Klacid XL Modified-Release Tablets 500mg

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

ATC code:

J01FA09

INN (International Name):

CLARITHROMYCIN 500 mg

Pharmaceutical form:

MODIFIED-RELEASE TABLET

Composition:

CLARITHROMYCIN 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2005-10-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KLACID XL MODIFIED-RELEASE TABLETS 500MG
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 KLACID XL is and what it is used for
2.
What you need to know before you take KLACID XL
3.
How to take KLACID XL
4.
Possible side effects
5.
How to store KLACID XL
6.
Contents of the pack and other information
1.
WHAT KLACID XL IS AND WHAT IT IS USED FOR
KLACID XL contains clarithromycin, an active substance belonging to a
group of medicines called
macrolide antibiotics. Antibiotics are medicines that block the growth
of bacteria that cause
infections.
KLACID XL is used to treat:
▪
respiratory tract infections such as bronchitis and pneumonia;
▪
throat infections (tonsillitis, pharyngitis) and paranasal sinus
infections;
▪
skin and tissue infections, for example impetigo, folliculitis,
erysipelas, furunculosis and infected
wounds.
KLACID XL is a medicinal product in the form of modified-release
tablets; this means that the active
substance is slowly released from the tablet. This means that KLACID
XL need only be taken once
per day.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLACID XL
DO NOT TAKE KLACID XL:
▪
if you are allergic to clarithromycin, to other types of macrolide
antibiotics, such as erythromycin
or azithromycin, or to any of the other ingredients of this medicine
(listed in section 6);
▪
if you are taking ergotamine or dihydroergotamine, medicines used to
treat headaches. The
combination of these medicines with KLACID could result in seriou

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Klacid XL Modified-Release Tablets 500mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains:
▪
Active substance: clarithromycin 500 mg;
▪
Excipients with known effect: lactose 115 mg and sodium 15.3 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Official guidelines on the appropriate use of antibacterial agents
should be considered.
KLACID is indicated in adults and adolescents 12 years and older.
Treatment for infection caused by pathogens susceptible to
clarithromycin.
Rhino-pharyngeal tract infections (tonsillitis, pharyngitis),
paranasal sinus infections.
Lower respiratory tract infections: bronchitis, bacterial pneumonia
and atypical pneumonia.
Skin infections: impetigo, erysipelas, folliculitis, furunculosis and
infected wounds.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose in
ADULTS AND ADOLESCENTS 12 YEARS AND OLDER
is 1 tablet per day to be taken
at meal times.
For more severe infections, the dosage can be increased to two 500-mg
modified-release tablets per
day, to be taken together in a single administration.
Treatment lasts 5 to 14 days, except for treatment of
community-acquired pneumonia and sinusitis,
which require 6 to 14 days.
Special populations
_Paediatric population _
The use of KLACID Modified-release tablets is not recommended IN CHILDREN UNDER 12 YEARS OF
AGE
.
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In this case,
USE KLACID 125 MG/5 ML GRANULES FOR ORAL SUSPENSION OR KLACID 250 MG/5
ML
GRANULES FOR ORAL SUSPENSION
in a bottle with a spoon or dosing syringe.
_Patients with renal impairment_
The clarithromycin dose should be halved in kidney failure patients
with a creatinine clearance value
lower than 30 ml/min, e.g. 250 mg once per day, or 250 mg twice per
day for severe infections.
Treatment should not last more than 14 days in these patients.
Since the tablet cannot b