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OLANZAPINE 10MG ORODISPERSIBLE TABLETS

Active substance(s): OLANZAPINE

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T00075-01 Malta Zejtun 190x380 PIL

Olanzapine 5mg, 10mg, 15mg and 20mg
Orodispersible Tablets
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.
• The full name of this medicine is Olanzapine 5mg,
10mg, 15mg and 20mg Orodispersible Tablets but
within the leaflet it will be referred to as Olanzapine
tablets

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

What is in this leaflet:
1 What Olanzapine tablets are and what they are
used for
2 What you need to know before you take
Olanzapine tablets
3 How to take Olanzapine tablets
4 Possible side effects
5 How to store Olanzapine tablets
6 Contents of the pack and other information

Children and adolescents

1 What Olanzapine tablets are and what they are

used for

Olanzapine tablets contain the active substance Olanzapine,
belong 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beliefs, unusual suspiciousness, and becoming withdrawn.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 tablets have 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 tablets

Do not take Olanzapine tablets 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.
• 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
tablets.
• The use of Olanzapine tablets 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 tablets 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
tablets. 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
tablets. Your doctor should do blood tests to check
blood sugar and certain fat levels before you start taking
Olanzapine tablets 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.
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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.
Olanzapine tablets are not for patients who are under 18
years.

Other medicines and Olanzapine tablets

Only take other medicines while you are on Olanzapine
tablets if your doctor tells you that you can. You might feel
drowsy if Olanzapine tablets is taken in combination with
antidepressants or medicines taken for anxiety or to help you
sleep (tranquillisers).
Tell your doctor 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
tablets dose.

Olanzapine tablets with alcohol

Do not drink any alcohol if you have been given Olanzapine
tablets 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 tablets can pass into breast milk.
The following symptoms may occur in newborn babies,
of mothers that have used Olanzapine tablets 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 tablets. If this happens do not drive or operate
any tools or machines. Tell your doctor.

Olanzapine tablets contains aspartame

Patients who cannot take phenylalanine should note
that Olanzapine tablets contains aspartame, which is a
source of phenylalanine. May be harmful for people with
phenylketonuria.

3 How to take Olanzapine tablets

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 tablets is between 5mg and 20mg.
Consult your doctor if your symptoms return but do not stop
taking Olanzapine tablets 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 tablets are for oral use.
Continued on next page

T00075-01 Malta Zejtun 190x380 PIL

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.

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; and prolonged and/or painful
erection.

1. Keep your hands dry. Do not push the tablet out of the
pocket
2. Separate one blister cell from the strip
3. Carefully peel off the backing
4. Take the tablet out of the pocket

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).

Put the tablet in your mouth. It will dissolve directly in your
mouth, so that it can be easily swallowed. You can also place
the tablet in a full glass or cup of water, orange juice, apple
juice or milk, and stir. With some drinks, the mixture may
change colour and possibly become cloudy. Drink it straight
away.

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 take more Olanzapine tablets than you
should

Patients who have taken more Olanzapine tablets 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. Show the doctor your pack of tablets.

In patients with Parkinson’s disease Olanzapine tablets 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 internet at
www.mhra.gov.uk/yellowcard Alternatively you can call
Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m.
Mondays to Fridays) or fill in a paper form available from your
local pharmacy. By reporting side effects you can help provide
more information on the safety of this medicine.

If you forget to take Olanzapine tablets

Take your tablets as soon as you remember. Do not take a
double dose to make up for a forgotten tablet.

If you stop taking Olanzapine tablets

Do not stop taking your tablets just because you feel better. It
is important that you carry on taking Olanzapine tablets for as
long as your doctor tells you.
If you suddenly stop taking Olanzapine tablets, 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 product,
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) include weight gain; sleepiness; and increases
in 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); problems with
speech; 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 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 spasm
(including eye movements); spasms of the muscle of the eye
causing rolling movement of the eye; 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; and changes in
breasts in males and females such as an abnormal production
of breast milk or abnormal growth.

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5 How to store Olanzapine tablets

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.
Olanzapine tablets should be stored in its 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 tablets contain

• The active substance is olanzapine. Each Olanzapine
Orodispersible Tablet contains either 5mg, 10mg, 15mg or
20mg of the active substance.
The other ingredients are
• magnesium stearate, L-Methionine, silica colloidal
anhydrous, hydroxypropyl cellulose (low substituted),
crospovidone (Type B), aspartame, microcrystalline
cellulose, guar gum, magnesium carbonate heavy and
orange flavour.

What Olanzapine tablets look like and contents of
the pack

Olanzapine 5mg orodispersible tablet is a round, biconvex,
yellow orodispersible tablet, 6mm in diameter and marked
with “O” on one side. Orodispersible tablet is the technical
name for a tablet which dissolves directly in your mouth, so
that it can be easily swallowed.
Olanzapine 10mg orodispersible tablet is a round biconvex,
yellow orodispersible tablet 8mm in diameter and marked
with “O1” on one side. Orodispersible tablet is the technical
name for a tablet which dissolves directly in your mouth, so
that it can be easily swallowed.
Olanzapine 15mg orodispersible tablet is a round, biconvex,
yellow orodispersible tablet, 9mm in diameter and marked
with “O2” on one side. Orodispersible tablet is the technical
name for a tablet which dissolves directly in your mouth, so
that it can be easily swallowed.
Olanzapine 20mg orodispersible tablet is a round, biconvex,
yellow orodispersible tablet, 10mm in diameter and marked
with “O3” on one side. Orodispersible tablet is the technical
name for a tablet which dissolves directly in your mouth, so
that it can be easily swallowed.
Pack sizes:
28 orodispersible tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavikurvegur 76-78 , 220
Hafnarfjörður, Iceland

Manufacturer
Actavis Ltd., B16, Bulebel Industrial Estate, Zejtun ZTN 08,
Malta
This leaflet was last revised in July 2016

If you would like a
leaflet with larger
text, please contact
01271 385257.
Actavis, Barnstaple, EX32 8NS, UK

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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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