FLU STRENGTH HOT LEMON POWDER - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Flu Strength Hot Lemon Powder.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Paracetamol 1000mg

For excipients see 6.1

3 PHARMACEUTICAL FORM

Powder for oral solution

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the relief of cold and flu symptoms.

4.2 Posology and method of administration

Posology

Adults and children 16 years and over:

The contents of one sachet dissolved in hot water every 4 hours.

The dose should not be repeated more than four times in any 24 hour period.

Maximum Daily dose

The maximum daily dose of Paracetamol must not exceed 4g (four sachets)

Maximum single dose is 1g (one sachet)

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

Paediatric Population

Children below 16years of age:

Flu Strength Hot Lemon Powder is not recommended in children aged less than 16 years

Method of administration

Flu Strength Hot Lemon Powder sachets are for oral administration ONLY. The contents of one sachet should be placed in hot water and allowed to dissolve completely before swallowing.

4.3 Contraindications

Allergic reactions and sensitivity to any of the constituents.

4.4 Special warnings and precautions for use

i. Do not exceed the stated dose.

ii. If you are receiving a course of medicinal treatment, consult your doctor or pharmacist.

iii. Contains paracetamol.

iv. Do not take with any other paracetamol containing-products

v. 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.

vi. The hazards of overdose are greater in those with non- cirrhotic alcoholic liver disease. Caution should be exercised in cases of chronic alcoholism. The daily dose should not exceed 2 grams in such case. Alcohol should not be used during the treatment with Paracetamol.

vii. Prolonged or frequent use is discouraged

viii. Caution is advised in the administration of Paracetamol to patients with moderate and severe renal insufficiency, mild to moderate hepatic insufficiency (including   Gilbert’s syn­drome), severe hepatic

insufficiency (child-pugh>9), acute hepatitis, concomitant treatment with medicinal products affecting hepatic functions, glucose-6-phosphatedehy­drogenase deficiency, hemolytic anemia, alcohol abuse dehydration and chronic malnutrition

ix. Caution is advised in asthmatic patients sensitive to aspirin, because light reaction bronchospasm with paracetamol (cross-reaction) has been reported in less than 5% of the patients tested.

x. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

xi. In the case of high fever, or signs of secondary infection or persistence of symptoms adoctor should be consulted.

Excipient warning

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicinal product contains 9.37mmol (or 215.5mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

4.5 Interaction with other medicinal products and other forms of interaction

Hepatotoxic substances may increase the possibility of Paracetamol accumulation and overdose. The risk of hepatotoxicity of paracetamol may be increased by drugs which induce liver microsomal enzymes such as barbiturates, tricyclic antidepressants, and alcohol.

Probenecid causes an almost 2-fold reduction in clearance of Paracetamol by inhibiting its conjugation with glucuronid acid. A reduction of the Paracetamol dose should be considered for concomitant treatment with probenecid.

Salicylamide may prolong the elimination t1/2 of Paracetamol

Metoclopramide and Domperidone: accelerate absorption of Paracetamol

Cholestyramine: reduces absorption of Paracetamol

Concomitant use of Paracetamol (4 g per day for at least 4 days) with oral anticoagulants may lead to slight variations of INR values. In this case, increased monitoring of INR values should be done during the duration of the combination and after its discontinuation. 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.

Isoniazid: Reduction of paracetamol clearance, with possible potentiation of its action and/or toxicity, by inhibiting its metabolism in the liver.

Lamotrigine: Decrease in the bioavailability of lamotrigine, with possible reduction of its effect, due to possible induction of its metabolism in the liver.

Reduced absorption with cholestyrarnine.

Interference with laboratory tests: Paracetamol may affect uric acid tests by wolframatop phosphoric acid, and blood sugar tests by glucose-oxydase-peroxydase.

4.6 Fertility, pregnancy and lactationPregnancy

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.

Following oral administration, Paracetamol is excreted into breast milk in small quantities. To date, no adverse reactions or undesirable effects are known in association with lactation. Therapeutic doses of Paracetamol can be administered during breast-feeding.

4.7 Effects on ability to drive and use machines

There are unlikely to be any problems with normal use.

4.8 Undesirable effects

The frequency using the following convention: very common (> 1/10); common (>1/100 to < 1/10); uncommon (>1/1000 to < 1/100); rare (>1/10000 to < 1/1000); very rare (< 1/10000), including isolated reports; not known: frequency cannot be estimated from the available data. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Not known: Oedema of the larynx, anaphylactic shock, anaemia, bronchospasm*, liver alteration and hepatitis, renal alteration (severe renal impairment, nephrite interstitial, haematuria, anuresis), gastrointestinal effects and vertigo have been reported.

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

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.

At the recommended dosage drowsiness, impaired mental functions and methaemoglobinaemia may occur. Allergic reactions and sensitivity are rare and may include skin rash, drug fever, mucosal lesions, neutropaenia, pancytopaenia and leukopaenia.

5.2 Pharmacokinetic properties

Absorption

Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring 30 minutes to 2 hours after ingestion.

Biotransformation

It is metabolised in the liver and excreted in the urine mainly as a glucuronide and sulphate conjugates. Less than 5 % is excreted as unchanged 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 overdose and can cause liver damage.

EliminationEli­mination is essentially through the urine. 90% of the ingested dose is eliminated via the kidneys within 24 hours, principally as glucuronide (60 to 80%) and sulphate conjugates (20 to 30%). Less than 5% is eliminated in unchanged form. Elimination half life is about 2 hours.

Renal Function

Renal Insufficiency: In cases of severe renal insufficiency (creatinine clearance lower than 10 ml/min) the elimination of paracetamol and its metabolites is delayed.

Elderly Subjects

The capacity for conjugation is not modified.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Paracetamol: useful anti- has analgesic and antipyretic actions similar to Aspirin. It has no inflammatory properties.

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 metabolised in the liver and excreted in the urine mainly as a glucuronide and sulphate conjugates. Less than 5 % is excreted as unchanged paracetamol. The elimination half-life varies from about 1–4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, but increases with increased concentration.

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 overdose and can cause liver damage.

Elimination is essentially through the urine. 90% of the ingested dose is eliminated via the kidneys within 24 hours, principally as glucuronide (60 to 80%) and sulphate conjugates (20 to 30%). Less than 5% is eliminated in unchanged form. Elimination half life is about 2 hours.

Renal Insufficiency: In cases of severe renal insufficiency (creatinine clearance lower than 10 ml/min) the elimination of paracetamol and its metabolites is delayed.

Elderly Subjects. The capacity for conjugation is not modified.

5.3 Preclinical safety data

In animal studies investigating the acute, sub chronic and chronic toxicity of paracetamol in the rat and mouse, gastrointestinal lesions, blood count changes, degeneration of the hepatic and renal parenchyma and necrosis were observed. These changes are, on the one hand, attributed to the mechanism of action and, on the other, to the metabolism of paracetamol. The metabolites that is probably responsible for the toxic effects and the corresponding organic changes have also been found in humans. Moreover, during long term use (i.e. 1 year) very rare cases of reversible chronic aggressive hepatitis have been described in the range of maximum therapeutic doses. At sub toxic doses, symptoms of intoxication can occur following a 3-week intake period. Paracetamol should therefore not be administered over a long period of time or at high doses.

Extensive investigations showed no evidence of any relevant genotoxic risk of paracetamol in the therapeutic, i.e. non-toxic, dose range.

Long-term studies in rats and mice yielded no evidence on relevant carcinogenic effects at non-hepatotoxic dosages of paracetamol.

Paracetamol crosses the placental barrier. Animal studies and clinical experience to date have not indicated any teratogenic potential.

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ascorbic acid

Sucrose

Sodium citrate,

Tartaric acid,

Citric acid,

Tapioca starch,

Sodium cyclamate,

Flav-o-lock lemon juice 610399,

Lemon flavour 8476,

Turmeric powder extract (curcumin, E 100).

6.2 Incompatibilities

None Known

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Paper/HDPE/alu­minium/polyet­hylene sachets

5 or 10 sachets in a carton. Each sachet contains 7.7 grams of powder.

6.6 Special precautions for disposal Not applicable.

7 MARKETING AUTHORISATION HOLDER

Bristol Laboratories Limited

Unit 3, Canalside, Northbridge road

Berkhamsted

Herts

HP4 1EG

UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 17907/0348

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28th January 2005