Ricesteele Manufacturing Ltd

Paralink Six Plus Paracetamol 250mg/5ml Oral Solution

Each 5 ml contains paracetamol 250mg.

Excipients

Each 5 ml also contains:

Nipasept is a mixture of methyl, ethyl and propyl parahydroxybenzoate (E218, E214, E216).

For a full list of excipients, see section 6.1.

Oral Solution.

Colourless / straw coloured sugar free oral solution with a strawberry odour and taste.

Paralink Six Plus Paracetamol 250mg/5ml Oral Solution is indicated as an analgesic and antipyretic. It is used in the treatment of mild to moderate pain, including headache, migraine, neuralgia, toothache and pain associated with teething. It is also indicated for the relief of symptoms of colds and influenza and to reduce fever.

Children aged 12 – 16 years: 10 – 15mL up to 4 times a day.

Adults and children over 16 years: 10 – 20mL up to 4 times a day.

Hereditary fructose intolerance.

Hypersensitivity to paracetamol or to any of the other constituents.

Never take or give more medicine than shown in the table.

Always use the syringe supplied with the pack.

Do not take or give more than 4 doses in any 24 hour period.

Leave at least 4 hours between doses.

Prolonged use without medical supervision can be harmful.

Do not take or give this medicine for more than 3 days without speaking to your doctor or pharmacist.

If symptoms persist consult your doctor.

Do not take or give with any other paracetamol-containing products.

As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.

The product should be administered with caution to patients with known liver or renal impairment.

Immediate medical advice should be sought in the event of overdose, because of the risk of irreversible liver damage.

Keep out of the reach and sight of children.

'The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased bleeding; occasional doses have no significant effect.

The rate of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by coleystyramine.

Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

The use of drugs that induce hepatic micosomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate.

Epidemologal studies in human pregnancy have shown no ill effects due to paracetamol used in the 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 does not contraindicate breast-feeding.

None.

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis.

Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods.

A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of the disease improved after paracetamol withdrawal.

Nephrotoxic effects following therapeutic doses of paracetamol are uncommon. Papillary necrosis has been reported after prolonged administration.

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 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 a liver unit.

Analgesic, Antipyretic; N02 BE01.

Paracetamol is an antipyretic and analgesic. Paracetamol produces antipyresis through action on the hypothalamic heat-regulation centre and analgesia by elevation of the pain threshold. Paracetamol has analgesic and antipyretic actions similar to those of aspirin but it has no useful anti-inflammatory properties.

Paracetamol has analgesic and antipyretic actions but only weak anti-inflammatory properties.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations occur within 30 to 60 minutes, with slightly faster absorption of liquid preparations. Usual analgesic doses produce total serum concentrations of 5 to 20µg/ml. A good correlation between serum concentration and analgesic effect has not been found.

Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Serum protein binding varies from 20% to 50% at toxic serum concentrations.

Paracetamol is metabolized predominantly in the liver and excreted in the urine mainly as glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 3 hours and is prolonged in neonates and in patients with hepatic impairment.

Total body clearance of paracetamol is reduced in neonates and increases with age.

Paracetamol is a well-established drug substance whose preclinical profile has been investigated thoroughly and is established.

Sorbitol (E420)

Maltitol (E965)

Propylene Glycol

Macrogol 4000

Glycerol

Potassium Sorbate

Nipasept (a mixture of the methyl, ethyl and propyl esters of hydroxybenzoic acid – E218, E214 and E216).

Citric Acid

Neohesperidin-dihydrochalcone

Saccharin Sodium

Strawberry flavour 221047

Purified Water

Not applicable.

2 years.

Store below 25°C.

Do not refrigerate.

Keep the bottle in the outer carton in order to protect from light.

Amber glass bottles with child-resistant tamper-evident closures.

The closure is manufactured from polypropylene with a polyethylene liner and tamper evident band.

A 5ml dosing syringe with markings at both 2.5ml and 5ml is provided with the bottle.

Pack size: 60 and 70 mls.

No special requirements.

Ricesteele Manufacturing Limited

Cookstown Industrial Estate,

Tallaght,

Dublin 24

Ireland

PA 95/7/6

Date of first authorization: 31^st July 2009

December 2011.