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OLANZAPINE 20 MG FILM-COATED TABLETS

Active substance(s): OLANZAPINE

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T00075-01 Malta Zejtun 190x380 PIL

Olanzapine 2.5mg, 5mg, 7.5mg,
10mg, 15mg and 20mg
Film-coated 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 the product is Olanzapine 2.5mg,
5mg, 7.5mg, 10mg, 15mg and 20mg Film-coated
Tablets but within the leaflet it will be referred to as
Olanzapine tablets.

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
1 What Olanzapine tablets are and what they

are used for

Olanzapine tablets 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beliefs, unusual suspiciousness, and becoming withdrawn.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 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 tablets

Do not take Olanzapine tablets if you

• a re 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.
•h
 ave 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 taking 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.
•W
 eight 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.
•H
 igh 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 and regularly during treatement.
• 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 formation of blood clots.
Continued top of next column
AAAH7933

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 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 are 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.
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.
You should not be given this medicine when breast-feeding,
as small amounts of Olanzapine tablets can pass into breast
milk.

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 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.

Olanzapine tablets contains lecithin soya.

If you are allergic to peanut or soya, do not take this
medicine.

3 How to take Olanzapine tablets
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 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.

Continued on next page

Olanzapine 2.5mg, 5mg, 7.5mg, 10mg, 15mg & 20mg Tablets PIL - UK

awstudio@actavis.co.uk

item no: AAAH7933

dimensions: 190/380 mm

print proof no: 2

pharmacode:

origination date: 23.03.15

min pt size: 9

colours/plates:
1.black
2.
3.
4.
5.
6.

approved for print/date

revision date: 27.03.15

Technical Approval
date sent: N/A
technically app. date*: N/A

Non Printing Colours
1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated.
Any technical changes madeby the supplier after approval are not the responsibility of the Artwork Studio.

T00075-01 Malta Zejtun 190x380 PIL

Olanzapine tablets are for oral use. You should swallow the
Olanzapine tablets whole with water.

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 if you experience
any of the above symptoms. Show the doctor your pack of
tablets.

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
medicine, ask your doctor or pharmacist.

4 Possible side effects

• 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 tablets may
worsen the symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: 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 tablets
Keep this medicine out of the sight and reach of children.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Do not use this medicine after the expiry date, which is
stated on the carton.

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).

Blister packs:
Store in the original package in order to protect from light
and moisture.

Very common side effects (may affect more than 1 in 10
people) include
• weight gain
• sleepiness
• increase 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
•d
 izziness
• r estlessness
• t remor
• unusual movements (dyskinesias)
• c onstipation
• dry mouth
• r ash
• 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 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

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 tablets contain

• The active substance is olanzapine. Each Olanzapine tablet
contains either 2.5mg, 5mg, 7.5mg, 10mg, 15mg or 20mg
of the active substance.
• The other ingredients are (tablet core) lactose anhydrous,
microcrystalline cellulose, crospovidone, magnesium
stearate and (tablet film-coating) polyvinyl alcohol,
titanium dioxide (E171), talc, lecithin soya (E322) and
xanthan gum (E415). In addition the 15mg tablets contain
indigo carmine (E132) and the 20mg tablets contain iron
oxide red (E172).

What Olanzapine tablets look like and contents of
the pack

Film-coated tablet 2.5mg: Round, biconvex, white film-coated
tablet 6mm in diameter, marked with “O” on one side.
Film-coated tablet 5mg: Round, biconvex, white film-coated
tablet 8mm in diameter, marked with “O1” on one side.
Film-coated tablet 7.5mg: Round, biconvex, white film-coated
tablet 9mm in diameter, marked with “O2” on one side.
Film-coated tablet 10mg: Round, biconvex, white film-coated
tablet 10mm in diameter, marked with “O3” on one side.
Film-coated tablet 15mg: Oval, biconvex, light blue film-coated
tablet 7.35 x 13.35mm in diameter, marked with “O” on one side.
Film-coated tablet 20mg: Oval, biconvex, light pink film-coated
tablet 7.5 x 14.5mm in diameter, marked with “O” on one side.
Pack sizes
2.5mg, 5mg, 10mg, 15mg, 20mg:
In blisters: 28 film-coated tablets.
7.5mg:
In blisters: 28 and 56 film-coated tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Manufacturer
Actavis Ltd
B16 Bulebel Industrial Estate
Zejtun ZTN 08
Malta
This leaflet was last revised in March 2015

If you would like a
leaflet with larger
text, please contact
01271 385257.

Continued top of next column
AAAH7933

Actavis, Barnstaple, EX32 8NS, UK

Olanzapine 2.5mg, 5mg, 7.5mg, 10mg, 15mg & 20mg Tablets PIL - UK

awstudio@actavis.co.uk

item no: AAAH7933

dimensions: 190/380 mm

print proof no: 2

pharmacode:

origination date: 23.03.15

min pt size: 9

colours/plates:
1.black
2.
3.
4.
5.
6.

approved for print/date

revision date: 27.03.15

Technical Approval
date sent: N/A
technically app. date*: N/A

Non Printing Colours
1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated.
Any technical changes madeby the supplier after approval are not the responsibility of the Artwork Studio.

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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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