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PROPAIN is a brand name for Diphenhydramine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Propain Caplets are 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. Propain Caplets may be used in the treatment of headache, migraine, muscular pain, period pain and…
Verbatim from this product's MHRA label. Tap a section to expand.
Before initiating treatment with Propain Caplets, treatment duration and treatment goals, should be agreed together with the patient, in accordance with pain management guidelines. 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.
The duration of treatment should be as short as possible, and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a healthcare professional. For oral administration Adults: take 1 or 2 caplets every 4 hours as required, up to a maximum of 10 caplets in 24 hours.
The suggested dosage may also be administered to the elderly (in the absence of other contra-indications).
Paediatric population:
Children aged 16-18 years: take 1 or 2 caplets every 6 hours as required, up to a maximum of 8 caplets in 24 hours. Children aged 12 years to 15 years: take 1 caplet every 6 hours when necessary up to a maximum of 4 caplets in 24 hours.
4).
Adverse reactions are listed below by system organ class and frequency.
Frequencies are defined as:
Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to<1/1000) and very rare (<1/10,000), not known (cannot be estimated from the available data) Paracetamol Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.
There have been reports of blood dyscrasias (including thrombocytopenia and agranulocytosis) and acute pancreatitis, but these were not necessarily causally related to paracetamol.
Body system Undesirable effect Blood and lymphatic system disorders Not known:
Thrombocytopenia*, agranulocytosis* Very rare: Blood dyscrasias* (blood disorder), cases of serious skin reactions have been reported, anaphylaxis, cutaneous hypersensitivity reactions including (amongst others) skin rashes and angioedema.
Immune system disorders Not known:
Anaphylaxis Respiratory, thoracic and mediastinal disorders Very rare: Bronchospasm – more likely in patients sensitive to aspirin and other NSAIDs Hepatobiliary disorders Very rare: Hepatic dysfunction Gastrointestinal disorders Not known: acute pancreatitis* Metabolism and nutrition disorders Not known: High anion gap metabolic acidosis** Skin and subcutaneous tissue disorders Very rare: Cutaneous hypersensitivity reactions including purpura, urticaria and angioedema.
Very rare cases of serious skin reactions have been reported. Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug induced dermatitis, acute generalised exanthematous pustulosis (AGEP).
Renal and urinary disorders Very rare:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.
Care should be observed in administering the product to any patient, whose condition may be exacerbated by opioids, including the elderly, who may be sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those with prostatic hypertrophy, hypothyroidism and those with inflammatory or obstructive bowel disorders, Addison's disease or myasthenia gravis.
Care should also be observed if prolonged therapy is contemplated. Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained, and treatment should be discontinued.
The diagnosis of medication overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications. Patients with obstructive bowel disorders or acute abdominal conditions should consult a doctor before using this product.
Patients with a history of cholecystectomy should consult a doctor before using this product as it may cause acute pancreatitis in some patients. 5) should not take this product. Paracetamol Dosage in excess of those recommended may cause severe liver damage.
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 non-cirrhotic alcoholic liver disease.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision. The dosage in renal impairment must be reduced. Precaution should be observed in patients with asthma who are sensitive to acetylsalicylic acid since mild bronchospasms are reported in association with paracetamol (cross reaction).
1. • In patients with respiratory depression, chronic constipation, severe liver disease, acute alcoholism, raised intracranial pressure, head trauma, risk of paralytic ileus, acute abdomen, stenosing peptic ulcer or pyloroduodenal obstruction.
6). • In patients for whom it is known 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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Sterile pyuria (cloudy urine) *Not necessarily causally related to paracetamol. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Codeine Codeine may cause nausea, vomiting, constipation and drowsiness in sensitive patients.
Other side effects include difficulty with micturition, ureteric or biliary spasm, dry mouth, sweating, respiratory depression, headache, facial flushing, vertigo, bradycardia, tachycardia, palpitations, postural hypotension, hypothermia, hallucinations, dysphoria, mood changes, miosis, decreased libido and potency, rashes, urticaria and pruritus.
Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is stopped. Prolonged use of a painkiller for headaches can make them worse. 4) Nervous system disorders Not known: Dizziness, hyperalgesia, light-headedness, drowsiness (somnolence) Eye disorders Not known: Miosis, blurred vision, double vision (diplopia) Ear and labyrinth disorders Not known: Vertigo Cardiac disorders Not known: Bradycardia, palpitations, tachycardia Vascular disorders Not known: Postural hypotension, hypotension, flushing of face Respiratory, thoracic and mediastinal disorders Not known: Respiratory depression Gastrointestinal disorders Not known: Constipation, nausea, vomiting, dry mouth, stomach cramps Hepatobiliary spasm Not known: Biliary spasm, sphincter of Oddi dysfunction Skin and subcutaneous tissue disorders Not known: Pruritus, sweating, urticaria, rash Musculoskeletal and connective tissue disorders Not known: Muscle rigidity Renal and urinary disorders Not known: Urinary retention, ureteral spasm, difficulties in micturition, dysuria, polyuria Reproductive system and breast disorders Not known: Decreased potency (erectile dysfunction) Not known: Hypothermia, facial oedema General disorders and administration site conditions Uncommon: Drug withdrawal syndrome Investigations Not known: Urine output decreased Drug dependence Repeated use of Propain Caplets can lead to drug dependence, even at therapeutic doses.
4). Diphenhydramine Drowsiness is seen with all of the older antihistamines such as diphenhydramine especially in high dosage. g. urinary retention), dry mouth, blurred vision and gastro-intestinal disturbance. Other less common side effects that have been reported with antihistamines are: palpitations, arrhythmias, hypotension, hypersensitivity reactions (inc.
bronchospasm, angioedema and anaphylaxis), rashes and photosensitivity, extrapyramidal effects, confusion, depression, sleep disturbance, tremor, convulsion, sweating, myalgia, paraesthesia, blood disorder, liver dysfunction and hair loss.
g. increased energy, restlessness, nervousness), depression, sleep disturbances *The elderly are more prone to confusion and paradoxical excitation Nervous system disorders Common: Sedation, drowsiness, disturbance in attention, unsteadiness, dizziness Not known: Convulsions, headache, paraesthesia, dyskinesias Eye disorders Not known: Blurred vision Cardiac disorders Not known: Tachycardia, palpitations, arrhythmias Respiratory, thoracic and mediastinal disorders Not known: Thickening of bronchial secretions Gastrointestinal disorders Common: Dry mouth Unknown: Gastrointestinal disturbance including nausea, vomiting Musculoskeletal and connective tissue disorders […]
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 The elderly are more likely to metabolise or eliminate opioid analgesics more slowly than young adults.
Use with caution in the elderly, who are more likely to experience side-effects. Avoid use in elderly patients with confusion. Codeine may cause faecal impaction, producing incontinence, spurious diarrhoea, abdominal pain and rarely colonic obstruction.
Dependence can develop with repeated use of codeine and therefore withdrawal symptoms may appear if the product is withdrawn abruptly. Caution is advised when treating patients with hypertension, hypothyroidism, adrenocortical insufficiency, prostatic hypertrophy, shock, obstructive bowel disorders, acute abdominal conditions, recent gastrointestinal surgery, gallstones, a history of cardiac arrhythmias or convulsions.
Care should be taken with patients with a history of drug abuse or emotional instability. Codeine, as with other opioids should be used with caution in patients with hypotension, hypothyroidism, head injury or raised intracranial pressure.
Tolerance and opioid use disorder (abuse and dependence):
Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Propain Caplets. Repeated use of Propain Caplets can lead to OUD. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD.
Abuse or intentional misuse of Propain Caplets may result in overdose and/or death. g. major depression, anxiety and personality disorders). The patient should be made aware of the risks and signs of OUD as set out in the package leaflet.
If these signs occur, patients should contact their physician. For patients who experience signs and symptoms of OUD, and/or exhibit drug seeking behaviours, review of concomitant opioids and psycho-active drugs (like benzodiazepines) and consultation with an addiction specialist may be required.
Hyperalgesia As with other opioids, in case of insufficient pain control in response to an increased dose of codeine, the possibility of opioid-induced hyperalgesia should be considered. A dose reduction or treatment review may be indicated.
This might be qualitatively and anatomically distinct from pain […]