OLANZAPINE 20MG FILM-COATED TABLETS

Active substance: OLANZAPINE

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2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE OLANZAPINE
FILM-COATED TABLETS

Pharma Code

Item Code

Package Leaflet: Information for the user Do not take Olanzapine Film-coated
Tablets:
• if you are allergic (hypersensitive) to
OLANZAPINE
olanzapine or any of the other ingredients
2.5mg, 5mg, 7.5mg, 10mg,
of this medicine (listed in section 6). An
15mg AND 20mg
allergic reaction may be recognised as a
FILM-COATED TABLETS
rash, itching, a swollen face, swollen lips
or shortness of breath. If this has
olanzapine
happened to you, tell your doctor.
Read all of this leaflet carefully before
• if you have been previously diagnosed
you start taking this medicine because it
with eye problems such as certain kinds
contains important information for you.
of glaucoma (increased pressure in the
• Keep this leaflet. You may need to
eye).
read it again.
• If you have any further questions, ask Warnings and precautions
Talk to your doctor or pharmacist before you
your doctor or pharmacist.
take Olanzapine Film-coated Tablets.
• This medicine has been prescribed
• The use of Olanzapine Film-coated
for you only. Do not pass it on to
Tablets in elderly patients with dementia
others. It may harm them, even if their
is not recommended as it may have
signs of illness are the same as yours.
serious side effects.
• If you get any side effects talk to your • Medicines of this type may cause
doctor or pharmacist. This includes
unusual movements mainly of the face or
any possible side effects not listed in
tongue. If this happens after you have
this leaflet.
been given Olanzapine Film-coated
IN THIS LEAFLET
1. What Olanzapine Film-coated Tablets
are and what they are used for
2. What you need to know before you take
Olanzapine Film-coated Tablets
3. How to take Olanzapine Film-coated
Tablets
4. Possible side effects
5. How to store Olanzapine Film-coated
Tablets
6. Contents of the pack and other
information
1. WHAT OLANZAPINE FILM-COATED
TABLETS ARE AND WHAT THEY
ARE USED FOR

Tablets 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 Film-coated Tablets.
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
Film-coated Tablets. Your doctor should
do blood tests to check blood sugar and
certain fat levels before you start taking
Olanzapine Film-coated Tablets and
regularly during treatment.
• Tell the doctor if you or someone else in
your family has a history of blood clots,
as medicines like these have been
associated with the formation of blood
clots.

Olanzapine Film-coated Tablets belong to a
group of medicines called antipsychotics
and are used to treat the following
conditions:
• Schizophrenia, a disease with symptoms
such as hearing, seeing or sensing things
which are not there, mistaken beliefs,
If you suffer from any of the following
unusual suspiciousness, and becoming illnesses tell your doctor as soon as
withdrawn. People with this disease may possible:
also feel depressed, anxious or tense.
• Stroke or “mini” stroke
• Moderate to severe manic episodes, a
(temporary symptoms of stroke)
condition with symptoms of excitement or • Parkinson’s disease
euphoria.
• Prostate problems
• A blocked intestine (Paralytic ileus)
Olanzapine has been shown to prevent
• Liver or kidney disease
recurrence of these symptoms in patients
• Blood disorders
with bipolar disorder whose manic episode
• Heart disease
has responded to olanzapine treatment.

• Diabetes
• Seizures
See also section 4, “Possible side effects”.
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 Film-coated Tablets are not
suitable for patients who are under 18
years.
Other medicines and Olanzapine
Film-coated Tablets
Only take other medicines while you are on
Olanzapine Film-coated Tablets if your
doctor tells you that you can. You might feel
drowsy if Olanzapine Film-coated Tablets
are taken in combination with
antidepressants or medicines taken for
anxiety or to help you sleep (tranquilisers).
Tell your doctor if you are taking, have
recently taken or might take any other
medicines.
In particular, 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) - it may be necessary to
change your Olanzapine dose

Driving and using machines
There is a risk of feeling drowsy when you
are given Olanzapine Film-coated Tablets. If
this happens do not drive or operate any
tools or machines. Tell your doctor.
Olanzapine Film-coated Tablets contain
lactose
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.
3. HOW TO TAKE OLANZAPINE
FILM-COATED TABLETS
Always take this medicine 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 Film-coated Tablets to take and
how long you should continue to take them.
The daily dose of Olanzapine Film-coated
Tablets is between 5 and 20mg. Consult
your doctor if your symptoms return but do
not stop taking Olanzapine Film-coated
Tablets unless your doctor tells you to.
You should take your Olanzapine
Film-coated 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 Film-coated Tablets are for oral
use. You should swallow the Olanzapine
Film-coated Tablets whole with water.

Olanzapine Film-coated Tablets with
alcohol
Do not drink any alcohol if you have been
If you take more Olanzapine Film-coated
given Olanzapine Film-coated Tablets as
Tablets than you should
Olanzapine and alcohol together may make
Patients who have taken more Olanzapine
you feel drowsy.
Film-coated Tablets than they should have
experienced the following symptoms:
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think rapid beating of the heart,
agitation/aggressiveness, problems with
you may be pregnant or are planning to
speech, unusual movements (especially of
have a baby, ask your doctor for advice
before taking this medicine. You should not the face or tongue) and reduced level of
be given this medicine when breast-feeding, consciousness. Other symptoms may be:
acute confusion, seizures (epilepsy), coma,
as small amounts of Olanzapine
a combination of fever, faster breathing,
Film-coated Tablets can pass into breast
sweating, muscle stiffness and drowsiness
milk.
or sleepiness, slowing of the breathing rate,
The following symptoms may occur in
aspiration, high blood pressure or low blood
newborn babies, of mothers that have used
pressure, abnormal rhythms of the heart.
Olanzapine in the last trimester (last three
months of their pregnancy): shaking,
Contact your doctor or hospital straight
muscle stiffness and/or weakness,
away if you experience any of the above
sleepiness, agitation, breathing problems,
symptoms. Show the doctor your pack of
and difficulty in feeding. If your baby
tablets.
develops any of these symptoms you may
need to contact your doctor.
CP.OLZ.JNT.T.V5P2

If you forget to take Olanzapine
Film-coated Tablets
Take your tablets as soon as you
remember. Do not take two doses in one
day.

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Item Code

Common side effects (may affect up to 1 in
10 people) include:
• changes in the levels of some blood
cells and circulating fats and early in
treatment, temporary increases in liver
enzymes
If you stop taking Olanzapine
• increases in the level of sugars in the
Film-coated Tablets
blood and urine
Do not stop taking your tablets just because • increases in levels of uric acid and
you feel better. It is important that you carry
creatine phosphokinase in the blood
on taking Olanzapine Film-coated Tablets
• feeling more hungry
for as long as your doctor tells you.
• dizziness
• restlessness
If you suddenly stop taking Olanzapine
• tremor
Film-coated Tablets, symptoms such as
• unusual movements (dyskinesias)
sweating, unable to sleep, tremor, anxiety
• constipation
or nausea and vomiting might occur. Your
• dry mouth
doctor may suggest you to reduce the dose
• rash
gradually before stopping treatment.
• loss of strength
• extreme tiredness
If you have any further questions on the
• water retention leading to swelling of
use of this medicine, ask your doctor or
the hands, ankles or feet, fever, joint pain
pharmacist.
and sexual dysfunction such as
decreased libido in males and females or
erectile dysfunction in males
4. POSSIBLE SIDE EFFECTS
Uncommon side effects (may affect up to 1
Like all medicines, this medicine can cause in 100 people) include:
• hypersensitivity (e.g. swelling in the
side effects, although not everybody gets
mouth and throat, itching, rash)
them.
• diabetes or the worsening of diabetes,
occasionally associated with ketoacidosis
Tell your doctor immediately if you
(ketones in the blood and urine) or coma
experience any of these symptoms:
• seizures, usually associated with a
• unusual movement (a common side
history of seizures (epilepsy)
effect that may affect up to 1 in 10
• muscle stiffness or spasms (including
people) mainly of the face or tongue
eye movements)
• blood clots in the veins (an uncommon
• problems with speech
side effect that may affect up to 1 in 100
people) especially in the legs (symptoms • slow heart rate
include swelling, pain, and redness in the • sensitivity to sunlight
• bleeding from the nose
leg), which may travel through blood
• abdominal distension
vessels to the lungs causing chest pain
• memory loss or forgetfulness
and difficulty in breathing. If you notice
• urinary incontinence; lack of ability to
any of these symptoms seek medical
urinate
advice immediately
• hair loss
• a combination of fever, faster breathing,
• absence or decrease in menstrual periods
sweating, muscle stiffness and
• changes in breasts in males and females
drowsiness or sleepiness (the frequency
such as abnormal production of breast
of this side effect cannot be estimated
milk or abnormal growth
from the available data)
Tell your doctor if any of the below side
effects start bothering you.

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 Film-coated Tablets may
worsen the symptoms.
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet.
Reporting of side effects
Also you can help to make sure that
medicines remain as safe as possible by
reporting any unwanted side effects via the
internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to
2 p.m. Mondays to Fridays) or fill in a paper
form available from your local pharmacy.
5. HOW TO STORE OLANZAPINE
FILM-COATED TABLETS
KEEP OUT OF THE SIGHT AND REACH
OF CHILDREN.
Do not use this medicine after the expiry
date, which is stated on the blister and
carton. The expiry date refers to the last
day of that month.
Store below 25°C.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required.
These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION

Rare side effects (may affect up to 1 in
1000 people) include:
What Olanzapine Film-coated Tablets
• lowering of normal body temperature
Very common side effects (may affect more
contain
• abnormal rhythms of the heart
than 1 in 10 people) include:
• The active substance is olanzapine.
• sudden unexplained death
• weight gain
Each Olanzapine Film-coated Tablet
• inflammation of the pancreas causing
• sleepiness
contains either 2.5mg, 5mg, 7.5mg,
severe stomach pain, fever and sickness
• increases in the levels of prolactin in the
10mg, 15mg or 20mg of the active
• liver disease appearing as yellowing of
blood
substance. The exact amount is shown
In the early stages of treatment, some
the skin and white parts of the eyes
on your Olanzapine tablet pack.
people may feel dizzy or faint (with a slow
• muscle disease presenting as
• The other ingredients are (tablet core)
heart rate), especially when getting up from
unexplained aches and pains
lactose monohydrate, hyprolose (E463),
a lying or sitting position. This will usually
• prolonged and/or painful erection
crospovidone (E1202), microcrystalline
pass on its own but if it does not, tell your
cellulose (E460), magnesium stearate
doctor.

(E572) and (tablet coating) polyvinyl
alcohol, talc (E553b), titanium dioxide
(E171), lactose monohydrate and
triacetin.
What Olanzapine Film-coated Tablets
look like and contents of the pack
Olanzapine 2.5mg Film-coated Tablets are
off-white to pale yellow and debossed with
“J” on one side and “2.5” on the other.
Olanzapine 5mg Film-coated Tablets are
off-white to pale yellow and debossed with
“J” on one side and “5” on the other.
Olanzapine 7.5mg Film-coated Tablets are
off-white to pale yellow and debossed with
“J” on one side and “7.5” on the other.
Olanzapine 10mg Film-coated Tablets are
off-white to pale yellow and debossed with
“J” on one side and “10” on the other.
Olanzapine 15mg Film-coated Tablets are
off-white to pale yellow and debossed with
“J” on one side and “15” on the other.
Olanzapine 20mg Film-coated Tablets are
off-white to pale yellow and debossed with
“J” on one side and “20” on the other.
Olanzapine 2.5mg, 5mg, 7.5mg, 10mg and
15mg Film-coated Tablets are available in
28, 50, 56, 60 and 70 tablet packs.
Olanzapine 20mg Film-coated Tablets are
available in 28 tablet packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited,
Ballymurray, Co. Roscommon, Ireland.
Distributor and manufacturer
responsible for batch release
Kent Pharmaceuticals Limited,
Repton Road, Measham, DE12 7DT, U.K.
PL 30464/0097-0102
This leaflet was last revised in June
2013.

CP.OLZ.JNT.T.V5P2

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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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