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OLANZAPINE SANDOZ 20 MG ORODISPERSIBLE TABLET

Active substance(s): OLANZAPINE

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Załącznik A/Enclosure A
nazwa/name:

LF 46106108 OLANZAPINE 5;10;15;20MG ODT GB
nr korekty/
pharmacode:
correction:

1
kolorystyka/colours:
PROCESS BLACK

strona/page

11292

1

wymiary wewnętrzne/dimentions [mm]

165x420

46106108

przygotowano do druku + data/prepared for print + date:

SMS/DRO/46106108

zatwierdził/accepted:

AW DESCRIPTION

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

Children and adolescents
Olanzapine is not for patients who are
under 18 years.

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.

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,
• carbamazepine (an anti-epileptic and
mood stabiliser), fluvoxamine (an
antidepressant) or ciprofloxacin (an
antibiotic) - it may be necessary
to change your Olanzapine dose.

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

Olanzapine with alcohol
Do not drink any alcohol if you have been
given Olanzapine as together with alcohol
it may make you feel drowsy.

1. WHAT OLANZAPINE IS AND
WHAT IT IS USED FOR

Olanzapine contains the active substance
olanzapine. It 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.

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.

Olanzapine has been shown to prevent
recurrence of these symptoms in patients
with bipolar disorder whose manic episode
has responded to olanzapine treatment.

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.

2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
OLANZAPINE

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.

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).

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 mg
and 20 mg.

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.
• 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.
Consider referral to a dietician or help
with a diet plan if necessary.
• 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.

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. Hold the blister strip at the edges
3.
Gently push the tablet out
4.
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 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 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

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.

draft: 44044665, 44044667,
44044664, 44044666
laetus code: 00000
mat.no.: 00000000

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.

Continued on the next page >>

Artwork Proof Box
Ref: R001: Renewal – Consolidation texts app Var 10, 12,13.
Proof no.
009.0

Date prepared:
07/11/2017

Colours:
Black
Black 20%
Dimensions: 165 x 594 mm

Font size:
10.5pt
Fonts:
Helvetica

Załącznik A/Enclosure A
nazwa/name:

LF 46106108 OLANZAPINE 5;10;15;20MG ODT GB
nr korekty/
pharmacode:
correction:

1

11292

2

wymiary wewnętrzne/dimentions [mm]

165x420

46106108

przygotowano do druku + data/prepared for print + date:

kolorystyka/colours:
PROCESS BLACK

strona/page

SMS/DRO/46106108

zatwierdził/accepted:

AW DESCRIPTION

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.

• 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).

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.

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.

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.

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.

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).

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 and
blister after EXP. The expiry date refers to
the last day of that 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.

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.

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

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.

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.

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).
• 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.
• Changes in breasts in males and females
such as an abnormal production of
breast milk or abnormal growth.

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. Domaniewska 50 C, 02-672
Warszawa, Poland

or

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179
Barleben, Germany

or

S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A,
RO-540472 Targu-Mures, Romania

draft: 44044665, 44044667,
44044664, 44044666
laetus code: 00000
mat.no.: 00000000

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.

This leaflet was last revised in 11/2017

00000000
SZ00000LT000

Artwork Proof Box
Ref: R001: Renewal – Consolidation texts app Var 10, 12,13.
Proof no.
009.0

Date prepared:
07/11/2017

Colours:
Black
Black 20%
Dimensions: 165 x 594 mm

Font size:
10.5pt
Fonts:
Helvetica

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