Skip to Content

MAYA 0.03 MG / 3 MG TABLETS

Active substance(s): DROSPIRENON / ETHINYLESTRADIOL / DROSPIRENON / ETHINYLESTRADIOL / DROSPIRENON / ETHINYLESTRADIOL

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

MAYA 0.03 mg/ 3 mg tablets
(Ethinylestradiol and 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 starts using 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 or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are same as yours.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.

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

What MAYA 0.03 mg/ 3 mg tablets is and what it is used for
What you need to know before you take MAYA 0.03 mg/ 3 mg tablets
How to take MAYA 0.03 mg/ 3 mg tablets
Possible side effects
How to store MAYA 0.03 mg/ 3 mg tablets
Contents of the pack and other information

1. What MAYA 0.03 mg/ 3 mg tablet is and what it is used for
• MAYA 0.03 mg/ 3 mg tablet 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 "combined oral
contraceptives".

1

2. What you need to know before you use MAYA 0.03 mg / 3 mg tablets
General Comments
Before you start using MAYA 0.03 mg / 3 mg tablets you should read the information on
blood clots (thrombosis) in section 2. It is particularly important to read the symptoms of
a blood clot – see Section 2 “Blood clots”).
Before you start taking MAYA 0.03 mg / 3 mg tablets, your doctor will ask you about
your personal health history and the health history of your close relatives. The doctor will
also measure your blood pressure and, depending on your personal health situation, the
doctor may also carry out some other tests.
In this leaflet, several situations are described where you should stop using MAYA 0.03
mg / 3 mg tablets or where the reliability of MAYA 0.03 mg / 3 mg tablets may be
decreased. In those situations you should either not have sex, or use an extra nonhormonal contraceptive precautions (for example use a condom) or another barrier
method. Do not use the temperature method or periodic withdrawal method. These
methods are unreliable because use of MAYA 0.03 mg / 3 mg tablets changes body
temperature and cervical mucus.
Like other hormonal contraceptives, MAYA 0.03 mg / 3 mg tablets does not protect
against infection with the HIV virus (AIDS) or other sexually transmitted diseases
(STDs).
Do not take MAYA 0.03 mg / 3 mg tablets
You should not use MAYA 0.03 mg / 3 mg tablets 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 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;
• 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 (thrombosis and embolus)’;
• if you have ever had a heart attack or a stroke;
• if you have (or have ever had) angina pectoris (a condition that causes severe chest
pain and may be a first sign of a heart attack) or transient ischaemic attack [TIA –
temporary stroke symptoms]);

2

• if you have any of the following diseases that may increase your risk of a clot in the
arteries:
– severe diabetes with blood vessel 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 liver disease and your liver function is still not normal;
• if your kidneys are not working properly (renal failure);
• if you have or have ever had a tumour in your liver;
• if you have or have ever had breast cancer or cancer of the reproductive organs;
• if you have unexplained bleeding from the vagina;
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine.

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 MAYA 0.03 mg / 3 mg
tablets, you should also tell your doctor.
• 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 (thrombosis)’);

3

• 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 MAYA 0.03 mg / 3 mg
tablets;
• if you have an inflammation in the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if someone in your immediate family has or has ever had breast cancer;
• if you have a disease of the liver or gallbladder;
• if you have diabetes;
• if you suffer from depression;
• if you have epilepsy;
• if you have a disease that first appeared during pregnancy or previous use of sex
hormones (for example hearing loss, a blood disorder called porphyria, skin rash with
blisters during pregnancy (herpes gestationes), disease of the nerves causing sudden
movements of the body (Sydenham's chorea));
• if you have or have ever had chloasma (a yellowish brown discoloration of the skin
especially of the face or neck, so called "pregnancy patches"). In this situation avoid
direct exposure to sunlight or ultraviolet light during the use of MAYA 0.03 mg / 3 mg
tablets;
• if you have hereditary angioedema, products containing oestrogens can cause or
worsen the symptoms. You should contact your doctor immediately if you experience
symptoms of angioedema such as swollen face, tongue or throat or difficulty in
swallowing or hives together with difficulty in breathing;
BLOOD CLOTS
Using a combined hormonal contraceptive such as MAYA 0.03 mg / 3 mg tablets
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 having a harmful blood clot due
to any MAYA 0.03 mg / 3 mg tablets is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.

4

Are you experiencing any of these signs?
• swelling of one leg or along a vein in the
leg or foot especially when accompanied
by:
• pain or tenderness in the leg which
may be felt only when standing or
walking.
• increased warmth in the affected leg.
• change in colour of the skin on the leg
e.g. turning pale, red or blue.
• sudden unexplained breathlessness or
rapid breathing;
• sudden cough without an obvious cause,
which may bring up blood;
• sharp chest pain which may increase with
deep breathing;
• severe light headedness or dizziness;
• rapid or irregular heartbeat;
• severe pain in your stomach;

What are you possibly suffering from?
Deep vein thrombosis

Pulmonary embolism

If you are unsure, talk to a doctor as some
of these symptoms such as coughing or
being short of breath may be mistaken for a
milder condition such as a respiratory tract
infection (e.g. a ‘common cold’).
Symptoms most commonly occur in one
eye:

Retinal vein thrombosis
(blood clot in the 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;

Heart attack

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

Stroke

5

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.
• 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.

6

When you stop MAYA 0.03 mg / 3 mg tablets 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 MAYA 0.03 mg / 3
mg tablets is small.
Chances of getting a blood clot are increased by taking the pill.
- 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 MAYA 0.03 mg / 3 mg tablets 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 MAYA 0.03 mg / 3 mg
tablets

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 MAYA 0.03 mg / 3 mg tablets 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);

7

• 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 MAYA 0.03 mg / 3 mg
tablets may need to be stopped several weeks before surgery or while you are less mobile.
If you need to stop MAYA 0.03 mg / 3 mg tablets 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 MAYA 0.03 mg / 3 mg tablets needs to be stopped.
If any of the above conditions change while you are using MAYA 0.03 mg / 3 mg tablets,
for example a close family member experiences a thrombosis for no known reason; or
you gain a lot of weight.
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 MAYA 0.03 mg
/ 3 mg tablets is very small but can increase:







with increasing age (beyond about 35 years);
if you smoke. When using a combined hormonal contraceptive like MAYA 0.03 mg /
3 mg tablets 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 that is not controlled through treatment;
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);

8





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 MAYA 0.03 mg / 3 mg tablets,
for example you start smoking, a close family member experiences a thrombosis for no
known reason; or you gain a lot of weight.
MAYA 0.03 mg / 3 mg tablets 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 decreases 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 MAYA 0.03 mg / 3 mg tablets, you may
have unexpected bleeding (bleeding outside the seven pill-free days). If this bleeding
occurs for more than a few months, or if it begins after some months, contact your doctor,
as they must find out what is wrong.
What to do if no bleeding occurs in the seven pill-free days
If bleeding does not occur in the seven pill-free days, even if you have taken all the
tablets correctly and if you have not vomited and did not have severe diarrhoea, and you
have not taken any other medication, then it is very unlikely that you are pregnant.
If the expected bleeding does not happen twice in a row, 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 MAYA 0.03 mg / 3 mg tablets
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines.

9

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 dispensing pharmacist)
that you are using MAYA 0.03 mg / 3 mg tablets. They can tell you if you need to use
additional contraceptive precautions (for example condoms) and, if so, how long to do
this.
Some medicines can make MAYA 0.03 mg / 3 mg tablets 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 infection with HIV (ritonavir, nevirapine) or other infections (antibiotics such as
griseofulvin, penicillin, tetracycline)
o high blood pressure in the blood vessels in the lung (bosentan)
• The herbal remedy St. John's wort.
MAYA 0.03 mg / 3 mg tablets may influence the effect of other medicines, such as:
• medicines that contain cyclosporine
• the anti-epileptic medicine lamotrigine (this could lead to an increased number of
seizures)
Ask your doctor or pharmacist for advice before taking any medicine.
MAYA 0.03 mg / 3 mg tablets with food and drink
MAYA 0.03 mg / 3 mg tablets may be taken with or without food, if necessary with a
little water.
Laboratory investigations
If you need a blood test, tell your doctor or the laboratory staff that you are taking
MAYA 0.03 mg / 3 mg tablets, because hormonal contraceptives can affect the results of
some tests.
Pregnancy, breast-feeding and fertility
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.

Do not use MAYA 0.03 mg / 3 mg tablets if you are pregnant. If you become pregnant
while taking MAYA 0.03 mg / 3 mg tablets, stop taking it immediately and contact your
doctor. If you want to become pregnant, you can stop using MAYA 0.03 mg / 3 mg
tablets at any time.

10

The use of MAYA 0.03 mg / 3 mg tablets is generally not advisable when a woman is
breast-feeding. If you want to use MAYA 0.03 mg / 3 mg tablets while you are breastfeeding, contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no information indicating that MAYA 0.03 mg / 3 mg tablets affects driving or
using machines.
MAYA 0.03 mg / 3 mg tablets contains lactose, E102, tartrazine and E110, sunset
yellow FCF
Lactose: If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
E102, E110: May cause allergic reactions.
3. How to take MAYA 0.03 mg / 3 mg tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

Take one tablet of MAYA 0.03 mg / 3 mg tablets daily with a little water if necessary.
You may take the tablets with or without food, but you should take the tablets every day
around the same time.
Each strip contains 21 tablets. Next to each tablet, is printed the day of the week when it
should be taken. For example, if you start on a Wednesday, take a tablet with
"Wednesday" next to it. Follow the direction of the arrow on the strip until you have
taken all 21 tablets.
After you have taken all 21 pills in the strip, you have seven days when you take no pills.
In the course of these 7 pill-free days (otherwise called stop or gap week), bleeding
should begin, (so called "withdrawal bleeding"). Usually bleeding starts on the second or
third day of the gap week.
On the eighth day, that is, after seven-day gap, you should start the next strip of tablets,
whether your bleeding has stopped or not. This means that each strip begins on the same
day of the week and withdrawal bleeding should occur on the same days each month.
If you use MAYA 0.03 mg / 3 mg tablets in this way, you are also protected against
pregnancy in 7 pill-free days.
When can you start with the first strip of MAYA 0.03 mg / 3 mg tablets

11

• If you have not used a hormonal contraceptive in the previous month
You can start taking MAYA 0.03 mg / 3 mg tablets on the first day of your menstrual
cycle and you are immediately protected against pregnancy. You may also start taking
MAYA 0.03 mg / 3 mg tablets on the 2nd to 5th day of the menstrual cycle, but in this
situation you should use additional contraceptive methods (for example condom) for the
first 7 days.
• Changing from a combined hormonal contraceptive, combined vaginal ring or
patch
You can start using MAYA 0.03 mg / 3 mg tablets on the day after the last active tablet
(the last tablet containing the active substances) of your previous pill, but not later than
the day following the tablet-free days of your previous pill (or after the last inactive tablet
of your previous pill). If you switch from a combined contraceptive vaginal ring or patch,
follow the advice of your doctor.
• Changing from a progestogen-only method (progestogen-only pill, also called
"mini-pill", injection or implant or a progestogen-releasing intrauterine device 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 taking MAYA 0.03 mg / 3 mg tablets.
• After a miscarriage or abortion
Follow the advice of your doctor.
• After childbirth
You can start talking MAYA 0.03 mg / 3 mg tablets between 21 to 28 days after
childbirth. If you start later than day 28, you should use additional barrier methods (for
example, a condom) during the first seven days of using MAYA 0.03 mg / 3 mg tablets.
If, after childbirth, you have had sex before starting MAYA 0.03 mg / 3 mg tablets, you
must first be sure that you are not pregnant or wait until your next period.
• If you are breastfeeding
Read the section “Pregnancy and breast-feeding"
Ask your doctor what to do if you are not sure when to start MAYA 0.03 mg / 3 mg
tablets.
If you take more MAYA 0.03 mg / 3 mg tablets than you should
There are no reports of serious harmful effects because of taking too many MAYA 0.03
mg / 3 mg tablets. If you take several tablets at once, you may experience nausea or
vomiting and young girls may experience vaginal bleeding.

12

If you have taken too many tablets, or you discover that a child has taken some, ask your
doctor or pharmacist for advice.
If you forget to take MAYA 0.03 mg / 3 mg tablets
• 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 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 must keep to the following
rules:
• If you forgot more than one tablet in this strip
Contact your doctor.
• If you forgot one tablet 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 an
additional contraceptive method such as a condom for the next 7 days.
If you have had sex in the week before missing the tablet, you may be pregnant. In this
case, contact your doctor.
• If you forgot one tablet in week 2
Take the forgotten tablet as soon as you remember, even if that means that you have two
tablets at the same time. Continue taking the tablets at the usual time. Contraceptive
protection is not reduced and you do not need to take extra contraceptive precautions.
• If you forgot one tablet in week 3
You have two options:
1. Take the forgotten tablet as soon as you remember (even if this means that you have to
take two tablets at the same time). Continue taking the tablets at the usual time. Start the
next strip as soon as the current strip is completed, so do not take a tablet-free break
between the strips. You may not have menstrual period until the end of the second strip,
but you may have spotting or breakthrough bleeding during the days of tablet-taking.
2. You can also stop taking the tablets from your current strip and go directly to the 7
tablet-free days (record the day when you forgot the tablet) and continue with the next
strip. If you want to start a new strip on the day you always start, make the tablet-free
period less than 7 days.

13

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 no bleeding occurs during the
tablet-free period, you may be pregnant. Consult your doctor before starting the next
strip.
Ask your doctor for advice

Several tablets
forgotten in 1 strip

yes

In week 1

Had sex in the previous week before forgetting
no

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

In week 2

•Take the forgotten tablet and
• Finish strip

• Take the forgotten tablet and Finish strip
•Instead of the gap week
•Go straight on next strip
In week 3

or

•Stop the strip immediately
•Begin the gap week (not longer than 7 days including the
forgotten tablet)

•Then go on to the next strip

What to do in 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 having severe
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 MAYA 0.03
mg / 3 mg tablets".
Delaying your period
Although it is not recommended, you can delay your period by directly going to a new
strip of MAYA 0.03 mg / 3 mg tablets instead of taking the tablet-free break, and finish

14

this strip. During the second strip you can experience minor or menstrual-like bleeding.
After the usual tablet-free period of 7 days, start the next strip.
Ask your doctor for advice before you decide to delay your menstrual period.
Changing the first day of your period
If you take the tablets as directed, your period will start during the tablet-free week. If
you need to change that day, you can reduce the number of tablet-free days (but never
increase them – 7 is the maximum!). For example, if your tablet-free days usually starts
on Friday, and you want to change to Tuesday (3 days earlier), you should start a new
strip 3 days earlier than usual. If you make the interval between taking tablets very short
(for example, 3 days or less) bleeding may not occur during this period. You can then
experience spotting (drops or flecks of blood) or breakthrough bleeding.
If you are not sure how to do this, ask your doctor for advice.
If you stop taking MAYA 0.03 mg / 3 mg tablets:
You can stop taking MAYA 0.03 mg / 3 mg tablets 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 MAYA 0.03 mg / 3 mg tablets and
wait until you have a menstrual period before trying to get pregnant. You can then
calculate the expected delivery date more easily.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist or nurse.
4. Possible side effects
Like all medicines, MAYA 0.03 mg / 3 mg tablets 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 MAYA 0.03 mg / 3 mg
tablets, 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 MAYA 0.03 mg / 3 mg tablets”.
The following is a list of side effects that have been associated with the use of MAYA
0.03 mg / 3 mg tablets.
Common (may affect up to 1 in 10 people):
- menstrual disorders, bleeding outside the break week, breast pain, breast tenderness

15

- headache, depression
- migraine
- nausea
- thick white vaginal discharge and yeast infections in the vagina
Uncommon (may affect up to 1 in 100 people)
-

larger breasts, altered interest in sex
increased blood pressure, decreased blood pressure
vomiting, diarrhoea
acne, skin rash, itching, hair loss (alopecia)
vaginal infection
fluid accumulation and changes in body weight

Rare (may affect up to 1 in 1,000 people)
- allergic reactions (hypersensitivity), asthma
- secretion from the nipples
- hearing problems or loss (impairment)
- blockage of a blood vessel caused by a blood clot formed elsewhere in the body
- skin erythema conditions nodosum (characterized by painful bluish-red skin nodules)
or erythema multiforme (characterized by rash with circular redness or blisters).
- harmful blood clots in a vein or artery for example:
• 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.
• in a lung (i.e. PE)
• in a leg or foot (i.e. DVT)
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 or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via the yellow card system at
www.mhra.go.uk/yellowcard. By Reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store MAYA 0.03 mg / 3 mg tablets
Keep this medicine out of the sight and reach of children.

16

Do not use this medicine after the expiry date stated on the blister / carton after ‘{EXP}’.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage condition.
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 MAYA 0.03 mg / 3 mg tablets contains
The active substances are ethinylestradiol and drospirenone. Each tablet contains 0.030
milligrams of ethinylestradiol and 3 milligrams of drospirenone.
The other ingredients are:
lactose monohydrate,
maize starch,
povidone,
crospovidone,
magnesium stearate,
lake blend yellow LB 520001 (composition: FD&C Yellow #5/Tartarazine Aluminum
Lake E102, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake E110 and FD&C
Blue #2/Indigo Carmine Aluminum Lake E132).
What MAYA 0.03 mg / 3 mg tablets looks like and contents of the pack
The tablets are round, yellow, 6.00 mm, uncoated biconvex, with '143' debossed on one
side and plain on the other side.
Each pack contains 1 and 3 strips of 21 tablets each.
Each carton contains blisters packed separately in an aluminium laminated sachet.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Mylan
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom
Manufacturer
Wessling Hungary Kft.
Fóti út 56. Budapest
H-1047, Hungary

17

M.A. No.: PL 04569/1694
This medicinal product is authorized in the Member States of the EEA under the
following names:
BE: Ethinylestradiol/Drospirenon Mylan 0,03 mg/ 3 mg tabletten
DE: Zambak 3 mg/ 0.03 mg Tabletten
ES: Drospirenone/ Ethinylestradiol Famy Care 3 mg/ 0.03 mg comprimidos EFG
IT: Drina 0,03 mg/ 3 mg compresse
NL: Ethinylestradiol/Drospirenon Mylan 0,03/3 mg; tabletten
UK: MAYA 0.03 mg / 3 mg tablets
This leaflet was last revised in 08/2016.

18

Expand Transcript

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