SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Paracetamol & Caffeine 500 mg / 65 mg Effervescent Tablets

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.

For a 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    CLINICAL PARTICULARS

4.1    Therapeutic indications

Paracetamol & Caffeine Effervescent Tablets are a mild analgesic and antipyretic formulated to give extra pain relief. The 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 tumbler of water.

Adults:

Two tablets up to four times daily.

Do not exceed 8 tablets in 24 hours.

Elderly:

As for adults.

Children:

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 any of the other constituents.

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 hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Excessive intake of tea or coffee 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.

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 product contains aspartame, a source of phenylalanine which may be harmful for people with phenylketonuria.

Each of these tablets contains 409 mg of sodium. This may interfere if you are on a low sodium 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.

4.6 Pregnancy and lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol and caffeine used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol and caffeine are 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 very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

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 produce nervousness, restlessness, insomnia, excitement, diuresis, facial flushing, muscle twitching, GI disturbance, tachycardia or cardiac arrhythmia, "rambling" flow of thought and speech, psychomotor agitation, or periods of inexhaustibility.

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.

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

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, Simeticone, Polysorbate 80 (E433), and 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

4- Ply laminate strip pack

These tablets are available in a pack size of 24.

6.6    Special precautions for disposal

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Cipla (EU) Limited

Hillbrow House

Hillbrow Road

Esher

Surrey

KT10 9NW

8    MARKETING AUTHORISATION NUMBER(S)

PL 36390/0040

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/06/2011

10 DATE OF REVISION OF THE TEXT

28/11/2012