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OLANZAPINE MILPHARM 7.5 MG TABLETS

Active substance(s): OLANZAPINE

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Olanzapine 2.5 mg tablets
Olanzapine 5 mg tablets
Olanzapine 7.5 mg tablets
Olanzapine 10 mg tablets
Olanzapine 15 mg tablets
Olanzapine 20 mg tablets
olanzapine
Read all of this leaflet carefully before you start using 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.

P150

P150

Olanzapine tablets

Package leaflet: Information for the user

Olanzapine tablets

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

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 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.

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

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.

1. WHAT OLANZAPINE IS AND WHAT IT IS USED FOR

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 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 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:

Diabetes

Heart disease

Liver or kidney disease

Parkinson’s disease

Seizures

Prostate problems

A blocked intestine (Paralytic ileus)

Blood disorders

Stroke or “mini” stroke (temporary symptoms of stroke)

Black

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.

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.
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.
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).

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 to protect the
environment.

Very common side effects: (may affect more than 1 in 10 people) include weight gain;
sleepiness; and increases in levels of prolactin in the blood

6. Contents of the pack and other information

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.

What Olanzapine contains

The active substance is olanzapine. Each Olanzapine tablet contains either 2.5 mg, 5
mg, 7.5 mg, 10 mg, 15 mg or 20 mg of the active substance. The exact amount is
shown on your Olanzapine tablet pack.

The other ingredients are - lactose monohydrate, crospovidone (type B), hydroxypropyl
cellulose and magnesium stearate.

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 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

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.

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)

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, 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.
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 (see details below).
By reporting side effects you can help provide more information on the safety of this
medicine.
The United Kingdom
Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard

What Olanzapine looks like and contents of the pack
Olanzapine 2.5 mg Tablets:
Yellow coloured, circular (5.2 mm in diameter), biconvex uncoated tablets, debossed with ‘C’
on one side and ‘45’ on the other side
Olanzapine 5 mg Tablets:
Yellow coloured, circular (6.5 mm in diameter), biconvex uncoated tablets, debossed with ‘C’
on one side and ‘46’ on the other side
Olanzapine 7.5 mg Tablets:
Yellow coloured, circular (7.5 mm in diameter), biconvex uncoated tablets, debossed with ‘C’
on one side and ‘47’ on the other side
Olanzapine 10 mg Tablets:
Yellow coloured, circular (8.0 mm in diameter), biconvex uncoated tablets, debossed with ‘C’
on one side and ‘48’ on the other side
Olanzapine 15 mg Tablets:
Yellow coloured, circular (9.0 mm in diameter), biconvex uncoated tablets, debossed with ‘C’
on one side and ‘49’ on the other side
Olanzapine 20 mg Tablets:
Yellow coloured, circular (10.5 mm in diameter), biconvex uncoated tablets, debossed with
‘C’ on one side and ‘50’ on the other side
Olanzapine tablets are available in:
PVC/Polyamide/Aluminium/PVC/Aluminium blister pack:
7, 14, 28, 30, 35, 50, 56, 70, 96, 98 & 100 tablets.
HDPE bottle and polypropylene closure with silica gel desiccant:
30 & 1000 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF 26, Hal Far Industrial Estate, Hal Far
Brizebbugia BBG 3000
Malta
This medicinal product is authorised in the Member States of the EEA under the
following names:
France
OLANZAPINE ARROW 5mg/ 7,5mg/ 10mg, comprimé
Germany
Olanzapin Aurobindo 2,5mg/ 5mg/ 7,5mg/ 10mg/ 15mg/ 20 mg Tabletten
Ireland
Olanzapine Aurobindo 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tablets
Italy
Olanzapina Aurobindo
Netherlands
Olanzapine Aurobindo 2,5mg/ 5mg/ 10mg/ 15mg/ 20mg, tabletten
Poland
Olanzapina Aurobindo
Portugal
Olanzapina Aurobindo
Romania
Olanzapina Aurobindo 5mg/ 10mg/ 15mg/ 20 mg comprimate
Spain
OLANZAPINA AUROBINDO 2,5mg/ 5mg/ 7,5mg/ 10mg, comprimidos
EFG
United Kingdom Olanzapine 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tablets
This leaflet was last revised in 06/2014.

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 outer carton, blister
and bottle label.

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Store below 25ºC.

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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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