Almus Pepti-Calm Suspension Bismuth Subsalicylate 525.6mg/30ml
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Pepti-Calm 525.6mg/30ml Oral Suspension,
Almus Pepti-Calm Suspension Bismuth Subsalicylate 525.6mg/30ml.
2. QUALITATIVE AND QUANTITIATIVE COMPOSITION
Active ingredient mg/30ml
Bismuth subsalicylate 525.6
For excipients, see 6.1
3. PHARMACEUTICAL FORM
Oral suspension Thick pink suspension.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the relief of indigestion, dyspepsia, nausea, upset stomach and diarrhoea.
4.2. Posology and method of administration
Adults and children over 16 years: 30ml to be taken every 30-60 minutes as required up to a maximum of eight doses in 24 hours.
Do not give to children under 16 years.
For oral administration.
4.3. Contraindications
Hypersensitivity to any of the ingredients, aspirin or other nonsteroidal antiinflammatory drugs and patients with renal disorders.
Pregnancy and breastfeeding (see section 4.6, Pregnancy and lactation).
4.4. Special warnings and special precautions for use
There is a possible association between salicylates and Reye's Syndrome when given to children. Reye’s Syndrome is a very rare disease which affects the brain and liver and can be fatal. For this reason it should not be given to children under 16, unless specifically indicated (e.g. Kawasaki’s disease).
Do not take with aspirin.
Do not take if suffering from gout.
If symptoms are severe or persist for more than 2 days, talk to your pharmacist or doctor.
Do not exceed the stated dose.
Keep all medicines out of the reach of children.
4.5. Interaction with other medicaments and other forms of interaction
Salicylates may enhance the effect of coumarin anticoagulants and oral hypoglycaemics of the sulphonylurea type. Salicylates diminish the action of uricosurics.
4.6. Pregnancy and lactation
The safety of Pepti-Calm during pregnancy and lactation has not been established and therefore use during these periods is not recommended. Animal studies are insufficient with respect to effects on pregnancy. The potential risk for humans is unknown. Pepti-Calm should not be used during pregnancy.
There is limited information on the excretion of bismuth subsalicylate in human or animal breast milk. Physico-chemical and available pharmacodynamic data on bismuth subsalicylate point to excretion in breast milk and a risk to the suckling child cannot be excluded. Pepti-Calm should not be used during breast feeding.
4.7. Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Nausea and vomiting have been reported as well as darkening or blackening of the faeces and tongue.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9. Overdose
The effects of bismuth intoxication include gastrointestinal disturbances, skin reactions, stomatitis and discolouration of the mucous membranes. A characteristic blue line may appear on the gums.
Salicylate poisoning is usually associated with plasma concentrations >350mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1mmol/L). Single doses less than 100mg/kg are unlikely to cause serious poisoning.
Common features of salicylate poisoning 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 of salicylate poisoning 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.
Give activated charcoal if an adult presents within one hour of ingestion of more than 250mg/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 >700mg/L (5.1mmol/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
Bismuth has weak antacid properties. Bismuth subsalicylate may exert its antidiarrhoeal 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.
5.2. Pharmacokinetic properties
Following oral administration, the amount of bismuth absorbed is negligible, whereas the salicylate component is absorbed completely and rapidly from the small intestine.
Bismuth subsalicylate is believed to be largely hydrolysed in the stomach to bismuth oxychloride and salicylic acid. In the small intestine non-dissociated bismuth subsalicylate reacts with other anions to form insoluble bismuth salts. In the colon, non-dissociated salicylate and other bismuth salts react with hydrogen sulphide to produce bismuth sulphide, a highly insoluble black salt responsible for blackening the tongue and faeces.
Bismuth is primarily excreted in the faeces, whereas the salicylate component is primarily excreted in the urine either as free salicylic acid or conjugated metabolites.
5.3. Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
PHARMACEUTICAL PARTICULARS
6
6.1. List of excipients
Maltitol liquid Glycerin.
Dispersible cellulose (containing microcrystalline cellulose and sodium carboxymethylcellulose)
Xanthan gum Citric acid monohydrate Sodium citrate Sodium benzoate
Rootbeer flavour (containing polypropylene glycol)
Carmoisine Edicol E (E122)
Purified water
6.2. Incompatibilities
None
6.3. Shelf-life
18 Months
6.4. Special precautions for storage
Do not store above 25°C
6.5. Nature and contents of container
A 150m1, 180m1 or 300m1 white flint glass bottle with a roll on aluminium closure and expanded polyethylene liner.
6.6. Instruction for use/handling
Not applicable
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00014/0615
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/03/2006
10 DATE OF REVISION OF THE TEXT
December 2014