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XANTHADU 0.02 MG/3 MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ETHINYLESTRADIOL / PLACEBO

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Package leaflet: Information for the user
Xanthadu 0.02 mg/3 mg film-coated tablets
Ethinylestradiol/Drospirenone
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, 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, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4



What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Xanthadu is and what it is used for
What you need to know before you take Xanthadu
How to take Xanthadu
Possible side effects
How to store Xanthadu
Contents of the pack and other information

1. What Xanthadu is and what is used for





Xanthadu is a contraceptive pill and is used to prevent pregnancy.
Each of the 24 pink tablets contain a small quantity of two different female hormones, namely
drospirenone and ethinylestradiol.
The 4 white tablets contain no active substances and are also called placebo tablets.
Contraceptive pills that contain two hormones are called “combination” pills.

2. What you need to know before you take Xanthadu
General notes
Before you start using [invented name] 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 Xanthadu, 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 Xanthadu, or where the
reliability of Xanthadu may be decreased. In such situations you should either not have sex or you
should take extra non-hormonal contraceptive precautions, for example, use a condom or another
barrier method. Do not use rhythm or temperature methods. These methods can be unreliable as
Xanthadu alters the monthly changes of body temperature and of cervical mucus.
Xanthadu, like other hormonal contraceptives, does not protect against HIV infection (AIDS)
or any other sexually transmitted disease.

When you should not use Xanthadu
You should not use [Invented name] 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.
Do not take Xanthadu


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 ‘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 the risk of a clot in the arteries.
o severe diabetes with blood vessels damage
o very high blood pressure
o a very high level of fat in the blood (cholesterol or triglycerides)
o 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) 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
Talk to your doctor or pharmacist before taking Xanthadu.
When do you need to take special care with Xanthadu?
When should you contact your doctor?
Seek urgent medical attention

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- 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”.
Tell your doctor if any of the following conditions apply to you.
In some situations you need to take special care while using Xanthadu or any other combination pill,
and your doctor may need to examine you regularly.. If the condition develops, or gets worse while
you are using Xanthadu, you should also tell your doctor.

















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 depressionif 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 uremic 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 Xanthadu
if you have an inflammation in the veins under the skin (superficial thrombophlebitis)
if you have varicose veins
if you have epilepsy (see page 5 "Other medicines and Xanthadu”)if you have adisease that first
appeared during pregnancy or earlier use of sex hormones (for example, hearing loss, a blood
disease called porphyria, skin rash withblisters during pregnancy (gestational herpes), a nerve
disease causing sudden movements of the body (Sydenham's chorea)
if you have or have ever had golden brown pigment patches (chloasma), so called "pregnancy
patches", especially on the face. If this is the case, avoid direct exposure to sunlight or ultraviolet
light.
If you have hereditary angioedema, products containingoestrogensmay cause or worsen the
symptoms. You should see your doctor immediately if you experience symptoms of
angioedema such as swollen face, tongue and/or pharynx, and/or difficulty swallowing or hives
together with difficulty breathing.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Xanthadu 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).

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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 Xanthadu 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;

What are you possibly suffering
from?
Deep vein thrombosis

Pulmonary embolism

If you are unsure, talk to a doctor as some of these
symptoms such as coughing or being short of
breath may be mistaken for 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

Retinal vein thrombosis
(blood clot in the eye)

 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;

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Heart attack

 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.

Stroke

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)

Blood clots blocking other blood
vessels

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).
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 Xanthadu 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 Xanthadu 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.

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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 Xanthadu, 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).

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 Xanthadu

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 Xanthadu 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 Xanthadu may need to be stopped
several weeks before surgery or while you are less mobile. If you need to stop Xanthadu 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 Xanthadu needs to be stopped.
If any of the above conditions change while you are using Xanthadu, 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.

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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 Xanthadu is very small but
can increase:

with increasing age (beyond about 35 years);

if you smoke. When using a combined hormonal contraceptive like Xanthadu 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 Xanthadu, 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.
Xanthadu 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 oncombination pills because they are examined by their doctor more often. The occurrence
of breast tumours becomes gradually less after stopping thecombination 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 livertumours, and in even fewer cases malignant liver tumourshave 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 Xanthadu, you may have unexpected bleeding
(bleeding outside the placebo days). 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 you must do if no bleeding occurs during the placebo days
If you have taken all the pink active tablets correctly, you 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. Only start the next strip if you are sure that you are not pregnant.
Other medicines and Xanthadu
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Always tell your doctor which medicines or herbal products you are already using. Also tell any
other doctor or dentist who prescribes another medicine (or the pharmacist) that you use Xanthadu.
They can tell you if you need to take additional contraceptives precautions (for example condoms)
and if so, for how long.
Some medicines can make Xanthadu less effective in preventing pregnancy, or can cause unexpected
bleeding. These include:
 medicines used for the treatment of
o epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
o tuberculosis (for example, rifampicin)
o HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as grisoefulvin,
penicillin, tetracyline)
o high blood pressure in the blood vessels in the lungs (bosentan)
 the herbal remedy St. John’s wort
Xanthadu may influence the effect of other medicines, e.g.
 medicines containing ciclosporin
 the anti-epilepticlamotrigine (this could lead to an increased frequency of seizures)
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Xanthadu with food and drink
Xanthadu 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
hormonal contraceptives can affect the results of some tests.
Pregnancy,breast-feeding and fertility
Pregnancy
If you are pregnant, you must not take Xanthadu. If you become pregnant while taking Xanthadu you
must stop immediately and contact your doctor. If you want to become pregnant, you can stop taking
Xanthadu at any time (see also “If you want to stop taking Xanthadu”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Xanthadu 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no information suggesting that use of Xanthadu affects driving or use of machines.
Xanthadu contains lactose.

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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 Xanthadu
Always take this medicine exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Each blister contains 24 active pink tablets and 4 white placebo tablets.
The two differently coloured tablets of Xanthadu are arranged in order. A strip contains 28 tablets.
Take one tablet of Xanthadu 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.
Do not confuse the tablets: take a pink tablet for the first 24 days and then a white tablet for the last
4 days. You must then start a new strip straight away (24 pink and then 4 white tablets). There is
therefore no gap between two strips.
Because of the different composition of the tablets it is necessary to begin with the first tablet on the
upper left and that you take the tablets every day. For the correct order, follow the direction of the
arrows on the strip.
Preparation of the strip
To help you keep track, there are 7 stickers each with 7 days of the week for each strip of Xanthadu.
Choose the week sticker that starts with the day you begin taking the tablets.For example, if you start
on a Wednesday, use the week sticker that starts with “WED”.
Stick the corresponding strip in the upper left hand corner of the pack, on the "Start" position. There
is now a day indicated above every tablet and you can see whether you have taken a certain pill. The
arrows show the order you are to take the pills.
During the 4 days when you are taking the white placebo tablets (the placebo days), bleeding should
begin (so-called withdrawal bleeding). This usually startson the 2nd or 3rd day after the last pink active
tablet of Xanthadu. Once you have taken the last white tablet, you should start with the following
strip, whether your bleeding has stopped or not. This means that you should start everystrip on the
same day of the week, and that the withdrawal bleed should occur on the same days each month.
If you use Xanthadu in this manner, you are protected against pregnancy also during the 4 days when
you are taking a placebo tablet.
When can you start with the first strip?


If you have not used a contraceptive with hormones in the previous month
Begin with Xanthadu on the first day of the cycle (that is, the first day of your period). If you start
Xanthadu on the first day of your menstruation 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 combined hormonal contraceptive, or combined contraceptive vaginal ring or
patch

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You can start Xanthadu 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 finish (or after the last inactive tablet of your previous pill). When changing
from a combined contraceptive vaginal ring or patch, follow the advice of your doctor.


Changing from a progestogen-only-method (progestogen-only pill, injection, implant or a
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
you must use extra protective measures (for example, a condom) for the first 7 days of tablettaking.



After a miscarriage
Follow the advice of your doctor.



After having a baby
You can start Xanthadu between 21 and 28 days after having a baby. If you start later than day
28, you must use a so-called barrier method (for example, a condom) during the first 7 days of
Xanthadu use.
If, after having a baby, you have had sex before starting Xanthadu (again), you must first be sure
that you are not pregnant or you must wait until your next period.



If you are breast-feeding and you want to start Xanthadu (again) after having a baby
Read the section on "Breast-feeding", page 6.

Ask your doctor what to do if you are not sure when to start.
If you take more Xanthadu than you should
There are no reports of serious harmful results of taking too many Xanthadu 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 Xanthadu tablets, or you discover that a child has taken some, ask your
doctor or pharmacist for advice.
If you forget to take Xanthadu
The last 4 tablets in the 4th row of the stripare placebo tablets. If you forget to take one of these
tablets, this will have no effect on the reliability of Xanthadu. Throw away the forgotten placebo
tablet.
If you forget a pink, active tablet (tablets 1-24 of your blister-strip) you must do the following:



If you are less than 24 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 24 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.

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The risk of incomplete protection against pregnancy is greatest if you forget a pink tablet at the
beginning or at the end of the strip. Therefore, you should keep the following rules (see also the
diagram on page 9):


More than one tablet forgotten in this strip
Contact your doctor.



One tablet forgotten between days 1 – 7 (first row)
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 realize that there is a risk of pregnancy. In that case, contact your doctor.



One tablet forgotten between days 8 – 14 (second row)
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 between days 15 – 24 (third or fourth row)
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 white placebo tablets on this strip, throw them away, and start the next strip (the starting
day will be different).
Most likely, you will have a period at the end of the second strip - while taking the white
placebo tablets - but you may have light or menstruation-like bleeding during the second strip.
2. You can also stop the active pink tablets and go directly to the 4 white placebo tablets (before
taking the placebo tablets, record the day on which you forgot your tablet). If you want
to start a new strip on the day you always start, take the placebo tablets for less than 4 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
placebo days, this may mean that you are pregnant. You must contact your doctor before you start
the next strip.

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More than 1 pink tablet
forgotten in 1 strip

Ask your doctor for advice
Yes
Day 1 - 7

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 pink tablet
forgotten (taken more
than 24 hours late)

Day 8 -14

Day 15 - 24

•Take the forgotten tablet
•Finish the strip
•Take the forgotten tablet
•Finish taking the pink tablets
•Throw away the 4 white tablets
•Start the next strip
or
•Stop the pink tablets immediately
á
•Go directly to the 4 white tablets
•Then,
the next
strip
- Despustart
é
ú

í

What todo in case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking an active pink 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. The situation is
almost the same as forgetting a tablet. After vomiting or diarrhoea, you must take another pink tablet
from a reserve strip as soon as possible. If possible take it within 24 hours of when you normally take
your pill. If this is not possible or 24 hours have passed, you should follow the advice given under "If
you forget to take Xanthadu", page 8.
Delaying your period: what you need to know
Even if it is not recommended, you can delay your period by not taking the white placebo tablets from
the 4th row and going straight to a newstrip of Xanthadu and finish it. You may experience light or
menstruation-like or bleeding while using this second strip. Finish this second strip by taking the 4
white tablets from the 4th row. Then start your next strip.
You might 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 placebo
days. If you have to change this day, reduce the number of placebo days – when you take the white
placebo tablets - (but never increase them – 4 is the maximum!). For example, if you start taking the
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placebo tablets on a Friday, and you want to change this to a Tuesday (3 days earlier) you must start
a new strip 3 days earlier than usual. You may not have any bleeding during this time. You may then
experience light or menstruation-like bleeding.
If you are not sure what to do, consult your doctor.
If you want to stop taking Xanthadu
You can stop taking Xanthadu 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 Xanthadu and wait for a menstrual 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, 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 Xanthadu, 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 Xanthadu”.
The following is a list of the side effects that have been linked with the use of Xanthadu:


Common side effects (may affect up to 1 in 10 people):
o mood swings
o headache
o nausea
o breast pain, problems with your periods, such as irregular periods, absence of periods



Uncommon side effects (may affect up to 1 in 100 people):
o depression, nervousness, sleepiness
o dizziness, “pins and needles”
o migraine, varicose veins, increased blood pressure
o stomach ache, vomiting, indigestion, intestinal gas, inflammation of the stomach, diarrhoea
o acne, itching, rash
o aches and pains, for instance back pain, limb pain, muscle cramps
o vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps,
uterine/vaginal bleeding (which usually subsides during continued treatment), genital
discharge, hot flushes, inflammation of the vagina (vaginitis), problems with your periods,
painful periods, reduced periods, very heavy periods, vaginal dryness, abnormal cervical
smear, decreased interest in sex
o lack of energy, increased sweating, fluid retention
o weight increase



Rare side effects (may affect up to 1 in 1,000 people):
o candida (a fungal infection)

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o
o
o
o
o
o
o
o
o

o
o
o
o
o

o
o

anemia, increase in the number of platelets in the blood
allergic reaction
hormonal (endocrine) disorder
increased appetite, loss of appetite, abnormally high concentration of potassium in the
blood, abnormally low concentration of sodium in the blood
failure to experience an orgasm, insomnia
giddiness, tremor
eye disorders, for instance inflammation of the eyelids, dry eyes
abnormally rapid heartbeat
harmful blood clots in a vein or artery for example:
o in a leg or foot (i.e. DVT)
o in a lung (i.e. PE)
o heart attack
o stroke
o mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic
attack (TIA)
o 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)
inflammation of a vein, nosebleed, fainting
enlarged abdomen, bowel disorder, feeling bloated, stomach hernia, fungal infection of the
mouth, constipation, dry mouth
pain of bile ducts or the gallbladder, inflammation of the gallbladder
yellow brown patches on the skin, eczema, hair loss, acne-like inflammation of the skin,
dry skin, lumpy inflammation of the skin, excessive hair growth, skin disorder, stretch
marks on the skin, skin inflammation, light-sensitive skin inflammation, skin nodules.
difficult or painful sex, inflammation of the vagina (vulvovaginitis), bleeding following
intercourse, withdrawal bleeding, breast cyst, increased number of breast cells
(hyperplasia), malignant lumps in the breast, abnormal growth on the mucosal surface of
the neck of the womb, shrinkage or wasting of the lining of the womb, ovarian cysts,
enlargement of the womb
feeling generally unwell
weight loss

The following side effects have also been reported, but their frequency cannot be estimated from the
available data: hypersensitivity, erythema multiforme (rash with target-shaped reddening or sores).
Reporting of side effects
If you get any side effects, talk to your doctor orpharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V.. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to storeXanthadu
Keep this medicine 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 packaging after "Do not use
after:" or "EXP:". The expiry date refers to the last day of that month.

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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 Xanthadu contains
 The active substances are ethinylestradiol and drospirenone.
Each pink active film-coated tablet contains 0.02 milligram ethinylestradiol and 3 milligram
drospirenone.
The white film-coated tablets do not contain active substances.


The other ingredients are
Pink active film-coated tablets: lactose monohydrate, pregelatinized starch (maize), povidone K30 (E1201), croscarmellose sodium, polysorbate 80, magnesium stearate (E572), poly (vinyl
alcohol), titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172), red
iron oxide (E172), black iron oxide (E172).
White inactive film-coated tablets: lactose anhydrous, povidone K-30 (E1201), magnesium
stearate (E572), poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc (E553b).

What Xanthadu looks like and contents of the pack




Each blister of Xanthadu contains 24 pink, active film-coated tabletsin the 1st, 2nd, 3rd and 4th rows
of the strip and 4 white placebo film-coated tablets in row 4.
Xanthadu tablets, both the pink and the white, are film-coated tablets; the core of the tablet is
coated.
Xanthadu is available in boxes of 1, 3, 6 and 13 blister strips, each containing 28 (24+4) tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder
Crescent Pharma Limited,
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton,
Hants RG25 3ED
United Kingdom
Manufacturer
Laboratorios León Farma, S.A.
C/ La Vallina s/n, Pol. Ind. Navatejera.
24008 - Navatejera, León.
Spain

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This medicinal product is authorised in the Member States of the EEA under the following names:

NL
PL
RO
GB
FR
DK
SE
CZ
SK
GR
SI

Xanthadu 0,02 mg/3 mg, filmomhulde tabletten
Axia Conti
Xanthadu 3 mg/ 0,02 mg comprimate filmate
Xanthadu 3 mg/0.02 mg, film-coated tablets
Vylespi 0,02 mg/3 mg, comprimé pelliculé
Xanthadu
Xanthadu
Xanthadu 0,02 mg/3 mg potahované tablety
Xanthadu 0,02/3 mg filmom obalené tablety
Xanthadu 3 mg/0.02 mg
Xanthadu 0,02 mg/3 mg filmsko obložene tablete

This leaflet was last revised in: 04/2016

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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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