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

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

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Package leaftet: 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.
• 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.
If any of the above conditions change while you are using Gedarel ED -28, for
BLOOD CLOTS
Using a combined hormonal contraceptive such as Gedarel ED -28 increases your risk example a close family member experiences a thrombosis for no known reason; or
you gain a lot of weight, tell your doctor.
The name of your medicine is `Gedarel ED 30 micrograms/150 micrograms -28 film-coated of developing a blood clot compared with not using one. In rare cases a blood clot
can block blood vessels and cause serious problems.
tablets’, but will be referred to as `Gedarel ED -28’ throughout the remainder of this leaflet.
BLOOD CLOTS IN AN ARTERY
Blood clots can develop
1. What Gedarel ED -28 is and what it is used for
– in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE) What can happen if a blood clot forms in an artery?
2. What you need to know before you use Gedarel ED -28
– in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’
3. How to take Gedarel ED -28
Like a blood clot in a vein, a clot in an artery can cause serious problems. For
or ATE).
4. Possible side effects
Recovery from blood clots is not always complete. Rarely, there may be serious lasting example, it can cause a heart attack or a stroke.
5. How to store Gedarel ED -28
6. Contents of the pack and other information
effects or, very rarely, they may be fatal.
Factors that increase your risk of a blood clot in an artery
It is important to remember that the overall risk of a harmful blood clot due to
It is important to note that the risk of a heart attack or stroke from using Gedarel ED -28
1. What Gedarel ED -28 is and what it is used for
Gedarel ED -28 is small.
is very small but can increase:
What is in this leaflet:

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.

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?

– 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;
– sudden cough without an obvious cause, which may bring
up blood;
– sharp chest pain which may increase with deep breathing;
– severe light headedness or dizziness;
– rapid or irregular heartbeat;
– severe pain in your stomach;

What are you
possibly suffering
from?
Deep vein
thrombosis

Pulmonary
embolism

If you are unsure, talk to a doctor as some of these symptoms
such as coughing or being short of breath may be mistaken for
Remember, combined oral contraceptive pills like Gedarel ED -28 will not protect you
a milder condition such as a respiratory tract infection (e.g. a
against sexually-transmitted diseases (such as AIDS). Only condoms can help to do this. ‘common cold’).
Retinal vein
Symptoms most commonly occur in one eye:
thrombosis (blood

immediate
loss
of
vision
or
2. What you need to know before you use Gedarel ED -28
– painless blurring of vision which can progress to loss of vision. clot in the eye)
– chest pain, discomfort, pressure, heaviness;
Heart attack
General notes
– sensation of squeezing or fullness in the chest, arm or below
Before you start using Gedarel ED -28 you should read the information on blood clots the breastbone;
– fullness, indigestion or choking feeling;
in section 2. It is particularly important to read the symptoms of a blood clot – see
– upper body discomfort radiating to the back, jaw, throat,
section 2 “Blood clots”.
arm and stomach;
Before you can begin taking Gedarel ED -28, your doctor will ask you some questions – sweating, nausea, vomiting or dizziness;
about your personal health history and that of your close relatives. The doctor will also – extreme weakness, anxiety, or shortness of breath;
measure your blood pressure, and depending upon your personal situation, may also – rapid or irregular heartbeats
carry out some other tests.
Stroke
– sudden weakness or numbness of the face, arm or leg,
especially on one side of the body;
Do not use Gedarel ED -28
– sudden confusion, trouble speaking or understanding;
You should not use Gedarel ED -28 if you have any of the conditions listed below. If
– sudden trouble seeing in one or both eyes;
you do have any of the conditions listed below, you must tell your doctor. Your doctor – sudden trouble walking, dizziness, loss of balance or
will discuss with you what other form of birth control would be more appropriate.
coordination;
– If you have (or have ever had) a blood clot in a blood vessel of your legs (deep
– sudden, severe or prolonged headache with no known cause;
vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
– loss of consciousness or fainting with or without seizure.
– 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
Sometimes the symptoms of stroke can be brief with an almost
or antiphospholipid antibodies;
immediate and full recovery, but you should still seek urgent
– if you need an operation or if you are off your feet for a long time (see section
medical attention as you may be at risk of another stroke.
‘Blood clots’);
– swelling and slight blue discolouration of an extremity;
Blood clots
– if you have ever had a heart attack or a stroke;
– severe pain in your stomach (acute abdomen)
blocking other
– if you have (or have ever had) angina pectoris (a condition that causes severe
blood vessels
chest pain and may be first sign of a heart attack) or transient ischaemic attack (TIA –
temporary stroke symptoms);
BLOOD CLOTS IN A VEIN
– if you have any of the following diseases that may increase your risk of a clot in
the arteries:
What can happen if a blood clot forms in a vein?
– severe diabetes with blood vessel damage
– The use of combined hormonal contraceptives has been connected with an
– very high blood pressure
increase in the risk of blood clots in the vein (venous thrombosis). However, these side
– a very high level of fat in the blood (cholesterol or triglycerides)
effects are rare. Most frequently, they occur in the first year of use of a combined
hormonal contraceptive.
– a condition known as hyperhomocysteinaemia;
– If a blood clot forms in a vein in the leg or foot it can cause a deep vein
– if you have (or have ever had) a type of migraine called ‘migraine with aura’;
thrombosis (DVT).
– 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 – If a blood clot travels from the leg and lodges in the lung it can cause a
pulmonary embolism.
normal;
– Very rarely a clot may form in a vein in another organ such as the eye (retinal vein
– 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 thrombosis).
genital organs;
When is the risk of developing a blood clot in a vein highest?
– if you have any unexplained bleeding from the vagina;
– if you have endometrial hyperplasia (excessive proliferation of the cells of the inner The risk of developing a blood clot in a vein is highest during the first year of taking
a combined hormonal contraceptive for the first time. The risk may also be higher if
lining of the womb);
you restart taking a combined hormonal contraceptive (the same product or a different
– if you are pregnant or think you might be;
– if you are allergic to ethinylestradiol or desogestrel, or any of the other ingredients product) after a break of 4 weeks or more.
of this medicine (listed in section 6). This can be recognised by itching, rash or
After the first year, the risk gets smaller but is always slightly higher than if you were
swelling.
not using a combined hormonal contraceptive.
Warnings and precautions
When you stop Gedarel ED -28 your risk of a blood clot returns to normal within a
Talk to your doctor or pharmacist before taking Gedarel ED -28.
few weeks.
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”.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal
contraceptive you are taking.

– 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.
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 make Gedarel ED -28 less effective in preventing pregnancy, or
can cause unexpected bleeding. These include medicines used for the treatment of
– epilepsy (e.g. primidone, bosentan, phenytoin, barbiturates, carbamazepine,
oxcarbazepine, topiramate, hydantoins, felbamat, modafinil, rifabutin)
– tuberculosis (e.g. rifampicin)
– HIV infections (ritonavir, nelfinavir, nevirapin. efavirenz) or other infectious
diseases (griseofulvin, ampicillin, tetracycline)
– the herbal remedy St. John’s wort.
Gedarel ED -28 may influence the efficacy of other medicines, e.g.
– medicines containing cyclosporine
– the anti-epileptic lamotrigine (this could lead to an increased frequency of
seizures).
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.
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
The overall risk of a blood clot in the leg or lung (DVT or PE) with Gedarel ED -28 is small. If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine.
– Out of 10,000 women who are not using any combined hormonal contraceptive The ingredient sunset yellow may cause allergic reactions.
and are not pregnant, about 2 will develop a blood clot in a year.
In some situations you need to take special care while using Gedarel ED -28 or
– Out of 10,000 women who are using a combined hormonal contraceptive that
any other combined hormonal contraceptive, and it may be necessary that you are
3. How to take Gedarel ED -28
contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a
regularly checked by your doctor. If any of the following conditions applies to you,
blood clot in a year.
Always take this medicines exactly as your doctor has told you. Check with your
you must inform your doctor before starting to use Gedarel ED -28.
– Out of 10,000 women who are using a combined hormonal contraceptive that
doctor if you are not sure.
contains desogestrel such as Gedarel ED -28 between about 9 and 12 women will
If before you started Gedarel ED -28, you took another contraceptive pill, you know
Tell your doctor if any of the following conditions apply to you.
develop a blood clot in a year.
that most contraceptive pills contain 21 tablets. With these contraceptive pills, you
If the condition develops, or gets worse while you are using Gedarel ED -28 you
– The risk of having a blood clot will vary according to your personal medical
take one tablet for 21 days and then have a gap (tablet-free) week of 7 days. The
should also tell your doctor.
history (see “Factors that increase your risk of a blood clot” below).
pattern when using Gedarel ED -28 is different. After the 21 white, active tablets, you
– If a close relative has or has had breast cancer;
Risk of developing a must continue right away with the 7 green placebo tablets; there is therefore no gap
– if you have a disease of the liver or the gallbladder;
blood clot in a year week but a “placebo” week.
– if you have diabetes;
– if you have depression;
Women who are not using a combined hormonal pill/
About 2 out of
– if you have epilepsy (see “Other medicines and Gedarel ED -28”);
Preparation of the strip
patch/ring and are not pregnant
10,000 women
– if you have a disease that first appeared during pregnancy or earlier use of sex
You must know on which day of the week you will take the first tablet.
Women using a combined hormonal contraceptive pill
About 5-7 out of
hormones (for example, hearing loss, porphyria (a disease of the blood), gestational
To help you keep track, there are 7 weekdays sticker strips marked with the 7 days of
containing levonorgestrel, norethisterone or norgestimate 10,000 women
herpes (skin rash with vesicles during pregnancy), Sydenham’s chorea (a disease of
the week. Choose the weekdays sticker strip that starts with the day you begin taking
Women using Gedarel ED -28
About 9-12 out of
the nerves in which sudden movements of the body occur);
the tablets. For example, if you start on a Wednesday, use the weekdays sticker strip
10,000 women
that starts with “Wed”.
– if you have or have ever had chloasma (golden brown pigment patches, so called
Fit the “ ” symbol on the strip to the same symbol on the blister card and place the
“pregnancy patches”, especially on the face). If this is the case, avoid direct exposure Factors that increase your risk of a blood clot in a vein
to sunlight or ultraviolet light;
strip into the area bordered with black line. Each day will line up with a row of pills.
– if you have hereditary angioedema, products containing estrogens may induce
The risk of a blood clot with Gedarel ED -28 is small but some conditions will increase There is now a day shown above every tablet and you can see whether you have
or worsen symptoms of angioedema. You should see your doctor immediately if you the risk. Your risk is higher:
taken a pill on a particular day. Follow the direction of the arrow on the wallet until all
experience symptoms of angioedema such as swollen face, tongue and/or pharynx
28 tablets have been taken.
– if you are very overweight (body mass index or BMI over 30 kg/m2);
and/or difficulty swallowing or hives together with difficulty breathing.
– if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel
– if one of your immediate family has had a blood clot in the leg, lung, or other
Following the direction of the arrow printed on the strip you should take one
disease);
organ at a young age (e.g. below the age of about 50). In this case you could have tablet each day for 28 days until the strip is empty.
– if you have systemic lupus erythematosus (SLE - a disease affecting your natural
a hereditary blood clotting disorder;
defence system);
– if you need to have an operation, or if you are off your feet for a long time because During the 7 days that you are taking the green placebo tablets (the placebo
– if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting
of an injury or illness, or you have your leg in a cast. The use of Gedarel ED -28 may 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
causing failure of the kidneys);
need to be stopped several weeks before surgery or while you are less mobile. If you
you have taken the last green tablet, you should start with the following strip,
– if you have sickle cell anaemia (an inherited disease of the red blood cells);
need to stop Gedarel ED -28 ask your doctor when you can start using it again.
whether your bleeding has stopped or not. This means that you should start the
– if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive – as you get older (particularly above about 35 years);
following strip on the same day of the week, and that the withdrawal bleed
family history for this condition. Hypertriglyceridaemia has been associated with an
– if you gave birth less than a few weeks ago.
should occur on the same days each month.
increased risk of developing pancreatitis (inflammation of the pancreas);
If you use Gedarel ED -28 in this manner, you are protected against pregnancy
– if you need an operation, or you are off your feet for a long time (see in section 2 The risk of developing a blood clot increases the more conditions you have.
also during the 7 days that you are taking a placebo tablet.
‘Blood clots’);
– if you have just given birth you are at an increased risk of blood clots. You should Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if
you have some of the other factors listed.
You should try to take your tablet at about the same time each day. You may find
ask your doctor how soon after delivery you can start taking Gedarel ED -28;
it easiest to take it either last thing at night or first thing in the morning.
– if you have an inflammation in the veins under the skin (superficial
It is important to tell your doctor if any of these conditions apply to you, even if you
thrombophlebitis);
are unsure. Your doctor may decide that Gedarel ED -28 needs to be stopped.
Swallow each tablet whole, with water if necessary.
– if you have varicose veins.

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.

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.
Changing to Gedarel ED -28 from a progestogen-product (progestogen-only-pills, If the expected bleeding does not happen twice in succession, you may be pregnant.
injection, implant or progestogen releasing IUD)
Contact your doctor immediately. Do not start the next strip until you are sure that you
You may switch any day from the progestogen-only tablet (from an implant or the
are not pregnant.
IUD on the day of its removal, from an injectable when the next injection would be
Ask your doctor for advice.
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.
Delay of menstrual period: what you must know
Even if not recommended, delay of your menstrual period (withdrawal bleed) is
After a miscarriage or abortion
possible by going straight on to a new strip of Gedarel ED -28 after the last white
Follow the advice of your doctor.
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
After having a baby
the usual placebo-tablet period of 7 days, continue with the following strip.
After having a baby, you can start Gedarel ED -28 between 21 and 28 days later.
You might ask your doctor for advice before deciding to delay your menstrual period.
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, 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/
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.
withdrawal bleed will begin whilst taking the placebo-tablets. If you have to change
Let your doctor advise you, in case you are not sure when to start.
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 change
If you are breast-feeding and want to start Gedarel ED -28 (again) after having a baby. this to a Tuesday (3 days earlier) you must start a new strip 3 days earlier than usual. If
Read the section on “Pregnancy and breast-feeding”.
you make the placebo-tablet period very short (for example, 3 days or less) then it may
be that you do not have any bleeding during this placebo-tablet period. You may then
If you take more Gedarel ED -28 than you should
experience spotting (droplets or flecks or blood) or breakthrough bleeding.
There are no reports of serious harmful results of taking too many Gedarel ED -28. If you If you are not sure how to proceed, contact your doctor for advice.
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 ED -28, If you stop taking Gedarel ED -28
or you discover that a child has taken some, ask your doctor or pharmacist for advice. You can stop taking Gedarel ED -28 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 forget to take Gedarel ED -28
The green tablets of the strip are placebo tablets. If you forget one these tablets,
If you have any further questions on the use of thismedicine, ask your doctor or
this has no effect on the reliability of Gedarel ED -28. You should throw away the
pharmacist.
forgotten placebo tablet so that you do not make the placebo week longer. This might
have a negative effect on the reliability of Gedarel ED -28.
If you miss a white tablet, you must follow the following advice:
4. Possible side effects
– 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.
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.
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 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
taking the green tablets- but you may also have spotting or breakthrough bleeding during the
second strip.
2. You can also stop taking the white tablets and go on directly on to the 7 green
placebo tablets (record the day on which you forgot your tablet). If you want to
start a new strip on your fixed start day, make the placebo 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 thenormal placebo week, 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

in week 2

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

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”.

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.
– 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 September 2015.

More serious reactions associated with combined hormonal contraceptive pills are
detailed above in section 2 under “Blood clots” and “The pill and cancer”. Please
read these subsections carefully, and if you have any questions, ask your doctor.
Like any medicine, hypersensitivity reactions (allergy to the ingredients of Gedarel ED -28)
may develop. Therefore, if you experience any of the following symptoms, such as
skin rash, itching, swelling of the face, painful joint or any unusual symptom (e.g. fever,
sore throat, difficulty breathing, fainting), you should see your doctor immediately.
The following serious side effects/conditions have been reported to occur or
worsen 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, 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).
The following side effects have been reported in women using the pill, which can
occur in the first few months after starting Gedarel ED -28, but they usually stop once
your body has adjusted to the pill.
Very common (may affect more than 1 in 10 people): irregular bleeding, weight gain.
Common (may affect up to 1 in 10 people): none or reduced bleeding, tender
breasts, breast pain, depression, mood altered, headache, nervousness, dizziness,
nausea, abdominal pain, acne, bleeding from the uterus that is not due to
menstruation.
Uncommon (may affect up to 1 in 100 people): decreased sexual desire, migraine,
rash, fluid retention, impaired hearing (otosclerosis), high blood pressure, vomiting,
diarrhoea, nettle-rash (urticaria), breast enlargement.
Rare (may affect up to 1 in 1,000 people): vaginal candidiasis (fungal infection),
hypersensitivity, increased sexual desire, eye irritation due to contact lens, loss of hair
(alopecia), itching, skin disorders (erythema nodosum - a skin disease associated with joint
pain, fever, hypersensitivity, or infection, and characterized by small, painful, pink to blue
nodules under the skin and on the shins that tend to recur, erythema multiforme - a skin
disease characterized by solid raised spots on the skin or fluid-filled blisters lesions and
reddening or discoloration of the skin often in concentric zones about the lesions), vaginal
discharge, breast discharge, weight loss.
– harmful blood clots in a vein or artery for example:
– in a leg or foot (i.e. DVT)
– in a lung (i.e. PE)
– heart attack
– stroke
– mini-stroke or temporary stroke-like symptoms, known as a transient
ischaemic attack (TIA)
– blood clots in the liver, stomach/intestine, kidneys or eye.
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).
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.
5. How to store Gedarel ED -28
Keep this medicine out of the sight and reach of children.

Store below 30°C, in the original packaging in order to protect from light.
Do not throw away any medicinesvia wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

K-23310-1.2

®

GEDAREL ED

00000000

30 micrograms/150 micrograms -28 film-coated tablets

00000000

• 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

Do not use this medicine after the expiry date. The expiry date refers to the last day of
the month.

30 micrograms/150 micrograms -28 film-coated tablets

in week 3

or

GEDAREL ® ED

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

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.

6. Contents of the pack and other information

UK

GEDAREL ED 30

pil

K-23310-1.2
345x635
P Black
9 pt
Kata - 2015.10.12.

37800

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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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