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OLANZAPINE DR REDDYS 5MG 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 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:






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.



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suspiciousness, and becoming withdrawn.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.

Other medicines and Olanzapine Tablets
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).



Moderate to severe manic episodes, a
condition with symptoms of excitement or
euphoria.

Tell your doctor if you are taking, have recently taken
or might take any other medicines.

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.

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 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.

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

In particular, tell your doctor if you are taking:

Medicines for Parkinson’s disease.

Carbamazepine (an anti-epileptic and mood
stabilizer), 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 breastfeeding, 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 aspartame.
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 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 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 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 the 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 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. CONTENTS OF THE PACK AND OTHER
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 02/2015

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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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