KLACID FORTE 500 MG FILM-COATED TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-05-2024
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Active ingredient:
CLARITHROMYCIN
Available from:
PCO Manufacturing
Dosage:
500 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2002-01-11
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Klacid Forte 500 mg Film-coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of clarithromycin
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Greece and Spain:_
Yellow, ovaloid, film-coated tablets
_Product imported from the Netherlands:_
Yellow, ovaloid, film-coated tablets with a symbol embossed on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarithromycin is indicated for treatment of infections due to susceptible organisms. Such infections include:
1. Lower respiratory tract infections (eg. bronchitis, pneumonia).
2. Upper respiratory tract infections (eg. pharyngitis, sinusitis).
3. Skin and soft tissue infections (eg. folliculitis, cellulitis, erysipelis).
4. Disseminated or localised mycobacterial infections due to _Mycobacterium avium or Mycobacterium intracellulare_.
Localised infections due to _Mycobacterium chelonae, Mycobacterium fortuitum, or Mycobacterium kansasii._
5. Clarithromycin is indicated for the prevention of disseminated _Mycobacterium avium complex _infection in HIV-
infected patients with CD4 lymphocyte counts less than or equal to 100/mm³.
6. Clarithromycin in the presence of acid suppression is indicated for the eradication of _H. pylori, _resulting in
decreased recurrence of duodenal ulcer. (See Further information).
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 Forte.
_FURTHER INFORMATION: H. pylori _is strongly associated with peptic ulcer disease. Ninety to 100% of patients with
duodenal ulce
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