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OLANZAPINE 7.5 MG ORODISPERSIBLE TABLETS

Active substance(s): OLANZAPINE / OLANZAPINE

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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 only for you.
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
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
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 belongs to a group of medicines called
antipsychotics and is used to treat the following
conditions:
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and becoming withdrawn.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.
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
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 or pharmacist before you take
Olanzapine
The use of Olanzapine in elderly patients with
dementia is not recommended as it may have
serious side effects.
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.
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 formation of
blood clots.
If you suffer from any of the following illnesses tell
your doctor as soon as possible:
• Stroke or “mini” stroke (temporary symptoms of
stroke)
• Parkinson’s disease
• Prostate problems
• A blocked intestine (Paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease

Colour Black

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 if you
experience any of the above symptoms. 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.

• Diabetes
• Seizures
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
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).
Tell your doctor if you are taking or 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 Torrent dose.
Olanzapine with alcohol
Do not drink any alcohol if you have been given
Olanzapine as together with alcohol it 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 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.

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 have 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).
Very common side effects (may affect more than 1
user in 10 people) include weight gain; sleepiness;
and increases in 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 side effects (may affect up to 1 to 10 people)
include changes 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 (dyskinesias); constipation; dry
mouth; rash; loss of strength; extreme tiredness;
water retention leading to swelling of the hands,
ankles or feet; fever; joint pain; and sexual
dysfunctions such as decreased libido in males and
females or erectile dysfunction in males.
Uncommon side effects (may affect up to 1 to 100
people) include 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); restless legs syndrome;
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; and
changes in breasts in males and females such as an
abnormal production of breast milk or abnormal
growth.
Rare side effects (may affect up to 1 in 1000 people)
include 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

3. HOW TO TAKE OLANZAPINE
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 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 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.
The score line is not intended for breaking the tablet.
Olanzapine tablets break easily, so you should handle
the tablets carefully. Therefore please do not push the
tablets through the blister foil. Do not handle the
tablets with wet hands as the tablets may break up.
Olanzapine is available in two different packaging
materials: blisters and peel-off blisters. For peel-off
blisters please follow these instruction steps:
1. 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.
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

LOCATION : Baddi
SIZE

COUNTRY : UK

: 160 x 350 mm_Front / Back Side

Supersedes A / W No.:
CODE : 8054991-7803

DATE : 14-02-2017

REMARK : Folding Length 35 mm
SUBSTRATE :
Activities

Department

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Date

Prepared By Pkg.Dev
Reviewed By Pkg.Dev
Approved By Quality

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aches and pains; and prolonged and/or painful erection.
Very rare side effects include serious allergic
reactions such as Drug Reaction with Eosinophilia and
Systemic Symptoms (DRESS). DRESS appears
initially as flu-like symptoms with a rash on the face
and then with an extended rash, high temperature,
enlarged lymph nodes, increased levels of liver
enzymes seen in blood tests and an increase in a type
of white blood cell (eosinophilia).
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.
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 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. The expiry date refers to the last
day of that month.
Store in the original package in order to protect from
light
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.
6. Contents of the pack and other information
What Olanzapine contains:
The active substance is: olanzapine.
Olanzapine 2.5 mg orodispersible tablets: Each
orodispersible tablet contains 2.5 mg of olanzapine.
Olanzapine 5 mg orodispersible tablets: Each
orodispersible tablet contains 5 mg of olanzapine.
Olanzapine 7.5 mg orodispersible tablets: Each
orodispersible tablet contains 7.5 mg of olanzapine.
Olanzapine 10 mg orodispersible tablets: Each
orodispersible tablet contains 10 mg of olanzapine.
Olanzapine 15 mg orodispersible tablets: Each
orodispersible tablet contains 15 mg of olanzapine.
Olanzapine 20 mg orodispersible tablets: Each
orodispersible tablet contains 20 mg of olanzapine.
The other ingredients are:
mannitol (E 421), aspartame (E 951), crospovidone,
microcrystalline cellulose, magnesium stearate.
What Olanzapine looks like and contents of the
pack:
Olanzapine 2.5mg are yellow coloured, round, flat,
bevel edged uncoated tablets, debossed “2.5” on one
side and plain on other side.
Olanzapine 5mg are yellow coloured, round, flat, bevel
edged uncoated tablets with a score line on one side
and debossed “5” on other side.
Olanzapine 7.5mg are yellow coloured, round, flat,
bevel edged uncoated tablets with a score line on one
side debossed “7.5” on other side.
Olanzapine 10mg are yellow coloured, round, flat,
bevel edged uncoated tablets with a score line on one
side and debossed “10” on other side.
Olanzapine 15mg are yellow coloured, round, flat,
bevel edged uncoated tablets with a score line on one
side and debossed “15” on other side.
Olanzapine 20mg are yellow coloured, round, flat,
bevel edged uncoated tablets with a score line on one
side and debossed “20” on other side.
Pack sizes:
Pack sizes: 10, 14, 28, 30, 35, 50, 56, 70 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court
County Oak Way, Crawley West Sussex, RH11 7XA
United Kingdom
Telephone: (01293) 574180
Fax: (01293) 533003
Email: drugsafety@torrentpharma.co.uk
This leaflet was last revised in 02/2017.
8054991-7803

PACKAGE LEAFLET: INFORMATION FOR THE USER
Olanzapine 2.5 mg orodispersible tablets
Olanzapine 5 mg orodispersible tablets
Olanzapine 7.5 mg orodispersible tablets
Olanzapine 10 mg orodispersible tablets
Olanzapine 15 mg orodispersible tablets
Olanzapine 20 mg orodispersible tablets
olanzapine

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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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