1. Name Of The Medicinal Product
Beechams Flu Plus Hot Lemon
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Powder
4. Clinical Particulars
4.1 Therapeutic Indications
Short term symptomatic relief of symptoms of influenza, feverishness, chills and colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated pain, and acute nasal catarrh.
4.2 Posology And Method Of Administration
Directions for use
Empty contents of sachet into a beaker. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired.
Recommended Dose and Dosage Schedule
Adults (including elderly) and children aged 12 years and over:
One sachet to be taken every four to six hours as necessary. Do not exceed four sachets per 24 hours.
Not to be given to children under 12 years of age, except on medical advice.
The product should not be used continuously for more than seven days without medical advice.
4.3 Contraindications
Known hypersensitivity to paracetamol or any of the other constituents.
Concomitant use of other sympathomimetic decongestants
Phaeochromocytoma
Closed angle glaucoma
Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease. Patients taking tricyclic antidepressants, or beta-blocking drugs and those who are taking or who have taken within the last two weeks monoamine oxidase inhibitors (see section 4.5).
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 hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Medical advice should be sought before taking this product in patients with these conditions:
• An enlargement of the prostate gland
• Occulusive Vascular disease (e.g. Raynaud's Phenomenon)
• Cardiovascular disease
This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Do not exceed the stated dose.
Patients should be advised not to take other paracetamol-containing or other cold, flu or decongestant products concurrently.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Consult your doctor if you are taking warfarin.
Special label warnings
Do not take with any other paracetamol-containing products. Do not take with other flu, cold or decongestant products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Special leaflet warnings
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.
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 daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.
Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported
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4.6 Pregnancy And Lactation
Due to the phenylephrine content this product should not be used in pregnancy or whilst breast-feeding without medical advice. Phenylephrine may be excreted in breast milk.
4.7 Effects On Ability To Drive And Use Machines
Patients should be advised not to drive or operate machinery if affected by dizziness.
4.8 Undesirable Effects
Paracetamol
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.
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* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Phenylephrine
The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.
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Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.
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4.9 Overdose
Paracetamol
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 the NPIS or a liver unit.
Phenylephrine
Symptoms and signs
Phenylephrine overdosage is likely to result in effects similar to those listed under advserse reactions. Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related toxicity.
Treatment
Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.
Ascorbic acid
Symptoms and signs
High doses of ascorbic acid (>3000 mg) may cause transient osmotic diarrhoea and gastrointestinal effects such as nausea and abdominal discomfort. Effects of overdose of ascorbic acid would be subsumed by severe liver toxicity caused by paracetamol overdose.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol: An analgesic and antipyretic.
Ascorbic acid: A common ingredient of cold and influenza combination products included to compensate for Vitamin C losses which may occur in the initial stages of acute viral infections.
Phenylephrine hydrochloride: A sympathomimetic decongestant.
The active ingredients are not known to cause sedation.
5.2 Pharmacokinetic Properties
Paracetamol: is readily absorbed from the gastrointestinal tract. It is
metabolised in the liver and excreted in the urine, mainly as glucoronide and sulphate conjugates.
Ascorbic Acid: is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues, 25% bound to plasma proteins. Ascorbic Acid in excess of the body's needs is eliminated in the urine as metabolites.
Phenylephrine Hydrochloride: is irregularly absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidase in the gut and liver; orally administered phenylephrine thus has reduced bioavailability. It is excreted in the urine almost entirely as the sulphate conjugate.
5.3 Preclinical Safety Data
Pre-clinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product and which have not already been mentioned elsewhere in this Summary.
The toxicity of paracetamol has been extensively studied in numerous animal species. Pre-clinical studies in rats and mice have indicated single dose oral LD50 values of 3.7 g/kg and 338 mg/kg, respectively. Chronic toxicity in these species at large multiples of the human therapeutic dose, occurs as degeneration and necrosis of hepatic, renal and lymphoid tissue, and blood count changes. The metabolites believed responsible for these effects have also been demonstrated in man. Paracetamol should not, therefore, be taken for long periods of time, and in excessive doses. At normal therapeutic doses, paracetamol is not associated with genotoxic or carcinogenic risk. There is no evidence of embryo-or foeto-toxicity from paracetamol in animal studies.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sucrose
Citric acid
Sodium citrate
Maize starch
Sodium cyclamate
Saccharin sodium
Colloidal anhydrous silica
Lemon flavour
Natural curcumin (E100).
6.2 Incompatibilities
None known
6.3 Shelf Life
Three years
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
The product is packed in laminate sachets comprising paper/polythene/aluminium foil/polythene. Five or ten sachets may be contained in a box board carton.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Beecham group PLC
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK
8. Marketing Authorisation Number(S)
UK: PL 0079/0323
9. Date Of First Authorisation/Renewal Of The Authorisation
14 September 1995
10. Date Of Revision Of The Text
June 2010.
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