ALOJA 150 (Pregabalin Capsules 150 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PREGABALIN

Boleh didapati daripada:

MYLAN HEALTHCARE SDN. BHD.

INN (Nama Antarabangsa):

PREGABALIN

Unit dalam pakej:

30 Capsules

Dikeluarkan oleh:

Mylan Laboratories Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
ALOJA 75 AND 150
Pregabalin (75 mg and 150 mg)
1
WHAT IS IN THIS LEAFLET
1.
What_ ALOJA_ is used for
2.
How_ ALOJA_ works
_3._
Before you use_ ALOJA_
_4._
How to use_ ALOJA_
5.
While you are using
_ALOJA_
6.
Side Effects
7.
Storage and Disposal of
_ALOJA_
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
MAL no.
12.
Serial Number
WHAT_ ALOJA_ IS USED FOR
_ALOJA_ is used to treat
long lasting
pain caused by damage to the nerves.
_ALOJA_ is used to treat a certain form
of epilepsy (partial
seizures with or
without secondary generalisation) in
adults.
_ALOJA_ is used to treat
Generalised
Anxiety Disorder (GAD).
Fibromyalgia
ALOJA
is
indicated
for
the
management of fibromyalgia
HOW_ ALOJA_ WORKS
_ALOJA helps_
decrease the number
of
nerve signals,
and as a result
calms down overly sensitive nerve
cells.
BEFORE YOU USE_ ALOJA_
_- When you must not use it_
If you are allergic to pregabalin or
any of the other ingredients of this
medicine (_Taking other medicines_).
_ALOJA_ should not
be taken during
pregnancy or when breast- feeding,
unless you are told otherwise by your
doctor.
Effective contraception must be used
by women of child-bearing potential.
If
you
are
pregnant
or
breast-
feeding,
think you may be pregnant
or are planning to have a baby,
ask
your doctor or pharmacist for advice
before taking this medicine.
The safety and efficacy in children
and adolescents (under 18 years of
age)
has not
been established and
therefore,
pregabalin should not be
used in this age group.
_-_
_Before you start to use it_
There have been reports
of
heart
failure in some patients when taking
_ALOJA_; these patients were mostly
elderly
with
cardiovascular
conditions.
BEFORE
TAKING
THIS
MEDICINE
YOU SHOULD TELL
YOUR
DOCTOR IF
YOU HAVE A HISTORY OF
HEART DISEASE.
Before
taking this
medicine
you
should tell your doctor if you have a
history of
alcoholism or
any drug
abuse or dependence.
Do not
take
more medicine than prescribed.
_-_
_Taking o

Ciri produk

ALOJA
TM 75 AND 150
(PREGABALIN CAPSULES 75 MG AND 150 MG)
1.
NAME OF THE MEDICINAL PRODUCT
ALOJA
TM 75
Pregabalin Capsules 75 mg
ALOJA
TM 150
Pregabalin Capsules 150 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALOJA
TM 75
Each Capsule contains:
Pregabalin Ph. Eur ....................................... 75 mg,
Excipients ...............................q.s.
For the full list of excipients, see section 6.1.
ALOJA
TM 150
Each Capsule contains:
Pregabalin Ph. Eur .........................................150 mg,
Excipients ...............................q.s.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
ALOJA
TM 75
Hard capsules
A No. 4, light peach opaque cap and light peach opaque body, hard-
shell gelatin capsule filled with white to off white powder. The
capsule
is axially printed with MYLAN over PB75 in black ink on cap and body.
ALOJA
TM 150
Hard capsules
A No. 2, light peach opaque cap and white opaque body, hard-shell
gelatin capsule filled with white to off-white powder. The capsule is
axially printed with MYLAN over PB150 in black ink on cap and body.
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.
_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
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 given
as 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 600 mg per day
after
an ad