PEPTI-CALM Oral suspension Ref.[27612] Active ingredients: Bismuth subsalicylate

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 salicylates should not be given to children aged under 16 years, 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.

Salicylates may enhance the effect of coumarin anticoagulants and oral hypoglycaemics of the sulphonylurea type. Salicylates diminish the action of uricosurics.

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.

No adverse effects known.

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.

None.