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LEANDRA 30MICROGRAMS/150 MICROGRAMS FILM-COATED TABLETS

Active substance(s): ETHINYLESTRADIOL / LEVONORGESTREL

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Patient Information Leaflet: Information for the User

Leandra 30 micrograms/ 150 micrograms Film-coated Tablets
Active substances: ethinylestradiol and levonorgestrel

Read all of this leaflet carefully before you start taking
the tablets
this leaflet; you may need to read it again.
• Keep
• If you have any further questions, please ask your doctor
or your pharmacist.
• This medicine has been prescribed for you personally and
you should not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If one of the listed side-effects seriously affects you, or if
you experience undesirable effects not listed in this
leaflet, please notify your physician or pharmacist.
The product will be referred to as Leandra throughout the
leaflet.
In this leaflet:
1. What Leandra Tablets are and what they are used for
2. Before you take Leandra Tablets
3. How to take Leandra Tablets
4. What are the possible side-effects
5. How to store Leandra Tablets
6. Further Information
1. WHAT LEANDRA TABLETS ARE AND WHAT THEY
ARE USED FOR
Leandra Tablets is a contraceptive pill and is used to
prevent pregnancy. Each tablet contains a small amount of
two different female hormones, namely levonorgestrel and
ethinylestradiol. Contraceptive pills that contain two
hormones are called “combination” pills.
2. BEFORE YOU TAKE LEANDRA TABLETS
General Notes
Before you can begin taking Leandra Tablets, 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 Leandra Tablets, or where the reliability of
Leandra Tablets may be decreased. In such situations you
should either not have intercourse 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 Leandra
Tablets alters the monthly changes of the body temperature
and of the cervical mucus.
Leandra Tablets, like other hormonal contraceptives, do
not protect against HIV infection (AIDS) or any other
sexually transmitted disease.
DO NOT TAKE LEANDRA TABLETS
Do not take Leandra tablets if you have or have had:
• a blood clot (thrombosis) in a blood vessel of the leg,
lung (embolus) or other organs
attack or stroke
• aa heart
• disease that can be a predictor of a heart attack (for
example, angina pectoris, which causes severe pain in
the chest) or of a stroke (for example, a transient stroke
with no residual effects).
• a disease that may increase the risk of a thrombosis in
the arteries. This applies to the following diseases:
with damaged blood vessels
• Diabetes
high blood pressure
• Very
• A very high level of fat in the blood (cholesterol or
triglycerides)
• a disturbance of blood clotting (for example, protein C
deficiency)
• a certain form of migraine (with so called focal
neurological symptoms)
inflammation of the pancreas (pancreatitis)
• an
disease and your liver function is still not normal
• liver
in the liver
• aortumour
if you are suspected as having breast cancer or

cancer of the genital organs
• any unexplained bleeding from the vagina
Do not take this medicine if you are allergic (hypersensitive)
to ethinylestradiol or levornegestrel, or any of the other
ingredients of Leandra Tablets. This can be recognised by
itching, rash, or swelling.
TAKE SPECIAL CARE WITH LEANDRA TABLETS
If any of the following conditions applies to you, you must
inform your doctor before starting to use Leandra Tablets.
You must also consult your doctor if any of the following
conditions develops or worsens during the use of Leandra
Tablets. If you have:
relative who has or has had breast cancer
• AA close
disease of the liver or gall bladder
• Diabetes
• Depression
• Crohn’s disease or ulcerative colitis (inflammatory

bowel disease)
• Haemolytic uraemic syndrome (a blood disease that
causes kidney damage)
• Sickle cell anaemia (an inherited disease of the red
blood cells)
(see “Taking other medicines”)
• Epilepsy
• Systemic Lupus Erythematous (a disease of the
immune system)
• A disease that first appeared during pregnancy or
earlier use of sex hormones (for example, hearing loss,
porphyria (a disease of the blood), gestational herpes
(skin rash with vesicles during pregnancy), Syndenham’s
chorea (a disease of the nerves in which sudden
movements of the body occur)).
• Chloasma (golden brown pigment patches, 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 estrogens
may induce or worsen symptoms of angioedema. 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.
LEANDRA TABLETS AND THROMBOSIS
Venous thrombosis
The use of any combination pill, including Leandra Tablets,
increases a woman’s risk of developing a venous
thrombosis (formation of a blood clot in vessels).
The risk of venous thrombosis in users of combined pills
increases:
increasing age
• With
are overweight
• IfIf you
• one of your close relatives has had a blood clot
(thrombosis) in the leg, lung, or other organ at a young
age
• If you must have an operation (surgery), any prolonged
period of immobilisation, or if you have had a serious
accident. It is important to tell your doctor in advance that
you are using Leandra Tablets as the treatment may have
to be stopped. Your doctor will tell you when to start
Leandra Tablets again. This is usually about two weeks
after you are back on your feet.
Arterial thrombosis
The use of combination pills has been connected with an
increase of the risk of arterial thrombosis (obstruction of an
artery), for example, in the blood vessels of the heart (heart
attack) or the brain (stroke).
The risk of arterial thrombosis in users of combined pills
increases if you:
• Smoke. You are strongly advised to stop smoking
when you use Leandra Tablets, especially if you are
older than 35 years
• Have an increased fat content in your blood
(cholesterol or triglycerides)
high blood pressure
• Have
migraine
• Have
• Have a problem with your heart (valve disorder, a
disturbance of the heart rhythm)

STOP TAKING Leandra Tablets and contact your doctor
immediately if you notice possible signs of thrombosis,
such as;
pain and/or swelling in one of your legs
• Severe
Sudden
severe pain in the chest which may reach the

left arm
breathlessness
• Sudden
cough without an obvious cause
• Sudden
• Any unusual, severe or long-lasting headache or
worsening of migraine
or complete blindness or double vision
• Partial
in speaking or inability to speak
• Difficult
Giddiness
fainting
• Weakness, or
strange feeling, or numbness in any part of

the body
Leandra tablets and cancer
Breast cancer has been observed slightly more often in
women using combined pills but it’s not known whether this is
caused by the treatment. For example it may be that more
tumours are detected in women on combined 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 unusual severe abdominal pain.
Bleeding between periods
During the first few months that you are taking Leandra
Tablets, you may have unexpected bleeding (bleeding
outside the gap week). If this bleeding lasts longer than a few
months, or if it begins after some months, your doctor must
investigate the cause.
What you must do if no bleeding occurs in the gap week
If you have taken the tablets correctly, have not had vomiting
or severe diarrhoea and you have not taken any other
medicines, it is highly unlikely that you are pregnant. If the
expected bleeding does not happen twice in succession, you
may be pregnant. Contact your doctor immediately. Do not
start the next strip until you are sure that you are not
pregnant.
TAKING OTHER MEDICINES
Leandra Tablets and taking other medicines
Always tell your doctor which medicines or herbal products
you are already using. 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 Leandra Tablets 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).
(e.g., rifampicin)
• Tuberculosis
• HIV infections (ritonavir, nevirapine) or other infections
(antibiotics such as griseofulvin, pencillin,
tetracycline)
• High blood pressure in the blood vessels in the lungs
(bosentan).
• The herbal remedy St. John’s wort.
Leandra Tablets may influence the effect of other medicines
e.g.
containing ciclosporin
• Medicines
• 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 oral contraceptives
can affect the results of some tests.
Pregnancy
If you are pregnant, YOU MUST NOT TAKE Leandra Tablets.
If you become pregnant while taking Leandra Tablets you
must stop immediately and contact your doctor.
Ask your doctor or pharmacist for advice before taking
any medicine
Breast-feeding
Use of Leandra Tablets is generally not advisable when a
woman is breast feeding. If you want to take the pill while you
are breast-feeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking
any medicine
Driving and using machines
There is no information suggesting that the use of Leandra
Tablets affects driving or use of machines
Important information about some of the ingredients of
Leandra Tablets
Leandra Tablets contain lactose. If you have been told by
your doctor that you have an intolerance to some sugars, you
should talk to your doctor before taking Leandra Tablets.
3. HOW TO TAKE LEANDRA TABLETS
Take one tablet every day, if necessary with a small amount
of water. You may take the tablets with or without food, but
you should take the tablets every day around the same time.
The strip contains 21 tablets. Take all 21 tablets.
Then take no tablets for 7 days. In the course of these 7
tablet-free days (otherwise called a stop or gap week)
bleeding should begin. This so-called “withdrawal bleeding”
usually starts on the 2nd or 3rd of the gap week.
On the 8th day after the last Leandra Tablets (that is, after the
7 day gap week), start the following strip, even if the bleeding
has not stopped. This means that you should start the
following strip on the same day of the week and that the
withdrawal bleed should occur on the same days each
month. If you use Leandra Tablets in this manner, you are
also protected against pregnancy during the 7 days that you
are not taking a tablet.
The strip contains 21 tablets. Next to each tablet is printed
the day of the week that it should be taken. If, for example,
you start on a Wednesday, take a tablet with “WED” next to it.
Follow the direction of the arrow on the strip until all 21
tablets have been taken.
When can you start with the first strip?
If you have not used a contraceptive with hormones in
the previous month
Begin with Leandra Tablets on the first day of the cycle (that
is the first day of your menstruation). If you start Leandra
Tablets 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 oral contraceptive, or
combined contraceptive vaginal ring or patch.
You can start Leandra tablets preferably on the day after the
last active tablet (the last tablet containing the active
substances) of your previous pill, but at the latest on the day
after the tablet-free days of your previous pill finish (or after
the last inactive tablet of your previous pill). When changing
from a combined contraceptive vaginal ring or patch, follow
the advice of your doctor.
Changing from a progestogen-only-method
(progestogen-only pill, injection, implant or a
progestogen-releasing IUD)
You may switch any day from the progestogen-only pill (from
an implant or the IUD on the day of its removal, from an
injectable when the next injection would be due) but in all of

these cases you must use extra protective measures (for
example a condom) for the first 7 days of tablet-taking.
After a miscarriage
Follow the advice of your doctor.
After having a baby
After having a baby, you can start Leandra Tablets between
21 and 28 days later. If you start later than day 28, you must
use a so-called barrier method (for example a condom)
during the first 7 days of Leandra tablets use. If, after having
a baby, you have had intercourse before starting Leandra
tablets (again), you must first be sure that you are not
pregnant or you must wait until the next menstrual bleed.
Let your doctor advise you if you are not sure when to
start
If you are breastfeeding and want to start Leandra Tablets
(again) after having a baby
Read the section on “Breast feeding”
If you take more Leandra Tablets than you should
There are no reports of serious harmful effects of taking too
many Leandra 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 Leandra Tablets, or you discover
that a child has taken some, ask your doctor or pharmacist
for advice.
If you forget to take Leandra Tablets
If you are less than 12 hours late taking a tablet, the
protection from pregnancy is not reduced. Take the tablet as
soon as you remember and then take the following tablets at
the usual time.
If you are more than 12 hours late taking a tablet, the
protection from pregnancy may be reduced. The greater the
number of tablets that you have forgotten, the greater is the
risk that the protection from pregnancy is reduced.
The risk of incomplete protection against pregnancy is
greatest if you forget a tablet at the beginning or the end of

the strip. Therefore, you should follow the rules given 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. Take the tablets again at the usual time and use extra
precautions for the next 7 days, for example a condom. If you
have had intercourse in the week before you forgot to take
the tablet or you have forgotten to start a new strip after the
tablet-free period, you must realise that there is a risk of
pregnancy. In that case, contact your doctor.
One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if
that means that you have to take two tablets at the same
time. Take the tablets again at the usual time. The protection
from 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 tablets as soon as you remember,
even if that means that you have to take two tablets at the
same time. Take the tablets again at the usual time.
Instead of the tablet-free period go straight on to the next
strip.
Most likely, you will have a period (withdrawal bleed) at
the end of the second strip but you may also have
spotting or breakthrough bleeding during the second strip.
• You can also stop the strip and go directly to the tabletfree period of 7 days (record the day on which you forgot
your tablet). If you want to start a new strip on your fixed
start day, make the tablet-free period less than 7 days.
If you follow either 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 bleeding in the first tablet-free period, this may
mean that you are pregnant. You must contact your
doctor before you go on to the next strip.

Several tablets forgotten in 1 strip

Ask your doctor for advice
Yes
Had sex in the previous week before
forgetting?

In week 1

No
Take the forgotten tablet
Use a barrier method (condom) for
the following 7 days
And finish strip
Only 1 tablet
forgotten (taken
more than 12
hours late)

Take the forgotten and finish the strip

In week 2

Take the forgotten tablet and
Finish the strip
Instead of the gap week
Go straight on to the next strip
Or

In week 3

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 you must 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 are not fully absorbed into your body. The situation
is similar to if you forget as 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 Leandra Tablets”.
Delay of menstrual period:
Even if not recommended, delay of your menstrual period
(withdrawal bleed) is possible by going straight on to a new
strip of Leandra Tablets instead of the tablet-free period, to
the end of the second strip. You may experience spotting
(drops or flecks of blood) or breakthrough bleeding while
using the second strip. After the usual tablet-free period of 7
days, continue with the following strip.
You might ask your doctor for advice before deciding to
delay your menstrual period.
Change of the first day of your menstrual period:
If you take the tablets according to the instructions, then your
menstrual period/withdrawal bleed will begin in the tablet-free
week. If you have to change this day, you do this by making
the tablet-free period shorter (but never longer!) For example,
if your tablet-free period begins on a Friday, and you want to
change this to a Tuesday (3 days earlier) you must start a
new strip 3 days earlier than usual. If you make the
tablet-free period very short (for example 3 days or less) then
it may be that you do not have any bleeding during this
tablet-free period. You may then experience spotting
(droplets or flecks of blood) or breakthrough bleeding.
If you are not sure what to do, contact your doctor for
advice
If you want to stop taking Leandra Tablets
You can stop taking Leandra 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 have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Leandra Tablets can cause
side-effects although not everybody gets them.

Uncommon: affects 1 to 10 users in 1,000
Changes in appetite (increase or decrease)
Abdominal cramps and bloating
Rash
Skin discolouration (Chloasma)
Excessive growth of body hair (Hirsutism)
Hair loss (Alopecia)
Increased blood pressure
Changes in blood lipid levels (hyper-triglyceridaemia)










Rare: affects 1 to 10 users in 10,000
Glucose intolerance
Incompatibility with contact lenses
Yellowing of the skin and eyes (Cholestatic jaundice)
Tender red nodules or lumps on the skin (Erythema
nodosum)






Very rare: affects less than 1 user in 10,000
Urticaria
Severe skin reaction with multiple skin lesions, including
blisters, often with fever, itching and joint pain (Erythema
multiforme)
carcinoma
• Hepatocellular
• Benign liver tumours




Not known: frequency cannot be estimated from the
available data
• Worsening of Systemic lupus erythematous (a severe
skin condition with joint pain, fever and tiredness)
• Herpes gestationis blistering skin disorder seen during
pregnancy
of chorea minor a movement disorder
• Worsening
nerve inflammation
• Optic
pain with blood in the stools (Ischemic colitis)
• Abdominal
of Crohn's disease and ulcerative colitis
• Worsening
• Pancreatitis with simultaneous serious
hypertriglyceridaemia
bladder disease including gall stones
• Gall
of varicose veins
• Worsening
• Haemolytic-uremic syndrome a syndrome of haemolytic
anaemia, thrombocytopenia and acute renal failure
abnormal bone growth in the middle ear
• Otosclerosis
• Worsening of porphyria
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.
5. HOW TO STORE LEANDRA TABLETS

The following frequency information is used for evaluating
side-effects:
very common: affects more than 1 user in 10
common:
affects 1 to 10 users in 100
uncommon:
affects 1 to 10 users in 1,000
rare:
affects 1 to 10 users in 10,000
very rare:
affects less than 1 user in 10,000
not known:
frequency cannot be estimated from the
available data

Keep all medicines out of the reach and sight of children.

Contact your doctor immediately if you experience any
of the following symptoms as they may be signs of an
allergic reaction:
of the face, lips, mouth, tongue or throat
• Swelling
breathing
• Difficulty
• Severe skin rashes

What Leandra Tablets contain:
Active substances are:
Each (a “Pill“) contains 30 microgram ethinylestradiol and
150 microgram levonorgestrel.
Other ingredients (excipients) are:
Tablet core: lactose monohydrate, maize starch, gelatine,
magnesium stearate
Tablet coating: hypromellose (3 cps), Macrogol 4000,
titanium dioxide (E171), iron oxide yellow (E172)

Other side effects
Very common: affects more than 1 user in 10
(including migraine)
• Headaches
• Spotting and intra-cyclic menstrual bleeding
Common: affects 1 to 10 users in 100
Inflammation of the vagina including fungal infection
(candidiasis)
Mood shifts including depression, changes in sex drive
(libido)
Nervousness
Dizziness
Nausea
Vomiting
Abdominal pain
Acne
Breast pain
Sensitivity of the breasts, enlargement of the breasts
Mammary gland secretion
Period pain (Dysmenorrhoea)
Changes in menstrual blood flow, this may mean no
menstrual bleeding (Amenorrhoea)
Changes on the cervix and cervical secretion
Changes in weight (increase or decrease)
Fluid retention


















The expiry date is printed on the pack. Do not use
Leandra Tablets after the expiry date which is stated on the
outer packaging and on the foil strip/blister pack after “Exp”.
The expiry date refers to the last day of that month. Do not
store above 25°C
6. FURTHER INFORMATION

What Leandra Tablets looks like and contents of the pack
Leandra Tablets are brownish, round convex, film-coated
tablets
Leandra Tablets are available in packages with:
Calendar pack with 21 film-coated tablets
Calendar pack with 3 x 21 film-coated tablets
Calendar pack with 6 x 21 film-coated tablets
Calendar pack with 12 x 21 film-coated tablets
Marketing Authorisation holder
MedRx Healthcare LLP,
9 St. George's Yard, Castle Street, Farnham, Surrey,
GU9 7LW, United Kingdom Telefon: +44 207002 5320
Manufacturer
Pharbil Waltrop GmbH
Im Wirrigen 25
D-45731, Waltrop
This leaflet was last revised in 02/2016

MXH0001/O/PIL/G1

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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