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Ingredient ATC Level 1 ATC Level 2 Year Of Switch Country Status Additional Information
Ibuprofen (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1983 UK OTC In 1996, maximum dose 125mg, maximum daily dose 500mg, maximum pack size 2.5g for rheumatic pain, muscular aches and pains, swellings such as sprains, strains, and sports injuries for use by adults and children over 12 years (general sale). In 2000: for external use, maximum strength 10%, maximum dose 125mg, maximum daily dose 500mg, maximum pack size 50g (Pharmacy sale). In 2012: ibuprofen 1% w/w with isopropyl myristate 10% w/w indicated for the topical relief of pain associated with mild to moderate sunburn in adults and children aged over 12 years (Pharmacy sale).
Ibuprofen (oral) M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1983 UK OTC Maximum dose 400mg. Prolonged release preparations: maximum dose 600mg. Maximum daily dose 1200mg. For use in rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, and symptoms of colds and influenza. In 1995, 200mg ibuprofen became GSL in pack size of 12 or under, in 1999 it was increased to pack size of 16 or under for all above indications except arthritic pain. Rheumatic and muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza. In 2002, liquid ibuprofen became available GSL with a maximum strength of 2% for internal use. In 2002, ibuprofen tablets for children under 12 years of age with a maximum dose of 200mg and a maximum daily dose of 800mg became available GSL. In 2002, ibuprofen lysine tablets became available GSL for adults and children over 12 with a maximum strength of 200mg, a maximum daily dose of 400mg and a maximum pack size of 1200mg.
Hydrocortisone (topical) D Dermatologicals. Dermatologicals D07. Corticosteroids, dermatological preparations 1987 UK OTC Pharmacy status: Maximum strength 1%. For use as a cream, ointment or spray either alone or in conjunction with crotamiton in irritant dermatitis, contact allergic dermatitis, insect bite reactions, mild to moderate eczema, and either in combination with clotrimazole or miconazole nitrate for athlete's foot and candidal intertrigo or in combination with lidocaine for anal and perianal itch associated with haemorrhoids. For use in adults and children 10 years or over. Maximum strength 0.5% for use in combination with nystatin of maximum strength 3% for intertrigo. Also see CSM Guidelines. Container or package containing not more than 15g of medicinal product (cream or ointment) or 30ml (spray). May be supplied on General sale: A spray containing hydrocortisone 0.2% and lidocaine hydrochloride 1.0% for the symptomatic relief of anal and perianal itch, irritation and pain associated with external haemorrhoids, maximum pack size 30ml. A cream for the treatment of insect bite and sting reactions, only, for use in adults and children aged 10 years and over, maximum strength 1%, maximum pack size 15g (switched in 2007 to GSL).
Dextromethorphan R Respiratory system. Respiratory system R05. Cough and cold preparations 1989 UK OTC (Hydrobromide) Pharmacy only supply. In case of a prolonged-release preparation, equivalent of maximum dose 30mg, maximum daily dose 75mg. In any other case, equivalent of: maximum dose 15mg, maximum daily dose 75mg.
Mebendazole P Antiparasitic products, insecticides and repellents. Antiparasitic products, insecticides and repellents P02. Anthelmintics 1989 UK OTC Pharmacy only supply. For oral use in the treatment of enterobiasis in adults and in children over 2 years. Maximum dose 100mg. Container or package containing not more than 800mg of medicinal product.
Nicotine (gum) N Nervous system. Nervous system N07. Other nervous system drugs 1991 UK OTC General sale. Maximum strength 6mg per gum. As from November 2009, a combination pack containing nicotine patches releasing 15mg over 16 hours of continuous application together with nicotine 2mg gum may be supplied on general sale as an aid to smoking cessation.
Hyoscine butylbromide A Alimentary tract and metabolism. Alimentary tract and metabolism A03. Drugs for functional gastrointestinal disorders 1991 UK OTC Pharmacy-only status: 1/ By inhaler - 2/ Otherwise than by inhaler: maximum dose 20mg, maximum daily dose 80mg, maximum pack size 240mg. For the symptomatic relief of irritable bowel syndrome. General Sale status (from 2004): Tablets for the relief of gastrointestinal tract spasm associated with medically confirmed irritable bowel syndrome (IBS) in adults and children aged 12 years and over. Maximum strength 10mg, maximum dose 20mg, maximum daily dose 80mg, maximum pack size 40 tablets.
Paracetamol + dihydrocodeine N Nervous system. Nervous system N02. Analgesics 1992 UK OTC Pharmacy only supply. Pack size limited to 32 tablets.
Carbenoxolone A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1992 UK OTC (Sodium). Pharmacy only if pellet maximum dose 5mg, maximum daily dose 25mg, gel maximum strength 2%, or granules for mouthwash in adults and children over 12 years, maximum dose 20mg, maximum daily dose 80mg and maximum strength 1% and container or package containing maximum 560mg carbenoxolone sodium. No product currently marketed.
Clotrimazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1992 UK OTC External use for treatment of vaginal candidiasis. Pharmacy only status. As from 2004, a combination pack of a 500mg pessary (for the treatment of vaginal candidiasis) and 2% (maximum 200mg of clotrimazole per pack) cream (for the treatment of candidal vulvitis and as an adjunct to treatment of candidal vaginitis) may be supplied on general sale.
Econazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1992 UK OTC Pharmacy only status when for external use only for the treatment of vaginal candidiasis.
Dihydrocodeine N Nervous system. Nervous system N02. Analgesics 1992 UK OTC In 2009 tighter controls where brought in by the UK Medicines Agency. Maximum pack size for OTC is 32 units. Pharmacy only supply. 7.46mg dihydrocodeine tartrate tables available. Indication restricted to short term treatment of acute moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone. Advertising to public possible through all media. Combination with paracetamol possible with these restrictions.
Hyoscine (Scopolamine) A Alimentary tract and metabolism. Alimentary tract and metabolism A04. Antiemetics and antinauseants 1992 UK OTC Hyoscine hydrobromide. Pharmacy only status when maximum dose 300 micrograms, maximum daily dose 900 micrograms. External (except ophthalmic) / internal (otherwise than by inhaler) routes. Hyoscine patches became available as a pharmacy-only product in 2004 for the prevention of travel sickness symptoms. For use in adults and children aged 10 years or over. Maximum strength: 1.5mg per patch, maximum pack size: 2 patches. Other preparations for internal use: maximum strength: 0.15%.
Miconazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1992 UK OTC External use only for the treatment of vaginal candidiasis. Pharmacy only status.
Cetirizine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1993 UK OTC Maximum daily dose 10mg. In 2002, the pack/container size limit of maximum 100mg was removed for pharmacy-only products. Maximum pack size for GSL supply: 30 tablets. As from 2004, the conditions for general sale supply were extended to include liquid preparations, for use in adults and children aged six years and over.
Loratadine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1993 UK OTC Maximum daily dose 10mg. In 2002, this formulation became available on General sale in a maximum pack size of 7 tablets.The maximum pack size available on general sale has increased from 7 to 30 tablets. Limit on pack/container size containing maximum 100mg was removed for sales under supervision of a pharmacist in 2002. Loratadine 1mg/ml syrup is available for general sale for the symptomatic relief of perennial or seasonal allergic rhinitis and idiopathic chronic urticaria in adults and children aged 2 years and over with a maximum saily doe of 10mg in adults and children weighing over 30kg and a maximum dose of 5mg in children weighing 30kg or less and with a maximum pack size of 70ml (70mg).
Aciclovir (topical) D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use 1993 UK OTC Maximum strength 5%. For treatment of herpes simplex virus infections of the lips and face (herpes labialis). Maximum pack/container size 2g. From 2004, 5% cream may be supplied on general sale for the treatment of cold sores.
Acrivastine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1993 UK OTC Maximum daily dose 24mg. Pack/container size containing maximum 240mg. 8mg capsules may be supplied GSL for the symptomatic relief of allergic rhinitis, including hayfever, and chronic idiopathic urticaria, in adults and children aged 12 to 65 years.
Cimetidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1994 UK OTC For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity and for the prophylaxis of meal-induced heartburn, maximum dose 200mg, maximum daily dose 800mg, maximum treatment period 14 days. For the prophylactic management of nocturnal heartburn, maximum dose 100mg, to be taken as a single dose at night, maximum treatment period 14 days. Pharmacy-only.
Ranitidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1994 UK OTC Pharmacy only for the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity or for the prevention of these symptoms when associated with consuming food and drink. Maximum dose 75mg, maximum daily dose 300mg, for a maximum period of 14 days. General sale restricted to maximum pack size of 12 tablets for the symptomatic relief of heartburn, dyspepsia, indigestion, and hyperacidity with a maximum strength of 75mg and maximum daily dose of 150mg.
Piroxicam (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1994 UK OTC Pharmacy only supply. Maximum strength 0.5%. For the relief of rheumatic pain, pain of non-serious arthritic conditions and muscular aches, pains and swellings such as strains, sprains, and sports injuries in adults and children over 12 years, for a maximum of 7 days. Maximum pack/container size not more than 30g.
Oxetacaine N Nervous system. Nervous system N01. Anesthetics 1994 UK OTC Maximum dose 10mg, maximum daily dose 30mg. Pack size containing maximum 400mg. No OTC product marketed yet.
Flunisolide (nasal) R Respiratory system. Respiratory system R01. Nasal preparations 1994 UK OTC Pharmacy only supply. Maximum strength 0.025%. For nasal administration in non-pressurised nasal spray for the prevention and treatment of seasonal allergic rhinitis including hay fever, in adults over 18 years. Maximum dose 50 micrograms per nostril. Maximum daily dose 100 micrograms per nostril. Maximum period of treatment 3 months. Pack/container size containing maximum 6000 micrograms.
Minoxidil (topical) D Dermatologicals. Dermatologicals D11. Other dermatological preparations 1994 UK OTC Pharmacy-only status: Maximum strength 5% for the treatment of alopecia androgenetica in men and women aged 18-65 years (5% foam for use in women switched from prescription-only to Pharmacy-only status in November 2015). Maximum pack size for men: 3 x 73ml. Maximum pack size for women: 2 x 73ml (equivament to 2 x 60g product providing 120 days' supply). Switched from Pharmacy only to General sale in 2002: Solution, gel or foam for the treatment of alopecia androgenetica in men aged between 18 and 65 years, maximum strength 5%, maximum pack size 3g of minoxidil.
Beclometasone (nasal) R Respiratory system. Respiratory system R01. Nasal preparations 1994 UK OTC As dipropionate, pharmacy only supply for nasal administration (other than by aerosol) for the prevention and treatment of allergic rhinitis in adults over 18 years. Maximum dose 100 micrograms per nostril, maximum daily dose 200 micrograms per nostril, maximum period of treatment 3 months. Pack/container size containing maximum 20000 micrograms. General sale when the following conditions are met: Nasal administration in non-aerosol form, for the treatment of seasonal allergic rhinitis in persons aged 18 years and over, for a maximum period of 1 month. Maximum dose 100 micrograms per nostril, maximum daily dose 200 micrograms per nostril, maximum pack size 5000 micrograms of beclometasone dipropionate.
Pseudoephedrine R Respiratory system. Respiratory system R01. Nasal preparations 1994 UK OTC Pharmacy only supply. In 1995, the maximum daily dose was increased from 180mg to 240mg. In 1997, increase in maximum dose in sustained release form to 120mg (from the previous 90mg). As from 1 April 2008, nasal decongestants containing more than 720mg pseudoephedrine and 180mg ephedrine per pack were switched back to prescription-only status.
Felbinac (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1994 UK OTC External use for the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injuries, such as sprains, strains and contusions for use in adults and children under 12 years. For a maximum of 7 days use. Maximum strength 3.17% or package containing not more than 30g of medicinal product. Pharmacy only status.
Tioconazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1994 UK OTC Pharmacy only for external use, maximum strength 2%. Pharmacy supply when for the treatment of vaginal candidiasis. However there is currently no marketed OTC product.
Famotidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1994 UK OTC Pharmacy only where for the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity, and prevention of these symptoms when associated with food and drink, including nocturnal symptoms. Maximum dose 10mg and maximum daily dose 20mg. For a maximum period of 14 days. General sale since 2000 for the short-term symptomatic relief of heartburn, indigestion, acid indigestion and hyperacidity, maximum dose 10mg, maximum daily dose 20mg and maximum 12 tablets per pack.
Cromoglicic acid R Respiratory system. Respiratory system R01. Nasal preparations 1994 UK OTC Pharmacy only supply for nasal use and as eye drops for treatment of acute seasonal or perennial allergic conjunctivitis in maximum strength 2%. Maximum pack size 10ml. (Eye ointment no longer on UK market). General sale as aqueous eye drops for the relief and treatment of eye symptoms of hay fever in adults and children over 6 years. Maximum strength 2%, maximum pack size 10ml of the product.
Fluconazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1995 UK OTC No topical products available. Pharmacy only when for oral administration for the treatment of vaginal candidiasis or associated candidal balanitis in adults (16-60 years). Maximum dose 150mg, maximum pack size 150mg.
Budesonide (nasal) R Respiratory system. Respiratory system R01. Nasal preparations 1995 UK OTC Pharmacy only supply. For nasal administration in aqueous form (other than by aerosol) for the prevention and treatment of seasonal allergic rhinitis in adults over 18 years. Maximum dose 200 micrograms per nostril, maximum daily dose 200 micrograms per nostril, maximum period of treatment 3 months. Pack/container size containing maximum 10mg.
Hydroxyzine N Nervous system. Nervous system N05. Psycholeptics 1995 UK OTC Pharmacy only supply for dermatological indication. Maximum dose 25mg per tablet, maximum daily dose 75mg for adults and 50mg in children aged 6-12 years. Maximum pack size 750mg. For the management of pruritis associated with acute or chronic urticaria or atopic dermatitis or contact dermatitis, in adults and in children.
Ketoconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1995 UK OTC Pharmacy only supply as shampoo for the prevention and treatment of dandruff and seborrhoeic dermatitis of the scalp. Maximum frequency of application: once every 3 days, maximum strength: 2% w/v, maximum pack size: 120ml of product, containing not more than 2400mg of ketoconazole. Pharmacy only supply also for the treatment of tinea pedis, tinea cruris and candidal intertrigo. Maximum strength: 2% w/w. General Sale (GSL) (in 2002) supply where a shampoo, for the prevention and treatment of dandruff and where maximum strength 2% w/v, maximum pack size 100ml of product. GSL also as a cream, for the treatment of tinea pedis and tinea cruris, with maximum strength 2% w/w and maximum pack size 30g.
Azelastine R Respiratory system. Respiratory system R01. Nasal preparations 1996 UK OTC Azelastine hydrochloride. Pharmacy only supply. For nasal administration in aqueous form (other than by aerosol) for the treatment of seasonal or perennial allergic rhinitis in adults and children aged 5 and over. Maximum dose 140 micrograms per nostril, maximum daily dose 280 micrograms per nostril. Pack/container size containing maximum 5040 micrograms. In 2002, eye drops containing 0.05% azelastine became available for the treatment of seasonal and perennial allergic conjunctivitis in adults and children over 12 years of age.
Nizatidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1996 UK OTC Pharmacy only for the prevention and treatment of the symptoms of food-related heartburn, and meal-induced indigestion. For use in adults and children over 16. Maximum dose 75mg, maximum daily dose 150mg. For a maximum period of 14 days.
Loperamide A Alimentary tract and metabolism. Alimentary tract and metabolism A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents 1997 UK OTC General sale for the symptomatic treatment of acute diarrhoea in adults and children over 12 years. For the symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome in adults aged 18 years and over following initial diagnosis by a doctor. Maximum strength 2mg, maximum dose 4mg, maximum daily dose 12mg, maximum pack size 6 caps or tabs. Pharmacy only for treatment of acute diarrhoea.
Picosulfate (sodium) A Alimentary tract and metabolism. Alimentary tract and metabolism A06. Laxatives 1997 UK OTC General sale if for adults and children over 10 years. Maximum strength 0.1%, maximum dose 15mg, maximum daily dose 15mg, maximum pack size 60ml. In 2004, the conditions for GSL supply were extended to include liquid-filled capsules with a maximum strength of 2.5mg and maximum pack size of 24 capsules.
Mebeverine A Alimentary tract and metabolism. Alimentary tract and metabolism A03. Drugs for functional gastrointestinal disorders 1997 UK OTC Pharmacy only status. For the symptomatic treatment of irritable bowel syndrome, maximum dose 135mg, maximum daily dose 405mg. For other uses: maximum dose 100mg, maximum daily dose 300mg.
Benzoyl peroxide D Dermatologicals. Dermatologicals D10. Anti-acne preparations 1997 UK OTC General Sale if maximum strength 2.5% for the treatment of spots or pimples on the face. Pharmacy only for external use with maximum strength 10%.
Miconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1997 UK OTC Miconazole nitrate. Maximum strength 2% for cream or powder (in case of spray powders 2% w/w excluding any propellants). General Sale for external use for the treatment of tinea pedis only. Pharmacy only status for fungal and associated bacterial infections of skin including nappy rash.
Paracetamol N Nervous system. Nervous system N02. Analgesics 1998 UK OTC General sales for tablets: children under 6 years, maximum strength 120mg. Children over 6 years, maximum strength 250mg. Adults, maximum strength 500mg. Maximum pack size 16 non-effervescent tablets and up to 30 effervescent tabs. Pharmacy only for larger pack sizes. Powders and granules may be supplied in general sales up to 240mg, maximum pack size of 10. 2001 - Liquid preparartions; children under 12 years, 2.4%, maximum dose 480mg, maximum daily dose 1920mg, maximum pack size 100ml. Children aged 6 years and above 5%, maximum pack size 80ml. Children above 12 years and adults, 5%, maximum pack size 160ml.
Levocabastine R Respiratory system. Respiratory system R01. Nasal preparations 1998 UK OTC Maximum strength: 0.05% for pharmacy only supply. For adults and children over 12 years. Maximum treatment period 4 weeks. Nasal spray: For the symptomatic treatment of seasonal allergic rhinitis, maximum pack size 10ml. Aqueous eye drops: For the symptomatic treatment of seasonal allergic conjunctivitis, maximum pack size 4ml.
Nystatin D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1999 UK OTC Pharmacy only when for external use in combination with Hydrocortisone of maximum strength 0.5 per cent for intertrigo. For use in adults and children not less than 10 years. Maximum strength 3%, maximum pack size 15g.
Nicotine (nasal spray) N Nervous system. Nervous system N07. Other nervous system drugs 2000 UK OTC General sale.
Terbinafine D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 2000 UK OTC In 2001, the 1% spray formulation was allowed for sale without a prescription for the treatment of tinea pedis, tinea cruris, and tinea corporis. Maximum strength 1%, maximum pack size 30ml. In 2001, the 1% gel formulation was allowed for the same indications in a maximum pack size of 30g. As from 2004, a cream preparation may be supplied as a General Sale medicine for the treatment of tinea pedis and tinea cruris (max pack size 15g). As from November 2009, a 1% cutaneous solution, to be administered as a single application (max pack size 4g), may be supplied on general sale for the treatment of tinea pedis in persons aged 18 years and older.
Prochlorperazine N Nervous system. Nervous system N05. Psycholeptics 2001 UK OTC Pharmacy only supply. For the treatment of nausea and vomiting in cases of previously diagnosed migraine only, in those aged 18 years and over. Maximum strength 3mg, maximum dose 12mg, maximum pack size 8 tablets.
Fenticonazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 2001 UK OTC Pharmacy only status when for external use only for the treatment of vaginal candidiasis.
Flurbiprofen (lozenges) R Respiratory system. Respiratory system R02. Throat preparations 2001 UK OTC Throat lozenges or granules for the short-term symptomatic relief of sore throat (Pharmacy-only status). Maximum strength 8.75mg, maximum daily dose 43.75mg, maximum pack size 140mg.
Levonorgestrel G Genito urinary system and sex hormones. Genito urinary system and sex hormones G03. Sex hormones and modulators of the genital system 2001 UK OTC Pharmacy only supply since 2001 as an emergency hormonal contraceptive for women aged 16 years and over. Otherwise it can be prescribed for any age group. Maximum strength 1.5mg.
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