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Promoting Responsible Consumer Health
POM – P Switches
This document was prepared by the Regulatory Department,
Proprietary Association of Great Britain. Whilst every effort has been
made to ensure this publication is as accurate as possible, no
responsibility can be accepted for inaccuracies, errors or omissions.
All rights are reserved. No part of this publication may be
reproduced,
stored in a retrieval system or transmitted in any form or by any
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without the prior written permission of PAGB.
Vernon House, Sicilian Avenue, London WC1A 2QS T: 020 7242 8331 F: 020 7405 7719 Proprietary Association of Great Britain is a Company Limited by Guarantee and Registered in England. ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Ibuprofen (oral)
Rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza. Max. single dose: 400 mg Max. daily dose: 1200 mg Loperamide hydrochloride
Hydrocortisone (topical)
insect bite reactions in adults and children not less Dextranomer (
Podophyllum resin (20%)
External use for plantar warts either as an ointment Astemizole
Treatment of hayfever in adults and children over 12 years. Max. daily dose: 10 mg Max. pack: 100 mg (PoM exemption removed in1998 12 Ibuprofen (topical)
Dextromethorphan m/r
Prolonged-release preparation for cough suppression Ibuprofen m/r (oral)
Treatment of prolonged-release preparation for Max. single dose in controlled release form: 600 mg Max. daily dose = 1200 mg Mebendazole
Enterobiasis in adults and children over 2 years. ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Nicotine (2mg) gum
Clotrimazole / Econazole /
Econazole nitrate /
Isoconazole
nitrate / Miconazole /
Miconazole
Carbenoxolone sodium
Treatment of adults and children not less than 12 mouthwash (granules)
Dihydrocodeine
Relief of toothache and other dental pain. For treatment of mild to moderate pain and as an antipyretic Max strength: 1.5% Max dose: 10 mg Hydrocortisone in
Relief of inflammation and pruritus associated with combination with crotamiton
irritant and allergic contact dermatitis, insect bite reactions and mild to moderate eczema Nicotine replacement
transdermal patches
Aciclovir (topical)
For treatment of herpes simplex virus infections of the lips and face (Herpes labialis). ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Acrivastine
Allergic rhinitis including hayfever, and allergic skin conditions Max daily dose = 24 mg Max pack = 240 mg hayfever Cetirizine hydrochloride
Allergic rhinitis including hayfever and allergic skin Max daily dose = 10 mg Max pack not more than 100 mg Ketoprofen (topical)
Muscular and rheumatic pain in adults and children aged 12 years and over for a maximum period of 7 Loratadine
Symptomatic relief of seasonal and perennial rhinitis; Terfenadine
Aluminium chloride
hexahydrate
<325 mg = 30 tablets <500 mg = 20 tablets Beclometasone dipropionate
Treatment of seasonal allergic rhinitis in adults and (non-aerosol nasal spray)
ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Cimetidine
Short-term symptomatic relief of heartburn, Max dose: 200 mg Max daily dose: 800 mg Max treatment period 2 weeks Diclofenac
Symptomatic relief of pain and inflammation in diethylammonium(topical)
trauma of tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism in adults and children aged 12 years and over for not more than 7 days Max strength: 1.16% Max pack: 30 Maximum treatment period: 14 days Famotidine
Short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity Max dose: 10 mg Max daily dose: 20 mg Max treatment 2 week Felbinac (topical)
Relief of symptoms associated with soft tissue injury such as strains, sprains and contusions, in adults and children aged 12 years and over for not more than 7 days Max strength: 3.17% Max pack: 30 g 12 ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Flunisolide (non-
Prevention and treatment of seasonal allergic rhinitis pressurized nasal spray)
including hayfever in adults and children aged 12 and over (age restriction increased to 18 years and over Max strength: 0.025% Max dose: adult 50 mcg per nostril; child (12- 16 years) 25 mcg per nostril Max daily dose: adult 100 mcg per nostril; child (12- 16 years) 75 mcg per nostril Max pack size: 240 metered doses = 6000 mcg 12( Hydrocortisone sodium
Aphthous ulceration of the mouth for adults and succinate (equivalent to
hydrocortisone 2.5 mg)
Max pack: 50 mg equivalent to hydrocortisone Hydrocortisone (topical)
Addition to existing indication: Mild to moderate Hydrocortisone (rectal)
Symptomatic relief of uncomplicated internal and external haemorrhoids and associated itching and irritation Mebendazole
Max pack size increased to 4x100 mg single doses. Amended in 1996 to allow pack of 8 tablets. Minoxidil 2% (topical)
Treatment of alopecia androgenetica in males and Nicotine (4 mg) gum
Oxetacaine (oxethazaine)
Local anaesthetic (available only as a combination Max dose: 10 mg Max daily dose: 30 mg Max pack: 400 mg ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Piroxicam (topical)
Relief of rheumatic pain and muscular aches, pains and swellings such as strains, sprains and sports injury for not more than 7 days in adults and children aged 12 years and over. Max strength: 0.5% Max pack: 30 g 7 Pseudoephedrine
hydrochloride
Ranitidine hydrochloride
Short-term symptomatic relief of heartburn, Max dose: equivalent of 75 mg ranitidine Max daily dose: equivalent of 300 mg ranitidine Max treatment period: 14 days Sodium cromoglicate
Max pack: 10 mL Max strength: 2% Ointment: Max pack: 5 g Max strength: 4% Tioconazole (2%) (topical)
Triamcinolone acetonide
Treatment of common mouth ulcers for max. 5 days Beclometasone dipropionate Addition to existing indication: Prevention of seasonal
(non-aerosol nasal spray)
ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Budesonide (aqueous
Prevention and treatment of seasonal allergic rhinitis nonaerosol nasal spray)
in adults and children not less than 12 years. Max pack size containing not more than 10 mg of budesonide (Age restriction increased to 18 years and over, max. period of 3 months, in 1998) Cadexomer-iodine
Fluconazole (oral)
Treatment of vaginal candidiasis in persons aged not less than 16 or more than 60 years of age. Hydroxyzine hydrochloride
Management of pruritus associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in adults and in children. Max daily dose in adults and children aged 12 years and over: 75 mg Max daily dose: 50 mg (children 6-12 years) Max dose in adults and children: 25 mg; Max pack: 750 mg Ketoconazole (topical)
Prevention and treatment of dandruff and Max frequency of application: once every 3 days Max strength: 2% w/w Max pack size: 120 mL containing not more than 2400 mg ketoconazole ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Pyrantel embonate
Treatment of enterobiasis in adults and children aged Max single dose, in adults and children aged 12 years and over: 750 mg Max single dose children 6-12 years: 500 mg Max single dose in children 2-5 years: 250 mg; Max pack: 750 mg Pseudoephedrine
hydrochloride
Treatment of seasonal allergic rhinitis in adults and lidocaine Relief of anal and perennial itch associated with haemorrhoids in adults and children not less than 10 Prevention of symptoms of food-related heartburn in persons aged not less than 16 years Max single dose: 75 mg Max dosage: 4 doses in 14 day Treatment of herpes simplex virus infections of the ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
dipropionate Addition to existing indication: Prevention and treatment of allergic rhinitis Max pack size: 5600 mcg (14 days use) Indigestion, acid indigestion, prophylaxis of mealinduced and nocturnal heartburn For nocturnal heartburn: Max dose: 100 mg to be taken as a single dose at night Max treatment period: 14 days Addition to existing indication: Prevention of heartburn, dyspepsia, indigestion, acid indigestion or hyperacidity symptoms when associated with consumption of food or drink including nocturnal symptoms. Max dose: 10 mg Max daily dose: 20 mg Max treatment period: 14 days. Addition to existing indication: Irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and in combination with clotrimazole for athlete’s foot and candidal intertrigo - by adults and children not less than 10 years. Addition to existing indication: Pain of non-serious (topical) Vaginal candidiasis (external use) ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
hydrochloride Symptomatic relief of irritable bowel syndrome. Addition to existing indication: Pain of non-serious Max dose increased to 120 mg in modified-release (topical) Antifungal for external use except for vaginal use hydrochloride Addition to existing indication: Symptomatic relief of acute diarrhoea associated with irritable Bowel Syndrome in adults following initial diagnosis by a doctor. Hayfever (POM exemption removed Sept 1998) Max pack size increased from 16 to 32 tablets/capsules. 1998 Beclometasonedipropionate Age restriction increased to 18 years and over, for a Budesonide (aqueous
Age restriction increased to 18 years and over, for a non-aerosol nasal spray)
Domperidone maleate
Relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating, belching, occasionally accompanied by epigastric discomfort and heartburn Max single dose: 10mg domperidone (as maleate) Max daily dose: 40 mg domperidone (as maleate) Max pack size: 100 mg domperidone (as maleate) ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Felbinac (topical)
Changed OTC indication: Relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries such as sprains, strains and contusions Flunisolide (nasal spray)
Age restriction increased to 18 years and over. Hydrocortisone / Miconazole
Athlete’s foot and candidal intertrigo nitrate combination (topical)
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 Max dose: 400 mg (600mg for prolonged release preps) Max daily dose: 1200mg Ketoconazole (topical)
Treatment of the following mycotic infections of the skin : tinea pedis, tinea cruris and candidal intertrigo Levocabastine
hydrochloride
Nasal spray: Symptomatic treatment of seasonal Max pack = 10 mL Aqueous eye drops: Symptomatic treatment of seasonal allergic conjunctivitis. Max pack = 4 mL Mebeverine
For uses other than the symptomatic relief of irritable hydrochloride
Max single dose: 100 mg Max daily dose: 300 mg Minoxidil 5% (topical)
Treatment of alopecia androgenetica, in men aged ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Nedocromil sodium
Prevention, relief and treatment of seasonal and perennial allergic conjunctivitis in adults and children over 6 years. Max strength: 2% Max pack = 3 mL 6 Nizatidine
Addition to existing indication: Treatment of symptoms of food-related heartburn and mealinduced indigestion in persons aged not less than 16 years. Max dose: 75 mg Max daily dose: 150 mg Max period of treatment: 14 days Paracetamol
Max strength: 120 mg for children less than 12 years Max strength: 500 mg for adults and children not less than 12 years Max pack size increased from 16 to 32 tablets/capsules Pharmacists can sell multiple packs up to a total quantity of 100 capsules or tablets in justifiable circumstances Ranitidine hydrochloride
Addition to existing indication: Prevention of heartburn, dyspepsia, indigestion, acid indigestion or hyperacidity symptoms when associated with consumption of food or drink Sodium cromoglicate
Addition to existing indication: Perennial allergic (cromoglycate)
Aspirin 75 mg
ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Beclometasone dipropionate
Max pack size of nasal spray amended to 20000 mcg (non-aerosol nasal spray)
Nystatin 3% /
For external use for intertrigo in adults and children Hydrocortisone 0.5%
combination (topical)
Max strength: Hydrocortisone 0.5%/Nystatin 3% Azelastine hydrochloride
Addition to existing indication: Treatment of perennial (non-aerosol nasal spray)
Age restriction lowered from 12 years to 5 years Domperidone
Domperidone maleate
Felbinac (topical)
Ibuprofen 10% (topical)
Max daily dose: 500 mg Max pack size: 50 g Levocarnitine
Lodoxamide trometamol eye
Treatment of ocular signs and symptoms of allergic drops 0.1%
conjunctivitis, in adults and in children aged 4 years Nicotine (nasal spray)
Paracetamol
Max strength replaces 120mg with 250mg The words “wholly or mainly” added to column in SI relating to ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Terbinafine hydrochloride
Terbinafine
cream (topical)
Triamcinolone acetonide
Treatment of symptoms of seasonal allergic rhinitis in (nonpressurised nasal
adults and children aged 18 years and over, for a maximum period of 3 months. Max daily dose: 110mcg per nostril/day Max pack restricted to contain triamcinolone Levonorgestrel
Emergency contraceptive in women aged 16 years Clobetasone butyrate cream
Short-term symptomatic treatment and control of patches of eczema and dermatitis (excluding (topical)
seborrhoeic dermatitis) in adults and in children aged Fenticonazole nitrate
For external use, but in the case of vaginal use, only for the treatment of vaginal candidiasis Prochlorperazine maleate
Treatment of nausea and vomiting in cases of buccal tablets
previously diagnosed migraine only in those aged 18 years and over. Max daily dose: 12 mg Max pack size: 8 tablets Fluconazole (oral)
Addition to existing indication: candidal balanitis ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Terbinafine 1% gel
Treatment of tinea pedis, tinea cruris and tinea Terbinafine hydrochloride
Treatment of tinea corporis, tinea cruris, and tinea 1% spray (topical)
Hydrocortisone acetate with
Athlete’s foot and candidal intertrigo in adults and Miconazole nitrate (topical)
Stannous fluoride dental gel
Prevention and treatment of dental caries and decalcification of the teeth. Max strength: 0.4% Flurbiprofen throat lozenges
Symptomatic relief of sore throat in adults and Max strength: 8.75 mg Max daily dose: 43.75 mg (Max 5 lozenges in 24 hours) Max pack size: 140 mg 12 Diphenoxylate with atropine
Short-term use as an adjunctive therapy to sulphate
appropriate rehydration in acute diarrhoea in those aged 16 years and over. Max pack size: 20 tablets Max strength: 2.5 mg Nicotine lozenge
Adenosine
For vitamin and mineral deficiency. Oral administration at a maximum daily dose of 750 micrograms in those over 14 years of age. ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Azelastine hydrochloride eye
Treatment of seasonal or perennial allergic conjunctivitis in adults and children aged 12 years and above. Max strength: 0.05%w/w Max pack size: 3 mg Fluticasone propionate
Prophylaxis and treatment of allergic rhinitis in those 0.05%nasal spray
aged 18 years and over for a maximum period of 3 (non-pressurised)
Griseofulvin 1% non
Treatment of tinea pedis (athlete’s foot) pressurized spray (topical)
Max daily dose: 1.2 mg Max treatment period: 4 weeks Max pack size: 20 mL Aspirin/Aloxiprin
Age restriction – Not to be given to children under 16 years of age, unless on the advice of a doctor. Diclofenac sodium (topical)
Local symptomatic relief of mild to moderate pain and inflammation following acute blunt trauma of small and medium sized joints and peri-articular structures, such as trauma of tendons, ligaments, muscles and joints eg: due to sprains and strains. Max length of treatment without medical advice: 7 days Max dose: 40 mg Max daily dose: 120 mg Max strength: 4% Max pack size: 25 g ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Diclofenac
Addition to existing indication: for the relief of the pain diethylammonium
of non-serious arthritic conditions. Maximum pack size has been increased to 50 g Omeprazole tablets
Relief of reflux-like symptoms such as heartburn in adults aged 18 years and over for a maximum period of 4 weeks. Max strength: 10 mg Max dose: 20 mg Max daily dose: 20 mg Max pack size: 28 tablets Hyoscine transdermal
Prevention of travel sickness symptoms e.g. nausea, vomiting, vertigo. For use in adults and children aged Max strength: 1.5 mg per patch Max pack size: 2 patches Simvastatin 10 mg tablets
To reduce the risk of a first major coronary event (non fatal myocardial infarction and Coronary Heart Disease (CHD) deaths) in people who are likely to be at moderate risk (approximately 10-15% 10 year risk of a first major event) of CHD. Treatment should be taken as part of a programme of actions to reduce the risk of CHD. Max strength: 10 mg Max daily dose: 10 mg Max pack: 28 tablets Chloramphenicol eye drops
Treatment of acute bacterial conjunctivitis in adults ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Alclometasone dipropionate
Short term treatment and control of patches of 0.05% (Pending) 05/392 ARM
eczema and dermatitis including atopic eczema and 29 (Diprolieve® cream)
primary irritant and allergic dermatitis in adults and children 12 years and above. Trimethoprim 200mg
Treatment of uncomplicated acute bacterial cystitis in (Pending) 05/427 ARM 30
women aged 16-70 years, who have had a previous (Cysticlear®Tablets)
diagnosis of the same confirmed by a doctor. Zolmitriptan 2.5mg (Pending)
For the acute treatment of migraine with or without 05/482 ARM 32 (Zomig®
orodisp)
Zolmitriptan2.5mg(
Penciclovir 10mg/g
Indicated for the treatment on cold sores (herpes For adults (incl elderly) and children over 12 years old. Pack Size: 2g tube Amorolfine hydrochloride
Treatment of mild cases of distal and lateral subungal onychomycoses caused by dermatophytes, yeasts Sumatriptan 50 mg
For the acute relief of migraine attacks, in those aged 18-65 years of age with or without aura in patients who have stable well established pattern of symptoms, for a max period of 1 day. Max daily dose: 100mg Pack size: 2 tab pack. ACTIVE INGREDIENT
OTC INDICATION OR RESTRICTION FOR OTCUSE
Chloramphenicol 1%
Treatment of acute bacterial conjunctivitis in adults Max length of treatment: 5 days Max pack size: 4 g Levonorgestrel
Emergency contraceptive in women aged 16 years and over. Max strength: 1.5 mg (dose increased from 0.75mg… Naproxen
Primary dysmenorrhoea (period pain) in women aged 250mg tablets. The maximum pack size is equivalent to 3 days treatment i.e. 9 tablets (Brand: Feminax Ultra) Azithromycin
Treatment of known or suspected asymptomatic Chlamydia Trachomatis genital infection in individuals aged 16 years and over. Two 500mg tablets, taken as a single 1g dose. Pack size 2 tablets.
Chlamydia Trachomatis Diclofenac potassium
For the short term relief of headache, dental pain, period pain, rheumatic and muscular pain, backache and the symptoms of cold and flu, including fever. Tablets contain 12.5mg of Diclofenac potassium (Brand: Voltarol Pain-eze tablets) Nitrofurantoin 10mg in the
ARM 51 - For the treatment of uncomplicated acute form of nitrofurantoin
bacterial cystitis in women aged between 16 and 70 macrocrystals nitrofurantoin
years of age who have had the condition on a monohydrate (Pending)
previous occasion when a physician confirmed the diagnosis.

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