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PALANDRA 0.03 MG/3 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Palandra®
0.03 mg / 3 mg film-coated tablets
Ethinylestradiol / Drospirenone

Read all of this leaflet carefully before you start taking
this medicine.
● Keep this leaflet, you may need to read it again.
● If you have any further questions, ask your doctor or
pharmacist.
● This medicine has been prescribed for you, do not pass it
on to others. It may harm them.
● If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet
1. WHAT PALANDRA IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE PALANDRA
3. HOW TO TAKE PALANDRA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PALANDRA
6. FURTHER INFORMATION

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1. WHAT PALANDRA IS AND WHAT IT IS USED FOR
● Palandra is a contraceptive pill and is used to prevent
pregnancy.
● Each light yellow tablet contains a small amount of two
different female hormones, namely drospirenone and
ethinylestradiol.
● Contraceptive pills that contain two hormones are called
“combination” pills.

2. BEFORE YOU TAKE PALANDRA
General notes
Before you can begin taking Palandra, 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 Palandra, or where the reliability of
Palandra 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 Palandra alters the
monthly changes of body temperature and cervical mucus.
Palandra, like other hormonal contraceptives, does not
protect against HIV infection (AIDS) or any other sexually
transmitted disease.
When you should not use Palandra
● if you have (or have ever had) a blood clot in a blood vessel
of the leg (thrombosis), of the lung (pulmonary embolism) or
other organs
● if you have (or have ever had) a heart attack or stroke
● if you have (or have ever had) a disease that can be an
indicator of a heart attack in the future (for example, angina
pectoris, which causes severe pain in the chest) or of a
stroke (for example, a passing slight stroke with no residual
effects)
● if you have a disease that may increase the risk of a clot in
the arteries. This applies to the following diseases:
– diabetes with damaged blood vessels
– very high blood pressure
– a very high level of fat in the blood (cholesterol or
triglycerides)
● if you have a disturbance of blood clotting (for example,
protein C deficiency)
● if you have (or have ever had) a certain form of migraine
(with so-called focal neurological symptoms)
● if you have (or have ever had) 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 Palandra. This may cause itching,
rash or swelling.
When do you need to take special care with Palandra?
In some situations you need to take special care while using
Palandra or any other combination pill, and your doctor may
need to examine you regularly. If any of the following
conditions applies to you, you must inform your doctor before
starting to use Palandra. Also, if any of the following conditions
develops or worsens while you are taking Palandra you must
consult your doctor:
If you have:
● a close relative who has had breast cancer
● a disease of the liver or the gallbladder
● diabetes
● depression
● Crohn’s disease or inflammatory bowel disease (ulcerative
colitis)
● a blood disease called HUS (haemolytic uraemic syndrome)
that causes kidney damage
● a blood disease called sickle cell anaemia
● epilepsy (see page 1 “Palandra and using other medicines”)
● a disease of the immune system called SLE (systemic lupus
erythematosus)
● a disease that first appeared during pregnancy or earlier use
of sex hormones (for example, hearing loss, a blood disease
called porphyria, yellowing of the skin or eyes (jaundice),
itching of the whole body (pruritis), skin rash with blisters
during pregnancy (gestational herpes), a nerve disease
causing sudden movements of the body (Sydenham’s
chorea) )
● 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.
● 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.
Palandra and venous and arterial blood clots
The use of any combination pill, including Palandra, increases
a woman’s risk of developing a venous blood clot (venous
thrombosis) compared with women who do not take any
contraceptive pill.
The risk of venous blood clot in users of combination pills
increases:
● with increasing age
● if you are overweight
● if one of your close relatives had a blood clot in the leg, lung
(pulmonary embolism), or other organ at a young age
● if you need to have surgery, if you have had a serious
accident or if you are immobilised for a long time. It is
important to tell your doctor in advance that you are using
Palandra as the treatment may have to be stopped. Your
doctor will tell you when to start Palandra again. This is
usually about two weeks after you are back on your feet.

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Your chances of having a blood clot are increased by taking
the pill.
● Of 100,000 women who are not on the pill and not pregnant,
about 5-10 may have a blood clot in a year.
● Of 100,000 women taking a pill like Palandra, 30-40 may
have a blood clot in a year, the exact number is unknown.
● Of 100,000 women who are pregnant, around 60 may have a
blood clot in a year.
A blood clot in the veins may travel to the lungs and may block
blood vessels (called a lung embolus). Formation of blood clots
in the veins may be fatal in 1-2% of cases.
The level of risk may vary according to the type of pill you take.
Discuss with your doctor the available options.
The use of combination pills has been connected with an
increase of the risk of an arterial blood clot (arterial
thrombosis), for example, in the blood vessels of the heart
(heart attack) or the brain (stroke).
The risk of an arterial blood clot in users of combination pills
increases if you:
● smoke. You are strongly advised to stop smoking when
you use Palandra, especially if you are older than
35 years.
● have high levels of blood cholesterol or triglycerides
● are overweight
● have a close relative who had a heart attack or stroke at a
young age
● have high blood pressure
● suffer from migraine
● have a problem with your heart (valve disorder, a disturbance
of the cardiac rhythm)
Stop taking Palandra and contact your doctor
immediately if you notice possible signs of a blood clot,
such as:
● severe pain and/or swelling in one of your legs
● sudden severe pain in the chest which may reach the left
arm
● sudden breathlessness
● sudden cough without an obvious cause
● any unusual, severe or long-lasting headache or worsening
of migraine
● partial or complete blindness or double vision
● difficulty in speaking or inability to speak
● giddiness or fainting
● weakness, strange feeling, or numbness in any part of the
body
● severe pain in the abdomen (known as acute abdomen)
Palandra 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 risk 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 Palandra, 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
so that they can find out if anything is wrong.
What you must do if no bleeding occurs during the seven
pill-free days
If you have taken all the tablets correctly, have not had
vomiting or severe diarrhoea and you have not taken any other
medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession,
you may be pregnant. Contact your doctor immediately. Only
start the next strip if you are sure that you are not pregnant.
Palandra and using other medicines
Always tell your doctor which medicines or herbal products
you are already using. Also tell any other doctor or dentist
who prescribes another medicine (or the pharmacist) that you
are taking Palandra. They can tell you if you need to take
additional contraceptive precautions (for example condoms)
and if so, for how long.
● Some medicines can make Palandra less effective in
preventing pregnancy, or can cause unexpected bleeding.
These include medicines used for the treatment of
– epilepsy (e.g. primidone, phenytoin, barbiturates,
carbamazepine, oxcarbazepine)
– tuberculosis (e.g. rifampicin)
– HIV infections (ritonavir, nevirapine) or other infections
(antibiotics such as griseofulvin, penicillin, tetracycline)
– high blood pressure in the blood vessels in the lungs
(bosentan)
– the herbal remedy St. John’s wort

● Palandra 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 hormonal contraceptives
can affect the results of some tests.
Pregnancy
If you are pregnant, you must not take Palandra. If you become
pregnant while taking Palandra stop taking it immediately and
contact your doctor. If you want to become pregnant, you can
stop taking Palandra at any time (see also page 2 “If you want
to stop taking Palandra”).
Ask your doctor or pharmacist for advice before taking any
medicine.
Breast-feeding
Use of Palandra is generally not advisable when a woman is
breast-feeding. If you want to take the pill while you are breastfeeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
There is no information suggesting that use of Palandra affects
driving or the use of machines.
Important information about some of the ingredients of
Palandra
Palandra contains lactose.
If you cannot tolerate certain sugars, contact your doctor
before you take Palandra.

3. HOW TO TAKE PALANDRA
Take Palandra every day for 21 days
Palandra comes in strips of 21 pills, each marked with a day of
the week.
● Take your pill at the same time every day.
● Start by taking a pill marked with the correct day of the
week.
● Follow the direction of the arrows on the strip. Take one pill
each day, until you have finished all 21 pills.
● Swallow each pill whole, with water if necessary. Do not
chew the pill.
Then have seven pill-free days
After you have taken all 21 pills in the strip, you have seven
days when you take no pills. So, if you take the last pill of one
pack on a Friday, you will take the first pill of your next pack on
the Saturday of the following week.
Within a few days of taking the last pill from the strip, you
should have a withdrawal bleed like a period. This bleed may
not have finished when it is time to start your next strip of pills.
You don’t need to use extra contraception during these seven
pill-free days – as long as you have taken your pills correctly
and start the next strip of pills on time.
Then start your next strip
Start taking your next strip of Palandra after the seven pill-free
days – even if you are still bleeding. Always start the new strip
on time.
During the seven pill-free days, when you take no tablets,
bleeding should begin (so-called withdrawal bleeding). This
usually starts on the 2nd or 3rd day after the last tablet of
Palandra. Start the following strip after the last day of the
seven pill-free days, whether your bleeding has stopped or not.
When can you start with the first strip?
● If you have not used a contraceptive with hormones in the
previous month
Begin with Palandra on the first day of your cycle (that is, the
first day of your period). If you start Palandra 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 Palandra 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 (progestogenonly pill, injection, implant or a progestogen-releasing
intrauterine system IUS)
You may switch any day from the progestogen-only pill (from
an implant or an IUS 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 taking Palandra.
● After a miscarriage or abortion
If you have had a miscarriage or abortion during the first
three months of pregnancy, your doctor may tell you to start
taking Palandra straight away. This means that you will have
contraceptive protection with your first pill.
● After having a baby
You can start taking Palandra between 21 and 28 days after
having a baby. If you start later than day
28, use a so-called barrier method (for example, a condom)
during the first seven days of taking Palandra.
If, after having a baby, you have had sex before starting
Palandra (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 want to start Palandra after
having a baby
Read the section on “Breast-feeding”, page 1.
Ask your doctor what to do if you are not sure when to start.
If you take more Palandra than you should
There are no reports of serious harmful results of taking too
many Palandra tablets.
If you take several tablets at once then you may have
symptoms of nausea or vomiting. Young girls may have
bleeding from the vagina.
If you have taken too many Palandra tablets, or you discover
that a child has taken some, ask your doctor or pharmacist for
advice
If you forget to take Palandra
● 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 should keep to the following rules (see also the
diagram on Page 2):
● More than one tablet forgotten in this strip
Contact your doctor.
● One tablet forgotten between days 1 - 7
Take the forgotten tablet as soon as you remember, even if that
means that you have to take two tablets at the same time.
Continue taking the tablets at the usual time and use extra
precautions for the next 7 days, for example, a condom. If you
have had sex in the week before forgetting the tablet you may
be pregnant. In that case, contact your doctor.
● One tablet forgotten between days 8 – 14
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. If you forget more than one tablet use an
additional barrier method such as a condom for 7 days.

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● One tablet forgotten between days 15 - 21
● 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 having seven pill-free days start the next strip as soon as
you have taken the last tablet.
Most likely, you will have a period at the end of the second
strip – but you may also have light or menstruation-like
bleeding during the second strip.
2. You can also stop the tablets and go directly to the tabletfree period (record the day on which you forgot your
tablet). If you want to start a new strip on the day you
always start, make the tablet-free period less than 7 days.
If you follow one of these two recommendations, you will
remain protected against pregnancy.
● If you have forgotten any of the tablets in a strip, and you do
not have a bleeding in the first tablet-free period, you may
be pregnant. Contact your doctor before you start the next
strip.
More than 1 tablet
forgotten in 1 strip

Ask your doctor for advice
yes

Days 1 - 7

Had sex in the previous week before
forgetting?
no
• Take the forgotten tablet
• Use a barrier method (condom) for the
following 7 days and
• Finish the strip

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

Days 8 - 14

• Take the forgotten tablet
• Finish the strip





Days 15 - 21

Take the forgotten tablet and
Finish the strip
Instead of the 7 tablet free days
Start the next strip
or

Stop the strip immediately
Begin the gap week (not longer than 7
days)
Then start the next strip

What to do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a tablet or you have
severe diarrhoea, there is a risk that the active substances in
the pill will not be fully taken up by your body. The situation is
almost the same as forgetting a tablet. After vomiting or
diarrhoea, you must 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 this is not possible or 12 hours
have passed, you should follow the advice given under “If you
forget to take Palandra” on page 1.
Delaying your period: what you need to know
Although it is not recommended, you can delay your period by
skipping the seven pill-free days and going straight to a new
strip of Palandra and finishing it. You may experience spotting
(droplets or flecks of blood) or breakthrough bleeding while
using this second strip. After the usual tablet-free period of
7 days start your next strip.
It is advisable to consult 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 seven pill-free days. If you have to
change this day, make the tablet-free period shorter – (but
never longer – 7 days is the maximum!). For example, if you
start the seven pill-free days on a Friday, and you want to
change this to a Tuesday (3 days earlier) start a new strip
3 days earlier than usual. You may not have any bleeding
during this time. You may then experience spotting (droplets or
flecks of blood) or breakthrough bleeding.
If you are not sure what to do, consult your doctor.
If you want to stop taking Palandra
You can stop taking Palandra 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 Palandra 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 product, ask
a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Like all medicines, Palandra can cause side effects although
not everybody gets them.
The following is a list of the side effects that have been linked
with the use of Palandra:
Serious side effects: – see your doctor straight away
Signs of a blood clot:
● a migraine for the first time, a migraine that is worse than
normal, or unusually frequent or severe headaches
● any sudden changes to your eyesight (such as loss of
vision or blurred vision)
● any sudden changes to your hearing, speech, sense of
smell, taste or touch
● pain or swelling in your leg
● stabbing pain when you breathe
● coughing for no apparent reason
● pain and tightness in the chest
● sudden weakness or numbness in one side or part of your
body
● dizziness or fainting
Signs of a severe allergic reaction to Palandra:
● swelling of the face, lips, mouth, tongue or throat
Signs of breast cancer include:
● dimpling of the skin
● changes in the nipple
● any lumps you can see or feel.
Signs of cancer of the cervix include:
● vaginal discharge that smells and/or contains blood
● unusual vaginal bleeding
● pelvic pain
● painful sex
Signs of severe liver problems include:
● severe pain in your upper abdomen
● yellow skin or eyes (jaundice)
● inflammation of the liver (hepatitis)
● your whole body starts itching
– If you think you may have any of these, see a doctor
straight away. You may need to stop taking Palandra
Common side effects (between 1 and 10 in every 100 users
may be affected):
● depressive mood
● headache, migraine
● nausea
● breast pain, breast tenderness, menstrual disorders,
bleeding between periods, thick whitish vaginal discharge,
vaginal yeast infection
Uncommon side effects (between 1 and 10 in every
1,000 users may be affected):
● breast enlargement
● altered interest in sex
● high blood pressure, low blood pressure
● vomiting, diarrhoea
● acne, severe itching, skin rash, hair loss (alopecia)
● vaginal infection
● fluid retention
● body weight changes
Rare side effects (between 1 and 10 in every 10,000 users
may be affected):
● hearing impairment
● asthma
● breast secretion
● blockage of a blood vessel by clot formed elsewhere in the
body
● hypersensitivity, erythema nodosum (characterized by
painful reddish skin nodules) or erythema multiforme
(characterized by rash with target-shaped reddening or
sores).
If any of the side effects gets serious or if you notice any side
effects not listed in this leaflet or if you think that this may be
the case, please tell your doctor or pharmacist.

What Palandra contains
● The active substances are drospirenone and ethinylestradiol.
Each active tablet contains 0.030 milligrams ethinylestradiol
and 3 milligrams drospirenone.
● Other ingredients in the active tablets are lactose
monohydrate, maize starch, pregelatinised maize starch,
povidone K25, magnesium stearate (E470b), hypromellose
(E464), macrogol 6000, talc (E553b), titanium dioxide (E171)
and iron oxide yellow (E172).
What Palandra looks like and content of the pack
● Palandra tablets are film-coated tablets; the core of the
tablet is coated. The tablets are light yellow, round with
convex surfaces; one side is embossed with the letters “DO”
in a regular hexagon.
● Palandra is available in packs of 1, 3, and 6 blisters each
with 21 tablets.
Marketing Authorisation Holder
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire,
RG14 1JA
Manufacturer
Bayer Pharma AG
or
Bayer Weimar GmbH und Co. KG
Berlin, Germany
Weimar, Germany
Date of the last revision of this leaflet: December 2012

5. HOW TO STORE PALANDRA
Keep Palandra out of the reach and sight of children.
Do not store above 25 °C. Store in the original package.
Expiry date
Do not take Palandra after the expiry date which is printed on
the pack after “EXP”
The expiry date refers to the last day of that month.

Palandra®

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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.

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