Eldepryl 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Selegiline hydrochloride

Available from:

Orion Pharma (UK) Ltd

ATC code:

N04BD01

INN (International Name):

Selegiline hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100; GTIN: 6432100001863 6432100017994

Patient Information leaflet

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 a

Summary of Product characteristics

OBJECT 1
ELDEPRYL 5MG TABLETS
Summary of Product Characteristics Updated 30-Apr-2015 | Orion Pharma
(UK) Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Eldepryl 5 mg Tablets
2. Qualitative and quantitative composition
Selegiline hydrochloride 5 mg
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Tablets for oral administration.
4. Clinical particulars
4.1 Therapeutic indications
Selegiline is indicated for the treatment of Parkinson's disease, or
symptomatic parkinsonism. It may be
used alone in early Parkinson's disease for symptomatic relief to
delay the need for levodopa (with or
without decarboxylase inhibitor). or as an adjunct to levodopa (with
or without decarboxylase inhibitor).
Selegiline in combination with maximal levodopa therapy is indicated
particularly in patients who
experience fluctuations in their condition such as 'end-dose' type
fluctuations, 'on-off' symptoms or other
dyskinesias.
4.2 Posology and method of administrat