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ACONDRO 3 MG/0.03 MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ETHINYLESTRADIOL

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Package leaflet: Information for the patient

Acondro 3 mg/0.03 mg
Film-coated Tablets
(drospirenone/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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
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”).

What is in this leaflet:

1. What Acondro is and what it is used for
2. What you need to know before you take Acondro
• Do not take Acondro
• Warnings and precautions
• Acondro and venous and arterial blood clots
• Acondro and cancer
• Bleeding between periods
• What to do if no bleeding occurs during the gap week
• Other medicines and Acondro
• Laboratory tests
• Pregnancy and breast-feeding
• Driving and using machines
• Acondro contains lactose
3. How to take Acondro
• When can you start with the first strip
• If you take more Acondro than you should
• If you forget to take Acondro
• What to do in the case of vomiting or severe diarrhoea
• Delaying your period: what you need to know
• Changing the first day of your period: what you need to know
• If you want to stop taking Acondro
4. Possible side effects
5. How to store Acondro
6. Contents of the pack and other information

1. What Acondro is and what it is used for
Acondro is a contraceptive pill and is used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones,
namely drospirenone and ethinylestradiol.
Contraceptive pills that contain two hormones are called “combination” pills.

2. What you need to know before you take Acondro
General notes
Before you start using Acondro 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 Acondro, 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
Acondro, or where the reliability of Acondro 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 Acondro alters the monthly changes of body
temperature and of the cervical mucus.
Acondro, like other hormonal contraceptives, does not protect against
HIV infection (AIDS) or any other sexually transmitted disease.

Do not take Acondro

You should not use Acondro if you have any of the conditions listed below.
If you do have any of the conditions listed below, you must tell your
doctor. Your doctor will discuss with you what other form of birth control
would be more appropriate.
• if you have (or have ever had) a blood clot in a blood vessel of your legs
(deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or
other organs;
• if you know you have a disorder affecting your blood clotting – for instance,
protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor
V Leiden or antiphospholipid antibodies;
• if you need an operation or if you are off your feet for a long time (see
section 2 ‘Blood clots’);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition that causes
severe chest pain and may be a first sign of a heart attack) or transient
ischaemic attack (TIA – temporary stroke symptoms);
• if you have any of the following diseases that may increase your risk of a
clot in the arteries:
* severe diabetes with blood vessel damage
* very high blood pressure
* a very high level of fat in the blood (cholesterol or triglycerides)
* a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called ‘migraine with aura’;
• if you have (or have ever had) a liver disease and your liver function is still
not normal;
• if your kidneys are not working well (renal failure);
• if you have (or have ever had) a tumour in the liver;
• if you have (or have ever had) or if you are suspected of having breast
cancer or cancer of the genital organs;
• if you have any unexplained bleeding from the vagina;
• if you are allergic to ethinylestradiol or drospirenone, or any of the other
ingredients of this medicine (listed in section 6). This may cause itching,
rash or swelling.

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

Tell your doctor if any of the following conditions apply to you.

If the condition develops or gets worse while you are using Acondro, you
should also tell your doctor. In some situations you need to take special care
while using Acondro or any other combination pill, and your doctor may
need to examine you regularly.
Talk to your doctor, pharmacist or nurse before taking Acondro.
• 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 Acondro;
• If you have an inflammation in the veins under the skin (superficial
thrombophlebitis);
• If you have varicose veins;
• if a close family member has or has ever had breast cancer;
• if you have cancer;
• if you have a disease of the liver or gallbladder;
• if you have other kidney problems and are taking medicines which increase
potassium levels in the blood;
• if you have diabetes;
• if you have depression;
• if you have epilepsy (see "Other medicines and Acondro");
• 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 disease of the nerves in which sudden movements of the body occur
(Sydenham’s chorea)];
• if you have high blood pressure during therapy which is not controlled by
treatment with medicine;
• if you have or have ever had chloasma (a discoulouration of the skin
especially of the face or neck known as “pregnancy patches”). If so, avoid
direct sunlight or ultraviolet light while taking this medicine;
• if you have hereditary angioedema, products containing estrogens may
cause or worsen the 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.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Acondro increases your
risk of developing a blood clot compared with not using one. In rare cases a
blood clot can block blood vessels and cause serious problems.
Blood clots can develop:
• in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’
or VTE);
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial
thromboembolism’ or ATE).
Recovery from blood clots is not always complete. Rarely, there may be
serious lasting effects or very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood clot
due to Acondro is small.

HOW TO RECOGNISE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs
or symptoms.

Drospirenone Ethinylestradiol 3 mg / 0.03 mg
Description 3x21

• swelling of one leg or along a vein in the leg or Deep vein thrombosis
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.

• 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.

• swelling and slight blue discolouration of an
extremity;
• severe pain in your stomach (acute abdomen)

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 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 Acondro 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 Acondro
is small.
Your chances of having a blood clot are increased by taking the Pill.
• 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 drospirenone such as Acondro, 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).
Risk of developing a
blood clot in a year
Women who are not using a combined hormonal
pill/patch/ring and are not pregnant

About 2 out of
10,000 women

Women using a combined hormonal
contraceptive pill containing levonorgestrel,
norethisterone or norgestimate

About 5-7 out of
10,000 women

Women using Acondro

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 Acondro 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
Acondro may need to be stopped several weeks before surgery or while
you are less mobile. If you need to stop Acondro ask your doctor when you
can start using it again;
• as you get older (particularly above about 35 years);
• if you gave birth less than a few weeks ago.
The risk of developing a blood clot increases the more conditions you have.
Air travel (>4 hours) may temporarily increase your risk of a blood clot,
particularly if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even
if you are unsure. Your doctor may decide that Acondro needs to be stopped.
If any of the above conditions change while you are using Acondro, for
example a close family member experiences a thrombosis for no known
reason or you gain a lot of weight, tell your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For
example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke from using
Acondro is very small but can increase:
• with increasing age (beyond about 35 years);
• if you smoke. When using a combined hormonal contraceptive like
Acondro 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 Acondro, 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.

Acondro 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 or abdominal swelling (which may be due
to enlargement of liver).

Bleeding between periods

During the first few months that you are taking Acondro, 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 Acondro
Tell your doctor which medicines or herbal products you are taking, have
recently taken or might take. Also tell any other doctor or dentist who
prescribes another medicine (or the pharmacist) that you use Acondro.
They can tell you if you need to take additional contraceptive precautions
(for example condoms) and if so, for how long or whether the use of
another medicine you need must be changed.

Date: 31 MAR 2016

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Blood clots blocking
other blood vessels

• 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).

Affiliate Item Code 814100

Trackwise Proof No. 3

Stroke

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

No. of colours

TrackWise PR No. 814100

Retinal vein thrombosis
(blood clot in the eye)

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.

Pharma Code TBC

Vendor Job No. 273309

Pulmonary embolism

• chest pain, discomfort, pressure, heaviness;
Heart attack
• 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.

Component Type Leaflet

Superceded Affiliate Item Code 652208

What are you possibly
suffering from?

Are you experiencing any of these signs?

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Some medicines can have an influence on the blood levels of Acondro
and can make it less effective in preventing pregnancy, or can cause
unexpected bleeding. These include:
• medicines used for the treatment of
* epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine,
oxcarbazepine, felbamate, topiramate);
* tuberculosis (e.g. rifampicin);
* HIV and Hepatitis C infections (so called protease inhibitors and
non-nucleoside reverse transcriptase inhibitors such as ritonavir,
nevirapine, efavirenz)
* fungal infections (e.g. griseofulvin or ketoconazole);
* arthritis, arthrosis (etoricoxib);
* high blood pressure in the blood vessels in the lungs (bosentan).
• the herbal remedy St. John's wort
If you are taking any of the above mentioned medicines along with Acondro
you should take additional contraceptive precautions (for example condoms)
during and for 28 days after the therapy.
Acondro may influence the effect of other medicines, e.g.
• medicines containing ciclosporin;
• the anti-epileptic lamotrigine (this could lead to an increased frequency
of seizures);
• theophylline (used to treat breathing problems);
• tizanidine (used to treat muscle pain and/or muscle cramps).
Your doctor may monitor your blood potassium levels if you are taking
certain medicines to treat heart problems (such as water tablets).

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 and breast-feeding
Pregnancy
If you are pregnant, do not take Acondro. If you become pregnant while
taking Acondro, stop immediately and contact your doctor. If you want to
become pregnant, you can stop taking Acondro at any time (see also “If you
want to stop taking Acondro”).
Breast-feeding
Use of Acondro 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.
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.

Driving and using machines
There is no information suggesting that use of Acondro affects driving or use
of machines.

Acondro contains lactose
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take Acondro
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Take one tablet of Acondro every day, if necessary with a small amount of
water. You may take the tablets with or without food but you should take the
tablets every day around the same time.
The strip contains 21 tablets. Next to each tablet is printed the day of the
week that it should be taken. If, for example, you start on a Wednesday, take
a tablet with "WED" next to it. Follow the direction of the arrow on the strip
until all 21 tablets have been taken.
Then take no tablets for 7 days. In the course of these 7 tablet-free days
(otherwise called a stop or gap week), bleeding should begin. This so-called
“withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week.
On the 8th day after the last Acondro tablet (that is, after the 7-day gap
week), you should start with the following strip, whether your bleeding has
stopped or not. This means that you should start every strip on the same day
of the week and that the withdrawal bleed should occur on the same days
each month.
If you use Acondro in this manner, you are also protected against pregnancy
during the 7 days when you are not taking a tablet.

When can you start with the first strip?

• If you have not used a contraceptive with hormones in the
previous month
Begin with Acondro on the first day of the cycle (that is, the first day of
your period). If you start Acondro on the first day of your period you are
immediately protected against pregnancy. You may also begin on day
2-5 of the cycle but then you must use extra protective measures (for
example, a condom) for the first 7 days.
• Changing from a combination hormonal contraceptive, or combination
contraceptive vaginal ring or patch
You should start taking Acondro preferably on the day after the last active
tablet (the last tablet containing the 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 progestogen-only-method (progestogen-only pill,
injection, implant or progestogen-releasing IUD)
You may switch any day from the progestogen-only pill (from an implant or
an IUD on the day of its removal, from an injectable when the next injection
would be due) but in all of these cases use extra protective measures (for
example, a condom) for the first 7 days of tablet-taking.
• After a miscarriage or termination of your pregnancy
Follow the advice of your doctor.
• After having a baby
You can start Acondro between 21 and 28 days after having a baby. If you
start later than day 28, use a so-called barrier method of contraception (for
example, a condom) during the first seven days of Acondro use.
If, after having a baby, you have had sex before starting Acondro, be sure
that you are not pregnant or wait until your next period.
• If you are breastfeeding and want to start Acondro (again) after
having a baby.
Read the section "Breast-feeding".
Ask your doctor what to do if you are not sure when to start.

If you take more Acondro than you should

There are no reports of serious harmful results of taking too many
Acondro tablets.
If you 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 Acondro tablets or you discover that a child has
taken some, ask your doctor or pharmacist for advice.

If you forget to take Acondro

• If you are less than 12 hours late taking a tablet, the protection against
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 against
pregnancy may be reduced. The greater the number of tablets that you
have forgotten, the greater is the risk of becoming pregnant.
The risk of incomplete protection against pregnancy is greatest if you forget
a tablet at the beginning or at the end of the strip. Therefore, you should
keep to the following rules (see 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. Continue taking the
tablets at the usual time and use extra precautions for the next 7 days, for
example, a condom. If you have had sex in the week before forgetting the
tablet you must realise 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. Continue taking the tablets
at the usual time. The protection against 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. Continue taking the
tablets at the usual time. Instead of taking the tablet-free period, start
the next strip.
Most likely, you will have a period at the end of the second strip or
you may also have light or menstruation-like bleeding during the
second strip.
2. You can also stop the strip and go directly to the tablet-free period of
7 days (including the days you missed tablets, record the day on which
you forgot your tablet). If you want to start a new strip on the day you
always start, make the tablet-free period less than 7 days.
If you follow one 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 a
bleeding during the first tablet-free period, you may be pregnant. Contact
your doctor before you start the next strip.
The following diagram describes how to proceed if you forget to take your
tablet(s):
More than 1 tablet
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 the strip

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

In week 2

• Take the forgotten tablet
• Finish the strip

In week 3

• Take the forgotten tablet
• Finish the strip
• Instead of the gap week
• Go straight on to the
next strip
or

What to do in the case of vomiting or severe diarrhoea

If you vomit within 3-4 hours after taking a tablet or you have severe
diarrhoea, there is a risk that the active substances in the pill will not be fully
taken up by your body in which case you may need to use extra protection
(such as a condom) to avoid pregnancy. The situation is almost the same as
forgetting a tablet. After vomiting or diarrhoea, take another tablet from a
reserve strip as soon as possible. If possible, take it within 12 hours of when
you normally take your pill. If that is not possible or 12 hours have passed,
you should follow the advice given under "If you forget to take Acondro".

Delaying your period: what you need to know

Even though it is not recommended, you can delay your period by going
straight to a new strip of Acondro instead of the tablet-free period and
finishing it. You may experience light or menstruation-like bleeding while
using this second strip. After the second strip is finished, take the usual
tablet-free period of 7 days and start the next strip.
You should ask your doctor for advice before deciding to delay your
menstrual period.

Changing the first day of your period: what you need to know

If you take the tablets according to the instructions, then your period will
begin during the tablet-free week. If you have to change this day, reduce the
number of tablet-free days (but never increase them – 7 is the maximum!).
For example, if your tablet-free days normally begin on a Friday and you
want to change this to a Tuesday (3 days earlier), start a new strip 3 days
earlier than usual. If you make the tablet‑free interval very short (for example,
3 days or less) you may not have any bleeding during these days. You may
then experience light or menstruation-like bleeding.
If you are not sure what to do, consult your doctor.

If you stop taking Acondro

You can stop taking Acondro 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 want to become pregnant, stop taking Acondro and wait for a period
before trying to become pregnant. You will be able to calculate the expected
delivery date more easily.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, Acondro can cause side effects, although not everybody
gets them.
If you get any side effects, particularly if severe and persistent or you have
any change to your health that you think may be due to Acondro, 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 take
Acondro”.
If any of the following side effects happen, you may need urgent medical
attention. Stop taking Acondro and contact a doctor or go to the nearest
hospital immediately.
Rare (may affect up to 1 in 1,000 people):
• hypersensitivity (with signs such as swollen face, tongue and/or throat and/
or difficulty in swallowing, or hives together with difficulty in breathing);
• harmful blood clots in a vein or artery for example:
* in a leg or foot (i.e. deep vein thrombosis (DVT))
* in a lung (i.e. pulmonary embolism (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).

Conditions that may occur or worsen during pregnancy or previous
use of the pill include:

• systemic lupus erythematosus (SLE, a disease affecting the
immune system);
• inflammation of the colon or other parts of the intestine with signs such as
bloody diarrhoea, pain when passing stools, pain in the abdomen (Crohn’s
disease and ulcerative colitis);
• epilepsy;
• uterine myoma (non-cancerous tumour that grows within the muscle tissue
of the uterus);
• a blood pigment disorder (porphyria);
• blister-like rash (herpes gestationis) whilst pregnant;
• Sydenham’s chorea (a disease of the nerves in which sudden movements of
the body occur);
• a certain blood disorder that causes kidney damage (haemolytic uraemic
syndrome, with signals such as decreased urine output, blood in the urine,
low red blood cells, nausea, vomiting, confusion and diarrhoea);
• yellowing of the skin or white of the eyes due to obstruction in the bile
duct (chloestatic jaundice).
Also, breast cancer (see section 2 ‘Acondro and cancer’) and non-cancerous
(benign) and cancerous (malignant) liver tumours (with signs such as swollen
abdomen, weight loss, abnormal liver function which may be seen in blood
tests) and chloasma (yellow brown patches on the skin and particularly the
face, so called “pregnancy patches”), which may be permanent, especially
in women who have previously had chloasma during pregnancy have
been observed.

Other possible side effects
Common (may affect up to 1 in 10 people):
• menstrual disorders, bleeding between periods, breast pain, breast
tenderness;
• headache;
• depressive mood;
• migraine;
• nausea;
• thick, whitish vaginal discharge and vaginal yeast infection.
Uncommon (may affect up to 1 in 100 people):
• breast enlargement;
• increased or decreased interest in sex;
• high blood pressure, low blood pressure;
• being sick (vomiting), diarrhoea;
• acne, skin rash, severe itching, hair loss (alopecia);
• infection of the vagina;
• fluid retention and increase or decrease in body weight.
Rare (may affect up to 1 in 1,000 people):
• asthma;
• breast secretion;
• hearing impairment;
• the skin conditions erythema nodosum (characterised by painful reddish
skin nodules) or erythema multiforme (characterised by rash with targetshaped reddening or sores).

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.

5. How to store Acondro
Keep Acondro out of the sight and reach of children.
Store below 30ºC.
Do not use this medicine after the expiry date which is stated on the blister/
carton after "Do not use after:" or "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 Acondro contains

• The active substances are drospirenone and ethinylestradiol.
• Each tablet contains 3 milligram drospirenone and 0.03 milligram
ethinylestradiol.
• Other ingredients are lactose monohydrate, maize starch, pregelatinised
starch (maize), crospovidone type B, povidone (E1201), polysorbate
80 (E433), magnesium stearate (E470b), polyvinyl alcohol partial
hydrolysed, titanium dioxide (E171), macrogol, talc (E553b), yellow iron
oxide (E172).

What Acondro looks like and contents of the pack

• Tablets are yellow, round, film-coated tablets.
• Acondro is available in boxes of 1, 2, 3, 6 and 13 blisters, each with
21 tablets.
Not all packages sizes may be marketed.

Marketing Authorisation Holder
Mylan,
Potters Bar,
Hertfordshire,
EN6 1TL,
United Kingdom.

Manufacturers

Laboratorios León Farma, S.A.,
C/ La Vallina s/n,
Pol. Ind. Navatejera.,
24008 - Navatejera,
León,
Spain.
Gerard Laboratories,
35-36 Baldoyle Industrial Estate,
Grange Road,
Dubin 13,
Ireland.
Mylan Hungary Kft,
2900 Komárom,
Mylan utca 1,
Hungary.
This leaflet was last revised in 03/2016.

• Stop the strip immediately
• Begin the gap week
(no longer than 7 days,
including the forgotten
tablet)
• Then start the next strip
814100

Drospirenone Ethinylestradiol 3 mg / 0.03 mg
Description 3x21

Date: 31 MAR 2016

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 814100

SAP No. N/A

Colours

Superceded Affiliate Item Code 652208
TrackWise PR No. 814100
MA No. 04569/1355
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 273309
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

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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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