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OLANZAPINE 7.5 MG ORODISPERSIBLE TABLETS

Active substance(s): OLANZAPINE

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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
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.
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and becoming withdrawn.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
Olanzepine. 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
• 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).

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.

Tell your doctor if you are taking or have recently
taken or might take any other medicines,

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
Common side effects (may affect up to 1 in 10 people)
include 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; and sexual dysfunctions
such as decreased libido in males and females or
erectile dysfunction in males.
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.
Uncommon side effects (may affect up to 1in 100
people) include slow heart rate; sensitivity to sunlight;
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.
Other additional side effects for which a frequency
cannot be estimated from the available data (not
known) include 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);
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; and prolonged and/or painful
erection.
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.

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.
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.
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.
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 if you experience any
of the above symptoms. Show the doctor your pack of
tablets.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

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.
Each orodispersible tablet contains 2.5 mg of
olanzapine.
Each orodispersible tablet contains 5 mg of olanzapine.
Each orodispersible tablet contains 7.5 mg of
olanzapine.
Each orodispersible tablet contains 10 mg of
olanzapine.
Each orodispersible tablet contains 15 mg of
olanzapine.
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 break line on one side
and debossed “5” onother side.
Olanzapine 7.5mg are yellow coloured, round, flat,
bevel edged uncoated tablets with a break line on one
side debossed “7.5” on other side.
Olanzapine 10mg are yellow coloured, round, flat,
bevel edged uncoated tablets with a break line on one
side and debossed “10” on other side.
Olanzapine 15mg are yellow coloured, round, flat,
bevel edged uncoated tablets with a break line on one
side and debossed “15” on other side.
Olanzapine 20mg are yellow coloured, round, flat,
bevel edged uncoated tablets with a break 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
Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg, Deutschland
Telephone: +49 (0) 911 4302 970
Fax: +49 (0) 911 4302 971
E-mail: mail@torrentpharma.de
Manufacturer
Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg, Deutschland
Telephone: +49 (0) 911 4302 970
Fax: +49 (0) 911 4302 971
E-mail: mail@torrentpharma.de
This leaflet was last approved in 07/2012

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

8036991-7803

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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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