AKM-PREGABALIN pregabalin 100 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pregabalin, Quantity: 100 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: purified talc; pregelatinised maize starch; titanium dioxide; purified water; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

56

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: White to off- white powder filled in size 3 capsules, orange opaque cap imprinted A010 and orange opaque body imprinted PREG 100 with black ink; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-06-05

Patient Information leaflet

Akm Pregabalin (Version- 04) Page
1
of
6
AKM PREGABALIN
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about Akm Pregabalin.
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 Akm Pregabalin 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 AKM PREGABALIN IS
USED FOR
Akm
Pregabalin
is
used
to
treat
neuropathic pain, which is pain caused
by an abnormality of, or damage to, the
nerves.
Akm Pregabalin 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.
Akm Pregabalin 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.
Akm Pregabalin also has pain relieving
effects.
Akm Pregabalin may be used alone, or
in combination with other medicines,
to treat your condition.
Your
doctor
may
prescribe
Akm
Pregabalin 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
AKM
PREGABALIN 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
AKM
PREGABALIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AKM PREGABALIN IF YOU
HAVE AN ALLERGY TO:
•
pregabalin,
the
active
ingredient in Akm Pregabalin,
or
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
r

Summary of Product characteristics

AKM-PREGABALIN
Ver 05
04
1
AUSTRALIAN PRODUCT INFORMATION- AKM-PREGABALIN
(PREGABALIN) CAPSULES
1.
NAME OF THE MEDICINE
Pregabalin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AKM-PREGABALIN 75 MG CAPSULES:
Each hard Gelatin capsule contains:
Pregabalin 75 mg
AKM-PREGABALIN 100 MG CAPSULES:
Each hard Gelatin capsule contains:
Pregabalin 100 mg
AKM-PREGABALIN 150 MG CAPSULES:
Each hard Gelatin capsule contains:
Pregabalin 150 mg
AKM-PREGABALIN 200 MG CAPSULES:
Each hard Gelatin capsule contains:
Pregabalin 200 mg
AKM-PREGABALIN 225 MG CAPSULES:
Each hard Gelatin capsule contains:
Pregabalin 225 mg
AKM-PREGABALIN 300 MG CAPSULES:
Each hard Gelatin capsule contains:
Pregabalin 300 mg
For the full list of excipients, see
SECTION 6.1- LIST OF EXCIPIENTS
WARNINGS
MISUSE, ABUSE POTENTIAL OR DEPENDENCE
Pregabalin is a potential drug of misuse, abuse, and dependence.
Pregabalin poses risks of
misuse, abuse and dependence which can lead to overdose and death
especially when used
concomitantly with opioids and other CNS depressants. Assess the
patient’s risk of misuse, abuse
or dependence before prescribing and monitor the patient regularly
during treatment, particularly
amongst
patients
with
current
or
past
misuse,
abuse
or
dependence
of
opioids
and/or
benzodiazepines (see Section 4.4 - Special warnings and precautions
for use).
AKM-PREGABALIN
Ver 05
04
2
3.
PHARMACEUTICAL FORM
AKM-PREGABALIN 75 MG CAPSULES:
Hard gelatin capsule, orange opaque cap imprinted
with 'A009' with black ink and white opaque body imprinted with
‘PREG 75’ with black ink.
AKM-PREGABALIN 100 MG CAPSULES:
Hard gelatin capsule, orange opaque cap imprinted
with 'A010' with black ink and orange opaque body imprinted with
‘PREG 100’ with black
ink.
AKM-PREGABALIN 150 MG CAPSULES:
Hard gelatin capsule, white opaque cap imprinted
with 'A011' with black ink and white opaque body imprinted with
‘PREG 150’ with black
ink.
AKM-PREGABALIN 200 MG CAPSULES:
Hard gelatin capsule, light orange opaque cap
imprinted with 'A012' with black ink and light or