stopping the combination hormonal contraceptives. It
symptoms.
is important to regularly check your breasts and you should contact your
doctor if you feel any lump.
What are
In rare cases, benign liver tumours, and in even fewer cases malignant
you possibly
Are you experiencing any of these signs?
liver tumours have been reported in contraceptives users. This can cause
suffering
internal bleeding leading to severe pain in the abdomen.
from?
• 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.

Contact your doctor if you have unusual severe abdominal pain. You may
need to stop taking Juliperla.
Deep vein
thrombosis

Cervical cancer has been reported to occur more often in women using
contraceptives for a long time. This finding may not be caused by the
contraceptives, but may be related to sexual behaviour and other factors.

Gestodene/Ethinylestradiol 75/20Mcg -,Pil, United Kingdom

colours/plates:
1. Black

item no: AAAH5137

dimensions: 222 x 680

print proof no: 04

pharmacode:

origination date: 16/12/14

min pt size: 9 pts

3.
4.
5.
6.

originated by: C.Grant
approved for print/date

2.

revision date: 22/12/14

Technical Approval

revised by: C.Grant

date sent: 16/12/14

supplier: Leon Farma S.A

technically app. date:

Non Printing Colours
1.
2.
3.

Bleeding between periods
During the first few months that you are taking Juliperla, you may have
unexpected bleeding (bleeding outside the gap week). If this bleeding
continues longer than a few months, or if it begins after some months,
your doctor must investigate the cause.

Yes

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, 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.
Other medicines and Juliperla
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Always tell the doctor, who prescribes Juliperla, which medicines or
herbal products you are already using. Also tell any other doctor or
dentist who prescribes another medicine (or the dispensing pharmacist)
that you use Juliperla. 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 Juliperla less effective in preventing
pregnancy, or can cause unexpected bleeding. These include
medicines used for the treatment of epilepsy (e.g. hydantoin,
topiramate, felbamate, lamotrigine, primidone, phenytoin, barbiturates,
carbamazepine, oxcarbamazepine) and tuberculosis (e.g. rifampicin),
immunomodulating agents (ciclosporin), HIV infections (ritonavir,
nevirapin) or other infectious diseases (rifabutin, griseofulvin, ampicillin,
tetracycline), antibiotics (penicillin and tetracyclins), anti-inflammation
drugs (phenylbutazone, dexamethasone), modafinil, theophylline,
cortecosteroids and the herbal remedy St. John’s wort.
•  If you want to use herbal products containing St. John’s wort while you
are already using Juliperla you should consult your doctor first.
• Juliperla may decrease the efficacy of other medicines, e.g. medicines
containing cyclosporin (medicine against infections), the anti-epileptic
lamotrigine or valproat (this could lead to an increased frequency of
seizures) or levothyroxine.
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you
are taking this medicine, because oral 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.

Ask your doctor for advice.

More than 1 tablet forgotten in 1 strip

Had sex in the previous week before
forgetting?

In week 1

No

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

•T
 ake the forgotten tablet
• Use a barrier method (condom) for the
following 7 days and
• Finish the strip
•T
 ake the forgotten tablet
• Finish the strip

In week 2

•T
 ake the forgotten tablet and finish
the strip
• Instead of the tablet-free period go
straight to the next strip
In week 3

Or
• S top the strip immediately
•G
 o directly to tablets-free period (not more
than 7 days including the forgotten tablet)
• T hen start the next strip

What you must do in the case of gastro-intestinal disturbances
In case of severe gastro-intestinal disturbances (e.g., vomiting or
diarrhoea), absorption may not be complete and additional contraceptive
measures should be taken. If you vomit within 3-4 hours of taking a tablet
or you have severe diarrhoea, the situation is 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 tablet. If this is not possible or 12 hours have
passed, you should follow the advice given under “If you forget to take
Juliperla”.
Delay of menstrual period: what you must know
Even if not recommended, delay of your menstrual period (withdrawal
bleed) is possible. This can be done by going straight on to a new strip
of Juliperla instead of the tablet-free period, after the first strip. You may
experience spotting (drops or flecks of blood) or breakthrough bleeding
while using this 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.

Change of the first day of your menstrual period: what you must know
If you are pregnant, you must not take Juliperla. If you become pregnant If you take the tablets according to the instructions, then your menstrual
while taking Juliperla you must stop immediately and contact you doctor. period/withdrawal bleed will begin in the tablet-free period. If you have to
change this day, you do this by making the tablet-free period shorter (but
Use of Juliperla is generally not advisable when a woman is breastnever longer than 7 days!). For example, if your tablet-free period begins
feeding. If you want to take the contraceptive while you are breaston a Friday, and you want to change this to a Tuesday (3 days earlier) you
feeding you should contact your doctor.
must start a new strip 3 days earlier than usual. If you make the tabletfree period very short (for example, for 3 days or less) then it may be that
Driving and using machines
you do not have any bleeding during this tablet-free period. You may
There is no information suggesting that use of Juliperla affects driving or then experience spotting (droplets or flecks or blood) or breakthrough
use of machines.
bleeding.
If you are not sure how to proceed, contact your doctor for advice.
Juliperla contains lactose
If you stop taking Juliperla
If you have been told by your doctor that you have an intolerance to
You can stop taking Juliperla whenever you want. If you do not want
some sugars, contact your doctor before taking this medicinal product.
to become pregnant, ask your doctor for advice about other reliable
methods of birth control.
3. How to take Juliperla
If you have any further questions on the use of this product, ask your
Always take this medicine exactly as your doctor or pharmacist has told
doctor or pharmacist.
you. Check with your doctor or pharmacist if you are not sure.
Take one tablet of Juliperla every day, if necessary with a small amount of
water. Your may take the tablets with or without food, but should take the 4. Possible side effects
tablets every day at approximately the same time.
Like all medicines, Juliperla can cause side effects, although not
everybody gets them. If you get any side effect, particularly if severe and
The strip contains 21 tablets. Next to each tablet the day of the week is
printed. If, for example you start on a Wednesday, take a tablet with “WED” persistent, or have any change to your health that you think may be due
to Juliperla, please talk to your doctor.
next to it. Follow the direction of the arrow on the strip until all 21 tablets
have been taken.
An increased risk of blood clots in your veins (venous thromboembolism
(VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is
Then take no tablets for 7 days. In the course of these 7 tablet-free days
present for all women taking combined hormonal contraceptives. For
(otherwise called a stop or gap week) bleeding should begin. This somore detailed information on the different risks from taking combined
called “withdrawal bleed should occur during this time.
hormonal contraceptives please see section 2 “What you need to know
before you use Juliperla”.
On the 8th day after the last tablet (that is, after the 7-day gap week), start
• harmful blood clots in a vein or artery for example:
the following strip, even if the bleeding has not stopped. This means that
- in a leg or foot (i.e. DVT)
you should start the following strip on the same day of the week and that
- in a lung (i.e. PE)
the withdrawal bleed should occur during this time.
- heart attack
- stroke
If you use Juliperla in this manner, you are also protected against
- mini-stroke or temporary stroke-like symptoms, known as a transient
pregnancy during the 7 days that you are not taking a tablet.
ischaemic attack (TIA)
- blood clots in the liver, stomach/intestine, kidneys or eye.
When can you start with the first strip
The chance of having a blood clot may be higher if you have any other
• If you have not used a contraceptive with hormones in the previous
conditions that increase this risk (See section 2 for more information on
month.
the conditions that increase risk for blood clots and the symptoms of a
 Begin with Juliperla on the first day of the cycle (that is the first day
blood clot)
of your menstruation). If you start Juliperla on the first day of your
The following is a list of the side effects that have been linked with the use
menstruation you are immediately protected against pregnancy. You
of Juliperla:
may also begin on day 2-5 of the cycle, but then you must use extra
Common (may affect up to 1 in 10 women):
protective measures (for example, a condom) for the first 7 days.
• headaches
• Changing from another combined hormonal contraceptive, or
• n
 ervousness
combined contraceptive vaginal ring or patch.
• poor tolerance of contact lenses
You can start Juliperla on the day after the tablet-free period of your
• v isual disturbances
previous contraceptive finishes (or after the last inactive tablet of
• n
 ausea
your previous contraceptive). When changing from a combined
• a
 cne
contraceptive vaginal ring or patch, follow the advice of your doctor.
• m
 igraine
• i ncrease in weight
• Changing from a preparation containing only a progestogen
 uid retentions
(progestogen-only tablet, injection, implant or a progestogen-releasing • fl
• 
b
leeding and spotting between your periods can sometimes occur for
IUD).
the first few months but this usually stops once your body has adjusted
You may switch any day from an injectable when the next injection
to Juliperla. If it continues, becomes heavy or starts again, contact your
would be due from the progestogen-only tablet and from an implant or
doctor
the IUD on the day of its removal). But in all of these cases you must use
extra protective measures (for example, a condom) for the first 7 days of • absence of menstruations
• s ore breasts
tablet-taking.
• l oss of interest in sex
• depressive moods
• After a miscarriage.
• i rritability.
Follow the advice of your doctor.
• After having a baby.
After having a baby, you can start with Juliperla 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 Juliperla
use.
If, after having a baby, you have had intercourse before starting Juliperla
(again), you must first be sure that you are not pregnant otherwise you
must wait until the next menstrual bleed.
Ask your doctor for advice in case you are not sure when to start taking
Juliperla
If you are breastfeeding and want to start Juliperla (again) after having a
baby.
Juliperla should not be used during breast feeding. Read the section 2.
“Pregnancy and breast feeding”.
If you take more Juliperla than you should
There are no reports of serious harmful results of taking too many
Juliperla tablets.
If you take several tablets at once then you may have symptoms of
nausea, dizziness, abdominal pain, drowsiness/fatigue or vomiting. Young
girls may have bleeding from the vagina.
If you have taken too many Juliperla tablets, or you discover that a child
has taken some, ask your doctor or pharmacist for advice.
If you forget to take Juliperla
• 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 take the following tablets again at the usual time.
• 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. Therefore, you
should adhere to the following rules (see also the diagram).
• If you forget more than one tablet in this strip
Contact your doctor.

Uncommon (may affect up to 1 in 100 women):
• excess of lipids in blood
• v omiting
• hypertension.
Rare (may affect up to 1 in 1,000 women):
• l iver disease
• s kin and subcutaneous tissue disorder (lupus erythematosus)
• middle ear disorders
• gallstones
• thrombosis (the formation of a clot in blood vessels)
• pigmentation disorders. This may happen even if you have been using
Juliperla for a number of months. This may be reduced by avoiding too
much sunlight
• changes in vaginal secretion.
Very rare (may affect up to 1 in 10,000):
• m
 ovement disorders
• affection of the pancreas.
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.
5. How to store Juliperla
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the strip
and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C. Keep the strip in the outer carton, in order to
protect from light.
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

• If you forget 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 tablet-free
period, you must realise that there is a risk of pregnancy. In that case,
contact your doctor.

What Juliperla contains
The active substances are gestodene and ethinylestradiol.
• E
 ach tablet contains 75micrograms gestodene and 20micrograms
ethinylestradiol
• T
 he other ingredients are: lactose monohydrate, microcrystalline
cellulose, povidone K-30, magnesium stearate and polacrilin potassium.
What Juliperla looks like and contents of the pack
Juliperla tablets are round, white tablets, with a diameter of 5.7mm
approximately and debossed with a ‘C’ on one side and ‘34’ on the other
side.

• If you forget 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 Marketing Authorisation Holder
at the usual time. The protection from pregnancy is not reduced, and
Actavis Group PTC ehf.
you do not need to take extra precautions.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
•If you forget one tablet in week 3
Iceland
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that means Manufacturer
that you have to take two tablets at the same time. Take the tablets
Laboratorios León Farma, S.A.
again at the usual time. Instead of the tablet-free period go straight on C/ La Vallina s/n, Poligono Industrial Navatejera, 24008
to the next strip.
Navatejera, León
Most likely, you will have a period (withdrawal bleed) at the end of the
Spain.
second strip but you may also have spotting or breakthrough bleeding
during the second strip.
This leaflet was last revised in December 2014
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 If you would like a
start a new strip on your fixed start day, make the tablet-free period less
leaflet with larger text,
than 7 days.
please contact
If you follow either of these two recommendations, you will remain
protected against pregnancy.
01271 385257.
• 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.

AAAH5137

Gestodene/Ethinylestradiol 75/20Mcg -,Pil, United Kingdom

colours/plates:
1. Black

item no: AAAH5137

dimensions: 222 x 680

print proof no: 04

pharmacode:

origination date: 16/12/14

min pt size: 9 pts

3.
4.
5.
6.

originated by: C.Grant
approved for print/date

2.

revision date: 22/12/14

Technical Approval

revised by: C.Grant

date sent: 16/12/14

supplier: Leon Farma S.A

technically app. date:

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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