Clorom 250 mg Film-Coated Tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Clarithromycin

זמין מ:

Rowex Ltd

קוד ATC:

J01FA; J01FA09

INN (שם בינלאומי):

Clarithromycin

כמות:

250 milligram(s)

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

Macrolides; clarithromycin

מצב אישור:

Marketed

תאריך אישור:

2004-10-08

מאפייני מוצר

Health Products Regulatory Authority
05 April 2022
CRN00CS3L
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clorom 250 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg of clarithromycin.
Excipients with known effect:
Each film-coated tablet contains 6.8 mg of lactose and 0.13 mmol (3.06
mg) of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, oblong, convex, coated tablets, scored on both faces.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clorom is indicated in adults and adolescents 12 years and older for
the treatment of the following bacterial infections, when
caused by clarithromycin-susceptible bacteria (see section 4.4 and
5.1):

Acute bacterial exacerbation of chronic bronchitis

Mild to moderate community acquired pneumonia

Acute bacterial sinusitis

Bacterial pharyngitis

Skin infections and soft tissue infections of mild to moderate
severity, such as folliculitis, cellulitis and erysipelas
Clorom can also be used in appropriate combination with antibacterial
therapeutic regimes and an appropriate ulcer healing
agent for the eradication of Helicobacter pylori in patients with
Helicobacter pylori associated ulcers (see section 4.2).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of clarithromycin depends on the clinical condition of the
patient and has to be defined in any case by the
physician.
Adults and adolescents (12 years and older)
The usual dosage is 250 mg twice daily.
In severe infections, dosage can be increased to 500 mg twice daily.
Children younger than 12 years
Use of clarithromycin film-coated tablets is not recommended for
children younger than 12 years.
Use clarithromycin paediatric suspensions.
Clinical trials have been conducted using clarithromycin pediatric
suspension in