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OLANZAPINE EXCALIBUR 5 MG ORODISPERSIBLE TABLETS

Active substance(s): OLANZAPINE

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Package leaflet: information for the user
Olanzapine Excalibur 5 mg orodispersible tablets
Olanzapine Excalibur 10 mg orodispersible tablets
Olanzapine Excalibur 15 mg orodispersible tablets
Olanzapine Excalibur 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, 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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Olanzapine Excalibur is and what it is used for
2. What you need to know before you take Olanzapine Excalibur
3. How to take Olanzapine Excalibur
4. Possible side effects
5. How to store Olanzapine Excalibur
6. Contents of the pack and other information

1. What Olanzapine Excalibur is and what it is used for
Olanzapine Excalibur contains the active substance olanzapine. Olanzapine Excalibur 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there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 Excalibur 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 Excalibur
Do not take Olanzapine Excalibur
• if you are allergic 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, pharmacist or nurse before taking Olanzapine Excalibur
• The use of Olanzapine Excalibur 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 Excalibur, 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 Excalibur. You and your doctor should
check your weight regularly. Consider referral to a dietician or help with a diet plan if necessary.
• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients
taking Olanzapine Excalibur. Your doctor should do blood tests to check blood sugar and certain
fat levels before you start taking Olanzapine Excalibur 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 Excalibur is not for patients who are under 18 years.
Other medicines and Olanzapine Excalibur
Only take other medicines while you are on Olanzapine Excalibur if your doctor tells you that you can.
You might feel drowsy if Olanzapine Excalibur 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 Excalibur dose.
Olanzapine Excalibur with alcohol
Do not drink any alcohol if you have been given Olanzapine Excalibur 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
Excalibur can pass into breast milk.
The following symptoms may occur in newborn babies, of mothers that have used Olanzapine
Excalibur 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 Excalibur. If this happens do not
drive or operate any tools or machines. Tell your doctor.
Olanzapine Excalibur contains aspartame
Contains a source of phenylalanine. May be harmful for people with phenylketonuria.

3. How to take Olanzapine Excalibur
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 Excalibur tablets to take and how long you should
continue to take them. The daily dose of Olanzapine Excalibur is between 5 mg and 20 mg. Consult
your doctor if your symptoms return but do not stop taking Olanzapine Excalibur unless your doctor
tells you to.
You should take your Olanzapine Excalibur 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 Excalibur orodispersible tablets are for oral use.
Olanzapine Excalibur 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.
2.
3.
4.

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.
Carefully peel off the backing.
Gently push the tablet out.
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 Excalibur than you should
Patients who have taken more Olanzapine Excalibur 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 Excalibur
Take your tablets as soon as you remember. Do not take a double dose to make up for a forgotten
dose.
If you stop taking Olanzapine Excalibur
Do not stop taking your tablets just because you feel better. It is important that you carry on taking
Olanzapine Excalibur for as long as your doctor tells you.
If you suddenly stop taking Olanzapine Excalibur, 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)
• serious allergic reactions, e.g. swelling in the mouth and throat, itching, rash (an uncommon side
effect that may affect up to 1 in 100 people)
• prolonged and/or painful erection (a rare side effect that may affect up to 1 in 1,000 people)
• inflammation of the pancreas causing severe stomach pain, fever and sickness (a rare side effect
that may affect up to 1 in 1,000 people)
• muscle disease e.g. rhabdomyolysis, presenting as unexplained aches and pains (a rare side effect
that may affect up to 1 in 1,000 people)
• liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching,
yellowing of the skin and eyes (jaundice), and dark coloured urine (a rare side effect that may
affect up to 1 in 1,000 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 and circulating fats and early in treatment, temporary
increases in liver enzymes.
• Increases in the levels 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.
Uncommon side effects (may affect up to 1 in 100 people) include
• 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) include
• Lowering of normal body temperature.
• Abnormal rhythms of the heart.
• Sudden unexplained death.
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 Excalibur may worsen the symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5. How to store Olanzapine Excalibur
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.
Store in the original package in order to protect from light and 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 to protect the environment.

6. Contents of the pack and other information
What Olanzapine Excalibur contains

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The active substance is olanzapine. Each Olanzapine Excalibur orodispersible tablet contains
either 5 mg, 10 mg, 15 mg or 20 mg of the active substance. The exact amount is shown on your
Olanzapine Excalibur pack.
The other ingredients are magnesium stearate, L-Methionine, silica colloidal anhydrous,
hydroxypropyl cellulose (low substituted), crospovidone (Type B), aspartame, microcrystalline
cellulose, guar gum, magnesium carbonate heavy and orange flavour.

What Olanzapine Excalibur looks like and contents of the pack
Olanzapine Excalibur 5 mg orodispersible tablet is a round, biconvex, yellow tablet, 6 mm in diameter
and marked with “O” on one side.
Olanzapine Excalibur 10 mg orodispersible tablet is a round biconvex, yellow tablet 8 mm in diameter
and marked with “O1” on one side.
Olanzapine Excalibur 15 mg orodispersible tablet is a round, biconvex, yellow tablet, 9 mm in
diameter and marked with “O2” on one side.
Olanzapine Excalibur 20 mg orodispersible tablet is a round, biconvex, yellow tablet, 10 mm in
diameter and marked with “O3” on one side.
Pack sizes:
Push-through blister packs: 10 (sample), 14, 28, 30, 56, 60, 98, 126 and 154 orodispersible tablets.
Peel-to open blister packs: 10 (sample), 14, 28, 30, 56, 60, 98, 126 and 154 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel
Germany
Manufacturers
Actavis ehf. Reykjavikurvegur 78, IS-220 Hafnarfjorour. Iceland
Actavis Ltd. B16, Bulebel Industrial Estate, Zejtun ZTN 08, Malta
Centrafarm Services B.V, Nieuwee Donk 9, NL-4879 AC Etten-Leur, The Netherlands
Clonmel Healtheare Ltd., Waterford Road, Clonmel, Co. Tiperrary, Ireland
LAMP S. Pospero S.P.A., Via della Pace 25/A, 41030 San Prospero (Modena), Italy
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
STADA Arzneimittel GmbH, Muthgasse 36/2, A-1190 Wien, Austria
N.V. Eurogenerics S.A., Heizel Esplanade Heysel b22, 1020 Brussel, BELGIUM
This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria
Olanzapin STADA 5/ 10/ 15 mg Schmelztabletten
Belgium
Olanzapine Instant EG 5mg, 10mg orodispergeerbare tabletten
Czech republic
Olanzapine STADA ORO 5mg, 10 mg
Hungary
Olanzapin STADA ORO 5, 10 mg szajban diszpergalódó tabletta
Ireland
Olanzapine Clonmel 5mg, 10mg, 15mg, 20 mg Orodispersible Tablets
Italy
OLANZAPINA EUROGENERICI 5mg, 10mg compresse orodispersibili
Luxembourg
Olanzapine Instant EG 5mg, 10mg comprimes orodispersibles
Portugal
Olanzapina CicIum
Slovak Republic Olanzapin STADA ORO 5mg, 10 mg
Spain
Olanzapina Flas STADA 5mg, 10 mg comprimidos bucodispersables EFG
Sweden
Olanzapin STADA 5mg, 10mg, 15mg, 20mg munsonderfallande tabletter
United Kingdom Olanzapine Excalibur 5/10/15/20 mg Orodispersible Tablets
This leaflet was last revised in 10/2015

Changes resulting from variation procedure UK/H/2067/001-004/IA/021

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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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