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OLANZAPINE 2.5MG FILM-COATED TABLETS

Active substance(s): OLANZAPINE

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Package leaflet: Information for the user
OLANZAPINE
2.5mg, 5mg, 7.5mg, 10mg,
15mg AND 20mg
FILM-COATED 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.
IN THIS LEAFLET
1. What Olanzapine Film-coated Tablets are and what they are used for
2. What you need to know before you take Olanzapine Film-coated Tablets
3. How to take Olanzapine Film-coated Tablets
4. Possible side effects
5. How to store Olanzapine Film-coated Tablets
6. Contents of the pack and other information
1. WHAT OLANZAPINE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED
FOR
Olanzapine Film-coated Tablets belong to a group of medicines called antipsychotics and are used to
treat the following conditions:
Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are
not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with
this disease may also feel depressed, anxious or tense.
Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria
Olanzapine has been shown to prevent recurrence of these symptoms in patients with bipolar disorder
whose manic episode has responded to olanzapine treatment.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OLANZAPINE FILM-COATED
TABLETS
Do not take Olanzapine Film-coated 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.
if you have been previously diagnosed with eye problems such as certain kinds ofglaucoma
(increased pressure in the eye).
Warnings and precautions
Talk to your doctor or pharmacist before you take Olanzapine Film-coated Tablets.
The use of Olanzapine Film-coated 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 Film-coated 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 Film-coated Tablets. You and your
doctor should check your weight regularly.
High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in
patients taking Olanzapine Film-coated Tablets. Your doctor should do blood tests to check
blood sugar and certain fat levels before you start taking Olanzapine Film-coated 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.
If you suffer from any of the following illnesses tell your doctor as soon aspossible:
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
See also section 4, “Possible side effects”.
If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever hada
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 Film-coated Tablets are not suitable for patients who are under 18 years.
Other medicines and Olanzapine Film-coated Tablets
Only take other medicines while you are on Olanzapine Film-coated Tablets if your doctor tells you
that you can. You might feel drowsy if Olanzapine Film-coated Tablets are taken in combinationwith
antidepressants or medicines taken for anxiety or to help you sleep (tranquilisers).
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 dose
Olanzapine Film-coated Tablets with alcohol
Do not drink any alcohol if you have been given Olanzapine Film-coated Tablets as Olanzapine and
alcohol together 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 Film-coated Tablets 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/orweakness,

sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any ofthese
symptoms you may need to contact your doctor.
Driving and using machines
There is a risk of feeling drowsy when you are given Olanzapine Film-coated Tablets. If this happens
do not drive or operate any tools or machines. Tell your doctor.
Olanzapine Film-coated Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. HOW TO TAKE OLANZAPINE FILM-COATED TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor orpharmacist
if you are not sure.
Your doctor will tell you how many Olanzapine Film-coated Tablets to take and how long you should
continue to take them. The daily dose of Olanzapine Film-coated Tablets is between 5 and 20mg.
Consult your doctor if your symptoms return but do not stop taking Olanzapine Film-coated Tablets
unless your doctor tells you to.
You should take your Olanzapine Film-coated 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 Film-coated Tablets are for oral use. You should swallow the Olanzapine Film-coated
Tablets whole with water.
If you take more Olanzapine Film-coated Tablets than you should
Patients who have taken more Olanzapine Film-coated 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 Film-coated Tablets
Take your tablets as soon as you remember. Do not take two doses in one day.
If you stop taking Olanzapine Film-coated Tablets
Do not stop taking your tablets just because you feel better. It is important that you carry on taking
Olanzapine Film-coated Tablets for as long as your doctor tells you.
If you suddenly stop taking Olanzapine Film-coated 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
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of these symptoms:
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 maytravel
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)
Tell your doctor if any of the below side effects start bothering you.
Very common side effects (may affect more than 1 in 10 people) include:
weight gain
sleepiness
increases in the levels of prolactin in the blood

In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate),
especially when getting up from a lying or sitting position. This will usually pass on its own
but if it does not, tell your doctor.
Common side effects (may affect up to 1 in 10 people) include:
changes in the levels of some blood cells and circulating fats 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
dysfunction such as decreased libido in males and females or erectile dysfunction inmales
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 inthe
blood and urine) or coma
seizures, usually associated with a history of seizures (epilepsy)
muscle stiffness or spasms (including eye movements)
problems with speech
slow heart rate
sensitivity to sunlight
bleeding from the nose
abdominal distension
memory loss or forgetfulness
urinary incontinence; lack of ability to urinate
hair loss
absence or decrease in menstrual periods

changes in breasts in males and females such as 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
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).
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 Film-coated Tablets may worsen thesymptoms.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
Reporting of side effects

Also you can help to make sure that medicines remain as safe as possible by reporting any
unwanted side effects 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
5. HOW TO STORE OLANZAPINE FILM-COATED TABLETS
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use this medicine after the expiry date, which is stated on the blister and carton. The expiry
date refers to the last day of that month.

Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Olanzapine Film-coated Tablets contain
The active substance is olanzapine. Each Olanzapine Film-coated Tablet contains either
2.5mg, 5mg, 7.5mg, 10mg, 15mg or 20mg of the active substance. The exact amount is
shown on your Olanzapine tablet pack.
The other ingredients are (tablet core) lactose monohydrate, hyprolose (E463), crospovidone
(E1202), microcrystalline cellulose (E460), magnesium stearate (E572) and (tablet coating)
polyvinyl alcohol, talc (E553b), titanium dioxide (E171), lactose monohydrate andtriacetin.
What Olanzapine Film-coated Tablets look like and contents of the pack
Olanzapine 2.5mg Film-coated Tablets are off-white to pale yellow and debossed with “J” on one side
and “2.5” on the other.

Olanzapine 5mg Film-coated Tablets are off-white to pale yellow and debossed with “J” on one side
and “5” on the other.
Olanzapine 7.5mg Film-coated Tablets are off-white to pale yellow and debossed with “J” on one side
and “7.5” on the other.
Olanzapine 10mg Film-coated Tablets are off-white to pale yellow and debossed with “J” on one side
and “10” on the other.
Olanzapine 15mg Film-coated Tablets are off-white to pale yellow and debossed with “J” on one side
and “15” on the other.
Olanzapine 20mg Film-coated Tablets are off-white to pale yellow and debossed with “J” on one side
and “20” on the other.
Olanzapine 2.5mg, 5mg, 7.5mg, 10mg and 15mg Film-coated Tablets are available in 28, 50, 56, 60
and 70 tablet packs.
Olanzapine 20mg Film-coated Tablets are available in 28 tablet packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.
Distributor and manufacturer responsible for batch release
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
PL 30464/0097-0102
This leaflet was last revised in June 2016

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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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