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CLEOSENSA 0.03MG/3MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ETHINYLESTRADIOL

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Package leaflet: Information for the user

Cleosensa 0.03mg/3mg Film-coated Tablets
Ethinylestradiol/Drospirenone
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. See section 4.
What is in this leaflet
1. What Cleosensa is and what it is used for
2. What you need to know before you take Cleosensa
3. How to take Cleosensa
4. Possible side effects
5. How to store Cleosensa
6. Contents of the pack and other information
1. What Cleosensa is and what it is used for
Cleosensa 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 Cleosensa
General notes
Before you can begin taking Cleosensa, 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
Cleosensa, or where the reliability of Cleosensa 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
Cleosensa alters the monthly changes of body temperature and of the cervical
mucus.
Cleosensa, like other hormonal contraceptives, does not protect against HIV
infection (AIDS) or any other sexually transmitted disease.
While you are receiving this medicine you should see your doctor regularly, at least
twice a year. 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 Cleosensa:
• if you have (or have ever had) a blood clot in a blood vessel of the leg
(thrombosis), of the lung (pulmonary embolism) or other organs
• if you have (or have ever had) a heart attack or stroke
• if you have (or have ever had) a disease that can be an indicator of a heart attack in
the future (for example, angina pectoris which causes severe pain in the chest) or
of a stroke (for example, a passing slight stroke with no residual effects)
• if you have a disease that may increase the risk of a blood clot in the arteries.
This applies to the following diseases:
- diabetes with damaged blood vessels
- very high blood pressure
- a very high level of fat in the blood (cholesterol or triglycerides)
• if you have a disturbance of blood clotting (for example, protein C deficiency)
• if you have (or have ever had) a certain form of migraine (with so-called focal
neurological symptoms)
• 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
In some situations you need to take special care while using Cleosensa or any other
combination pill, and your doctor may need to examine you regularly. If any of the
following conditions applies to you, tell your doctor before starting to use Cleosensa.
Also, if any of the following applies or if any of the conditions develops or worsens
while you are using Cleosensa consult 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 depression
• if you have Crohn’s disease or inflammatory bowel disease (ulcerative colitis)
• if you have a blood disease called HUS (haemolytic uraemic syndrome) which
causes kidney damage
• if you have a blood disease called sickle cell anaemia
• if you have epilepsy (see also “Other medicines and Cleosensa”)
• if you have a disease of the immune system called SLE (systemic lupus
erythematosus)
• if you have a disease that first appeared during pregnancy or earlier use of sex
hormones (for example, hearing loss, a blood disease called porphyria, skin rash
with blisters during pregnancy (gestational herpes), a nerve disease causing
sudden movements of the body (Sydenham’s chorea))
• if you have or have ever had chloasma (a discolouration 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 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.
Cleosensa and venous and arterial blood clots
The use of any combination pill, including Cleosensa, increases a woman’s risk of
developing a venous blood clot (venous thrombosis) compared with women who
do not take any contraceptive pill.

Stop taking Cleosensa and contact your doctor immediately if you notice
possible signs of a blood clot, such as:
• severe pain and/or swelling in one of your legs
• sudden severe pain in the chest which may reach the left arm
• sudden breathlessness
• sudden cough without an obvious cause
• any unusual, severe or long-lasting headache or worsening of migraine
• partial or complete blindness or double vision
• difficulty in speaking or inability to speak
• giddiness or fainting
• weakness, strange feeling, or numbness in any part of the body.
Cleosensa 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 Cleosensa 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 Cleosensa
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 Cleosensa. They can tell you if you need to take additional
contraceptive precautions (for example condoms) and if so, for how long.
Some medicines can make Cleosensa 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)
- tuberculosis (e.g. rifampicin)
- HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as
griseofulvin, penicillin, tetracycline)
- high blood pressure in the blood vessels in the lungs (bosentan)
• the herbal remedy St John’s wort.
Cleosensa 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).
Ask your doctor or pharmacist for advice before taking any medicine.
Cleosensa with food and drink
Cleosensa 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 and breast-feeding
Pregnancy
If you are pregnant, do not take Cleosensa. If you become pregnant while taking
Cleosensa stop immediately and contact your doctor. If you want to become
pregnant, you can stop taking Cleosensa at any time (see also “If you stop taking
Cleosensa”).
Breast-feeding
Use of Cleosensa 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 Cleosensa affects driving or use of
machines.
Cleosensa contains lactose
If you have been told by your doctor that you have intolerance to some sugars,
contact your doctor before taking this medicine.
3. How to take Cleosensa
Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Take one tablet of Cleosensa 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 risk of venous blood clots in users of combination pills increases:
• with increasing age
• if you are overweight
• if one of your close relatives ever had a blood clot in the leg, lung (pulmonary
embolism), or other organ at a young age
• if you have to have surgery, if you have had a serious accident or if you are
immobilised for a long time. It is important to tell your doctor that you are using
Cleosensa as you may have to stop taking it. Your doctor will tell you when to start
again. This is usually about two weeks after you are back on your feet.

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.

Your chances of having a blood clot are increased by taking the Pill.
• Of 100,000 women who are not on the Pill and not pregnant, about 5-10 may have
a blood clot in a year.
• Of 100,000 women taking a Pill like Cleosensa, between 30-40 may have a blood
clot in a year, the exact number is unknown.
• Of 100,000 women who are pregnant, around 60 may have a blood clot in a year.

On the 8th day after the last Cleosensa 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.

A blood clot in the veins may travel to the lungs and may block blood vessels (called
a lung embolus). Formation of blood clots in the veins may be fatal in 1-2 % of cases.
The level of risk may vary according to the type of pill you take. Discuss with your
doctor the available options.
The use of combination pills has been connected with an increase of the risk of an
arterial blood clot (arterial thrombosis), for example, in the blood vessels of the
heart (heart attack) or the brain (stroke).
The risk of an arterial blood clot in users of combination pills increases:
• if you smoke. You are strongly advised to stop smoking when you use
Cleosensa, especially if you are older than 35 years
• if the fat content of your blood is increased (cholesterol or triglycerides)
• if you are overweight
• if one of your close relatives ever had a heart attack or stroke at a young age
• if you have high blood pressure
• if you suffer from migraine
• if you have a problem with your heart (valve disorder, a disturbance of the cardiac
rhythm).

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.

If you use Cleosensa 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 Cleosensa on the first day of the cycle (that is the first day of your period).
If you start Cleosensa 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 can start Cleosensa 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 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 use extra protective measures (for example, a condom) for
the first 7 days of tablet-taking.
After a miscarriage
Follow the advice of your doctor.

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Drospirenone/Ethinylestradiol 3mg/30mcg -, PIL, United Kingdom

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approved for print/date

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approved:

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After having a baby
You can start Cleosensa 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 Cleosensa use.
If, after having a baby, you have had sex before starting Cleosensa (again), be sure
that you are not pregnant or wait until your next period.
If you are breast-feeding and want to start Cleosensa (again) after having a
baby
Read the section on “Breast-feeding”.
Ask your doctor what to do if you are not sure when to start.

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 take several tablets at once then you may have symptoms of nausea or
vomiting. Young girls may have bleeding from the vagina.

If you stop taking Cleosensa
You can stop taking Cleosensa 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 Cleosensa 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 taken too many Cleosensa tablets, or you discover that a child has taken
some, ask your doctor or pharmacist for advice.

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

If you take more Cleosensa than you should
There are no reports of serious harmful results of taking too many Cleosensa tablets.

If you forget to take Cleosensa
• 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 may be pregnant. 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.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
The following is a list of the side effects that have been linked with the use of
Cleosensa.
Common (may affect up to 1 in 10 people):
• m
 enstrual disorders, bleeding between periods, breast pain, breast tenderness
• h
 eadache, depressive mood
• m
 igraine
• n
 ausea
• t hick, whitish vaginal discharge and vaginal yeast infection.
Uncommon (may affect up to 1 in 100 people):
• b
 reast enlargement, changes in interest in sex
• h
 igh blood pressure, low blood pressure
• v omiting, diarrhoea
• a cne, skin rash, severe itching, hair loss (alopecia)
• infection of the vagina
• fl
 uid retention and body weight changes.

Rare (may affect up to 1 in 1,000 people):
• a llergic reactions (hypersensitivity), asthma
• b
 reast secretion
• h
 earing impairment
One tablet forgotten in week 3
• b
 lockage of a blood vessel by a clot formed elsewhere in the body
You can choose between two possibilities:
• t he skin conditions erythema nodosum (characterised by painful reddish skin
1. Take the forgotten tablet as soon as you remember, even if that means that you
nodules) or erythema multiforme (characterised by rash with target-shaped
have to take two tablets at the same time. Continue taking the tablets at the usual
reddening or sores).
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 but you may have Reporting of side effects
light or menstruation-like bleeding during the second strip.
If you get any side effects, talk to your doctor or pharmacist. This includes any
2. You can also stop the strip and go directly to the tablet-free period of 7 days
possible side effects not listed in this leaflet. You can also report side effects directly
(record the day on which you forgot your tablet). If you want to start a new
via Yellow Card Scheme, Website: www.mhra.gov. uk/yellowcard. By reporting side
strip on the day you always start, make the tablet-free period less than 7 days.
effects you can help provide more information on the safety of this medicine.
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.

5. How to store Cleosensa
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton 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

More than 1
tablet forgotten
in 1 strip

Ask your doctor for
advice

Yes

What Cleosensa contains
- The active substances are ethinylestradiol 0.03mg and drospirenone 3mg.
• The other ingredients are:
•  Tablet core: lactose monohydrate, maize starch, pregelatinised starch (maize),
crospovidone, povidone K‑30 (E1201), polysorbate 80, magnesium stearate (E572).
• Coating: Polyvinyl alcohol partial hydrolyzed, titanium dioxide (E171), macrogol
3350, talc (E553b), yellow iron oxide (E172).
What Cleosensa looks like and contents of the pack
Yellow, round film-coated tablets.

In week 1

Had sex in the previous
week before forgetting?

No

• Take the forgotten tablet
• Use a barrier method
(condom) for the
following 7 days and
• Finish strip
Only 1 tablet
forgotten
(taken more than 12
hours late)

Cleosensa is available in boxes of 3 blisters, each one containing 21 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Laboratorios León Farma, S.A.
C/ La Vallina s/n, Poligono Industrial Navatejera,
Villaquilambre, 24008 - León
Spain
This leaflet was last revised in December 2013.

In week 2

• Take the forgotten tablet
• Finish the strip

• Take the forgotten tablet
and
• Finish the strip
• Instead of the gap week
• Start the next strip
In week 3

If you would like a
leaflet with larger text,
please contact
01271 385257.

Or
• Stop the strip
immediately
• Begin the gap week
not longer than 7 days,
(including the forgotten
tablet)
• Then start the next strip

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.
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 Cleosensa”.
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 Cleosensa instead of the tablet-free period and finishing it. You may
experience light or menstruation-like bleeding while using this second strip. After the
usual tablet-free period of 7 days, start the next strip.
You might ask your doctor for advice before deciding to delay your menstrual
period.

AAAG3335

Actavis, Barnstaple, EX32 8NS UK

continued top of next column

Drospirenone/Ethinylestradiol 3mg/30mcg -, PIL, United Kingdom

colours/plates:
1. black

item no: AAAG3335

dimensions: 222 x 510

print proof no: 02

pharmacode: 8pt

origination date: 06/12/13

min pt size:

3.
4.
5.
6.

originated by: C.Paull
approved for print/date

2.

revision date: 09/12/13

Technical Approval

revised by: C.Paull

date sent:

supplier: León Farma

approved:

06/12/13

Non Printing Colours
1.
2.
3.

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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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