Skip to Content

UK Edition. Click here for US version.

ARMENTINAR 0.02 MG/3 MG FILM-COATED TABLETS

Active substance(s): DROSPIRENONE / ETHINYLESTRADIOL

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Armentinar 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.
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. What Armentinar is and what it is used for
2. What you need to know before you take Armentinar
Do not take Armentinar
Warnings and precautions
Armentinar and venous and arterial blood clots
Armentinar and cancer
Bleeding between periods
What to do if no bleeding occurs during the placebo days
Other medicines and Armentinar
Armentinar with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
Armentinar contains lactose
3. How to take Armentinar
Preparation of the strip
When can you start with the first strip?
If you take more Armentinar than you should
If you forget to take Armentinar
What to do in case of vomiting or severe diarrhoea
Delaying your period: what you need to know
Changing the first day of your period: what you need to know
If you want to stop taking Armentinar
4. Possible side effects
Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

1

5. How to store Armentinar
6. Contents of the pack and other information

1. What Armentinar is and what it is used for





Armentinar is a contraceptive pill and is used to prevent pregnancy.
Each of the 24 pink tablets contains a small amount 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 Armentinar
General notes
Before you start using Armentinar 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 Armentinar, 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 Armentinar, or where
the reliability of Armentinar 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 Armentinar alters the monthly changes of body temperature and of cervical mucus.
Armentinar, like other hormonal contraceptives, does not protect against HIV infection
(AIDS) or any other sexually transmitted disease.

Do not take Armentinar
You should not use Armentinar if you have any of the conditions listed below. If you do have any
of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what
other form of birth control would be more appropriate.






if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein
thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs
if you know you have a disorder affecting your blood clotting – for instance, protein C
deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or
antiphospholipid antibodies;
if you need an operation or if you are off your feet for a long time (see section ‘Blood clots’);
if you have (or 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);
o if you have any of the following diseases that may increase the risk of a clot in the
arteries. severe diabetes with blood vessel damage

Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

2











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 a disturbance of blood clotting (for example, protein C deficiency)
if you have (or have ever had) an inflammation of the pancreas (pancreatitis)
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

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”.
In some situations you need to take special care while using Armentinar or any other combination
pill, and your doctor may need to examine you regularly. ArmentinarArmentinar
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Armentinar, 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 depression
if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
if you have systemic lupus erythematosus (SLE –; a disease affecting your natural defence
system);
if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of
the kidneys);
if you have sickle cell anaemia (an inherited disease of the red blood cells);
if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family
history for this condition. Hypertriglyceridaemia has been associated with an increased risk of
developing pancreatitis (inflammation of the pancreas);

Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

3












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 Armentinar;
If you have an inflammation in the veins under the skin (superficial thrombophlebitis);
If you have varicose veins.
if you have epilepsy (see "Other medicines and Armentinar")
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 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 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 pharynx, and/or difficulty swallowing or hives
together with difficulty breathing.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Armentinar increases your risk of developing a
blood clot compared with not using one. In rare cases a blood clot can block blood vessels and
cause serious problems.
Blood clots can develop


in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)



in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or,
very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood clot due to Armentinar is
small.

HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.

What are you possibly
suffering from?

Are you experiencing any of these signs?

Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

4

What are you possibly
suffering from?

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;

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



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

Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

5

Retinal vein thrombosis
(blood clot in the eye)

Heart attack

What are you possibly
suffering from?

Are you experiencing any of these signs?


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 Armentinar 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 Armentinar is small.

Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

6

-

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 Armentinar, between about 9 and 12 women will develop a blood clot
in a year.

-

The risk of having a blood clot will vary according to your personal medical history (see
“Factors that increase your risk of a blood clot” below)
Risk of developing a blood clot
in a year

Women who are not using a combined hormonal
pill/patch/ring and are not pregnant

About 2 out of 10,000 women

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

About 5-7 out of 10,000 women

Women using Armentinar

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 Armentinar 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 Armentinar may need to be stopped several
weeks before surgery or while you are less mobile. If you need to stop Armentinar 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 Armentinar needs to be stopped.
If any of the above conditions change while you are using Armentinar, 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
Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

7

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 Armentinar is very small
but can increase:


with increasing age (beyond about 35 years);



if you smoke. When using a combined hormonal contraceptive like Armentinar 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 very 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 Armentinar, 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.
Armentinar 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

Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

8

During the first few months that you are taking Armentinar, 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 to 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 Armentinar
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
Armentinar. 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 Armentinar 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)
o and the herbal remedy St John's wort
• Armentinar may influence the effect of other medicines, for instance:
o medicines containing ciclosporin
o the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)
Ask your doctor or pharmacist for advice before taking any medicines.

Armentinar with food and drink
Armentinar 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
If you are pregnant, you must not take Armentinar. If you become pregnant while taking
Armentinar you must stop immediately and contact your doctor. If you become pregnant, you can
stop taking Armentinar at any time (see also “If you stop taking Armentinar”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Armentinar 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.
Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

9

Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no information suggesting that use of Armentinar affects driving or use of machines.
Armentinar contains lactose
If you cannot tolerate certain sugars, contact your doctor before you take Armentinar.

3. How to take Armentinar
Each blister contains 24 active pink tablets and 4 white placebo tablets.
The two differently coloured tablets of Armentinar are arranged in order. A strip contains 28
tablets.
Take one tablet of Armentinar 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
Armentinar. 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 week sticker along the top of the blister where it reads “Place the label here”, so that the
first day is above the tablet marked “1”. 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
start (so-called withdrawal bleeding). This usually starts on the 2nd or 3rd day after the last pink
active tablet of Armentinar. 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 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 Armentinar 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?
Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

10












If you have not used a contraceptive with hormones in the previous month
Begin with Armentinar on the first day of the cycle (that is, the first day of your period). If you
start Armentinar 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
You can start Armentinar 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 Armentinar 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 Armentinar use.
If, after having a baby, you have had sex before starting Armentinar (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 Armentinar (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.
If you take more Armentinar than you should
There are no reports of serious harmful results of taking too many Armentinar tablets.
If you take several tablets at once you may have symptoms of nausea or vomiting. Young girls may
have bleeding from the vagina.
If you have taken too many Armentinar tablets, or you discover that a child has taken some, ask
your doctor or pharmacist for advice.
If you forget to take Armentinar
The last 4 tablets in the 4th row of the strip are placebo tablets. If you forget to take one of these
tablets, this will have no effect on the reliability of Armentinar. 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:

Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

11



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 pink tablet at the
beginning or at the end of the strip. Therefore, you should keep to the following rules (see also the
diagram):


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.

Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

12

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

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

-- Tome
Take el
thecomprimido
forgotten tablet
olvidado
-- Utilice
Use aun
barrier
mé method (condom) for the following
7 days
ías and
siguientes
-- Finish the strip

Day 8 - 14

Day 15 - 24

- Take the forgotten tablet
- Finish the strip
- forma
Takeseguida
the forgotten
and blister
con eltablet
siguiente
- Finish taking the pink tablets
- Throw away the 4 white tablets
- Start the next strip
or
incluyendo el comprimido olvidado)
-- Despu
Stop the
immediately
é pink tablets
ú

- Go on directly to the 4 white tablets
- Then start the next strip

What to do 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 12 hours of when you
normally take your pill. If this is not possible or 12 hours have passed, you should follow the advice
given under "If you forget to take Armentinar".
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 new strip of Armentinar and finishing it. You may
experience light or menstruation-like 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
placebo tablets on a Friday, and you want to change this to a Tuesday (3 days earlier) you must start
Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

13

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 Armentinar
You can stop taking Armentinar 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 Armentinar 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 medicine, 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 Armentinar, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in
your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal
contraceptives. For more detailed information on the different risks from taking combined hormonal
contraceptives please see section 2 “What you need to know before you use Armentinar”.

The following is a list of the side effects that have been linked with the use of Armentinar:


Common side effects (between 1 and 10 in every 100 users may be affected):
o mood swings
o headache
o nausea
o breast pain, problems with your periods, such as irregular periods, absence of
periods



Uncommon side effects (between 1 and 10 in every 1,000 users may be affected):
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, muscular 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

Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

14



Rare side effects (between 1 and 10 in every 10,000 users may be affected):
o candida (a fungal infection)
o anaemia, increase in the number of platelets in the blood
o allergic reaction
o hormonal (endocrine) disorder
o increased appetite, loss of appetite, abnormally high concentration of potassium in
the blood, abnormally low concentration of sodium in the blood
o failure to experience an orgasm, insomnia
o giddiness, tremor
o eye disorders, for instance inflammation of the eyelid, dry eyes
o abnormally rapid heartbeat
o inflammation of a vein, nosebleed, fainting
o enlarged abdomen, bowel disorder, feeling bloated, stomach hernia, fungal
infection of the mouth, constipation, dry mouth
o pain of bile ducts or the gallbladder, inflammation of the gallbladder
o 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.
o 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
o feeling generally unwell
o weight loss


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)
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 or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.

Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

15

5. How to store Armentinar
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the date which is stated on the carton and blister after "EXP". The
expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Armentinar 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:
Tablet core: lactose monohydrate, pregelatinized starch (maize), povidone (E1201),
croscarmellose sodium, polysorbate 80, magnesium stearate (E572).
Tablet film-coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow
iron oxide (E172), red iron oxide (E172), black iron oxide (E172).






White inactive film-coated tablets:
Tablet core: lactose anhydrous, povidone (E1201), magnesium stearate (E572).
Tablet film-coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

What Armentinar looks like and content of the pack




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

Not all pack sizes may be marketed

Marketing Authorisation Holder
Laboratorios León Farma, S.A.
Polígono Industrial Navatejera;
Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

16

La Vallina s/n;
24008-Villaquilambre, León
Spain
Manufacturer
Laboratorios León Farma, S.A.
Polígono Industrial Navatejera;
La Vallina s/n;
24008-Villaquilambre, León
Spain
This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands:
Iradier 0.02 mg/3 mg, fimomhulde tabletten
Czech Republic:
Yosefinne
Germany:
Iradier 3 mg/0.02 mg Filmtabletten
Poland:
Vixpo
Italy:
Lerna
France:
Drospirenone / Ethinylestradiol Mylan Pharma Continu 3 mg/ 0,02 mg,
comprimé pelliculé
Spain:
Etinilestradiol/drospirenona Stada 0,02 mg/3 mg, comprimidos
recubiertos con película (24+4) EFG
Norway:
Iradier 0,02 mg/3 mg filmdrasjerte tabletter
Sweden:
Estrelen 0,02 mg/3 mg filmdragerade tabletter
United Kingdom:
Armentinar 0.02 mg/3 mg film-coated tablets
This leaflet was last revised in May 2014

Drospirenone 3mg /ethinyl estradiol 0.02 mg, 24+4
NL/2351/001/IB/004 -Jan2014

17

Expand view ⇕

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.

Hide