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PROPAIN PLUS is a brand name for Doxylamine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Codeine is 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, ibuprofen or aspirin (alone). Treatment of tension headache, headache, toothache, backache, migraine, neuralgia, dysmenorrhoea, muscular…
Verbatim from this product's MHRA label. Tap a section to expand.
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.
Adults:
One to two tablets every 6 hours.
Elderly:
Dosage as for adults. Do not exceed 8 tablets per 24 hours.
Paediatric population:
Children aged 16 years to 18 years: The recommended dose for children 16 years and older should be one to two tablets every 6 hours when necessary.
Children aged 12 years to 15 years:
The recommended dose for children 12 to 15 years should be one tablet every 6 hours when necessary, up to a maximum of 4 doses in 24 hours. 4).
Route of Administration:
Oral.
Adverse effects of paracetamol:
System Organ Class Frequency Adverse Reactions Very Rare Thrombocytopenia, neutropenia, leukopenia. Blood and lymphatic system disorders Not Known Agranulocytosis, haemolytic anaemia in particular in patients with underlying glucose 6- phosphate-dehydrogenase deficiency.
Immune system disorders Not known Hypersensitivity including skin rash may occur. Anaphylactic shock, angioedema. Very Rare Very rare cases of serious skin reactions have been reported. Erythema, urticaria, rash. Skin and subcutaneous tissue disorders Not Known Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis, fixed drug eruption.
Hepatobiliary disorders Very rare Cytolytic hepatitis, which may lead to acute hepatic failure. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
Adverse effects of Codeine:
The most frequent undesirable effects of codeine are constipation and drowsiness. Less frequent effects are nausea, vomiting, sweating, facial flushing, dry mouth, blurred or double vision, dizziness, orthostatic hypotension, malaise, tiredness, headache, anorexia, vertigo, bradycardia, palpitations, respiratory depression, dyspnoea, allergic reactions (itch, skin rash, facial oedema) and difficulties in micturition (dysuria, increased frequency, decrease in amount).
Side effects, which occur rarely, include convulsions, hallucinations, nightmares, uncontrolled muscle movements, muscle rigidity, mental depression and stomach cramps. Very rare cases of pancreatitis have been reported. Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is stopped.
Paracetamol Care is advised in the administration of paracetamol-containing product to patients with severe renal or severe hepatic impairment and in those with non- cirrhotic alcoholic liver disease. The hazards of overdose are greater in those with alcoholic liver disease.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision. The dosage in renal impairment must be reduced. Dosage in excess of those recommended may cause severe liver damage. 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.
Codeine Codeine, consumed in higher doses and over a prolonged period, may cause addiction. Codeine has a primary potential for dependence. Tolerance, psychological and physical dependence develops with prolonged use of high doses with withdrawal symptoms after sudden discontinuation of the drug.
Cross- tolerance with other opioids exists. Rapid relapses can be expected in patients with pre-existing opiate dependence (including those in remission). There have been reports of drug abuse with codeine, including cases in children and adolescents.
Caution is particularly recommended for use in children, adolescents, young adults, and in patients with a history of drug and/or alcohol abuse. Codeine may induce faecal impaction, producing incontinence, spurious diarrhoea, abdominal pain and rarely colonic obstruction.
Elderly patients may metabolise or eliminate opioid analgesics more slowly than younger adults. Administration must be discontinued gradually after prolonged treatments. Dependence can develop with repeated use of codeine and therefore withdrawal symptoms may appear if the product is withdrawn abruptly.
• Hypersensitivity to paracetamol, doxylamine succinate, codeine phosphate, caffeine or any of the other ingredients in the product. 5). 4). 6). • Respiratory insufficiency • In the event of impending childbirth or in case of risk of premature birth • Children below 12 years of age In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.
Severe hepatocellular insufficiency.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Doxylamine in United Kingdom.
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Prolonged use of a painkiller for headaches can make them worse. System Organ Class Frequency Adverse Reactions Immune system disorders Not Known Hypersensitivity. Psychiatric disorders Not Known Confusional state, dysphoriam, euphoria.
Long-term use also entails the risk of drug dependence. Nervous system disorders Not Known Seizure, headache, somnolence, dizziness, sedation. Eye disorders Not Known Miosis. Visuomotor coordination and visual acuity may be adversely affected in a dose-dependent manner at higher doses or in particularly sensitive patients.
Ear and labyrinth disorders Not Known Tinnitus. Skin and subcutaneous tissue Not Known Pruritus. disorders Renal and urinary disorders Not Known Urinary retention. Vascular disorders Not Known Hypotension.
Adverse effects of doxylamine succinate:
Common side effects: CNS effects: Drowsiness (usually diminishes within a few days), paradoxical stimulation, headaches, psychomotor impairment.
Antimuscarinic effects:
Urinary retention, dry mouth, blurred vision, gastrointestinal disturbances, thickened respiratory tract secretions Rare side effects: Hypotension, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, palpitation, arrhythmia hypersensitivity reactions, blood disorders and liver dysfunction.
Adverse effects of Caffeine Side effects of caffeine include nausea, headache and insomnia. Large doses may cause restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles. Caffeine increases gastric secretion and may cause gastric ulceration.
System Organ Class Frequency Adverse Reactions Psychiatric disorders Not Known Anxiety, insomnia, restlessness and tremor. Gastrointestinal disorders Not Known Gastric disorders. Cardiac disorders Not Known Heart rate increased. 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.
Keep out of the reach and sight of children. g. peptic ulcer), recent gastrointestinal surgery, gallstones, myasthenia gravis, a history of cardiac arrhythmias or convulsions, and in patients with a history of drug abuse or emotional instability.
3). 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. 3 regarding contraindication of taking Propain Plus with MAOIs because of the doxylamine component.
g. coffee, tea, foods, other drugs and beverages) should be avoided while taking this product. Severe cutaneous adverse reactions (SCARs) Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS), and Toxic epidermal necrolysis (TEN) have been reported with the use of Propain Plus.
Patients should be advised of the signs and symptoms and monitored closely for skin reactions. g. progressive skin rash often with blisters or mucosal lesions) occur, patients should immediately stop Propain Plus treatment and seek medical advice.
Patients who have had a cholecystectomy should be treated with caution. The contraction of the sphincter of Oddi can cause symptoms resembling those of myocardial infarction or intensify the symptoms in patients with pancreatitis. Propain Plus must be administered with caution in certain patients, such as those with hypotension.
Propain Plus must be administered with caution in certain patients, such as those who present impaired cardiac, hepatic or renal function, adrenal insufficiency (Addison's disease), hypothyroidism, multiple sclerosis, chronic ulcerative colitis, gallbladder conditions and diseases that present with reduced respiratory capacity such as emphysema, kyphoscoliosis and severe obesity.
Risks from concomitant use of opioids and benzodiazepines Concomitant use of opioids, including codeine, and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma, and death.
Because of these risks, concomitant prescribing of sedative medicines, such as benzodiazepines or related drugs, with opioids should be reserved for patients for whom alternative treatment options are not possible. 2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation.
5). Caution is advised in patients with: • Anxiety disorders (risk of enhancement). • Arrhythmia (risk of tachycardia or extra systoles enhancement). Propain Plus should be used upon medical advice in patients with: • Mild-to-moderate hepatocellular insufficiency • Severe renal insufficiency • Chronic alcohol use […]