ELDEPRYL selegiline hydrochloride 5 mg tablet

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

selegiline hydrochloride, Quantity: 5 mg

Διαθέσιμο από:

Orion Pharma (AUS) Pty Limited

Φαρμακοτεχνική μορφή:

Tablet, uncoated

Σύνθεση:

Excipient Ingredients: magnesium stearate; povidone; maize starch; microcrystalline cellulose; mannitol

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

30 and 100 tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

As an adjunct in the management of late stage Parkinson's disease in patients being treated with levodopa and/or a peripheral decarboxylase inhibitor, who exhibit deterioration in the quality of their response to the therapy. Indications as approved 22 January 1999 - ELDEPRYL is indicated for the treatment of patients with Parkinson's disease. It can be used as monotherapy in the early phases of the disease and as adjunctive therapy with levodopa (with/without a peripheral decarboxylase inhibitor) As an adjunct in the management of late stage Parkinson's disease in patients being treated with levodopa and/or a peripheral decarboxylase inhibitor, who exhibit deterioration in the quality of their response to the therapy. Indications as approved 22 January 1999 - ELDEPRYL is indicated for the treatment of patients with Parkinson's disease. It can be used as monotherapy in the early phases of the disease and as adjunctive therapy with levodopa (with/without a peripheral decarboxylase inhibitor)

Περίληψη προϊόντος:

Visual Identification: White, round, convex, scored, uncoated tablet 6mm diameter.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

1994-01-18

Φύλλο οδηγιών χρήσης

ELDEPRYL™ - Consumer Medicine Information
1
ELDEPRYL™
_Selegiline hydrochloride 5 mg tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
ELDEPRYL tablets. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ELDEPRYL
tablets against the benefits the
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ELDEPRYL IS
USED FOR
ELDEPRYL tablets are used to treat
the symptoms of Parkinson's disease.
This is a disease of the brain that
affects movement.
People with Parkinson's disease do
not have enough nerve cells in the
part of the brain that controls
movement. These nerve cells
produce a substance called
dopamine. It is a lack of dopamine
which causes problems with
movement.
ELDEPRYL tablets keep dopamine
around longer, helping with
difficulties in movement.
BEFORE YOU TAKE IT
TELL YOUR DOCTOR OR PHARMACIST IF
YOU ARE TAKING, HAVE RECENTLY
TAKEN, OR MIGHT TAKE ANY OTHER
MEDICINES, INCLUDING ANY THAT YOU
GET WITHOUT A PRESCRIPTION FROM
YOUR PHARMACY, SUPERMARKET OR
HEALTH FOOD SHOP.
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ELDEPRYL TABLETS IF:
1. you have ever had an allergic
reaction to:
•
medicines containing
selegiline
•
any of the ingredients listed at
the end of this leaflet.
2. you have taken or are taking
antidepressants known as
selective serotonin reuptake
inhibitors (SSRIs) such as
Proza c
®
(fluoxetine), Aropax
®
(paroxetine) or Zoloft
®
(sertraline) within the last five
weeks.
3. you are taking antidepressants
known as serotonin noradrenaline
reuptake inhibitors (SNRIs) such
as Efexor-XR
®
(venlafaxine),
Pristiq
®
(desvenlafaxine) and
Cymbalta
®
(duloxetine).
4. you are taking pethidine (a strong
pain killer) or other opiates
(chec

Αρχείο Π.Χ.Π.

PI – Eldepryl (selegiline hydrochloride)
1 of 12
AUSTRALIAN PRODUCT INFORMATION
– ELDEPRYL (SELEGILINE HYDROCHLORIDE) TABLET
1
NAME OF THE MEDICINE
selegiline hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg selegiline hydrochloride.
For the full list of excipients, see _section 6.1 List of excipients_.
3
PHARMACEUTICAL FORM
Tablet
White, round, convex, scored, uncoated tablet 6mm diameter.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ELDEPRYL is indicated for the treatment of patients with Parkinson's
disease. It can be used
as monotherapy in the early phases of the disease and as adjunctive
therapy with levodopa
(with / without a peripheral decarboxylase inhibitor).
4.2 DOSE AND METHOD OF ADMINISTRATION
Selegiline is administered as monotherapy in the early phase of the
disease, or as adjunctive
therapy with levodopa (with / without a peripheral decarboxylase
inhibitor). In each case the
initial dose is 5 mg taken at breakfast and lunch. There is no
evidence that additional benefit
will be obtained from the administration of higher doses.
After two to three days of adjunctive therapy, an attempt may be made
to reduce the dose of
levodopa (10-30%) if levodopa-related adverse reactions occur. Further
reductions of
levodopa may be possible during continued selegiline therapy.
Double-blind studies on early-phase parkinsonian patients showed that
patients receiving
selegiline monotherapy manage significantly longer without levodopa
therapy than controls
receiving placebo. These patients could also maintain their ability to
work longer.
After the initiation of levodopa therapy, selegiline potentiates and
extends the effect of
levodopa, and thus a reduction of levodopa dosage is possible. By
adding selegiline to
levodopa therapy the fluctuations in disability, _ e.g._ end-of-dose
type fluctuations, can be
reduced.
4.3 CONTRAINDICATIONS
Known hypersensitivity to selegiline or any other components of the
formulation.
When selegiline is prescribed in combination with levodopa,