
1 

(1) This Order may be cited as the Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 and shall come into force on 16th September 1998.
(2) In this Order “the principal Order” means the Prescription Only Medicines (Human Use) Order 1997.
2 
In paragraph 4(b)(i) of article 8 of the principal Order (exemptions for emergency sale or supply), before the words “an aerosol” there are inserted the words “a preparation of insulin,”.
3 
In Schedule 1 to the principal Order (which specifies substances which when included in medicinal products make those products prescription only medicines and exemptions from restrictions on the sale and supply of prescription only medicines)–
(a) in relation to the substance Aspirin, there is substituted for the entry “(1) 325 mg” in column 2, “(1) 500 mg”;
(b) in relation to the substance Astemizole, the entries in columns 3, 4 and 5 are deleted;
(c) in relation to each of the substances Beclomethasone Dipropionate and Budesonide–
(i) there are substituted for the entry “For use in adults and children not less than 12 years” in column 3, the entry “For use in persons aged 18 years and over”, and
(ii) there is inserted in column 4, after the entry “200 mcg per nostril (MDD)”, the entry “For a maximum period of 3 months”;
(d) in relation to the substance Domperidone Maleate, there is substituted for the entry “10 mg (MD) 40 mg (MDD)” in column 4, the following entry“10 mg of Domperidone as Domperidone Maleate (MD)40 mg of Domperidone as Domperidone Maleate (MDD)”;
(e) in relation to the substance Felbinac, there is substituted for the entry “For the relief of symptoms associated with soft tissue injury such as strains, sprains and contusions” in column 3, the entry–“For the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries such as sprains, strains and contusions”;
(f) in relation to the substance Flunisolide–
(i) there are substituted for the entry “For use in adults and children not less than 16 years” in column 3, the entry “For use in persons aged 18 years and over”,
(ii) there is inserted in column 4, after the entry “100 mcg per nostril (MDD)”, the entry “For a maximum period of 3 months”, and
(iii) the entries under the letter “(b)” in columns 3, 4 and 5 are deleted;
(g) in relation to the substance Ketoconazole–
(i) there is inserted in column 3, before the entry “For the prevention and treatment of dandruff and seborrhoeic dermatitis of the scalp”, the entry “External”,
(ii) there are inserted in the entries in columns 3, 4 and 5, at the beginning of each of the first entries, the letter “(a)”, and
(iii) there is inserted in column 3, after the entry “In the form of a shampoo”, the entry “(b) For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo”;
(h) in relation to the substance Nedocromil Sodium there are inserted the following entries–
 in column 2“2.0 per cent”,
 in column 3“For the prevention, relief and treatment of seasonal and perennial allergic conjunctivitis”, and
 in column 5“Container or package containing not more than 3 ml of medicinal product”; and
(i) there are inserted in column 1, and, as the case may be, columns 2, 3, 4 and 5, at the appropriate point in the alphabetical order of the entries as they appear in column 1, each of the entries set out in column 1 of the Schedule to this Order, together with the corresponding text in columns 2, 3, 4 and 5 respectively of that Schedule.
4 
In Schedule 5 to the principal Order (exemptions for certain persons from the provisions of section 58(2) of the Medicines Act 1968)–
(a) in Part I there is inserted in the list in column 2 of paragraph 4, after the substance Pentazocine Hydrochloride, “Phytomenadione”, and
(b) in Part III there is inserted in the list in column 2 of paragraph 1, after the substance Lignocaine hydrochloride with adrenaline, “Mepivacaine hydrochloride”.
Signed by authority of the Secretary of State for Health
Paul Boateng
Parliamentary Under Secretary of State,
Department of Health
21st August 1998Jon Owen Jones
Parliamentary Under Secretary of State, The Welsh Office
27th August 1998Sam Galbraith
Minister for Health, The Scottish Office
25th August 1998Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on
D.C. Gowdy
Permanent Secretary
24th August 1998.
THE SCHEDULE
Article 3(i)


Column 1 Column 2 Column 3 Column 4 Column 5
Substance Maximum strength Route of administration, use or pharmaceutical form Treatment limitations Maximum quantity
Aloxiprin 
(1) 620 mg 
(1) Non-effervescent tablets and capsules  
(1) The quantity sold or supplied in one container or package shall not exceed 32
 The quantity of non-effervescent tablets, capsules or a combination of both sold or supplied to a person at any one time shall not exceed 100
  
(2) All preparations other than non-effervescent tablets or capsules
Diphenhydramine Hydrochloride  All preparations except liquid-filled capsules
Hydrocyanic Acid
Ibuprofen Lysine  Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza
  Internal 
(a) In the case of a prolonged release preparation 600 mg (MD) 1,200 mg (MDD)
(b) in any other case 400 mg (MD) 1,200 mg (MDD)
Levocabastine Hydrochloride Equivalent of 0.05 per cent Levocabastine 
(1) Nasal spraysFor the symptomatic treatment of seasonal allergic rhinitis  
(1) Container or package containing not more than 10 ml of medicinal product
  
(2) Aqueous eye dropsFor the symptomatic treatment of seasonal allergic conjunctivitis  
(2) Container or package containing not more than 4 ml of medicinal product
Nilutamide
Phytomenadione  Any use except the prevention or treatment of haemorrhagic disorders
Strychnine Nitrate
Sulfabenzamide