HEALTH ESSENTIALS PAIN RELIEF EXTRA

Dose:

Unless otherwise directed by a doctor – Adults, Elderly and children 16 years and over: 1 to 2 tablets every 4 – 6 hours. Do not take more than 8 tablets in 24 hours. Dose should not be taken more frequently than at 4 hourly intervals and not more than 4 times in any 24 hour period.

Children 12 – 15 years:

One tablet every 4-6 hours when necessary to a maximum of 4 doses in any 24 hours.

Children under 12 years of age:

Do not give to children unless advised by a doctor.

Route of administration:

Oral with water.

). 5 Interactions). 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.

Caffeine:

Care is advised in the administration of caffeine to patients with cardiac disease. g. coffee, tea and some canned drinks) should be avoided while taking this product. Generally: * Do not exceed the stated dose * If symptoms persist, consult your doctor.

Do not take for more than 3 days without consulting a doctor. * If you are receiving a course of medicinal treatment, consult your doctor.

The label text shall state:

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.

The leaflet text shall state:

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

5. 4) Analgesics: Diflunisal increases blood concentrations of paracetamol.

Anion- exchange resins:

Absorption reduced by colestyramine; administration should be separated by at least 1 hour.

Antibacterials:

Isoniazid may increase the risk of hepatotoxicity with therapeutic doses of paracetamol. 4). Anticoagulants. The anticoagulant effect of warfarins and other coumarins may be enhanced by prolonged regular daily use of paracetamol, with increased risk of bleeding, but occasional doses have no significant effect.

Antiepileptics:

Carbamazepine, phenobarbital, phenytoin and primidone can reduce the effects of paracetamol and increase the risk of hepatotoxicity.

Cytotoxic drugs:

Paracetamol possibly inhibits metabolism of intravenous busulfan (manufacturer of intravenous busulfan advises caution within 72 hours of paracetamol).

Motility stimulants:

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone.

Oral contraceptives:

Paracetamol is cleared from the body more quickly in women taking oral contraceptives and the analgesic effects may be reduced.

Uricosurics:

Probenecid can reduce the loss of paracetamol from the body.

Caffeine:

Antibacterials: Some quinolone antibiotics, including enoxacin, pipemidic acid and ciprofloxacin can reduce the clearance of caffeine and prolong its plasma half-life.

Antidepressants:

Fluvoxamine can reduce the clearance of caffeine and increase its stimulant and side effects.

Antiepileptics:

Phenytoin may increase the clearance of caffeine.

Antipsychotics:

Caffeine may increase serum clozapine levels.

Benzodiazepines:

Caffeine can reduce the sedative effects of diazepam. Disulfiram: may reduce the clearance of caffeine.

Diuretics:

Concomitant use of xanthines with diuretics may increase the risk of hypokalaemia.

Ephedrine/ephedra alkaloids in dietary supplements (Ma Huang):

Concomitant use may raise blood pressure; hypertension, tachycardia, subarachnoid haemorrhage, cardiac arrest and neurosis have been reported.

Lithium:

Caffeine may increase the clearance of lithium. Mexiletine: may reduce the clearance of caffeine.

Oestrogens and progestogens:

Oral contraceptives or oestrogen replacement therapy may reduce the clearance of caffeine.

Phenylpropanolamine:

Concomitant administration may increase blood pressure, resulting in hypertensive crises in a few susceptible individuals. Manic psychosis has occurred. Phenylpropanolamine can increase serum caffeine levels. Theophylline: concomitant administration can increase plasma theophylline and plasma caffeine levels.

6 Fertility, pregnancy and lactation Paracetamol: Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol use in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

Caffeine:

Taken during pregnancy it appears that the half-life of caffeine is prolonged. Caffeine crosses the placenta, and foetal blood and tissue levels similar to maternal concentrations are achieved. This is a possible contributing factor in hyperemesis gravidarum.

Cardiac dysrhythmias have been noted in the foetuses […]

Paracetamol:

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazards of overdose are greater in those with alcoholic liver disease. Paracetamol should be given with care to patients with alcohol dependence.

Paracetamol is well tolerated by the majority of people with asthma. However a small percentage of aspirin sensitive asthmatics are also sensitive to paracetamol. The likelihood of a reaction to paracetamol increases with a patient’s level of sensitivity to aspirin.

8 Undesirable effects). Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with intravenous busulfan (see section

1.

Caffeine:

Hypersensitivity to caffeine. Do not give to patients with a history of peptic ulceration.