CO-DYDRAMOL

4). 4). 4). Method of administration For oral administration. Co-dydramol tablets should, if possible be taken during or after meals. Do not exceed recommended dose. Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

The information below lists reported adverse reactions, ranked using the following MedDRA 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).

At the recommended dosage, paracetamol may cause the following side effects: • Allergic reactions - rare but may include skin rash, drug fever, mucosal lesions. • Effects on CNS - drowsiness, impaired mental functions • Effects on GI system – Abdominal Pain.

Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year, and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. Acute pancreatitis has been reported.

A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long- term users of paracetamol, nor was the control of their disease improved after paracetamol withdrawal.

• Effects on CVS - toxic myocarditis. • Effects on blood - methaemoglobinaemia, neutropenia, pancytopenia, leukopenia, thrombocytopenic purpura, haemolytic anaemia, thrombocytopenia and agranulocytosis. • Effects on GU system - Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients (frequency unknown)* • Other effects - Most reports of adverse reactions to paracetamol relate to overdosage with the drug. 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 ileus 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. • General disorders and administration site conditions - uncommon: drug withdrawal syndrome • 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. NOTE - tolerance diminishes rapidly after withdrawal so a previously tolerated dose may prove fatal. • 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. • Prolonged use of a painkiller for headaches can make them worse. There have been very rare occurrences of pancreatitis. * cannot be estimated from the available data 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.

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. 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.

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 online, 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 dihydrocodeine.

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 Co-dydramol should be used with caution in patients with: • hepatic function impairment (avoid if severe) and those with non-cirrhotic alcoholic liver disease. g. Addison's disease • hypotension and shock • myasthenia gravis • phaeochromocytoma - opioids may stimulate catecholamine release by inducing the release of endogenous histamine.

Where analgesics are used long-term (>3 months) with administration every two days or more frequently, headache may develop or worsen. Headache induced by overuse of analgesics (MOH medication-overuse headache) should not be treated by dose increase.

In such cases, the use of analgesics should be discontinued in consultation with the doctor. Alcohol should be avoided. When dihydrocodeine is prescribed for chronic use, care should be taken to avoid unnecessary increase in dosage. 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). Dosage should be reduced in the elderly, in hypothyroidism, in renal insufficiency and in chronic hepatic disease. Patients should be advised not to exceed the recommended dose and not to take other paracetamol-containing products […]

1. • Respiratory depression, obstructive airways disease, or during an attack of asthma. • Diarrhoea caused by poisoning until the toxic material has been eliminated, or diarrhoea associated with pseudomembranous colitis. • Liver disease.