Pregabalin Sandoz 150mg Capsules

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

PREGABALIN

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

PREGABALIN

Unit dalam pakej:

30capsule Capsules; 28capsule Capsules

Dikeluarkan oleh:

SALUTAS PHARMA GMBH

Risalah maklumat

PREGABALIN SANDOZ CAPSULES
Pregabalin (
50mg, 75mg & 150mg capsules)
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET:
1.
What is PREGABALIN
SANDOZ used for
2.
How PREGABALIN SANDOZ
works
3.
Before you use PREGABALIN
SANDOZ
4.
How to use PREGABALIN
SANDOZ
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
PREGABALIN SANDOZ
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT IS PREGABALIN
SANDOZ USED FOR
PREGABALIN SANDOZ is used to
treat:
Neuropathic pain
Pregabalin is indicated for the
treatment of peripheral and central
neuropathic pain in adults.
Epilepsy
Pregabalin is indicated as adjunctive
therapy in adults with partial seizures
with or without secondary
generalisation
Generalised Anxiety Disorder
Pregabalin is indicated for the
treatment of Generalised Anxiety
Disorder (GAD) in adults.
Fibromyalgia
Pregabalin is indicated for the
management of fibromyalgia.
HOW PREGABALIN SANDOZ
WORKS
Pregabalin helps decrease the number
of nerve signals, and as a result calms
down overly sensitive nerve cells.
BEFORE YOU USE
PREGABALIN SANDOZ
_When you must not use it _
Do not start taking Pregabalin Sandoz
if you are allergic to pregabalin or
any of the ingredients in Pregabalin
Sandoz. See the end of this leaflet for
a complete list of ingredients in
Pregabalin Sandoz.
Symptoms of an allergic reaction to
Pregabalin Sandoz may include:
•
Serious, even life-
threatening allergic reactions
•
Suicidal thoughts or actions
•
Swelling of your hands, legs
and feet
•
Dizziness and sleepiness
_Before you start use it _
You should inform your doctor if
you have or had any of the following
conditions:
•
depression, mood problems or
suicidal thoughts or behavior
•
kidney problems or get kidney
dialysis
•
heart problem including heart
failure
•
bleeding problem or a low blood
platelet count
•
abuse of prescription medicines,
street drugs, or alcohol in the past
•
swelling in your face, mouth,
tongue, lips, gums, neck or throat

Ciri produk

1
| P a g e
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Sandoz 50 mg Capsules
Pregabalin Sandoz 75 mg Capsules
Pregabalin Sandoz 150 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin Sandoz 50 mg Capsules
Each hard capsule contains 50 mg of pregabalin.
Hard-gelatin capsule size 3 with white to nearly white coloured powder
as filling mass.
Capsule shell top part (cap)
-
White opak, axial: black imprinting “P”;
Capsule shell bottom part (body)
-
White opak, axial: black imprinting: “50”.
Pregabalin Sandoz 75 mg Capsules
Each hard capsule contains 75 mg of pregabalin.
Hard-gelatin capsule size 4 with white to nearly white coloured powder
as filling mass.
Capsule shell top part (cap)
-
Swedish orange opak, axial: black imprinting “P”;
Capsule shell bottom part (body)
-
White opak, axial: black imprinting: “75”.
Pregabalin Sandoz 150 mg Capsules
Each hard capsule contains 150 mg of pregabalin.
Hard-gelatin capsule size 2 with white to nearly white coloured powder
as filling mass.
Capsule shell top part (cap)
-
White opak, axial: black imprinting “P”;
Capsule shell bottom part (body)
-
White opak, axial: black imprinting: “150”.
3.
PHARMACEUTICAL FORM
Hard gelatin capsule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Neuropathic Pain
Pregabalin is indicated for the treatment of peripheral and central
neuropathic pain in adults.
Epilepsy
As adjunctive therapy in adults with partial seizures with or without
secondary generalisation.
Generalised Anxiety Disorder
Treatment of Generalised Anxiety Disorder (GAD) in adults.
Fibromyalgia
Management of fibromyalgia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 given
in either two or three divided doses. Based on
individual patient response and tolerability, the dose may be
increased to 300 mg per day after an interval of 3 to 7
days, and if needed, to a maximum dose of 60