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OLANZAPINE JENSON PHARMACEUTICAL SERVICES LIMITED 15MG ORODISPERSIBLE TABLETS

Active substance(s): OLANZAPINE / OLANZAPINE / OLANZAPINE

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PACKAGE LEAFLET

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Package leaflet: Information for the patient
Olanzapine Jenson Pharmaceutical Services Limited 5 mg Orodispersible Tablets
Olanzapine Jenson Pharmaceutical Services Limited 10 mg Orodispersible Tablets
Olanzapine Jenson Pharmaceutical Services Limited 15 mg Orodispersible Tablets
Olanzapine Jenson Pharmaceutical Services Limited 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 or your 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 your pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
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

1.

What Olanzapine is and what it is used for

Olanzapine Jenson Pharmaceutical Services Limited contains the active substance olanzapine which
belongs to a group of medicines called antipsychotics. This medicine will be referred to as Olanzapine
throughout the package leaflet.
Olanzapine is used to treat schizophrenia, a disease with signs 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things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.
Olanzapine is used to treat moderate to severe manic episodes, a condition with symptoms such as
feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very
quickly with racing ideas and sometimes severe irritability. It is also a mood stabiliser that prevents
further occurrences of the disabling high and low (depressed) extremes of mood associated with this
condition.

2.

What you need to know before you take Olanzapine

Do not take Olanzapine:
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,
tongue, throat, difficulty breathing 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 taking Olanzapine.

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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 are elderly with dementia as you may get serious side effects.
if you have diabetes
if you have heart disease
if you have been told that you have salt imbalances in the blood (especially low levels of
potassium or magnesium)
if you were born with prolonged QT interval (seen on ECG, an electrical recording of the heart)
if you have problems with your liver or kidneys
if you have Parkinson’s disease
if you have history of fits or seizures (epilepsy)
if you have an enlarged prostate
if you have blocked intestine (paralytic ileus)
if you have low blood white blood cell counts (which can be caused by some medicines,
radiation therapy, chemotherapy or bone marrow disease)
if you have been told that you have increased levels of some white blood cells or a disease of
the bone marrow in which excessive blood cells are made called myeloproliferative disease
stroke or “mini” stroke (temporary symptoms of stroke)
if you are a smoker (because your dose of olanzapine may need to be adjusted).

During treatment
If you experience a combination of a very high fever, faster breathing, excessive sweating, a change in
mood, muscle stiffness, high blood pressure and drowsiness or sleepiness, speak to your doctor as your
doctor may decide to discontinue Olanzapine.
If you experience uncontrollable movements of the face or tongue, speak to your doctor as your doctor
may consider to reduce the dose or discontinue Olanzapine.
Weight gain has been seen in patients taking olanzapine. 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. Your doctor may wish to carry out blood tests to check levels of sugar and certain
fats in the blood before you start taking this medicine.
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 recommended for patients who are under 18 years.
Other medicines and Olanzapine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Especially tell your doctor if you are taking any of the following:







medicines for Parkinson’s disease.
antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers) as you may
feel drowsy.
carbamazepine (used as an anti-epileptic or mood stabiliser)
fluvoxamine (an antidepressant)
ciprofloxacin, (an antibiotic)
medicines that can alter your heart rhythm such as anti-arrhythmics (like amiodarone, sotalol,
quinidine, disopyramide), antibiotics (that belong to the group of macrolides), tricyclic
antidepressants.

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activated charcoal (a chemical substance used to absorb other medicines), this should be taken
at least 2 hours before or after olanzapine intake because it can interfere with the absorption of
olanzapine.

Olanzapine with alcohol
Do not drink any alcohol if you have been given Olanzapine as taking it with alcohol 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 or pharmacist 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.
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 or dizzy when you are given Olanzapine. If this happens do not drive
or operate any tools or machines. Tell your doctor.
Olanzapine contains aspartame
Contains a source of phenylalanine. May be harmful for people with phenylketonuria.

3.

How to take Olanzapine

Always take this medicine exactly as your doctor or pharmacist 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 recommended 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 orodispersible tablets are for oral use.
Olanzapine 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. For perforated blisters, 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.
2. Carefully peel off the backing. For non-perforated blisters, take care not to peel off the backing of
adjacent tablets.
3. Gently push the tablet out.
4. 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.

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If you take more Olanzapine than you should
Contact your doctor or hospital straight away. Show the doctor your pack of tablets.
Patients who have taken more olanzapine than they should have experienced the following signs: rapid
beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially
of the face or tongue) and reduced level of consciousness. Other signs 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, inhaling fluid into the windpipe and lungs
(aspiration), high blood pressure or low blood pressure, abnormal rhythms of the heart.
If you forget to take Olanzapine
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
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 signs such as sweating, difficulty sleeping, shaking (tremor),
anxiety or feeling sick (nausea) and being sick (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.
If you notice any of the following side effects and contact your doctor straight away:
Common (may affect up to 1 in 10 people):

an increase in the number of infections that you get causing sore throat, mouth ulcers or fever),
these may be signs of a reduction in the number of white blood cells that help fight infection
(leukopenia, neutropenia)
Uncommon (may affect up to 1 in 100 people):

allergic reactions such as rash, itching, swelling of the face, lips, mouth or throat that may cause
difficulty swallowing or breathing

blood clots in the veins especially in the legs (signs include swelling, pain, and redness in the
leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in
breathing.

diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the
blood and urine causing loss of appetite, unexplained weight loss, nausea, vomiting, stomach
pain, difficulty breathing, slow heart beat, unusual muscle pain or feeling weak, tired or
uncomfortable) or coma.

abnormal rhythm of the heart

fits (seizures), usually associated with a history of fits

uncontrolled movements of the mouth, tongue, cheeks or jaws, which may progress to the arms
and legs (tardive dyskinesia)

difficulty passing urine or emptying the bladder
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Rare (may affect up to 1 in 1,000 people):

yellowing of the whites of the eyes or skin, dark urine, pale coloured bowel movements, itching,
feeling drowsy or tired, fever, nausea, weakness and abdominal pain (may be signs of problems
with your liver)

a combination of very high fever, faster breathing, excessive sweating, change in mood, muscle
stiffness, high blood pressure and feeling drowsy or sleepy (neuroleptic malignant syndrome)

unusual or dangerously fast heart beat (ventricular tachycardia/fibrillation)

inflammation of the pancreas causing severe pain in the stomach, which spreads to the back

lowering of normal body temperature causing shivering, cold or pale skin

destruction of muscle fibres causing muscle pain, weakness or tenderness accompanied by dark
urine (rhabdomyolysis)

prolonged and/or painful erection
Not known (cannot be estimated from the available data)

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). These may be signs of Drug Reaction with Eosinophilia
and Systemic Symptoms (DRESS).

Other possible side effects include
Very common (may affect more than 1 in 10 people):

weight gain

sleepiness

increase in levels of prolactin which may be seen in a blood test

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 (may affect up to 1 in 10 people):

increases in the levels of some white blood cells, circulating fats and early in treatment,
temporary increases in liver enzymes which may be seen in a blood test

increases in the level of sugars in the blood and urine which may be seen in a blood or urine
test.

increases in levels of uric acid, alkaline phosphatase and creatine phosphokinase which may be
seen in a blood test

feeling more hungry

dizziness

restlessness or difficulty sitting still

tremor, rigid posture, slow movements and a shuffling, unbalanced walk (Parkinsonism)

unusual movements (dyskinesia)

constipation.

dry mouth.

rash.

unusual weakness

extreme tiredness

water retention leading to swelling of the hands, ankles or feet

fever

joint pain

sexual problems such as decreased sex drive in males and females or inability to get or maintain
an erection in males
Uncommon (may affect up to 1 in 100 people):
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uncontrollable muscle stiffness or spasms affecting the head (including eye movements), neck
and body
restless legs syndrome
problems with speech
slow heart rate.
increase sensitivity of skin to sunlight
bleeding from the nose
feeling bloated (abdominal distension)
memory loss or forgetfulness
inability to control urination difficulty starting to urinate or maintaining the flow
hair loss
absence or decrease in menstrual periods
changes in breast size in males and females
abnormal production of breast milk in females
increase in levels of bilirubin in the blood which may be seen in a blood test.

Rare (may affect up to 1 in 1,000 people):

signs of withdrawal such as sweating, difficulty sleeping, shaking, anxiety, feeling or being sick

bleeding or bruising for longer than normal or unexpectedly (thrombocytopenia)
Not known (frequency cannot be estimated from the available data):

signs of withdrawal in newborns such as blotchy skin colouring, diarrhoea, excessive sucking or
crying, poor feeding, slow weight gain, sneezing
While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, inability
to control urination, falls, extreme tiredness, visual hallucinations (seeing things that are not there), 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 and cause hallucinations
(seeing, hearing or feeling things that are not there).
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 via 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

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 and blister/bottle.
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 protect the environment.

6.

Contents of the pack and other information

What Olanzapine contains
Each orodispersible tablet contains 5 mg of olanzapine as the active ingredient.
Each orodispersible tablet contains 10 mg of olanzapine as the active ingredient.
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Each orodispersible tablet contains 15 mg of olanzapine as the active ingredient.
Each orodispersible tablet contains 20 mg of olanzapine as the active ingredient.
The other ingredients are mannitol, microcrystalline cellulose, guar gum, crospovidone, magnesium
stearate, colloidal anhydrous silica, aspartame (E951) (see section 2 “Olanzapine contains aspartame”)
and sodium laurilsulfate.
What Olanzapine looks like and contents of the pack
Olanzapine 5 mg is supplied as light yellow to yellow coloured, plain to mottled, round, flat faced,
beveled edged tablets debossed with “M” on one side and “OE1” on other side.
Olanzapine 10 mg is supplied as light yellow to yellow coloured, plain to mottled, round, flat faced,
beveled edged tablets debossed with “M” on one side and “OE2” on other side.
Olanzapine 15 mg is supplied as light yellow to yellow coloured, plain to mottled, round, flat faced,
beveled edged tablets debossed with “M” on one side and “OE3” on other side.
Olanzapine 20 mg is supplied as light yellow to yellow coloured, plain to mottled, round, flat faced,
beveled edged tablets debossed with “M” on one side and “OE4” on other side.
Olanzapine orodispersible tablets are supplied in non-perforated blisters containing 28, 35, 56, 70 or
98 tablets and perforated unit-dose blisters containing (28, 35, 56, 70 or 98) x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Mylan,
Potters Bar,
Hertfordshire,
EN6 1 TL,
United Kingdom

Manufacturers:
McDermott Laboratories Limited T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.

This medicinal product is authorised in the Member States of the EEA under the following
names:
IT:
UK:

OLANZAPINA MYLAN PHARMA 5mg, 10 mg, 15 mg, & 20 mg
Olanzapine Jenson Pharmaceutical Services Limited 5 mg, 10 mg, 15 mg, and 20 mg
Orodispersible Tablets

This leaflet was last revised in January 2017.

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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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