SUMMARY OF PRODUCT 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.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

To give effective relief from the symptoms of cold and flu.

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 hazard of overdose is greater in those with non-cirrhotic, alcoholic liver disease.

Patients should be advised not to take other paracetamol-containing products concurrently.

Keep out of the sight and reach of children.

On the label:

'Do not take anything else containing paracetamol while taking this medicine'. 'Talk to a doctor at once if you take too much of this medicine, even if you feel well.’

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

On the leaflet (or label if no leaflet exists):

‘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.’

4.5. Interactions 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 cholestyramine.

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.

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.

4.7. Effects on ability to drive and use machines

None.

Undesirable effects

Adverse effects of paracetamol are rare. Very rare cases of serious skin reactions have been reported. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally 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.

4.9. Overdose

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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10 g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

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 and any patient who has ingested around 7.5 g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Paracetamol has analgesic and antipyretic effects and is useful in the treatment of mild to moderate pain.

5.2. Pharmacokinetic properties

Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to two hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol.

5.3. Preclinical safety data

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

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.

Shelf life

Three years.

6.4.    Special precautions for storage

Do not store above 25°C.

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.

ADMINISTRATION DETAILS

7. MARKETING AUTHORISATION HOLDER

Bell Sons & Co (Druggists) Ltd

Gifford House

Slaidburn Crescent

Southport

Merseyside

PR9 9AL

United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 03105/0070

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29 November 2000

10 DATE OF REVISION OF THE TEXT

03/05/2016