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GEDAREL 150/30 MICROGRAMS FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GEDAREL® 30/150
microgram film-coated tablets
Ethinylestradiol and Desogestrel
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.
What is in this leaflet:
The name of your medicine is ‘Gedarel 30/150 microgram filmcoated tablets’, but will be referred to as ‘Gedarel’ throughout
the remainder of this leaflet.
1. What Gedarel is and what it is used for
2. What you need to know before you take Gedarel
3. How to take Gedarel
4. Possible side effects
5. How to store Gedarel
6. Contents of the pack and other information
1. WHAT GEDAREL is AND WHAT IT IS USED FOR
Gedarel is a COC, also called the pill. It contains two types of
female hormones: a progestogen, desogestrel, and an oestrogen,
ethinylestradiol in a low dose. These help to stop you from
getting pregnant, just as your natural hormones would stop you
conceiving again when you are already pregnant.
The COC 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.
General information
If taken correctly, the pill is an effective reversible form
of contraception. However, in certain circumstances the
effectiveness of the pill may reduce or you should stop taking
the pill (see later). In these cases either do not have sex,
or use extra contraceptive precautions (such as condoms
or spermicides) during intercourse to ensure effective
contraception.
Do not use rhythm or temperature methods. These methods
can be unreliable because Gedarel alters the monthly changes
of body temperature and of cervical mucus.
Remember, COC pills like Gedarel will not protect you against
sexually-transmitted diseases (such as AIDS). Only condoms
can help to do this.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
GEDAREL
Before you can begin taking Gedarel , 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.
Do not take Gedarel

­ if you have (or have had in the past) a blood clot
(thrombosis) in a blood vessel of the leg, lung (embolus) or
other organs,

­ if you have (or have had in the past) a heart attack or stroke

­ if you have (or have had in the past) 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. 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 (had) a certain form of migraine (with so-called
focal neurological symptoms).

­ if you have (had) an inflammation of the pancreas
(pancreatitis)

­ if you have or have had in the past a liver disease and your
liver function is still not normal.

­ if you have or have had a tumour in the liver.

­ if you have (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 are pregnant or think you might be,

­ if you have endometrial hyperplasia (a condition
characterised by overgrowth of the lining of the uterus),

­ if you are allergic to ethinylestradiol or desogestrel, or any of
the other ingredients of this medicine (listed in section 6).
This can be recognised by itching, rash or swelling.
Warnings and precautions
Talk to your doctor or pharmacist before taking Gedarel.

period of immobilization, or if you have had an serious
accident. It is important to tell your doctor in advance
that you are using Gedarel as the treatment may have to
be stopped. Your doctor will tell you when to start Gedarel
again. This is usually about two weeks after you are back on
your feet.
•­ and possibly also with superficial thrombophlebitis (forming

of blood clots in and inflammation of superficial veins) and
varicose veins.
Arterial thrombosis
The use of combination pills has been connected with an
increase of the risk of arterial thrombosis (obstruction of an
artery), for example, in the blood vessels of the heart (heart
attack) or the brain (stroke).
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 Gedarel , especially if you are older than 35 years.

­ if you have an increased fat content in your blood
(cholesterol or triglycerides)

­ if you have high blood pressure

­ if you have migraine

­ if you are overweight

­ if you have a problem with your heart (valve disorder, a
disturbance of the heart rhythm).

­ if one of your close relatives has had a heart attack or stroke
at a young age
Stop taking Gedarel and contact your doctor immediately
if you notice possible signs of thrombosis, 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

­ movement disorders,

­ acute abdomen syndrome (dynamically developing
symptoms like stomachache, nausea and vomiting which
may require surgical intervention).
The pill and cancer
An increased risk of cervical carcinoma in long-term users of
COCs has been reported in some epidemiological studies, but
there is controversy about the extent to which this finding is
attributable to the confounding effects of sexual behaviour and
other factors such as human papilloma virus (HPV).
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 COCs. 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 COC users.
Contact your doctor if you have unusual severe abdominal
pain.
Bleeding between periods
During the first few months that you are taking Gedarel, 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, your doctor must investigate the
cause.
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.
Children and adolescents
The safety and efficacy of desogestrel in adolescents below
18 years has not yet been established. No data are available.
Other medicines and Gedarel
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

In some situations you need to take special care while using
Gedarel 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 applies to you, you must
inform your doctor before starting to use Gedarel . Also if any
of the following conditions develops or worsens during the use
of Gedarel you must consult your doctor:

­ 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 sickle cell anaemia (an inherited disease of the red
blood cells)

­ if you have epilepsy (see “Other medicines and Gedarel”)

­ 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 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
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.

Always tell the doctor, who prescribes Gedarel, 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 Gedarel. They can tell you
if you need to take additional contraceptive precautions (for
example condoms) and if so, for how long.

The pill and blood clots (thrombosis)

You must not use Gedarel when you are pregnant. If you
become pregnant or you think you might be pregnant, stop
taking Gedarel and talk to your doctor immediately.

Venous thrombosis
The use of any combination pill, including Gedarel , increases a
woman’s risk of developing a venous thrombosis (formation of
a blood clot in vessels) compared with a woman who does not
take any (contraceptive) pill.
Your chances of having a blood clot are only increased
slightly by taking the Pill.
• Of 100,000 women who are not on the Pill and not pregnant,
about 5-10 will have a blood clot in a year.
• Of 100,000 women taking a Pill such as Gedarel, about 30-40
will have a blood clot in a year.
• Of 100,000 women who are pregnant, around 60 will have a
blood clot in a year.
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

Some medicines can make Gedarel 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, hydantoins,
felbamat)

­ tuberculosis (e.g. rifampicin, rifabutin)

­ HIV infections (ritonavir, nelfinavir, nevirapin, efavirenz) or
other infectious diseases (griseofulvin, ampicillin,
tetracycline)

­ increase of blood pressure in the lung vasculature (bosentan)

­ sleeping disorders (modafinil)

­ the herbal remedy St. John’s wort

­ muscle spasticity (tizanidine)

­ hormone deficiency (levothyroxine).
If you want to use herbal products containing St. John’s wort
while you are already using Gedarel you should consult your
doctor first.
Gedarel may decrease the efficacy of other medicines, e.g.
medicines containing cyclosporin, or the anti-epileptic
lamotrigine (this could lead to an increased frequency of
seizures).
Ask your doctor or pharmacist for advice before taking any
medicine.
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.

Gedarel should not be taken during breast-feeding. If you are
breast feeding and want to take the pill, you should discuss this
with your doctor.
Driving and using machines
You can drive or operate machinery while taking Gedarel.
Gedarel contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicinal product.
3. HOW TO TAKE GEDAREL
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.
Each pack of Gedarel contains 1 calendar strip of 21 coated
tablets or 3, 6, 13 calendar strips of 21 coated tablets. The
calendar strip has been designed to help you remember to take
your tablets.

The strip is marked with the day of the week on which each
tablet should be taken. Following the direction of the arrow
printed on the strip you should take one tablet each day for
21 days until the strip is empty.
Then you have 7 days when you do not take a tablet.
During the 7 tablet-free days, on day 2 or 3, you will have
menstruation-like withdrawal bleeding, i.e. your “monthly
period”.
Start your next strip on the 8th day (following the 7 tabletfree days) – even if the bleeding has not yet ended. As long
as you take Gedarel correctly, you will always start each
new strip on the same day of the week, and you will always
have your monthly period on the same day of the week in
each month (in every 28 days).
You should try to take your tablet at about the same time
each day. You may find it easiest to take it either last thing at
night or first thing in the morning.
Swallow each tablet whole, with water if necessary.
Starting the first pack
If no oral contraception has been used during the preceding
cycle
Take the first tablet on the first day of your period. This is the
first day of your cycle - the day when bleeding starts. Take
a tablet marked for that day of the week (for example, if it
is Tuesday when your period starts, take the tablet marked
Tuesday on the pack). Follow the direction of the arrow and
continue taking one tablet each day until the strip is empty.
If you start on day 2-5 of your period, you should use another
method of contraception as well, such as the condom, for the
first seven tablet-taking days, but this is only for the first pack.
Changing to Gedarel from another COC, or combined
contraceptive vaginal ring or patch
You should start taking Gedarel preferably on the day after
the last active tablet (the last tablet containing the active
substance) of your previous COC, but at the latest on the day
following the usual tablet-free interval or following the last
placebo tablet of your previous COC.
In case a vaginal ring or a transdermal patch has been used,
the woman should start using Gedarel preferably on the day of
removal, but at the latest when the next application would have
been due.
Changing to Gedarel from a progestogen-product
(progestogen-only-pills, injection, implant or progestogen
releasing IUD)
You may switch any day from the progestogen-only tablet
(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 Gedarel between 21 and
28 days later. If you start later than day 28, you must use a socalled barrier method (for example, a condom) during the first
seven days of Gedarel use. If, after having a baby, you have had
intercourse before starting Gedarel (again), you must first be
sure that you are not pregnant or you must wait until the next
menstrual bleed.
Let your doctor advise you, in case you are not sure when to
start.
If you are breast-feeding and want to start Gedarel (again)
after having a baby.
Read the section on “Pregnancy and breast-feeding”.
If you take more Gedarel than you should
There are no reports of serious harmful results of taking too
many Gedarel 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
Gedarel tablets, or you discover that a child has taken some, ask
your doctor or pharmacist for advice.
If you forget to take Gedarel

­ 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 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. 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 realize that there is a risk of pregnancy. 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.
Take the tablets again at the usual time. The protection from
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. Take the 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 either 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, this may mean
that you are pregnant. You must contact your doctor before
you go on to 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

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 Gedarel”.
Delay of menstrual period: what you must know
Even if not recommended, delay of your menstrual period
(withdrawal bleed) is possible by going straight on to a new
strip of Gedarel 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 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 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, you 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 or blood) or
breakthrough bleeding.
If you are not sure how to proceed, contact your doctor for
advice.
If you stop taking Gedarel
You can stop taking Gedarel 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 have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Serious reactions
More serious reactions associated with COC pills are detailed
above in section 2 under “The pill and thrombosis” and “The pill
and cancer”. Please read these subsections carefully, and if you
have any questions, ask your doctor.
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
Gedarel, but they usually stop once your body has adjusted to
the pill. The most commonly reported undesirable effects
(> 10 %) is irregular bleeding.
Common (may affect up to 1 in 10 people): depression,
mood altered, none or reduced bleeding, painful bleeding,
premenstrual syndrome with tender breasts, headache,
nervousness, dizziness, nausea, abdominal pain, acne, breast
pain, and weight gain.
Uncommon (may affect up to 1 in 100 people): breast
enlargement, decreased sexual desire, migraine, vomiting,
diarrhoea, impaired hearing (otosclerosis), rash, nettle-rash
(urticaria), fluid retention, high blood pressure
Rare (may affect up to 1 in 1,000 people) vaginal candidiasis
(fungal infection), venous and arterial thromboembolism,
hypersensitivity, increased sexual desire, eye irritation due
to contact lens, loss of hair (alopecia), itching, skin disorders
(erythema nodosum, erythema multiforme), abnormal cervical
smear, breast discharge, weight loss.
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).
Before you have any blood tests
Tell your doctor or the laboratory staff that you are taking the
pill, because oral contraceptives can affect the results of some
tests.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. 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 GEDAREL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP.) which is
stated on the package. The expiry date refers to the last day of
the month.
Store below 30ºC. Store in the original package.
Do not throw away any medicines via waste water 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 Gedarel contains

­ The active substances are ethinylestradiol and desogestrel.
One film-coated tablet contains 30 micrograms
ethinylestradiol and 150 micrograms desogestrel.

­ The other ingredients are:
Tablet core: Potato starch; stearic acid; all-rac-alpha-tocopherol;
lactose monohydrate; magnesium stearate; silica colloidal
anhydrous; povidone K 30.
Tablet coating: Hypromellose; Macrogol 6000; propylene glycol.
What Gedarel looks like and contents of the pack
White, or almost white, round shaped, biconvex film-coated
tablets of 6 mm diameter, with P8 sign on one side and RG sign
on other side.
Each box contains 1, 3, 6 or 13 calendar pack(s) of 21 filmcoated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Gedeon Richter Plc.,
1103 Budapest, Gyömrői út 19-21,
Hungary
Distributed by:
Consilient Health (UK) Ltd.,
500 Chiswick High Road,
London W4 5RG
Manufacturer:
Gedeon Richter Plc.,
1103 Budapest, Gyömrői út 19-21,
Hungary

in week 2

in week 3

• Take the forgotten tablet and
• Finish the strip

This medicinal product is authorised in the Member States
of the EEA under the following names:

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

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

Belgium, Luxembourg: Deso 30
Denmark, Ireland: Leticia
Sweden: Desogestrel/Ethinylestradiol Gedeon Richter
United Kingdom: Gedarel

Or
• Stop the strip immediately
gap week week (not
• Begin the tablet-free(not longer
than 7 than 7 days, including
longer days, including the
forgotten tablet)
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

This leaflet was last revised in August 2013.

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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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