KLACID LA MODIFIED-RELEASE 500MG TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
29-04-2024
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Active ingredient:
CLARITHROMYCIN
Available from:
PCO Manufacturing
Dosage:
500 Milligram
Pharmaceutical form:
Modified-release Tablets
Authorization date:
2004-05-07
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Klacid LA 500mg Modified-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg of clarithromycin.
Excipients: also contains lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified Release Tablets.
_Product imported from Greece, Spain, the Netherlands and the UK:_
Yellow, ovaloid tablets, plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Klacid LA is indicated for treatment of infections caused by susceptible organisms. Indications include:
Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia.
Upper respiratory tract infections for example, sinusitis and pharyngitis.
Skin and soft tissue infections, for example folliculitis, cellulitis and erysipelas.
As with other antibiotics, it is recommended that guidelines on the prevalence of local resistance, and associated
medical practice regarding the prescription of antibiotics, be consulted before prescribing Klacid LA.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults: _The usual recommended dosage of Klacid LA in adults is one 500mg modified-release tablet daily to be taken
with food.
In more severe infections, the dosage can be increased to two 500mg modified-release tablets daily. The usual duration
of treatment is 6 to 14 days.
_Children older than 12 years: _As for adults.
_Children younger than 12 years: _Use Klacid Paediatric Suspension.
_Patients with renal impairment: _Klacid LA should not be used in patients with renal impairment (creatinine clearance
less than 30 mL/min). Klacid immediate release tablets may be used in this patient population. _(See 4.3 Contra-_
_indications)._
4.3 CONTRAINDICATIONS
Clarithromycin is contraindicated in patients wit
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