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OLANZAPINE SANDOZ 2.5 MG FILM-COATED TABLETS

Active substance(s): OLANZAPINE / OLANZAPINE / OLANZAPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ05101LT05A

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withdrawn.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.

you need to know before
2 What
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)
• Parkinson’s 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 Parkinson’s 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.

Continued on the next page >>

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.
• Restless legs syndrome
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.
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.
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 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.

of the pack and other
6 Contents
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., 16 Podlipie Str., 95-010 Strykow,
Poland
or
LEK S.A., 50 Domaniewska Str., 02-672
Warsaw, Poland
or
Lek Pharmaceuticals d.d., Verovskova 57,
SI-1526 Ljubljana, Slovenia
This leaflet was last revised in 08/2017.
SZ05101LT05A
46210785

LF 46210785 OLAN SDZ 2,5;5;7,5;10;15;20MG GB
1
PROCESS BLACK

13 303

1

165x594

46210785

AW DESCRIPTION

draft: 44037734, 44037735, 44037736,
44040184, 44037737, 44037738,
44037739
laetus code: 13303
mat.no.: 46210785

Artwork Proof Box

Ref: N003 - Cutter guide update and BR amendment
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Date prepared:
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Colours:
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Dimensions: 165 x 594 mm

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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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