CLEAR DISSOLVING PAIN RELIEF TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Clear Dissolving Pain Relief Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient

mg/tablet

Anhydrous caffeine (ALKD) powder EP

Paracetamol powder EP

Paracetamol DC FP 272 GSR HSE

30.0

250.0

260.0

contains 10mg of gelatin

3 PHARMACEUTICAL FORM

Tablet

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For effective relief of headache, rheumatic and muscular pains, backache and symptoms of colds and 'flu.

4.2 Posology and method of administration

Adults and Children over 16 Years

One to two tablets every 4–6 hours when necessary to a maximum of 4 doses in 24 hours.

Children 12 to 15 years

One tablet every 4–6 hours when necessary to a maximum of 4 doses in 24 hours.

These doses should be taken dissolved in half a tumbler of water.

Elderly

There is no need for dosage reduction in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Severe liver disease.

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 (non- cirrhotic) alcoholic liver disease.

Do not give for more than three days without consulting your

doctor. Do not give to children under 6 years, without medical

advice.

Do not exceed the stated dose.

If symptoms persist, consult your

doctor. Contains paracetamol.

Do not take with any other paracetamol-containing

products. Keep all medicines out of the reach of children.

La bel:

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

Leaflet or combined

Label/Leaflet:

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 cholestyramine.

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 effect.

4.6 Fertility, pregnancy and lactation

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.

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

No adverse effects known.

4.8 Undesirable effects

Side effects are usually mild and may include nausea, vomiting, insomnia, anxiety, restlessness, vertigo, palpitations, skin rashes and other allergic reactions. Very rare cases of serious skin reactions have been reported. There have been 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.mhra.gov.uk/yellowcard.

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.

Other symptoms of overdosage, associated with the caffeine component, include maniacal behaviour, diuresis, tremor, delirium, hyperthermia, tachycarida, tachypnoea, electrolyte disturbances and convulsions.

Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of toxic metabolite (usually adequate 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 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetlycysteine, which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

Metabolic abnormalities should be corrected and convulsions controlled by the intravenous administration of diazepam.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Paracetamol is an analgesic with antipyretic activity.

Caffeine is a central nervous system stimulant and contributes to the feeling of well being.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half life varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, although this is dose dependent.

Caffeine is absorbed readily after oral administration and is widely distributed throughout the body. Caffeine passes readily into the CNS and into saliva. In adults, caffeine is metabolised almost completely via oxidation, demethylation and acetylation and is excreted in the urine as various metabolites with only about 1% being excreted unchanged. Elimination half life is approximately 3 to 6 hours in adults.

5.3 Preclinical safety data

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

Citric acid monohydrate

Anhydrous sodium carbonate

Purified water

Refined sugar

Sodium benzoate

Sodium hydrogen carbonate

Sodium saccharin powder

Gelatin

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package.

6.5 Nature and contents of container

Blisters of nylon/alumini­um/polyethyle­ne laminate backed with aluminium/poly­ethylene laminate. Packed in a cardboard carton.

Pack sizes:

6,8,10,12,16,­18,20,24,25,30,36,48,96,­100