PREGABALIN-TEVA pregabalin 150mg hard gelatin capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pregabalin, Quantity: 150 mg

Available from:

Teva Pharma Australia Pty Ltd

INN (International Name):

Pregabalin

Pharmaceutical form:

Capsule, hard

Composition:

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

Administration route:

Oral

Units in package:

56 capsules, 21 capsules, 60 capsules, 14 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Pregabalin is indicated for the treatment of neuropathic pain in adults

Product summary:

Visual Identification: PREGABALIN-TEVA 150 mg capsules are ivory opaque capsules imprinted with '150' on capsule body in black ink; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-09-23

Patient Information leaflet

PREGABALIN-TEVA
_Pregabalin (PRE-gab-a-lin)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about 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 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 PREGABALIN IS
USED FOR
Pregabalin is used to treat
neuropathic pain, which is pain
caused by an abnormality of, or
damage to, the nerves.
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.
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.
Pregabalin also has pain relieving
effects.
Pregabalin may be used alone, or in
combination with other medicines, to
treat your condition.
Your doctor may prescribe
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 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
PREGABALIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PREGABALIN IF YOU HAVE
AN ALLERGY TO:
•
pregabalin, the active ingredient
in pregabalin capsules, or
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, wheezing or
di

Summary of Product characteristics

Teva Pharma Australia Pty Ltd
Version 4.0
1
AUSTRALIAN PRODUCT INFORMATION – PREGABALIN-TEVA (PREGABALIN)
CAPSULE
1
NAME OF THE MEDICINE
Pregabalin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin-Teva capsules contain 25 mg, 50 mg, 75 mg, 100 mg, 150 mg,
200 mg, 225 mg or 300 mg of
pregabalin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pregabalin-Teva 25 mg capsules: ivory opaque capsules imprinted with
“25” on capsule body in black ink.
Pregabalin-Teva 50 mg capsules: ivory opaque capsules imprinted with
radial black band on capsule cap and
“50” and radial black band on capsule body in black ink. The body
is also marked with a black band.
Pregabalin-Teva 75 mg capsules: opaque capsules with pink cap and
ivory body imprinted with “75” in black ink.
Pregabalin-Teva 100 mg capsules: pink opaque capsules imprinted with
“100” on capsule body in black ink.
Pregabalin-Teva 150 mg capsules: ivory opaque capsules imprinted with
“150” on capsule body in black ink.
Pregabalin-Teva 200 mg capsules: flesh opaque capsules imprinted with
“200” on capsule body in black ink.
Pregabalin-Teva 225 mg capsules: flesh opaque capsules with flesh cap
and ivory body imprinted with “225” on
capsules body in black ink.
Pregabalin-Teva 300 mg capsules: opaque capsules with pink cap and
ivory body imprinted with “300” on
capsule body in black ink.
All strengths or pack sizes may not be available in Australia.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Pregabalin is indicated for the treatment of neuropathic pain in
adults.
Pregabalin is indicated as adjunctive therapy in adults with partial
seizures with or without secondary
generalisation.
Teva Pharma Australia Pty Ltd
Version 4.0
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dose range is 150 to 600 mg per day given in two 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, given
as two divided doses. Bas