BELLS HOT BLACKCURRANT COLD RELIEF POWDERS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Bell’s Hot Blackcurrant Cold Relief Powders

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Paracetamol 650 mg

For excipients see 6.1.

3. PHARMACEUTICAL FORM

Powder for oral solution.

Unit doses of purple powder contained in individual laminate sachets.

4.1 Therapeutic indications

For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, feverishness and feverish colds.

4.2. Posology and method of administration

Adults, the elderly and children over 12 years: one sachet every four hours to a maximum of 4 sachets in any 24 hour period.

Empty the contents of one sachet into a tumbler and fill with hot water. Stir till dissolved.

If symptoms persist for more than 3 days, consult your doctor.

4.3. Contra-indications

Hypersensitivity to paracetamol or any of the other constituents.

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.

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

Contains Paracetamol.

Do not take anything else containing paracetamol while taking this medicine.

Talk to your doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

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

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

Keep out of the sight and reach of children.

Patients should be advised that paracetamol may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.

4.5 Interaction with other medicinal products and other forms of interaction

Cholestyramine: The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal analgesia is required.

Metoclopramide and Domperidone: The absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use need not be avoided.

Warfarin: 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 affect.

Chloramphenicol: Increased plasma concentration of chloramphenicol.

4.6 Pregnancy and Lactation

Epidemiological 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 do not contraindicate breast feeding.

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.

4.7. Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Adverse effects of paracetamol are rare. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia purpura, methaemogloenaemia and agranulocytosis, but these were not necessarily causality related to paracetamol.

Reporting of suspected adverse reactions

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.yellowcard.mhra.gov.uk. or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Post marketing data__________­____________________

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

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).

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 not 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 24 hours from ingestion should be discussed with the NPIS or a liver unit.

5.1 Pharmacodynamic properties

Mechanisms of Action/Effect

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.

Antipyretic – paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

5.2 Pharmacokinetic properties

Absorption and Fate

Paracetamol is readily absorbed from the gastro-intestinal tract

The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma halflife is 1 – 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 – 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation.

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 Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

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

Citric Acid Anhydrous

Tartaric Acid

Sodium Cyclamate

Spray Dried Blackcurrant Flavour

Blackcurrant Flavour

Blackcurrant Aroma

Starch (modified edible) Anthocyanin E163.

6.2. Incompatibilities

None known.

6.3. Shelf life

Three years.

6.4 Special precautions for storage

Do not store above 25oC

Do not use this medicine after the ‘EXP’ date shown on the pack.

6.5. Nature and contents of container

A laminated sachet containing 5 g of powder. Pack size: 5, 8 or 10 sachets per carton. The laminate consists of an inner polyethylene layer, followed by aluminium foil, a second polyethylene layer and an outer paper coating.

6.6. Instructions for use and handling

Not applicable.

7.

8.

Bell Sons & Co (Druggists) Ltd

Gifford House

Slaidburn Crescent

Southport

Merseyside

PR9 9AL

United Kingdom

MARKETING AUTHORISATION NUMBER

PL 03105/0070

9. DATE OF FIRST AUTHORISATION/RE­NEWAL OF THE AUTHORISATION

29 November 2000