ADIRAMEDICA PREGABALIN pregabalin150 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pregabalin, Quantity: 150 mg

Available from:

AdiraMedica Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: mannitol; pregelatinised starch; purified talc; Gelatin; titanium dioxide; indigo carmine aluminium lake; sodium lauryl sulfate

Administration route:

Oral

Units in package:

20 capsules, 56 capsules, 60 capsules, 14 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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.

Product summary:

Visual Identification: Blue Opaque Cap and White Opaque Body of Size '1' hard gelatin capsules containing wihite coloured granular powder; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-03-28

Summary of Product characteristics

Version: 01
Page 1 of 22
WARNINGS
MISUSE, ABUSE POTENTIAL OR DEPENDENCE
ADIRAMEDICA PREGABALIN is a potential drug of misuse, abuse, and
dependence.
ADIRAMEDICA 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).
AUSTRALIAN
PRODUCT
INFORMATION
-
ADIRAMEDICA PREGABALIN (PREGABALIN) CAPSULES
1.
NAME OF THE MEDICINE
Pregabalin
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
ADIRAMEDICA PREGABALIN capsules contain 25 mg, 75 mg, 150 mg and 300
mg pregabalin.
EXCIPIENT(S) WITH KNOWN EFFECT:
Contains mannitol.
For the full list of excipients, see Section 6.1 – List of
excipients.
3.
PHARMACEUTICAL
FORM
ADIRAMEDICA PREGABALIN 25 mg capsules: Brown Opaque Cap and White
Opaque Body of
Size‘1’ hard gelatin capsules containing white coloured granular
powder.
ADIRAMEDICA PREGABALIN 75 mg capsules: Yellow Opaque Cap and Yellow
Opaque body of
Size ‘1’ hard gelatin capsules containing white coloured granular
powder.
ADIRAMEDICA PREGABALIN 150 mg capsules: Blue Opaque Cap and White
Opaque body of
Size ‘1’ hard gelatin capsules containing white coloured granular
powder.
ADIRAMEDICA PREGABALIN 300 mg capsules: Green Opaque Cap and Green
Opaque body of
Size ‘0’ hard gelatin capsules containing white coloured granular
powder.
Version: 01
Page 2 of 22
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The dose range is 150 to 600 mg per day given in two divided doses.
ADIRAM