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OLANZAPINE DOC 10 MG ORODISPERSIBLE TABLETS

Active substance(s): OLANZAPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Olanzapine DOC 5 mg orodispersible tablet
Olanzapine DOC 10 mg orodispersible tablet
Olanzapine DOC 15 mg orodispersible tablet
Olanzapine DOC 20 mg orodispersible tablet

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

1.

What Olanzapine DOC is and what it is used for

Olanzapine DOC 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mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 maniac episodes a condition with symptoms of excitement or euphoria.
Olanzapine DOC has been shown to prevent recurrence of these symptoms in patients with bipolar disorder
whose manic episode has responded to olanzapine treatment.
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What you need to know before you take Olanzapine DOC

Do not take Olanzapine DOC
• 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 DOC
• The use of Olanzapine DOC 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 DOC, tell your doctor.
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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 DOC. 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 DOC. Your doctor should do blood tests to check blood sugar and certain fat levels before
you start taking Olanzapine DOC 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 DOC is not for patients who are under 18 years.
Other medicines and Olanzapine DOC
Only take other medicines while you are on Olanzapine DOC if your doctor tells you that you can. You
might feel drowsy if Olanzapine DOC 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 DOC dose.
Olanzapine DOC with alcohol
Do not drink any alcohol if you have been given Olanzapine DOC 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 DOC can pass into breast milk. The following symptoms may occur in
newborn babies, of mothers that have used Olanzapine DOC 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

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There is a risk of feeling drowsy when you are given Olanzapine DOC. If this happens do not drive or
operate any tools or machines. Tell your doctor.
Important information about some of the ingredients of Olanzapine DOC
Patients who cannot take phenylalanine should note that Olanzapine DOC contains aspartame, which is a
source of phenylalanine. May be harmful for people with phenylketonuria.

3.

How to take Olanzapine DOC

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 DOC tablets to take and how long you should continue to
take them. The daily dose of Olanzapine DOC is between 5 and 20 mg. Consult your doctor if your
symptoms return but do not stop taking Olanzapine DOC unless your doctor tells you to.
You should take your Olanzapine DOC 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 DOC orodispersible tablets are for oral use.
Olanzapine DOC 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. Keep your hands dry. Do not push the tablet out of the pocket
2. Separate one blister cell from the strip
3. Carefully peel off the backing
4. Take the tablet out of the pocket
5. Put the tablet in your mouth

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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 DOC than you should
Patients who have taken more Olanzapine DOC 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 DOC
Take your tablets as soon as you remember. Do not take two doses in one day.
If you stop taking Olanzapine DOC
Do not stop taking your tablets just because you feel better. It is important that you carry on taking
Olanzapine DOC for as long as your doctor tells you.
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If you suddenly stop taking Olanzapine DOC, 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).
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. 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); problems with speech;
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;
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; 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 DOC 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.
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5.

How to store Olanzapine DOC

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. 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 DOC contains
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The active substance is olanzapine. Each Olanzapine DOC 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 DOC
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 DOC looks like and contents of the pack
Olanzapine DOC 5 mg orodispersible tablet is a round, biconvex, yellow tablet, 6 mm in diameter and
marked with “O” on one side.
Olanzapine DOC 10 mg orodispersible tablet is a round biconvex, yellow tablet 8 mm in diameter and
marked with “O1” on one side.
Olanzapine DOC 15 mg orodispersible tablet is a round, biconvex, yellow tablet, 9 mm in diameter and
marked with “O2” on one side.
Olanzapine DOC 20 mg orodispersible tablet is a round, biconvex, yellow tablet, 10 mm in diameter and
marked with “O3” on one side.
Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that
it can be easily swallowed.
Pack sizes:
Push-through blister packs containing 28 orodispersible tablets.
Peel-to open blister packs containing 28 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
DOC Generic srl
Via Turati, 40
20121 Milano
Italy
Manufacturer
Actavis hf.
5

Reykjavíkurvegi 78
IS-220 Hafnarfjörður
Iceland
Actavis Ltd.
B16, Bulebel Industrial Estate
Zejtun ZTN 08
Malta
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Olanzapine DOC 5 mg, 10 mg, 15 mg, 20 mg orodispersible tablets
IT: OLANZAPINA DOC 5 mg, 10 mg, 15 mg, 20 mg compresse orodispersibili
This leaflet was last revised in 08/2013.

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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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