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GEDAREL ED 30 MICROGRAMS/150 MICROGRAMS -28 FILM-COATED TABLET

Active substance(s): DESOGESTREL / ETHINYLESTRADIOL / NO ACTIVES PRESENT

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Package leaflet: Information for the user
®
30 micrograms/150 micrograms -28 film-coated tablets
ethinylestradiol/desogestrel

GEDAREL ED

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, 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. See section 4.

What is in this leaflet:

–– if you need an operation, or you are off your feet for a long time (see in section 2
‘Blood clots’);
The name of your medicine is `Gedarel ED 30 micrograms/150 micrograms -28 film- –– if you have just given birth you are at an increased risk of blood clots. You should
coated tablets’, but will be referred to as `Gedarel ED -28’ throughout the remainder ask your doctor how soon after delivery you can start taking Gedarel ED -28.
of this leaflet.
–– if you have an inflammation in the veins under the skin (superficial
thrombophlebitis);
1. What Gedarel ED -28 is and what it is used for
–– if you have varicose veins.
2. What you need to know before you use Gedarel ED -28
3. How to take Gedarel ED -28
BLOOD CLOTS
4. Possible side effects
Using a combined hormonal contraceptive such as Gedarel ED -28 increases your
5. How to store Gedarel ED -28
risk of developing a blood clot compared with not using one. In rare cases a blood
6. Contents of the pack and other information
clot can block blood vessels and cause serious problems.
1. What Gedarel ED -28 is and what it is used for
Gedarel ED -28 is a contraceptive pill and is used to prevent pregnancy.
Each white film-coated tablet contains a small amount of two different female
hormones, namely, desogestrel and ethinylestradiol. The green film-coated tablets
contain no active substances and are also called placebo tablets.
Contraceptive pills that contain two hormones are called “combination” pills.
The combined contraceptive pill protects you against getting pregnant in three ways.
These hormones
1. stop the ovary from releasing an egg each month (ovulation).
2. also thicken the fluid (at the neck of the womb making it more difficult for the
sperm to reach the egg.
3. alter the lining of the womb to make it less likely to accept a fertilised egg.
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 ED -28 alters the monthly changes of body temperature and of cervical
mucus.
Remember, combined oral contraceptive pills like Gedarel ED -28 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 use Gedarel ED -28
General notes
Before you start using Gedarel ED -28 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”.
Before you can begin taking Gedarel ED -28, 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 use Gedarel ED -28
You should not use Gedarel ED -28 if you have any of the conditions listed below. If
you do have any of the conditions listed below, you must tell your doctor. Your doctor
will discuss with you what other form of birth control would be more appropriate
–– if you have (or have ever had) a blood clot in a blood vessel of your legs (deep
vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
–– if you know you have a disorder affecting your blood clotting – for instance,
protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden
or antiphospholipid antibodies;
–– if you need an operation or if you are off your feet for a long time (see section
‘Blood clots’);
–– if you have ever had a heart attack or a stroke;
–– if you have (or have ever had) angina pectoris (a condition that causes severe
chest pain and may be a first sign of a heart attack) or transient ischaemic attack
(TIA – temporary stroke symptoms);
–– if you have any of the following diseases that may increase your risk of a clot in
the arteries:
–– severe diabetes with blood vessel damage
–– very high blood pressure
–– a very high level of fat in the blood (cholesterol or triglycerides)
–– a condition known as hyperhomocysteinaemia;
–– if you have (or have ever had) a type of migraine called ‘migraine with aura’;
–– if you have (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 of having breast cancer or cancer of the
genital organs;
–– if you have any unexplained bleeding from the vagina;
–– if you have endometrial hyperplasia (excessive proliferation of the cells of the inner
lining of the womb);
–– if you are pregnant or think you might be;
–– 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 ED -28.
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 clots’ (thrombosis)
section below).
For a description of the symptoms of these serious side effects please go to “How to
recognise a blood clot”.
In some situations you need to take special care while using Gedarel ED -28 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 ED -28.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Gedarel ED -28 you
should also tell 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 epilepsy (see “Other medicines and Gedarel ED -28”);
–– 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.
–– if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel
disease);
–– if you have systemic lupus erythematosus (SLE - a disease affecting your natural
defence system);
–– if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting
causing failure of the kidneys);
–– if you have sickle cell anaemia (an inherited disease of the red blood cells);
–– if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive
family history for this condition. Hypertriglyceridaemia has been associated with an
increased risk of developing pancreatitis (inflammation of the pancreas).

–– if you are very overweight (body mass index or BMI over 30 kg/m2);
–– if one of your immediate family has had a blood clot in the leg, lung, or other
organ at a young age (e.g. below the age of about 50). In this case you could have
a hereditary blood clotting disorder.
–– if you need to have an operation, or if you are off your feet for a long
time because of an injury or illness, or you have your leg in a cast. The use of
Gedarel ED -28 may need to be stopped several weeks before surgery or while
you are less mobile. If you need to stop Gedarel ED -28 ask your doctor when you
can start using it again.
–– as you get older (particularly above about 35 years);
–– if you gave birth less than a few weeks ago.

The risk of developing a blood clot increases the more conditions you have.
Blood clots can develop
–– in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE) Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if
–– in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial
you have some of the other factors listed.
thromboembolism’ or ATE).
Recovery from blood clots is not always complete. Rarely, there may be serious
It is important to tell your doctor if any of these conditions apply to you, even if you
lasting effects or, very rarely, they may be fatal.
are unsure. Your doctor may decide that Gedarel ED -28 needs to be stopped.
It is important to remember that the overall risk of a harmful blood clot due to
Gedarel ED -28 is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.
Are you experiencing any of these signs?

What are you
possibly suffering
from?
Deep vein thrombosis

–– swelling of one leg or along a vein in the leg or foot
especially when accompanied by:
•• pain or tenderness in the leg which may be felt only
when standing or walking
•• increased warmth in the affected leg
•• change in colour of the skin on the leg e.g. turning
pale, red or blue.
–– sudden unexplained breathlessness or rapid breathing; Pulmonary embolism
–– sudden cough without an obvious cause, which may
bring up blood;
–– sharp chest pain which may increase with deep
breathing;
–– severe light headedness or dizziness;
–– rapid or irregular heartbeat;
–– severe pain in your stomach.
If you are unsure, talk to a doctor as some of these
symptoms such as coughing or being short of breath may
be mistaken for a milder condition such as a respiratory
tract infection (e.g. a ‘common cold’).
Symptoms most commonly occur in one eye:
–– immediate loss of vision or
–– painless blurring of vision which can progress to loss
of vision.
–– chest pain, discomfort, pressure, heaviness;
–– sensation of squeezing or fullness in the chest, arm or
below the breastbone;
–– fullness, indigestion or choking feeling;
–– upper body discomfort radiating to the back, jaw,
throat, arm and stomach;
–– sweating, nausea, vomiting or dizziness;
–– extreme weakness, anxiety, or shortness of breath;
–– rapid or irregular heartbeats
–– sudden weakness or numbness of the face, arm or leg,
especially on one side of the body;
–– sudden confusion, trouble speaking or understanding;
–– sudden trouble seeing in one or both eyes;
–– sudden trouble walking, dizziness, loss of balance or
coordination;
–– sudden, severe or prolonged headache with no known
cause;
–– loss of consciousness or fainting with or without
seizure.
Sometimes the symptoms of stroke can be brief with an
almost immediate and full recovery, but you should still
seek urgent medical attention as you may be at risk of
another stroke.
–– swelling and slight blue discolouration of an extremity;
–– severe pain in your stomach (acute abdomen)

Retinal vein thrombosis
(blood clot in the eye)

Heart attack

Stroke

If any of the above conditions change while you are using Gedarel ED -28, for
example a close family member experiences a thrombosis for no known reason; or
you gain a lot of weight, tell your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems. For
example, it can cause a heart attack or a stroke.
Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using Gedarel ED -28 is
very small but can increase:
–– with increasing age (beyond about 35 years);
–– if you smoke. When using a combined hormonal contraceptive like Gedarel ED -28,
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 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 Gedarel ED -28, for
example you start smoking, a close family member experiences a thrombosis for no
known reason; or you gain a lot of weight, tell your doctor.
The pill and cancer
An increased risk of cervical carcinoma in long-term users of oral contraceptives
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 combination hormonal contraceptives. It is important to regularly
check your breasts and you should contact your doctor if you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours
have been reported in pill users. Contact your doctor if you have unusual severe
abdominal pain.
Children and adolescents
The safety and efficacy of desogestrel in adolescents below 18 years has not yet
been established. No data are available.

Blood clots blocking
other blood vessels

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
–– The use of combined hormonal contraceptives has been connected with an
increase in the risk of blood clots in the vein (venous thrombosis). However, these
side effects are rare. Most frequently, they occur in the first year of use of a combined
hormonal contraceptive.
–– If a blood clot forms in a vein in the leg or foot it can cause a deep vein
thrombosis (DVT).
–– If a blood clot travels from the leg and lodges in the lung it can cause a
pulmonary embolism.
–– Very rarely a clot may form in a vein in another organ such as the eye (retinal vein
thrombosis).

Other medicines and Gedarel ED -28
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Also tell any other doctor or dentist who prescribes another medicine (or the
dispensing pharmacist) that you use Gedarel ED -28. They can tell you if you need
to take additional contraceptive precautions (for example condoms) and if so, for
how long.

Some medicines can have an influence on the blood levels of Gedarel ED -28 and
can make it less effective in preventing pregnancy, or can cause unexpected
bleeding. These include medicines used for the treatment of
–– epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate,
oxcarbazepine, topiramate),
–– tuberculosis (e.g. rifampicin),
–– HIV and Hepatitis C Virus infections (so-called protease inhibitors and nonnucleoside reverse transcriptase inhibitors such as ritonavir, nevirapin, efavirenz),
–– Fungal infections (e.g. griseofulvin),
–– increase of blood pressure in the lung vasculature (bosentan),
When is the risk of developing a blood clot in a vein highest?
–– the symptomatic treatment of arthrosis (etoricoxib),
The risk of developing a blood clot in a vein is highest during the first year of taking
–– the herbal remedy St. John’s wort. If you want to use herbal products containing
a combined hormonal contraceptive for the first time. The risk may also be higher if
St. John’s wort while you are already using Gedarel ED -28 you should consult your
you restart taking a combined hormonal contraceptive (the same product or a different doctor first.
product) after a break of 4 weeks or more.
Gedarel ED -28 may influence the efficacy of other medicines, e.g.
After the first year, the risk gets smaller but is always slightly higher than if you were
–– ciclosporin (medicine used for the treatment of suppression of tissue rejection
not using a combined hormonal contraceptive.
following transplant surgery),
–– lamotrigine (anti-epileptic medicine; this could lead to an increased frequency of
When you stop Gedarel ED -28 your risk of a blood clot returns to normal within a
seizures),
few weeks.
–– tizanidine (medicine used for the treatment of muscle spasticity),
–– levothyroxine (medicine used for the treatment of hormone deficiency).
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal
Ask your doctor or pharmacist for advice before taking any medicine.
contraceptive you are taking.
Before you have any blood tests
The overall risk of a blood clot in the leg or lung (DVT or PE) with Gedarel ED -28
Tell your doctor or the laboratory staff that you are taking the pill, because oral
is small.
contraceptives can affect the results of some tests.
–– Out of 10,000 women who are not using any combined hormonal contraceptive
and are not pregnant, about 2 will develop a blood clot in a year.
–– Out of 10,000 women who are using a combined hormonal contraceptive that
contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a
blood clot in a year.
–– Out of 10,000 women who are using a combined hormonal contraceptive that
contains desogestrel such as Gedarel ED -28 between about 9 and 12 women will
develop a blood clot in a year.
–– The risk of having a blood clot will vary according to your personal medical
history (see “Factors that increase your risk of a blood clot” below).

Women who are not using a combined hormonal
pill/patch/ring and are not pregnant
Women using a combined hormonal contraceptive
pill containing levonorgestrel, norethisterone or
norgestimate
Women using Gedarel ED -28

Risk of developing a blood
clot in a year
About 2 out of
10,000 women
About 5-7 out of
10,000 women
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 Gedarel ED -28 is small but some conditions will
increase the risk. Your risk is higher:

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.
You must not use Gedarel ED -28 when you are pregnant. If you become pregnant or
you think you might be pregnant, stop taking Gedarel ED -28 and talk to your doctor
immediately.
Gedarel ED -28 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 ED -28.
Gedarel ED -28 contains lactose and sunset yellow
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine.
The ingredient sunset yellow may cause allergic reactions.
3. How to take Gedarel ED -28
Always take this medicine exactly as your doctor has told you. Check with your
doctor if you are not sure.
If before you started Gedarel ED -28, you took another contraceptive pill, you know
that most contraceptive pills contain 21 tablets. With these contraceptive pills, you

take one tablet for 21 days and then have a gap (tablet-free) week of 7 days. The
pattern when using Gedarel ED -28 is different. After the 21 white, active tablets, you
must continue right away with the 7 green placebo tablets; there is therefore no gap
week but a “placebo” week.
Preparation of the strip
You must know on which day of the week you will take the first tablet.
To help you keep track, there are 7 weekdays sticker strips marked with the 7 days of
the week. Choose the weekdays sticker strip that starts with the day you begin taking
the tablets. For example, if you start on a Wednesday, use the weekdays sticker strip
that starts with “Wed”.
Fit the “ ” symbol on the strip to the same symbol on the blister card and place the
strip into the area bordered with black line. Each day will line up with a row of pills.
There is now a day shown above every tablet and you can see whether you have
taken a pill on a particular day. Follow the direction of the arrow on the wallet until
all 28 tablets have been taken.
Following the direction of the arrow printed on the strip you should take one
tablet each day for 28 days until the strip is empty.

Ask your doctor for advice

Several tablets forgotten in 1 strip

yes
Had sex in the previous week
before forgetting?

in week 1

•• Take the forgotten tablet
•• Use a barrier method (condom)
for the following 7 days
•• And finish strip

in week 2

During the 7 days that you are taking the green placebo tablets (the placebo
week), bleeding should begin (so-called withdrawal bleeding). This usually starts
on the 2nd or 3rd day after the last white active tablet of Gedarel ED -28. Once
you have taken the last green tablet, you should start with the following strip,
whether your bleeding has stopped or not. 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.
If you use Gedarel ED -28 in this manner, you are protected against pregnancy
also during the 7 days that you are taking a placebo tablet.

If you have not used a contraceptive with hormones in the previous month
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 the first tablet and 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 ED -28 from another combined hormonal contraceptive, or
combined contraceptive vaginal ring or patch
Start taking Gedarel ED -28 on the day after the tablet-free period of your previous
pill finishes (or after the last inactive tablet of your previous pill). If a vaginal ring or a
transdermal patch has been used, you should start using Gedarel ED -28 preferably
on the day of removal of the ring/patch, but at the latest when the next application/
insertion would have been due.
Changing to Gedarel ED -28 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 or abortion
Follow the advice of your doctor.
After having a baby
After having a baby, you can start Gedarel ED -28 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 Gedarel ED -28 use. If, after having a baby,
you have had intercourse before starting Gedarel ED -28 (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.

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

6. Contents of the pack and other information

•• Continue taking the tablets
as usual skipping out the missed
tablet.

in week 4

What to do in case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea, there
is a risk that the active substances in the tablet are not fully absorbed into your body.
The situation is similar to if you forget a tablet. After the vomiting or diarrhoea has
stopped, you must take another tablet from a reserve strip as soon as possible. This
should be done within 12 hours of when you normally take your tablet. If this is not
possible and more than 12 hours have passed, you should follow the advice given
under “If you forget to take Gedarel ED -28”.
Bleeding between periods
During the first few months that you are taking Gedarel ED -28, you may have
unexpected bleeding (bleeding outside the placebo period). 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 placebo-tablet 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.
Ask your doctor for advice.
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 ED -28 after the last white
active tablet instead of taking the green placebo tablets. You may experience
spotting (drops or flecks of blood) or breakthrough bleeding while using this second
strip. After the usual placebo-tablet period of 7 days, continue with the following strip.
You might ask your doctor for advice before deciding to delay your menstrual
period.

If you are breast-feeding and want to start Gedarel ED -28 (again) after having a
Change of the first day of your menstrual period: what you must know
baby.
If you take the tablets according to the instructions, then your menstrual period/
Read the section on “Pregnancy and breast-feeding”.
withdrawal bleed will begin whilst taking the placebo-tablets. If you have to change
this day, you do this by making the placebo-tablet period shorter (but never longer!).
If you take more Gedarel ED -28 than you should
There are no reports of serious harmful results of taking too many Gedarel ED -28. For example, if your placebo-tablet 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
If you take several tablets at once then you may have symptoms of nausea or
than usual. If you make the placebo-tablet period very short (for example, 3 days
vomiting. Young girls may have bleeding from the vagina. If you have taken too
or less) then it may be that you do not have any bleeding during this placebomany Gedarel ED -28, or you discover that a child has taken some, ask your
tablet period. You may then experience spotting (droplets or flecks or blood) or
doctor or pharmacist for advice.
breakthrough bleeding.
If you are not sure how to proceed, contact your doctor for advice.
If you forget to take Gedarel ED -28
The green tablets of the strip are placebo tablets. If you forget one these tablets,
If you stop taking Gedarel ED -28
this has no effect on the reliability of Gedarel ED -28. You should throw away the
You can stop taking Gedarel ED -28 whenever you want. If you do not want to
forgotten placebo tablet so that you do not make the placebo week longer. This
become pregnant, ask your doctor for advice about other reliable methods of birth
might have a negative effect on the reliability of Gedarel ED -28.
control.
If you miss a white tablet, you must follow the following advice:
–– 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 placebo tablets period, you must realize that there is a risk of pregnancy. In
that case, contact your doctor.

What Gedarel ED -28 contains
–– The active substances are ethinylestradiol and desogestrel in each white, or almost
white tablet. One white, or almost white film-coated tablet contains 30 micrograms
ethinylestradiol and 150 micrograms desogestrel.

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

Starting the first pack

Store below 30°C, in the original packaging 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.

or

Swallow each tablet whole, with water if necessary.

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 that month.

•• Take the forgotten tablet and
•• Finish the strip

in week 3

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.

5. How to store Gedarel ED -28
Keep this medicine out of the sight and reach of children.

no

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

Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via 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.

–– The green placebo (inactive) film-coated tablet does not contain active substances.
–– The other ingredients are:
Active film-coated tablets:
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.
Placebo film-coated tablets:
Tablet core: cellulose, microcrystalline; lactose anhydrous, maize starch,
pregelatinised, magnesium stearate, silica, colloidal anhydrous.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc,
Indigo Carmine (E132), Quinoline Yellow (E104), iron oxide, black (E172), Sunset
Yellow (E110).
What Gedarel ED -28 looks like and contents of the pack
The active film-coated tablet: white, or almost white, round shaped, biconvex filmcoated tablets of 6 mm diameter, with P8 sign on one side and RG sign on other
side.
The placebo film-coated tablet is green, round, biconvex film-coated tablet, diameter
about 6 mm, without engraving.
Gedarel ED 30 micrograms/150 micrograms -28 film-coated tablets are packed into
the PVC/PVDC//Aluminium blisters. The blisters are packed into cardboard box with
a patient information leaflet, an etui storage bag and weekdays sticker(s) enclosed in
each box.
Each box contains 1, 3, 6 or 13 calendar pack(s) of 21 active film-coated
tablets+7 placebo film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Gedeon Richter Plc.
H-1103 Budapest
Gyömrői út 19-21.
Hungary
This medicinal product is authorised in the Member States of the EEA under the
following names:
Denmark: Leticia 28
Belgium: DESO 30 CONTINU
Luxembourg: DESO 30 CONTINU
United Kingdom: Gedarel ED-28
This leaflet was last revised in June 2016.

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. If you get any side effect, particularly if severe and persistent, or have any
change to your health that you think may be due to Gedarel ED -28, please talk to
your doctor.
An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or
blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women
taking combined hormonal contraceptives. For more detailed information on the
different risks from taking combined hormonal contraceptives please see section 2
“What you need to know before you use Gedarel ED -28”.
Very common (may affect more than 1 in 10 people): irregular bleeding.
Common (may affect up to 1 in 10 people): depression, mood altered, headache,
dizziness, nervousness, nausea, abdominal pain, acne, tender breasts, breast pain,
absence of menstruation, painful menstruation, pre-menstrual syndrome (physical and
emotional problems before the start of menstruation), weight gain.

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. Provided that
Uncommon (may affect up to 1 in 100 people): fluid retention, decreased sexual
the tablets have been taken correctly for the 7 days preceding the forgotten tablet, the
protection from pregnancy is not reduced, and you do not need to take extra precautions. desire, migraine, impaired hearing (otosclerosis), high blood pressure, diarrhoea,
vomiting, rash, nettle-rash (urticaria), breast enlargement.
One tablet forgotten in week 3
Rare (may affect up to 1 in 1,000 people): hypersensitivity, increased sexual
You can choose between two possibilities:
desire, eye irritation due to contact lens, skin disorders (erythema nodosum - a
1. Take the forgotten tablet as soon as you remember, even if that means that you
skin disease associated with joint pain, fever, hypersensitivity, or infection, and
have to take two tablets at the same time. Take the tablets again at the usual time.
characterized by small, painful, pink to blue nodules under the skin and on the
Instead of taking the green tablets (placebo tablets), go straight on to the next strip.
Most likely, you will have a period (withdrawal bleed) at the end of the second strip -during shins that tend to recur, erythema multiforme - a skin disease characterized by solid
taking the green tablets- but you may also have spotting or breakthrough bleeding during the raised spots on the skin or fluid-filled blisters lesions and reddening or discoloration
of the skin often in concentric zones about the lesions), chloasma (discolouration of
second strip.
the skin, so called “pregnancy patches”), vaginal discharge, breast discharge and
weight loss.
2. You can also stop taking the white tablets and go on directly on to the 7 green
–– Harmful blood clots in a vein or artery for example:
placebo tablets (record the day on which you forgot your tablet). If you want to
–– in a leg or foot (i.e. DVT)
start a new strip on your fixed start day, make the placebo period less than 7 days.
–– in a lung (i.e. PE)
–– heart attack
One tablet forgotten in week 4
–– stroke
The contraceptive effect is not reduced, you can continue taking the tablets as usual.
–– mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic
attack (TIA)
If you follow either of these two recommendations, you will remain protected against
–– blood clots in the liver, stomach/intestine, kidneys or eye.
pregnancy.
If you have forgotten any of the tablets in a strip, and you do not have bleeding in the The chance of having a blood clot may be higher if you have any other conditions
that increase this risk (see section 2 for more information on the conditions that
normal placebo week, this may mean that you are pregnant. You must contact your
increase risk for blood clots and the symptoms of a blood clot).
doctor before you go on to the next strip.

00000000

30 micrograms/150 micrograms -28 film-coated tablets

GEDAREL ® ED

00000000

30 micrograms/150 micrograms -28 film-coated tablets

GEDAREL ® ED

K-23310-1.3

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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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