Panadol Period Pain

Panadol Extra Advance 500 mg/65 mg Tablets

Panadol Period Pain 500 mg/65 mg Tablets

Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.

Tablet.

White to off-white, oval shaped, film-coated tablets debossed with 'xPx', with the P enclosed within a circle on one side and plain on the other side.

A mild analgesic and antipyretic formulated to give extra pain relief. The tablets are recommended for the treatment of most painful and febrile conditions, for example, headache, including migraine, backache, toothache, rheumatic pain and dysmenorrhoea, and the relief of the symptoms of colds, influenza and sore throat.

Oral use.

Adults (including the elderly), and children aged 16 years and over:

Two tablets up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 8 tablets in 24 hours.

Children aged 12-15 years: One tablet up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 4 tablets in 24 hours.

Not recommended for children under 12 years.

Hypersensitivity to paracetamol, caffeine or any of the other constituents.

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.

Do not exceed the stated dose.

Sodium methyl-, sodium ethyl- and sodium propyl- parahydroxybenzoates (E 219, E 215 and E 217) may cause allergic reactions (possibly delayed).

Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised not to take other paracetamol-containing products concurrently.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Pack Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products.

Patient Information Leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

None.

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Post marketing data

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient

a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b) Regularly consumes ethanol in excess of recommended amounts.

Or

c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

Caffeine

Symptoms

Overdose of caffeine may result in epigastric pain, vomitting, diuresis, tachycardia or cardia arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).

It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related toxicity.

Management

Patients should receive general supportive care (e.g. hydration and maintenance of vital signs). The administration of activated charcoal may be beneficial when performed within one hour of the overdose, but can be considered for up to four hours after the overdose. The CNS effects of overdose may be treated with intravenous sedatives.

Summary

Treatment of overdose requires assessment of plasma paracetamol levels for antidote treatment, with signs and symptoms of caffeine toxicity being managed symptomatically.

ATC code: N02B E51

The combination of paracetamol and caffeine is a well established analgesic combination.

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. It is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal, in the form of conjugated metabolites. Caffeine is absorbed readily after oral administration. Maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65 - 80% of administered caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine.

Panadol Extra Advance 500 mg/65 mg Tablets contain a disintegrant system which accelerates tablet dissolution compared to standard parcetamol and caffeine tablets.

Human pharmacokinetic data demonstrate that the time taken to reach plasma paracetamol threshold (4-7 mcg/ml) is at least 44% faster with Panadol Extra Advance 500 mg/65 mg Tablets compared with standard paracetamol and caffeine tablets.

Total extent of absorption of paracetamol and caffeine from Panadol Extra Advance 500 mg/65 mg Tablets is equivalent to that from standard paracetamol and caffeine tablets.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Tablet core:

Starch pregelatinised,

Povidone k-25,

Calcium carbonate,

Crospovidone,

Alginic acid,

Magnesium stearate,

Sodium methyl (E 219), Sodium ethyl (E 215) and Sodium propyl (E 217) parahydroxybenzoates.

Film coat and polish:

Titanium dioxide (E 171),

Hypromellose,

Macrogol,

Polysorbate 80,

Carnauba wax

None.

24 months.

Store below 25°C.

PVC 250 µm or 300 µm aluminium foil 30 µm blister packs in an outer cardboard carton, containing 4, 6, 8, 12, 14 or 16 tablets, or PVC/aluminium foil blister packs in a carboard/PVC wallet containing 14 or 16 tablets.

None.

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

PL 44673/0078

26/02/2010

March 2017