Clear Dissolving Pain Relief Tablets
SUMMARY OF PRODUCT 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 30.0
Paracetamol powder EP 250.0
Paracetamol DC FP 272 GSR HSE 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 12 Years
One to two tablets, if necessary, three or four times daily at intervals of not less than four hours, up to a maximum of eight tablets in 24 hours.
Children 5 to 12 years
Half to one tablet, if necessary, three or four times daily at intervals of not less than four hours, up to a maximum of four tablets 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 (noncirrhotic) alcoholic liver disease.
Do not give for more than three days without consulting your doctor. Do not give to children under 5 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.
Label:
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 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
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. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
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 caffeine is metabolised almost completely via oxidation, demethylation and acetylation and is excreted in the urine as various metabolites with only about being excreted unchanged. Elimination half life is approximately 3 to 6 hours adults.
adults,
1%
in
5.3 Preclinical safety data
Not applicable.
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
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Max Remedies Limited 10 Town End View Holmfirth West Yorkshire HD9 1AX
8 MARKETING AUTHORISATION NUMBER(S)
PL 31308/0019
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/03/2009
10 DATE OF REVISION OF THE TEXT
04/03/2009
11 DOSIMETRY (IF APPLICABLE)
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)