Diarrhea, nausea, heartburn, indigestion, upset stomach. Hypersensitivity to bismuth, aspirin, other salicylates. Infectious diarrhea, high fever, von Willebrand disease, hemorrhage, ulcer or GI bleeding with black or bloody stool, hemophilia. In pediatric patients, chicken pox or influenza (risk of Reye syndrome); changes in behavior with nausea and vomiting may be early sign of Reye syndrome.

Anti-dyspeptic/Carminatives

The demulcent base provides a protective coating of the lower oesophagus and a partial coating in the stomach which holds the Bismuth Subsalicylate in suspension. Bismuth subsalicylate may exert its antidiarrheal action not only by stimulating absorption of fluid and electrolytes across the intestinal wall but also when hydrolysed to salicylic acid, by inhibiting synthesis of a prostaglandin responsible for intestinal inflammation and hypermotility. In addition, Bismuth Subsalicylates binds toxins produced by E. coli.

Administration: Drink plenty of clear fluids to prevent dehydration caused by diarrhea Do not use for >2 days Adult Dose: Adult: 30 ml 3-4 times daily 30 mintues before meal. Child Dose: Child: 3-12 years: 5-15 ml <3 years: Safety and efficacy not established

Bismuth Subsalicylate Contains salicylates therefore care should be exercised if receiving drugs to thin the blood (anticoagulant therapy) or oral therapy for diabetes or treatment for gout or arthritis.

Hypersensitivity to bismuth, aspirin, other salicylates. Infectious diarrhea, high fever, von Willebrand disease, hemorrhage, ulcer or GI bleeding with black or bloody stool, hemophilia. In pediatric patients, chicken pox or influenza (risk of Reye syndrome); changes in behavior with nausea and vomiting may be early sign of Reye syndrome.

>10% Nausea (12%) 1-10% Diarrhea (7%),Abdominal pain (7%),Melena (3%),Upper respiratory tract infection (2%),Constipation (2%),Anorexia (2%),Vomiting (2%),Asthenia (2%),Discolored tongue (2%),Headache (2%),Dyspepsia (2%),Dizziness (2%),Stool abnormality (1%),Duodenal ulcer (1%),Sinusitis (1%),Taste perversion (1%),Flatulence (1%),GI hemorrhage (1%),Pain (1%),Insomnia (1%),Anal discomfort (1%),Paresthesia (1%) Frequency Not Defined Anxiety,Confusion,Depression,Tinnitus,Weakness,Gray-black stool,Impaction,Muscle spasm,Neurotoxicity (rare)

Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Precaution: May cause black tongue and/or black stool.

Bismuth intoxication may present as an acute encephalopathy with confusion, myoclonic movements, tremor, dysarthria and walking and standing disorders. Bismuth intoxication may also cause gastrointestinal disturbances, skin reactions, discoloration of mucous membranes, and renal dysfunction as a result of acute tubular necrosis. Treatment includes gastric lavage, purgation and hydration. Chelating agents may be effective in the early stages following ingestion and haemodialysis may be necessary. Overdose of Bismuth Subsalicylate may also give symptoms of salicylate intoxification e.g. dizziness, tinnitus, sweating, nausea, headache. If symptoms occur, use of Bismuth Subsalicylate  should be discontinued. Management of overdose is the same as that for salicylate overdose.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Antimicrobial anti-inflammatory action (bismuth); antisecretory effect (salicylate).

Pregnancy category: C; D in 3rd trimester Lactation: Salicylates enter breast milk; use with caution