COMPOSITION :

Each F/C Tablet contains : Hyoscine-N-butylbromide B.P. 10 mg.

Each 5ml (teaspoonful) contains : Hyoscine-N-butylbromide B.P. 5 mg.

DESCRIPTION :

Spazmo-max (Hyoscine-N-butylbromide) is a quaternary ammonium derivatives, it exerts a specific and potent

antispasmodic action on the smooth muscles of the gastro intestinal, biliary and urinary tract. It does not pass the

blood brain barrier.Therefore, anticholinergic side effects at the central nervous system not occur. Its binding to plasma

proteins is low and approximately half of the clearance is renal.

INDICATIONS :

Spazmo-max is indicated in the treatment of :

- Gastrointestinal spasm and hypermotility.

- Irritable bowel syndrome and spastic colon.

- Biliary colics and cholelithiasis.

- Renal colics and urolithiasis.

- Dysmenorrhea and nocturnal enuresis.

- Peptic ulcer (in conjunction with antacid or histamine H2-antagonist).

DOSAGE & ADMINISTRATION :

• Adults and children over 6 years : 1 - 2 tablets or 2 teaspoonful 3 - 5 times daily.

• Children over one year : 1 - 2 teaspoonful 3 times daily.

• Infants : One teaspoonful 3 times daily.

RESTRICTIONS ON USE :

Contraindications

- In patient with hypersensitivity to Hyoscine-N-butylbromide.

- In patient with myasthenia gravis and megacolon.

Use in pregnancy and lactation

Caution should be exercised when use Hyoscine-N-butylbromide in pregnancy especially during the first trimester, and

safety of it during lactation has not yet been established.

Precautions

Caution is recommended when Hyoscine-N-butylbromide is given to patients having narrow angle glaucoma, prostatic

enlargement, cardiac disorders, mechanical stenosis in the gastro intestinal tract, and urinary outlet obstruction,

hepatic and renal function impairment and hypertension.

DRUG INTERACTION :

- The anticholenergic effect of tricyclic antidepressants, antihistamines, Quinidine, Amantadine and Disopyramide may

be intensified by Hyoscine-N-butylbromide.

- Concomitant treatment with dopamine antagonists such as Metoclopramide may result in diminution of the effect of

both drugs on the gastrointestinal tract.

- Tachycardic effects of beta-adrenergic agents may be enhanced by Hyoscine-N-butylbromide.

- Antacids and Antidiarrhoeals may reduce absorption of anticholenergics, doses should be spaced 2 to 3 hours apart.

ADVERSE REACTIONS :

Adverse effects of Hyoscine-N-butylbromide are generally mild and self limited, such as constipation, drowsiness and

dryness of the mouth, throat, nose and skin. tachycardia and urinary retension may occur.

STORAGE INSTRUCTIONS :

Tablets : Store between 15 - 25oC, in a dry place.Protect from light.

Syrup : Store at 25oC, protect from light.

PRESENTATIONS :

Spazmo-max Tablet : Pack of 10 and 20 tablets and hospital packs of different sizes.

Spazmo-max Syrup : Pack of 60 ml.