SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Paracetamol 1000mg Soluble Tablets.

Parasolve Max 1000mg Soluble Tablets.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 1000mg of the active ingredient paracetamol.

For a full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Effervescent tablet.

Paracetamol 1000mg Soluble Tablets are white to off white coloured, circular, flat bevelled tablets, plain on both sides.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of headache including migraine, neuralgia, toothache, period pain, and rheumatic aches and pains.

Symptomatic relief of colds and influenza, and sore throats.

4.2 Posology and method of administration

For oral administration. Dissolve the tablets in water (about 200 ml) before swallowing.

Adults and the elderly: One tablet to be taken up to four times daily. Maximum dose of 4 tablets in 24 hours.

Children under 12 years of age: Not recommended.

The dose should not be repeated more frequently than every 4 hours, and not more than 4 doses should be taken in any 24 hour period.

Dosage should not be continued for more than 3 days without consulting a doctor.

4.3 Contraindications

Hypersensitivity to paracetamol and/or any of the other ingredients.

4.4 Special warnings and precautions for use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with noncirrhotic alcoholic liver disease.

Each tablet contains 586.11mg of sodium and may be harmful to people on a low sodium diet.

The tablets also contain aspartame (a source of phenylalanine) and so should not be taken by people with phenylketonuria.

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.

Do not take with any other paracetamol containing products.

Do not exceed the recommended dose.

If symptoms persist consult your doctor.

Keep out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

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 use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Fertility, pregnancy and lactation

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

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

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, purpura and methaemoglobinaemia but these were not necessarily causality related to paracetamol.

4.9    Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if 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 infective, 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, coma 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

It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are employed), become irreversibly bound to liver tissue.

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 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 24 hours from ingestion should be discussed with the NPIS or a liver unit.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Paracetamol is an effective analgesic and antipyretic agent. The drug has no effect on the cardiovascular and respiratory systems, and it does not cause gastric irritation or bleeding like salicylates.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring 30 minutes to 2 hours after ingestion. It is distributed in most body tissues; it crosses the placenta and is present in breast milk. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentration. The elimination half life varies from about 1 to 3 hours.

Paracetamol is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted unchanged as paracetamol. A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione, may accumulate following paracetamol overdosage and cause liver damage.

5.3 Preclinical safety data

No data of relevance which is additional to that already included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Citric Acid (anhydrous) (E330)

Povidone

Sodium Bicarbonate (E500)

Sodium Saccharin

Sodium Carbonate (anhydrous)

Simeticone (E900)

Polysorbate 80 (E433)

Aspartame (E951).

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25 °C. Store in the original package. Protect from moisture.

6.5    Nature and contents of container

Strip (4 layer - paper/LDPE/aluminium/LDPE), laminate on both sides of strip.

Pack sizes 8, 12, 16 and tablets.

Not all packs may be marketed

6.6    Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Fannin (UK) Limited 42-46 Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 20417/0062

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16/07/2010

10 DATE OF REVISION OF THE TEXT

01/08/2011