ADVIL BACK PAIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IBUPROFEN; METHOCARBAMOL

Available from:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATC code:

M03BA53

INN (International Name):

METHOCARBAMOL, COMBINATIONS EXCL PSYCHOLEPTICS

Dosage:

200MG; 500MG

Pharmaceutical form:

TABLET

Composition:

IBUPROFEN 200MG; METHOCARBAMOL 500MG

Administration route:

ORAL

Units in package:

100

Prescription type:

OTC

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0248961001; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-07-09

Summary of Product characteristics

PRODUCT MONOGRAPH
ADVIL BACK PAIN
500 MG METHOCARBAMOL AND 200 MG IBUPROFEN TABLETS
THERAPEUTIC CLASSIFICATION
MUSCLE RELAXANT / ANALGESIC
GLAXOSMITHKLINE CONSUMER HEALTHCARE INC.
DATE OF PREPARATION:
7333 MISSISSAUGA ROAD NOVEMBER 4, 2011
MISSISSAUGA, ONTARIO
L5N 6L4
DATE OF REVISION:
JULY 6, 2020
CONTROL # 239840
TABLE OF CONTENTS
Page
1.
Clinical Pharmacology
........................................................... 3
2.
Indications
.............................................................................
6
3.
Contraindications
................................................................... 6
4.
Warnings
...............................................................................
7
5.
Precautions
.........................................................................
11
6.
Drug Interactions
................................................................. 12
7.
Adverse Reactions
.............................................................. 14
8.
Symptoms and Treatment of Overdose .............................. 16
9.
Dosage and Administration
................................................. 18
10.
Pharmaceutical Information
................................................. 18
11.
Composition
........................................................................
20
12.
Availability
...........................................................................
20
13.
Information for the
Consumer.............................................. 20
15.
Toxicology
...........................................................................
23
16.
Bibliography
.........................................................................
28
3
CLINICAL PHARMACOLOGY
A bioavailability study has demonstrated that methocarbamol and
ibuprofen when taken (orally) in
combination, are bioequivalent to methocarbamol and ibuprofen when
taken individually. This
indicates that the absorption and bioavailability of these drugs is
independent of each other’s
presence. There is no pharmacological interaction between
methoca