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LEANDRA 30MICROGRAMS/150 MICROGRAMS FILM-COATED TABLETS

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

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 if you have (or have ever had) a liver disease and your liver function is still not normal
 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 levonorgestrel, or any of the other ingredients of this medicine
(listed in section 6). This may cause itching, rash or swelling.
Warnings and precautions

Leandra 30 micrograms/150 micrograms
Film-coated Tablets
Leandra 30 micrograms/150 micrograms
Film-coated Tablets

Package leaflet: Information for the patient

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

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, please ask your doctor or pharmacist.
 This medicine has been prescribed for you only, do not pass it on to others. It may harm them.
 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.
The product will be referred to as Leandra Tablets throughout the leaflet.
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
1. What Leandra Tablets are and what they are used for
2. What you need to know before you take Leandra Tablets
3. How to take Leandra Tablets
4. Possible side effects
5. How to store Leandra Tablets
6. Contents of the pack and other information

When should you contact your doctor?
Seek urgent medical attention
 if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg
(i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a
stroke (see ‘Blood clots` section below).
For a description of the symptoms of these serious side effects please go to “How to recognise a blood
clot”.
In some situations you need to take special care while using Leandra Tablets or any other combination pill,
and your doctor may need to examine you regularly.
Tell your doctor if any of the following conditions develops or gets worse while you are using
Leandra Tablets.
Talk to your doctor or pharmacist before taking Leandra Tablets
 if a close relative has or has ever had breast cancer
 if you have a disease of the liver or the gallbladder
 if you have diabetes
 if you have depression
 if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
 if you have 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/Levonorgestrel
 if you have an inflammation in the veins under the skin (superficial thrombophlebitis)
 if you have varicose veins
 if you have epilepsy (see page 10 “Other medicines and Ethinylestradiol/Levonorgestrel”)
 if you have systemic lupus erythematosus (SLE –; a disease affecting your natural defence system)
 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 discoloration of the skin especially of the face or neck
known as “pregnancy patches”). If so, avoid direct sunlight or ultraviolet light while taking this
medicine.
 if you have hereditary angioedema, products containing oestrogens may cause or worsen the
symptoms. You should see your doctor immediately if you experience symptoms of angioedema such
as swollen face, tongue and/or throat and/or difficulty swallowing, or hives together with difficulty
breathing.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Leandra 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.

 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;
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’).

Pulmonary embolism

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)

Heart attack

When you should not use Leandra Tablets
You should not use Leandra Tabelts 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.

 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

DO NOT TAKE LEANDRA TABLETS
 if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT),
your lungs (pulmonary embolus, PE) or other organs.
 if you know you have a disorder affecting your blood clotting – for instance, protein C deficiency,
protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
 if you need an operation or if you are off your feet for a long time (see section ‘Blood clots’);
 if you have 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 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’

 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

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 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 Leandra Tablets
alters the monthly changes of 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.

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 Leandra 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 Leandra Tablets 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
such as Leandra Tablets about 5-7 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

About 5-7 out of 10,000 women

Women using Leandra Tablets

About 5-7 out of 10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Leandra 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);
 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 Leandra Tablets may need to be stopped several
weeks before surgery or while you are less mobile. If you need to stop Leandra 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 Leandra Tablets needs to be stopped.
If any of the above conditions change while you are using Leandra Tablets, 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

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 Leandra Tablets is very small but
can increase:
 with increasing age (beyond about 35 years);
 if you smoke. When using a combined hormonal contraceptive like Leandra 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;
 if a member of your immediate family has had a heart attack or stroke at a young age (less then about
50). In this case you could also have a higher risk of having a heart attack or stroke;
 if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or
triglycerides);
 if you get migraines, especially migraines with aura;
 if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial
fibrillation)
 if you have diabetes.

What are you possibly suffering from?

General notes
Before you start using Leandra Tablets, 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”.

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

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

2. WHAT YOU NEED TO KNOW BEDORE YOU TAKE LEANDRA TABLETS

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).

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.

 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

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.

Blood clots blocking other blood vessels

It is important to remember that the overall risk of a harmful blood clot due to Leandra Tablets is
small.

Are you experiencing any of these signs?

1. WHAT LEANDRA TABLETS ARE AND WHAT THEY ARE USED FOR

 swelling and slight blue discolouration of an
extremity;
 severe pain in your stomach (acute abdomen)

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 [invented name], 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.
Leandra 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 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.
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 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 gap week
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. Do not start the next strip until you are sure that you are not pregnant.
Other medicines and Leandra Tablets
Tell your doctor which medicines or herbal products you are already taking/using, have recently
taken/used or might take/use. Also tell any other doctor or dentist who prescribes another medicine (or the
pharmacist) that you take Leandra Tablets. They can tell you if you need to take additional contraceptive
precautions (for example condoms) and if so, for how long, or whether the use of another medicine you
need must be changed.
Some medicines
 can have an influence on the blood levels of Leandra Tablets
 can make it less effective in preventing pregnancy
 can cause unexpected bleeding.

 After having a baby
You can start Leandra Tablets 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 Leandra
Tablets use.
If, after having a baby, you have had sex before starting Leandra Tablets (again), be sure that you are
not pregnant or wait until your next period.
 If you are breast-feeding and want to start Leandra Tablets (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 Leandra Tablets than you should
There are no reports of serious harmful results 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 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 tablet at the beginning or at
the end of the strip. Therefore, you should keep to the following rules (see the diagram):
 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 may be pregnant. 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. Continue taking the tablets at the usual time. The protection against
pregnancy is not reduced, and you do not need to take extra precautions.

These include:
 medicines used for the treatment of
 epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate,
topiramate)
 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)
 fungal infections (e.g. griseofulvin)
 arthritis, arthrosis (etoricoxib)
 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.
 medicines containing ciclosporin
 the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)
 theophylline (used to treat breathing problems)
 tizanidine (used to treat muscle pain and/or muscle cramps).
 midazolam (used to help you sleep and reduce anxiety)

 One tablet forgotten in week 3
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that means that you have to take two
tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the tablet-free
period start the next strip.
Most likely, you will have a period at the end of the second strip but you may have light or
menstruation-like bleeding during the second strip.
2. You can also stop the strip and go directly to the tablet-free period of 7 days (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 during the first
tablet-free period, 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):

More than 1 tablet forgetten in 1 strip

Yes

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.

In week 1

Driving and using machines
There is no information suggesting that use of Leandra Tablets affects driving or use of machines.

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)

In week 2

In week 3

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

The strip contains 21 tablets. Next to each tab let 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.

On the 8th day after the last Leandra tablet (that is, after the 7-day gap week), 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 Leandra tablets in this manner, you are also protected against pregnancy also during the 7 days
when you are not taking a tablet.
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 period). If you start
Leandra Tablets 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 can start Leandra Tablets 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 (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 tablet-taking.
 After a miscarriage
Follow the advice of your doctor.

Or
Stop the strip immediately
Begin the gap week (not longer than
7 days, Including the forgotten tablet)
Then start the next strip

Take one Leandra 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.

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 day of
the gap week.

Take the forgotten
Finish the strip
Take the forgotten tablet and
Finish the strip
Instead of the gap week
Start the next strip

Leandra Tablets 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.
3. HOW TO TAKE LEANDRA TABLETS

Had sex in the previous week before
forgetting?
No

Pregnancy and breast-feeding
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. If you want to become pregnant, you can stop
taking Leandra Tablets at any time (see also page 15 “If you stop taking Leandra Tablets”).
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 for advice

What to do in the 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 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 Leandra Tablets”.
Delaying your period: what you need to know
Even though it is not recommended, you can delay your period by going straight to a new strip of Leandra
Tablets instead of the tablet-free period and finishing it. You may experience light or menstruation-like
bleeding while using this second strip. After the second strip is finished, take the usual tablet-free period of
7 days, start the 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 tablet-free week.
If you have to change this day, reduce the number of tablet-free days (but never increase them - 7 is the
maximum!). For example, if your tablet-free days normally begin 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 tablet-free 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 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 want to become pregnant, stop taking
Leandra Tablets 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, this medicine can cause side effects although not everybody gets them.
If you get any side effect, particularly if severe and persistent, or have any change to your health that you
think may be due to Leandra 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 take Leandra Tablets”.
The following is a list of the side effects that have been linked with the use of Leandra Tablets.
Very common (may affect more than 1 in 10 people)
 headache (including migraine)
 bleeding or spotting between periods
Common (may affect up to 1 in 10 people):
 mood swings, including depression, changes in sexual urges (libido)
 inflammation of the vagina, including fungal infestation (candidiasis)
 nervousness, stupor, dizziness
 abdominal pain (stomach ache)
 nausea, vomiting, abdominal pain
 fluid retention in tissue (oedema)
 acne
 breast pain, breast enlargement, breast tenderness, nipple discharge, changes in vaginal secretion,
changes in cervical secretion, painful or irregular periods, absence of periods
 weight gain or loss
Uncommon (may affect up to 1 in 100 people):
 increased or decreased appetite
 stomach cramps, flatulence
 rash, yellowish-brown flecks on the skin (chloasma), possibly persistent, increasedhairiness, hair loss
 increased blood pressure, changes in the serum lipid level, including hypertriglyceridaemia
 reduced ability to break down glucose (glucose intolerance)
Rare (may affect up to 1 in 1,000 people):
 a serious allergic reaction which includes signs such as rash, itching or hives on the skin, swelling of
the face, lips, tongue or throat which may cause difficulty in breathing and swallowing.
 yellowing of the skin or whites of the eyes due to obstruction in the bile duct (cholestatic jaundice)
 allergic reactions such as itchy and painful skin
 tolerance of contact lenses
 erythema nodosum (characterized by painful reddish skin nodules)
 decreased serum folic acid level (serum folic acid levels can be decreased by the Pill. In the event of a
pregnancy that occurs shortly after discontinuation of the oral contraceptive, decreased serum folic
acid levels may be of clinical relevance)
Very rare (may affect up to 1 in 10,000 people)
 liver cell cancer (with symptoms such as swollen abdomen, weight loss, abdominal liver function
which may be seen in in blood tests, jaundice)
 severe rash (erythema multiforme)
The following conditions have also been associated with combination oral contraception:
Not known (frequency cannot be estimated from the available data)
 inflammation of the optic nerve (optic neuritis), thrombosis in the blood vessels of the eye (retinal
vascular thrombosis which may cause sudden blurring or vision loss in all or part of one eye)
 inflammation of the pancreas (pancreatitis) with increase in triglycerides seen in blood tests
 a condition where the large intestine becomes inflamed due to inadequate blood supply; symptoms
include stomach pain, diarrhoea, fever and bleeding from the rectum (ischaemic colitis)
 liver damage (including inflammation of the liver (hepatitis) or liver dysfunction with signs such as
severe abdominal pain or changes in the liver function as seen in blood tests)
 a particular blood disorder that leads to kidney damage (haemolytic-uraemic syndrome, with signs
such as decreased urine output, blood in the urine, low red blood cells, nausea, vomiting, confusion
and diarrhoea)
 worsening of a particular immune system disorder (systemic lupus erythematosus)
 worsening of a metabolic disorder with breakdown of the production of haemoglobin (porphyria)
 worsening of Sydenham's chorea (a disease of the nerves in which sudden movements of the body to
occur)
 inflammation of the colon or other parts of the intestine (with signs such as bloody diarrhoea, pain
when passing stools, pain in the abdomen) (Crohn’s disease, ulcerative colitis)
 worsening of varicose veins
 gall bladder disease, including gallstones
 blister-like rash (herpes gestationis) whilst pregnant
 deafness which can also be inherited (otosclerosis)
 worsening of depression
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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
5. HOW TO STORE LEANDRA TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Do not use after:” or
“EXP.:”
Do not store above 25°C.
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 Leandra Tablets contain:
The active substances are:
One film-coated tablet (a “Pill”) contains 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel
The other ingredients are:
Tablet core:
lactose monohydrate (see section 2 “Leandra Tablets contain latctose”), maize starch,
gelatin, magnesium stearate
Tablet coating:

hypromellose, macrogol, titanium dioxide (E171), iron oxide yellow (E172)

What Leandra Tablets looks like and contents of the pack
Leandra tablets are brownish, round convex, film-coated tablets.
Leandra Tablets are available in blister packs with:
calendar pack with 1 x 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 13 x 21 film-coated tablets
100 x 21 film-coated tablets (hospital pack)
Not all pack sizes may be marketed.
Marketing Authorisation holder
MedRx Licences Limited,
9 St. George’s Yard, Castle Street, Farnham, Surrey, GU9 7LW, United Kingdom
Manufacturer
Pharbil-Waltrop
Im Wirrigen 25, 45731 Waltrop, Germany. Telefon: +49(2309) 93750 Telefax: +49(2309) 9375313
This medicinal product is authorised in the Member States of the EEA under the following names
This leaflet was last revised in 04/2017

MXL0001/O/PIL/G2

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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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