Cautionary and advisory labels for dispensed medicines

Cautionary and advisory labels for dispensed medicines 

     Numbers following the preparation entries in the BNF correspond to the code numbers of the cautionary labels that pharmacist are recommended to add when dispensing. It is also expected that pharmacists will counsel patients when necessary.

    Counselling needs to be related to the age, experience, background, and understanding of the individual patient. The pharmacist should ensure that the patient understands how to take or use the medicine and how to follow the correct dosage schedule. Any effects of the medicine on driving or work, any foods or medicines to be avoided, and what to do if a dose is missed should be explained. Other matters, such as the possibility of staining of the clothes or skin by a medicine should also be mentioned. 

     For some preparations there is a special need for counselling, such as an unusual method or time of administration or a potential interaction with a common food or domestic remedy, and this is indicated where necessary.

Original Packs

    Most preparations are dispensed in unbroken original packs that include further advice for the patient in the form of patient information leaflets. Label 10 may be of value where appropriate. More general leaflets advising in the administration of preparations such ad eye drops, eye ointments, inhalers and suppositories are also available.

Scope of labels 

   In general no label recommendations have been made for injections on the assumption that they will be administered by a healthcare professional or well-instructed patient. The labelling is not exhaustive and pharmacists are recommended to use their professional discretion in labelling new preparations and those for which no labels are shown.

   Individual labelling advice is not  given on the administration of the large variety of antacids. In the absence of instructions  from the prescriber, and if on enquiry the patient has had no verbal instructions, the directions given under 'Dose' should be used on the label.

   It is recognised that there may be occasions when pharmacist will use their knowledge and professional discretion and decide to omit one or more of the recommended labels for a particular patient. In this case counselling is of the utmost importance. There may also be an occasion when a prescriber does not wish additional cautionary labels to used, in which case prescription should be endorsed 'NCL' (NO CAUTIONARY LABELS). The exat wording that is required instead should then be specified on the prescription.

  Pharmacist label medicines with various wording in addition to those directions specified on the prescription. Such labels include 'shake the bottle' ; 'For external use only', and 'Store in a cool place' as well as 'Discard .......days after opening and ' Do not use after .......' which apply particularly to antibiotic mixtures, diluted liquid and topical preparations, and to eye-drops. Although not listed on the BNF these labels should continue to be used when appropriate; indeed, 'For external use only' is a legal requirement on external liquid preparations, while 'Keep out of the reach of children' is a legal requirement on all dispensed medicines. Care should be taken not to obscure other relevant information with adhesive labelling.

   Ii is the usual Practise for patients to take Standard tablets with water or other liquid and for this reason no separate label has been recommended.

   The label wording recommended by the BNF apply to medicine dispensed against a prescription. Patients should be aware that a dispensed medicine should never taken by, o hared with, anyone other than for whom the prescriber intended it. therefore, the BNF does not include warnings against the use of a dispensed medicine by persons other than for whom it was specifically prescribed.

   The label  or Lables each preparations are recommended after careful consideration of the information available.However, it is recognised that in some cases this information may be either incomplete or open to a full different interpretation.

                                                                                                                                                               

Recommended Label Wordings 

     Wording which can be given as separate warnings are labels 1-19, 29-30, and 32. Wordings which can be incorporated in an appropriate position in the directions for dosage or administration are labels 21-28. A Label has been omitted for number 20; Labels 31 and 33 no longer apply to any medications in the BNF and have therefore been deleted.

     If separate labels are used it is recommended that the wordings be used without modification. If changes are made to suit computer requirements, care should be taken to retain the sense of the original. 

01. Warning : This medicine may make you sleepy.

To be used on preparations for children containing antihistamines, or other preparations given to children where the warnings of label 2 on driving or alcohol would be appropriate. 

02. Warning : This medicine may make you sleepy, If this happens, do not drive or use tools or         machines. Do not drink alcohol.

To be used on Preparations for adults that can cause to drive and operate hazardous machinery; Label 1 is more appropriate for children. It is an offence to drive while under the influence of drink or drugs.

Some of these preparations only cause drowsiness in the first few days of treatment and some only cause drowsiness in higher doses.

In such cases the patient should be told that the advice applies until the effects have worn off. However many of these preparations can produce a sowing of reaction time and a loss of mental concentration that can have the same effects as drowsiness. 

Avoidance of alcoholic drink is recommended because the effects of CNS depressants are enhanced by alcohol. Strict prohibition however could lead to some patients not taking the medicine.  Pharmacists should therefore explain the risk and encourage compliance, particularly in patient who may think they  already tolerate the effects of alcohol. Queries from patient with epilepsy regarding fitness to drive should be referred back toe the patient's Doctor.

 Side-effects unrelated to drowsiness that may affect a patient's ability to drive or operate machinery safely include blurred vision, dizziness, or nausea. In general, no label has been recommended to cover these cases, but the patient should be suitably counselled. 

03. Warning: This medicine may make you sleepy. If this happens, do not drive or use tools or          machines. 

To be used on preparations containing monoamine-oxidase inhibitors, the warning to avoid alcohol and dealcoholised  (Low alcohol ) drink is covered by the patient information leaflet. Also to be used as for label 2 but where alcohol is not an issue. 

04. Warning: Do not drink alcohol.

 To be used on preparations where a reaction such as flushing may occur if alcohol is taken (e.g. metronidazole). Alcohol may also enhance the hypoglycemia produced by some oral anti-diabetic drugs but routine application of a warning label is not considered necessary.

Patients should be advised not to drink alcohol for as long ad they are receiving/using a course of medication, and in some cases for a period of time after the course is finished.

05. Do not take indigestion remedies two hours before or after you take this medicine.

 To be used with label 25 on preparations coated to resit gastric acid (e.g. enteric-coated tablets). This is to avoid the possibility of premature dissolution of the coating in the presence of an alkaline pH.

Label 5 also applies to drugs such as ketoconazole where the absorption is significantly affected by antacids. Pharmacists will be aware (from a knowledge of physiology) that the usual time during which indigestion remedies should be avoided is at least two hours before and after the majority of medicines have been taken; when a manufacturer advises a different time period, this can be followed, and should be explained to the patient.

06. Do not take indigestion remedies, or medicines containing iron, or zinc, two hours before or        after you take this medicine.

To be used on preparations containing  ofloxacin and some other quinolones, doxycycline, lymecycine, nad penicillamine. these drugs chelate calcium, iron and zinc and are less well absorbed when taken with calcium containing antacids or preparations containing iron or zinc. Pharmacists will be aware that these incompatible preparations should betaken at least two hours apart for the majority of the medicines; when a manufacturer advises a different time period, this can be followed, and should be explained to the patient.

07. Do not take milk, indigestion remedies, or medicines containing iron or zinc, Two hours              before or after you take this medicine. 

To be used on preparations containing ciprofloxacin, norfloxaxin, or tetracyclines that chelate calcium, iron, magnesium, and zinc and are thus less available for absorption. Pharmacists will be aware that these incompatible preparations should be taken at east two hours apart for the majority of medicines; when a manufacturer advises a different time period, this can be followed, and should be explained to the patient. Doxycycline, lymecycline, and minocycline are less liable to form chelates and therefore only equire label 6.

08. Warning: Do not stop taking this medicine unless your doctor tells you to stop. 

To be used on preparations that contain a drug which is required to be taken over long periods without the patient necessarily perceiving any benefit. (e.g. antituberculous drugs).

          Also to be used on preparations that contain a drug whose withdrawal is likely to be a                          particular  hazard (e.g. clonidine for hypertension). Label 10 is more appropriate for                            corticosteroids.

09. Space the doses evenly throughout the day. Keep taking this medicine until the course is              finished,  unless you are told to stop.

   To be used in preparations where a course of treatment should be completed to reduce the incidence of replace or failure of treatment. The preparations are antimicrobial drugs  given by mouth. Very occasionally, some may have severe side-effects (e.g. diarrhoea in patients receiving clindamycin) and in such cases the patient may need to be advised of reasons for stopping treatment and returning to the doctor.

10. Warning: Read the additional information given with this medicine. 

To be used particularly on preparations containing anticoagulants, lithium, and oral corticosteroids. The appropriate treatment card should be given to the patient and any necessary explanations given. 

This label may given also be used on other preparations to remind the patient of the instructions that have been given. 

11. Protect your skin from sunlight-even on a bright but cloudy day. Do not use sunbeds. 

To be used on preparations that may cause photo-toxic or photo-allergic reactions if  the patients is exposed to ultraviolet radiation. Many digs other than those listed on appendix 3(e.g. phenothiazines in susceptible patients. Exposure to high intensity ultraviolet radiation from sun ray lamps and sunbeds is particularly likely to cause reactions. 

12. Do not take anything containing aspirin while taking this medicine.

To be used on preparations containing probencid and sulfinpyrazone whose activity is reduced by aspirin. Label 12 should be not used for anticoagulants since label 10 is more appropriate.

13. Dissolve or mix with water before taking. 

To be used on preparations that are intended to be dissolved in water (e.g. soluble tablets) or mixed with water (e.g. powders, granules) before use. In a few cases other liquids such as fruit juice or milk may be used.

14. This medicine may colour your urine. This is harmless. 

To be used on preparations that may cause the patient's urine to turn an unusual colour. These include tiamterene (blue under some lights), levopoda (dark reddish), and rifampicin (red).

15. Caution: flammable. Keep your body away from fire or flames after you have put on the            medicine.

To be used on preparations containing sufficient flammable solvent to render them flammable if exposed to a naked flame. 

16. Dissolve the tablet under your tongue - do note swallow. Store the tablets in this bottle with        the cap tightly closed. Get a new supply 8 weeks after opening. 

To be used on glyceryl trinitrate tablets to remind the patient not to transfer the tablets to plastic or less suitable containers.

17. Do not take more than........ in 24 hours. 

To be used on preparations for the treatment of acute migraine except those containing ergotamine, for which label 18 is used. The dose form should be specified. e.g. tablets or capsules. It may also be used on preparations for which no dose has been specified by the prescriber

18. Do not take more than....24 hours. Also, do not take more than.... in any one week.

To be used on preparations containing ergotamine. The dose form should be specified, e.g. tablets or supositories.

19. Warning: This medicine makes you sleepy. If you still feel sleepy the next day, do not drive          or use tools or machines. Do not dink alcohol. 

To be used on preparations containing hypnotics (or some other drugs with sedative effects) prescribed to be taken at night. On the rare occasions when hyponotics are prescribed for daytime administration (e.g. nitrazepam in epilepsy), this label would clearly not be appropriate. Also to be used as an alternative to the label 2 wording (the choice being at the discretion of the pharmacists) for anxiolytics prescribed to be taken at night. It is hoped that this wording will convey after taking 'sleeping tablets'.

21. Take with o just after food, or a meal. 

To be used on preparations that are liable to cause gastric irritation, or those that are better absorbed with food. Patients should be advised that a small amount of food is sufficient. 

22. Take 30 to 60 minutes before food. 

To be used on some preparations whose absorption is thereby improved. Most oral antibacterials require label 23 instead.

23. Take this medicine when your stomach is empty. This means an hour before food or two              hours after food.

To be used on oral antibacterials whose absorption may be reduced by the presence of food and acid in the stomach. 

24. Suck or chew this medicine.  

 To be used on preparations that should be sucked or chewed. the pharmacist should use discretion as to which of these words is appropriate. 

25. Swallow this medicine whole. Do not chew or crush.

To be used on preparations that are enteric-coated or designed for modified-release. Also to be used on preparations that taste very unpleasant or may damage the mouth if not swallowed whole. Patients should be advised (where relevant) that some modified- release preparations can be broken in half, but that the halved tablet should still be swallowed whole, and not chewed or crushed.

26. Dissolve this medicine under your tongue. 

To be used on preparations designed for sublingual use. Patients should be advised to hold under the tongue and avoid swallowing until dissolved. The buccal mucosa between the gum and cheek is occasionally specified by the prescriber.

27. Take with a full glass of water.

 To be used on preparations that should be well diluted (e.g. chloral hydrate), where a high fluid intake is required (e.g. sulfonamides). or where water is required to aid the action (e.g. methyl-cellulose). The patient should be advised that 'a full glass' means at least 150 ml. In most cases fruit juice, tea, or coffee may be used.

28. Spread thinly on the affected skin only. 

To be used on external preparations that should be applied sparingly (e.g. corticosteroids, dithranol).

29. Do not take more then two at any one time. Do not take more than eight in 24 hours. 

To be used on containers of dispensed solid dose preparations containing paracetamol for adults when the instruction on the label indicates that the dose can be taken on an 'as required' basis. The dose form should be specified, e.g. tablets o capsules. This label has been  introduced because of the serious consequences of over-dosage with paracetamol.

30. Contains Paracetamol. Do not take anything else containing paracetamol while taking this          medicine. 

To be used on all containers of dispensed preparations containing paracetamol. 

32. Contains aspirin. Do not take anything else containing aspirin while taking this medicine. 

To be used on containers of dispensed preparations containing aspirin when the name on the label does not include the word 'aspirin'.

Source BNF 64