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EDESIA 75 MICROGRAMS/20 MICROGRAMS COATED TABLETS

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Package leaflet: Information for the user
Edesia 75 micrograms/20 micrograms coated tablets
gestodene/ethinylestradiol

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.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1.
What Edesia is and what it is used for
2.
What you need to know before you take Edesia
3.
How to take Edesia
4.
Possible side effects
5.
How to store Edesia
6.
Contents of the pack and other information

1.

What Edesia is and what it is used for

Edesia is a combined oral contraceptive belongs to a group of drugs which is frequently called as “the
Pill”. It contains two types of hormone: an oestrogen, named ethinylestradiol and a progestogen type,
named gestodene. These hormones stop the ovary from releasing an egg each month (ovulation). They
also thicken the fluid (mucus) at the neck of the womb (cervix) making it more difficult for the sperm
to reach the egg, and alter the lining of the womb to make it less likely to accept a fertilised egg.
Medical researches and vast experience have shown that, if taken correctly, the Pill is an effective
reversible form of contraception.
Edesia, like other hormonal contraceptives, will not protect you against HIV infection (AIDS) and
other sexually transmitted diseases. Only condoms can do this.
How does the pill work?
The combined contraceptive pills such as Edesia contain hormones which are equivalent to those that
your body produces (oestrogen and progestogen). These hormones help to prevent you from getting
pregnant, just as your natural hormones would stop you from conceiving again when you are already
pregnant.
The combined contraceptive pill protects you against getting pregnant in three ways:




You will not release an egg to be fertilised by sperm.
The fluid in the neck of your womb thickens so it is more difficult for sperm to enter.
The lining of your womb does not thicken enough for an egg to start to grow in.

2.

What you need to know before you take Edesia

General notes
Before you can begin taking Edesia, 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.

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In this leaflet, several situations are described where you should stop using Edesia, or where the
reliability of Edesia may be decreased. In such situations you should either not have sex or you should
take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method. Do
not use rhythm or temperature methods. These methods can be unreliable because Edesia alters the
monthly changes of body temperature and of the cervical mucus.
Edesia, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or
any other sexually transmitted disease.
While you are receiving this medication you should see your doctor regularly, according to your
doctor’s advice.
If you have any unusual symptoms such as unexplained pains in the chest, abdomen or legs you must
consult your doctor immediately.
Do not take Edesia
You should not use Edesia 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 decide whether Edesia is suitable
for you or will advise you to use another method of contraception.
If you are allergic to the actives substances or any of the other ingredients of this medicine
(listed in section 6).
If you have ever had a disorder affecting your blood circulation known as thrombosis (for
example, blood clots in your legs, lungs, heart, brain, eyes or in any other part of your body).
If you or any members of your close family have any medical condition which causes an
increased risk to develop blood clots (see also the section 'The Pill and thrombosis').
If you have ever had a heart attack or angina (severe chest pain) or a stroke (such as sudden
weakness or tingling in one side of your body).
If you have any of the following conditions now, or have ever had them:
Breast cancer or other cancer, for example ovarian cancer, cervical cancer, or cancer of
the uterus (womb).
Severe liver disease, including liver tumour.
Severe disturbances of fat metabolism.
Severe high blood pressure or uncontrolled hypertension.
Severe diabetes with changes to the blood vessels.
Headache (including migraine).
Vaginal bleeding of unknown origin.
In case of hepatitis (inflammation of the liver caused by a virus) and until liver function tests
return to normal.
If you are pregnant or think you might be.
Warnings and precautions
In some situations you need to take special care while using Edesia or any other combination pill, and
your doctor may need to examine you regularly. Talk to your doctor or pharmacist before taking
Edesia:
if a close relative has or has ever had breast cancer
if you have a disease of the liver or the gallbladder
if you have diabetes
if you have depression
if you have Crohn’s disease or inflammatory bowel disease (ulcerative colitis)
if you have a blood disease called HUS (haemolytic uraemic syndrome) which causes kidney
damage
if you have a blood disease called sickle cell anaemia
if you have epilepsy (see “Other medicines and Edesia”)
if you have a disease of the immune system called SLE (systemic lupus erythematosus)
if you have a disease that first appeared during pregnancy or earlier use of sex hormones (for
example, hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy
(gestational herpes), a nerve disease causing sudden movements of the body (Sydenham’s
chorea))

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-

if you have or have ever had chloasma (a discoloration of the skin especially of the face or neck
known as “pregnancy patches”). If so, avoid direct sunlight or ultraviolet light.
if you have hereditary angioedema, products containing oestrogens may cause or worsen
symptoms. You should see your doctor immediately if you experience symptoms of angioedema
such as swollen face, tongue and/or throat and/or difficulty swallowing or hives together with
difficulty breathing.

Edesia and venous and arterial blood clots
The use of any combination pill, including Edesia, increases a woman’s risk of developing a venous
blood clot (venous thrombosis) compared with women who do not take any contraceptive pill.
The risk of venous blood clots in users of combination pills increases:
with increasing age
if you are overweight
if one of your close relatives ever had a blood clot in the leg, lung (pulmonary embolism), or
other organ at a young age
if you have to have surgery, if you have had a serious accident or if you are immobilized for a
long time. It is important to tell your doctor that you are using Edesia as you may have to stop
taking it. Your doctor will tell you when to start again. This is usually about two weeks after
you are back on your feet.
Your chances of having a blood clot are increased by taking the Pill.
Of 100,000 women who are not on the Pill and not pregnant, about 5-10 may have a blood clot
in a year.
Of 100,000 women taking a Pill like Edesia,30-40 may have a blood clot in a year, the exact
number is unknown.
Of 100,000 women who are pregnant, around 60 may have a blood clot in a year.
A blood clot in the veins may travel to the lungs and may block blood vessels (called a lung
embolus). Formation of blood clots in the veins may be fatal in 1-2% of cases.
The level of risk may vary according to the type of pill you take. Discuss with your doctor the
available options.
The use of combination pills has been connected with an increase of the risk of an arterial blood clot
(arterial thrombosis), for example, in the blood vessels of the heart (heart attack) or the brain
(stroke).
The risk of an arterial blood clot in users of combination pills increases:
if you smoke. You are strongly advised to stop smoking when you use Edesia, especially if
you are older than 35 years.
if the fat content of your blood is increased (cholesterol or triglycerides)
with increasing age
if you are overweight
if one of your close relatives ever had a heart attack or stroke at a young age
if you have high blood pressure
if you suffer from migraine
if you have a problem with your heart (valve disorder, a disturbance of the cardiac rhythm)
Stop taking Edesia and contact your doctor immediately if you notice possible signs of a blood
clot, such as:
severe pain and/or swelling in one of your legs
sudden severe pain in the chest which may reach the left arm
sudden breathlessness
sudden cough without an obvious cause
any unusual, severe or long-lasting headache or worsening of migraine
partial or complete blindness or double vision
difficulty in speaking or inability to speak
giddiness or fainting
weakness, strange feeling, or numbness in any part of the body
severe pain in the stomach
movement disorders

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Edesia and cancer
Breast cancer has been observed slightly more often in women using combination 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 combination 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 unusually severe abdominal pain.
Bleeding between periods
During the first few months that you are taking Edesia you may have unexpected bleeding (bleeding
outside the gap week). If this bleeding occurs for more than a few months, or if it begins after some
months, your doctor must find out what is wrong.
What to do if no bleeding occurs during the gap week
If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea and you have not
taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant. Contact your
doctor immediately. Do not start the next strip until you are sure that you are not pregnant.
Other medicines and Edesia
Tell your doctor if you are taking, have recently taken or might take any other medicines.
The concomitant administration of some other medicines such as anti-epileptic agents, tranquillisers,
antibiotics, drugs to treat fungal or viral infections and tuberculosis, as well as herbal remedies
containing St. John’s wort (Hypericum perforatum), phenytoin, griseofulvin, topiramate, barbiturates,
rifampicin, rifabutin, phenylbutazone, dexamethasone, primidone, carbamazepine, some protease
inhibitors, modafinil and possibly also oxcarbazepine, felbamate, ritonavir and nevirapine may reduce
the contraceptive efficacy of Edesia.
Atorvastatin, ascorbic acid, paracetamol, indinavir, fluconazole, voriconazole and troleandromycin
may increase the serum concentrations of Edesia.
Lamotrigine, levothyroxin, valproate, cyclosporine, theophylline and corticosteroids serum level may
be changed after concomitant use with Edesia.
You may have to use another method of contraception as well, such as the condom, while you are
taking these medicines - and for a further seven days afterwards. Your doctor may advise you to use
these extra precautions for even longer.
Interactions can involve drugs taken recently or subsequently.
If you are taking Edesia and rifampicin concomitantly, you will need to use an additional method of
contraception while you are taking rifampicin and for 4 weeks after cessation of treatment.
If you suffer from diabetes, your doctor may alter the dose of medicine required to treat your diabetes.
Edesia with food and drink
Edesia may be taken with or without food, if necessary with a small amount of water.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because
hormone contraceptives can affect the results of some tests.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Pregnancy

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If you are pregnant, do not take Edesia. If you become pregnant while taking Edesia stop immediately
and contact your doctor. If you want to become pregnant, you can stop taking Edesia at any time (see
also “If you stop taking Edesia”).
Breast-feeding
Use of Edesia is generally not advisable when a woman is breast-feeding. If you want to take the pill
while you are breast-feeding you should contact your doctor.
Driving and using machines
Edesia has no or negligible influence on the ability to drive and use machines.
Edesia contains lactose monohydrate and sucrose
Edesia contains 37.165 mg of lactose monohydrate and 19.66 mg of sucrose per coated tablets.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3.

How to take Edesia

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not
sure.
This package is designed to help you remember to take your pills.
Before starting to take Edesia, a complete medical and gynaecological examination should be
performed to exclude diseases which may cause a risk by using oral contraceptives.
During the use of this preparation medical check-ups should be repeated regularly.
One tablet should be taken daily, preferably always at the same time, starting on the first day of the
monthly period for 21 days. This is followed by a tablet-free period of 7 days, during which a
menstruation-like bleeding occurs. Intake of the next 21 tablets should be started on the 8th day, even if
bleeding has not stopped. You should start the second pack of Edesia on the same day of the week as
the first one. Your periods will be probably lighter but it is not harmful.
How to start Edesia
Taking Edesia for the first time
Wait for your period to begin, and take extra contraceptive precautions (use condom or cap plus
spermicide). The first tablet should be taken the first day of your period.
You can also start taking your Pills the day 2 to 5 of the menstrual cycle, but in this case additional
contraceptive precautions (condom or cap plus spermicide) must be taken for the first 7 days of using
the Pill during the first cycle.
Changing from a combined contraceptive (combined oral contraceptive -COC, vaginal ring or
transdermal patch) to Edesia
You can start Edesia preferably on the day after the last active tablet (the last tablet containing active
substances) of your previous pill, but at the latest on the day after the tablet-free days of your previous
pill (or after the last inactive tablet of your previous pill). When changing from a combination
contraceptive vaginal ring or patch, follow the advice of your doctor.
Changing from a progestin-only method (progestin-only pill, injection, implant or a progestogenreleasing intrauterine device (IUD))
You can change from the mini-pill on any day (for an implant or IUD, on the same day it is removed;
for an injectable method, when the next injection is due), but in all cases, it is recommended that you
use additional methods of contraception (for example, a condom) for the first 7 days of pill-taking.
Use after an abortion in the 1st trimester
After an abortion or miscarriage you can start using Edesia immediately, according to the instructions
of your doctor. In this case no additional contraceptive precaution is required.

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Use after delivery or an abortion in the 2nd trimester
You can start taking Edesia between 21 and 28 days after having a baby. If you start later than day 28,
use a so-called barrier method (for example, a condom) during the first seven days of taking Edesia.
If, after having a baby, you have had sex before starting Edesia (again), you must first be sure that you
are not pregnant or wait until your next period.
After an abortion in the 2nd trimester: Follow the advice of your doctor.
If you take more Edesia than you should
No serious ill-effects have been reported after the intake of a considerable dose of the oral
contraceptive. The symptoms which may occur are breast tenderness, dizziness, tummy pain, fatigue,
nausea, vomiting and, in young girls, small vaginal bleeding. However, if you have taken more Edesia
than you should, talk to your doctor or pharmacist immediately.
If you forget to take Edesia
If you forget to take the Pill at the usual time, you should take it within 12 hours. Take the next pill at
your normal time.
Beyond 12 hours the reliability of the Pill may be reduced. You should take the last missed tablet as
soon as you remember, even if it means that you need to take 2 tablets at the same time. From then
onwards you should continue to take the tablets at the usual time. Additional contraceptive precautions
are required for the next 7 days of tablet taking. If less than 7 tablets are left in the current pack:
you should begin the next pack immediately after you took the last tablet from the current pack;
that means no pause between packages. In this case, a withdrawal bleeding should not be
expected until the end of the second pack; however, spotting and breakthrough bleeding may
occur.
you should stop taking tablets from the current pack. In that case you should observe a tablet-free
period for up to 7 days, including the days when you missed the tablets, and then proceed with the
next pack.
If no withdrawal bleeding occurs after having finished the second pack, consult your doctor.
What to do if you have a stomach upset?
If you have been sick or had diarrhoea within 3-4 hours after taking the Pill, the active substances in
the Pill may not be fully absorbed into your body. In this case the advice concerning missed pills,
described above, should be followed. In case of vomiting or diarrhoea, use extra contraceptive
precautions, such as condom, for any intercourse during the stomach upset and for the next 7 days.
Inducing or postponing a period
In order to induce the menstrual bleeding an earlier day of the week than the usual one would happen
by the present tablet intake, it is advised to shorten the following tablet-free interval by the desired
number of days. The shorter the tablet-free break, the higher the risk that breakthrough bleeding or
spotting will be experienced while taking the tablets from the second pack (like in case of
postponement of menstrual bleeding).
In order to postpone the menstrual bleeding, a new pack of Edesia should be started the day after
finishing the current pack, without a break between them. Postponement of menstrual bleeding may
last as long as required up to the end of the second pack. During the use of the second pack
breakthrough bleeding or spotting may occur. Regular intake of Edesia can be restored after the usual
7 tablet-free days.
If you stop taking Edesia
If you stop taking Edesia before the end of a strip, contraceptive protection will not be full, therefore,
additional contraceptive precaution is recommended.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following serious adverse events have been reported in women using combined oral
contraceptives (see section 2 under “The Pill and thrombosis” and ”The Pill and cancer”).

Venous thrombo-embolism (a blood clot in vessels)

Arterial thrombotic disorders (obstruction of an artery)

Cervical cancer (cancer of the neck of the womb).
In case of very severe allergic reactions with very rare cases of nettle rash, painful swelling of skin and
mucous membranes (angioedema) and respiratory and circulatory symptoms, contact your doctor
immediately.
REASONS FOR STOPPING EDESIA IMMEDIATELY
If you experience any of the following conditions whilst taking Edesia, take no further tablets and tell
your doctor straight away. In the meantime use another non-hormonal method of contraception such as
condom.

signs suggestive of thrombosis (chest pain, which may radiate to the left arm; unusually severe
pain in the legs; weakness or numbness in any part of your body; breathlessness, unusual cough
(especially with blood-tinged sputum); dizziness or fainting; disturbances of vision, hearing,
speech; sensory loss; first occurrence or aggravation of migraine; unusually intense, recurrent or
persisting headache;

jaundice;

palpable mass in the breasts;

severe abdominal pain of abrupt onset;

unusually intense vaginal bleeding or absence of menses twice in a row;

prolonged immobilization, or 4 weeks prior to a planned operation;

suspected pregnancy;

increase in blood pressure;

convulsions.
These side effects have been reported in women using the Pill. They may occur during the first few
months after starting to take Edesia, but they usually stop once your body has adjusted to the Pill.
The very commonly reported undesirable effects (may affect more than 1 in 10 people) are:
fluid retention/oedema, headache, including migraines, irregular bleeding and spotting between
periods.
Common side effects (may affect up to 1 in 10 people):
fungal infection of vagina, mood altered including depression, libido disorder, dizziness, nervousness,
nausea, vomiting, abdominal pain, acne, breast pain or tender breast, breast enlargement, breast
discharge, dysmenorrhoea, amenorrhea, hypomenorrhea, menstrual disorder, change in menstrual
flow, changes of the ectropion and secretion of the cervix , changes in weight, irritability.
Uncommon (may affect up to 1 in 100 people) and rare (may affect up to 1 in 1,000 people) side
effects:
changes in appetite, abdominal cramps, abdominal distension, rash, chloasma (yellowish-brown
patches on the skin), hairiness, baldness, high blood pressure, increase in blood fat levels, elevated
triglyceride concentration in the blood, anaphylactic reaction, angioedema, nettle rash, glucose
intolerance, poor tolerance of contact lenses, jaundice, erythema nodosum (painful nodes on lower
extremities), ear disorders, change in folate level.
Very rare side effects (may affect up to 1 in 10,000 people):

7

liver tumour, a blood disorder called haemolytic uraemic syndrome - HUS (a disorder where blood
clots cause the kidneys to fail), exacerbation of auto-immune disease (SLE), porphyria aggravated,
exacerbation of chorea, inflammation in the nerve of eye, blood clot in the eye’s artery, aggravation of
varicose veins, colitis ischemic, inflammation of the pancreas (pancreatitis), gallbladder disorder, gall
stones, erythema multiforme.
Not known (frequency cannot be estimated from available data):
inflammatory bowel disease (Crohn’s disease, colitis ulcerative), hepatocellular injury (hepatitis,
hepatic function abnormal).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.

5.

How to store Edesia

Keep this medicine out of the sight and reach of children.
Store below 25°C. Store in the original package in order to protect from light and moisture.
Do not use this medicine after the expiry date. The expiry date refers to the last day of that month.
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

What Edesia contains
-

The active substances are: 75 micrograms gestodene and 20 micrograms ethinylestradiol in
each coated tablet.
The other ingredients are:
Tablet core: Sodium calcium edetate, magnesium stearate, silica colloidal anhydrous, povidone
K-30, maize starch, lactose monohydrate.
Tablet coat: Quinoline yellow (E 104), povidone K-90, titanium dioxide (E 171), macrogol
6000, talc, calcium carbonate (E170), sucrose.

What Edesia looks like and contents of the pack
Pale yellow, round, biconvex coated tablets, 5.1 to 6.1 mm in diameter, without engraving.
Edesia 75 micrograms/20 micrograms coated tablets are packaged in PVC/PVDC-Al blister packs.
Pack sizes:
1×21 coated tablets
3×21 coated tablets
6×21 coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrıi út 19-21,
H-1103 Budapest
Hungary

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This medicinal product is authorised in the Member States of the EEA under the following
names:
Denmark
Italy
Portugal
Spain
United Kingdom

Edesia
Edesia
Edesia
Edesia
Edesia

This leaflet was last revised in 03/2012.

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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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