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ARKOLAMYL 5MG ORODISPERSIBLE TABLETS

Active substance(s): OLANZAPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ARKOLAMYL 5 mg
ORODISPERSIBLE
TABLETS
ARKOLAMYL 10 mg
ORODISPERSIBLE
TABLETS
ARKOLAMYL 15 mg
ORODISPERSIBLE
TABLETS
ARKOLAMYL 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 pharmacist. This includes
any possible side effects not listed in
this leaflet.
What is in this leaflet:
1. What Arkolamyl is and what it is used for.
2. What you need to know before you
take Arkolamyl.
3. How to take Arkolamyl.
4. Possible side effects.
5. How to store Arkolamyl.
6. Contents of the pack and other
information.
1. WHAT ARKOLAMYL IS AND WHAT IT
IS USED FOR
Arkolamyl 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becoming withdrawn.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.
Arkolamyl has been shown to prevent
recurrence of these symptoms in patients
with bipolar disorder whose manic
episode has responded to Arkolamyl
treatment.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ARKOLAMYL
Do not take Arkolamyl:
• 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 you pharmacist before you
take Arkolamyl:
• The use of Arkolamyl 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 Arkolamyl 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 Arkolamyl. 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
Arkolamyl. Your doctor should do
blood tests to check blood sugar
and certain fat levels before you
start taking Arkolamyl 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.
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
Arkolamyl is not for patients who are
under 18 years.
Other medicines and Arkolamyl
Only take other medicines while you
are on Arkolamyl if your doctor tells you
that you can. You might feel drowsy
if Arkolamyl 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 Arkolamyl dose.
Arkolamyl with alcohol
Do not drink any alcohol if you have
been given Arkolamyl 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 Arkolamyl can pass into breast milk.
The following symptoms may occur
in newborn babies, of mothers that
have used Arkolamyl 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 Arkolamyl. If this happens
do not drive or operate any tools or
machines. Tell your doctor.
Arkolamyl contains 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 ARKOLAMYL
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
Arkolamyl tablets to take and how long
you should continue to take them.
The daily dose of Arkolamyl is between
5 and 20 mg. Consult your doctor if your
symptoms return but do not stop taking
Arkolamyl unless your doctor tells you to.
You should take your Arkolamyl 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.
Arkolamyl orodispersible tablets are for
oral use.
Arkolamyl 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. 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.
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.

Uncommon side effects: (may affect up
to 1 in 100 people):
• 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
If you take more Arkolamyl than you
• hair loss
should
• absence or decrease in menstrual
Patients who have taken more
periods
Arkolamyl than they should, have
• changes in breasts in males and females
experienced the following symptoms:
such as an abnormal production of
rapid beating of the heart, agitation/
breast milk or abnormal growth.
aggressiveness, problems with speech,
Rare side effects (may affect up to 1 in
unusual movements (especially of the
1000 people) include:
face or tongue) and reduced level of
• 
lowering of normal body temperature
consciousness. Other symptoms may
• 
abnormal rhythms of the heart
be: acute confusion, seizures (epilepsy),
• 
sudden unexplained death
coma, a combination of fever, faster
• 
inflammation of the pancreas causing
breathing, sweating, muscle stiffness
severe stomach pain, fever and sickness
and drowsiness or sleepiness, slowing
• 
liver disease appearing as yellowing
of the breathing rate, aspiration, high
of the skin and white parts of the eyes
blood pressure or low blood pressure,
• 
muscle disease presenting as
abnormal rhythms of the heart. Contact
unexplained aches and pains
your doctor or hospital straight away if

prolonged and/or painful erection
you experience any of the symptoms.
Show the doctor your pack of tablets.
While taking olanzapine, elderly patients
with dementia may suffer from stroke,
If you forget to take Arkolamyl
Take your tablets as soon as you remember. pneumonia, urinary incontinence, falls,
extreme tiredness, visual hallucinations,
Do not take two doses in one day.
a rise in body temperature, redness of
If you stop taking Arkolamyl
the skin and have trouble walking. Some
Do not stop taking your tablets just
fatal cases have been reported in this
because you feel better. It is important
particular group of patients.
that you carry on taking Arkolamyl for
In patients with Parkinson's disease
as long as your doctor tells you.
Arkolamyl may worsen the symptoms.
If you suddenly stop taking Arkolamyl
Reporting of side effects
symptoms such as sweating, unable to
If you get any side effects, talk to your
sleep, tremor, anxiety or nausea and
doctor or pharmacist. This includes any
vomiting might occur. Your doctor
possible side effects not listed in this
may suggest you to reduce the dose
leaflet. You can also report side effects
gradually before stopping treatment.
directly via the Yellow Card Scheme
If you have any further questions on the
Website: www.mhra.gov.uk/yellowcard.
use of this product, ask your doctor or
By reporting side effects you can help
pharmacist.
provide more information on the
safety of this medicine.
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ARKOLAMYL
Like all medicines, this medicine can
cause side effects, although not
Keep this medicine out of sight and
everybody gets them.
reach of children. Do not use Arkolamyl
Tell your doctor immediately if you have: after the expiry date, which is stated
on the carton and blister after 'EXP'.
• unusual movement (a common side
The expiry date refers to the last day
effect that may affect up to 1 in 10
of the month. Store in the original
people) mainly of the face or tongue
• blood clots in the veins (an uncommon pack in order to protect from light and
moisture. Do not throw away any
side effect that may affect up to
medicines
via wastewater or household
1 in 100 people) especially in the
waste.
Ask
your pharmacist how to
legs (symptoms include swelling,
throw
away
medicines you no longer
pain, and redness in the leg), which
use.
These
measures
will help to protect
may travel through blood vessels
the
environment.
to the lungs causing chest pain and
difficulty in breathing. If you notice
6. CONTENTS OF THE PACK AND
any of these symptoms seek medical
OTHER INFORMATION
advice immediately.
What Arkolamyl contains:
• a combination of fever, faster breathing,
• The active substance is olanzapine.
sweating, muscle stiffness and
Each Arkolamyl orodispersible tablet
drowsiness or sleepiness (the frequency
contains 5 mg, 10 mg, 15 mg or 20 mg
of this side effect cannot be estimated
of the active substance.
from the available data).
• The other ingredients are crospovidone
Very common side effects: (may affect
(type A), lactose monohydrate,
more than 1 in 10 people):
colloidal silicon dioxide (anhydrous),
• weight gain
hydroxypropylcellulose, mint flavour
• sleepiness
(consisting of: mint oil, terpeneless
• increases in the levels of prolactin in the mint oil, eucalyptol, menthone,
blood.
isomenthone, methylene acetate,
• in the early stages of treatment, some
menthol), talc, magnesium stearate.
people may feel dizzy or faint (with
What Arkolamyl looks like and contents
a slow heart rate), especially when
of the pack
getting up from a lying or sitting
Arkolamyl 5 mg, 10 mg, 15 mg and
position. This will usually pass on its
20 mg are yellow orodispersible tablets.
own but if it does not, tell your doctor.
Orodispersible tablet is the technical
Common side effects: (may affect up to
name for a tablet which dissolves directly
1 in 10 people):
in your mouth, so that it can be easily
• changes in the levels of some blood
swallowed. Arkolamyl 5 mg, 10 mg,
cells, circulating fats and early in
15 mg and 20 mg are available in cartons
treatment, temporary increases in
containing: 10, 28, 30, 56, 60, 70,
liver enzymes.
84, 90, 98, 100, 112 orodispersible tablets
• increases in the level of sugars in the
Not all pack sizes may be marketed
blood and urine
Marketing Authorisation Holder
• increases in levels of uric acid and
Mylan, Potters Bar, Hertfordshire,
creatine phosphokinase in the blood.
EN6 1TL, United Kingdom.
• feeling more hungry
Manufacturers
• dizziness
Pharmathen S.A. , Dervenakion,
• restlessness
6 15351 Pallini, Attiki, Greece.
• tremor
• unusual movements(dyskinesias);
Gerard Laboratories, 35/36 Baldoyle
• constipation
Industrial Estate, Grange Road, Dublin 13,
• dry mouth
Ireland.
• 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.
• fever
• joint pain
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.

This leaflet was last revised in 09/2013

10004735

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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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