Eldepryl 5 mg Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Selegiline hydrochloride

Disponible depuis:

PCO Manufacturing Ltd.

Code ATC:

N04BD; N04BD01

DCI (Dénomination commune internationale):

Selegiline hydrochloride

Dosage:

5 milligram(s)

forme pharmaceutique:

Tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Monoamine oxidase B inhibitors; selegiline

Statut de autorisation:

Authorised

Date de l'autorisation:

2013-02-22

Notice patient

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELDEPRYL
® 5 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 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 Eldepryl
(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 a group of medicines known as
sympathomimetics which are used to treat for example
asthma,

Résumé des caractéristiques du produit

Health Products Regulatory Authority
15 November 2018
CRN008LXK
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eldepryl 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of selegiline hydrochloride.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
_Product imported from The UK:_
A white or almost white, round, convex uncoated tablet having a single
scoreline on
one face.
4 CLINICAL PARTICULARS
As per PA1327/003/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1327/003/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Mannitol (E421)
Maize starch
Microcrystalline cellulose
Povidone
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
Health Products Regulatory Authority
15 November 2018
CRN008LXK
Page 2 of 2
The shelf life expiry date for this product shall be the date shown on
the bottle and
outer package of the product on the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC.
Keep the container tightly closed.
Store in the original container.
6.5 NATURE AND CONTENTS OF CONTAINER
White HDPE bottle with HDPE closure placed in cardboard outer carton.
Pack size: 100 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 MARKETING AUTHORISATION NUMBER
PPA0465/304/001
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/304/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 22
nd
February 2013
Last updated: May 2015
10 DATE OF REVISION OF THE TEXT
November 2018