CO-DYDRAMOL

Route of administration:

Oral Co-dydramol 20/500 mg Tablets should, if possible, be taken during or after meals. Children aged 12-15 years: 1 tablet every 4-6 hours Do not take more than 4 tablets in any 24-hour period Adults and children over 16 years of age: One to two tablets every four to six hours.

Maximum of eight tablets daily.

Children under 12 years:

Not recommended.

Elderly:

One to two tablets every four to six hours. Maximum of eight tablets daily. Reduce dosage if renal or hepatic function is impaired. 4).

The information below lists reported adverse reactions, using the following frequency classification: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Constipation, if it occurs, is readily treated with a mild laxative. Abdominal pain. Other side-effects of dihydrocodeine which may occur in a few patients are nausea, vomiting, headache, vertigo, giddiness, urinary retention, pruritus, sedation, dysphoria, hallucinations and allergic reactions including skin rashes.

Adverse effects of paracetamol are rare but hypersensitivity reactions including skin rash, blood dyscrasias, acute pancreatitis have been reported. Very rare cases of serious skin reactions have been reported.

Metabolism and nutrition disorders - frequency unknown:

High anion gap metabolic acidosis. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Dependence may occur. Regular prolonged use of dihydrocodeine is known to lead to addiction and tolerance.

4). Symptoms of restlessness and irritability may result when treatment is then stopped. General disorders and administration site conditions - uncommon: 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.

Co-dydramol tablets should be given with caution in patients with allergic disorders and should not be given during an attack of asthma. Caution should be also observed if there is marked impairment of liver function, advanced kidney disease and in chronic alcoholics.

g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended.

The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors. Do not exceed the recommended dose. Patients should be advised not to take other paracetamol-containing products concurrently.

Dosage should be reduced in the elderly, in hypothyroidism and in chronic hepatic disease. An overdose can cause hepatic necrosis. Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors and should be avoided in those patients with raised intracranial pressure or head injury.

Use with caution in patients with prostatic hypertrophy since dihydrocodeine may cause urinary retention. The risk-benefit of continued use should be assessed regularly by the prescriber, and in particular the prescriber should take care to avoid any unnecessary increase in dosage especially where there is evidence of a previous history of drug dependence or abuse.

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.

Respiratory depression, obstructive airways disease, hypersensitivity to paracetamol, dihydrocodeine or other tablet constituents.