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SOLPADOL is a brand name for Acetaminophen (also known as Paracetamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the relief of severe pain. Indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone).
Verbatim from this product's MHRA label. Tap a section to expand.
4).
Adults:
Two tablets not more frequently than every 4 to 6 hours, up to a maximum of 8 tablets in any 24 hour period.
Elderly:
As adults, however a reduced dose may be required. See warnings.
Children aged 16 to 18 years:
One to two tablets every 6 hours when necessary to a maximum of 8 tablets in 24 hours.
Children aged 12 to 15 years:
One tablet every 6 hours when necessary to a maximum of 4 tablets in 24 hours.
Children under 12:
Not recommended for children under 12 years of age. 4). The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. Solpadol Caplets are for oral administration.
Codeine can produce typical opioid effects including constipation, nausea, vomiting, dizziness, light-headedness, confusion, drowsiness and urinary retention. The frequency and severity are determined by dosage, duration of treatment and individual sensitivity.
Tolerance and dependence can occur, especially with prolonged high dosage of codeine. • Regular prolonged use of codeine 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.
Adverse effects of paracetamol are rare:
Blood and lymphatic system disorders Very rare: thrombocytopenia, neutropenia, leucopenia. Not known: agranulocytosis. Immune system disorders Hypersensitivity including skin rash may occur.
Not known:
Anaphylactic shock, angioedema. 4). Vascular disorders Not known: hypotension (with high doses). 4). Skin and subcutaneous disorders Very rare cases of serious skin reactions have been reported. General disorders and administration site conditions Uncommon: drug withdrawal syndrome.
Very rare occurrence of pancreatitis. 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.
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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 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.
Hypersensitivity to paracetamol or codeine which is rare. Hypersensitivity to any of the other constituents. 6) Monoamine oxidase inhibitor therapy, concurrent or within 14 days. 4). In patients for whom it is known that they are CYP2D6 ultra-rapid metabolisers.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. CYP2D6 metabolism Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects.
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 nausea, vomiting, constipation, lack of appetite, somnolence, shallow breathing, small pupils and confusion.
In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. 3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.
Children with compromised respiratory function Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
These factors may worsen symptoms of morphine toxicity. Risks from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Solpadol 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 Solpadol 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).
Risks from concomitant use of opioids and alcohol:
Concomitant use of opioids, including codeine, with alcohol […]