SIRANALEN CAPSULES 75MG

Country: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

Pregabalin

Fáanlegur frá:

MEDOCHEMIE SINGAPORE PTE. LTD.

ATC númer:

N03AX16

Lyfjaform:

CAPSULE

Samsetning:

Pregabalin 75mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

MEDOCHEMIE (FAR EAST) LTD -ORAL FACILITY

Leyfisstaða:

ACTIVE

Leyfisdagur:

2019-11-25

Upplýsingar fylgiseðill

spc-pregab-caps-2.0
SIRANALEN HARD CAPSULES
(Pregabalin)
1. NAME OF THE MEDICINAL PRODUCT
Siranalen 75 mg hard capsules
Siranalen 150 mg hard capsules
Siranalen 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 75 mg, 150 mg or 300 mg of pregabalin.
Excipient with known effect:
lactose monohydrate. Siranalen 300mg also contains carmoisine (E122).
Each 75 mg hard capsule contains 8.25 mg lactose monohydrate.
Each 150 mg hard capsule contains 16.50 mg lactose monohydrate.
Each 300 mg hard capsule contains 33 mg lactose monohydrate and
0.0881mg carmoisine (E122).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsule.
Siranalen 75 mg hard capsules: Blue-white hard gelatin capsules size
“4” (approximately 14.3mm in
length) filled with off white powder.
Siranalen 150 mg hard capsules: White-white hard gelatin capsules size
“2” (approximately 18.0 mm
in length) filled with off white powder.
Siranalen 300 mg hard capsules: Maroon-white hard gelatin capsules
size “0” (approximately 21.4 mm
in length) filled with off white powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS_ _
Neuropathic pain
Siranalen is
i n d i c a t e d
f or
t h e
t r e a t m e nt
o f
n e u r o pa t h i c
p a i n ,
w h i c h
i n c l u d e s
d i a b e t i c
p e r i p he r a l
neuropathy and post-herpetic neuralgia in adults.
Epilepsy
Siranalen
i s
i n d i c a t e d
a s
a d j u n c t i v e
t h e r a p y
of
p a r t i a l
seizures,
w i t h
o r
w i t h o u t
s e c o n d a r y
generalization, in adults.
Generalised Anxiety Disorder
Siranalen is indicated for the treatment of Generalised Anxiety
Disorder (GAD) in adults.
Fibromyalgia
spc-pregab-caps-2.0
Pregabalin is indicated for the management of fibromyalgia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose range is 150 to 600 mg per day given in either two or three
divided doses.
_Neuropathic pain _
Pregabalin treatment can be started at a dose of 150 mg per day.
Based on individual patient response an

Vara einkenni

12/2022