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1 NAPROXEN v01 1/10 NAPROXEN PGD Details Version 1.0 Legal category Staff grades Approved by POM Paramedic (Non-ECP) Nurse (Non-ECP) Emergency Care Practitioner (Paramedic) Emergency Care Practitioner (Nurse) Medicines Management Group Date issued 31/01/2013 Review date 30/01/2015 Clinical Publication Category Mandatory (RED) - No deviation from document permissible Clinical Requirements Competencies Continuing education Successful completion of a competency assessment in the use of this medicine for the indications stated; Completion of education in both the legal and professional aspects of PGD administration and the supply of medicines; Registered paramedics must have successfully completed a recognised Emergency Care Practitioner course; Registered nurses must be employed as Nurse Practitioners or have successfully completed a recognised Emergency Care Practitioner course. The clinician is responsible for keeping him/herself aware of any changes to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of their own individual scope of practice.

2 NAPROXEN v01 2/10 Clinical Situation Clinical situation Inclusion criteria Exclusion criteria Management of acute musculoskeletal disorders and dysmenorrhoea; Management of pain and inflammation in acute gout. Adults & children 16 years and over with acute musculoskeletal disorders and dysmenorrhoea; Adults over 16 years of age with pain and inflammation in acute gout. Patients with a hypersensitivity to naproxen or any other NSAID (including those in whom attacks of asthma, angioedema, urticaria or rhinitis have been precipitated by aspirin or any other NSAID); Asthmatic patients who have never taken an NSAID; Pregnancy; Breast-feeding; Women undergoing investigation for infertility or attempting to conceive; Patients with coagulation defects (decreases platelet aggregation and increases bleeding time); Severe heart failure; Previous or active peptic ulceration; Children <16years; Moderate or severe renal impairment; Severe liver disease (liver enzymes 3x upper limit of normal); Hypovolaemia or dehydration; Porphyria; Patients already taking: NSAIDs (check OTC use); Lithium; Corticosteroids; Anti-coagulants; Clopidogrel; Ciclosporin; Methotrexate; Tacrolimus; SSRIs; Quinolone antibiotics; Heparin.

3 NAPROXEN v01 3/10 Cautions CSM Warning (asthma): Any degree of worsening of asthma may be related to the ingestion of NSAIDS, either prescribed or (in the case of ibuprofen and others) purchased over the counter; CSM Advice (Aspirin 75mg): The combination of a NSAID and low dose aspirin may increase the risk of GI side-effects. This combination should only be used if absolutely necessary and the patient monitored closely; CSM advice (gastro-intestinal side-effects): All NSAIDS are associated with gastrointestinal toxicity; the risk is higher in the elderly. Evidence on the relative safety of 7 non-selective NSAIDS indicates differences in the risks of serious upper GI side-effects. Ibuprofen is associated with the lowest risk, naproxen with intermediate risk; Patients with hypertension should be treated with caution as naproxen may antagonise the effect of anti-hypertensive drugs by causing fluid retention and therefore increasing blood pressure; Naproxen may increase the plasma concentration of cardiac glycosides, e.g. digoxin; Aseptic meningitis has rarely been reported with NSAIDs. Patients with connective tissue disorders such as systemic lupus erythematosus may be especially susceptible; Naproxen may provoke renal failure in someone who is dehydrated especially if the person has diabetes; All patients greater than 65 years of age are at risk of an adverse event even in the absence of cardiovascular or renal risk factors; Excessive alcohol consumption, smoking and H. pylori infection are additional GI risk factors; Consider co-morbidity: Cardiovascular disease, renal disease (including dehydration), diabetes, hypertension and hepatic disease as they increase the risk of an adverse event; Naproxen may impair female fertility.

4 NAPROXEN v01 4/10 Side effects Action if excluded Action if patient declines Hypersensitivity reactions including skin rashes (common), angioedema and bronchospasm; Gastro-intestinal discomfort, nausea, diarrhoea and occasionally bleeding and ulceration. (NB Systemic as well as local effects contribute to GI damage); CNS toxicity including headache, dizziness, nervousness, depression, drowsiness, insomnia and vertigo; Hearing disturbances including tinnitus; Photosensitivity; Haematuria; Renal failure may be provoked especially in patients with renal impairment; Hepatic damage, alveolitis, eye changes, pancreatitis; Thirst, myalgia, pyrexia, muscle weakness; Female infertility. If patient meets exclusion criteria consider alternative pain management or /and refer to a medical practitioner if necessary; Record in patient clinical record the reason for exclusion and any action taken. If patient declines treatment or advice, ensure the patient clinical record details: The advice given by the clinician; Details of any referral made; The intended actions of the patient (including parent or guardian).

5 NAPROXEN v01 5/10 Description of Treatment Generic name Presentation Route Naproxen. 250mg tablets (EC). Oral. Method Administration Supply Dose Acute musculoskeletal disorders and dysmenorrhoea: 500mg (two tablets) initially followed by 250mg (one tablet) at six to eight hour intervals as needed. With a maximum daily dose after the first day of 1250mg (five tablets). Acute gout: 750mg at once then 250mg every eight hours until the attack has passed. Frequency Duration of treatment Quantity to supply See dose. Shortest duration necessary to control symptoms. 1 x 28 tablets; Ensure that each pack of medicine supplied is labelled with the patient s name, the date and the Trust s contact details.

6 NAPROXEN v01 6/10 Follow Up Referral arrangements and safety netting Advice to patients Records References Ensure that there is a communication to the patient s registered GP to inform him/her about the consultation, the outcomes of that consultation and any treatment given using local mechanisms. This information must also be available to other healthcare professionals who may be required to administer care to the patient following the consultation; If rash, bronchospasm or other signs of hypersensitivity occur, stop taking the medicine and contact your doctor for advice; Patients who experience dizziness or other CNS disturbances while taking naproxen should refrain from driving or operating machinery; Do not take other painkillers at the same time as taking this medicine without asking your doctor or pharmacist for advice; Seek further medical attention if symptoms persist or they deteriorate. Undesirable effects can be reduced by taking the lowest effect dose for the shortest duration necessary to control symptoms; Swallow tablets whole and take with or after food. Taking naproxen with food can reduce symptoms such as dyspepsia. Complete patient clinical record. British National Formulary 64, September 2012 (BNF); Clinical Knowledge Summaries nhs.uk.

7 NAPROXEN v01 7/10 Authorisation Chief Executive Officer Medical Director Pharmaceutical Advisor Name Ken Wenman Signature Date 01/02/2013 Name Dr Andy Smith Signature Date 01/02/2013 Name Sue Oakley Signature Date 01/02/2013 This must be signed by the Chief Executive Officer, Medical Director and Pharmaceutical Advisor to be legally valid.

8 NAPROXEN v01 8/10 Individual Authorisation (Staff Copy) Individual Name Signature Date / / Authorising officer Name Signature Date / / I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this document. PGDs do not remove inherent professional obligations or accountability. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct. This signed page must be retained by the member of staff, together with the full PGD, which must be available in clinical practice.

9 NAPROXEN v01 9/10 Individual Authorisation (Trust Copy) Individual Name Signature Date / / Authorising officer Name Signature Date / / I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this document. PGDs do not remove inherent professional obligations or accountability. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct. This signed page must be retained by the member of staff, together with the full PGD, which must be available in clinical practice.

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