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GEDAREL ED 20 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
®
20 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.
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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:
The name of your medicine is `Gedarel ED 20 micrograms/150 micrograms -28
film-coated tablets’, but will be referred to as `Gedarel ED -28’ throughout the
remainder of this leaflet.
1. What Gedarel ED -28 is and what it is used for
2. What you need to know before you take Gedarel ED -28
3. How to take Gedarel ED -28
4. Possible side effects
5. How to store Gedarel ED -28
6. Contents of the pack and other information
1. What Gedarel ED -28 is and what it is used for

BLOOD CLOTS
Using a combined hormonal contraceptive such as Gedarel ED -28 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.
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
Gedarel ED -28 is a contraceptive pill and is used to prevent pregnancy.
Seek urgent medical attention if you notice any of the following signs or symptoms.
Each slightly yellow film-coated tablet contains a small amount of two different female
hormones, namely desogestrel and ethinylestradiol. The green film-coated tablets
Are you experiencing any of these signs? What are you possibly suffering
contain no active substances and are also called placebo tablets.
from?
Contraceptive pills that contain two hormones are called “combination” pills.
–– swelling of one leg or along a
Deep vein thrombosis
vein in the leg or foot especially when
The combined contraceptive pill protects you against getting pregnant in three ways.
accompanied by:
These hormones
–– pain or tenderness in the leg which
1. stop the ovary from releasing an egg each month (ovulation).
may be felt only when standing or
2. also thicken the fluid (at the neck of the womb making it more difficult for the
walking
sperm to reach the egg.
–– increased warmth in the affected leg
3. alter the lining of the womb to make it less likely to accept a fertilised egg.
–– change in colour of the skin on the
leg e.g. turning pale, red or blue
General information


sudden unexplained breathlessness or
Pulmonary embolism
If taken correctly, the pill is an effective reversible form of contraception. However,
rapid breathing;
in certain circumstances the effectiveness of the pill may reduce or you should
–– sudden cough without an obvious cause,
stop taking the pill (see later). In these cases either do not have sex, or use extra
which may bring up blood;
contraceptive precautions (such as condoms or spermicides) during intercourse to
–– sharp chest pain which may increase
ensure effective contraception.
with deep breathing;
–– severe light headedness or dizziness;
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. –– rapid or irregular heartbeat
–– severe pain in your stomach;
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. 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
2. What you need to know before you take Gedarel ED -28
infection (e.g. a ‘common cold’).
Symptoms most commonly occur in one eye: Retinal vein thrombosis (blood clot in
General notes
the eye)
Before you start using Gedarel ED -28 you should read the information on blood clots –– immediate loss of vision or
–– painless blurring of vision which can
in section 2. It is particularly important to read the symptoms of a blood clot – see
progress to loss of vision
section 2 “Blood clots”.
–– chest pain, discomfort, pressure,
Heart attack
Before you can begin taking Gedarel ED -28, your doctor will ask you some
heaviness;
questions about your personal health history and that of your close relatives. The
–– sensation of squeezing or fullness in the
doctor will also measure your blood pressure, and depending upon your personal
chest, arm or below the breastbone;
situation, may also carry out some other tests.
–– fullness, indigestion or choking feeling;
–– upper body discomfort radiating to the
Do not take Gedarel ED -28
back, jaw, throat, arm and stomach;
You should not use Gedarel ED -28 if you have any of the conditions listed below. If
–– sweating, nausea, vomiting or dizziness;
you do have any of the conditions listed below, you must tell your doctor. Your doctor –– extreme weakness, anxiety, or shortness
will discuss with you what other form of birth control would be more appropriate
of breath;
–– if you have (or have ever had) a blood clot in a blood vessel of your legs (deep
–– rapid or irregular heartbeats
vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
–– sudden weakness or numbness of the
Stroke
–– if you know you have a disorder affecting your blood clotting – for instance,
face, arm or leg, especially on one side of
protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden the body;
or antiphospholipid antibodies;
–– sudden confusion, trouble speaking or
–– if you need an operation or if you are off your feet for a long time (see section
understanding;
‘Blood clots’);
–– sudden trouble seeing in one or both eyes;
–– if you have ever had a heart attack or a stroke;
–– sudden trouble walking, dizziness, loss
–– if you have (or have ever had) angina pectoris (a condition that causes severe
of balance or coordination;
chest pain and may be a first sign of a heart attack) or transient ischaemic attack
–– sudden, severe or prolonged headache
[TIA – temporary stroke symptoms];
with no known cause;
–– if you have any of the following diseases that may increase your risk of a clot in
–– loss of consciousness or fainting with or
the arteries:
without seizure.
–– severe diabetes with blood vessel damage
–– very high blood pressure
Sometimes the symptoms of stroke can be
–– a very high level of fat in the blood (cholesterol or triglycerides)
brief with an almost immediate and full
–– a condition known as hyperhomocysteinaemia;
recovery, but you should still seek urgent
–– if you have (or have ever had) a type of migraine called ‘migraine with aura’;
medical attention as you may be at risk of
–– if you have (had) an inflammation of the pancreas (pancreatitis);
another stroke.
–– if you have or have had in the past a liver disease and your liver function is still
–– swelling and slight blue discolouration of Blood clots blocking other blood
not normal;
an extremity;
vessels
–– 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 –– severe pain in your stomach (acute
abdomen).
genital organs;
–– if you have any unexplained bleeding from the vagina;
–– if you have endometrial hyperplasia (excessive proliferation of the cells of the inner BLOOD CLOTS IN A VEIN
lining of the womb);
–– if you are pregnant or think you might be;
What can happen if a blood clot forms in a vein?
–– if you are allergic to ethinylestradiol or desogestrel, or any of the other ingredients of –– The use of combined hormonal contraceptives has been connected with an
this medicine (listed in section 6). This can be recognised by itching, rash or swelling.
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
Warnings and precautions
hormonal contraceptive.
Talk to your doctor or pharmacist before taking Gedarel ED -28.
–– If a blood clot forms in a vein in the leg or foot it can cause a deep vein
thrombosis (DVT).
When should you contact your doctor?
–– If a blood clot travels from the leg and lodges in the lung it can cause a
Seek urgent medical attention
pulmonary embolism.
–– if you notice possible signs of a blood clot that may mean you are suffering
–– Very rarely a clot may form in a vein in another organ such as the eye (retinal vein
from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung
thrombosis).
(i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood clots’ (thrombosis)
section below).
When is the risk of developing a blood clot in a vein highest?
For a description of the symptoms of these serious side effects please go to “How to The risk of developing a blood clot in a vein is highest during the first year of taking
recognise a blood clot”.
a combined hormonal contraceptive for the first time. The risk may also be higher if
you restart taking a combined hormonal contraceptive (the same product or a different
In some situations you need to take special care while using Gedarel ED -28 or
product) after a break of 4 weeks or more.
any other combined hormonal contraceptive, and it may be necessary that you are
After the first year, the risk gets smaller but is always slightly higher than if you were
regularly checked by your doctor.
not using a combined hormonal contraceptive.
When you stop Gedarel ED -28 your risk of a blood clot returns to normal within a
Tell your doctor if any of the following conditions apply to you.
few weeks.
If the condition develops, or gets worse while you are using Gedarel ED -28, you
should also tell your doctor
What is the risk of developing a blood clot?
–– if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel
The risk depends on your natural risk of VTE and the type of combined hormonal
disease);
contraceptive you are taking.
–– if you have systemic lupus erythematosus (SLE – a disease affecting your natural
The overall risk of a blood clot in the leg or lung (DVT or PE) with Gedarel ED -28
defence system);
is small.
–– if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting
–– Out of 10,000 women who are not using any combined hormonal contraceptive
causing failure of the kidneys);
and are not pregnant, about 2 will develop a blood clot in a year.
–– if you have sickle cell anaemia (an inherited disease of the red blood cells);
–– Out of 10,000 women who are using a combined hormonal contraceptive that
–– if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a
family history for this condition. Hypertriglyceridaemia has been associated with an
blood clot in a year.
increased risk of developing pancreatitis (inflammation of the pancreas).
–– Out of 10,000 women who are using a combined hormonal contraceptive that
–– if you need an operation, or you are off your feet for a long time (see in section 2 contains desogestrel such as Gedarel ED -28 between about 9 and 12 women will
‘Blood clots’);
develop a blood clot in a year.
–– if you have just given birth you are at an increased risk of blood clots. You should –– The risk of having a blood clot will vary according to your personal medical
ask your doctor how soon after delivery you can start taking Gedarel ED -28.
history (see “Factors that increase your risk of a blood clot” below).
–– if you have an inflammation in the veins under the skin (superficial
thrombophlebitis);
Risk of developing a blood clot in a year
–– if you have varicose veins;
Women who are not using a combined About 2 out of 10,000 women
–– if a close relative has or has had breast cancer;
hormonal pill/patch/ring and are not
–– if you have a disease of the liver or the gallbladder;
pregnant
–– if you have diabetes;
Women using a combined hormonal
About 5-7 out of 10,000 women
–– if you have depression;
contraceptive
pill
containing
–– if you have epilepsy (see “Other medicines and Gedarel ED -28”);
levonorgestrel, norethisterone or
–– if you have a disease that first appeared during pregnancy or earlier use of sex
norgestimate
hormones (for example, hearing loss, porphyria (a disease of the blood), gestational
Women using Gedarel ED -28
About 9-12 out of 10,000 women
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 Factors that increase your risk of a blood clot in a vein
“pregnancy patches”, especially on the face). If this is the case, avoid direct exposure The risk of a blood clot with Gedarel ED -28 is small but some conditions will
to sunlight or ultraviolet light.
increase the risk. Your risk is higher:
–– if you have hereditary angioedema, products containing estrogens may induce
–– if you are very overweight (body mass index or BMI over 30kg/m2);
or worsen symptoms of angioedema. You should see your doctor immediately if you –– if one of your immediate family has had a blood clot in the leg, lung or other
experience symptoms of angioedema such as swollen face, tongue and/or pharynx organ at a young age (e.g. below the age of about 50). In this case you could have
and/or difficulty swallowing or hives together with difficulty breathing.
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.
Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if
you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even if you
are unsure. Your doctor may decide that Gedarel ED -28 needs to be stopped.
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 than 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 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.
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 (HCV) (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);
–– the symptomatic treatment of arthrosis (etoricoxib);
–– the herbal remedy St. John’s wort. If you want to use herbal products containing
St. John’s wort while you are already using Gedarel ED -28 you should consult your
doctor first.
Gedarel ED -28 may also influence the efficacy of other medicines, e.g.
–– ciclosporin (medicine used for the treatment of suppression of tissue rejection
following transplant surgery),
–– lamotrigine (anti-epileptic medicine; this could lead to an increased frequency of
seizures),
–– tizanidine (medicine used for the treatment of muscle spasticity),
–– levothyroxine (medicine used for the treatment of hormone deficiency).
Ask your doctor or pharmacist for advice before taking any medicine.
Before you have any laboratory tests
Tell your doctor or the laboratory staff that you are taking the pill, 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.
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 slightly yellow, 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.

Several tablets forgotten in 1 strip

yes

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.

Had sex in the previous week
before forgetting?

in week 1

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.
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 slightly yellow 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.

no
•• Take the forgotten tablet
•• Use a barrier method (condom)
for the following 7 days
•• And finish strip
Only 1 tablet
forgotten (taken
more than
12 hours late)

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

in week 2

••
••
••
••

Swallow each tablet whole, with water if necessary.
Starting the first pack
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.

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
increase risk for blood clots and the symptoms of a blood clot).

Ask your doctor for advice

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

in week 3

in week 4

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 carton after EXP.
The expiry date refers to the last day of that month.
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.
6. Contents of the pack and other information

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

The active substances are ethinylestradiol and desogestrel in each slightly yellow
tablet.
One slightly yellow film-coated tablet contains 20 micrograms ethinylestradiol and
150 micrograms desogestrel.

•• Take the next tablet at the
usual time
•• Finish the strip as usually

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,
quinoline yellow (E104).
Tablet coating: hypromellose; macrogol 6000; propylene glycol.

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.

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.

4. Possible side effects

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 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.

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 take Gedarel ED -28”.

You can choose between two possibilities:

5. How to store Gedarel ED -28

What Gedarel ED -28 contains

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,
What you must do if no bleeding occurs in the placebo-tablet week
you have had intercourse before starting Gedarel ED -28 (again), you must first be
If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea
sure that you are not pregnant or you must wait until the next menstrual bleed.
and you have not taken any other medicines, it is highly unlikely that you are pregnant.
Let your doctor advise you, in case you are not sure when to start.
If the expected bleeding does not happen twice in succession, you may be pregnant.
If you are breast-feeding and want to start Gedarel ED -28 (again) after having a Contact your doctor immediately. Do not start the next strip until you are sure that you
are not pregnant.
baby.
Read the section on “Pregnancy and breast-feeding”.
Ask your doctor for advice.
If you take more Gedarel ED -28 than you should
Delay of menstrual period: what you must know
There are no reports of serious harmful results of taking too many Gedarel ED -28
Even if not recommended, delay of your menstrual period (withdrawal bleed) is
tablets. If you take several tablets at once then you may have symptoms of nausea
possible by going straight on to a new strip of Gedarel ED -28 after the last slightly
or vomiting. Young girls may have bleeding from the vagina. If you have taken too
many Gedarel ED -28 tablets, or you discover that a child has taken some, ask your yellow 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
doctor or pharmacist for advice.
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
If you forget to take Gedarel ED -28
period.
The green tablets of the strip are placebo tablets. If you forget one these tablets,
this has no effect on the reliability of Gedarel ED -28. You should throw away the
Change of the first day of your menstrual period: what you must know
forgotten placebo tablet so that you do not make the placebo week longer. This
If you take the tablets according to the instructions, then your menstrual period/
might have a negative effect on the reliability of Gedarel ED -28.
withdrawal bleed will begin whilst taking the placebo-tablets. If you have to change
If you miss a slightly yellow tablet, you must follow the following advice:
this day, you do this by making the placebo-tablet period shorter (but never longer!).
For example, if your placebo-tablet period begins on a Friday, and you want to
–– 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 change this to a Tuesday (3 days earlier) you must start a new strip 3 days earlier
than usual. If you make the placebo-tablet period very short (for example, 3 days
tablets again at the usual time.
–– If you are more than 12 hours late taking a tablet, the protection from pregnancy or less) then it may be that you do not have any bleeding during this placebotablet period. You may then experience spotting (droplets or flecks or blood) or
may be reduced. The greater the number of tablets that you have forgotten, the
breakthrough bleeding.
greater is the risk that the protection from pregnancy is reduced.
If you are not sure how to proceed, contact your doctor for advice.
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 If you stop taking Gedarel ED -28
You can stop taking Gedarel ED -28 whenever you want. If you do not want to become
rules (see also the diagram below):
pregnant, ask your doctor for advice about other reliable methods of birth control.
More than one tablet forgotten in this strip
If you have any further questions on the use of this medicine, ask your doctor or
Contact your doctor.
pharmacist.
One tablet forgotten in week 1

One tablet forgotten in week 3

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.

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: slightly yellow, round shaped, biconvex film-coated
tablets of about 6 mm diameter, with P9 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 20 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 tablet.
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: Myrzi 28
Belgium: DESO 20 CONTINU
Luxembourg: DESO 20 CONTINU
United Kingdom: Gedarel ED-28
This leaflet was last revised in May 2016.

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.

Very common (may affect more than 1 in 10 people): irregular bleeding.
Common (may affect up to 1 in 10 people): depression, mood altered,
nervousness, headache, dizziness, 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.

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

00000000

®

20 micrograms/150 micrograms -28 film-coated tablets

®

GEDAREL ED

00000000

20 micrograms/150 micrograms -28 film-coated tablets

GEDAREL ED

K-23308-1.3

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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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