LYRICA 150MG CAPSULES

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PREGABALIN

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

PREGABALIN

Unit dalam pakej:

56Capsule Capsules; 14Capsule Capsules; 112Capsule Capsules

Dikeluarkan oleh:

Pfizer Manufacturing Deutschland GmbH.

Risalah maklumat

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LYRICA
®
Pregabalin (50 mg, 75 mg, 150 mg Capsules)
1
PLD TITLE
: LYRICA
®
PLD DATE
: 03 May 2019
COUNTRY
: Malaysia
REFERENCES
: Malaysia LPD dated 16 January 2017
REASON
: To update PRH address change
To delete the line stating “MAH Holder / Imported by”
: To update serial number
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LYRICA
®
Pregabalin (50 mg, 75 mg, 150 mg Capsules)
2
WHAT IS IN THIS LEAFLET
1.
What LYRICA is used for
2.
How it works
3.
Before you take LYRICA
4.
How to take LYRICA
5.
While you are using LYRICA
6.
Side Effects
7.
Storage and Disposal of
LYRICA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT LYRICA IS USED FOR
LYRICA 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 LYRICA WORKS
LYRICA helps decrease the number
of nerve signals, and as a result calms
down overly sensitive nerve cells.
BEFORE YOU USE LYRICA
_- When you must not use it_
DO NOT START TAKING LYRICA IF YOU
ARE ALLERGIC TO PREGABALIN OR ANY OF
THE INGREDIENTS IN LYRICA. See the
end of this leaflet for a complete list
of ingredients in LYRICA.
Symptoms of an allergic reaction to
LYRICA 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 to take it:_
Tell your healthcare provider about
all your medical conditions including
if you:
- have or had depression, mood
problems or suicidal thoughts or
behavior
- have kidney problems or get kidney
dialysis
- hav

Ciri produk

Pfizer Confidential
LPD Title : Pregabalin
LPD Date : 19 March 2019
Country : Malaysia
Reference Document : UK SmPC dated August 2018 (LY 34_0); USPI dated May 2018;
CDS version 19 dated 10 June 2016
Reason for Change : Update to Section 4.4 Warning and Precautions
Deleted co ntent related to pediatric patients in section 4.4 as per BoH
request.
PFIZER
LYRICA ®
Pregabalin
1. NAME OF THE MEDICINAL PRODUCT
LYRICA
® 50 mg, 75 mg and 150 mg hard capsules.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
50 mg
Each hard capsule cont ains 50 mg of pregabalin.
75 mg
Each hard capsule contains 75 mg of pregabalin.
150 mg
Each hard capsule contains 150 mg of pregabalin.
3. PHARMACEUTICAL FORM
50 mg hard capsules
White, marked “Pfizer” on the cap and “PGN 50” on the body with black ink . The body is also
marked with a black band.
75 mg hard capsules
White and orange, marked “Pfizer” on the cap and “PGN 75” on the body with black ink.
150 mg hard capsules
White, marked “Pfizer” on the cap and “PGN 150” on the body with black ink.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Neuropathic pain
Pregabalin is indicated for the treatment of peripheral and central neuropathic pain in adults.
Epilepsy