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Soluble Cupanol-Paracetamol Effervescent Tablets 500mg Lemon Flavour

Document: leaflet MAH BRAND_PL 08215-0095 change

PATIENT INFORMATION LEAFLET

SOLUBLE CUPANOL-PARACETAMOL EFFERVESCENT TABLETS

500mg LEMON FLAVOUR

Please read this leaflet carefully before you start to use this product. If you have any questions or are unsure about anything, ask you doctor or pharmacist.

Soluble Cupanol-Paracetamol Effervescent Tablets 500mg Lemon Flavour contains the following active ingredient:

Paracetamol 500 mg

In addition, they contain the following inactive ingredients:

Citric acid (E330), povidone, sodium saccharin, sodium cyclamate, sodium bicarbonate, sodium carbonate, polyethylene glycol 6000, lemon flavour.

Your medicine

Soluble Cupanol-Paracetamol Effervescent Tablets 500mg Lemon Flavour are white, Round, flat tablets for oral administration. They are packed in cartoned strip packs of 16, 20, 24, 56, 60 and 100 tablets.

Product type

Soluble Cupanol-Paracetamol Effervescent Tablets 500mg Lemon Flavour contain Paracetamol which possesses analgesic and antipyretic properties which assists in reducing pain and feverishness.

Product license holder

Kent Pharmaceuticals Ltd,

Repton Road,

Measham,

DE12 7DT, UK.

Manufacturer

Cupal Ltd King Street Blackburn BB2 2DX

Uses

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

Before Using Soluble Cupanol-Paracetamol Effervescent Tablets 500mg Lemon Flavour

The following information should be read before using this medicine.

1.    Do not use the product if you are sensitive to paracetamol, or any of the ingredients listed at the beginning of this leaflet.

2.    This product should not be used if you suffer from impaired kidney or liver function.

3.    This product contains 18.9 mmol (or 433.3mg) of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

4.    If you are taking any of the following, consult your doctor before use: alcohol, barbiturates (to depress CNS activity), anticonvulsants, antidepressants, chloramphenicol, cholestyramine, metoclopramide, or domperidone.

5.    Consult your doctor or pharmacist before taking this product if you are taking Warfarin or any other anticoagulant treatment as prolonged regular use of Paracetamol may enhance the anticoagulant effect.

6.    Do not give this product to children under 12 years of age.

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

8.    This product contains paracetamol - do not exceed the stated dose.

9.    Prolonged use of this product, except under medical supervision, can be harmful.

10.    Make sure Soluble-Cupanol Paracetamol Effervescent Tablets 500mg Lemon Flavour are suitable for you to use - ask your doctor or pharmacist.

Directions For Using Soluble Cupanol-Paracetamol Effervescent Tablets 500mg Lemon Flavour

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 8 tablets in any 24 hour period.

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

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.

Side Effects

The following undesirable effects have been reported following use of this product:

1.    Skin rashes

2.    Blood disorders

If you experience any of these or any other form of reaction not mentioned above, discontinue taking the product and report this to your doctor or pharmacist who will advise you on the necessary action to take.

Storage Conditions

This product has a two year shelf life from the date of manufacture; its expiry date is given on the carton label.

Do not use Soluble-Cupanol Paracetamol Effervescent Tablets 500mg Lemon Flavour after the expiry date shown on the label.

This product should be stored at or below 25oC, in a dry place, out of the reach of children.

Date of revision June 2016