HYOSCINE N-BUTYLBROMIDE

SPASMOSAN
20mg/mL Solution for Injection (IM/IV)
ANTI-CHOLINERGIC

Formulation:
Each ampoule contains:
Hyoscine N-Butylbromide . . . . . . . . . . . . . . . . 20 mg
Excipient : Sodium Chloride, Sodium Hydrochloride, Hydrochloric Acid,
Water for Injection
DESCRIPTION:
Hyoscine N-Butylbromide (Spasmosan) possesses profound
anticholinergic and spasmolytic actions at the parasympathetic
ganglia in the walls of the viscera. As a result, it produces specific
antispasmodic actions on the smooth muscles of the gastrointestinal,
biliary and urinary tracts. Although it exerts marked gangalionic and
curariform properties, it is devoid of the central stimulant action of
atropine on the central nervous system and salivary glands when taken
in recommended dosages.

INDICATIONS:
For the symptomatic relief of gastrointestinal or genitor-urinary disorders
characterized by smooth muscle spasm.

DOSAGE AND ADMINISTRATION:

By intramuscular or intravenous injection, acute spasm and spasm in
diagnostic procedures, 20 mg repeated after 30 minutes if necessary
(may repeated more frequently in endoscopy); child not
recommended or as prescribe by the physician.

ADVERSE REACTIONS:
Slightly increase in pulse rate. Occasionally, transient disturb the
accommodation.
CONTRAINDICATIONS:
There are known contraindications for the oral therapy. Parenterally, it
should not be administered in cases of glaucoma, megacolon,
prostate hypertrophy and tachycardia.

WARNING AND PRECAUTIONS:

1. Because of the potential risk of anticholinergic complications,
caution should be observed when using hyoscine n-butylbromide
(Spasmosan) in patients prone to glaucoma as well as patients
susceptible to intestinal or urinary outlet obstructions and in those
inclined to tachyarrhythmia.
2. Effects on Ability to Dive or Operate Machinery: Because of visual
accommodation disturbances patients should not drive or operate
machinery after parenteral administration of hyoscine
n-butylbromide (Spasmosan) until vision has normalized.
3. Use in pregnancy & lactation long experience has shown no
evidence of ill-effects during human pregnancy.
4. However, the usual precautions regarding the use of drugs in
pregnancy, especially during the 1st trimester, should be observed.
5. Safety during lactation has not yet been established.

STORAGE:
Store at temperatures not exceeding 30˚C and protect from light.

CAUTION:
FOODS, DRUGS, DEVICES and COSMETICS ACT prohibits dispensing
without prescription.

AVAILABILITY:
1 mL ampoule x 100 ampoule per box

Contract Giver by:

ORIENTAL CHEMICAL WORKS INC.
No. 12, Lane 195, Chung-shan 2nd Rd., Luchou Dist.,
New Taipei City, Taiwan

Manufacturers:
SIU GUAN CHEM. IND.CO.,LTD
No.128, Shin Min Rd. Chiayi600, Taiwan