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OLANZAPINE ZENTIVA 7.5MG FILM-COATED TABLETS

Active substance(s): OLANZAPINE

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OLANZAPINE 2.5MG, 5MG, 7.5MG, 10MG,
15MG AND 20MG FILM-COATED TABLETS
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. See section 4.
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becoming withdrawn.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).
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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 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 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 is not for patients who are under 18 years of age.
Other medicines and olanzapine
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.
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Package leaflet: Information for the user

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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 dose.
Olanzapine with alcohol
• Do not drink any alcohol if you have been given olanzapine 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. If this happens,
do not drive or operate any tools or machines. Tell your doctor.
Olanzapine 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.

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)
• Reduced level of consciousness.

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
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 tablets are for oral use.
• You should swallow the Olanzapine tablets whole with water.
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If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

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Other symptoms may be:
• Acute confusion,
• Seizures (epilepsy),
• A combination of fever, faster breathing, sweating, muscle stiffness and
drowsiness or sleepiness,
• Slowing of the breathing rate, aspiration, coma,
• 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.

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,
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A combination of fever, faster breathing, sweating, muscle stiffness and
drowsiness or sleepiness (a rare side effect that may affect up to 1 in
1000 people).

Very common side effects (may affect more than 1 in 10 people) include:
• Weight gain,
• Sleepiness,
• 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, 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,
• Sexual dysfunctions such as decreased libido in males and females or
erectile dysfunction in males.

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,
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,
• Prolonged and/or painful erection.
While taking olanzapine, elderly patients with dementia may suffer from:
• Stroke,
• Pneumonia,
• Urinary incontinence,
• Falls or have trouble walking,
• Extreme tiredness,
• Visual hallucinations,
• A rise in body temperature,
• Redness of the skin.
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 or pharmacist. 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.
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Marketing Authorisation Holder
Zentiva One Onslow Street, Guildford, Surrey GU1 4YS, UK.

5. HOW TO STORE OLANZAPINE





Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton.
The expiry date refers to the last day of that month
Olanzapine should be stored in its original package in order to protect from
moisture
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 protect the environment.

Manufacturer
Sanofi-Aventis Sp. z. o.o., Drug production and Distribution Plant, ul. Lubelska
52, 35-233, Rzeszów, POLAND
S.C. Zentiva S.A., Site: B-dul Theodor Pallady nr.50, sector 3, Bucuresti,
cod032266, Romania.
This leaflet was last updated in February 2014

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What olanzapine contains
• 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 of olanzapine.
• The other ingredients are: (tablet core): mannitol, lactose anhydrous,
sodium starch glycolate (type A), hydroxypropylcellulose, magnesium
stearate and (tablet coating): polyvinyl alcohol, titanium dioxide (E171),
talc, lecithin soya (E322), xanthan gum.
• Olanzapine 15 mg also contains Indigo carmine (E132) and olanzapine
20mg also contains red iron oxide (E172).
What olanzapine looks like and contents of the pack
• Olanzapine 2.5 mg are round, plain, biconvex white film-coated tablets
• Olanzapine 7.5 mg are round, biconvex, white film-coated tablets with a
distinguishing mark “Z” on one side
• Olanzapine 5 mg and 10 mg are round, white biconvex film-coated tablets
with a break line on one side and plain on the other side.
• Olanzapine 15 mg are capsule shaped, biconvex, blue film-coated tablets
with a break line on one side and plain on the other side.
• Olanzapine 20 mg are capsule shaped, biconvex, pink film-coated tablets
with a break line on one side and plain on the other side.
Olanzapine 5 mg, 10 mg, 15 mg and 20 mg film-coated tablets can be divided
into equal halves
Olanzapine is available in blister packs of 14, 28, 35 56 or 70 tablets.
Not all pack sizes may be marketed.
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Uncommon side effects (may affect up to 1 in 100 people) include:
• Hypersensitivity (e.g. swelling in the mouth and throat, itching, rash),
• Diabetes or 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,
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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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