High levels of morphine can lead to serious effects, such as breathing difficulties. The PRAC considered that, although morphine-induced side effects may occur in patients of all ages, the way codeine is converted into morphine in children below 12 years is more variable and unpredictable, making this population at special risk of such side effects. In addition, children who already have problems with their breathing may be more susceptible to respiratory problems due to codeine.
The PRAC also noted that cough and cold are generally self-limiting conditions and the evidence that codeine is effective at treating cough in children is limited.
In addition to the new measures for children, codeine must also not be used in people of any age who are known to convert codeine into morphine at a faster rate than normal 'ultra-rapid metabolisers' nor in breastfeeding mothers, as codeine can harm the baby because it passes into breast milk. This review comes after a previous review of codeine for pain relief in children , which resulted in several restrictions being introduced in order to ensure that the medicine was used as safely as possible.
As it was realised that similar considerations could apply to the use of codeine for cough and cold in children, a second EU-wide review of such use was started. The restrictions for codeine for cough and cold are largely in line with the previous recommendations for codeine when used for pain relief.
As the CMDh has now agreed the PRAC measures by consensus, the measures will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable. These new measures follow a review of available safety and efficacy data on codeine when used for cough and cold, including data from clinical studies, observational studies and meta-analyses, post-marketing data in Europe and other published literature on the use of codeine in children.
In total, 14 cases of codeine intoxication in children aged from 17 days to 6 years related to the treatment of cough and respiratory infection were identified in the published literature, four of which had a fatal outcome. The available data indicate that the way codeine is converted into morphine in children below 12 years is more variable and unpredictable, making this population at special risk of morphine-induced side effects.
In addition, the evidence that codeine is effective at treating cough in children is limited and international guidelines emphasise that cough associated with viral infections may be satisfactorily managed with fluids and increased ambient humidity; in the case of chronic cough, treatment should be directed at the underlying disease.
Codeine is an opioid medicine that is converted into morphine in the body. It is widely used for pain relief and for the treatment of the symptoms of coughs and colds.
In the EU, codeine-containing medicines have been approved via national procedures, and are available either on prescription or over the counter in the different Member States. Codeine is marketed as a single-ingredient medicine or in combination with other active substances.
On 22 April the CMDh adopted its position by consensus, so the measures recommended by the PRAC will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.
It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. It can sometimes close up the bronchial tubes air passages of the lungs and make breathing difficult.
Codeine belongs to the group of medicine called narcotic analgesics pain medicines. It acts on the central nervous system CNS to relieve pain. There is a problem with information submitted for this request. Sign up for free, and stay up-to-date on research advancements, health tips and current health topics, like COVID, plus expert advice on managing your health.
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Updated visitor guidelines. You are here Home » codeine and promethazine. Top of the page. What is the most important information I should know about codeine and promethazine? What is codeine and promethazine? Codeine and promethazine contains an opioid narcotic cough medicine, and may be habit-forming. What should I discuss with my healthcare provider before taking codeine and promethazine?
You should not use this medicine if you are allergic to codeine or promethazine, or if you have:. Codeine and promethazine is not approved for use by anyone younger than 12 years old. How should I take codeine and promethazine? Call your doctor if your symptoms do not improve after 5 days of treatment.
What happens if I miss a dose? What happens if I overdose? What should I avoid while taking codeine and promethazine? Do not drink alcohol.
Dangerous side effects or death could occur. What are the possible side effects of codeine and promethazine? Stop using this medicine and call your doctor at once if you have:. What other drugs will affect codeine and promethazine?
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