ASAPHEN E.C. 80 MG TABLET (DELAYED-RELEASE)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ACETYLSALICYLIC ACID

Tilgængelig fra:

PHARMASCIENCE INC

ATC-kode:

N02BA01

INN (International Name):

ACETYLSALICYLIC ACID

Dosering:

80MG

Lægemiddelform:

TABLET (DELAYED-RELEASE)

Sammensætning:

ACETYLSALICYLIC ACID 80MG

Indgivelsesvej:

ORAL

Enheder i pakken:

500/1000

Recept type:

OTC

Terapeutisk område:

SALICYLATES

Produkt oversigt:

Active ingredient group (AIG) number: 0101169013; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2007-01-02

Produktets egenskaber

PRESCRIBING INFORMATION
ASAPHEN
®
80 mg Tablets
(Acetylsalicylic acid tablets, USP)
ASAPHEN
® E.C. 80 MG
80mg Tablets
(Acetylsalicylic acid delayed-release tablets, USP)
ANALGESIC, ANTI-INFLAMMATORY, AND ANTIPYRETIC
PHARMASCIENCE, INC
Date of Preparation:
6111 Royalmount Ave # 100
March 26, 2008
Montreal, Quebec
H4P 2T4
Date of Revision:
October 16, 2018
www.pharmascience.com
ASAPHEN
®
is a registered trademark of Pharmascience Inc.
Submission Control N
o
: 220701
_ASAPHEN & ASAPHEN E.C. 80 mg Prescribing Information Page 2 of 10_
PRESCRIBING INFORMATION
ASAPHEN
®
80 mg Tablets
(Acetylsalicylic acid tablets, USP)
ASAPHEN
® E.C. 80 MG
80mg Tablets
(Acetylsalicylic acid delayed-release tablets, USP)
THERAPEUTIC OR PHARMACOLOGICAL CLASSIFICATION
ANALGESIC, ANTI-INFLAMMATORY, AND ANTI-PYRETIC
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM / STRENGTH
CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS
Oral
Tablet /80 mg
Delayed-Release tablets/
E.C. 80 mg
DC Yellow #10, FDC Red #40, Mannitol, Natural Orange Flavor,
Pregelatinized Starch, Sodium Saccharin, Stearic Acid.
Colloidal Silicon Dioxide, Glyceryl Stearate, Lactose Anhydrous,
Methacrylic Acid Copolymer, Methylated Silica, Methylcellulose,
Polydimethylsiloxane, Polysorbate, Pregelatinized Starch, Sodium
Lauryl Sulfate, Sodium Bicarbonate, Stearic Acid, Sorbic acid,
Sulfuric Acid, Talc, Titanium Dioxide, Triethyl Citrate.
ACTION AND CLINICAL PHARMACOLOGY
ASA interferes with the production of prostaglandins in various organs
and tissues through
acetylation of the enzyme cyclo-oxygenase. Prostaglandins are
themselves powerful irritants and
produce headaches and pain on injection in man. Prostaglandins also
appear to sensitize pain
receptors to other noxious substances such as histamine and
bradykinin. By preventing the synthesis
and release of prostaglandins in inflammation, ASA may avert the
sensitization of pain receptors.
The antipyretic activity of ASA is due to its ability to interfere
with the production of
prostaglandin E
1
in the brain. Prost