CO-DYDRAMOL

4). It is recommended that this product should be taken during or after meals.

Adults and children over 16 years:

One to two tablets every four to six hours when necessary up to a maximum of eight tablets in 24 hours.

Elderly:

As for adults, however a reduced dose maybe required if renal or hepatic function is impaired.

Paediatric Population:

Children 12-15 years: One tablet every 4-6 hours when necessary to a maximum of 4 tablets in 24 hours.

Children under 12 years:

Not recommended. Method of Administration For oral administration.

The information below lists reported adverse reactions, ranked 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).

At the recommended dosage, paracetamol may cause the following side effects:

System Organ Class Frequency ADR Immune system disorders Rare Allergic reactions (skin rash, drug fever, mucosal lesions) Nervous system Not known Drowsiness, impaired mental disorders functions Gastrointestinal disorders Very rare Acute pancreatitis1 Vascular disorders Not known Toxic myocarditis Blood and lymphatic system disorders Not known Methaemoglobinaemia, neutropenia, pancytopenia, leukopenia, haemolytic anaemia, agranulocytosis, thrombocytopenia Uncommon NephrotoxicityRenal and urinary disorders Not known Papillary necrosis2 Skin and subcutaneous tissue disorder Very rare Cases of serious skin reactions have been reported.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 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.

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.

4) Gastrointestinal disorders Not known Constipation1, GI irritation, biliary spasm, nausea, vomiting, loss of appetite, dry mouth, paralytic ileus or toxic megacolon, abdominal pain. Vascular disorders Not known Bradycardia, palpitations, hypotension Eye disorders Not known Blurred or double vision Renal and urinary disorders Not known Ureteral spasm, antidiuretic effect Skin and subcutaneous tissue disorders Not known Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis, fixed drug eruption General disorders and administration site conditions Uncommon Drug withdrawal syndrome 1 If constipation occurs it can be treated with a gentle laxative 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. Tolerance diminishes rapidly after withdrawal so a previously tolerated dose may prove fatal. Regularly prolonged use of dihydrocodeine is known to lead to addiction and tolerance.

Symptoms of restlessness and irritability may result when treatment is then 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.

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 Co- Dydramol Tablets.

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. Dihydrocodeine may bring about histamine release, therefore it should not be given during an asthma attack and it should be administered with due care to persons liable to such attack.

The dosage should be reduced in hypothyroidism and in renal insufficiency. Alcohol should be avoided. When dihydrocodeine is prescribed for chronic use, care should be taken to avoid unnecessary increase in dosage. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment.

The hazards of overdose are greater in those with alcoholic liver disease. Patients should be advised not to exceed the recommended dose and not to take other paracetamol-containing products concurrently. 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. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of co-dydramol 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-dydramol 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). The risk-benefit of continued use should be assessed regularly by the prescriber. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of […]

1. • Diarrhoea caused by poisoning until the toxic material has been eliminated, or diarrhoea associated with pseudomembraneous colitis • Respiratory depression • Obstructive airways disease • Liver disease