Paracetamol and Caffeine 500 mg/65 mg Effervescent Tablets

Boots Paracetamol Extra Effervescent Tablets 500 mg/65 mg

Parasolve^® Extra 500 mg/65 mg Effervescent Tablets

Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.

Each effervescent tablet contains 4.5 mg of aspartame

Each effervescent tablet contains 409 mg of sodium.

For a full list of excipients, see Section 6.1.

Effervescent Tablet.

Paracetamol & Caffeine 500 mg/65 mg Effervescent Tablets are white to off white coloured circular flat bevelled tablets plain on both sides.

Paracetamol and Caffeine Effervescent Tablets are 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 relief of the symptoms of colds, influenza and sore throat.

Paracetamol and Caffeine Effervescent Tablets should be dissolved in at least half a tumbler of water.

Dosage

Adults

One to two tablets dissolved in water not more frequently than every 4-6 hours when necessary to a maximum of 8 tablets in 24 hours.

Elderly

Same as adult dose. A reduced dose may be required

Paediatric population:

Children aged 16-18 years:

One to two tablets dissolved in water every 4-6 hours when necessary to a maximum of 8 tablets in 24 hours.

Children aged 12-15 years:

One tablet dissolved in water every 6 hours when necessary to a maximum of 4 tablets in 24 hours.

Children aged less than 12 years:

Not recommended for children under 12years.

Method of Administration

Paracetamol and Caffeine 500 mg/65 mg Effervescent Tablets are for oral administration only.

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

Do not exceed the stated dose.

Contains paracetamol. Do not use with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose.

Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.

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.

Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis (see section 4.9).

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

This medicinal product contains 409 mg sodium per dose (one tablet), equivalent to 20.45% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 163.6% of the WHO recommended maximum daily intake for sodium. Paracetamol and Caffeine 500 mg/65 mg Effervescent Tablets is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

This medicinal product contains aspartame. Neither non-clinical nor clinical data are available to assess aspartame in infants below 12 weeks of age.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

If symptoms persist, medical advice must be sought.

Keep out of the sight and reach of children.

Pack Label:

Talk to a doctor at once if you take too much of this medicine, even if you feel well. Do not take anything else containing paracetamol while taking this medicine.

Patient Information Leaflet:

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.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. Caffeine may increase clearance of lithium. Concomitant use is therefore not recommended.

Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.

Caffeine in breast milk may potentially have a stimulating effect on breast fed infants.

Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.”

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 MedDRA System Organ Class.

Adverse reactions identified during post-marketing use are reported voluntarily from a population of uncertain size, the frequency of these reactions is unknown but likely to be very rare (<1/10,000).

Post marketing data

PARACETAMOL

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

Caffeine

When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Paracetamol

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

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

Or

• Regularly consumes ethanol in excess of recommended amounts.

Or

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

Symptoms

Symptoms of paracetamol overdose 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, vomiting, diuresis, tachycardia or cardiac 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 with Cope Sachets requires assessment of plasma paracetamol levels for antidote treatment, with signs and symptoms of codeine and caffeine toxicity being managed symptomatically.

Sodium bicarbonate

High doses of sodium bicarbonate may be expected to induce gastrointestinal symptoms including belching and nausea. In addition, high doses of sodium bicarbonate may cause hypernatraemia; electrolytes should be monitored and patients managed accordingly.

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.

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

Paracetamol: Conventional studies using the currently accepted standards for the evaluation of toxicity of reproduction and development are not available.

Citric Acid (anhydrous) (E330), Povidone, Saccharin Sodium, Sodium Hydrogen Carbonate (E500) , Sodium Carbonate Anhydrous, Simeticone, Polysorbate 80 (E433), and Aspartame (E951).

Not applicable.

3 years.

Store in the original package and protect from moisture.

4- Ply laminate strip pack

These tablets are available in a pack size of 24.

No special requirements.

Kent Pharma UK Limited, The Bower, 4 Roundwood Avenue, Stockley Park, Heathrow, United Kingdom, UB11 1AF.

PL 51463/0023

02 July 2010

January 2022