Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.02 mg/3 mg film-coated tablets

Main information

  • Trade name:
  • Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.02 mg/3 mg film-coated tablets
  • Dosage:
  • 0.02/3 milligram(s)
  • Pharmaceutical form:
  • Film-coated tablet
  • Prescription type:
  • Product subject to prescription which may be renewed (B)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.02 mg/3 mg film-coated tablets
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Not marketed
  • Authorization number:
  • PA1474/006/001
  • Authorization date:
  • 09-10-2009
  • Last update:
  • 21-04-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Package leaflet: Information for the user

Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.02 mg/3 mg 28 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 no pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

They are one of the most reliable reversible methods of contraception if used correctly

They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first

year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks

Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section

2 “Blood clots”)

What is in this leaflet:

What Ethinylestradiol/Drospirenone Leon Farma & Placebo is and what it is used for

What you need to know before you take Ethinylestradiol/Drospirenone Leon Farma & Placebo

How to take Ethinylestradiol/Drospirenone Leon Farma & Placebo

Possible side effects

How to store Ethinylestradiol/Drospirenone Leon Farma & Placebo

Contents of the pack and other information

1.

What Ethinylestradiol/Drospirenone Leon Farma & Placebo is and what it is used for

Ethinylestradiol/Drospirenone Leon Farma & Placebo is a contraceptive pill and is used to

prevent pregnancy.

Each of the 21 pink tablets contains a small amount of two different female hormones, namely

drospirenone and ethinylestradiol.

The 7 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 Ethinylestradiol/Drospirenone Leon Farma &

Placebo

General notes

Before you start using Ethinylestradiol/Drospirenone Leon Farma & Placebo 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 Leon Farma & Placebo, 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 alsocarry out some other tests.

In this leaflet, several situations are described where you should stop using

Ethinylestradiol/Drospirenone Leon Farma & Placebo, or where the reliability of

Ethinylestradiol/Drospirenone Leon Farma & Placebo 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 Ethinylestradiol/Drospirenone Leon Farma & Placebo alters

the monthly changes of body temperature and of the cervical mucus.

Ethinylestradiol/Drospirenone Leon Farma & Placebo, like other hormonal contraceptives,

does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take Ethinylestradiol/Drospirenone Leon Farma & Placebo

You should not use Ethinylestradiol/Drospirenone Leon Farma & Placebo 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

deficiency,

antithrombin-III

deficiency,

Factor

Leiden

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)

if you have any of the following diseases that may increase the risk of a clot in the arteries.

severe diabetes with blood vessels damage

very high blood pressure

a very high level of fat in the blood (cholesterol or triglycerides)

a condition known as hyperhomocysteinaemia

if you have (or have ever had) a type of migraine called “migraine with aura”

if you have (or have ever had) a liver disease and your liver function is still not normal

if your kidneys are not working well (renal failure)

if you have (or have ever had) a tumour in the liver

if you have (or have ever had) or if you are suspected of having breast cancer or cancer of the

genital organs

if you have any unexplained bleeding from the vagina

if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this

medicine (listed in section 6). This may cause itching, rash or swelling.

have

hepatitis

taking

medicinal

products

containing

ombitasvir/paritaprevir/ritonavir

dasabuvir

(see

also

section

Other

medicines

Ethinylestradiol/Drospirenone Leon Farma & Placebo).

Warnings and precautions

Talk to your doctor or pharmacist before taking Ethinylestradiol/Drospirenone Leon Farma &

Placebo.

When to take special care with Ethinylestradiol/Drospirenone Leon Farma & Placebo

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 clot’ (thrombosis)) section below.

For a description of the symptoms of these serious side effects please go to “How to recognise a blood

clot”.

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

If the condition develops, or gets worse while you are using Ethinylestradiol/Drospirenone Leon

Farma & Placebo, you should also tell your doctor. In some situations you need to take special care

while using Ethinylestradiol/Drospirenone Leon Farma & Placebo or any other combination pill, and

your doctor may need to examine you regularly.

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. Some women using hormonal contraceptives including {product name}

have reported depression or depressed mood. Depression can be serious and may sometimes lead

to suicidal thoughts. If you experience mood changes and depressive symptoms contact your

doctor for further medical advice as soon as possible.

if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)

if you have systemic lupus erythematosus (SLE –; a disease affecting your natural defence

system);

if you have haemolytic uraemic syndrome (HUS- a disorder of blood clotting causing failure of

the kidneys)

if you have sickle cell anaemia (an inherited disease of the red blood cells)

if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history

for this condition. Hypertriglyceridaemia has been associated with an increased risk of

developing pancreatitis (inflammation of the pancreas);

if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots’);

if you have just given birth you are at an increased risk of blood clots. You should ask your doctor

how soon after delivery you can start taking Ethinylestradiol/Drospirenone Leon Farma &

Placebo;

If you have an inflammation in the veins under the skin (superficial thrombophlebitis);

If you have varicose veins.

if you have epilepsy (see "Ethinylestradiol/Drospirenone Leon Farma & Placebo and using other

medicines")

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

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 Leon Farma &

Placebo 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

Ethinylestradiol/Drospirenone Leon Farma & Placebo 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?

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

Deep vein thrombosis

sudden unexplained breathlessness or rapid breathing;

sudden cough without an obvious cause, which may bring

up blood;

Pulmonary embolism

Are you experiencing any of these signs?

What are you possibly

suffering from?

sharp chest pain which may increase with deep breathing;

severe light headedness or dizziness;

rapid or irregular heartbeat

severe pain in your stomach;

If you are unsure, talk to a doctor as some of these symptoms

such as coughing or being short of breath may be mistaken for a

milder condition such as a respiratory tract infection (e.g. a

‘common cold’).

Symptoms most commonly occur in one eye:

immediate loss of vision or

painless blurring of vision which can progress to loss of

vision

Retinal vein thrombosis

(blood clot in the eye)

chest pain, discomfort, pressure, heaviness

sensation of squeezing or fullness in the chest, arm or

below the breastbone;

fullness, indigestion or choking feeling;

upper body discomfort radiating to the back, jaw, throat,

arm and stomach;

sweating, nausea, vomiting or dizziness;

extreme weakness, anxiety, or shortness of breath;

rapid or irregular heartbeats

Heart attack

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.

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.

Stroke

Are you experiencing any of these signs?

What are you possibly

suffering from?

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 Leon Farma & Placebo 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

Leon Farma & Placebo 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 Leon Farma & Placebo, 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 Ethinylestradiol/Drospirenone Leon Farma

& Placebo

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 Leon Farma & Placebo 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/m

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 Leon Farma

& Placebo may need to be stopped several weeks before surgery or while you are less mobile. If

you need to stop Ethinylestradiol/Drospirenone Leon Farma & Placebo 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 Leon Farma & Placebo needs to be stopped.

If any of the above conditions change while you are using Ethinylestradiol/Drospirenone Leon Farma

& Placebo, 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

Leon Farma & Placebo 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 Leon Farma & Placebo 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 Leon Farma

& Placebo, 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/Drospirenone Leon Farma & Placebo 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 Leon Farma &

Placebo, you may have unexpected bleeding (bleeding outside the week when you are taking the

white tablets). 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, 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 Ethinylestradiol/Drospirenone Leon Farma & Placebo

Tell your doctor which medicines or herbal products you are taking, have recently taken or might

take.. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that

you use Ethinylestradiol/Drospirenone Leon Farma & Placebo. They can tell you if you need to

take additional contraceptive precautions (for example condoms) and if so, for how long.

Do not use Ethinylestradiol/Drospirenone Leon Farma & Placebo if you have Hepatitis C and are

taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may

cause increases in liver function blood test results (increase in ALT liver enzyme).

Your doctor will prescribe another type of contraceptive prior to start of the treatment with these

medicinal products.

Ethinylestradiol/Drospirenone Leon Farma & Placebo can be restarted approximately 2 weeks after

completion of this treatment. See section “Do not use Ethinylestradiol/Drospirenone Leon Farma &

Placebo”.

Some medicines can have an influence on the blood levels of Ethinylestradiol/Drospirenone Leon

Farma & Placebo and can make it less effective in preventing pregnancy, or can cause unexpected

bleeding. These include:

medicines used for the treatment of

epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)

tuberculosis (e.g. rifampicin)

HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-

nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) or

other infections (griseofulvin)

high blood pressure in the blood vessels in the lungs (bosentan)

the herbal remedy St John's wort

Ethinylestradiol/Drospirenone Leon Farma & Placebo 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.

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 Ethinylestradiol/Drospirenone Leon Farma & Placebo. If you

become pregnant while taking Ethinylestradiol/Drospirenone Leon Farma & Placebo stop

immediately and contact your doctor. If you want to become pregnant, you can stop taking

Ethinylestradiol/Drospirenone Leon Farma & Placebo at any time (see also “If you want to stop

taking Ethinylestradiol/Drospirenone Leon Farma & Placebo”).

Breast-feeding

Use of Ethinylestradiol/Drospirenone Leon Farma & Placebo 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 Ethinylestradiol/Drospirenone Leon Farma & Placebo

affects driving or use of machines.

Ethinylestradiol/Drospirenone Leon Farma & Placebo contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially `sodium-

free´.

3.

How to take Ethinylestradiol/Drospirenone Leon Farma & Placebo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

Each blister contains 21 active pink tablets and 7 white placebo tablets.

The two differently coloured tablets of Ethinylestradiol/Drospirenone Leon Farma & Placebo are

arranged in order. A strip contains 28 tablets.

Take one tablet of Ethinylestradiol/Drospirenone Leon Farma & Placebo 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 once per day for the first 21 days, and then one white

tablet per day for the last 7 days. Then you should start a new strip (21 pink tablets and 7 white

tablets). So there is no gap between two strips.

Due to 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 remember to take the contraceptive, every strip (blister) of <Drosp/EE> tablets comes

with seven adhesive stickers which have the days of the week printed on them. You must know the

day of the week you are going to start taking the tablets.

According to the day of the week you are going to start taking the tablets, you should choose the

corresponding adhesive week sticker. For example, if you begin on Wednesday, use the sticker which

says "WED". Then stick the corresponding sticker in the upper left hand corner of the strip, on the

"Start" position. Now you have a day of the week above every tablet and you can see if you have

taken a tablet. The arrows show the order you should take the tablets in.

During the 7 days when you are taking the white placebo tablets (the placebo days), bleeding should

begin (so-called withdrawal bleeding). This usually starts on the 2

or 3

day after the last pink active

tablet of Ethinylestradiol/Drospirenone Leon Farma & Placebo. 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 Ethinylestradiol/Drospirenone Leon Farma & Placebo in this manner, you are protected

against pregnancy also during the 7 days when you are taking a placebo tablet.

When can you start with the first strip?

If you have not used a contraceptive with hormones in the previous month

Begin with Ethinylestradiol/Drospirenone Leon Farma & Placebo on the first day of your usual

cycle (that is the first day of your period). If you start Ethinylestradiol/Drospirenone Leon Farma

& Placebo on the first day of your period you are immediately protected against pregnancy. You

may also begin on day 2-5 of the cycle, but then you must use extra protective measures (for

example, a condom) for the first 7 days.

Changing from a combination hormonal contraceptive, or combination contraceptive vaginal

ring or patch

You should start taking Ethinylestradiol/Drospirenone Leon Farma & Placebo preferably on the

day after the last active tablet (the last tablet containing 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 however, (from an implant or an IUD

you should switch on the day of its removal, from an injectable when the next injection would be

due) but in all of these cases use extra protective measures (for example, a condom) for the first

7 days of tablet-taking.

After a miscarriage or termination of your pregnancy

Follow the advice of your doctor.

After having a baby

You can start Ethinylestradiol/Drospirenone Leon Farma & Placebo between 21 and 28 days after

having a baby. If you start later than day 28, use a so-called barrier method of contraception (for

example, a condom) during the first seven days of Ethinylestradiol/Drospirenone Leon Farma &

Placebo use.

If, after having a baby, you have had sex before starting Ethinylestradiol/Drospirenone Leon

Farma & Placebo, be sure that you are not pregnant or wait until your next period.

If you are breast-feeding and want to start Ethinylestradiol/Drospirenone Leon Farma & Placebo

(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 Ethinylestradiol/Drospirenone Leon Farma & Placebo than you should

There are no reports of serious harmful results of taking too many Ethinylestradiol/Drospirenone

Leon Farma & Placebo tablets.

If you take several tablets at once then you may have signs of overdose such as of nausea or vomiting.

Young girls may have bleeding from the vagina.

If you have taken too many Ethinylestradiol/Drospirenone Leon Farma & Placebo tablets, or you

discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take Ethinylestradiol/Drospirenone Leon Farma & Placebo

The tablets in the 4

th

row of the strip are the placebo tablets. If you forget one of these tablets, this

has no effect on the reliability of Ethinylestradiol/Drospirenone Leon Farma & Placebo . Throw away

the forgotten placebo tablet.

If you miss a pink active tablet from the 1

st

, 2

nd

or 3

rd

row do as follows:

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 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 should contact your doctor as there is a chance you may have become pregnant.

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:

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.

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.

You can also stop the active pink tablets and go directly to the 7 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 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

normal placebo days, you may be pregnant. Contact your doctor before you start the next strip.

The following diagram describes how to proceed if you forget to take your tablet(s):

Olvido de varios

comprimidos del

mismo blister

Pida consejo a su médico

Olvido de 1 sólo

comprimido

(tomado más de

12 horas tarde)

En la

semana 2

En la

semana 3

- Tome el comprimido olvidado y

- Finalice el blister

- Tome el comprimido olvidado

- Utilice un método de barrera (preservativo) durante

los 7 días siguientes

- Y finalice el blister

- Tome el comprimido olvidado y

- Finalice el blister

- En lugar de la semana de descanso comience de

forma seguida con el siguiente blister

- Pare de tomar los comprimidos del blister

inmediatamente

- Inicie la semana de descanso (no más de 7 días,

incluyendo el comprimido olvidado)

- Después, continúe con el siguiente blister

En la

semana 1

¿Mantuvo relaciones sexuales la semana anterior?

Olvido de varios

comprimidos del

mismo blister

Pida consejo a su médico

Olvido de 1 sólo

comprimido

(tomado más de

12 horas tarde)

En la

semana 2

En la

semana 3

- Tome el comprimido olvidado y

- Finalice el blister

- Tome el comprimido olvidado

- Utilice un método de barrera (preservativo) durante

los 7 días siguientes

- Y finalice el blister

- Tome el comprimido olvidado y

- Finalice el blister

- En lugar de la semana de descanso comience de

forma seguida con el siguiente blister

- Pare de tomar los comprimidos del blister

inmediatamente

- Inicie la semana de descanso (no más de 7 días,

incluyendo el comprimido olvidado)

- Después, continúe con el siguiente blister

En la

semana 1

¿Mantuvo relaciones sexuales la semana anterior?

More than 1

pink tablet

forgotten in 1

strip

Ask your doctor for advice

Only 1 pink

tablet forgotten

(taken more

than 12 hours

late)

In week 1

In week 2

In week 3

Had sex in the previous week before forgetting?

- Take the forgotten tablet

- Use a barrier method (condom) for the following 7

days and

Finish the strip.

- Take the forgotten tablet

Finish the strip.

- Take the forgotten tablet and

Finish taking the pink tablets

Throw away the 7 white tablets

Start the next strip.

- Stop the pink tablets immediately.

Go directly to the 7 white tablets

Then, start the next strip.

What to do in the case of vomiting or severe diarrhea

If you vomit within 3-4 hours after 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, 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 that is not possible or 12 hours have passed, you should follow the advice given under “If you

forget to take Ethinylestradiol/Drospirenone Leon Farma & Placebo".

Delaying your period: what you need to know

Even though it is not recommended, you can delay your period by not taking the white placebo tablets

from the 4

row and going straight to a new strip of Ethinylestradiol/Drospirenone Leon Farma &

Placebo and finishing it. You may experience light or menstruation-like bleeding while using this

second strip. Finish this second strip by taking the 7 white tablets from the 4

row. Then start your

next strip.

You should ask your doctor for advice before deciding to delay your menstrual period.

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

If you take the tablets according to the instructions, then your period will begin during the placebo

week. If you have to change this day, reduce the number of placebo days – when you take the white

placebo tablets – (but never increase them - 7 is the maximum!). For example, if you normally start

taking the placebo tablets 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 placebo 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 Leon Farma & Placebo

You can stop taking Ethinylestradiol/Drospirenone Leon Farma & Placebo 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 Leon Farma &

Placebo 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 medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, Ethinylestradiol/Drospirenone Leon Farma & Placebo 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 Leon

Farma & Placebo, 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

section

“What

need

know

before

take

Ethinylestradiol/Drospirenone Leon Farma & Placebo”.

following

list

side

effects

that

have

been

linked

with

Ethinylestradiol/Drospirenone Leon Farma & Placebo.

Common side effects (may affect up to 1 in 10 people)

mood swings

headache

abdominal pain (stomach ache),

acne

breast pain, breast enlargement, breast tenderness, painful or irregular periods

weight gain

Uncommon side effects (may affect up to 1 in 100 people):

Candida (fungal infection)

cold sores (herpes simplex)

allergic reactions

increased appetite

depression, nervousness, sleep disorder

feeling of “pins and needles”, giddiness (vertigo),

problems with vision

irregular heart beat or unusually fast heart rate

high blood pressure, low blood pressure, migraine, varicose veins

sore throat

nausea, vomiting, inflammation of stomach and/or intestine, diarrhoea, constipation

sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty

swallowing or hives together with difficulty breathing (angioedema),

hair loss (alopecia),

eczema, itching, rashes, dry skin, oily skin disorders (seborrheic dermatitis)

neck pain, limb pain, muscle cramps

bladder infection

breast lump (benign and cancer), milk production while not pregnant (galactorrhea), ovarian

cysts, hot flushes, absence of periods, very heavy periods, vaginal discharge, vaginal dryness,

lower abdominal (pelvic) pain, abnormal cervical smear (Papanicolaou or Pap smear), decreased

interest in sex

fluid retention, lack of energy, excessive thirst, increased sweating

weight loss

Rare side effects (may affect up to 1 in 1000 people):

asthma

hearing impairment

blockage of a blood vessel by a clot formed elsewhere in the body

erythema nodosum (characterized by painful reddish skin nodules)

erythema multiforme (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.

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 or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website:

www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can help provide more

information on the safety of this medicine.

5.

How to store Ethinylestradiol/Drospirenone Leon Farma & Placebo

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister/carton after "Do not use

after:" or "EXP:" The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Ethinylestradiol/Drospirenone Leon Farma & Placebo contains:

A strip of Ethinylestradiol/Drospirenone Leon Farma & Placebo contains 21 pink active tablets

in the 1

and 3

rows of the strip and 7 white placebo tablets in row 4.

Active tablets:

The active substances are ethinylestradiol 0.02 mg and drospirenone 3 mg.

The other ingredients are:

Tablet core: lactose monohydrate, pregelatinised starch (maize), povidone, croscarmellose sodium,

polysorbate 80, magnesium stearate.

Coating: Polyvinyl alcohol partial hydrolized, titanium dioxide (E171), macrogol 3350, talc, yellow

iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Placebo tablets:

Tablet core: lactose anhydrous, povidone, magnesium stearate.

Coating: Polyvinyl alcohol partial hydrolized, titanium dioxide (E171), macrogol 3350, talc.

What Ethinylestradiol/Drospirenone Leon Farma & Placebo looks like and contents of the pack

Active tablets are pink, round film-coated tablets.

Placebo tablets are white, round film-coated tablets.

Ethinylestradiol/Drospirenone Leon Farma & Placebo is available in boxes of 1, 2, 3, 6 and 13

blisters, each one containing 28 tablets (21 active plus 7 placebo tablets)

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Leon Farma, S.A.,

Poligono Industrial Navatejera, 17

c/La Vallina s/n,

Navatejera,

Leon, 24008,

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera.

C/ La Vallina s/n

24008 - Villaquilambre, León.

Spain

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

names:

Norway

Drosetil 28

Austria

Naraya

Bulgary

Drosetil

Denmark

Drospera

Estonia

LluviEight

Greece

Estrofixelle 0.02 mg/3 mg επικαλυμμένο με λεπτό υμένιο δισκίο

Spain

Etinilestradiol/drospirenona diario cinfalab 0,02 mg/3 mg

comprimidos recubiertos con película EFG

Hungary

ALTFORALLE 3 mg / 0,02 mg 28 Filmtabletta

Ireland

Ethinylestradiol/Drospirenone Leon Farma & placebo

Portugal

Drosurall

Romania

Drosetil

Slovak Republic

ALTFORALLE

This leaflet was last revised in 05/2019