PREGABALIN GH pregabalin 25 mg capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
11-01-2021
Summary of Product characteristics
(SPC)
18-09-2021
Public Assessment Report
(PAR)
19-10-2017
Active ingredient:
pregabalin, Quantity: 25 mg
Available from:
Lupin Australia Pty Limited
INN (International Name):
Pregabalin
Pharmaceutical form:
Capsule, hard
Composition:
Excipient Ingredients: pregelatinised maize starch; purified talc; propylene glycol; purified water; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; potassium hydroxide; iron oxide black; titanium dioxide; Gelatin; sodium lauryl sulfate; ethanol absolute
Administration route:
Oral
Units in package:
60, 20, 14, 56
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Pregabalin GH is indicated for the treatment of neuropathic pain in adults. Pregabalin GH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Product summary:
Visual Identification: Size '4' capsules with white cap and white body, imprinted with "PG" on cap and "25" on body in black ink, containing white to off white powder.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Registered
Authorization date:
2014-12-05
Patient Information leaflet
CONSUMER MEDICINE INFORMATION
PREGABALIN GH
(PREGABALIN) CAPSULES
WARNING: BEFORE TAKING PREGABALIN GH, TELL YOUR DOCTOR IF YOU HAVE A
HISTORY OF DRUG ABUSE.
PREGABALIN GH POSES RISKS OF MISUSE, ABUSE AND DEPENDENCE. USING
PREGABALIN GH WITH OTHER
MEDICINES THAT CAN MAKE YOU FEEL DROWSY SUCH AS SLEEPING TABLETS AND
OTHER PAIN RELIEVERS
(EG. BENZODIAZEPINES AND OPIOIDS), ANTIHISTAMINES, ANTIDEPRESSANTS,
ANTIPSYCHOTICS, CANNABIS, AND
ALCOHOL MAY RESULT IN SEVERE DROWSINESS, DECREASED AWARENESS,
BREATHING PROBLEMS, COMA AND
DEATH. IF YOU HAVE ANY CONCERN ABOUT TAKING THIS MEDICINE, SPEAK TO
YOUR DOCTOR.
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Pregabalin GH.
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 GH against the
benefits it is expected to have
for you.
IF YOU HAVE ANY CONCERN ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT PREGABALIN GH IS
USED FOR
Pregabalin GH is used to treat
neuropathic pain, which is pain
caused by an abnormality of, or
damage to, the nerves.
Pregabalin GH 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 GH 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 GH also has pain
relieving effects.
Pregabalin GH may be used
alone, or in combination with
other medicines, to treat your
condition.
Your doctor may prescribe
Pregabalin GH 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 THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor
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Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION – PREGABALIN GH
(PREGABALIN) CAPSULE
WARNINGS
MISUSE, ABUSE POTENTIAL OR DEPENDENCE
Pregabalin GH is a potential drug of misuse, abuse, and dependence.
Pregabalin GH 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).
1
NAME OF THE MEDICINE
Pregabalin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pregabalin GH contain 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225
mg or 300 mg of pregabalin.
List of excipients with known effect: Contains traces of sulfites.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pregabalin GH 25 mg capsules: Size '4' capsules with white cap and
white body, imprinted with "PG" on
cap and "25" on body in black ink, containing white to off white
powder.
Pregabalin GH 50 mg capsules: Size '4' capsules with white cap and
white body, imprinted with "PG" on
cap and with a band and with "50" on body in black ink, containing
white to off white powder.
Pregabalin GH 75 mg capsules: Size '4' capsules with dark brown cap
and white body, imprinted with
"PG" on cap and "75" on body in black ink, containing white to off
white powder.
Pregabalin GH 100 mg capsules: Size '3' capsules with dark brown cap
and dark brown body, imprinted
with "PG" on cap and "100" on body in black ink, containing white to
off_ _white powder.
Pregabalin GH 150 mg capsules: Size '2' capsules with white cap and
white body, imprinted with "PG"
on cap and "150" on body in black ink, containing white to off white
powder.
Pregabalin GH 200 mg capsules: Size '1' capsules with light brown cap
and light brown body, imprinted
with "PG" on cap and "200" on body i
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