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OLANZAPINE JENSON PHARMACEUTICAL SERVICES LIMITED 15 MG ORODISPERSIBLE TABLETS

Active substance(s): OLANZAPINE

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Package leaflet: Information for the patient

OLANZAPINE 5 mg
ORODISPERSIBLE TABLETS
OLANZAPINE 10 mg
ORODISPERSIBLE TABLETS
OLANZAPINE 15 mg
ORODISPERSIBLE TABLETS
OLANZAPINE 20 mg
ORODISPERSIBLE TABLETS
olanzapine

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
your pharmacist.
• 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 the same as yours.
• If you get any side effects, talk to your doctor or your
pharmacist. This includes any possible side effects not
listed in this leaflet.
What is in this leaflet
1. What Olanzapine is and what it is used for
2. What you need to know before you take Olanzapine
3. How to take Olanzapine
4. Possible side effects
5. How to store Olanzapine
6. Contents of the pack and other information
1. WHAT OLANZAPINE IS AND WHAT IT IS USED FOR
Olanzapine contains the active substance olanzapine and
belongs to a group of medicines called antipsychotics.
Olanzapine is used to treat schizophrenia, a disease with
symptoms such as hearing, seeing or sensing things which
are not there, mistaken beliefs, unusual suspiciousness,
and becoming withdrawn. People with this disease may
also feel depressed, anxious or tense.
Olanzapine is used to treat moderate to severe manic
episodes, a condition with symptoms such as feeling
"high", having excessive amounts of energy, needing
much less sleep than usual, talking very quickly with
racing ideas and sometimes severe irritability. It is also a
mood stabiliser that prevents further occurrences of the
disabling high and low (depressed) extremes of mood
associated with this condition.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
OLANZAPINE
Do not take Olanzapine:
• If you are allergic (hypersensitive) to olanzapine or
any of the other ingredients of this medicine (listed in
section 6). An allergic reaction may be recognised as a
rash, itching, a swollen face, swollen lips or shortness of
breath. If this has happened to you, tell your doctor.
• If you have been previously diagnosed with eye
problems such as certain kinds of glaucoma (increased
pressure in the eye).
Warnings and precautions
Talk to your doctor before taking Olanzapine.
• Medicines of this type may cause unusual movements
mainly of the face or tongue. If this happens after you
have been given Olanzapine tell your doctor.
• Rarely, medicines of this type cause a combination of
fever, faster breathing, sweating, muscle stiffness and
drowsiness or sleepiness. If this happens, contact your
doctor at once.
• If you or someone else in your family has a history of
blood clots, as medicines like these have been associated
with formation of blood clots.
• Weight gain has been seen in patients taking Olanzapine.
You and your doctor should check your weight regularly.
• High blood sugar and high levels of fat (triglycerides
and cholesterol) have been seen in patients taking
Olanzapine. Your doctor should do blood tests to check
blood sugar and certain fat levels before you start taking
Olanzapine and regularly during treatment.
• The use of Olanzapine in elderly patients with dementia
is not recommended as it may have serious side effects.
If you suffer from any of the following illnesses tell your
doctor as soon as possible:
• Diabetes
• Heart disease
• If you have been told that you have salt imbalances
in the blood (especially low levels of potassium or
magnesium)
• If you were born with prolonged QT interval (seen on
ECG, an electrical recording of the heart)
• Liver or kidney disease
• Parkinson’s disease
• Epilepsy
• Prostate problems
• A blocked intestine (Paralytic ileus)
• Blood disorders with low blood white blood cell counts
(which can be caused by some medicines, radiation
therapy, chemotherapy or bone marrow disease)
• If you have been told that you have increased levels
of some white blood cells or a disease of the bone
marrow in which excessive blood cells are made called
myeloproliferative disease
• Stroke or “mini” stroke (temporary symptoms of stroke)
If you suffer from dementia, you or your carer/relative
should tell your doctor if you have ever had a stroke or
“mini” stroke.

As a routine precaution, if you are over 65 years your blood
pressure may be monitored by your doctor.
Children and adolescents
Olanzapine is not for patients who are under 18 years.
Other medicines and Olanzapine
Tell your doctor if you are taking, have recently taken or
might take any other medicines. Especially tell your doctor
if you are taking medicines for Parkinson’s disease.
Only take other medicines while you are on Olanzapine if
your doctor tells you that you can. You might feel drowsy
if Olanzapine is taken in combination with antidepressants
or medicines taken for anxiety or to help you sleep
(tranquillisers).
You should tell your doctor if you are taking
carbamazepine (used as an anti-epileptic or mood
stabiliser), fluvoxamine (an antidepressant), or
ciprofloxacin (an antibiotic), as it may be necessary to
change your Olanzapine dose.
Also tell your doctor if you:
- smoke (because your dose of olanzapine may need to be
adjusted)
- are taking medicines that can alter your heart rhythm
such as anti-arrhythmics (like amiodarone, sotalol,
quinidine, disopyramide), antibiotics (that belong to the
group of macrolides), tricyclic antidepressants.
If you are taking activated charcoal (a chemical substance
used to bind other drugs), this should be taken at least
2 hours before or after olanzapine intake because it can
interfere with the absorption of olanzapine.
Olanzapine with alcohol
Do not drink any alcohol if you have been given Olanzapine
as taking it with alcohol may make you feel drowsy.
Pregnancy and breast-feeding
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. You
should not be given this medicine when breast-feeding, as
small amounts of Olanzapine can pass into breast milk.
The following symptoms may occur in newborn babies, of
mothers that have used Olanzapine in the last trimester (last
three months of their pregnancy): shaking, muscle stiffness
and/or weakness, sleepiness, agitation, breathing problems,
and difficulty in feeding. If your baby develops any of these
symptoms you may need to contact your doctor.
Driving and using machines
There is a risk of feeling drowsy or dizzy when you are
given Olanzapine. If this happens do not drive or operate
any tools or machines. Tell your doctor.
Olanzapine contains aspartame
Patients who cannot take phenylalanine should note
that Olanzapine contains aspartame, which is a source
of phenylalanine. May be harmful for people with
phenylketonuria.
3. HOW TO TAKE OLANZAPINE
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Your doctor will tell you how many Olanzapine tablets to
take and how long you should continue to take them. The
recommended daily dose of Olanzapine is between 5 and
20 mg. Consult your doctor if your symptoms return but do
not stop taking Olanzapine unless your doctor tells you to.
You should take your Olanzapine tablets once a day
following the advice of your doctor. Try to take your tablets
at the same time each day. It does not matter whether you
take them with or without food. Olanzapine orodispersible
tablets are for oral use.
Olanzapine tablets break easily, so you should handle the
tablets carefully. Do not handle the tablets with wet hands
as the tablets may break up.
1. For perforated blisters, hold the blister strip at the edges
and separate one blister cell from the rest of the strip by
gently tearing along the perforations around it.
2. Carefully peel off the backing. For non-perforated
blisters, take care not to peel off the backing of adjacent
tablets.
3. Gently push the tablet out.
4. Put the tablet in your mouth. It will dissolve directly in
your mouth, so that it can be easily swallowed.
You can also place the tablet in a full glass or cup of water,
orange juice, apple juice, milk or coffee, and stir. With
some drinks, the mixture may change colour and possibly
become cloudy. Drink it straight away.

If you take more Olanzapine than you should
Patients who have taken more Olanzapine than they
should have experienced the following symptoms: rapid
beating of the heart, agitation/aggressiveness, problems
with speech, unusual movements (especially of the face
or tongue) and reduced level of consciousness. Other
symptoms may be: acute confusion, seizures (epilepsy),
coma, a combination of fever, faster breathing, sweating,
muscle stiffness and drowsiness or sleepiness, slowing of
the breathing rate, aspiration, high blood pressure or low
blood pressure, abnormal rhythms of the heart. Contact
your doctor or hospital straight away. Show the doctor
your pack of tablets.

If you forget to take Olanzapine
Take your tablets as soon as you remember. Do not take
two doses in one day.
If you stop taking Olanzapine
Do not stop taking your tablets just because you feel
better. It is important that you carry on taking
Olanzapine for as long as your doctor tells you.
If you suddenly stop taking Olanzapine symptoms such as
sweating, unable to sleep, tremor, anxiety or nausea and
vomiting might occur. Your doctor may suggest you to
reduce the dose gradually before stopping treatment.
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.
Tell your doctor immediately if you have:
• unusual movement (a common side effect that may
affect up to 1 in 10 people) mainly of the face or tongue.
• blood clots in the veins (an uncommon side effect that
may affect up to 1 in 100 people) especially in the legs
(symptoms include swelling, pain, and redness in the
leg), which may travel through blood vessels to the
lungs causing chest pain and difficulty in breathing. If
you notice any of these symptoms seek medical advice
immediately.
• a combination of fever, faster breathing, sweating,
muscle stiffness and drowsiness or sleepiness (the
frequency of this side effect cannot be estimated from
the available data).
Other side effects
Very common (may affect more than 1 in 10 people):
• Weight gain.
• Sleepiness.
• Increases in the levels of prolactin in the blood.
In the early stages of treatment, some people may feel
dizzy or faint (with a slow heart rate), especially when
getting up from a lying or sitting position. This will usually
pass on its own but if it does not, tell your doctor.
Common (may affect up to 1 in 10 people):
• Increases in the levels of some blood cells, circulating
fats and early in treatment, temporary increases in liver
enzymes.
• Increases in the level of sugars in the blood and urine.
• Increases in levels of uric acid and creatine
phosphokinase in the blood;
• Feeling more hungry.
• Dizziness.
• Restlessness.
• Tremor
• Unusual movements (dyskinesia)
• Constipation.
• Dry mouth.
• Rash.
• Loss of strength
• Extreme tiredness
• Water retention leading to swelling of the hands, ankles
or feet
• Fever; joint pain
• Sexual dysfunctions such as decreased libido in males
and females or erectile dysfunction in males.
Uncommon (may affect up to 1 in 100 people):
• hypersensitivity (e.g. swelling in the mouth and throat,
itching, rash)
• diabetes or the worsening of diabetes, occasionally
associated with ketoacidosis (ketones in the blood and
urine) or coma
• seizures, usually associated with a history of seizures
(epilepsy)
• muscle stiffness or spasms (including eye movements)
• problems with speech
• slow heart rate.
• sensitivity to sunlight.
• bleeding from the nose
• abdominal distension
• memory loss or forgetfulness
• urinary incontinence
• lack of ability to urinate
• hair loss.
• absence or decrease in menstrual periods
• changes in breasts in males and females such as an
abnormal production of breast milk or abnormal growth.

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 Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE OLANZAPINE
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date, which is
stated on the carton and blister/bottle.
Store in the original container in order to protect from
light and moisture.
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 Olanzapine contains
Olanzapine 5 mg contains 5 mg of olanzapine as the
active ingredient.
Olanzapine 10 mg contains 10 mg of olanzapine as the
active ingredient.
Olanzapine 15 mg contains 15 mg of olanzapine as the
active ingredient.
Olanzapine 20 mg contains 20 mg of olanzapine as the
active ingredient.
The other ingredients are mannitol, microcrystalline
cellulose, guar gum, crospovidone (type A), magnesium
stearate, colloidal anhydrous silica, aspartame (E951) and
sodium laurilsulfate.
What Olanzapine looks like and contents of the pack
Olanzapine 5 mg is supplied as light yellow to yellow
coloured, plain to mottled, round, flat faced, bevelled
edged tablets debossed with “M” on one side and “OE1” on
other side.
Olanzapine 10 mg is supplied as light yellow to yellow
coloured, plain to mottled, round, flat faced, bevelled
edged tablets debossed with “M” on one side and “OE2” on
other side.
Olanzapine 15 mg is supplied as light yellow to yellow
coloured, plain to mottled, round, flat faced, bevelled
edged tablets debossed with “M” on one side and “OE3” on
other side.
Olanzapine 20 mg is supplied as light yellow to yellow
coloured, plain to mottled, round, flat faced, bevelled
edged tablets debossed with “M” on one side and “OE4” on
other side.
Olanzapine orodispersible tablets are supplied in nonperforated blisters containing 7, 10, 14, 28, 30, 35, 56,
60, 70, 98, 100 tablets, perforated unit-dose blisters
containing (7, 10, 14, 28, 30, 35, 56, 60, 70, 98, 100) x
1 tablets and bottles containing 7, 10, 14, 28, 30, 56, 98,
100, 250, 500 tablets. The bottles also contain a desiccant.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Jenson Pharmaceutical Services Limited
Carradine House
237 Regents Park Road
London N3 3LF
Manufacturers:
Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Mylan Hungary Kft,
H-2900 Komarom,
Mylan utca 1,
Hungary.
This leaflet was last revised in May 2014.

Rare side effects (may affect up to 1 in 1000 people)
• lowering of normal body temperature.
• abnormal rhythms of the heart
• sudden unexplained death
• inflammation of the pancreas causing severe stomach pain
• fever and sickness
• liver disease appearing as yellowing of the skin and
white parts of the eyes
• muscle disease presenting as unexplained aches and pains
• prolonged and/or painful erection.
While taking olanzapine, elderly patients with dementia
may suffer from stroke, pneumonia, urinary incontinence,
falls, extreme tiredness, visual hallucinations (seeing things
that are not there), a rise in body temperature, redness of
the skin and have trouble walking. Some fatal cases have
been reported in this particular group of patients.
In patients with Parkinson’s disease Olanzapine may
worsen the symptoms and cause hallucinations (seeing,
hearing or feeling things that are not there).

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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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