Summary of medicine characteristics - SOLUBLE CUPANOL-PARACETAMOL EFFERVESCENT TABLETS 500 MG LEMON FLAVOUR
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.
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.
This medicinal product contains 433.3 mg sodium per dose, equivalent to 22% of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 176 % of the WHO recommended maximum daily intake for sodium.
Soluble Cupanol-Paracetamol Effervescent Tablets 500mg Lemon Flavour 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
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 Fertility, 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
4.9 OverdoseIf 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
5.1
Paracetamol exhibits both analgesic and antipyretic properties.
5.2 Pharmacokinetic properties
None stated.
5.3 Preclinical safety data
5.3 Preclinical safety dataNone stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric acid anhydrous
Povidone
Sodium Cyclamate
Polyethylene glycol 6000
Sodium bicarbonate
Sodium carbonate (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
6.4 Special precautions for storageStore at or below 25°C in a dry place.
6.5 Nature and contents of container
Store at or below 25°C in a dry place.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Northumbria Pharma Ltd
Netpark
Thomas Wright Way
Sedgefield
County Durham
TS21 3FD
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 48259/0028
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
28/02/1990 / 18/03/1996