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ETHINYLESTRADIOL/DROSPIRENONE 0.030 MG / 3 MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ETHINYLESTRADIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ethinylestradiol/Drospirenone 0.03 mg / 3 mg film-coated tablets
Ethinylestradiol / Drospirenone
Read all of this leaflet carefully before you start taking this medicine.


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, do not pass it on to others. It may harm them.



If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

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”).

In this leaflet
1. WHAT ETHINYLESTRADIOL/DROSPIRENONE IS AND
WHAT IT IS USED FOR...................................................................... 2
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ETHINYLESTRADIOL/DROSPIRENONE ........................................ 2
When you should not use Ethinylestradiol/Drospirenone ..................... 3
When to take special care with Ethinylestradiol/Drospirenone ............ 4
Blood clots ............................................................................................. 5
Ethinylestradiol/Drospirenone and cancer .......................................... 10
Bleeding between periods.................................................................... 10
What to do if no bleeding occurs during the gap week ....................... 10
Ethinylestradiol/Drospirenone and using other medicines .................. 10
Taking Ethinylestradiol/Drospirenone with food and drink ................ 11
Laboratory tests ................................................................................... 11
Pregnancy ............................................................................................ 11
Breast-feeding...................................................................................... 11

Driving and using machines ................................................................ 11
Important information about some of the ingredients of
Ethinylestradiol/Drospirenone..................................................... 11
3. HOW TO TAKE ETHINYLESTRADIOL/DROSPIRENONE ......... 11
When can you start with the first strip? ............................................... 12
If you take more Ethinylestradiol/Drospirenone than you
should .......................................................................................... 13
If you forget to take Ethinylestradiol/Drospirenone ............................ 13
What to do in the case of vomiting or severe diarrhoea ...................... 14
Delaying your period: what you need to know ................................... 15
Changing the first day of your period: what you need to know .......... 15
If you want to stop taking Ethinylestradiol/Drospirenone .................. 15
4. POSSIBLE SIDE EFFECTS ............................................................... 15
5. HOW TO STORE ETHINYLESTRADIOL/DROSPIRENONE ....... 16
6. FURTHER INFORMATION .............................................................. 17

1.

WHAT ETHINYLESTRADIOL/DROSPIRENONE IS AND WHAT IT IS USED
FOR



Ethinylestradiol/Drospirenone 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
ETHINYLESTRADIOL/DROSPIRENONE

General notes
Before you start using Ethinylestradiol/Drospirenone, 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 Ethinylestradiol/Drospirenone, 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
Ethinylestradiol/Drospirenone, or where the reliability of Ethinylestradiol/Drospirenone may be
decreased. In such situations you should either not have sex or you should take extra nonhormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use
rhythm or temperature methods. These methods can be unreliable because
Ethinylestradiol/Drospirenone alters the monthly changes of body temperature and of the
cervical mucus.
Ethinylestradiol/Drospirenone, like other hormonal contraceptives, does not protect
against HIV infection (AIDS) or any other sexually transmitted disease.
When you should not use Ethinylestradiol/Drospirenone
You should not use Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone:
• 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 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.
o severe diabetes with blood vessel 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) 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
Ethinylestradiol/Drospirenone. This may cause itching, rash or swelling.
When to take special care with Ethinylestradiol/Drospirenone
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
In some situations you need to take special care while using Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone, you should also tell your
doctor.

• Ethinylestradiol/DrospirenoneEthinylestradiol/Drospirenoneif 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 ulcerative colitis (chronic inflammatory bowel disease;)
• 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 Ethinylestradiol/Drospirenone

• If you have an inflammation in the veins under the skin (superficial thrombophlebitis)
• If you have varicose veins
• if you have epilepsy (see page 10 “Ethinylestradiol/Drospirenone and using other medicines”);
• if you have systemic lupus erythematosus (SLE – a disease affecting your natural defence system);
• 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 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.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Ethinylestradiol/Drospirenone increases your risk of
developing a blood clot compared with not using one. In rare cases a blood clot can block 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
Ethinylestradiol/Drospirenone 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?

What are you possibly
suffering from?



Deep vein thrombosis

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;

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



chest pain, discomfort, pressure, heaviness



sensation of squeezing or fullness in the chest, arm or
below the breastbone;



fullness, indigestion or choking feeling;



upper body discomfort radiating to the back, jaw, throat,
arm and stomach;



sweating, nausea, vomiting or dizziness;



extreme weakness, anxiety, or shortness of breath;



rapid or irregular heartbeats



sudden weakness or numbness of the face, arm or leg,
especially on one side of the body;



sudden confusion, trouble speaking or understanding;

Retinal vein thrombosis
(blood clot in the eye)

Heart attack

Stroke



sudden trouble seeing in one or both eyes;



sudden trouble walking, dizziness, loss of balance or
coordination;



sudden, severe or prolonged headache with no known
cause;



loss of consciousness or fainting with or without seizure.

Sometimes the symptoms of stroke can be brief with an almost
immediate and full recovery, but you should still seek urgent
medical attention as you may be at risk of another stroke..


swelling and slight blue discolouration of an extremity;



severe pain in your stomach (acute abdomen)

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 Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone is
small.
-

Out of 10,000 women who are not using any combined hormonal contraceptive and are not
pregnant, about 2 will develop a blood clot in a year.
Out of 10,000 women who are using a combined hormonal contraceptive that contains
levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a year.

Out of 10,000 women who are using a combined hormonal contraceptive that contains drospirenone
such as Ethinylestradiol/Drospirenone, between about 9 and 12 women will develop a blood clot in a
year.
-

Ethinylestradiol/DrospirenoneThe 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 Ethinylestradiol/Drospirenone

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 Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone may need to be
stopped several weeks before surgery or while you are less mobile. If you need to stop
Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone needs to be stopped.
If any of the above conditions change while you are using Ethinylestradiol/Drospirenone, 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 Ethinylestradiol/Drospirenone is
very small but can increase:


with increasing age (beyond about 35 years);



if you smoke. When using a combined hormonal contraceptive like Ethinylestradiol/Drospirenone,
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 than 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 Ethinylestradiol/Drospirenone, 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.
Ethinylestradiol/DrospirenoneEthinylestradiol/DrospirenoneEthinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone, 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.
Ethinylestradiol/Drospirenone and using other medicines
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
Ethinylestradiol/Drospirenone. 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 Ethinylestradiol/Drospirenone 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
Ethinylestradiol/Drospirenone 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.
Taking Ethinylestradiol/Drospirenone with food and drink
Ethinylestradiol/Drospirenone 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
If you are pregnant, do not take Ethinylestradiol/Drospirenone. If you become pregnant while taking
Ethinylestradiol/Drospirenone stop immediately and contact your doctor. If you want to become pregnant,
you can stop taking Ethinylestradiol/Drospirenone at any time (see also page 15 "If you want to stop
taking Ethinylestradiol/Drospirenone").
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone affects driving or use of
machines.
Important information about some of the ingredients of Ethinylestradiol/Drospirenone
Ethinylestradiol/Drospirenone contains lactose.
If you cannot tolerate certain sugars, contact your doctor before you take Ethinylestradiol/Drospirenone.

3.

HOW TO TAKE Ethinylestradiol/Drospirenone

Take one tablet of Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone on the first day of the cycle (that is, the first day of your
period). If you start Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone 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.



After having a baby
You can start Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone use.
If, after having a baby you have had sex before starting Ethinylestradiol/Drospirenone (again), be sure
that you are not pregnant or wait until your next period.



If you are breastfeeding and want to start Ethinylestradiol/Drospirenone (again) after having a baby
Read the section on “Breast feeding”, page 11.

Ask your doctor what to do if you are not sure when to start.
If you take more Ethinylestradiol/Drospirenone than you should
There are no reports of serious harmful results of taking too many Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone tablets, or you discover that a child has taken
some, ask your doctor or pharmacist for advice.
If you forget to take Ethinylestradiol/Drospirenone



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 on page 14):



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.

• 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 (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.
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

in week 2

than 12 hours late)

•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

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
Ethinylestradiol/Drospirenone”, page 13.
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
Ethinylestradiol/Drospirenone 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
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 tabletfree 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 want to stop taking Ethinylestradiol/Drospirenone
You can stop taking Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone 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, Ethinylestradiol/Drospirenone 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 Ethinylestradiol/Drospirenone, 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
Ethinylestradiol/Drospirenone”.
The following is a list of the side effects that have been linked with the use of
Ethinylestradiol/Drospirenone:

Common side effects (between 1 and 10 in every 100 users may be affected):
• menstrual disorders, bleeding between periods, breast pain, breast tenderness
• headache, depressive mood
• migraine
• nausea
• thick, whitish vaginal discharge and vaginal yeast infection.
Uncommon side effects (between 1 and 10 in every 1,000 users may be affected):
• breast enlargement, changes in interest in sex
• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, skin rash, severe itching, hair loss (alopecia)
• infection of the vagina
• fluid retention and body weight changes.
Rare side effects (between 1 and 10 in every 10,000 users may be affected):
• allergic reactions (hypersensitivity), asthma
• breast secretion
• hearing impairment
• the skin conditions erythema nodosum (characterized by painful reddish skin nodules) or erythema
multiforme (characterized by rash with target-shaped reddening or sores).


harmful blood clots in a vein or artery for example:
in a leg or foot (i.e. DVT)
in a lung (i.e. PE)
heart attack
stroke
mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA)
blood clots in the liver, stomach/intestine, kidneys or eye.

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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)

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 Ethinylestradiol/Drospirenone

Keep Ethinylestradiol/Drospirenone out of the reach and sight of children.

Expiry date
Do not take Ethinylestradiol/Drospirenone after the date on the packaging after “Do not use after:” or
“EXP.:”
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose medicines no longer required. These measures will help to protect the environment.
6.

FURTHER INFORMATION

What Ethinylestradiol/Drospirenone contains


The active substances are drospirenone and ethinylestradiol.
Each tablet contains 3 milligrams drospirenone and 0.030 milligram ethinylestradiol.



Other ingredients (excipients) are lactose monohydrate, maize starch, pregelatinised maize starch,
povidone K25, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide (E 171),
iron oxide, yellow (E 172).

What Ethinylestradiol/Drospirenone looks like and content of the pack


Each blister of Ethinylestradiol/Drospirenone contains 21 light yellow, film-coated tablets



Ethinylestradiol/Drospirenone tablets are film-coated tablets; the core of the tablet is coated. The
tablets are light yellow, round with convex surfaces, one side is embossed with the letters "DO" in a
regular hexagon.



Ethinylestradiol/Drospirenone is available in packs of 1, 3, 6 and 13 blisters each with 21 tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Midas Pharma GmbH
Rheinstrasse 49
D-55218 Ingelheim
Germany
Tel.: +49 6132 990-0
Fax: +49-6132 990-40
e-mail: info@midas-pharma.com
Manufacturer
Midas Pharma GmbH
Rheinstrasse 49
D-55218 Ingelheim
Germany

This medicinal product is authorised in the Member States of the EEA under the following names:
DE
Drospin Mipha 3 mg/0.030 mg Filmtabletten
This leaflet was last approved in 07/2014

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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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