SELEGOS TABLET 5 mg

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

SELEGILINE HCl

Tilgjengelig fra:

MEDOCHEMIE SINGAPORE PTE. LTD.

ATC-kode:

N04BD01

Legemiddelform:

TABLET

Sammensetning:

SELEGILINE HCl 5 mg

Administreringsrute:

ORAL

Resept typen:

Prescription Only

Produsert av:

MEDOCHEMIE LTD

Autorisasjon status:

ACTIVE

Autorisasjon dato:

1996-04-30

Preparatomtale

SG-JUL2021
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Selegos 5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg of Selegiline hydrochloride.
Excipient with known effect: lactose monohydrate. Each 5 mg tablet
contains 85 mg
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Round, white, flat, scored tablets with 7mm diameter.
4.0
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
SELEGOS is indicated for the treatment of Parkinson’s disease or
symptomatic
parkinsonism.
SELEGOS may be used alone in early Parkinson’s disease to delay the
need for
levodopa (with or without decarboxylase inhibitor). SELEGOS may also
be used as
an adjunct to levodopa (with or without decarboxylase inhibitor).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
SELEGOS 10mg (2 tablets) daily either alone or as an adjunct to
levodopa or
levodopa/peripheral decarboxylase inhibitor.
SG-JUL2021
2
SELEGOS may be administered either as a single dose in the morning or
in two
divided doses of 5mg taken at breakfast and lunch.
When SELEGOS is added to a levodopa regimen it is possible to reduce
the
levodopa dosage by an average of 30 per cent.
4.3.
CONTRAINDICATIONS
None.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The precise dose at which selegiline becomes a non-selective inhibitor
of all MAO
has not been determined, but with doses higher than 10 mg/day there is
a theoretical
risk of hypertension after ingestion of tyramine-rich food.
Concomitant treatment with medicines which inhibit MAO-A, (or
non-selective
MAO inhibitors) can cause hypotensive reactions.
Hypotension,
sometimes
sudden
in
onset,
has
been
reported
with
conventional
selegiline.
_Serotonin syndrome _
Concomitant administration of Selegos and buprenorphine/opioids may
result in
serotonin syndrome, a potentially life-threatening condition (see
section 4.5).
If concomitant treatment with other serotonergic agents is
clinically
warranted,
careful observation of the patient is