PEPTI-CALM

Posology 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. 3). Method of administration Pepti-Calm can be taken before or after meals, on either an empty or full stomach.

For oral administration.

Tabulated list of adverse reactions Adverse reactions are listed in the below table by System Organ Class and in order of decreased seriousness within each frequency grouping.

Frequencies are defined as:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). The most common AEs are benign and transient blackening of the faeces (~15%) and discoloration (blackening) of the surface of the tongue (~8%).

This phenomenon is caused by the reaction of malodorous sulfide gases from fermentation of food residues with bismuth resulting in an odorless black insoluble bismuth sulfide salt. System Organ Class Frequency Adverse reaction Common Black tongueGastrointestinal disorders Very common Black stool 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. uk/yellowcard

− Pepti-Calm should be stopped if symptoms get worse, if they last more than 2 days, or if ringing in the ears appears (tinnitus). − This medicine should not be used if symptoms are severe or persist for more than 2 days. 3). This is particularly important in those who have or are recovering from a viral infection such as chicken pox or flu.

− In patients with diarrhoea, especially in frail and elderly patients, fluid and electrolyte depletion may occur. In such cases administration of appropriate fluid and electrolyte replacement therapy is the most important measure. − Do not take with aspirin or other salicylates.

− Caution should be exercised by patients who have blood clotting disorders or gout or who are taking medicines for anti-coagulation (thinning of blood), diabetes or gout. − 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 severe side effects (notably bismuth and salicylate intoxication). − Keep all medicines out of reach and sight of children. Important information about some of the ingredients in this medicine.

Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains maltitol which may have a mild laxative effect. 3 kcal/g maltitol. This medicine contains glycerin which may cause headache, stomach upset and diarrhoea.

This medicine contains 30 mg of sodium benzoate in each 30ml, which is equivalent to 1mg/ml. This medicine contains carmoisine edicol (E122) which may cause allergic reactions. 15 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

4).