DICETEL TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

PINAVERIUM BROMIDE

Inapatikana kutoka:

BGP PHARMA ULC

ATC kanuni:

A03AX04

INN (Jina la Kimataifa):

PINAVERIUM

Kipimo:

100MG

Dawa fomu:

TABLET

Tungo:

PINAVERIUM BROMIDE 100MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

20/100

Dawa ya aina:

Prescription

Eneo la matibabu:

MISCELLANEOUS GI DRUGS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2011-01-04

Tabia za bidhaa

PRODUCT MONOGRAPH
PR
DICETEL
®
(PINAVERIUM BROMIDE)
50 MG & 100 MG FILM-COATED TABLETS
GASTROINTESTINAL CALCIUM ANTAGONIST
BGP Pharma Inc.
8401 Trans-Canada Highway
Saint-Laurent, Quebec
H4S 1Z1
Date of Preparation:
December 18, 2014
Submission Control No: 180422
®
Registered Trade-mark Abbott Products Operations AG, licensed use by
BGP Phamrma Inc., Saint-Laurent, Quebec, H4S 1Z1
2
PRODUCT MONOGRAPH
PR
DICETEL
®
(Pinaverium Bromide)
50 mg & 100 mg film-coated tablets
THERAPEUTIC CLASSIFICATION
Gastrointestinal calcium antagonist
CLINICAL PHARMACOLOGY
DICETEL
® (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
DICETEL
®
(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.
3
CONTRAINDICATIONS
DICETEL
®
(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 DICETEL
® (pinaverium bromide) 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 wate