FLU STRENGTH HOT LEMON PARACETAMOL POWDERS - summary of medicine characteristics

Flu Strength Hot Lemon Paracetamol Powders

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Paracetamol 1000 mg

For excipients see section 6.1

Powder for oral solution. Unit dose sachets

Light yellow free flowing granules with a characteristic odour of lemon.

4.1 Therapeutic Indications

Paracetamol is used for the relief from cold and flu symptoms.

Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever and aches.

4.2 Posology and Method of Administration

Posology:

Adults, the elderly and children 16 years and over:

The contents of one sachet dissolved in hot water every four to six hours. This dose should not be repeated more frequently than every four to six hours nor should more than 4 doses be given in any 24hour period.

Not suitable for children under 16 years of age except on the advice of a doctor. The dosage should not be continued for more than 3 days without consulting a doctor.

Method of administration:

Oral administration only.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other constituents.

4. CLINICAL PARTICULARS

4.4 Special Warning and Precautions for Use

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

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

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.

Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.

If symptoms persist consult your doctor.

Keep this medicine out of sight and reach of children.

Contains Paracetamol.

Do not take anything else containing paracetamol while taking this medicine and talk to a doctor at once if you take too much of this medicine, even if you feel well. Do not take if you are sensitive to paracetamol or to any of the other ingredients.

Talk to a doctor at once if you take too much of this medicine even if you feel well because of the risk of delayed, serious liver damage.

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 decreased 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. CLINICAL PARTICULARS

4.6 Fertility, Pregnancy and Lactation

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.

4.7 Effects on ability to drive and use machines

There are unlikely to be any problems with normal use.

4. CLINICAL PARTICULARS

4.8 Undesirable Effects

Adverse events of paracetamol 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.

Very rare cases of serious skin reactions have been reported.

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.

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 the patient has risk factors (see below).

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 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.

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.

5.1. Pharmacodynamic Properties

ATC Code N02BE01 Other analgesics and antipyretics.

Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependant on the inhibition of prostaglandin synthesis. This inhibition appears, however to be on a selective basis.

5.2. Pharmacokinetic Properties

5.  PHARMACOLOGICAL PROPERTIES

5.3    Preclinical Safety Data

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ascorbic acid

Sucrose

sodium citrate

tartaric acid

citric acid

tapioca starch

sodium cyclamate

Flav-O-lok Lemon Juice 610399

Lemon Flavour 8476

Turmeric powder extract (Curcumin, E100).

6.2 Incompatibilities

None known

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

5 or 10 sachets in a carton. Each sachet contains 7.7 grammes of powder. Sachet specifications: 44 gsm paper, 10 gsm high density polythene, 8 micron soft tempered aluminium foil and 25 gsm polythene.

6.6 Special precautions for disposal

No special instruction necessary

7 MARKETING AUTHORISATION HOLDER

Aspar Pharmaceuticals Ltd

Albany House,

Acrewood way,

St Albans,

AL4 0JY,

United Kingdom