- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Pepto-Bismol, 17.5mg/ml Oral Suspension
2. Qualitative and quantitative composition
Each ml of suspension contains 17.5mg Bismuth SubsalicylateOne 30ml dose contains 526mg Bismuth SubsalicylateFor excipients see 6.1
3. Pharmaceutical form
Liquid suspensionPink, viscous liquid suspension
4. Clinical particulars
4.1 Therapeutic indications
For upset stomach, indigestion, heartburn and nausea. Controls diarrhoea.
4.2 Posology and method of administration
Adults and children 16 years and over: 30ml in dosing cup provided, or 6 x 5ml spoonfulsRepeat dose every 1/2 to 1 hour if needed. No more than 8 doses to be taken in 24 hours.Do not exceed the recommended dose, shake bottle before useFor Oral use only.
Pepto-Bismol should not be used by patients hypersensitive to Aspirin or other salicylates.Pepto-Bismol should not be used by patients hypersensitive to any ingredient in the formulation.Pepto-Bismol should not be used by children under 16 years of age.
4.4 Special warnings and precautions for use
Do not take with aspirin or other salicylates.Pepto-Bismol should not be used by those aged under 16 due to a possible association between salicylates and Reye`s syndrome, a very rare but very serious disease.Caution should be exercised by patients taking medicines for anti-coagulation (thinning of blood), diabetes or gout.Pepto-Bismol should not be used if symptoms are severe or persist for more than 2 days.Do not exceed the recommended dose. Do not use for more than 2 days except on the advice of a doctor. Use at doses higher than recommended or for prolonged periods is associated with an increased risk of side effects (notably bismuth intoxication).Keep all medicines out of reach and sight of children.
4.5 Interaction with other medicinal products and other forms of interaction
Pepto-Bismol 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.Use of Pepto-Bismol with tetracycline antibiotics can lead to reduced bioavailability due to interaction with aluminium magnesium silicate in the formulation.
4.6 Pregnancy and lactation
There are no adequate date concerning the use of Pepto-Bismol in pregnant women.Animal studies are insufficient with respect to effects on pregancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown.Pepto-Bismol should not be used during pregnancy and lactation unless clearly necessary
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
Gastrointestinal disorders:Black tongue is common (>1/100, <1/10) Black stool is very common (>1/10)
BismuthBismuth 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, discolouration 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.
SalicylateSalicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (95.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.SymptomsCommon features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of 4 years. In children aged 4 years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.
ManagementGive activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under 10 years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic code: ATC code A07B BThe demulcent base provides a protective coating of the lower oesophagus and a partial coating in the stomach which holds the bismuth subsalicylate in suspension. Limited in vitro studies have shown BSS to have some activity against enteropathogens, ie Clostridium. Bacteroides, E. Coli, Salmonella Shigella, campylobacter (Helicobacter) and Yersinia, but not against anaerobes. There are insufficient data to determine whether these findings have any relevance to treatment outcomes in the patient population who may receive BSS.
5.2 Pharmacokinetic properties
Bismuth subsalicylate is converted to bismuth carbonate and sodium salicylate in the small intestineThe oral bioavailability of bismuth administered as Bismuth subsalicylate is extremely low. Very little is known about bismuth distribution in human tissue. Renal clearance is the primary route of elimination for absorbed bismuth, however biliary clearance may also have a role. The remainder is eliminated as insoluble bismuth salts in the faeces. Following the maximum recommended daily adult dose, the mean biological half life is approximately 33 hours and peak plasma bismuth levels remain below 35ppb.Salicylate is absorbed from the intestine and rapidly distributed to all body tissues. Peak plasma levels after maximum recommended daily dosing are about 110 micrograms/ml. Salicylate is rapidly excreted from the body and has a mean biological half life of approximately 4 - 5.5 hours.
5.3 Preclinical safety data
There are no pre-clinical safety data of relevance to health professionals, other than those already included in other sections of the SPC.
6. Pharmaceutical particulars
6.1 List of excipients
Aluminium magnesium silicateMethylcelluloseMethyl salicylateSalicylic acidSaccharin sodiumSodium salicylateAmaranth (E123)Sorbic AcidBenzoic AcidPurified water
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
120, 240, 480ml PET bottle with white polypropylene child resistant closure. Polystyrene dosing cup is shrink wrapped onto the sealed bottle.
6.6 Special precautions for disposal and other handling
Shake bottle well before use
7. Marketing authorisation holder
Procter & Gamble (Health & Beauty Care) Limited The Heights Brooklands Weybridge SurreyKT13 0XP
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
Procter & Gamble (Health & Beauty Care) Ltd.
The Heights, Brooklands, Weybridge, Surrey, KT13 0XP, UK
+44 (0)191 297 6295
Customer Care direct line
+44 (0) 8000 850367 (UK)
+44 (0)191 297 5000
Customer Care direct line
+353 (1) 800 509 301 (Ireland)