Klacid XL 500mg Modified-Release Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CLARITHROMYCIN

Available from:

Mylan Products Limited

ATC code:

J01FA09

INN (International Name):

CLARITHROMYCIN

Pharmaceutical form:

MODIFIED-RELEASE TABLET

Composition:

CLARITHROMYCIN 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Patient Information leaflet

LEAFLET: PATIENT INFORMATION
KLACID
®
XL 500 MODIFIED-RELEASE TABLETS
Clarithromycin
READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT
CONTAINS INFORMATION THAT IS IMPORTANT FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you alone. Do not pass it on to
other people, even if their symptoms are the same as yours, because it
could be dangerous.
-
If you develop any side effects including any that are not listed in
this
leaflet, please contact your doctor or pharmacist. See section 4.
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.
Potential 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 ingredient belonging to a
group of
drugs called antibiotic macrolides. Antibiotics are drugs that stop
the growth
of bacteria that cause infections.
KLACID XL is used to treat:

respiratory infections, such as bronchitis and pneumonia;

throat infections (tonsillitis, pharyngitis) and sinus infections;

skin and tissue infections, for instance impetigo, folliculitis,
erysipelas,
furunculosis and infected wounds;
KLACID XL is a medicine in modified-release tablets, this means that
the active
ingredient is released from the tablet slowly. This means KLACID XL
can be
taken just once a day.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLACID XL DO NOT TAKE KLACID
XL
IF:

you are allergic to clarithromycin or other kinds of macrolide
antibiotics,
such as erythromycin or azithromycin, or any of the other components
of
this medicine (listed in section 6);

you are taking ergotamine or dihydroergotamine, drugs that are used
for
migraine. The combination of these drugs with KLACID XL could cause
serious side effects. Speak with your doctor who will recommend
alternative medic

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
KLACID XL 500 mg Modified-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains:

active ingredient: clarithromycin 500 mg;

excipients with known effects: lactose (115 mg per tablet).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
KLACID is indicated in adults and children aged 12 years and older.
Treatment of infections caused by pathogens susceptible to
clarithromycin.
Infections of the rhino-pharyngeal tract (tonsillitis, pharyngitis),
paranasal sinuses.
Infections of the lower respiratory tract: bronchitis, bacterial
pneumonia and atypical pneumonia.
Skin and soft tissue infections: impetigo, erysipelas, folliculitis,
furunculosis and infected wounds;
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for ADULTS AND CHILDREN OVER 12 YEARS OF AGE is 1
tablet per day to be taken with
food.
For more severe infections, the dosage may be increased up to 2
modified-release 500 mg tablets per day to
be taken in a single administration.
The usual duration of therapy is 5 - 14 days, excluding any treatment
for community-acquired pneumonia
and sinusitis which requires 6 - 14 days of therapy.
_Paediatric population _
IN CHILDREN UNDER 12 YEARS OF AGE, the use of KLACID modified-release
tablets is not recommended. In
these patients USE KLACID 125 MG/5 ML GRANULES FOR ORAL SUSPENSION OR
KLACID 250 MG/5 ML
GRANULES FOR ORAL SUSPENSION.
_Patients with renal impairment_
In patients suffering from renal impairment with creatinine clearance
of less than 30 mL/min, the dosage of
clarithromycin should be reduced by half, for instance 250 mg once
daily, or 250 mg twice daily for severe
infections. In these patients, treatment should not be extended beyond
14 days.
Since the tablet is not abl