PREGABALIN-DRLA pregabalin 25 mg capsule blister pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

pregabalin, Quantity: 25 mg

Доступна з:

Dr Reddys Laboratories Australia Pty Ltd

ІПН (Міжнародна Ім'я):

Pregabalin

Фармацевтична форма:

Capsule, hard

Склад:

Excipient Ingredients: purified talc; titanium dioxide; sodium lauryl sulfate; lactose monohydrate; Gelatin; purified water; maize starch

Адміністрація маршрут:

Oral

Одиниць в упаковці:

20, 56, 60, 14

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

Pregabalin-DRLA (pregabalin) is indicated for the treatment of neuropathic pain in adults.,Pregabalin-DRLA (pregabalin) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Огляд продуктів:

Visual Identification: Size 4 hard gel capsule with opaque white coloured cap and white coloured body, imprinted "RDY" on cap and "291" on body with black imprinting ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизація:

Licence status A

Дата Авторизація:

2016-12-21

інформаційний буклет

PREGABALIN-DRLA
_Pregabalin (PRE-gab-a-lin)_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pregabalin-DRLA.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Pregabalin-
DRLA against the benefits it is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PREGABALIN-
DRLA IS USED FOR
Pregabalin-DRLA is used to treat
neuropathic pain, which is pain
caused by an abnormality of, or
damage to, the nerves.
Pregabalin-DRLA is also used to
control epilepsy. Epilepsy is a
condition where you have repeated
seizures (fits). There are many
different types of seizures, ranging
from mild to severe.
Pregabalin-DRLA belongs to a group
of medicines called anticonvulsants.
These medicines are thought to work
by controlling brain chemicals which
send signals to nerves so that seizures
do not happen.
Pregabalin-DRLA also has pain
relieving effects.
Pregabalin-DRLA may be used
alone, or in combination with other
medicines, to treat your condition.
Your doctor may prescribe
Pregabalin-DRLA in addition to
your current therapy when your
current treatment is no longer
working as well as before.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
PREGABALIN-DRLA HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN_
There is not enough information to
recommend the use of this medicine
in children under the age of 18 years.
BEFORE YOU TAKE
PREGABALIN-DRLA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PREGABALIN-DRLA IF
YOU HAVE AN ALLERGY TO:
•
pregabalin, the active ingredient
in Pregabalin-DRLA, or
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic

Характеристики продукта

AUSTRALIAN PRODUCT INFORMATION – PREGABALIN-DRLA
(PREGABALIN) CAPSULES
1
NAME OF THE MEDICINE
Pregabalin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PREGABALIN-DRLA contains the active ingredient pregabalin. Pregabalin
is an analogue of the
neurotransmitter gamma-aminobutyric acid (GABA). It has analgesic and
anticonvulsant
activity. PREGABALIN-DRLA capsules contain 25 mg, 50 mg, 75 mg, 100
mg, 150 mg, 200 mg,
225 mg or 300 mg pregabalin.
Excipient(s) with known effect:
•
Sugars as lactose monohydrate
For the full list of excipients, see Section 6.1 – List of
excipients
3
PHARMACEUTICAL FORM
PREGABALIN-DRLA 25 mg capsules: an opaque white hard gelatin capsule
of size 4, imprinted
‘RDY’ on the cap and ‘291’ on the body with black ink.
PREGABALIN-DRLA 50 mg capsules: an opaque white hard gelatin capsule
of size 3, imprinted
‘RDY’ on the cap and ‘292’ on the body with black ink. The
capsule body is also marked
with a black band.
PREGABALIN-DRLA 75 mg capsules: a hard gelatin capsule of size 4, i m
pr i n te d ‘ RD Y ’ o n
t h e o pa q ue r e d co lo ur ed c a p a nd ‘2 9 3’ o n t he o pa
q ue w h i te c olo u re d b o dy
w i t h b lac k i nk .
PREGABALIN-DRLA 100 mg capsules: a hard gelatin capsule of size 3,
imprinted ‘RDY’ on the
opaque red coloured cap and ‘294’ on the opaque red coloured body
with black ink.
PREGABALIN-DRLA
150
mg
capsules:
an
opaque
white
hard
gelatin
capsule
of
size
2,
imprinted ‘RDY ’ on the cap and ‘295’ on the body with black
ink.
PREGABALIN-DRLA 200 mg capsules: a n o p a q u e light red coloured
hard gelatin capsule
of size 1,
i m p r i n t e d
‘ R D Y ’
o n
t h e c a p a n d
‘ 2 9 6 ’
o n
t h e b o d y w i t h
b l a c k i n k .
PREGABALIN-DRLA 225 mg capsules: a hard gelatin capsule of size 1,
imprinted ‘RDY’ on the
opaque light red coloured cap and ‘297’ on the opaque white
coloured body with black
ink.
PREGABALIN-DRLA 300 mg capsules: a hard gelatin capsule of size 0,
imprinted ‘RDY ’ on the
1
opaque red coloured cap and