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OLANZAPINE DR REDDYS 7.5 MG FILM-COATED TABLETS

Active substance: OLANZAPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Olanzapine 2.5, 5, 7.5, 10, 15 and 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, 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.
What is in this leaflet
1. What Olanzapine is and what it is used
for
2. What you need to know before you take
Olanzapine
3. How to take Olanzapine
4. Possible side effects
5. How to store Olanzapine
6. Contents of the pack and other
information
1. WHAT OLANZAPINE 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withdrawn.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 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
Do not take Olanzapine
 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 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 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. You and your doctor
should check your weight regularly.
 High blood pressure and high levels of
fat (triglycerides and cholesterol) have
been seen in patients taking Olanzapine.
Your doctor should do blood tests to
check blood sugar and certain fat levels
before you start taking Olanzapine 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
 Prostrate 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 is not for patients who are under
18 years.
Other medicines and Olanzapine
Only take other medicines while you are
taking Olanzapine Tablets 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 dose of Olanzapine
Tablets.

Olanzapine 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 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 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
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 Tablets
unless your doctor tells you to.
You should take your Olanzapine Tablet
once a day following the advice of your
doctor. Try to take your tablet at the same
time each day. It does not matter whether you
take them with or without food. Olanzapine
Tablets are for oral use. You should swallow
the tablet whole with water.
If you take more Olanzapine 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
Take your tablets as soon as you remember.
Do not take two doses in one day.
If you stop taking Olanzapine
Do not stop taking your tablets just because
you feel better. It is important that you carry
on taking Olanzapine for as long as your
doctor tells you.
If you suddenly stop taking Olanzapine,
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.
• Increases in levels of prolactin in the
blood.
Common side effects (may affect up to 1 in
10 people) include
• Changes in the levels of some blood
cells and circulating fats.
• Increases in the level of sugars in the
blood and urine.
• Feeling more hungry.
• Dizziness.
• Restlessness.
• Tremor.
• Muscle stiffness or spasm (including eye
movements)
• Problems with speech.
• Constipation.
• Dry mouth.
• Rash.
• Loss of strength.
• Extreme tiredness.
• Water retention leading to swelling of the
hands, ankles or feet.
• Sexual dysfunctions such as decreased
libido in males and females or erectile
dysfunction in males
• 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.
.
Uncommon side effects (may affect up to 1 in
100 people) include
• Slow heart rate.
• Sensitivity to sunlight.
• Urinary incontinence, lack of ability to
urinate.
• Hair loss.
• Absence or decrease in menstrual
periods.
• Changes in breasts in males and
females such as an abnormal production
of breast milk or abnormal growth.

Other additional side effects for which a
frequency cannot be estimated from the
available data (not known) include
• Allergic reaction (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.
• Lowering of normal body temperature.
• Seizures, usually associated with a
history of seizures (epilepsy).
• Spasms of the muscle of the eye
causing rolling movement of the eye.
• 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, 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.
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet.
5. HOW TO STORE OLANZAPINE
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. Do not
store above 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 Tablets contain:
The active substance is olanzapine. Each
tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg,
15 mg or 20 mg of olanzapine.
The other ingredients are lactose
monohydrate, microcrystalline cellulose,
crospovidone, hydroxypropyl cellulose,
magnesium stearate. The tablet coating
contains hypromellose, titanium dioxide
(E171), macrogol 400.
The tablet coating for 5, 7.5 and 10 mg
tablets also contains indigo carmine
aluminium lake (E132).
What Olanzapine Tablets look like and
contents of the pack
Olanzapine 2.5 mg film-coated tablets are
white, oval, biconvex film-coated tablets,
debossed “OLZ” on one side and “2.5” on
other side.
Olanzapine 5 mg film-coated tablets are blue,
oval, biconvex film-coated tablets, debossed
“OLZ” on one side and “5” on other side.
Olanzapine 7.5 mg film-coated tablets are
blue, oval, biconvex film-coated tablets,
debossed “OLZ” on one side and “7.5” on
other side.
Olanzapine 10 mg film-coated tablets are
blue, oval, biconvex film-coated tablets,
debossed “OLZ” on one side and “10” on
other side.
Olanzapine 15 mg film-coated tablets are
white, round, biconvex film-coated tablets,
debossed “OLZ” on one side and “15” on
other side.
Olanzapine 20 mg film-coated tablets are
white, oval, biconvex film-coated tablets,
debossed “OLZ” on one side and “20” on
other side.
Cartons contain 7, 14, 28, 35, 56, 70, 98 filmcoated tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and
Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd, 6
Riverview Road, Beverley, HU17 0LD, UK
This leaflet was last approved in
16/11/2012

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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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