Clorom XL 500 mg Prolonged-Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clarithromycin

Available from:

Morningside Healthcare (Malta) Limited

ATC code:

J01FA; J01FA09

INN (International Name):

Clarithromycin

Dosage:

500 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

Macrolides; clarithromycin

Authorization status:

Marketed

Authorization date:

2011-04-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOROM XL 500 MG PROLONGED RELEASE TABLETS
CLARITHROMYCIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Clorom XL Tablets are and what they are used for
2.
What you need to know before you take Clorom XL Tablets
3.
How to take Clorom XL Tablets
4.
Possible side effects
5.
How to store Clorom XL Tablets
6.
Contents of the pack and other information
1.
WHAT CLOROM XL TABLETS ARE AND WHAT THEY ARE USED FOR
Clorom XL 500 mg Prolonged Release Tablets (Called Clorom XL Tablets
in this leaflet)
contain the active ingredient clarithromycin citrate. Clarithromycin
belongs to a group of
medicines called macrolide antibiotics. Antibiotics stop the growth of
bacteria (bugs) which
cause infections. Clorom XL Tablets are used to treat infections such
as:
1.
Chest infections such as bronchitis and pneumonia
2.
Throat and sinus infection
3.
Mild
to
moderate
skin
and
tissue
infections,
e.g.
cellulitis,
folliculitis
or
erysipelas.
Clorom XL Tablets are used in adults and children 12 years and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOROM XL TABLETS
DO NOT TAKE CLOROM XL TABLETS

If you know that you are allergic to clarithromycin or other
antibiotics from the same
drug class (macrolide antibiotics) such as erythromycin or
azithromycin, or if you are
allergic to any of the other ingredients of this medicine (listed in
section 6).

If you are taking ergot alkaloids (e.g. ergotamine or
dihydroergotamine tablets) or use
ergotamine inhalers for migraine

Summary of Product characteristics

Health Products Regulatory Authority
24 September 2021
CRN00CLCM
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clorom XL 500 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated prolonged release tablet contains;
Clarithromycin citrate equivalent to clarithromycin 500 mg.
Excipient with known effect:
Each tablet contains 298 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Yellow coloured, film-coated, oblong shaped, biconvex tablet, with
both sides plain.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Clorom XL 500 mg Tablets are indicated in adults and children 12 years
and older.
Clorom XL 500 mg Tablets are indicated for treatment of infections
caused by susceptible organisms. Indications include:
Lower respiratory tract infections for example, acute and chronic
bronchitis, and pneumonia (see section 4.4 and 5.1 regarding
Sensitivity Testing).
Upper respiratory tract infections for example, sinusitis and
pharyngitis.
Clorom XL 500 mg Tablets are also indicated in skin and soft tissue
infections of mild to moderate severity, for example
folliculitis, cellulitis and erysipelas (see section 4.4 and 5.1
regarding Sensitivity Testing).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual recommended dosage of Clorom XL Tablets in adults is one 500
mg modified-release tablet daily to be taken with
food. In more severe infections, the dosage can be increased to two
500 mg modified-release tablets daily. The usual duration
of treatment is 6 to 14 days.
_Children older than 12 years_
As for adults.
Do not crush or chew Clorom XL 500 mg Tablets.
Clorom XL 500 mg should not be used in patients with significant renal
impairment (creatinine clearance less than 30 mL/min),
as appropriate clarithromycin dosage reduction is not possible when
administering this prod