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OLANZAPINE AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO 20 MG ORODISPERSIBLE TABLETS

Active substance(s): OLANZAPINE / OLANZAPINE

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Package leaflet: Information for the user
Olanzapine Aziende Chimiche Riunite Angelini Francesco 5 mg orodispersible tablets
Olanzapine Aziende Chimiche Riunite Angelini Francesco 10 mg orodispersible tablets
Olanzapine Aziende Chimiche Riunite Angelini Francesco 15 mg orodispersible tablets
Olanzapine Aziende Chimiche Riunite Angelini Francesco 20 mg orodispersible tablets

Olanzapine
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
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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 side effects not
listed in this leaflet. See section 4.

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

1.

What Olanzapine Aziende Chimiche Riunite Angelini Francesco is and what it is used for

Olanzapine Aziende Chimiche Riunite Angelini Francesco contains the active substance olanzapine.
Olanzapine Aziende Chimiche Riunite Angelini Francesco belongs to a group of medicines called
antipsychotics and is used to treat the following conditions:
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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mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 Aziende Chimiche Riunite Angelini Francesco 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 Aziende Chimiche Riunite Angelini
Francesco

Do not take Olanzapine Aziende Chimiche Riunite Angelini Francesco
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

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The use of Olanzapine Aziende Chimiche Riunite Angelini Francesco 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 Aziende Chimiche Riunite Angelini Francesco, 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 Orodispersible Tablets. 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 Orodispersible Tablets. Your doctor should do blood tests to check blood sugar and
certain fat levels before you start taking Olanzapine Orodispersible Tablets and regularly during
treatment.
If you or someone else in your family has a history of blood clots, as medicines like these have been
associated with 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 Aziende Chimiche Riunite Angelini Francesco is not for patients who are under 18 years.
Other medicines and Olanzapine
Only take other medicines while you are on Olanzapine Aziende Chimiche Riunite Angelini Francesco if
your doctor tells you that you can. You might feel drowsy if Olanzapine Aziende Chimiche Riunite Angelini
Francesco 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 stabilisers), fluvoxamine (an antidepressant), or
ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Aziende Chimiche
Riunite Angelini Francesco dose.
Olanzapine Aziende Chimiche Riunite Angelini Francesco with alcohol
Do not drink any alcohol if you have been given Olanzapine Aziende Chimiche Riunite Angelini Francesco
as Olanzapine Aziende Chimiche Riunite Angelini Francesco as together with alcohol it may make you feel
drowsy.
Pregnancy, breast-feeding and fertility

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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 Aziende Chimiche Riunite Angelini Francesco 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 Aziende Chimiche Riunite Angelini
Francesco . If this happens do not drive or operate any tools or machines. Tell your doctor.
Olanzapine Aziende Chimiche Riunite Angelini Francesco Orodispersible tablets contain aspartame
Patients who cannot take phenylalanine should note that Olanzapine Aziende Chimiche Riunite Angelini
Francesco Orodispersible tablets contains aspartame, which is a source of phenylalanine. May be harmful for
people with phenylketonuria.

3.

How to take Olanzapine Aziende Chimiche Riunite Angelini Francesco

Always take Olanzapine Aziende Chimiche Riunite Angelini Francesco exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many Olanzapine Aziende Chimiche Riunite Angelini Francesco tablets to
take and how long you should continue to take them. The daily dose of Olanzapine Aziende Chimiche
Riunite Angelini Francesco is between 5 and 20 mg. Consult your doctor if your symptoms return but do not
stop taking Olanzapine Aziende Chimiche Riunite Angelini Francesco unless your doctor tells you to.
You should take your Olanzapine Aziende Chimiche Riunite Angelini Francesco 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 Aziende Chimiche Riunite Angelini Francesco orodispersible tablets are for oral use.
Olanzapine Aziende Chimiche Riunite Angelini Francesco orodispersible tablets break easily, so you should
handle the tablets carefully. Do not handle the tablets with wet hands as the tablets may break up.
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 or milk and stir. Drink it
straight away.
If you take more Olanzapine Aziende Chimiche Riunite Angelini Francesco than you should
Patients who have taken more Olanzapine Aziende Chimiche Riunite Angelini Francesco 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 Aziende Chimiche Riunite Angelini Francesco
Take your tablets as soon as you remember. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Olanzapine Aziende Chimiche Riunite Angelini Francesco
Do not stop taking your tablets just because you feel better. It is important that you carry on taking
Olanzapine Aziende Chimiche Riunite Angelini Francesco for as long as your doctor tells you.
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If you suddenly stop taking Olanzapine Aziende Chimiche Riunite Angelini Francesco , 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.

4.

Possible side effects

Like all medicines, Olanzapine Aziende Chimiche Riunite Angelini Francesco orodispersible tablets 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); 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); restless legs syndrome; spasms of the muscle of the
eye causing rolling movement of the eye; 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.
Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and
Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and
then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen
in blood tests and an increase in a type of white blood cell (eosinophilia).

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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 Aziende Chimiche Riunite Angelini Francesco
orodispersible tablets 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
(Website: 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 Aziende Chimiche Riunite Angelini Francesco

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.
Store in the original package in order to protect from light and moisture.
Do not be 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 Aziende Chimiche Riunite Angelini Francesco orodispersible tablets contain
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The active substance is olanzapine. Each Olanzapine Aziende Chimiche Riunite Angelini Francesco
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 Aziende Chimiche Riunite Angelini Francesco 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 Aziende Chimiche Riunite Angelini Francesco looks like and contents of the pack
Olanzapine Aziende Chimiche Riunite Angelini Francesco 5 mg orodispersible tablet is a round, biconvex,
yellow tablet, 6 mm in diameter and marked with “O” on one side.
Olanzapine Aziende Chimiche Riunite Angelini Francesco 10 mg orodispersible tablet is a round biconvex,
yellow tablet 8 mm in diameter and marked with “O1” on one side.
Olanzapine Aziende Chimiche Riunite Angelini Francesco 15 mg orodispersible tablet is a round, biconvex,
yellow tablet, 9 mm in diameter and marked with “O2” on one side.
Olanzapine Aziende Chimiche Riunite Angelini Francesco 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: 28 orodispersible tablets.
Peel-to open blister packs: 28 orodispersible tablets.
Not all pack sizes may be marketed.

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Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Viale Amelia 70,
00181 Rome
Italy
Manufacturer

Actavis hf.
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:
Italy – Olanzapina Aziende Chimiche Riunite Angelini Francesco

This leaflet was last approved in

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Expand Transcript

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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