BNF for Children 2011-2012

BNFC 2011–2012 Appendix 3: Cautionary and advisory labels 789If separate labels are used it is recommended that thewordings be used without modification. If changes aremade to suit computer requirements, care should betaken to retain the sense of the original.1 Warning: This medicine may make you sleepyTo be used on preparations for children containingantihistamines, or other preparations given to childrenwhere the warnings of label 2 on driving oralcohol would not be appropriate.2 Warning: This medicine may make you sleepy. If thishappens, do not drive or use tools or machines. Donot drink alcoholTo be used on preparations for adults that can causedrowsiness, thereby affecting coordination and theability to drive and operate hazardous machinery;label 1 is more appropriate for children. It is an offenceto drive while under the influence of drink or drugs. Itshould be remembered that children and adolescentsdo, on occasion, consume alcohol and should bemade aware of potential problems.Some of these preparations only cause drowsiness inthe first few days of treatment and some only causedrowsiness in higher doses.In such cases the patient should be told that theadvice applies until the effects have worn off. Howevermany of these preparations can produce a slowing ofreaction time and a loss of mental concentration thatcan have the same effects as drowsiness.Avoidance of alcoholic drink is recommended becausethe effects of CNS depressants are enhanced byalcohol. Strict prohibition however could lead to somepatients not taking the medicine. Pharmacists shouldtherefore explain the risk and encourage compliance,particularly in patients who may think they alreadytolerate the effects of alcohol (see also label 3).Queries from patients with epilepsy regarding fitnessto drive should be referred back to the patient’sdoctor.Side-effects unrelated to drowsiness that may affect apatient’s ability to drive or operate machinery safelyinclude blurred vision, dizziness, or nausea. In general,no label has been recommended to cover thesecases, but the patient should be suitably counselled.3 Warning: This medicine may make you sleepy. If thishappens, do not drive or use tools or machinesTo be used on preparations containing monoamineoxidaseinhibitors; the warning to avoid alcohol anddealcoholised (low alcohol) drink is covered by thepatient information leaflet.Also to be used as for label 2 but where alcohol is notan issue.4 Warning: Do not drink alcoholTo be used on preparations where a reaction such asflushing may occur if alcohol is taken (e.g. metronidazole).Alcohol may also enhance the hypoglycaemiaproduced by some oral antidiabetic drugs but routineapplication of a warning label is not considerednecessary.Patients should be advised not to drink alcohol for aslong as they are receiving/using a course of medication,and in some cases for a period of time after thecourse is finished.5 Do not take indigestion remedies 2 hours before orafter you take this medicineTo be used with label 25 on preparations coated toresist gastric acid (e.g. enteric-coated tablets). This isto avoid the possibility of premature dissolution of thecoating in the presence of an alkaline pH.Label 5 also applies to drugs such as ketoconazolewhere the absorption is significantly affected byantacids. Pharmacists will be aware (from a knowledgeof physiology) that the usual time during whichindigestion remedies should be avoided is at least 2hours before and after the majority of medicines havebeen taken; where a manufacturer advises a differenttime period, this can be followed, and should beexplained to the patient.6 Do not take indigestion remedies, or medicines containingiron or zinc, 2 hours before or after you takethis medicineTo be used on preparations containing ofloxacin andsome other quinolones, doxycycline, lymecycline,minocycline, and penicillamine. These drugs chelatecalcium, iron, and zinc and are less well absorbedwhen taken with calcium-containing antacids or preparationscontaining iron or zinc. Pharmacists will beaware (from a knowledge of physiology) that theseincompatible preparations should be taken at least 2hours apart for the majority of medicines; where amanufacturer advises a different time period, this canbe followed, and should be explained to the patient.7 Do not take milk, indigestion remedies, or medicinescontaining iron or zinc, 2 hours before or after youtake this medicineTo be used on preparations containing ciprofloxacin,norfloxacin, or tetracyclines that chelate calcium, iron,magnesium, and zinc, and are thus less available forabsorption. Pharmacists will be aware (from a knowledgeof physiology) that these incompatible preparationsshould be taken at least 2 hours apart for themajority of medicines; where a manufacturer advises adifferent time period, this can be followed, and shouldbe explained to the patient. Doxycycline, lymecycline,and minocycline are less liable to form chelates andtherefore only require label 6 (see above).8 Warning: Do not stop taking this medicine unlessyour doctor tells you to stopTo be used on preparations that contain a drug whichis required to be taken over long periods without thepatient necessarily perceiving any benefit (e.g. antituberculousdrugs).Also to be used on preparations that contain a drugwhose withdrawal is likely to be a particular hazard(e.g. clonidine for hypertension). Label 10 (see below)is more appropriate for corticosteroids.9 Space the doses evenly throughout the day. Keeptaking this medicine until the course is finished,unless you are told to stopTo be used on preparations where a course of treatmentshould be completed to reduce the incidence ofrelapse or failure of treatment.The preparations are antimicrobial drugs given bymouth. Very occasionally, some may have severe sideeffects(e.g. diarrhoea in patients receiving clindamycin)and in such cases the patient may need to beadvised of reasons for stopping treatment quickly andreturning to the doctor.10 Warning: Read the additional information given withthis medicineTo be used particularly on preparations containinganticoagulants, lithium, and oral corticosteroids. Theappropriate treatment card should be given to thepatient and any necessary explanations given.This label may also be used on other preparations toremind the patient of the instructions that have beengiven.11 Protect your skin from sunlight—even on a bright butcloudy day. Do not use sunbedsTo be used on preparations that may cause phototoxicor photoallergic reactions if the patient is exposed toultraviolet radiation. Many drugs other than thoselisted (e.g. phenothiazines and sulfonamides) may, onrare occasions, cause reactions in susceptiblepatients. Exposure to high intensity ultraviolet radiationfrom sunray lamps and sunbeds is particularlylikely to cause reactions.12 Do not take anything containing aspirin while takingthis medicineTo be used on preparations containing probenecidand sulfinpyrazone whose activity is reduced byaspirin.Label 12 should not be used for anticoagulants sincelabel 10 is more appropriate.Appendix 3: Cautionary and advisory labels