LYRICA 150MG CAPSULES

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PREGABALIN

Boleh didapati daripada:

VIATRIS SDN. BHD.

INN (Nama Antarabangsa):

PREGABALIN

Unit dalam pakej:

56Capsule Capsules; 14Capsule Capsules; 112Capsule Capsules

Dikeluarkan oleh:

Pfizer Manufacturing Deutschland GmbH.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
LYRICA
® CAPSULES
Pregabalin (50 mg, 75 mg, 150 mg Capsules)
1
WHAT IS IN THIS LEAFLET
1.
What LYRICA is used for
2.
How LYRICA works
3.
Before you use LYRICA
4.
How to use 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
11.
Serial Number
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
_Pregnancy and lactation_
Animal studies have shown that
pregabalin, the active ingredient in
LYRICA, causes reproductive
toxicity. Hence it should not be
taken during pregnancy. Effective
contraception must be used in
women of child bearing potential.
LYRICA is excreted in the milk of
lactating women. As the safety of
LYRICA in infants is not known,
breast-feeding is not recommended
during treatment with LYRICA.
You and your healthcare provider
should discuss whether you should
take LYRICA or breast-feed, but
you should not do both.
-
_Before you start to take it_
Tell your healthc

Ciri produk

1
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 contains 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 “VTRS” 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 “VTRS” on the cap and “PGN 75” on the
body with black ink.
150 mg hard capsules
White, marked “VTRS” 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
Pregabalin is indicated as adjunctive therapy in adults with partial
seizures with or without secondary
generalisation.
2
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.
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.
Pregabalin may be taken with or without food.
Neuropathic pain
Pregabalin treatment can be started at a dose of 150 mg per day. Based
on individual patient response
and tolerability, the dosage may be increased to 300 mg per day after
an interval of 3 to 7 days, and if
needed, to a maximum dose of 600 mg per day after an additional 7-day
interval.
Fibromyalgia
The usual dose range for most patients is 300 to 450 mg per day given
in two divided doses. Some
patients may derive additional benefit at 600 mg per day. Dosing
should begin at 75 mg two times a
day (150 mg/day) and may be increased to 150 mg two times a day (300
mg/day) within 1 week based
on efficacy and tolerability. Patients who do not experience
sufficient benefit wi