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OLANZAPINE ALKEM 10 MG FILM-COATED TABLETS

Active substance(s): OLANZAPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Olanzapine 2.5 mg film-coated tablets
Olanzapine 5 mg film-coated tablets
Olanzapine 7.5 mg film-coated tablets
Olanzapine 10 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 or nurse.
- 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 or nurse. 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 film-coated tablets
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becoming withdrawn.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 or nurse 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.
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.
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 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, breast-feeding and fertility
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 problem, 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 medicine.

3. HOW TO TAKE OLANZAPINE
Always take this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many olanzapine film-coated tablets to take and how
long you should continue to take them. The daily dose of olanzapine is between 5 and
10 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.
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 product, ask your doctor or
pharmacist or nurse.

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 movements ( a common side effect that may affect up to 1 in 10
peoples) mainly of the face or tongue;
- blood clots in the veins (an uncommon side effects 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; and increases in the 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 peoples) 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; and sexual dysfunctions such as
decreased libido in males and females or erectile dysfunction in males.
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 the 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; slow heart
rate; sensitive 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; and 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; 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
possibleside effects not listed in this leaflet.

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 pack in order to protect from light and
moisture.
Stored below 25oC.
Do not throw away any medicine via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Olanzapine contains
 The active substance is olanzapine. Each olanzapine tablet contains either 2.5
mg, 5 mg, 7.5 mg and 10 mg of the active substance. The exact amount is
shown on your olanzapine tablet pack.
 The other ingredients are
- (tablet core) lactose monohydrate, low-substituted hydroxypropyl
cellulose, hydroxypropyl cellulose, mannitol, magnesium stearate and
- (tablet coating) talc, pectin, triacetin, titanium dioxide(E171), and
- (tablet imprinting) opacode black, isopropyl alcohol.

What Olanzapine looks like and contents of the pack
Olanzapine 2.5 mg, 5 mg, 7.5 mg and 10 mg film-coated tablets are white.

Olanzapine is available in packs containing 28, 35, 56 and 70 tablets. Not all pack
sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alkem Pharma GmbH
Gutenbergstraße 13,
24941 Flensburg
Germany
Manufacturer
Wave Pharma Limited
4th Floor, Cavendish House
369 Burnt Oak Broadway, Edgware,
Middlesex HA8 5AW,
United Kingdom
This leaflet was last revised in 09/2015

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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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