NAME OF THE MEDICINAL PRODUCT

Abdine Cold Relief Powder

Abdine Hot Lemon Cold Relief Powders

Alexander’s Hot Lemon Cold Relief 650 mg Powder For Oral Solution

Bell’s Hot Lemon Cold Relief Powders

Cold & Flu Relief Powders Lemon Flavour

Cold Relief Powders Lemon Flavour

Menthodex Hot Lemon Powders (export only)

Superdrug Hot Lemon Cold Relief 650 mg Powder For Oral Solution Wilko Hot Lemon Cold Relief Powders

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Paracetamol BP 650 mg.

3.    PHARMACEUTICAL FORM

Powder for oral solution.

4.    CLINICAL PARTICULARS

4.1. Therapeutic indications

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

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.

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 special 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.

Do not exceed the recommended dose.

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

If symptoms persist, consult your doctor.

Keep out of the reach of children.

On the label:

‘Do not take with any other paracetamol-containing products’.

‘Immediate medical advice should be sought in the event of an overdose, even if you feel well’.

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

‘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’.

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.

4.8.    Undesirable effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

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

This product is a mixture of active ingredients and excipients in powder form. When the contents of a sachet are passed through a disintegration unit (BP method) none of the granules are left on the wire mesh.

5.2. Pharmacokinetic properties

Sources: Martindale, The Extra Pharmacopoeia, 29^th Edition.

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 glucuronride 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 BP, Citric Acid BP, Tartaric Acid BP, Sodium Cyclamate, Spray Dried Lemon Juice, Lemon Aroma, Starch (modified, edible) and Natural Colour E100.

6.2. Incompatibilities

None known.

6.3. Shelf life

As packaged for sale: Three years.

Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

A trifoil laminated sachet containing 5 g of powder. Pack size: 5, 8 or 10 sachets per carton.

6.6. Instructions for use and handling

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

7. MARKETING AUTHORISATION HOLDER

Bell Sons & Co (Druggists) Ltd Gifford House Slaidburn Crescent Southport

Merseyside PR9 9AL