Summary of medicine characteristics - PARACETAMOL & CAFFEINE 500 MG / 65 MG EFFERVESCENT TABLETS
Paracetamol & Caffeine 500 mg / 65 mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 500 mg and caffeine 65 mg.
Excipient with known effect
Each tablet contains 409 mg of sodium
Each tablet contains 4.5 mg of aspartame
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet.
Paracetamol/Caffeine 500 mg / 65 mg effervescent tablets are white to off white coloured circular flat bevelled tablets plain on both sides.
4.1 Therapeutic indications
Paracetamol/Caffeine effervescent tablets are a mild analgesic and antipyretic formulated to give extra pain relief. The soluble tablets are recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, backache, toothache, rheumatic pain and dysmenorrhoea, and relief of the symptoms of colds, influenza and sore throat.
4.2 Posology and method of administration
Paracetamol/Caffeine effervescent tablets should be dissolved in at least half a tumblerful of water.
Adults (including the elderly) and children 16 years and over:
Two tablets up to four times daily.
Do not exceed 8 tablets in 24 hours.
Children aged 12 years to 15 years:
1 tablet dissolved in water every 4 to 6 hours when necessary up to a maximum of 4 tablets in 24 hours.
Paediatric population:
Paracetamol/Caffeine effervescent tablets are not recommended for children under 12 years.
Method of administration
Paracetamol/Caffeine effervescent tablets are for oral administration only.
4.3 Contraindications
Hypersensitivity to paracetamol, caffeine or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Contains paracetamol. Do not use with any other paracetamol containing products. The concomitant use with other products containing paracetamol may lead to an overdose.
Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.
Care 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.
Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis (see section 4.9).
Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Keep out of the sight and reach of children.
Pack label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products.
Patient information 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.
This medicine contains 4.5 mg aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicinal product contains 409 mg sodium per dose, equivalent to >20% of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 167% of the WHO recommended maximum daily intake for sodium.
This medicinal product is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
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. Caffeine may increase clearance of lithium. Concomitant use is therefore not recommended.
4.6 Fertility, pregnancy and lactation
Pregnancy:
Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.
Breast-feeding:
Caffeine in breast milk may potentially have a stimulating effect on breast fed infants.
Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class. Adverse reactions identified during postmarketing use are reported voluntarily from a population of uncertain size, the frequency of these reactions is unknown but likely to be very rare (<1/10,000).
Post marketing data:
PARACETAMOL
| Body System | Undesirable effect |
| Blood and lymphatic system disorders | Thrombocytop enia Agranulocytosis |
| Immune system disorders | Very rare cases of serious skin reactions have been reported. Anaphylaxis Cutaneous hypersensitivity reactions including (amongst others) skin rashes and, angioedema |
| Respiratory, thoracic and mediastinal disorders | Bronchospasmmore likely in patients sensitive to aspirin and other NSAIDs |
| Hepatobiliary disorders | Hepatic dysfunction |
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.
| Body System | Undesirable effect |
| Central Nervous system | Headache Dizziness |
| Cardiac disorders | Palpitation |
| Psychiatric disorders | Insomnia Restlessness Anxiety and irritability |
| Gastrointestinal disorders | Gastrointestinal disturbances |
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Paracetamol
Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk Factors:
If the patient
Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
Regularly consumes ethanol in excess of recommended amounts.
Or
Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdose 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 NPIS or a liver unit.
Caffeine
Symptoms
Overdose of caffeine may result in epigastric pain, vomitting, diuresis, tachycardia or cardia arrhythmia, 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 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 with Cope Sachets requires assessment of plasma paracetamol levels for antidote treatment, with signs and symptoms of codeine and caffeine toxicity being managed symptomatically.
Sodium bicarbonate
High doses of sodium bicarbonate may be expected to induce gastrointestinal symptoms including belching and nausea. In addition, high doses of sodium bicarbonate may cause hypernatraemia; electrolytes should be monitored and patients managed accordingly.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other Analgesics and Antipyretics – Anilides.
ATC Code – N02B E51
The combination of paracetamol and caffeine is a well established analgesic combination.
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 absorbed readily after oral administration, maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65 – 80% of administered caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine.
5.3 Preclinical safety data
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
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
Citric acid (anhydrous) (E330),
Povidone,
Saccharin sodium,
Sodium hydrogen carbonate (E500),
Sodium carbonate anhydrous,
Simethicone (E900),
Polysorbate 80 (E433),
Aspartame (E951).
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store in the original package and protect from moisture.
6.5 Nature and contents of container
6.5 Nature and contents of container4– Ply laminate strip pack
These tablets are available in a pack size of 24.
6.6 Special precautions for disposal
No special requirements for disposal.
7. MARKETING AUTHORISATION HOLDER
Cipla (EU) Limited,
Dixcart House, Addlestone Road,
Bourne Business Park,
Addlestone, Surrey,
KT15 2LE, United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 36390/0040
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
15/06/2011