BLOOMS THE CHEMIST PREGABALIN pregabalin 100 mg capsule blister pack

Main information

  • Trade name:
  • BLOOMS THE CHEMIST PREGABALIN pregabalin 100 mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BLOOMS THE CHEMIST PREGABALIN pregabalin 100 mg capsule blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 193301
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

193301

BLOOMS THE CHEMIST PREGABALIN pregabalin 100 mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

19/09/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. BLOOMS THE CHEMIST PREGABALIN pregabalin 100 mg capsule blister pack

Product Type

Single Medicine Product

Effective date

10/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. BLOOMS THE CHEMIST PREGABALIN pregabalin 100 mg capsule blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Capsule with an orange body/orange cap; imprinted with "APO" and "P100"

in black ink.

Active Ingredients

Pregabalin

100 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 06:58:10 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Summary of Product characteristics: dosage, interactions, side effects

Product Information – Australia

Blooms The Chemist Pregabalin capsules

Page 1

BLOOMS THE CHEMIST PREGABALIN CAPSULES

NAME OF THE MEDICINE

Pregabalin.

Chemical Name:

(S)-3-(aminomethyl)-5-methylhexanoic acid

Structural Formula:

Molecular Formula:

Molecular Weight:

159.23

CAS Registry Number:

148553-50-8

DESCRIPTION

Pregabalin is an analogue of the neurotransmitter gamma-aminobutyric acid (GABA). It has analgesic

and anticonvulsant activity. Pregabalin is a white to off-white solid. It is freely soluble in water and basic

and acidic aqueous solutions.

Each capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin,

as the active ingredient.

In addition, each capsule contains the following inactive ingredients: lactose monohydrate, maize starch,

purified talc, gelatin, purified water, titanium dioxide, sodium lauryl sulfate and TekPrint SW 9008 black

ink. The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain iron oxide red.

PHARMACOLOGY

Pharmacological Actions

In vitro studies show that pregabalin binds to an auxiliary subunit (α2δ protein) of voltage-gated calcium

channels in the central nervous system, potently displacing [3H]-gabapentin. Two lines of evidence

indicate that binding of pregabalin to the α2δ site is required for analgesic and anticonvulsant activity in

animal models: (1) Studies with the inactive R-enantiomer and other structural derivatives of pregabalin

and (2) Studies of pregabalin in mutant mice with defective drug binding to the α2δ protein. In addition,

pregabalin reduces the release of several neurotransmitters, including glutamate, noradrenaline and

substance P. The significance of these effects for the clinical pharmacology of pregabalin is not known.

Pregabalin does not show affinity for receptor sites or alter responses associated with the action of

several common drugs for treating seizures or pain. Pregabalin does not interact with either GABA

GABA

receptors; it is not converted metabolically into GABA or a GABA agonist; it is not an inhibitor of

acute GABA uptake or degradation.

Pregabalin prevents pain-related behaviours in animal models of neuropathic and post-surgical pain,

including hyperalgesia and allodynia.

Pregabalin also shows efficacy in animal models of seizures including: maximal electroshock tonic

extensor seizures in mice or rats; threshold clonic seizures from pentylenetetrazol, behavioural and

electrographic seizures in hippocampal kindled rats; and tonic and clonic seizures in DBA/2 audiogenic

mice. Pregabalin does not reduce the incidence of spontaneous absence seizures in Genetic Absence

Epilepsy in Rats from Strasbourg (GAERS).

Pharmacokinetics

Pregabalin

steady-state

pharmacokinetics

similar

healthy

volunteers,

patients

with

epilepsy

receiving anti-epileptic drugs and patients with chronic pain.

Product Information – Australia

Blooms The Chemist Pregabalin capsules

Page 2

Absorption

Pregabalin is rapidly absorbed when administered in the fasted state, with peak plasma concentrations

occurring

within

hour

following

both

single

multiple

dose

administration.

Pregabalin

oral

bioavailability is estimated to be ≥ 90% and is independent of dose. Following repeated administration,

steady state is achieved within 24 - 48 hours. The rate of pregabalin absorption is decreased when given

with food resulting in a decrease in C

by approximately 25 - 30% and a delay in T

to approximately

2.5 hours. However, administration of pregabalin with food has no clinically significant effect on the extent

of pregabalin bioavailability.

Distribution

In preclinical studies, pregabalin has been shown to cross the blood brain barrier in mice, rats and

monkeys. Pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating

rats. In humans, the apparent volume of distribution of pregabalin following oral administration is

approximately 0.56 L/kg. Pregabalin is not bound to plasma proteins. At clinical doses of 150 and

600 mg/day, the average steady-state plasma pregabalin concentrations were approximately 1.5 and

6.0 μg/mL, respectively.

Metabolism

Pregabalin undergoes negligible metabolism in humans. Following a dose of radiolabelled pregabalin,

approximately

radioactivity

recovered

urine

unchanged

pregabalin.

N-methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for

0.9%

dose.

preclinical

studies,

there

indication

racemisation

pregabalin

S-enantiomer to the R-enantiomer.

Excretion/Elimination

Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug.

Renal clearance (CrCl) derived from Phase I studies was 73 mL/min.

Pregabalin mean elimination half-life is 6.3 hours. Pregabalin plasma clearance and renal clearance are

directly proportional to creatinine clearance (see Special Populations, Renal Impairment).

Pregabalin

clearance

reduced

patients

with

impaired

renal

function

(see

DOSAGE

AND

ADMINISTRATION, Use in Renal Impairment, Table 7).

Linearity / Non-linearity

Pregabalin

pharmacokinetics

linear

over

recommended

daily

dose

range.

Inter-subject

pharmacokinetic variability for pregabalin is low (< 20%). Multiple dose pharmacokinetics are predictable

from single-dose data.

Special Populations

Race

Population pharmacokinetic analyses of the Phase 2/3 studies in patients with chronic pain, general

anxiety disorder (GAD) or partial seizures showed that the relationship between daily dose and pregabalin

exposure is similar among Caucasians, Blacks and Hispanics.

Gender

Population pharmacokinetic analyses of the Phase 2/3 studies in patients with chronic pain, GAD or

partial seizures showed that the relationship between daily dose and pregabalin drug exposure is similar

between genders when adjusted for gender-related differences in CrCl.

Renal Impairment

Pregabalin clearance is directly proportional to creatinine clearance. In addition, pregabalin is effectively

removed from plasma by haemodialysis (following a 4-hour haemodialysis treatment, plasma pregabalin

concentrations are reduced by approximately 50%). Since renal elimination is the major elimination

pathway, dosage reduction in patients with renal impairment and dosage supplementation following

haemodialysis is necessary (see DOSAGE AND ADMINISTRATION, Use in Renal Impairment, Table

7).

Hepatic Impairment

No specific pharmacokinetic studies were carried out in patients with impaired liver function. Since

pregabalin does not undergo significant metabolism and is excreted predominantly as unchanged drug in

urine,

impaired

liver

function

would

expected

significantly

alter

pregabalin

plasma

concentrations.

Product Information – Australia

Blooms The Chemist Pregabalin capsules

Page 3

Elderly (> 65 years)

Pregabalin clearance tends to decrease with increasing age. This decrease in pregabalin oral clearance is

consistent with decreases in creatinine clearance associated with increasing age. Reduction of pregabalin

dose may be required in patients who have age related compromised renal function (see DOSAGE AND

ADMINISTRATION, Use in Renal Impairment, Table 7).

Paediatrics (< 18 years)

No specific pharmacokinetic studies have been undertaken in patients < 18 years of age.

Breastfeeding Women

The pharmacokinetics of 150 mg pregabalin given every 12 hours (300 mg daily dose) was evaluated in

10 lactating women who were at least 12 weeks postpartum. Lactation had little to no influence on

pregabalin

pharmacokinetics.

Pregabalin

excreted

into

breast milk

with

average

steady-state

concentrations approximately 76% of those in maternal plasma. The estimated average daily infant dose

of pregabalin from breast milk (assuming mean milk consumption of 150 mL/kg/day) was 0.31 mg/kg/day,

which on a mg/kg basis would be approximately 7% of the maternal dose (see PRECAUTIONS, Use in

Lactation).

CLINICAL TRIALS

Neuropathic Pain

The effectiveness of pregabalin for the management of neuropathic pain was investigated in 11 double-

blind, placebo-controlled, multi-centre studies with either twice a day (BID) or three times a day (TID)

dosing.

The analysis of the primary efficacy variable is provided below for each study within the diabetic peripheral

neuropathy and post-herpetic neuralgia population.

The overall picture of the primary efficacy variable across populations is confirmed by the responder rates.

The response rates for a 30% reduction in pain score showed that the proportion of patients responding

increased with increasing doses, from 34 - 49% at 150 mg/day to 54 - 65% at 600 mg/day, compared with

19 - 45% for placebo. The response rates for a 50% reduction in pain score showed that the proportion of

patients responding increased with increasing doses, from 19 - 34% at 150 mg/day to 39 - 50% at

600 mg/day, compared with 8 - 30% for placebo.

Up to 88% of patients treated with 300 or 600 mg/day pregabalin reported benefit, compared with

26 - 66% for placebo, as measured by an improvement in the Patient Global Impressions of Change

(PGIC) score. The PGIC is a patient-rated instrument that measures change in a patient’s overall status

on a scale ranging from 1 (very much improved) to 7 (very much worse).

A significant reduction in pain was seen by Week 1 and maintained relative to placebo throughout the

treatment. Significant reductions in sleep interference were seen, when patients were treated with

pregabalin for neuropathic pain, by Week 1 and maintained throughout the treatment.

Diabetic Peripheral Neuropathy

The effectiveness of pregabalin for the management of neuropathic pain was investigated in 6 double-

blind, placebo-controlled, multi-centre studies with either twice a day (BID) or three times a day (TID)

dosing. A total of 1525 patients were enrolled in the 6 studies. To enter the study patients had to have

moderate to severe pain. The mean age of patients in these studies was 59 years (range 21 to 85 years),

89% of patients had Type II diabetes mellitus with an average HbA1c of 8.9%.

In the 5 completed studies, the average age was 59 years, the duration of diabetes was 11 years and the

average baseline pain score was 6.5. The use of concurrent medication that may affect the assessments

was prohibited. Antidiabetic medication was required to be stable and constant during the study.

Product Information – Australia

Blooms The Chemist Pregabalin capsules

Page 4

Table 1: Results of the Primary Outcome (Endpoint Mean Pain Scores) for Diabetic Peripheral

Neuropathy Studies

Study/Treatment Group

Treatment Comparisons

(Pregabalin – Placebo)

Diabetic Peripheral Neuropathy

Pain Model

n

Mean

Baseline

Mean

End-point

Difference

95% CI

Study 014 TID [6 weeks] n = 246

Placebo (n = 85)

Pregabalin 150 mg/day (n = 79)

Pregabalin 600 mg/day (n = 82)

5.55

5.11

4.29

-0.44

-1.26

(-1.08, 0.20)

(-1.89, -0.64)

Study 029 TID [5 weeks] n = 337

Placebo (n = 97)

Pregabalin 75 mg/day (n = 77)

Pregabalin 300 mg/day (n = 81)

Pregabalin 600 mg/day (n = 82)

5.06

4.91

3.80

3.60

-0.15

-1.26

-1.45

(-0.76, 0.46)

(-1.86, -0.65)

(-2.06, -0.85)

Study 040 TID [8 weeks] n = 167

Placebo (n = 81)

Pregabalin 600 mg/day (n = 86)

4.60

3.96

-0.64

(-1.37, 0.08)

Study 131 TID [8 weeks] n = 146

Placebo (n = 70)

Pregabalin 300 mg/day (n = 76)

5.46

3.99

-1.47

(-2.19, -0.75)

Study 149 BID [12 weeks] n = 395

Placebo (n = 96)

Pregabalin 150 mg/day (n = 99)

Pregabalin 300 mg/day (n = 99)

Pregabalin 300/600 mg/day

(n = 101)

4.66

4.33

4.48

3.69

-0.33

-0.18

-0.97

(-0.94, 0.28)

(-0.79, 0.43)

(-1.58, -0.36)

Study 173 BID [12 weeks] n = 147

Placebo (n = 31)

Pregabalin 150 mg/day (n = 34)

Pregabalin 300 mg/day (n = 44)

Pregabalin 300/600 mg/day

(n = 39)

5.33

4.77

4.99

4.09

-0.55

-0.34

-1.24

(-1.54, 0.43)

(-1.29, 0.61)

(-2.21, -0.27)

CI = Confidence Interval

* Patients randomised to the 300/600 mg/day pregabalin group received either 300 or 600 mg/day based on their

CrCl.

Post-herpetic Neuralgia

The effectiveness of pregabalin for the management of neuropathic pain was investigated in 5 double-

blind, placebo-controlled, multi-centre studies with either BID or TID dosing. A total of 1250 patients were

enrolled in the 5 studies. To enter the study patients had to have moderate to severe pain for ≥ 3 months

(or ≥ 6 months in one study). The mean duration of post-herpetic neuralgia for patients in these studies

was 3 years (range < 1 to 22 years).

In the 4 completed studies, the average age was 71 years, the average duration of post-herpetic neuralgia

was 38 months and the average baseline pain score was 6.6. Concomitant use of analgesics and

antidepressants was allowed, provided the regimen was stable and in place at the time of randomisation.

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Blooms The Chemist Pregabalin capsules

Page 5

Table 2: Results of the Primary Outcome (Endpoint Mean Pain Scores) for Post-herpetic Neuralgia

Studies

Study/Treatment Group

Treatment Comparisons

(Pregabalin – Placebo)

Post-herpetic Neuralgia

Pain Model

n

Mean

Baseline

Mean

End-point

Difference

95% CI

Study 030 TID [5 weeks] n = 225

Placebo (n = 88)

Pregabalin 75 mg/day (n = 84)

Pregabalin 150 mg/day (n = 83)

5.59

5.46

5.52

-0.14

-0.07

(-0.71, 0.43)

(-0.64, 0.50)

Study 045 TID [8 weeks] n = 238

Placebo (n = 81)

Pregabalin 150 mg/day (n = 81)

Pregabalin 300 mg/day (n = 76)

6.33

5.14

4.76

-1.20

-1.57

(-1.81, -0.58)

(-2.20, -0.95)

Study 127 TID [8 weeks] n = 173

Placebo (n = 84)

Pregabalin 300/600 mg/day

(n = 89)

5.29

3.60

-1.69

(-2.33, -1.05)

Study 132 BID [12 weeks†] n = 216

Placebo (n = 52)

Pregabalin 150 mg/day (n = 51)

Pregabalin 300 mg/day (n = 62)

Pregabalin 300/600 mg/day

(n = 51)

6.23

5.05

4.90

4.26

-1.18

-1.33

-2.02

(-1.90, -0.46)

(-2.01, -0.65)

(-2.74, -1.31)

Study 196 BID [13 weeks] n = 368

Placebo (n = 93)

Pregabalin 150 mg/day (n = 87)

Pregabalin 300 mg/day (n = 98)

Pregabalin 300/600 mg/day

(n = 90)

6.14

5.26

5.07

4.35

-0.88

-1.07

-1.79

(-1.53, -0.23)

(-1.70, -0.45)

(-2.43, -1.15)

CI = Confidence Interval

* Patients randomised to the 300/600 mg/day pregabalin group received either 300 or 600 mg/day based on their

CrCl.

† Study stopped prematurely.

Epilepsy

The efficacy of pregabalin as adjunctive therapy was investigated in three 12-week, randomised, double-

blind, placebo-controlled, multi-centre studies involving 1052 patients, with BID and/or TID dosing.

Patients had refractory partial seizures with or without secondary generalisation and had mean baseline

seizure rates of 21 to 22 and median baseline seizure rates of 10 to 12 seizures per 28 days.

The primary efficacy measure in all studies was based on seizure reduction as analysed by response ratio

(RRatio), a measure of change defined as [(T - B)/(T + B)] × 100, where B is the patient’s baseline seizure

frequency and T is the patient’s seizure frequency during treatment. The RRatio is distributed within the

range -100 to +100. A zero value indicates no change and a complete elimination of seizures would give a

value of -100. Responder rate was defined as the proportion of patients who have a ≥ 50% reduction in

partial seizure frequency during treatment as compared to baseline.

Product Information – Australia

Blooms The Chemist Pregabalin capsules

Page 6

Table 3. Results of the Primary Outcomes (RRatio and Responder Rate) for Epilepsy Studies

Responder Rate

Treatment difference between

Pregabalin and Placebo

95% CI

(22.4, 44.7)

(28.5, 50.4)

(-0.5, 16.3)

(26.0, 48.5)

(-9.3, 10.8)

(5.5, 29.3)

(13.8, 38.2)

(24.1, 49.0)

SD = Standard deviation; SE = Standard error; CI = Confidence interval

* Statistically significant based on Hochberg’s (Study 009) or the Ruberg (Studies 011 and 034) procedure (α = 0.049 for Studies 009 and 034, α = 0.05 for Study 011).

p Value

0.001

0.001

0.087

0.001

0.840

0.006

0.001

0.001

(SE)

(5.7)

(5.6)

(4.3)

(5.7)

(5.1)

(6.1)

(6.2)

(6.3)

%

33.5

39.5

37.2

17.4

26.0

36.6

Responder

(%)

9 (9.2)

44 (42.7)

54 (48.7)

6 (6.2)

14 (14.1)

40 (43.5)

14 (14.0)

13 (14.8)

274 (31.4)

36 (40.0)

45 (50.6)

RRatio

Treatment difference between

Pregabalin and Placebo

95% CI

(-38.9, -19.0)

(-46.4, -27.0)

(-20.5, -4.3)

(-40.6, -24.0)

(-11.7, 7.1)

(-26.1, -7.2)

(-33.3, -14.6)

(-42.9, -24.1)

p Value

0.0001

0.0001

0.0007

0.0001

0.4232

0.0001

0.0001

0.0001

(SE)

(5.0)

(5.0)

(4.1)

(4.2)

(4.8)

(4.8)

(4.8)

(4.8)

Mean

-36.7

-12.4

-32.3

-2.3

-16.6

-24.0

-33.5

Median

-0.4

-21.7

-31.7

-27.1

-4.5

-22.5

-34.1

SD

28.8

36.7

22.9

36.3

25.6

23.7

29.6

36.5

44.4

Mean

-28.4

-36.1

-11.5

-31.4

-3.8

-6.2

-20.5

-27.8

-37.4

n

Study/Treatment Group

Study 009 BID/TID

Placebo

Pregabalin 600 mg/day BID

Pregabalin 600 mg/day TID

Study 011 TID

Placebo

Pregabalin 150 mg/day

Pregabalin 600 mg/day

Study 034 BID

Placebo

Pregabalin 50 mg/day

Pregabalin 150 mg/day

Pregabalin 3000 mg/day

Pregabalin 600 mg/day

Product Information – Australia

Blooms The Chemist Pregabalin capsules

Page 7

A significant reduction in seizure frequency was observed by Week 1. Overall, there was a significant

reduction in seizure frequency over the 12-week treatment period.

Long-term efficacy data in support of the chronic use of pregabalin for the treatment of patients with partial

seizures were provided by four open label extension studies. These studies permitted pregabalin as

adjunctive therapy with marketed antiepileptic drugs (AEDs). Data from the long-term studies support the

long-term use of pregabalin for the treatment of patients with partial seizures, as well as demonstrating the

maintenance of effect over the long term.

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.

CONTRAINDICATIONS

Pregabalin is contraindicated in patients who have demonstrated hypersensitivity to pregabalin or to any

of the excipients.

PRECAUTIONS

Hereditary Problems of Galactose Metabolism

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-

galactose malabsorption should not take this medicine.

Weight Gain

In the controlled studies, weight gain occurred more frequently in patients treated with pregabalin than in

patients treated with placebo. Pregabalin-associated weight gain was related to dose and length of

exposure, but did not appear to be associated with baseline BMI, gender or age.

In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin

treatment may need to adjust hypoglycaemic medications.

Hypersensitivity Reactions

There have been reports in the post-marketing experience of hypersensitivity reactions, including cases of

angioedema. Pregabalin should be discontinued immediately if symptoms of angioedema occur, such as

facial, perioral or upper airway swelling.

Dizziness and Somnolence

Pregabalin causes dizziness and somnolence (see ADVERSE EFFECTS). In the controlled studies,

dizziness and somnolence generally began shortly after initiation of pregabalin and occurred more

frequently at higher doses. Dizziness and somnolence were the adverse events most frequently leading to

withdrawal (4% each) from controlled studies. In pregabalin-treated patients reporting these adverse

events in short-term controlled studies, dizziness persisted until the last dose in 31% and somnolence

persisted until the last dose in 46%.

There have also been reports of loss of consciousness, confusion and mental impairment

Suicidal Behaviour and Ideation

Antiepileptic drugs (AEDs), including pregabalin, increase the risk of suicidal thoughts or behaviour in

patients taking these drugs for any indication. Patients treated with any AED for any indication should be

monitored for the emergence or worsening of depression, suicidal thoughts or behaviour and/or any

unusual changes in mood or behaviour.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different

AEDs showed that patients randomised to one of the AEDs had approximately twice the risk (adjusted

Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behaviour compared to patients randomised to

placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate

of suicidal behaviour or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24%

among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal

thinking or behaviour for every 530 patients treated. There were four suicides in drug-treated patients in

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Page 8

the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about

drug effect on suicide.

The increased risk of suicidal thoughts or behaviour with AEDs was observed as early as one week after

starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most

trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behaviour

beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behaviour was generally consistent among drugs in the data analysed.

The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications

suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by

age (5 to 100 years) in the clinical trials analysed. Table 4 shows absolute and relative risk by indication

for all evaluated AEDs.

Table 4: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis

Indication

Placebo

Patients with

Events

per 1000

Patients

Drug Patients

with Events

per 1000

Patients

Relative Risk:

Incidence of Events in

Drug

Patients/Incidence in

Placebo Patients

Risk Difference:

Additional Drug

Patients with Events

per 1000 Patients

Epilepsy

Psychiatric

Other

TOTAL

The relative risk for suicidal thoughts or behaviour was higher in clinical trials for epilepsy than in clinical

trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and

psychiatric indications.

Anyone considering prescribing pregabalin or any other AED must balance this risk with the risk of

untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves

associated with morbidity and mortality and an increased risk of suicidal thoughts and behaviour. Should

suicidal thoughts and behaviour emerge during treatment, the prescriber needs to consider whether the

emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers and families should be informed that AEDs increase the risk of suicidal thoughts

and behaviour and should be advised of the need to be alert for the emergence or worsening of the signs

and symptoms of depression, any unusual changes in mood or behaviour, or the emergence of suicidal

thoughts, behaviour or thoughts about self-harm. Behaviours of concern should be reported immediately

to the treating doctor.

Monotherapy for Seizure Control

There are insufficient data on seizure control when pregabalin is used as monotherapy once concomitant

antiepileptic medical products have been withdrawn in patients where pregabalin was used as add-on

therapy.

Substance Misuse, Abuse and Dependence

There have been post-marketing reports of substance misuse and abuse with pregabalin. As with any

CNS drug, patients should be carefully evaluated for a history of substance abuse and observed for signs

of pregabalin misuse or abuse (e.g. development of tolerance, increase in dose, drug-seeking behaviour).

Renal Failure

Renal failure is a rare adverse reaction to pregabalin. Although the effects of discontinuation on the

reversibility of renal failure have not been systematically studied, cases of renal failure have been reported

and in some cases discontinuation of pregabalin did show reversibility of this adverse reaction.

Discontinuation

After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have

been observed in some patients. The following events have been mentioned: insomnia, headache,

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Page 9

nausea, anxiety, hyperhidrosis and diarrhoea.

Blurred Vision

In controlled studies, a higher proportion of patients treated with pregabalin reported blurred vision than

did patients treated with placebo (see ADVERSE EFFECTS). In the majority of cases, blurred vision

resolved with continued dosing. If blurred vision persists, further assessment should be considered.

Post marketing experience with pregabalin has reported transient visual blurring and other changes in

visual acuity. Discontinuation of pregabalin may result in resolution or improvement of these visual

symptoms.

Congestive Heart Failure

There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin.

Pregabalin should be used with caution in these patients.

Peripheral Oedema

In controlled studies, peripheral oedema occurred more frequently in patients treated with pregabalin than

in patients treated with placebo (see ADVERSE EFFECTS). Peripheral oedema was not associated with

laboratory changes suggestive of deterioration in renal or hepatic function. There are limited data on the

use of pregabalin in patients with congestive heart failure and pregabalin should be used with caution in

these patients.

Creatine Kinase Elevations

Treatment with pregabalin was associated with creatine kinase elevations. Mean changes in creatine

kinase from baseline to the maximum value were 60 U/L for pregabalin treated patients and 28 U/L for the

placebo patients. In all controlled trials across multiple patient populations, 2% of patients on pregabalin

and 1% of placebo patients had a value of creatine kinase at least three times the upper limit of normal.

Three pregabalin treated subjects had events reported as rhabdomyolysis in premarketing clinical trials.

The relationship between these myopathy events and pregabalin is not completely understood because

the cases had documented factors that may have caused or contributed to these events. Pregabalin

should be discontinued if myopathy is diagnosed or suspected or if markedly elevated creatine kinase

levels occur.

Effects on Fertility

Preclinical data

In male rats, oral administration of high doses of pregabalin resulted in reversible decreased sperm

motility and fertility. These were not observed at exposures (plasma AUC) up to 11 times the expected

human exposure at the maximum recommended clinical dose of 600 mg/day. There were also no drug-

related effects on sperm parameters in a long-term monkey study with exposures up to 8 times the

expected maximum human exposure. In female rats, oestrus cycles were prolonged by high oral doses of

pregabalin, but fertility was unaffected and an increase in post-implantation loss also occurred. No

adverse effects were seen at an exposure approximately 50 times the expected maximum human

exposure.

Human data

In a double-blind, placebo-controlled clinical trial to assess the effect of pregabalin on sperm motility, 30 of

46 healthy male subjects were exposed to pregabalin at 600 mg/day for 3 months. Pregabalin did not

exhibit detrimental effects on the reproductive function of healthy male subjects, as measured by semen

analysis.

Use in Pregnancy (Category B3)

Pregabalin has not been studied in pregnant women and it should not be used during pregnancy unless

the benefit to the mother clearly outweighs the potential risk to the foetus. In a pre- and post-natal study in

rats, pregabalin treatment resulted in offspring developmental toxicity at exposures (plasma AUC)

≥ 5 times the expected human exposure at the maximum recommended clinical dose of 600 mg/day.

Offspring development was unaffected at 2 times the expected maximum human exposure.

Labour and Delivery

The effects of pregabalin on labour and delivery in pregnant women are unknown. In a pre- and post-natal

development study in rats, pregabalin prolonged gestation and induced dystocia at exposures (plasma

AUC) approximately 50 times the expected human exposure at the maximum recommended clinical dose

of 600 mg/day. These effects were not observed at an exposure that was approximately 12 times the

expected human exposure.

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Teratogenicity

Pregabalin was not teratogenic in mice, rats or rabbits. Foetal developmental toxicity was not observed

after treatment of pregnant mice and rabbits with oral doses that resulted in respective pregabalin

exposures

that

were

times

times

expected

human

exposure

maximum

recommended clinical dose of 600 mg/day. Increased foetal skeletal variations were seen in rats at oral

doses resulting in exposures > 17 times the expected maximum human exposure, but lower doses were

not tested in a full study.

Use in Lactation

Pregabalin is excreted in the milk of lactating women (see PHARMACOLOGY, Pharmacokinetics,

Breastfeeding Women). As the safety of pregabalin in infants is not known, breastfeeding is not

recommended

women

taking

pregabalin.

decision

must

made

whether

discontinue

breastfeeding or to discontinue pregabalin therapy, taking into account the benefit of breastfeeding for the

child and the benefit of therapy for the woman.

Use in the Elderly (> 65 years)

Pregabalin treatment has been associated with dizziness and somnolence, which may increase the

occurrence of accidental injury (falls) in the elderly population.

Genotoxicity

Pregabalin is not genotoxic based on results of in vitro and in vivo tests. It was not mutagenic in bacteria

or in mammalian cells in vitro, not clastogenic in mammalian systems in vitro and in vivo and did not

induce unscheduled DNA synthesis in mouse or rat hepatocytes.

Carcinogenicity

Two-year carcinogenicity studies with pregabalin were conducted in rats and mice. No increased

incidence of tumours was observed in rats at exposures (plasma AUC) up to 25 times the expected

human exposure at the maximum recommended clinical dose of 600 mg/day. In mice, no increased

incidence of tumours was found at exposures similar to the expected maximum human exposure, but an

increased incidence of haemangiosarcoma was observed at exposures 6 - 33 times the expected

maximum

human

exposure.

precise

non-genotoxic

mechanism

pregabalin-induced

tumour

formation is not fully characterised. However, available data show that platelet changes associated with

the formation of this tumour in mice are not seen in rats, monkeys or humans. Although long-term data in

humans are limited, these findings in mice are thought not to pose a risk to humans.

Effect on Laboratory Tests

Pregabalin is not known to interfere with any laboratory tests. Some changes in clinical laboratory tests

have been noted in patients taking pregabalin (see ADVERSE EVENTS, Table 6 - Body System:

Investigations).

Effects on Ability to Drive and Use Machines

Pregabalin may cause dizziness and somnolence and therefore may have an influence on the ability to

drive or use machines. Patients are advised not to drive, operate complex machinery or engage in other

potentially hazardous activities until it is known whether this medication affects their ability to perform

these activities.

INTERACTIONS WITH OTHER MEDICINES

Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in

humans (< 2 % of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro and

is not bound to plasma proteins, pregabalin is unlikely to produce, or be subject to, pharmacokinetic

interactions.

Accordingly, in in vivo studies, no clinically relevant pharmacokinetic interactions were observed between

pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone

or ethanol. In addition, population pharmacokinetic analysis indicated that the three commonly used drug

classes, oral antidiabetics, diuretics and insulin, and the commonly used antiepileptic drugs phenytoin,

carbamazepine, valproic acid, lamotrigine, phenobarbital, tiagabine and topiramate, had no clinically

significant effect on pregabalin clearance. Similarly, these analyses indicated that pregabalin had no

clinically significant effect on the clearance of phenytoin, carbamazepine, valproic acid, lamotrigine,

topiramate and phenobarbital.

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Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol did

not influence the steady-state pharmacokinetics of either agent.

Pregabalin may potentiate the effects of ethanol and lorazepam. In controlled clinical trials, multiple oral

doses of pregabalin co-administered with oxycodone, lorazepam or ethanol did not result in clinically

important effects on respiration. Pregabalin appears to be additive in the impairment of cognitive and

gross motor function caused by oxycodone. In post-marketing experience, there are reports of respiratory

failure and coma in patients taking pregabalin and other CNS depressant medications.

There are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g.

intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications

that have the potential to produce constipation, such as opioid analgesics.

No specific pharmacodynamic interaction studies were conducted in elderly volunteers.

ADVERSE EFFECTS

The pregabalin clinical programme involved over 9000 patients who were exposed to pregabalin, of whom

over 5000 were in double-blind, placebo-controlled trials. The clinical efficacy program included patients

treated for a maximum of 12 weeks duration.

The most commonly reported adverse effects were dizziness and somnolence. Adverse effects were

usually mild to moderate in intensity. In all controlled studies, the discontinuation rate due to adverse

events was 13% for patients receiving pregabalin and 7% for patients receiving placebo.

The most common adverse effects resulting in discontinuation from pregabalin treatment groups were

dizziness and somnolence.

The adverse effects listed may also be associated with the underlying disease and concomitant

medications.

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Table 5: Adverse Events Reported in at least 1% of Patients in Pregabalin Controlled Epilepsy and

Neuropathic Pain Studies (% of Patients)

Pregabalin (PGB) Total Daily Dose

MedDRA Preferred Term

Placebo

150 mg/day

300 mg/day

600 mg/day

All PGB

a

n = 1151

n = 699

n = 723

n = 918

n = 2589

Dizziness

13.2

24.5

30.4

21.9

Somnolence

13.1

19.5

13.2

Vision blurred

Fatigue

Weight increased

Dry mouth

Headache

Ataxia

Oedema peripheral

Balance impaired NOS

Diplopia

Tremor

Constipation

Gait abnormal

Nausea

Confusional state

Dysarthria

Lethargy

Memory impairment

Appetite increased NOS

Oedema NOS

Disturbance in attention

Vertigo

Diarrhoea NOS

Coordination abnormal NOS

Peripheral swelling

a The All PGB group also includes patients who received pregabalin 50 or 75 mg/day.

Additional adverse effects, reported in a pooled analysis of all pregabalin clinical trials, are listed in the

next table by System Organ Class (SOC). The frequency of these terms have been based on all-causality

adverse drug reactions in the clinical trial data set (very common (≥ 1/10), common (≥ 1/100, < 1/10),

uncommon (≥ 1/1000, < 1/100) and rare (< 1/1000)).

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Table 6: Adverse Drug Reactions from Pregabalin Clinical Trial Experiences

Body System

Rate

Adverse Effect

Blood and lymphatic system

disorders

Uncommon

Neutropenia

Cardiac disorders

Uncommon

Tachycardia, atrioventricular block first degree,

sinus bradycardia

Rare

Sinus tachycardia, sinus arrhythmia

Ear and labyrinth disorders

Common

Vertigo

Uncommon

Hyperacusis

Eye disorders

Common

Vision blurred, diplopia

Uncommon

Visual disturbance, visual field defect, dry eye, eye

swelling, visual acuity reduced, eye pain,

asthenopia, lacrimation increased,

photopsia,

peripheral vision loss, eye irritation,

Rare

Mydriasis, oscillopsia, altered visual depth

perception, strabismus, visual brightness

Gastrointestinal disorders

Common

Vomiting, constipation, flatulence, abdominal

distension, dry mouth

Uncommon

Salivary hypersecretion, gastrooesophageal reflux

disease, hypoaesthesia oral

Rare

Ascites, dysphagia, pancreatitis

General disorders and

administration site conditions

Common

Oedema peripheral, oedema, gait abnormal, fall,

feeling drunk, feeling abnormal, fatigue

Uncommon

Asthenia, thirst, chest tightness, generalised

oedema, pain, chills,

pyrexia

Infections and Infestations

Common

Nasopharyngitis

Investigations

Common

Weight increased

Uncommon

Alanine aminotransferase increased, blood creatine

phosphokinase increased, aspartate

aminotransferase increased, platelet count

decreased, blood glucose increased, blood

potassium decreased, weight decreased

Rare

Blood creatinine increased, white blood cell count

decreased, blood sodium increased, blood urea

increased

Metabolism and nutrition

disorders

Common

Appetite increased

Uncommon

Anorexia, hypoglycaemia

Musculoskeletal and

connective tissue disorders

Common

Muscle cramp, arthralgia, back pain, pain in limb,

cervical spasm

Uncommon

Muscle twitching, joint swelling, myalgia, muscle

stiffness, neck pain

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Body System

Rate

Adverse Effect

Rare

Rhabdomyolysis

Nervous system disorders

Very

common

Dizziness, somnolence

Common

Ataxia, co-ordination abnormal, tremor, dysarthria,

amnesia, memory impairment, disturbance in

attention, paraesthesia, hypoaesthesia, sedation,

balance disorder, lethargy

Uncommon

Cognitive disorder, nystagmus, speech disorder,

myoclonus, hyporeflexia, dyskinesia, psychomotor

hyperactivity, dizziness postural, hyperaesthesia,

burning sensation, intention tremor, syncope

Rare

Hypokinesia, parosmia, dysgraphia,

encephalopathy, muscle spasticity, ageusia, stupor

Psychiatric disorders

Common

Euphoric mood, confusion, irritability, depression,

disorientation, insomnia, libido decreased.

Uncommon

Depersonalisation, anorgasmia, restlessness,

agitation, mood swings, depressed mood, word

finding difficulty, hallucination, abnormal dreams,

libido increased, elevated mood

Rare

Disinhibition, panic attack, apathy

Renal and urinary disorders

Uncommon

Dysuria, urinary incontinence

Rare

Oliguria, renal failure

Reproductive system and

breast disorders

Uncommon

Ejaculation delayed, sexual dysfunction, erectile

dysfunction, dysmenorrhoea

Rare

Amenorrhoea, breast pain, breast discharge, breast

enlargement

Respiratory, thoracic and

mediastinal disorders

Uncommon

Dyspnoea, cough, epistaxis, nasal congestion,

rhinitis, snoring

Rare

Throat tightness, nasal dryness

Skin and subcutaneous

tissue disorders

Uncommon

Sweating, rash papular, urticaria

Rare

Cold sweat, Henoch-Schonlein purpura

Vascular disorders

Uncommon

Hypotension, hypertension, flushing, hot flushes,

peripheral coldness

Rare

Petechiae

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Post-Marketing Experience

The following adverse events were reported during post-marketing surveillance:

Immune system disorders

Uncommon:

Hypersensitivity

Rare:

Angioedema, allergic reaction

Nervous system disorders

Very common:

Headache

Uncommon:

Loss of consciousness, mental impairment

Cardiac disorders

Rare:

Congestive heart failure

Eye disorders

Rare:

Keratitis

Gastrointestinal disorders

Common:

Nausea, diarrhoea

Rare:

Swollen tongue

General disorders and administration site conditions

Uncommon:

Malaise

Skin and subcutaneous tissue disorders

Uncommon:

Face swelling, pruritis, alopecia

Renal and urinary disorders

Rare:

Urinary retention

Reproductive system and breast disorders

Rare:

Gynaecomastia

Respiratory, thoracic and mediastinal disorders

Rare:

Pulmonary oedema

Vital Signs

No consistent changes in vital signs have been seen in patients taking pregabalin. Changes in vital signs

reported in controlled clinical trials are shown in Table 6.

Elderly (> 65 years)

In a total of 998 elderly patients, no overall differences in safety were observed compared with patients

less than 65 years of age.

DOSAGE AND 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. Based on

individual patient response and tolerability, the dosage may be increased to 300 mg/day, given as two

divided doses, after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg/day after an

additional 7-day interval.

Since

diabetes

frequently

complicated

renal

disease,

patients

with

diabetic

neuropathy,

accordance with current clinical practice, should be assessed for renal impairment prior to commencing

pregabalin and dosage adjusted appropriately.

The effectiveness of pregabalin in the treatment of neuropathic pain has not been assessed in controlled

clinical trials for treatment periods longer than 12 weeks (see CLINICAL TRIALS). The risks and benefits

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of treatment to an individual patient should be assessed before extending therapy for longer than

12 weeks.

Epilepsy

Pregabalin treatment can be started with a dose of 150 mg/day given as two divided doses. Based on

individual patient response and tolerability, the dosage may be increased to 300 mg/day given as two

divided doses after 1 week. The maximum dosage of 600 mg/day given as two divided doses may be

achieved after an additional week.

necessary

monitor

plasma

pregabalin

concentrations

optimise

pregabalin

therapy.

Pregabalin does not alter the plasma concentrations of other commonly used antiepileptic drugs (AEDs).

Similarly, commonly used AEDs do not alter plasma concentrations of pregabalin (see INTERACTIONS

WITH OTHER MEDICINES).

Discontinuation of Pregabalin

In accordance with current clinical practice, if pregabalin has to be discontinued, it is recommended this

should be done gradually over a minimum of one week.

Use in Renal Impairment

Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug.

pregabalin

clearance

directly

proportional

creatinine

clearance

(see

Pharmacokinetics,

Elimination), dosage reduction in patients with compromised renal function must be individualised

according to creatinine clearance (CrCl), as indicated in Table 7 determined using the following formula:

CrCl (mL/min) =

[140 – age (years)] × weight (kg)

(× 0.85 for female population)

72 × serum creatinine (mg/dL)

Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients

receiving haemodialysis, the pregabalin daily dose should be adjusted based on renal function. In addition

daily

dose,

supplementary

dose

should

given

immediately

following

every

4-hour

haemodialysis treatment (see Table 7).

Table 7: Pregabalin Dosage Adjustment Based on Renal Function

Creatinine Clearance

(CrCl)

(mL/min)

Total Pregabalin Daily dose *

Dose Regimen

Starting dose

(mg/day)

Maximum dose

(mg/day)

≥ 60

Two divided doses

30 - 60

Single daily dose or two divided doses

15 - 30

25 - 50

Single daily dose or two divided doses

< 15

Single daily dose

Supplementary dosage following haemodialysis (mg)

Single dose+

* Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose

+ Supplementary dose is a single additional dose

Use in Hepatic Impairment

No dosage adjustment is required for patients with hepatic impairment (see Pharmacokinetics, Hepatic

Impairment).

Paediatric Use (< 18 years)

The safety and effectiveness of pregabalin has not been established in patients below the age of 18

years, with either epilepsy or neuropathic pain.

Use in the Elderly (> 65 years)

No dosage adjustment is necessary for elderly patients unless their renal function is compromised (see

Table 7).

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OVERDOSAGE

Symptoms

In overdoses up to 15 g, no unexpected adverse effects were reported.

In post-marketing experience, the most commonly reported adverse events observed when pregabalin

was taken in overdose included affective disorder, somnolence, confusional state, depression, agitation

and restlessness. Seizures were also reported.

Management

There is no specific antidote for pregabalin. Treatment of pregabalin overdose should be symptomatic and

supportive.

Consider administration of activated charcoal in the event of a potentially toxic ingestion. Activated

charcoal is most effective when administered within one hour of ingestion. In patients who are not fully

conscious or have impaired gag reflex, consideration should be given to administering activated charcoal

via nasogastric tube once the airway is protected.

Haemodialysis may be useful in patients with severe toxicity or those with significant renal impairment

(see

DOSAGE

AND

ADMINISTRATION,

Use

in

Renal

Impairment).

Standard

haemodialysis

procedures result in significant clearance of pregabalin (approximately 50% in 4 hours). Emesis is not

recommended because of the potential for CNS depression and seizures.

For information on the management of overdose, contact the Poisons Information Centre on

13 11 26 (Australia).

PRESENTATION AND STORAGE CONDITIONS

Blooms The Chemist Pregabalin capsules are intended for oral administration.

Each capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of

pregabalin, as the active ingredient.

25 mg capsules:

Capsules with a white body/white cap; imprinted with “APO” and “P25” in black ink.

Blister packs (PVC/Al) of 14, 20, 56, 60 capsules (AUST R 193298).

50 mg capsules:

Capsules with a white body/white cap; imprinted with “APO” and “P50” in black ink.

Blister packs (PVC/Al) of 14, 20, 56, 60 capsules (AUST R 193299).

75 mg capsules:

Capsules with a white body/orange cap; imprinted with “APO” and “P75” in black ink.

Blister packs (PVC/Al) of 14, 20, 56, 60 capsules (AUST R 193300).

100 mg capsules:

Capsules with an orange body/orange cap; imprinted with “APO” and “P100” in black ink.

Blister packs (PVC/Al) of 14, 20, 56, 60 capsules (AUST R 193301).

150 mg capsules:

Capsules with a white body/white cap; imprinted with “APO” and “P150” in black ink.

Blister packs (PVC/Al) of 14, 20, 56, 60 capsules (AUST R 193302).

200 mg capsules:

Capsules with a light orange body/light orange cap; imprinted with “APO” and “P200” in black ink.

Blister packs (PVC/Al) of 14, 20, 56, 60 capsules (AUST R 193303).

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225 mg capsules:

Capsules with a white body/light orange cap; imprinted with “APO” and “P225” in black ink.

Blister packs (PVC/Al) of 14, 20, 56, 60 capsules (AUST R 193304).

300 mg capsules:

Capsules with a white body/orange cap; imprinted with “APO” and “P300” in black ink.

Blister packs (PVC/Al) of 14, 20, 56, 60 capsules (AUST R 193305).

* Not all strengths and/or pack sizes may be available.

Storage

Store below 25°C.

POISON SCHEDULE OF THE MEDICINE

S4 - Prescription Only Medicine.

NAME AND ADDRESS OF THE SPONSOR

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

DATE OF FIRST INCLUSION IN THE AUSTRALAN REGISTER OF THERAPEUTIC GOODS (THE

ARTG): 19 September 2012

DATE OF MOST RECENT AMENDMENT: 18 May 2017