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OLANZAPINE DR REDDYS 20 MG ORODISPERSIBLE TABLETS

Active substance(s): OLANZAPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Olanzapine 5 mg orodispersible Tablets
Olanzapine 10 mg orodispersible Tablets
Olanzapine 15 mg orodispersible Tablets
Olanzapine 20 mg orodispersible Tablets
Olanzapine
Read all of this leaflet carefully before you start taking this medicine.
 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. Do not pass it on to others. It may harm them, even if their symptoms are the
same as yours.
 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Olanzapine is and what it is used for
2. Before you take Olanzapine
3. How to take Olanzapine
4. Possible side effects
5. How to store Olanzapine
6. Further information

1. WHAT OLANZAPINE IS AND WHAT IT IS
USED FOR
Olanzapine belongs to a group of medicines called
antipsychotics.
Olanzapine is used to treat 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becoming withdrawn.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.
Olanzapine is used to treat moderate to severe manic
episodes, with symptoms such as feeling "high", having
excessive amounts of energy, needing much less sleep than
usual, talking very quickly with racing ideas and sometimes
severe irritability. It is also a mood stabiliser that prevents
further occurrences of the disabling high and low
(depressed) extremes of mood associated with bipolar
disorder.

2. BEFORE YOU TAKE OLANZAPINE
Do not take Olanzapine
 if you are allergic (hypersensitive) to olanzapine or any
of the other ingredients of Olanzapine Tablets (see
Section 6. Further Information). 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).
Take special care with Olanzapine
 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.
 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.
 Weight gain has been seen in patients taking
Olanzapine. 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. Your doctor should do blood tests to check
blood sugar and certain fat levels before you start taking
Olanzapine Tablets and regularly during treatment.
 The use of Olanzapine Tablets in elderly patients with
dementia is not recommended as it may have serious
side effects.
If you suffer from any of the following illnesses tell your
doctor as soon as possible:
 Diabetes
 Heart disease
 Liver or kidney disease
 Parkinson's disease
 Epilepsy
 Prostate problems
 A blocked intestine (Paralytic ileus)
 Blood disorders
 Stroke or "mini" stroke (temporary symptoms of stroke)
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.
Olanzapine is not for patients who are under 18 years.
Taking other medicines
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).
You should tell your doctor if you are taking fluvoxamine (an
antidepressant), or ciprofloxacin (an antibiotic), as it may be
necessary to change your dose of Olanzapine Tablets.
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines obtained
without a prescription. Especially tell your doctor if you are
taking medicines for Parkinson's disease.
Taking Olanzapine with food and drink
Do not drink any alcohol if you have been given Olanzapine
Tablets as olanzapine and alcohol together may make you
feel drowsy.
Pregnancy and breast-feeding
Tell your doctor as soon as possible if you are pregnant or
think you may be pregnant. You should not take this
medicine when pregnant, unless you have discussed this
with your doctor. 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.
Important information about some of the ingredients of
Olanzapine Tablets
Patients who cannot take phenylalanine should note that
these tablets contain aspartame (E951), which is a source of
phenylalanine and may be harmful for people with
phenylketonuria.

3.

HOW TO TAKE OLANZAPINE

Always take Olanzapine Tablets exactly as your doctor has
told you. You should 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 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 Tablets are for oral use.
Olanzapine orodispersible Tablets break easily, so you
should handle the tablets carefully. Do not handle the tablets
with wet hands as the tablets may break up.
1. Hold the blister strip at the edges and separate one
blister cell from the rest of the strip by gently tearing
along the perforations around it.
2. Carefully peel off the backing.
3. Gently push the tablet out.
4. Put the tablet in your mouth. It will dissolve directly in
your mouth, so that it can be easily swallowed.

You can also place the tablet in a full glass or cup of water,
orange juice, apple juice, milk or coffee, and stir. With some
drinks, the mixture may change colour and possibly become
cloudy. Drink it straight away.
If you take more Olanzapine than you should
Patients who have taken more Olanzapine 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. 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 product,
ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Olanzapine Tablets can cause side
effects, although not everybody gets them.
Some side effects can be serious and you should
immediately contact your doctor or pharmacist if you
notice any of the following symptoms:
 Changes in the levels of some blood cells and
circulating fats. These may not show any specific signs
or symptoms and will only be confirmed following a
blood test. Possible signs of changes in blood cells can
include wheezing, rashes, feeling unwell, tiredness,
weakness, bruising or bleeding easily.
 Rash, changes in blood pressure, swelling and
increased fluid in tissues, an increased heart rate,
difficulty with breathing and collapse. These may be
signs of a severe allergic reaction.
 Combination of fever, faster breathing, sweating,
muscle stiffness, drowsiness or sleepiness, and
confusion or agitation, or if you experience jerky muscle
movement which you can’t control. These may be the
symptoms of a serious condition known as neuroleptic
malignant syndrome.
 Blood clots such as deep venous thrombosis of the leg
(symptoms include swelling, pain and redness in the
leg) or blood clot of the lungs causing chest pain and
difficulty in breathing.
 Liver disease appearing as yellowing of the skin and
white parts of the eyes.
 Muscle disease presenting as unexplained aches and
pains.
Other side effects that have been reported include:
Very common side effects: affect 1 user in 10
 Weight gain.
 Sleepiness.
 Increases in the levels of prolactin in the blood.
Common side effects: affect 1 to 10 users in 100
 Increases in the level of sugars in the blood and urine.
 Feeling more hungry.
 Dizziness.
 Restlessness.
 Tremor.
 Problems with speech.
 Unusual movement (especially of the face or tongue).
 Constipation.
 Dry mouth.
 Rash.
 Loss of strength.
 Extreme tiredness.
 Water retention leading to swelling of the hands, ankles
or feet.
 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.



Sexual dysfunctions such as decreased libido in males
and females or erectile dysfunction in males.

Uncommon side effects: affect 1 to 10 users in 1,000
 Slow heart rate.
 Make you sensitive to sunlight.
 Urinary incontinence.
 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 possible side effects: frequency cannot be estimated
from the available data.
 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).
 Combination of fever, faster breathing, sweating, muscle
stiffness and drowsiness or sleepiness.
 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.
 Difficulty in passing urine.
 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.
Rarely women taking medicines of this type for a long
time have started to secrete milk and have missed
periods or had irregular periods. If this persists tell your
doctor.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

5. HOW TO STORE OLANZAPINE
Keep out of the reach and sight of children.
Do not use Olanzapine after the expiry date, which is stated
on the carton after ‘Expiry:’ and on blister after ‘Exp:’. The
expiry date refers to the last day of that month.
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. FURTHER INFORMATION
What Olanzapine Tablets contain
The active substance is olanzapine. Each tablet contains
5 mg, 10 mg, 15 mg or 20 mg of olanzapine.
The other ingredients are microcrystalline cellulose (E460a),
mannitol (E421), pregelatinised maize starch, crospovidone,
sodium laurilsulfate, aspartame (E951), guar gum (E412),
colloidal anhydrous silica (E551), magnesium stearate
(E572).
What Olanzapine Tablets look like and contents of the
pack
The tablets are yellow round tablets that are convex on one
side and flat on the other side.
Tablets are blister packed in cartons of 7, 14, 28, 35, 56, 70,
98, 100 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 revised in 04/2012

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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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