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OLANZAPINE ACCORD 10MG 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.

9 (Page 1 of 2) (IB012)

Date

10_09_14 (Olanzapine (ACC-UK)IB012-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

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 your 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 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withdrawn.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.
• 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 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 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.

Approved By
Quality Assurance

• Weight gain has been seen in patients taking
Olanzapine 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 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.
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 is not for patients who are
under 18 years.
Other medicines and Olanzapine Tablets:
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 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 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 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 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 coated tablets are
for oral use. You should swallow the
Olanzapine Tablets whole with water.

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.

9 (Page 2 of 2) (IB012)

Date

10_09_14 (Olanzapine (ACC-UK)IB012-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

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.

Approved By
Quality Assurance

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,
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.

If you forget to take Olanzapine Tablets
Take your tablets as soon as you remember.
Do not take two doses in one day.
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 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 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); 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.
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.
While taking olanzapine, elderly patients with
dementia may suffer from stroke, pneumonia,

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
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
Olanzapine,
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 2.5 mg: White to off white round,
biconvex, film-coated tablets plain on both
sides
Olanzapine 5 mg: White to off white round
biconvex, film coated tablets, debossed with
‘O1’ on one side and plain on other side.
Olanzapine 7.5 mg: White to off white round
biconvex, film coated tablets, debossed with
‘O2’ on one side and plain on other side.
Olanzapine 10 mg: White to off white round
biconvex, film coated tablets, debossed with
‘O3’ on one side and plain on other side.
Olanzapine 15 mg Tablets: Light blue
coloured, round, biconvex, film coated tablets
plain on both sides
Olanzapine 20 mg Tablets: Light pink coloured,
round, biconvex, film coated tablets plain on
both sides
The 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 tablets are available in pack sizes of 28,
30, 35, 56 or 70 tablets for the 7.5 mg
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:
Cemelog BRS Limited,
2040 Budaörs, Vasút u. 13, Hungary.
or
Accord Healthcare Limited,
Sage House, 319, Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom.
The leaflet was last revised in 09/2014.

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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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