OLANZAPINE SANDOZ 2.5 MG FILM-COATED TABLETS

Active substance: OLANZAPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Olanzapine Sandoz 2.5 mg Film-coated Tablets
Olanzapine Sandoz 5 mg Film-coated Tablets
Olanzapine Sandoz 7.5 mg Film-coated Tablets
Olanzapine Sandoz 10 mg Film-coated Tablets
Olanzapine Sandoz 15 mg Film-coated Tablets
Olanzapine Sandoz 20 mg Film-coated 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 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becoming withdrawn.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.
• 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.
• 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.
• 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.

If you suffer from any of the following
illnesses tell your doctor as soon as
possible:

• Stroke or “mini” stroke (temporary
symptoms of stroke)
• Parkinsonʼs disease
• Prostate problems
• A blocked intestine (Paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• 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 or pharmacist if you are
taking, have recently taken or might take
any other medicines.

In particular, tell your doctor if you are
taking:
• medicines for Parkinsonʼs disease
(dopamine agonists)
• carbamazepine (an anti-epileptic and
mood stabiliser), fluvoxamine (an
antidepressant) or ciprofloxacin (an
antibiotic) - it may be necessary to
change your Olanzapine 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 who 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 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

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 film-coated tablets are for oral
use. You should swallow the Olanzapine
tablets with water.

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.

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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).

Very common side effects (may affect
more than 1 in 10 people):
• Weight gain
• Sleepiness
• Increases in the levels of prolactin in the
blood.

Common side effects (may affect up to 1 in
10 people):
• 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 people):
• Slow heart rate
• Sensitivity 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.

Other additional side effects for which a
frequency cannot be estimated from the
available data (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)
• 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
• 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.

5

How to store Olanzapine

Keep this medicine out of the sight and
reach of children.

Do not use this medicine after the expiry
date which is stated on the carton and on
the blister/label of the HDPE-bottle. The
expiry date refers to the last day of that
month.
This medicinal product does not require
any special storage conditions.

Do not use Olanzapine after 6 months
have elapsed from opening of the
HDPE-bottle.

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 film-coated tablet contains either
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or
20 mg of olanzapine.

The other ingredients are
Tablet core: lactose monohydrate,
hydroxypropylcellulose, crospovidone,
microcrystalline cellulose, magnesium
stearate.
Tablet coat: polyvinyl alcohol, macrogol
3350, titanium dioxide (E 171), talc.
In addition for Olanzapine 15 mg
film-coated tablets: indigo carmine (E 132).
In addition for Olanzapine 20 mg
film-coated tablets: iron oxide red (E 172).
What Olanzapine looks like and
contents of the pack
Olanzapine Sandoz 2.5 mg Film-coated
Tablets are white and round (6.5 mm
diameter).

Olanzapine Sandoz 5 mg Film-coated
Tablets are white and round (8 mm
diameter) with a breaking notch on one
side. The film-coated tablets can be
divided into equal doses.

Olanzapine Sandoz 7.5 mg Film-coated
Tablets are white and round (9 mm
diameter).

Olanzapine Sandoz 10 mg Film-coated
Tablets are white and round (10 mm
diameter) with a breaking notch on one
side. The film-coated tablets can be
divided into equal doses.

Olanzapine Sandoz 15 mg Film-coated
Tablets are light blue and oval (12 mm
length) with a breaking notch on both
sides. The film-coated tablets can be
divided into equal doses.

Olanzapine Sandoz 20 mg Film-coated
Tablets are pink and oval (13 mm length)
with a breaking notch on both sides. The
film-coated tablets can be divided into
equal doses.

Olanzapine is available in blister packs
containing 7, 10, 14, 20, 28, 30, 35, 50, 56,
60, 70, 98, 100 or 500 film-coated tablets
and in HDPE-bottles containing 50, 100,
250 or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany
or

Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen,
Germany
or

LEK S.A.,
Ul. Podlipie 16 C, 95010 Strykow,
Poland
or

LEK S.A.,
Ul. Domaniewska 50 C, 02-672 Warsaw,
Poland
or

Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljublana,
Slovenia.

This leaflet was last revised in 02/2013.

In patients with Parkinson's disease
Olanzapine may worsen the symptoms.

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

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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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