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OLANZAPINE ACCORD 2.5MG FILM-COATED TABLETS

Active substance(s): OLANZAPINE

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Olanzapine

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9.5

Version No.

17 (Page 1 of 2) (IB/18)

Date

05_06_17 (Olanzapine (ACC-UK)VAR-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

If you suffer from any of the following illnesses
tell your doctor as soon as possible:
PACKAGE LEAFLET: INFORMATION FOR
THE USER

Olanzapine 2.5 mg
Film-coated
Tablets
Olanzapine 5 mg
Film-coated
Tablets
Olanzapine 7.5 mg
Film-coated
Tablets
Olanzapine 10 mg
Film-coated
Tablets
Olanzapine 15 mg
Film-coated
Tablets
Olanzapine 20 mg
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, please 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 tablets is and what it is
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 is
and what it is used for
Olanzapine tablets contains the active
substance olanzapine. Olanzapine tablets
belongs to a group of medicines called
antipsychotics and is used to treat the
following conditions:

• 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 is 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

• 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 are allergic (hypersensitive) to
olanzapine or any of the other ingredients of
this medicine (listed in section 6). An allergic
reaction may be recognized 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 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.

Note: PIL is required centrally folded in bible paper

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.

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 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. Olanzapine coated 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 two doses in one day.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Olanzapine

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9.5

Version No.

17 (Page 2 of 2) (IB/18)

Date

05_06_17 (Olanzapine (ACC-UK)VAR-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

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
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);
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 to
100 people) include hypersensitivity (e.g.
swelling in the mouth and throat, itching, rash);
diabetes or the worsening of diabetes,
occasionally associated with ketoacidosis
(ketones in the blood and urine) or coma;
seizures, usually associated with a history of
seizures (epilepsy); muscle stiffness or spasms
(including eye movements); restless legs
syndrome; problems with speech; slow heart
rate; sensitivity to sunlight; bleeding from the
nose; abdominal distension; memory loss or
forgetfulness; urinary incontinence; lack of
ability to urinate; hair loss; absence or decrease
in menstrual periods; and changes in breasts in
males and females such as an abnormal
production of breast milk or abnormal growth.

Approved By
Quality Assurance

the last day of that month.
• Do not store above 30°C.
• 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 film-coated tablet contains either 2.5 mg ;
5 mg ; 7.5 mg ; 10 mg ; 15 mg or 20 mg of the
active substance,
The tablet also contains: Lactose
monohydrate, Cellulose microcrystalline,
Crospovidone, Hydroxypropylcellulose,
Magnesium stearate
Film coating contains: Hypromellose (E464),
Titanium dioxide (E171), Macrogol 400,
Polysorbate 80 (E433). In addition film coat of
15 mg tablets also contains Indigo carmine
aluminium lake (E132) and 20 mg tablets
contains iron oxide red ( E172 )
What Olanzapine tablets looks like and
content of the pack:
Olanzapine tablets 2.5 mg: White to off white
round, biconvex, film-coated tablets plain on
both sides
Olanzapine tablets 5 mg: White to off white
round biconvex, film coated tablets, debossed
with ‘O1’ on one side and plain on other side.
Olanzapine tablets 7.5 mg: White to off white
round biconvex, film coated tablets, debossed
with ‘O2’ on one side and plain on other side.
Olanzapine tablets 10 mg: White to off white
round biconvex, film coated tablets, debossed
with ‘O3’ on one side and plain on other side.
Olanzapine tablets 15 mg: Light blue coloured,
round, biconvex, film coated tablets plain on
both sides
Olanzapine tablets 20 mg: Light pink coloured,
round, biconvex, film coated tablets plain on
both sides
“The Olanzapine tablets are available in pack
sizes of 15, 28, 30, 35, 56 or 70 tablets for the
2.5 mg, 5 mg, 10 mg and 15 mg strengths.
The Olanzapine tablets are available in pack
sizes of 28, 30, 35, 56 or 70 tablets for the 7.5
mg and 20mg strengths.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Accord Healthcare Limited,
Sage House, 319, Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom.
Manufacturer:
Accord Healthcare Limited,
Sage House, 319, Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom.
The leaflet was last revised in 06/2017.

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.
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 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 sight and reach of
children.
• Do not use this medicine after expiry date,
which is stated on the blister as well as
carton after ‘EXP’. The expiry date refers to

Note: PIL is required centrally folded in bible paper

INP001
10 00000 0 000000

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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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