Document: spc-doc_PL 16431-0054 change

• spc-doc_PL 08215-0095
• spc-doc_PL 16431-0054
• spc-doc_PL 16431-0184

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Soluble Cupanol-Paracetamol Effervescent Tablets 500mg Lemon Flavour

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Paracetamol 500mg

3 PHARMACEUTICAL FORM

Effervescent tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, rheumatic and period pains.

4.2 Posology and method of administration

Route of Administration: Oral.

Adults, the elderly and children over 12 years of age:

One to two tablets to be taken every four hours if necessary. Do not exceed eight (8) tablets in any 24 hour period.

Unsuitable for children under 12 years of age.

Directions:

The tablets must be dissolved in half a glass of water (100ml). The tablets dissolve more quickly in warm water or if stirred.

4.3 Contraindications

Hypersensitivity to paracetamol and/or other ingredients.

This product is contraindicated in patients having impaired liver or kidney function.

Caution: each tablet contains 433.3mg (18.9millimole) of Na+. This sodium should be taken into account when prescribing for patients on a sodium restricted diet.

4.4 Special warnings and precautions for use

If symptoms persist for more than three days, consult your doctor.

Do not exceed the stated dose.

Keep out of the reach of children.

Do not take with any other paracetamol containing products.

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

Alcohol, barbiturates, anti-convulsants and tricyclic anti-depressants may increase the hepatotoxicity of paracetamol particularly after an overdose. Paracetamol may increase the half-life of chloramphenicol.

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 mat be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy and lactation

There is epidemiological evidence for the safety of paracetamol in human pregnancy. It may therefore be taken during human pregnancy. It may also be taken during lactation.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

If given in therapeutic doses, side effects are very rare. Haematological reactions have been reported. Skin rashes and other allergic reactions may occur occasionally. Most reports of adverse reactions to paracetamol relate to overdosage with the drug.

4.9 Overdose

Immediate treatment is essential in the management of paracetamol overdose. Despite lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who had ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

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 tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Liver damage is possible in adults who have taken 10g or more of paracetamol.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Paracetamol exhibits both analgesic and antipyretic properties.

5.2    Pharmacokinetic properties

None stated

5.3    Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Citric acid anhydrous

Povidone

Sodium Cyclamate

Polyethylene glycol 6000

Sodium bicarbonate

Sodium bicarbonate (monohydrate)

Sodium saccharin

Lemon F-O-L 61046E

Water

IMS

6.2 Incompatibilities

None stated

6.3 Shelf life

24 months

6.4 Special precautions for storage

Store at or below 25°C in a dry place.

6.5 Nature and contents of container

16, 20, 24, 56, 60, 100 tablets: strip pack using PPFM laminate comprising: 40gsm MGBK paper, 12gsm LDPE, 8p aluminium foil, 23gsm LDPE. Strips are packed in an outer carton.

6.6 Special precautions for disposal

None stated

7    MARKETING AUTHORISATION HOLDER