PINAVERIUM TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PINAVERIUM BROMIDE

Verfügbar ab:

AA PHARMA INC

ATC-Code:

A03AX04

INN (Internationale Bezeichnung):

PINAVERIUM

Dosierung:

100MG

Darreichungsform:

TABLET

Zusammensetzung:

PINAVERIUM BROMIDE 100MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

10X10BLISTERS/100

Verschreibungstyp:

Prescription

Therapiebereich:

MISCELLANEOUS GI DRUGS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0113429002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2017-11-07

Fachinformation

Page 1 of 23
PRODUCT MONOGRAPH
PR
PINAVERIUM
PINAVERIUM BROMIDE TABLETS
50 MG AND 100 MG PINAVERIUM BROMIDE
GASTROINTESTINAL CALCIUM ANTAGONIST
AA PHARMA INC.
1165 CREDITSTONE ROAD UNIT #1
VAUGHAN, ONTARIO
L4K 4N7
Date of Revision:
March 8, 2021
Submission Control No.: 248903
Page 2 of 23
PRODUCT MONOGRAPH
PR
PINAVERIUM
Pinaverium Bromide Tablets
50 mg and 100 mg pinaverium bromide
THERAPEUTIC CLASSIFICATION
Gastrointestinal calcium antagonist
CLINICAL PHARMACOLOGY
PINAVERIUM (pinaverium bromide) is a calcium antagonist which inhibits
the calcium influx
by blocking the voltage-dependent calcium channel at the smooth muscle
cell level. It possesses
a high degree of selectivity for the intestinal smooth muscle.
5,7,19,32,36,48,50
Many studies showed that pinaverium bromide induces a relaxation of
the gastrointestinal and
the biliary tracts and mainly of the colon, an inhibition of the motor
colonic response to food
and/or pharmacological stimulations, implying the action of the drug
in irritable bowel
syndrome.
4,9,37,47
INDICATIONS AND CLINICAL USE
PINAVERIUM (pinaverium bromide) is indicated:
-
for the treatment and relief of symptoms associated with irritable
bowel syndrome (IBS):
abdominal pain, bowel disturbances and intestinal discomfort.
-
for the treatment of symptoms related to functional disorders of the
biliary tract.
Page 3 of 23
CONTRAINDICATIONS
PINAVERIUM (pinaverium bromide) is contraindicated in patients with
known hypersensitivity
to pinaverium bromide or any of the excipients.
No other contraindications have been identified at this time.
WARNINGS
Contact of PINAVERIUM with the oesophageal mucosa may be irritating.
Therefore, it is
strongly recommended that the tablet be taken with a glass of water
during mealtime. The
tablet must be swallowed without being chewed or sucked. If more than
three tablets are
prescribed per day, the additional tablet(s) should be taken
concurrently with a glass of water
and a snack.
Because of a risk of oesophageal lesions, instructions on the method
of administration