In Australia, Canada, New Zealand, Romania, Sweden, the United Kingdom, the United States, and plenty of different international locations, codeine is regulated below numerous narcotic management laws. In some international locations it's accessible with out prescription together preparations from licensed pharmacists in doses as much as 15 mg/pill in Australia, New Zealand, Poland, Romania (Codamin), and Costa Rica, 12.eight mg/pill within the UK, 10 mg/pill in Russia and Israel and eight mg/pill in Canada and Estonia.
Australia
In Australia, codeine preparations have to be offered solely at a pharmacy. The merchandise is given over-the-counter, no prescriptions, on the discretion of the Pharmacist. It's thought-about an S3 (schedule three) medication. It should be labelled and utilization historical past monitored by the Pharmacist to assist deter misuse and dependance. The exception to this rule is chilly and flu preperations equivalent to "Codral". These preparations include phenylephrine (5mg), paracetamol(500mg) and codeine(9.5mg). The strongest obtainable over-the-counter preparation containing codeine has 15 mg (with paracetamol, model title Panadeine Additional); something stronger requires a prescription.
Denmark
In Denmark codeine is bought over-the-counter with max 9.6 mg in mixture. The merchandise is given over-the-counter, no prescriptions. The strongest obtainable over-the-counter preparation containing codeine has 9.6 mg (with aspirin, model title Kodimagnyl); something stronger requires a prescription.
France
In France, most preparations containing codeine don't require a physician's prescription. Instance merchandise containing codeine embody Néocodeion (cough capsules), Codoliprane (codeine with paracetamol), Prontalgine and Migralgine (codeine, paracetamol and caffeine).
Germany, Switzerland and Austria
Codeine is listed underneath the Betäubungsmittelgesetz in Germany and the equally named narcotics and managed substances legislation in Switzerland. In Austria, the drug is listed beneath the Suchtmittelgesetz in classes equivalent to their classification underneath the Single Conference on Narcotic Drugs. Shelling out of merchandise containing codeine and comparable medicine (dihydrocodeine, nicocodeine, benzylmorphine, ethylmorphine etc.), normally, require a prescription order from a physician or the discretion of the pharmacist. Municipal and provincial rules could influence availability, specifically in Austria and Switzerland, which permits cities and provinces to control the promoting of the least-regulated schedule of the SMG/BtMG; and, in fact, particular person chemists' retailers can decide out of offering them or imposing quantity, frequency, or single-buy limitations and different issues of the identical store. Plain codeine hydrochloride tablets (which within the USA would share CSA Schedule II with medication like morphine, cocaine, hydromorphone, and bezitramide) in addition to different non-injectable types of codeine and its midrange derivatives will be allotted on this approach; the identical goes for many chemical lessons of benzodiazepines, nearly all of non-barbiturate sedative/hypnotics, and at the very least a handful of barbiturates.
Title seventy six of the Schengen treaty has made it attainable for international locations inside the signatory states to import and export medication with varied provisos, recording and ordering necessities, and numerous different rules.
Greece
Codeine is classed as an unlawful drug in Greece, and people possessing it may conceivably be arrested, even when they have been legitimately prescribed it out of the country, it's offered solely with a docs prescription (Lonarid).
Hong Kong
In Hong Kong, codeine is regulated below Schedule 1 of Hong Kong's Chapter 134 Harmful Medication Ordinance. It may be used legally solely by well being professionals and for college analysis purposes. The substance will be given by pharmacists underneath a prescription. Anybody who provides the substance with out prescription may be fined $10,000 (HKD). The utmost penalty for trafficking or manufacturing the substance is a $5,000,000 (HKD) wonderful and life imprisonment. Possession of the substance for consumption with out license from the Division of Well being is prohibited with a $1,000,000 (HKD) superb and/or 7 years of jail time.
Nonetheless, codeine is out there with out prescription from licensed pharmacists in doses as much as 0.1% (5 mg/5ml) in response to Hong Kong "Harmful Medication Ordinance".
Iceland
Preparations of paracetamol and codeine require a prescription in Iceland. These tablets are generally known as Parkódín.
Eire
Within the Republic of Eire, new rules got here into impact on August 1, 2010 regarding codeine, because of worries in regards to the overuse of the drug. Codeine stays a non-prescriptive, over-the-counter drug, however codeine merchandise have to be out of the view of the general public to facilitate the legislative requirement that these merchandise “will not be accessible to the general public for self-choice”. In follow, this implies clients should ask pharmacists for the product containing codeine in identify, and the pharmacist makes a judgement whether or not it's appropriate for the affected person to be utilizing codeine, and that sufferers are absolutely suggested of the proper use of those products.
Italy
Codeine tablets or preparations require a prescription in Italy. A preparation of paracetamol and codeine is accessible in Italy as CoEfferalgan.
Japan
Codeine and comparable mid-degree centrally appearing brokers together with non-opioid analgesics, antihistamines, nutritional vitamins, inert GI brokers like kaolin & pectin, gentle laxatives, antacids, and natural preparations, will be bought over-the-counter, with 10 mg being the ceiling for OTC dispensing. That is additionally true of ethylmorphine and dihydrocodeine, and in addition diphenoxylate, some weak family members of the thiambutene opioid family.
North America
Narcotic content material numbers
Narcotic content material quantity within the US names of codeine tablets and mixture merchandise like Tylenol With Codeine No. three, Emprin With Codeine No. four, and pure codeine tablets are as follows: No. 1 - 7½ or eight mg (1/eight grain), No. 2 - 15 or sixteen mg (1/four grain), No. three - 30 or 32 mg (half grain), No. four - 60 or sixty four mg (1 grain). The Canadian "Frosst 222" sequence is equivalent to the above checklist: "222" accommodates eight mg codeine, "282" 15 mg, "292" 30 mg, and "293" 60 mg. This technique, which can be used at current within the commerce names of some dihydrocodeine and ethylmorphine merchandise each in and outdoors of North America, was inaugurated with the Pure Meals and Drug Act of 1906 and associated laws and refined since.
Equal scales for labeling stronger opioids resembling diacetylmorphine (heroin), morphine, opium salts mixtures, and others have been in frequent use up to now, and occasionally one can discover previous references to model names for hydrocodone (invented 1920, launched in US 1943), hydromorphone (invented 1924), oxycodone (invented 1916), paregoric and comparable medicine containing narcotic content material numbers. For example. from circa 1900 to 1925, the commonest cough medication was terpin hydrate With Heroin Elixir No. 2.
Opposite to the promoting matter of some pharmacies, 60 mg is No. four, not No. 6, and tablets with forty five mg of codeine should not No. four and would in all chance be categorized as No. three½ underneath that system. Whether or not the dimensions goes to No. 5 and better is moot at this level, as within the United States and Canada single-dose-unit concentrations of greater than sixty four mg aren't manufactured. The United States Managed Substances Act of 1970 does place dosage unit strengths of ninety mg of codeine and better in Schedule II, even when combined with one other energetic ingredient. Oral tablets, hypodermic tablets, liquid varieties, and capsules of much less widespread doses can be found in some circumstances the equal dihydrocodeine, dionine, benzylmorphine, and opium dosages have been beforehand accessible in North America (and generally nonetheless are in different nations, significantly the forty five mg paracetamol/codeine and 50 and one hundred mg single-ingredient codeine tablets).
Canada
In Canada, codeine preparations should be bought solely at a pharmacy and be both behind the allotting counter (or elsewhere, like in a again room) or on cabinets in an space of the shop that may be seen from the dishing out counter. Additional, codeine may be offered over-the-counter solely together with extra elements, which has resulted within the prevalence of co-codaprin (or "AC&C"), which comprises acetylsalicylic acid (ASA), codeine, and caffeine, and comparable mixtures utilizing acetaminophen (paracetamol) moderately than acetylsalicylic acid (aspirin). Caffeine, being a stimulant, tends to offset the sedative results of codeine. It can also enhance the effectiveness and absorption price of analgesics in some circumstances. Co-codaprin containing eight mg codeine is usually requested and bought as "Frosst 222" at pharmacies, the place it's typically accessible over the counter. Formulations containing greater than eight mg of codeine can be found by prescription only.
United States
Within the United States, codeine is regulated by the Managed Substances Act. It's a Schedule II managed substance for ache-reduction merchandise containing codeine alone or greater than ninety mg per dosage unit. Tablets of codeine together with aspirin or acetaminophen (paracetamol/Tylenol) made for ache reduction are listed as Schedule III; and cough syrups are Schedule III or V, relying on formula. The acetaminophen/codeine ache-aid elixir (commerce identify Tylenol Elixir with Codeine) is a Schedule V managed substance.
Preparations for cough or diarrhea containing small quantities of codeine together with extra different energetic elements are Schedule V within the US, and in some states could also be disbursed in quantities as much as four fl. oz. per forty eight hours (one or restrict at four fl. oz. per seventy two hours) with out a prescription. Schedule V particularly consigns the product to state and native regulation past sure required file-holding necessities (a dispensary log have to be maintained for 2 years in a ledger from which pages can not simply be eliminated and/or are pre-numbered, and the pharmacist should ask for photograph identification) and in addition keep managed substances within the closed system on the root of the régime meant by the Managed Substances Act of 1970; the codeine in these merchandise was a Schedule II substance when the corporate making the Schedule V product acquired it for mixing up the tip-product.
In locales the place dilute codeine preparations are non-prescription, wherever from only a few to maybe a average proportion of pharmacists will promote these preparations and not using a prescription. Nevertheless, many states have their very own legal guidelines that do require a prescription for Schedule V drugs. The December 2008 problem of The Bulletin of the Nationwide Codeine OTC Foyer (Vol. XVIII, No. four) listed 12 states with some form of OTC entry to codeine, noting that small unbiased pharmacies are the more than likely to have it. This case is roughly equal to that in February 1991, when the aforementioned organisation undertook its first complete examine of Schedule V and total codeine, dihydrocodeine, ethylmorphine, and hydrocodone availability.
Different medication which can be current in Schedule V narcotic preparations just like the codeine syrups are ethylmorphine and dihydrocodeine. Paregoric and hydrocodone have been transferred to Schedule III from Schedule V even when the preparation incorporates extra different lively substances, and diphenoxylate is often coated by state prescription legal guidelines despite the fact that this relative of pethidine is a Schedule V substance when adulterated with atropine to forestall abuse.
Around the globe, codeine is, contingent on its focus, a Schedule II and IV drug below the Single Conference on Narcotic Drugs.
Spain
Codeine tablets or preparations require a prescription in Spain though it is usually not enforced and lots of pharmacies will promote codeine merchandise with out the requirement of a prescription.
Turkey
Codeine is on the market by a physician's prescription. It's nonetheless attainable to search out some pharmacies who promote codeine with none prescription. In huge cities, pharmacies typically do not promote the drug at all. For OTC codeine containing mixtures, the selection is as much as the pharmacist.
United Kingdom
Within the United Kingdom, greater-power codeine formulations - resembling 30/500 co-codamol, the place 30 mg of codeine phosphate is mixed with 500 mg paracetamol - are prescription-solely medicines (POM). Decrease-power mixtures, reminiscent of eight/500 (varied manufacturers) or 12.eight/500 (Panadol Extremely, Solpadeine MAX and others) can be found as pharmacy supervised ("behind the counter") medicines. Codeine can be obtainable mixed with Ibuprofen; a typical formulation is 12.eight mg codeine alongside 200 mg Ibuprofen. Additionally it is obtainable 'behind the counter' with aspirin in doses of eight mg codeine phosphate and 500mg aspirin (Codis). Codeine Linctus of 15 mg per 5ml can be obtainable behind the counter at some pharmacies, though a purchaser must request it particularly from the pharmacist. Intramuscular injection of codeine is a managed drug underneath the Misuse of Medication Act 1971.
