Cautionary and advisory labels for medicines

CAUTIONARY AND

ADVISORY LABELS

(CALS)

B y Kiran SharmaKIET School of Pharmacy

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Cautionary and advisory labels (Cals) are sometimes added (with the dispensing label) to a medicine dispensed by the pharmacist to the patient.

Standard cautionary and advisory labels offer advice but are not exhaustive.

The labels are not a substitute for adequate counseling by prescribers and dispensers (most medicines are dispensed by pharmacists) but are intended to reinforce essential information the patient needs to know.

CALs

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2 Types of CALs* for providing advice regarding medication use*for warning consumers about undesirable effects

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Recommended label wording can offer advice about: Timing of doses in relation to food Completing the course of treatment What has to be done if a dose is

missed The correct storage of a medicine Dissolution of the medicine in water

before taking it Limits to the number of tablets that

should be taken in a given time

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Recommended label wording can offer warnings about:

Effects of the medicine on driving or work (e.g. through drowsiness)

Foods or medicines that should be avoided

Avoidance of exposure of the skin to sunlight or sun lamps

Medicines that can discolor the urine Medicines that can stain clothes or skin

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Some Examples

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Example

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Updating the CALs

Addition of a new label statement; Amendment to the wording of an existing label

statement; Deletion of a label statement; Application of an existing statement to a new

substance or class of substances; Application of a new label statement to a

substance or a class of substances; Removal of the requirement for an advisory

statement for a substance or class of substances.

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THANKS