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AIDULAN 20/75 MICROGRAM FILM COATED TABLETS

Active substance(s): ETHINYLESTRADIOL / GESTODENE

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Transcript
2021
PACKAGE LEAFLET: INFORMATION FOR THE USER
Aidulan 20 / 75 micrograms Film-Coated Tablets
Ethinylestradiol / Gestodene
Important things to know about combined hormonal contraceptives
(CHCs):
• They are one of the most reliable reversible methods of contraception if
used correctly
• They slightly increase the risk of having a blood clot in the veins and
arteries, especially in the first year or when restarting a combined hormonal
contraceptive following a break of 4 or more weeks
• Please be alert and see your doctor if you think you may have symptoms
of a blood clot (see section 2 “Blood clots”)
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again
- If you have any further questions, ask your doctor or pharmacist
- This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.









What is in this leaflet:
1. What Aidulan 20/75 Tablets are and what they are used for
2. What you need to know before you take Aidulan 20/75 Tablets
3. How to take Aidulan 20/75 Tablets
4. Possible side effects
5. How to store Aidulan 20/75 Tablets
6. Contents of the pack and other information



1. What Aidulan 20/75 tablets are and what they are used for
Aidulan 20/75 is a combined oral contraceptive and belongs to a group
of medicines which is frequently called “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.
Aidulan 20/75, 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 Aidulan 20/75 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 Aidulan 20/75 tablets
General notes
Before you start using Aidulan 20/75 you should read the information on
blood clots in section 2. It is particularly important to read the symptoms of a
blood clot – see Section 2 “Blood clots”).
Before you can begin taking Aidulan 20/75, 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.
In this leaflet, several situations are described where you should stop using
Aidulan 20/75, or where the reliability of Aidulan 20/75 may be decreased. In
such situations you should either not have sex or you should take extra nonhormonal contraceptive precautions, e.g. use a condom or another barrier
method. Do not use rhythm or temperature methods. These methods can
be unreliable because Aidulan 20/75 alters the monthly changes of body
temperature and of the cervical mucus.
Aidulan 20/75, 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 Aidulan 20/75
You should not use Aidulan 20/75 if you have any of the conditions listed
below. If you do have any of the conditions listed below, you must tell your
doctor. Your doctor will discuss with you what other form of birth control
would be more appropriate.
• if you have (or have ever had) a blood clot in a blood vessel of your legs

K







(deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or
other organs;
if you know you have a disorder affecting your blood clotting – for instance,
protein C deficiency, protein S deficiency, antithrombin-III deficiency,
Factor V Leiden or antiphospholipid antibodies;
if you need an operation or if you are off your feet for a long time (see
section ‘Blood clots’);
if you have ever had a heart attack or a stroke;
if you have (or have ever had) angina pectoris (a condition that causes
severe chest pain and may be a first sign of a heart attack) or transient
ischaemic attack (TIA – temporary stroke symptoms);
if you have any of the following diseases that may increase your risk of a
clot in the arteries:
• severe diabetes with blood vessel damage
• very high blood pressure
• a very high level of fat in the blood (cholesterol or triglycerides)
• a condition known as hyperhomocysteinaemia
if you have (or have ever had) a type of migraine called “migraine with
aura”
If you are allergic to gestodene, ethinylestradiol or any of the other
ingredients of this medicine (listed in section 6).
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 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.
• 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 Aidulan 20/75
or any other combination pill, and your doctor may need to examine you
regularly. Tell your doctor if any of the following conditions apply to you. If
the condition develops, or gets worse while you are using Aidulan 20/75, you
should also tell your doctor.
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory
bowel disease);
• if you have systemic lupus erythematosus (SLE –; a disease affecting your
natural defence system);
• if you have haemolytic uraemic syndrome (HUS - a disorder of blood
clotting causing failure of the kidneys);
• if you have sickle cell anaemia (an inherited disease of the red blood
cells);
• if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a
positive family history for this condition. Hypertriglyceridaemia has been
associated with an increased risk of developing pancreatitis (inflammation
of the pancreas);
• if you need an operation, or you are off your feet for a long time (see in
section 2 ‘Blood clots ’);
• if you have just given birth you are at an increased risk of blood clots.
You should ask your doctor how soon after delivery you can start taking
Aidulan 20/75;
• If you have an inflammation in the veins under the skin (superficial
thrombophlebitis);
• If you have varicose veins.
• 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 epilepsy (see “Other medicines and Aidulan 20/75”)
• if you have a disease that first appeared during pregnancy or during 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))
• 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.

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 Aidulan 20/75 is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or
symptoms.
Are you experiencing any of these signs?
• 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;
If you are unsure, talk to a doctor as some of these
symptoms such as coughing or being short of
breath may be mistaken for a milder condition such
as a respiratory tract infection (e.g. a ‘common
cold’).
Symptoms most commonly occur in one eye:
• immediate loss of vision or
• painless blurring of vision which can progress to
loss of vision
• chest pain, discomfort, pressure, heaviness
• sensation of squeezing or fullness in the chest,
arm or below the breastbone;
• fullness, indigestion or choking feeling;
• upper body discomfort radiating to the back, jaw,
throat, arm and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety, or shortness of
breath;
• rapid or irregular heartbeats
• sudden weakness or numbness of the face, arm or
leg, especially on one side of the body;
• sudden confusion, trouble speaking or
understanding;
• sudden trouble seeing in one or both eyes;
• sudden trouble walking, dizziness, loss of balance
or coordination;
• sudden, severe or prolonged headache with no
known cause;
• loss of consciousness or fainting with or without
seizure.
Sometimes the symptoms of stroke can be brief
with an almost immediate and full recovery, but you
should still seek urgent medical attention as you
may be at risk of another stroke.
• swelling and slight blue discolouration of an
extremity;
• severe pain in your stomach (acute abdomen)

What are you possibly
suffering from?
Deep vein thrombosis

taking 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 product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if
you were not using a combined hormonal contraceptive.
When you stop Aidulan 20/75 your risk of a blood clot returns to normal
within a few weeks.
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.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Aidulan
20/75 is small.
 Out of 10,000 women who are not using any combined hormonal
contraceptive and are not pregnant, about 2 will develop a blood clot in
a year.
 Out of 10,000 women who are using a combined hormonal contraceptive
that contains levonorgestrel, norethisterone, or norgestimate about 5-7
will develop a blood clot in a year.
 Out of 10,000 women who are using a combined hormonal contraceptive
that contains gestodene such as Aidulan 20/75 between about 9 and 12
women will develop a blood clot in a year.
 The risk of having a blood clot will vary according to your personal medical
history (see “Factors that increase your risk of a blood clot” below)

Pulmonary embolism
Women who are not using a combined
hormonal pill/patch/ring and are not
pregnant
Women using a combined hormonal
contraceptive pill containing
levonorgestrel, norethisterone or
norgestimate
Women using Aidulan 20/75

Retinal vein
thrombosis
(blood clot in the eye)
Heart attack

Stroke

Risk of developing a blood clot
in a year
About 2 out of 10,000 women
About 5-7 out of 10,000 women

About 9-12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Aidulan 20/75 is small but some conditions will
increase the risk. Your risk is higher:
• if you are very overweight (body mass index or BMI over 30kg/m2);
• if one of your immediate family has had a blood clot in the leg, lung or
other organ at a young age (e.g. below the age of about 50). In this case
you could have a hereditary blood clotting disorder;
• if you need to have an operation, or if you are off your feet for a long time
because of an injury or illness, or you have your leg in a cast. The use
of Aidulan 20/75 may need to be stopped several weeks before surgery
or while you are less mobile. If you need to stop Aidulan 20/75 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 (longer than 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 Aidulan 20/75 needs to be
stopped.
If any of the above conditions change while you are using Aidulan 20/75,
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.

Blood clots blocking
other blood vessels

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 clot’ (thrombosis) section below.
For a description of the symptoms of these serious side effects please go to
“How to recognise a blood clot”.

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

BLOOD CLOTS
Using a combined hormonal contraceptive such as Aidulan 20/75 increases

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of

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
Aidulan 20/75 is very small but can increase:
• with increasing age (beyond about 35 years);
• if you smoke. When using a combined hormonal contraceptive like Aidulan
20/75 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 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 Aidulan 20/75, 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.
Aidulan 20/75 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 Aidulan 20/75 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 Aidulan 20/75
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 Aidulan
20/75.
Atorvastatin, ascorbic acid, paracetamol, indinavir, fluconazole, voriconazole
and troleandromycin may increase the serum concentrations of Aidulan
20/75.
Lamotrigine, levothyroxin, valproate, cyclosporine, theophylline and
corticosteroids serum level may be changed after concomitant use with
Aidulan 20/75.
You may have to use another method of contraception as well, such as the
condom, while you are taking the medicines listed above and for a further
seven days afterwards. Your doctor may advise you to use these extra
precautions for even longer.
Interactions can involve medicines taken recently or subsequently.
If you are taking Aidulan 20/75 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.
Aidulan 20/75 with food and drink
Aidulan 20/75 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
If you are pregnant, do not take Aidulan 20/75. If you become pregnant while
taking Aidulan 20/75 stop immediately and contact your doctor. If you want to
become pregnant, you can stop taking Aidulan 20/75 at any time (see also “If
you stop taking Aidulan 20/75”).
Breast-feeding
Use of Aidulan 20/75 is generally not advisable when a woman is breastfeeding. If you want to take the pill while you are breast-feeding you should
contact your doctor.
Driving and using machines
Aidulan 20/75 has no or only minor influence on the ability to drive and use
machines.
Aidulan 20/75 contains lactose monohydrate
Aidulan 20/75 contains 50 mg of lactose monohydrate per tablet.
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 Aidulan 20/75 tablets.
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 Aidulan 20/75, 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 medicine, 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 tabletfree period of 7 days, during which a menstruation-like
bleeding occurs.
th
Intake of the next 21 tablets should be started on the 8 day, even if bleeding
has not stopped. You should start the second pack of Aidulan 20/75 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 Aidulan 20/75
Taking Aidulan 20/75 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 on day 2 to 5 of the menstrual cycle, but
ensure that additional contraceptive precautions are 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 Aidulan 20/75
You can start taking Aidulan 20/75 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 (mini pill),
injection, implant or a progestogen-releasing intrauterine device (IUD))
You can change from the mini-pill on any day. When changing from an injection,
Aidulan 20/75 should be started when the next injection is due to the given.
When changing from an implant or IUD, Aidulan 20/75 should be started on
the same day the implant is removed. In all cases, it is recommended that you
use additional methods of contraception (for example, a condom) for the first
7 days you take Aidulan 20/75.
Use after an abortion in the 1st trimester
After an abortion or miscarriage you can start using Aidulan 20/75 immediately,
according to the instructions of your doctor. In this case no additional
contraceptive precaution is required.
Use after having a baby or an abortion in the 2nd trimester
You can start taking Aidulan 20/75 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 Aidulan 20/75.
If, after having a baby, you have had sex before starting Aidulan 20/75
(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 Aidulan 20/75 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, light vaginal bleeding. However, if you have taken more Aidulan 20/75
than you should, talk to your doctor or pharmacist immediately
If you forget to take Aidulan 20/75
If you forget to take a pill at the usual time, you should take it within 12 hours.
Take the next pill at your normal time. Your protection against pregnancy is
not reduced.
If you are more than 12 hours late in taking a pill, 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 can choose between two
possibilities:
• 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.
If you have forgotten any of the tablets in a strip, and you do not have a
bleeding during the first tablet-free period, you may be pregnant. Contact your

doctor before you start the next strip.

disorder, change in menstrual flow, changes in weight, irritability.

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.

Uncommon side effects (may affect up to 1 in 100 people)
• 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,
Rare side effects (may affect up to 1 in 1,000 people):
• 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, 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)
Very rare side effects (may affect up to 1 in 10,000 people):
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.

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 Aidulan 20/75
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 Aidulan 20/75
can be restored after the usual 7 tablet-free days.
If you stop taking Aidulan 20/75
If you stop taking Aidulan 20/75 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.
4. Possible side effects
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard By reporting side effects you can help provide more information
on the safety of this medicine.
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 Aidulan 20/75,
please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism
(VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is
present for all women taking combined hormonal contraceptives. For more
detailed information on the different risks from taking combined hormonal
contraceptives please see section 2 “What you need to know before you use
Aidulan 20/75”.
The following serious side effects 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 reaction 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 AIDULAN 20/75 IMMEDIATELY
If you experience any of the following conditions whilst taking Aidulan 20/75,
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 Aidulan 20/75, 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, dysmenorrhoea, amenorrhea, menstrual

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 Aidulan 20/75 Tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25oC. Store in the original package.
Do not use this medicine after the expiry date which is stated on the carton
and blister after EXP. 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 Aidulan 20/75 Tablets contains
• The active ingredients are ethinylestradiol and gestodene. Each tablet
contains 20 micrograms ethinylestradiol and 75micrograms gestodene.
• The other ingredients are:
Common Tablet Core:
Lactose monohydrate, Maize starch, Sodium calcium edetate dihydrate,
Povidone K30 and Magnesium stearate
Tablet coating: Opadry White 03B28796 containing Hypromellose, Titanium
dioxide (E171) and Macrogol 400.
What Aidulan 20/75 Tablets look like and contents of the pack:
Aidulan 20/75 tablets are white to off-white, round, biconvex, approximately
5mm diameter, film coated tablets debossed with “GE1” on one side and plain
on the other side.
Aidulan 20/75 tablets are available in blister packs containing 21 tablets in
packs of 21(1x21), 63 (3x21), 126 (6x21) and 273(13x21) * packaged in
cartons.
* Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Ltd.
Victoria Court
Bexton Road
Knutsford
Cheshire, WA16 0PF
UK
The leaflet was last revised in 05/2014

ID#: 237035

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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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