
1 

(1) This Order may be cited as the Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2001 and shall come into force on 31st December 2001.
(2) In this Order, “the principal Order” means the Prescription Only Medicines (Human Use) Order 1997;
2 
In Schedule 1 to the principal Order (which specifies substances which if 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 Cetirizine Hydrochloride, the entry in column 5 is deleted;
(b) in relation to the substance Flurbiprofen—
(i) in column 2, there is inserted “8.75 mg”;
(ii) in column 3, there is inserted “Throat lozenges”;
(iii) in column 4, there is inserted “43.75 mg (MDD)”; and
(iv) in column 5, there is inserted “Container or package containing not more than 140 mg of Flurbiprofen”;
(c) in relation to the substance Loratadine, the entry in column 5 is deleted;
(d) in relation to the substance Terbinafine—
(i) in column 2, there is inserted “1.0 per cent”;
(ii) in column 3, there is inserted “External use for the treatment of tinea pedis, tinea cruris and tinea corporis. In the form of a gel”; and
(iii) in column 5, there is inserted “Container or package containing not more than 30 grams of medicinal product”;
(e) there is inserted in column 1, at the appropriate place in the alphabetical order of the entries as they appear in that column, the entries set out in column 1 in the Table below, and, against those entries, there is inserted in columns 2, 3, 4 and 5 the corresponding text in columns 2, 3, 4 and 5 below:

Column 1 Column 2 Column 3 Column 4 Column 5
Substance Maximum strength Route of administration, use, or pharmaceutical form Treatment limitations Maximum quantity
Diphenoxylate Hydrochloride 2.5 mg In combination with Atropine Sulphate for short term use as an adjunctive therapy to appropriate rehydration in acute diarrhoea 25 mg (MDD) Container or package containing not more than 20 tablets
  For use in persons aged 16 years and over  
  Tablets  
Dolasetron Mesilate    
Ropinirole Hydrochloride    
Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State,
Department of Health
9th December 2001Bairbre de Brún
Minister of Health, Social Services and Public Safety
6th December 2001