Procolic Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info

Concise Prescribing Info

Contents

Hyoscine butylbromide 10 mg, paracetamol 500 mg

Indications/Uses

Paroxysmal pain in gastric or intestinal diseases, biliary tract, urinary tract & female genital organ dysfunction eg, dysmenorrhea.

Dosage/Direction for Use

Adult 1-2 tab 3 times daily. Max: 6 tab daily.

Administration

May be taken with or without food: Swallow whole w/ sufficient water, do not chew.

Contraindications

Hypersensitivity. Mechanical stenosis of GIT, achalasia, paralytic ileus, intestinal atony, prostate hypertrophy w/ urinary retention, myasthenia gravis, glaucoma, pathological tachyarrhythmia, megacolon. Porphyria. Impaired liver function. Severe hepatocellular disorders (Child-Pugh ≥9).

Special Precautions

G6PD deficiencies, liver or kidney dysfunction, Gilbert's syndrome, hepatocellular disorders (Child-Pugh ≥9). Pregnancy.

Adverse Reactions

Pancytopenia, agranulocytosis, thrombocytopenia, leucopenia; anaphylactic shock, anaphylaxis reactions, dyspnea, dry skin, hypersensitivity reactions; tachycardia; bronchospasm, dry mouth, increased transaminase; urinary retention.

View ADR Monitoring Form

Drug Interactions

May cause liver damage w/ hypnotic & antiepileptic drugs (ie, glutethimide, phenobarb, phenytoin, carbamazepine), rifampicin, alcohol. May prolong t_½ of chloramphenicol. Oral anticoagulants, zidovudine, probenecid, colestyramine. May enhance the effect of anticholinergic agents ie, TCA, antihistamine, clonidine, amantadine, disopyramide, other anticholinergics (ie, tiotropium, ipratropium). Dopamine antagonist eg, metoclopramide. May enhance tachycardia effect of β-adrenergic drugs.

MIMS Class

Antispasmodics / Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

ATC Classification

N02BE51 - paracetamol, combinations excl. psycholeptics ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
A03DB04 - butylscopolamine and analgesics ; Belongs to the class of belladonna and derivatives antispasmodics in combination with analgesics. Used in the treatment of functional gastrointestinal disorders.

Regulatory Classification

Presentation/Packing

Form

Procolic FC tab

Packing/Price

10 × 10's

Procolic

Manufacturer:

Meprofarm