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

blood pressure may be monitored by your doctor.

1.
2.
3.
4.
5.
6.

Children and adolescents

What Olanzapine is and what it is used for
What you need to know before you take Olanzapine
How to take Olanzapine
Possible side effects
How to store Olanzapine
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becoming withdrawn.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 show 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

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.



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.

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.

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.

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
10people) 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,



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.

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 film-coated 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 on. 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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