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OLANZAPINE JUBILANT 5MG 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 15 mg film-coated tablets
Olanzapine 20 mg film-coated tablets
Jubilant
olanzapine
Read all of this leaflet carefully before you start taking this medicine.
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. 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.
In this leaflet:
1. What Olanzapine film-coated tablets are and what they are used for
2. What you need to know before you take Olanzapine film-coated tablets
3. How to take Olanzapine film-coated tablets
4. Possible side effects
5. How to store Olanzapine film-coated tablets
6. Contents of the pack and other information
1.

What Olanzapine film-coated tablets are and what they are used for

Olanzapine film-coated tablets belong 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withdrawn.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 film-coated tablets

Do not take Olanzapine film-coated tablets
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 film-coated tablets.
The use of Olanzapine film-coated tablets 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 film-coated tablets
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 Jubilant 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 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 (epilepsy)
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 film-coated tablets are not for patients who are under 18 years.
Other medicines and Olanzapine film-coated tablets
Only take other medicines while you are on Olanzapine film-coated tablets if your
doctor tells you that you can. You might feel drowsy if Olanzapine film-coated tablets
are taken in combination with antidepressants or medicines taken for anxiety or to help
you sleep (tranquillisers).
You should 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), as it may be necessary to change
your olanzapine dose.
Olanzapine film-coated tablets with alcohol
Do not drink any alcohol if you have been given Olanzapine film-coated tablets as
Olanzapine film-coated tablets and alcohol together may make you feel drowsy.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 breastfeeding, as small amounts of Olanzapine film-coated tablets
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 film-coated tablets. If
this happens do not drive or operate any tools or machines. Tell your doctor.
Olanzapine film-coated tablets contain 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 film-coated tablets

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 film-coated tablets to take and how
long you should continue to take them. The daily dose of Olanzapine film-coated
tablets is between 5 and 20 mg. Consult your doctor if your symptoms return but do not
stop taking Olanzapine film-coated tablets unless your doctor tells you to.
You should take your Olanzapine film-coated 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 film- coated tablets are for oral use. You should swallow the Olanzapine
film-coated tablets whole with water.
If you take more Olanzapine film-coated tablets than you should
Patients who have taken more Olanzapine film-coated tablets 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 film-coated tablets
Take your tablets as soon as you remember. Do not take two doses in one day.
If you stop taking Olanzapine film-coated tablets
Do not stop taking your tablets just because you feel better. It is important that you
carry on taking Olanzapine film-coated tablets for as long as your doctor tells you.
If you suddenly stop taking Olanzapine film-coated tablets, 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, this medicine can cause side effects, although not everybody gets
them.
Tell your doctor immediately if you experience any of these symptoms:
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;
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
Weight gain.
?
Sleepiness.
?
Increases in the levels of prolactin in the blood.
?
Common side effects: may affect up to 1 in 10 people
Changes in the levels of some blood cells and circulating fats.
?
Increases in the level of sugars in the blood and urine.
?
Feeling more hungry.
?
Dizziness.
?
Restlessness.
?
Tremor.
?
Muscle stiffness or spasm (including eye movements).
?
Problems with speech.
?
Constipation.
?
Dry mouth.
?
Rash.
?
Loss of strength.
?
Extreme tiredness.
?
Water retention leading to swelling of the hands, ankles or feet.
?
Sexual dysfunctions such as decreased libido in males and females or erectile
?
dysfunction in males.
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.
Uncommon side effects: may affect up to 1 in 100 people
Slow heart rate.
?
Make you sensitive to sunlight.
?
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.
Other possible side effects: frequency cannot be estimated from the available data.
Allergic reaction (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.
Lowering of normal body temperature.
?
Seizures, usually associated with a history of seizures (epilepsy).
?
Spasms of the muscle of the eye causing rolling movement of the eye.
?
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 film-coated tablets 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.
5.

How to store Olanzapine film-coated tablets

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use Olanzapine film-coated tablets after the expiry date, which is stated on the
blister and carton after EXP. The expiry date refers to the last day of that month.
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
protect the environment.
6.

Contents of the pack and other information

What Olanzapine film-coated tablets contain
The active substance is olanzapine. Each Olanzapine film-coated 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
(tablet core) lactose monohydrate, hyprolose (E463), crospovidone (E1202),
microcrystalline cellulose (E460), magnesium stearate (E572) and
(tablet coating) polyvinyl alcohol, talc (E553b), titanium dioxide (E171),
lactose monohydrate and triacetin

What Olanzapine film-coated tablets look like and contents of the pack
Olanzapine 2.5 mg film-coated tablets are off-white to pale yellow and debossed with
“J” on one side and “2.5” on the other.
Olanzapine 5 mg film-coated tablets are off-white to pale yellow and debossed with
“J” on one side and “5” on the other.
Olanzapine 7.5 mg film-coated tablets are off-white to pale yellow and debossed with
“J” on one side and “7.5” on the other.
Olanzapine 10 mg film-coated tablets are off-white to pale yellow and debossed with
“J” on one side and “10” on the other.
Olanzapine 15 mg film-coated tablets are off-white to pale yellow and debossed with
“J” on one side and “15” on the other.
Olanzapine 20 mg film-coated tablets are off-white to pale yellow and debossed with
“J” on one side and “20” on the other.
Olanzapine 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg film-coated tablets are available in
28, 50, 56, 60 and 70 tablet packs.
Olanzapine 20 mg fim-coated tablets are available in 28 tablet packs.
Not all pack sizes may be marketed.
MarketingAuthorisation Holder and Manufacturer
Marketing Authorisation Holder:
Jubilant Pharmaceuticals nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Manufacturer:
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Distributed by:
Aspire Pharma Ltd,
Antrobus House,
18 College Street,
Petersfield, Hampshire,
GU31 4AD,
United Kingdom
This medicinal product is authorised in the Member States of the EEA under the
following names:
The Netherlands:
Olanzapine Jubilant 2.5mg, 5mg, 7.5mg, 10 mg, 15mg, 20mg filmomhulde tabletten
UK:
Olanzapine Jubilant 2.5mg, 5mg, 7.5mg, 10 mg, 15mg, 20mg film-coated tablets
This leaflet was last revised inAugust 2012.

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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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