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OLANZAPINE 10 MG ORODISPERSIBLE TABLETS

Active substance(s): OLANZAPINE / OLANZAPINE / OLANZAPINE

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Olanzapine 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 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
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unusual suspiciousness, and becoming withdrawn.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.


2.

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.

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.




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

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, breast-feeding and fertility
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.

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.


P15xxxxx

P15xxxxx

Olanzapine orodispersible

Package leaflet: Information for the user

1.

Olanzapine orodispersible

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

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. 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.

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.

Black

3.

How to take Olanzapine

Always take this medicine exactly as your doctor or pharmacist 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 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.

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).

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 (see details below). By reporting
side effects you can help provide more information on the safety of
this medicine.
The United Kingdom
Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard
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 box & blister label after EXP. The expiry date refers to
the last day of that month.

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).

Store in the original package 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 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

What Olanzapine contains

6.


The active substance is olanzapine. Each orodispersible tablet
contains 5 mg/ 10 mg/ 15 mg/ 20 mg olanzapine.



The other ingredients are: Mannitol (SD 200), mannitol
(Mannitol 35), polacrilin potassium, crospovidone (Type A),
silica, colloidal anhydrous, aspartame (E951), cellulose,
microcrystalline (grade 112), sodium stearyl fumarate and art
pineapple (FL SD # 883) [contains flavouring ingredients and
modified food starch].

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, circulating fats and
early in treatment, temporary increases in liver enzymes

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 and sexual dysfunctions such as decreased libido in
males and females or erectile dysfunction in males
Uncommon side effects (may affect up to 1 in 10 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

Sensitive 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 1000 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, 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.

Contents of the pack and other information

What Olanzapine looks like and contents of the pack
Orodispersible tablet.
Olanzapine 5 mg orodispersible tablets
Yellow coloured, circular, flat faced beveled edge tablets debossed
with ‘C’ on one side and ‘51’ on the other side.
Olanzapine 10 mg orodispersible tablets
Yellow coloured, circular, flat faced beveled edge tablets debossed
with ‘C’ on one side and ‘52’ on the other side.
Olanzapine 15 mg orodispersible tablets
Yellow coloured, circular, flat faced beveled edge tablets debossed
with ‘C’ on one side and ‘53’ on the other side.
Olanzapine 20 mg orodispersible tablets
Yellow coloured, circular, flat faced beveled edge tablets debossed
with ‘C’ on one side and ‘54’ on the other side.
Olanzapine 5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets
are available in Blister.
Blister: Polyamide/Aluminium foil coated with Primer, PE
coex/polyethylene with Desiccant and PE coex coating as forming
material/Aluminium foil coated with PE as the lidding material.
Pack sizes
Blister packs: 1, 10, 14, 28, 30, 35, 56, 60, 70, 98 and 100
orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
or
Orion Corporation, Orion Pharma
Orionintie 1,
FI-02200 Espoo,
Finland
This leaflet was last revised in 01/2017.

P15xxxxx

4.

Package leaflet: Information for the user
Olanzapine 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 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 is used to treat the
following conditions:



2.

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.

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 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. 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.

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
medicinesIn 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.

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, breast-feeding and fertility
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 or pharmacist 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 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 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).
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, circulating fats and early in treatment,
temporary increases in liver enzymes

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 and 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

















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
Sensitive 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 1000 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, 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.
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 (see details
below). By reporting side effects you can help provide more information on the safety of
this medicine.
The United Kingdom
Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard

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 box & blister
label after EXP. The expiry date refers to the last day of that month.
Store in the original package 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
protect the environment.

6.

Contents of the pack and other information

What Olanzapine contains

The active substance is olanzapine. Each orodispersible tablet contains 5 mg/ 10 mg/
15 mg/ 20 mg olanzapine.

The other ingredients are: Mannitol (SD 200), mannitol (Mannitol 35), polacrilin
potassium, crospovidone (Type A), silica, colloidal anhydrous, aspartame (E951),
cellulose, microcrystalline (grade 112), sodium stearyl fumarate and art pineapple
(FL SD # 883) [contains flavouring ingredients and modified food starch].
What Olanzapine looks like and contents of the pack
Orodispersible tablet.
Olanzapine 5 mg orodispersible tablets
Yellow coloured, circular, flat faced beveled edge tablets debossed with ‘C’ on one side and
‘51’ on the other side.
Olanzapine 10 mg orodispersible tablets
Yellow coloured, circular, flat faced beveled edge tablets debossed with ‘C’ on one side and
‘52’ on the other side.
Olanzapine 15 mg orodispersible tablets
Yellow coloured, circular, flat faced beveled edge tablets debossed with ‘C’ on one side and
‘53’ on the other side.
Olanzapine 20 mg orodispersible tablets
Yellow coloured, circular, flat faced beveled edge tablets debossed with ‘C’ on one side and
‘54’ on the other side.
Olanzapine 5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets are available in Blister.
Blister: Polyamide/Aluminium foil coated with Primer, PE coex/polyethylene with
Desiccant and PE coex coating as forming material /Aluminium foil coated with PE as
the lidding material.
Pack sizes
Blister packs: 1, 10, 14, 28, 30, 35, 56, 60, 70, 98 and 100 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 01/2017.

Package leaflet: Information for the user
Olanzapine 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 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 is used to treat the
following conditions:



2.

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.

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 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. 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.

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
medicinesIn 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.

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, breast-feeding and fertility
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 or pharmacist 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 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 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).
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, circulating fats and early in treatment,
temporary increases in liver enzymes

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 and 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

















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
Sensitive 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 1000 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, 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.
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 (see details
below). By reporting side effects you can help provide more information on the safety of
this medicine.
The United Kingdom
Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard

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 box & blister
label after EXP. The expiry date refers to the last day of that month.
Store in the original package 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
protect the environment.

6.

Contents of the pack and other information

What Olanzapine contains

The active substance is olanzapine. Each orodispersible tablet contains 5 mg/ 10 mg/
15 mg/ 20 mg olanzapine.

The other ingredients are: Mannitol (SD 200), mannitol (Mannitol 35), polacrilin
potassium, crospovidone (Type A), silica, colloidal anhydrous, aspartame (E951),
cellulose, microcrystalline (grade 112), sodium stearyl fumarate and art pineapple
(FL SD # 883) [contains flavouring ingredients and modified food starch].
What Olanzapine looks like and contents of the pack
Orodispersible tablet.
Olanzapine 5 mg orodispersible tablets
Yellow coloured, circular, flat faced beveled edge tablets debossed with ‘C’ on one side and
‘51’ on the other side.
Olanzapine 10 mg orodispersible tablets
Yellow coloured, circular, flat faced beveled edge tablets debossed with ‘C’ on one side and
‘52’ on the other side.
Olanzapine 15 mg orodispersible tablets
Yellow coloured, circular, flat faced beveled edge tablets debossed with ‘C’ on one side and
‘53’ on the other side.
Olanzapine 20 mg orodispersible tablets
Yellow coloured, circular, flat faced beveled edge tablets debossed with ‘C’ on one side and
‘54’ on the other side.
Olanzapine 5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets are available in Blister.
Blister: Polyamide/Aluminium foil coated with Primer, PE coex/polyethylene with
Desiccant and PE coex coating as forming material /Aluminium foil coated with PE as
the lidding material.
Pack sizes
Blister packs: 1, 10, 14, 28, 30, 35, 56, 60, 70, 98 and 100 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 06/201601/2017.

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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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