KAPAKE

4).

Posology Adults:

One or two capsules every four hours as required. Maximum of eight capsules daily. 4).

Paediatric population:

Children aged 12 and over: One capsule to be taken every six hours as required, up to a maximum of four capsules in any 24-hour period. 4). 4). Codeine should be used at the lowest effective dose for the shortest period of time. The duration of treatment should be limited to three days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.

Dosage should be adjusted according to the severity of the pain and the response of the patient. Method of administration For oral use.

Adverse effects of paracetamol are rare but hypersensitivity including skin rash and angioedema may occur. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia, leucopenia, neutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. The frequency of high anion gap metabolic acidosis is not known (cannot be estimated from the available data).

The most common adverse effects to codeine are dizziness, drowsiness, nausea and vomiting. These effects are often more common in the ambulatory patient and thus may be alleviated if the patient lies down. Other side effects to codeine which may occur include constipation, urinary retention, light headedness, headache, respiratory depression (with high doses), dyspnoea, hallucination, confusion, euphoria, dysphoria, miosis, bradycardia, abdominal pain (rarely codeine-induced pancreatitis has been reported in patients with a history of cholecystectomy), allergic reactions, urticaria and pruritus.

4). Drug withdrawal syndrome may occur when treatment is stopped. 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.

CYP2D6 metabolism 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 up to 7% of the Caucasian population may have this deficiency.

However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.

General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal.

9% Northern European 1% to 2% 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.

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. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Kapake/Co-Codamol 30mg/500mg Capsules 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 Kapake/Co-Codamol 30mg/500mg Capsules concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

Patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Kapake/Co-Codamol 30mg/500mg Capsules should be used with caution in the elderly and debilitated as these patients may be more sensitive to the effects of opioids, those with prostatic hypertrophy, inflammatory or obstructive bowel disorders, convulsive disorders, hypothyroidism, myasthenia gravis, urethral stenosis or Addison’s disease.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. There is a risk of hepatotoxicity in association with paracetamol, even at doses within the normal therapeutic range, in patients who are at particular risk of such adverse effects.

These include: patients who are underweight (adults or adolescents less than 50kg) or of low body mass index, malnourished, dehydrated, those with chronic alcoholism, co-existing renal or hepatic impairment, concomitantly taking hepatotoxic drugs and those with conditions that may predispose to glutathione deficiency or depletion.

For some patients considered to be at higher risk, a lower starting dose, a reduction in […]

1. Conditions where morphine and opioids are contraindicated, such as raised intracranial pressure or head injury, respiratory depression, obstructive airway disease, acute asthma, acute alcoholism and following biliary surgery. 4). 5).

6) and also in patients for whom it is known they are CYP2D6 ultra-rapid metabolisers. 4). Kapake/Co-Codamol 30mg/500mg Capsules are not recommended for children under 12 years of age.