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OLANZAPINE SANDOZ 10 MG ORODISPERSIBLE TABLET

Active substance(s): OLANZAPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

OLANZAPINE SANDOZ 5 MG ORODISPERSIBLE TABLETS
OLANZAPINE SANDOZ 10 MG ORODISPERSIBLE TABLETS
OLANZAPINE SANDOZ 15 MG ORODISPERSIBLE TABLETS
OLANZAPINE SANDOZ 20 MG ORODISPERSIBLE TABLETS

SZ00000LT000

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 your 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. 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 it 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and becoming withdrawn.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 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 older people 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.
• 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 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.

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 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.
1 & 2.
3.
4.

Hold the blister strip at the edges
Gently push the tablet out
Put the tablet in your mouth. It will dissolve
directly in your mouth, so 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 and possibly become cloudy. Drink it straight
away.

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.

Continued on the next page >>

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.
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 (a
rare side effect that may affect up to 1 in 1,000
people).

Very common side effects (may affect more than 1 in
10 people) include:
• Weight gain
• Sleepiness
• Increases in the 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 in 10
people) include:
• Changes in the levels of some blood cells and
circulating fats.
• Temporary increases in liver enzymes, especially
early in treatment.
• 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.
• 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) 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).
• 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.
• 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 1,000 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 aches
and pains.
• Prolonged and/or painful erection.
While taking olanzapine, older people 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 (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 the sight and reach of
children.

Do not use this medicine after the expiry date, which
is stated on the carton and blister after EXP. The
expiry date refers to the last day of the month.
Store in the original pack in order to protect from
light and moisture.

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
Olanzapine Orodispersible Tablet contains 5 mg,
10 mg, 15 mg or 20 mg of the active substance.
• The other ingredients are crospovidone (type A),
lactose monohydrate, colloidal silicon dioxide
(anhydrous), hydroxypropylcellulose mint flavour
(consisting of: mint oil, terpeneless mint oil,
eucalyptol, menthone, isomenthone, methylene
acetate, menthol), talc, magnesium stearate

What Olanzapine looks like and contents of the
pack
Olanzapine 5 mg, 10 mg, 15 mg and 20 mg are
yellow Orodispersible Tablets. Orodispersible Tablet
is the technical name for a tablet which dissolves
directly in your mouth, so that it can be easily
swallowed.
Olanzapine 5 mg, 10 mg, 15 mg and 20 mg
Orodispersible Tablets are available in cartons
containing 7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 70,
98, 100 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer
Lek Pharmaceuticals d.d., Verovškova 57, 1526
Ljubljana, Slovenia or Lek Pharmaceuticals d.d.,
Trimlini 2D, 9220 Lendava, Slovenia or LEK S.A., ul.
Podlipie 16, 95-010 Stryków, Poland or LEK S.A., ul.
Domaniewska 50 C, 02-672 Warszawa, Poland or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or Salutas Pharma
GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany
or S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A,
RO-540472 Targu-Mures, Romania
This leaflet was last revised in 12/2013

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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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