Eldepryl 5 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Selegiline hydrochloride

Available from:

Orion Corporation

ATC code:

N04BD; N04BD01

INN (International Name):

Selegiline hydrochloride

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Monoamine oxidase B inhibitors; selegiline

Authorization status:

Marketed

Authorization date:

1996-01-03

Patient Information leaflet

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 tak

Summary of Product characteristics

Health Products Regulatory Authority
17 July 2023
CRN00DMLF
Page 1 of 7
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
A white or almost white, round, convex uncoated tablet having a single
scoreline on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eldepryl is indicated for the treatment of Parkinson’s disease, or
symptomatic parkinsonism. Eldepryl may be used alone in
early Parkinson’s disease to delay the need for levodopa (with or
without decarboxylase inhibitor). Eldepryl may also be used in
the management of patients with Parkinson’s disease not adequately
controlled by conventional therapy or in whom on-off
symptoms or other dyskinesias develop during maximal levodopa therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults only:
5-10 mg daily either alone or as an adjunct to levodopa or
levodopa/peripheral decarboxylase inhibitor. When Eldepryl is
added to a levodopa regimen it is possible to reduce the levodopa
dosage by an average of 30%.
Method of administration
Eldepryl may be administered either as a single dose in the morning or
in two divided doses of 5 mg, taken at breakfast and
lunch.
_Special Populations_
_Hepatic impairment_
No data are known on dose adjustment in patients with mild hepatic
impairment.
_Renal impairment_
No data are known on dose adjustment in patients with mild renal
impairment.
4.3 CONTRAINDICATIONS
Hypersensitivity to selegiline or to any of the excipients of the
product listed in section 6.1.
Selegiline should not be used in combination with selective serotonin
reuptake inhibitors (SSRI), serotonin noradrenaline
reuptake inhibitor (SNRI) (e.g. venlafaxine), tricyclic
antidepressants, sympathomimetics, monoamine oxidase inhibitors (e.g.
linezolide), and opioids (e.g. pethidine) (see section 4.5).
Selegiline should not be used in pa