PEPTOL-BISMOL

Posology Adults and children 16 years and over: 2 tablets. Repeat dose every 1/2 to 1 hour if needed. No more than 16 tablets to be taken in 24 hours. One adult dose (2 tablets) contains 525mg of Bismuth Subsalicylate. Do not exceed the recommended dose.

3). Method of administration Pepto-Bismol can be taken before or after meals, on either an empty or full stomach. For oral use only.

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. 4). 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. 4 Business Use

− Pepto-Bismol use should be stopped if symptoms get worse, if they last more than 2 days, or if ringing in the ears appears (tinnitus). − Pepto-Bismol 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.

Excipients with known effect:

Sodium: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'. 75 mg aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Amaranth:

May cause allergic reactions.

4).