DISPERSIBLE CO-CODAPRIN

4). Posology Adults over 18 years: 1 to 2 tablets. This dose may be taken, up to 4 times a day at intervals of not less than 4 hours.

Paediatic population aged 16 years to 18 years:

The recommended dose for children 16 years and older is 1 to 2 tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours. g. for Kawasaki's disease). 4). 4). 3).

Elderly:

The normal adult dose is still appropriate in the elderly. Do not take for more than 3 days continuously without medical review. Method of Administration To be dispersed in water for oral use.

Adverse effects of aspirin treatment which have been reported include: • Allergic reaction - aspirin may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions in susceptible individuals. Effects on GI system - gastrointestinal bleeding or ulceration which can occasionally be major (may develop bloody or black tarry stools, severe stomach pain and vomiting blood), gastrointestinal irritation (mild stomach pain, heartburn and nausea) and hepatitis (particularly in patients with SLE or connective tissue disease) • Effects on blood - anaemia, haemolytic anaemia, hypoprothrombinaemia, thrombocytopenia, aplastic anaemia, pancytopenia • Effects on sensory system - tinnitus • Salicylism - mild chronic salicylate intoxication may occur after repeated administration of large doses, symptoms include dizziness, tinnitus, deafness, sweating, nausea, vomiting, headache and mental confusion, and may be controlled by reducing the dose Adverse effects of opioid treatment which have been reported include: • Allergic reactions (may be caused by histamine release) - including rash, urticaria, difficulty breathing, increased sweating, redness or flushed face • effects on CNS - confusion, drowsiness, vertigo, dizziness, changes in mood, hallucinations, CNS excitation (restlessness/excitement), convulsions, mental depression, headache, trouble sleeping, or nightmares, raised intracranial pressure, tolerance or dependence • effects on GI system - constipation, GI irritation, biliary spasm, nausea, vomiting, loss of appetite, dry mouth, paralytic ileius or toxic megacolon • effects on CVS - bradycardia, palpitations, hypotension • effects on sensory system -blurred or double vision • effects on GU system - ureteral spasm, antidiuretic effect • other effects - trembling, unusual tiredness or weakness, malaise, miosis, hypothermia • effects of withdrawal - abrupt withdrawal precipitates a withdrawal syndrome.

Symptoms may include tremor, insomnia, nausea, vomiting, sweating and increase in heart rate, respiratory rate and blood pressure. 4) • General disorders and administration site conditions - Drug withdrawal syndrome • Prolonged use of a painkiller for headaches can make them worse.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Drug dependence, tolerance and potential for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. , 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. 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.

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. There is a possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which affects the brain and liver, and can be fatal.

g. for Kawasaki’s disease). Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Co-codaprin and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.

Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Co-codaprin concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Co-codaprin should be used with caution in patients with: • allergic disease • anaemia (may be exacerbated by GI blood loss) • asthma (increased risk of bronchospastic sensitivity reactions) • cardiac failure (conditions which predispose to fluid retention) • dehydration • glucose-6-phosphate dehydrogenase deficiency (aspirin rarely causes haemolytic anaemia) • gout (serum urate may be increased) • hepatic function impairment (avoid if severe) • renal function impairment • surgery.

Aspirin should be discontinued several days before scheduled surgery (including dental extractions) • systemic lupus erythematosus and other connective tissue disorders (hepatic and renal function may be impaired in these conditions) • thyrotoxicosis (may be exacerbated by large doses of salicylates) • hypothyroidism (risk of depression and prolonged CNS depression is increased) • inflammatory bowel disease - risk of toxic megacolon • Opioids should not be administered during an asthma attack • convulsions - may be induced or exacerbated • drug abuse, dependence (including alcoholism), enhanced instability, suicidal ideation or attempts - predisposed to drug abuse • head injuries or conditions where intracranial pressure is raised • gall bladder disease or gall stones - opioids may cause biliary contraction • gastro-intestinal surgery - use with caution after recent GI surgery as opioids may alter GI motility • prostatic hypertrophy or recent urinary tract surgery • adrenocortical insufficiency, eg Addison’s Disease • hypotension and shock • myasthenia gravis • phaeochromocytoma - opioids may stimulate catecholamine release by inducing the release of endogenous histamine CYP2D6 metabolism4 Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite.

If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Estimates indicate that […]

1. • Other ingredients in the product, other opioids, other salicylates or non- steroidal anti-inflammatory drugs (a patient may have developed anaphylaxis, angioedema, asthma, rhinitis or urticaria induced by aspirin or other NSAIDs).

• Nasal polyps associated with asthma (high risk of severe sensitivity reactions). • Active peptic ulceration or a past history of peptic ulceration or dyspepsia. • Haemophilia or other haemorrhagic disorder (including thrombocytopenia) as there is an increased risk of bleeding.

• Concurrent anticoagulant therapy should be avoided. • Diarrhoea caused by poisoning until the toxic material has been eliminated, or diarrhoea associated with pseudomembraneous colitis • respiratory depression • obstructive airways disease • third trimester of pregnancy • In children below the age of 12 years for the symptomatic treatment of cold due to an increased risk of developing serious and life-threatening adverse reactions.

g. Kawasaki’s disease). 6) • In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers