OLANZAPINE 10 MG TABLETS

Active substance: OLANZAPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapine 2.5mg, 5mg, 7.5mg, 10mg,
15mg, 20mg 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 pharmacist.
• This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
• If you get any side effects talk to your
doctor or 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. Before you take Olanzapine tablets.
3. How to take Olanzapine tablets.
4. Possible side effects.
5. How to store Olanzapine tablets.
6. Contents of the pack and other
information
1. What olanzapine is and what is it
used for
Olanzapine 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withdrawn.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 of excitement or euphoria.
Olanzapine has been shown to prevent
recurrence of these symptoms in
patients with bipolar disorder whose
manic episode has responded to
olanzapine treatment.
2. What you need to know before
you take Olanzapine tablets
Do not take Olanzapine tablets
• If you are allergic (hypersensitive)
to olanzapine or to any of the other
ingredients of this medicine (listed in
section 6). An allergic reaction can
be recognised as a rash, itching,
a swollen face, swollen lips or
shortness of breath. If this 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 or pharmacist before
you take Olanzapine tablets.
• Tell your doctor 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.
• 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.
• Very 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.
• 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
• Liver or kidney disease
• Parkinson’s disease
• Seizures

• Prostate problems
• A blocked intestine (Paralytic ileus)
• Blood disorders
• 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
tablets
Only take other medicines while you
are on olanzapine if your doctor tells
you that you can. You may feel drowsy
if olanzapine is taken in combination
with antidepressants or medicines
taken for anxiety or to help you sleep
(tranquillisers).
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.
• carbamazepine (an anti-epileptic and
mood stabiliser), fluvoxamine (an
antidepressant) or ciprofloxacin (an
antibiotic), as it may be necessary to
change your olanzapine dose.
Olanzapine tablets with alcohol
Do not drink any alcohol while you have
been given olanzapine as olanzapine
and alcohol together 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
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 when
you are given olanzapine. If this
happens, do not drive or operate any
tools or machines. Tell your doctor.
Olanzapine tablets contain lactose
This medicine contains lactose. If you
have been told by your doctor that
you have intolerance to some sugars
contact your doctor before taking this
medicine.
3. How to take Olanzapine tablets
• Always take Olanzapine tablets
exactly as your doctor 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 daily dose of olanzapine
is between 5 and 20 mg. Consult
your doctor if your symptoms return
but do not stop taking Olanzapine
tablets 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 tablets are for oral use.
You should swallow the Olanzapine
tablets whole with water.
If you take more Olanzapine tablets
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 if you experience
any of the above symptoms. Show the
doctor your pack of tablets.
If you forget to take Olanzapine
tablets
Take your tablet as soon as you
remember it. Do not take two doses in
one day.
If you stop taking Olanzapine tablets
Do not stop taking your tablets just
because you feel better. It is important
that you carry on taking Olanzapine
tablets for as long as your doctor tells
you.
If you suddenly stop taking Olanzapine
tablets, 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.

Other possible side effects which
frequency cannot be estimated from
the available data: frequency not
known
• Allergic reaction (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.
• Lowering of normal body temperature.
• Seizures usually associated with a
history of seizures (epilepsy).
• Combination of fever, faster breathing,
sweating, muscle stiffness and
drowsiness or sleepiness.
• Spasms of the muscle of the eye
causing rolling movement of the eye.
• 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.
• Difficulty in passing urine.
• Prolonged and/or painful erection.

4. Possible Side effects

While taking olanzapine, elderly
patients with dementia may suffer
from stroke, pneumonia, urinary
incontinence, falls, extreme tiredness,
visual hallucinations, 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.

Like all medicines, olanzapine can
cause side effects, although not
everybody gets them.

If you get any side effects, talk to your
doctor or pharmacist. This includes any
side effects not listed in this leaflet.

Tell your doctor immediately if you
have:
• unusual movement (a common side
effect that may affect up to 1 in 10
users) mainly of the face or tongue;
• blood clots in the veins (an uncommon
side effect that may affect up to 1
in 100 users) 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).

5. How to store Olanzapine tablets
Keep this medicine out of the reach and
sight of children.
Do not use this medicine after the expiry
date which is stated on the carton.
Store in the original package.
This medicine does not require any
special storage conditions.
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 to protect the
environment.

If you have any further questions on
the use of this product, ask your doctor
or pharmacist.

Very common side effects: may
affect more than 1 in 10 users
• Weight gain.
• Sleepiness.
• Increases in the levels of prolactin in
the blood.
Common side effects: may affect up
to 1 in 10 users
• Changes in the levels of some blood
cells and circulating fats.
• Increases in the level of sugars in the
blood and urine.
• Feeling more hungry.
• Dizziness.
• Restlessness.
• Tremor.
• Muscle stiffness or spasm (including
eye movements).
• Problems with speech.
• Constipation.
• Dry mouth.
• Rash.
• Loss of strength.
• Extreme tiredness.
• Water retention leading to swelling of
the hands, ankles or feet.
• 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.
• Sexual dysfunctions such as
decreased libido in males and
females or erectile dysfunction in
males.
Uncommon side effects: may affect
up to 1 in 100 users
• Slow heart rate.
• Make you sensitive to sunlight.
• 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.

6. Contents of the pack and other
information
What Olanzapine tablets contain
The active substance is olanzapine.
Each Olanzapine tablet contains either
2.5mg, 5mg, 7.5mg, 10mg, 15mg or
20mg of the active substance.
The other ingredients are:
Microcrystalline cellulose, anhydrous
lactose, crospovidone, magnesium
stearate.
What Olanzapine tablets look like
and contents of the pack
Olanzapine is supplied in the form of
tablets.
Description: Olanzapine 2.5mg, 5mg,
7.5mg, 10mg, 15mg tablets are yellow,
cylindrical and biconvex.
Olanzapine 20 mg tablets are yellow,
oblong and biconvex.
Olanzapine tablets are available in 28,
30, 56 and 100 tablets packs.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Galenicum Health, S.L. Avda Diagonal
123, planta 11, 08005 Barcelona,
Spain
Manufacturer and Distributor:
Dexcel®-Pharma Ltd., 7 Sopwith
Way, Drayton Fields Industrial Estate,
Daventry, Northamptonshire, NN11
8PB, UK
This leaflet was last revised in
02/2013
Other sources of information
Detailed information on this medicine is
available on the web site of electronic
Medicines Compendium (eMC) web
site: http://www.medicines.org.uk/emc/

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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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