Codeine Phosphate 60mg Overview

Codeine Phosphate 60mg is a prescription medicine used to treat the symptoms of mild to moderately severe pain. Codeine Phosphate may be used alone or with other medications.

Codeine Phosphate belongs to a class of drugs called Analgesics, Opioids.

It is not known if Codeine Phosphate is safe and effective in children.

Warnings and precautions’

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief.

Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

The label will state (To be displayed prominently on outer pack –not boxed):

• Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can to lead to addiction.

Drug dependence, tolerance and potential for abuse

For all patients, prolonged use of Codeine Phosphate 60mg may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with current or past history of substance misuse disorder (including alcohol misuse) or mental health disorder (e.g., major depression).

Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse.

A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.

Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance.

The risks of developing tolerance should be explained to the patient.

Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.

Patients should be closely monitored for signs of misuse, abuse, or addiction.

The clinical need for analgesic treatment should be reviewed regularly.

Discontinuation should be carried out gradually in patients who may have developed physical dependence, to avoid precipitating withdrawal symptoms.

Drug withdrawal syndrome

Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with^Codeine Phosphate 60mg .

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.

The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.

Hyperalgesia

Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.

This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality. Symptoms of hyperalgesia may resolve with a reduction of opioid dose.

Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine as it contains lactose.

• Alcohol: the hypotensive, sedative and respiratory depressive effects of alcohol may be enhanced.
• Anaesthetics: concomitant administration of codeine and anaesthetics may cause increased CNS depression and/or respiratory depression and/or hypotension.
• Anti-arrhythmics: codeine delays the absorption of mexiletine. The analgesic activity of codeine is likely to be significantly impaired by quinidine which impairs codeine metabolism.
• Antidepressants: The depressant effects of opioid analgesics may be enhanced by tricyclic antidepressants.
• MAOIs taken with pethidine have been associated with severe CNS excitation or depression (including hypertension or hypotension). Although this has not been documented with codeine, it is possible that a similar interaction may occur and therefore the use of codeine should be avoided while the patient is taking MAOIs and for 2 weeks after MAOI discontinuation.
• Antihistamines: concomitant administration of codeine and antihistamines with sedative properties may cause increased CNS depression and/or respiratory depression and/or hypotension.
• Antipsychotics: enhanced sedative and hypotensive effect.
• Anxiolytics and hypnotics: enhanced sedative effect.
• Domperidone and metoclopramide: codeine antagonises the effect of cisapride, metoclopramide and domperidone on gastrointestinal activity.
• Sodium oxybate: concomitant administration of codeine and sodium oxybate may cause increased CNS depression and/or respiratory depression and/or hypotension.
• Ulcer-healing drugs: Cimetidine may inhibit the metabolism of codeine resulting in increased plasma concentrations.
• Interference with laboratory tests: Opioids may interfere with gastric emptying studies as they delay gastric emptying and with hepatobiliary imaging using technetium Tc 99m disofenin as opioid treatment may cause constriction of the sphincter of Oddi and increase biliary tract pressure.
• Sedative medicines such as benzodiazepines or related drugs:

Pregnancy:

As with all medications caution should be exercised during pregnancy, especially in the first trimester. A possible association with respiratory and cardiac malformations has been reported following first trimester exposure to codeine.

Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate.

If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.

Opioid analgesics may cause gastric stasis during labour, increasing the risk of inhalation pneumonia in the mother.

Breast feeding

Administration to nursing women is not recommended as Codeine Phosphate may be secreted in breast milk and may cause respiratory depression in the infant.

If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.

• Regular prolonged use of Codeine Phosphate 60mg is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped.
• In therapeutic doses, codeine is much less liable than morphine to produce adverse effects.
• Prolonged use of a painkiller for headaches can make them worse.
• Tolerance and some of the most common side effects – drowsiness, nausea, and vomiting, and confusion – generally develops with long term use.
• Immune system disorders: maculopapular rash has been seen as part of a hypersensitivity syndrome associated with oral codeine phosphate; fever, splenomegaly and lymphadenopathy also occurred.
• Endocrine disorders: hyperglycaemia.
• Metabolism and nutrition disorders: anorexia.
• Psychiatric disorders: mental depression, hallucinations and nightmares, restlessness, confusion, mood changes, euphoria and dysphoria.
• Nervous system disorders: convulsions (especially in infants and children), dizziness, drowsiness, headache (prolonged use of a painkiller for headaches can make them worse). Raised intracranial pressure may occur in some patients.
• Eye disorders: blurred or double vision or other changes in vision. Miosis.
• Ear and labyrinth disorders: vertigo.
• Cardiac disorders: tachycardia, palpitations and bradycardia.
• Vascular disorders: postural hypotension, facial flushing. Large doses produce hypotension.
• Respiratory, thoracic and mediastinal disorders: Dyspnoea. Large doses produce respiratory depression.
• Gastrointestinal disorders: nausea, vomiting, constipation, dry mouth, stomach cramps, pancreatitis.
• Hepatobiliary disorders: Biliary spasm (may be associated with altered liver enzyme values).
• Skin and subcutaneous tissue disorders: allergic reactions such as skin rashes, urticaria, pruritus, sweating and facial oedema.
• Musculoskeletal and connective tissue disorders: Uncontrolled muscle movements. Muscle rigidity may occur after high doses.
• Renal and urinary disorders: difficulty with micturation, urinary retention, ureteric spasm, dysuria. An antidiuretic effect may also occur with codeine.
• Reproductive system and breast disorders: sexual dysfunction, erectile dysfunction, decreased potency. Decreased libido.
• General disorders and administration site conditions: malaise, tiredness, hypothermia.
• Uncommon: drug withdrawal syndrome.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.