DOLFLASH Orodispersible Tablet 500 Milligram
Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Produkta apraksts
(SPC)
19-04-2024
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Aktīvā sastāvdaļa:
PARACETAMOL
Pieejams no:
Ethypharm
Deva:
500 Milligram
Zāļu forma:
Orodispersible Tablet
Autorizācija datums:
2003-03-07
Produkta apraksts
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dolflash 500 mg orodispersible tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet cotains 500 mg paracetamol (as coated paracetamol cystals)
Excipients: each tablet also includes 40 mg aspartame (E951).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
White, round, bi-convex tablet with central concave depression with a characteristic odour of blackcurrant.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment for mild to moderate pain and/or fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY_
This medicinal product is for ADULT USE ONLY_._
The maximum recommended posology is 3000mg of paracetamol per day, corresponding to 6 tablets daily. The usual
posology is 1 tablet of 500mg, to be repeated if necessary after a minimum of 4 hours. In the event of intense pain or
intense fever, 2 tablets of 500mg, to be repeated if necessary after a minimum interval of 4 hours.
Do not exceed 6 tablets of 500mg over a period of 24 hours.
_Maximum recommended posology_: The total dose of paracetamol should not exceed 3g daily for adults _(See Section_
_4.9, Overdose)._
_Frequency of administration_
In adults, administration should take place at intervals of a minimum of four hours.
_Renal insufficiency_
In the case of severe renal insufficiency the minimum interval between 2 administrations should be 8 hours.
_METHOD OF ADMINISTRATION_
Oral route.
The tablet should be sucked but not chewed. The tablet may also be dispersed in a half glass of water.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/04/2012_
_CRN 2105529_
_page number: 1_
4.3
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