Paracetamol And Caffeine 500 Mg/65 Mg Tablets
PL 00071/0659
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol and Caffeine 500 mg / 65 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg paracetamol and 65mg caffeine. For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White capsule-shaped, film-coated tablets printed on one side.
4.1 Therapeutic indications
Paracetamol and Caffeine 500 mg / 65 mg tablets are indicated for the symptomatic treatment of mild to moderate pain and relief of fever. The tablets are recommended for the treatment of most painful conditions including headache, migraine, backache, toothache, pain of osteoarthritis, and dysmenorrhoea, and for relieving the fever, aches and pains of colds and flu and sore throat.
4.2 Posology and method of administration
Adults:
Two tablets up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 8 tablets in 24 hours.
Elderly:
As for adults. Children:
Not recommended for children under 12 years.
For oral administration only.
4.3 Contraindications
Hypersensitivity to paracetamol, caffeine and/or any of the other constituents.
4.4 Special warnings and precautions for use
Medical consultation is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Excessive intake of caffeine containing drinks should be avoided while taking this product.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised not to take other paracetamol-containing products concurrently.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
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 colestyramine. 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
Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased risk of spontaneous abortion associated with caffeine consumption.
Caffeine in breast milk may potentially have a stimulating effect in breast fed infants but significant toxicity has not been observed.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects Paracetamol
|
Body System |
Undesirable effect |
Frequency |
|
Blood and Lymphatic system disorders |
Thrombocytop enia |
Very rare (<1/10,000) |
|
Immune System disorders |
Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson Syndrome |
Very rare (<1/10,000) |
|
Respiratory, thoracic and mediastinal disorders |
Bronchospasm in patients sensitive to aspirin and other NSAIDs |
Very rare (<1/10,000) |
|
Hepatobiliary disorders |
Hepatic dysfunction |
Very rare (1/10,000) |
Caffeine
|
Body System |
Undesirable effect |
Frequency |
|
Central Nervous System |
Nervousness |
Not Known |
|
Dizziness |
Not Known |
When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine- related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches,gastrointestinal disturbances and palpitations.
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 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 24h from ingestion should be discussed with the National Poisons Information Service (NPIS) or a liver unit.
Caffeine
Symptoms
Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, or CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).
It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity.
Management
Patients should receive general supportive care (e.g. hydration and maintenance of vital signs). The administration of activated charcoal may be beneficial when performed within one hour of the overdose, but can be considered for up to four hours after the overdose. The CNS effects of overdose may be treated with intravenous sedatives.
Summary
Treatment of overdose requires assessment of plasma paracetamol levels for antidote treatment, with signs and symptoms of caffeine toxicity being managed symptomatically.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Anilides ATC code: N02B E01
The combination of paracetamol and caffeine is a well established analgesic combination.
Paracetamol is an antipyretic and analgesic. Its mechanism of action is believed to include inhibition of prostaglandin synthesis, primarily within the central nervous system. The lack of peripheral prostaglandin inhibition confers important pharmacological properties such as the maintenance of the protective prostaglandins within the gastrointestinal tract. Paracetamol is, therefore, particularly suitable for patients with a history of disease or on concomitant medication where peripheral prostaglandin inhibition would be undesirable (such as, for example, those with a history of GI bleeding or the elderly).
Clinical data has demonstrated that the combination of paracetamol and caffeine gives better efficacy than paracetamol alone.
5.2 Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. It is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal, in the form of conjugated metabolites.
Caffeine is rapidly absorbed from the gastrointestinal tract and is widely distributed throughout the body. It is almost completely metabolized in the liver by oxidation and demethylation to various xanthine derivatives, which are excreted in the urine. The mean plasma half life is about 4.9 hours
5.3 Preclinical safety data
There are no pre-clinical 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
Starch pregelatinised Maize starch Purified Talc Croscarmellose sodium Stearic acid Povidone Potassium sorbate Hypromellose Triacetin
Printing Ink:
Propylene glycol Shellac
Brilliant Blue FCF (E133)
Sodium Lactate Dimethylpolysiloxane
6.2 Incompatibilities
None.
6.3 Shelf life
60 months.
6.4 Special precautions for storage
Do not store above 25 °C.
6.5 Nature and contents of container
Polypropylene (PP) 300pm / PP lidding film 90pm blister packs in an outer cardboard carton, containing 4, 6, 8, 10, 12, 16, 20, 24, 30, 32 tablets.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
SmithKline Beecham (SWG) Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00071/0659
DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
THE
19/05/2010
10
DATE OF REVISION OF THE TEXT
09/12/2015