CO-DYDRAMOL

).

Adults and children 16 years and over:

Analgesia: One to two tablets every four to six hours. Do not take more than 8 tablets in 24 hours.

Children 12 – 15 years:

One tablet every 4-6 hours when necessary to a maximum of 4 doses in any 24 hours.

Children under 12 years of age:

Do not give to children under 12 years.

Elderly:

The initial dose should be reduced in the elderly and subsequently adjusted according to response. 8 Undesirable Effects) For concomitant illnesses/conditions where dose reduction may be appropriate, see

4 Special Warnings and Precautions for Use. Method of administration For oral use. 3 Contraindications Raised intercranial pressure or head injury (in addition to the risk of respiratory depression and increased intracranial pressure, may affect papillary and other responses vital for neurological assessment).

Known hypersensitivity to paracetamol or dihydrocodeine tartrate, or to other opioid analgesics or to any of the excipients. Not to be given to children under twelve years. Severe hepatic dysfunction. Acute respiratory depression, obstructive airways disease.

Acute alcoholism. g. pseudomembranous colitis) or diarrhoea caused by poisoning. Dihydrocodeine should not be given to comatose patients. 4 Special warnings and precautions for use Co-dydramol should be given in reduced doses or with caution to patients with asthma and decreased respiratory reserve.

3 Contraindications). 8 Undesirable Effects). 5 Interactions). 8 Undesirable Effects) and in patients with adrenocortical insufficiency, prostatic hyperplasia, urethral stricture, hypotension, shock, inflammatory or obstructive bowel disorders, hypothyroidism, convulsive disorders or myasthenia gravis.

It should be avoided or the dose reduced in patients with hepatic or renal impairment. Use with caution in patients with a history of drug abuse. Discontinuation should be carried out gradually in patients who may have developed physical dependence, to avoid precipitating withdrawal symptoms.

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 to 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 dihydrocodeine tartrate.

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 respiratory rate or heart rate. 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 may resolve with a reduction of opioid dose.

Opioid analgesics should be avoided in patients with biliary tract disorders or used in conjunction with an antispasmodic. Administration of pethidine and possibly other opioid analgesics to patients taking a monoamine oxidase inhibitor (MAOI) has been associated with very severe and sometimes fatal reactions.

5). Alcohol should be avoided whilst under treatment with Co-dydramol. The risk-benefit of continued use should be assessed regularly by the prescriber. The leaflet will state in a prominent position in the ‘before taking’ section: • Do not take for longer than directed by your prescriber • Taking dihydrocodeine (DHC) regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.

• Taking a painkiller for headaches too often […]

Method of administration For oral use. 3 Contraindications Raised intercranial pressure or head injury (in addition to the risk of respiratory depression and increased intracranial pressure, may affect papillary and other responses vital for neurological assessment).

Known hypersensitivity to paracetamol or dihydrocodeine tartrate, or to other opioid analgesics or to any of the excipients. Not to be given to children under twelve years. Severe hepatic dysfunction. Acute respiratory depression, obstructive airways disease.

Acute alcoholism. g. pseudomembranous colitis) or diarrhoea caused by poisoning. Dihydrocodeine should not be given to comatose patients. 4 Special warnings and precautions for use Co-dydramol should be given in reduced doses or with caution to patients with asthma and decreased respiratory reserve.

3 Contraindications). 8 Undesirable Effects). Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with intravenous busulfan (see section

Raised intercranial pressure or head injury (in addition to the risk of respiratory depression and increased intracranial pressure, may affect papillary and other responses vital for neurological assessment). Known hypersensitivity to paracetamol or dihydrocodeine tartrate, or to other opioid analgesics or to any of the excipients.

Not to be given to children under twelve years. Severe hepatic dysfunction. Acute respiratory depression, obstructive airways disease. Acute alcoholism. g. pseudomembranous colitis) or diarrhoea caused by poisoning. Dihydrocodeine should not be given to comatose patients.