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ELDEPRYL 10 MG/5 ML SYRUP

Active substance(s): SELEGILINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Eldepryl® 5 mg Tablets
Eldepryl® 10 mg Tablets
(Selegiline hydrochloride)
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. See section 4.
What is in this leaflet
1. What Eldepryl is and what it is used for
2. What you need to know before you
take Eldepryl
3. How to take Eldepryl
4. Possible side effects
5. How to store Eldepryl
6. Contents of the pack and other
information
1. WHAT ELDEPRYL® IS AND
WHAT IT IS USED FOR
Eldepryl is available as a 5 mg and 10 mg
Tablet. Eldepryl contains the active
substance
selegiline
hydrochloride.
Eldepryl is a monoamine oxidase-B
inhibitor, and is used in the treatment of
Parkinson’s disease. Eldepryl may be taken
alone in the early stages of your condition,
delaying the need for the addition of other
medicines. Eldepryl however can also be
used in conjunction with other treatments
such as Levodopa to reduce the on-off
symptoms or uncontrolled movements
you may experience. This happens
especially when the effects of the other
treatments are wearing-off.
Your doctor will explain why this medicine
has been chosen for you.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE ELDEPRYL®
Do not take Eldepryl
-- if you are allergic (hypersensitive) to
selegiline hydrochloride or any of the
other ingredients of this medicine (listed
in section 6)
-- if you are taking any antidepressants
(see Other medicines and Eldepryl).
Antidepressants should be stopped a
number of weeks before taking Eldepryl,
speak to your doctor for further advice
-- if you are taking pethidine or any other
opioid painkillers such as codeine or
tramadol
-- if you are taking any monoamine oxidase
(MAO) inhibitors e.g. the antibiotic
linezolid
-- if you are taking any medicines for
migraine e.g. sumatriptan, naratriptan,
zolmitriptan and rizatriptan
-- if you are taking any sympathomimetic
medicines e.g. medicines used in the
treatment of asthma or to relieve nasal
congestion
-- if you suffer from stomach or duodenal
ulcers
-- if you suffer from a movement or muscle
disorder not connected to Parkinson’s
disease.
Taking Eldepryl with Levodopa
Do not take Eldepryl together with
Levodopa if you suffer from any of the
following conditions:
-- major heart or blood vessel problems
(cardiovascular disease)
-- chest pain (angina)
-- high blood pressure (arterial hypertension)
-- an erratic or fast heartbeat (e.g. tachycardia
or arrhythmias)
-- an overactive thyroid gland (hyperthyroid
disease)
-- an eye condition called narrow angle
glaucoma
-- a tumour of your adrenal gland
(phaeochromocytoma) or prostate
(prostatic adenoma)
-- major
mental
health
problems
(e.g. schizophrenia or advanced dementia).
Warnings and Precautions
Talk to your doctor or pharmacist before
taking Eldepryl if any of the following
applies to you:
-- if you have uncontrolled high blood
pressure, chest pain (angina), the
sensation of feeling your heartbeat
(palpitations) or an abnormal or erratic
heartbeat (arrhythmia)
-- if you have kidney or liver problems
-- if you are being treated for any mental
illness, anxiety or sleep problems
-- if you have a history of stomach ulcers
-- if you are already taking a medicine
called Levodopa as it can cause agitation
and uncontrollable movements. Your
doctor may need to monitor you closely
and alter your dose
-- if you are going to have surgery as
Eldepryl may interfere with some of
the medicines used as part of a general
anaesthetic
-- if you have a history of any unusual
urges and/or behaviours (such as
excessive gambling or excessive sexual
behaviour). See section 4.
Children
Eldepryl should not be given to children.
Other medicines and Eldepryl
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines. In particular it is
important that you tell your doctor if you
are taking any of the following:
--
amantadine, dopamine or levodopa
(used to treat Parkinson’s disease)
-- any type of antidepressant e.g. citalopram,
escitalopram, fluoxetine, fluvoxamine,
paroxetine,
sertraline,
venlafaxine,
amitriptyline and protriptyline cannot be
taken with Eldepryl
-- pethidine or any other opioid painkillers
such as codeine or tramadol cannot be
taken with Eldepryl
-- the antibiotic linezolid cannot be taken
with Eldepryl
-- if you are taking any sympathomimetic
medicines e.g. medicines used in the
treatment of asthma or to relieve nasal

--

----

-------

congestion - these medicines cannot be
taken with Eldepryl
any medicines for migraine e.g.

sumatriptan, naratriptan, zolmitriptan
and rizatriptan cannot be taken with
Eldepryl
medicines for high or low blood pressure
medicines for mood or mental illness
medicines to treat anxiety, sleep

problems or to relax the gut muscles
(medicines that act on the central
nervous system)
medicines used as part of an anaesthetic
medicines to treat heart problems (e.g.

digitalis) as you may need more frequent
check-ups with your doctor
medicines

to
thin
the
blood
(anticoagulants) as you may need more
frequent check-ups with your doctor
HRT (hormone replacement therapy)
altretamine (used to treat ovarian

cancer)
oral contraceptives (The ‘pill’, other forms
of contraception should be discussed with
your doctor).

Eldepryl needs a period of time to be
completely removed from the body before
starting certain other medicines. Please
talk to your doctor for advice if you are
thinking about starting other medication.
Eldepryl with food, drink and alcohol
You may take Eldepryl with food and drink.
Alcohol should be avoided whilst you are
taking Eldepryl.
Your doctor may recommend that you
avoid certain foods containing tyramine
such as mature cheese, broad beans,
Bovril, yeast extracts or fermented soya
bean products.
Pregnancy and breast-feeding
-- You should not take Eldepryl if you are
pregnant, planning to become pregnant
or if you think you may be pregnant.
-- You should not take Eldepryl if you are
breast-feeding.
Ask your doctor or pharmacist for advice
before taking this medicine.
Driving and using machines
Eldepryl may make you feel dizzy, drowsy
or slow your reactions, therefore your
ability to drive or operate machinery may
be affected. If you experience these side
effects then do not drive, use tools or
operate machinery.
The medicine can affect your ability to
drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine
until you know how it affects you.
• It is an offence to drive if this medicine
affects your ability to drive.
• However, you would not be committing
an offence if:
-- The medicine has been prescribed to
treat a medical or dental problem and
-- You have taken it according to the
instructions given by the prescriber or
in the information provided with the
medicine and
-- It was not affecting your ability to drive
safely
Talk to your doctor or pharmacist if you are
not sure whether it is safe for you to drive
while taking this medicine.
3. HOW TO TAKE ELDEPRYL®
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 normally start you on a
dose of 10 mg Eldepryl each day.
This may be taken either as one 10 mg or
two 5 mg tablets.
-- Eldepryl can be taken as a single daily
dose in the morning, or the prescribed
daily dose taken in two parts, half dose in
the morning and half dose at lunchtime.
If you take your tablets in the evening or
before going to bed they may keep you
awake at night.
-- Your doctor will tell you how long you
should continue to take this medicine.
Make sure you ask your pharmacist if the
label on your medicine does not tell you
how to take Eldepryl.
If you take more Eldepryl than you
should
Your doctor has carefully chosen the
correct dosage for you so do not take
more than the prescribed dose. However,
if you accidentally take too much Eldepryl
immediately contact your doctor or
contact your nearest hospital casualty
department.
Symptoms of an overdose include agitation,
feeling irritable, restless or tired, severe
headache, shaking, high or low blood
pressure, difficulty breathing, shortness of
breath, experiencing situations, visions or
sounds which are not real (hallucinations),
dizziness, fast irregular heartbeat, chest
pain, severe muscle spasms, fever, excessive
sweating, loss of consciousness and fits.
If you forget to take Eldepryl
If you forget to take a dose, take a dose as
soon as you remember, but do not take
more than the recommended dose every
24 hours. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Eldepryl
Do not stop taking Eldepryl unless told
to do so by your doctor. If you have
any further questions on the use of this
medicine, ask your doctor or pharmacist.
If someone else takes your medicine
If someone else has swallowed any of your
medicine, contact your nearest hospital
casualty department or tell a doctor
immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Very Common (may affect more than 1
in 10 people)
• Sore mouth and swollen gums
(stomatitis).
Common (may affect up to 1 in 10
people)
• Difficulty controlling your movements
or loss of balance (dyskinesias, akinesia,
bradykinesia), fall
• slow heart beat (bradycardia)
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• dizziness, feeling faint, headache,

shaking
• sleep disorders, confusion, experiencing
situations, visions or sounds which are
not real (hallucinations)
• feeling down (depressed)
• high or low blood pressure
• abnormal liver tests due to increase in
liver enzymes
• feeling sick, constipation, diarrhoea,
mouth ulcers
• blocked nose, sore throat
• back pain, joint pain (arthralgia), muscle
cramps
• tiredness
• ear disorders giving the sensation of
dizziness (vertigo)
• excessive sweating.
Uncommon (may affect up to 1 in 100
people)
• Chest pain (angina pectoris), irritability,
swelling of the ankles
• irregular, erratic or fast heartbeat, the
sensation of feeling your heart beat
(palpitations)
• problems sleeping, strange dreams,
feeling anxious or agitated, changes
in mood, altered mental state / loss of
contact with reality (psychoses)
• shortness of breath (dyspnoea)
• blurred vision
• low blood pressure leading to a feeling
of light-headedness particularly when
standing up (orthostatic hypotension)
• problems starting, passing and stopping
urination or altered frequency of
urination (micturition disorders)
• abnormal liver tests due to increase in
liver enzymes (transient rise of serum
alanine aminotransferase (ALAT))
• muscle weakness (myopathy)
• low level of white blood cells
(leucocytopenia)
and
platelets
(thrombocytopenia) in the blood which
may increase the risk of bleeding,
bruising or infections
• loss of appetite
• sore throat (pharyngitis), dry mouth
• hair loss, blisters or spots on skin.
Rare (may affect up to 1 in 1,000 people)

5. HOW TO STORE ELDEPRYL®
Keep this medicine out of the sight and
reach of children. Your medicine could
harm 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 your tablets at a temperature below
25ºC, in a dry safe place. Tablets provided
in plastic bottles should be kept in the
container with the lid tightly closed and
tablets provided in blister packs should
be stored in the original carton, in order to
protect them from moisture. If your doctor
decides to stop treatment, return any leftover medicine to your pharmacist. Only
keep it if your doctor tells you to.
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 Eldepryl contains
The active substance is selegiline
hydrochloride. The tablets contain either 5
mg or 10 mg of the active ingredient.
The other ingredients are mannitol,
maize starch, microcrystalline cellulose,
povidone and magnesium stearate.
What Eldepryl looks like and contents
of the pack.
Eldepryl Tablets are white in colour.
Eldepryl 5 mg Tablets are available in a
bottle of 100 tablets or blister-packs of
30, 50, 60 or 100 tablets. Eldepryl 10 mg
Tablets are available in a bottle of 50 or
100 tablets or blister-packs of 30, 50, 60
or 100 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Orion Corporation, Orionintie 1,
FIN-02200 Espoo, Finland.
Manufacturer
Orion Corporation
FI-02200 Espoo, Finland

• Low blood pressure leading to a feeling Distributed in the UK by
of light-headedness, dizziness or
fainting, particularly when standing up
(postural hypotension)
• skin reactions.

Not Known (frequency cannot be
estimated from the available data)
However these events can be considered
to be very rare
• Hypersexuality (altered sexual interest
and behaviour of significant concern to
the patient or to others)
• unusual urges and/or behaviours
(such as excessive gambling or other
behaviours)
• inability or difficulty passing urine.
Side effects when Eldepryl is used with
Levodopa
When Eldepryl is taken with levodopa this
may increase the side effects of levodopa
such as:
• excessive, uncontrollable movements
after taking your medicine
• confusion, hallucinations, problems
sleeping, agitation, feeling restless
• feeling your heartbeat (palpitations),
irregular, erratic heartbeat, chest pain,
swollen ankles and shortness of breath
• a feeling of sickness, dizziness, feeling
faint, dry mouth, loss of appetite and
problems passing urine
• low blood pressure leading to a feeling
of light-headedness, particularly when
standing up
• hypersexuality (altered sexual interest
and behaviour of significant concern to
the patient or to others)
• low level of white blood cells
(leucocytopenia)
and
platelets
(thrombocytopenia) in the blood which
may increase the risk of bleeding,
bruising or infections and temporary
liver problems
• headache, skin reaction and loss of hair.
These side effects will usually stop when
the amount of levodopa you are taking is
reduced.
Talk to your doctor about reducing the
dose if you experience any of these effects.
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 the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help
provide more information on the safety of
this medicine.

Orion Pharma (UK) Ltd
Oaklea Court, 22 Park Street,
Newbury, Berkshire RG14 1EA
This leaflet was last revised in November
2015
For information on Parkinson’s disease
and help available please contact:
Parkinson’s UK, 215 Vauxhall Bridge Road,
SW1V 1EJ

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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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