Klacid LA 500mg Modified release tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Clarithromycin

Beszerezhető a:

Viatris Healthcare Limited

ATC-kód:

J01FA; J01FA09

INN (nemzetközi neve):

Clarithromycin

Gyógyszerészeti forma:

Modified-release tablet

Terápiás terület:

Macrolides; clarithromycin

Engedélyezési státusz:

Marketed

Engedély dátuma:

1997-03-21

Betegtájékoztató

Package leaflet: Information for the patient
KLACID LA 500 MG MODIFIED 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 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 LA is and what it is used for
2. What you need to know before you take Klacid LA
3. How to take Klacid LA
4. Possible side effects
5. How to store Klacid LA
6. Contents of the pack and other information
1.
WHAT KLACID LA IS AND WHAT IT IS USED FOR
Klacid LA is an antibiotic belonging to a group called the macrolides.
Antibiotics stop
the growth of certain germs that cause infections. Its use is
described below. Klacid LA
tablets are modified release tablets, which means that the active
ingredient is released
slowly from the tablet so that you only have to take the medicine once
a day.
WHAT ARE KLACID LA TABLETS USED FOR?
The Klacid LA tablets are used to treat infections such as:
1.
Chest infections such as bronchitis and pneumonia
2.
Throat and sinus infections
3.
Skin and soft tissue infections, which may also be called cellulitis,
folliculitis or
erysipelas.
Klacid LA Tablets are used in adults and children 12 years and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLACID LA
DO NOT TAKE KLACID LA 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
dihydroergotam

Termékjellemzők

Health Products Regulatory Authority
20 March 2024
CRN00F5XF
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Klacid LA 500mg Modified release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Clarithromycin 500 mg
Excipients with known effect: lactose and sodium
Each tablet contains 115 mg lactose monohydrate and 15.3 mg sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified release tablet.
Yellow, ovaloid modified-release tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Klacid LA is indicated in adults and children aged 12 years and older
for the treatment of the following infections caused by
susceptible organisms (see section 5.1).

Lower respiratory tract infections for example bronchitis and
pneumonia (see section 4.4).

Upper respiratory tract infections for example sinusitis and
pharyngitis.

Skin and soft tissue infections for example folliculitis, cellulitis
and erysipelas (see section 4.4).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS: The usual recommended dosage of Klacid LA 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 taken as one dose daily. Dose
must be taken at the same time every day.
Tablets must be swallowed whole.
The usual duration of treatment is 6 to 14 days.
CHILDREN OLDER THAN 12 YEARS: As for adults.
CHILDREN YOUNGER THAN 12 YEARS: The use of Klacid LA has not been
studied in children less than 12 years of age. Clinical trials
have been conducted using clarithromycin paediatric suspension in
children 6 months to 12 years of age. Use of Klacid LA is
not recommended for children younger than 12 years. Therefore,
children under 12 years of age should use clarithromycin
paediatric suspension (granules for oral suspension).
PATIENTS WITH RENAL IMPAIRMENT: In pat