Klacid LA 500 mg modified-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clarithromycin

Available from:

PCO Manufacturing Ltd.

ATC code:

J01FA; J01FA09

INN (International Name):

Clarithromycin

Dosage:

500 milligram(s)

Pharmaceutical form:

Modified-release tablet

Prescription type:

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

Therapeutic area:

Macrolides; clarithromycin

Authorization status:

Authorised

Authorization date:

2014-07-18

Patient Information leaflet

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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
dihydroerg

Summary of Product characteristics

Health Products Regulatory Authority
21 May 2019
CRN008Y1P
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Klacid LA 500 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains clarithromycin 500 mg
Excipients with known effects: lactose and sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified release tablet.
_Product imported from the Czech Republic:_
Yellow, ovaloid modified-release tablet.
4 CLINICAL PARTICULARS
As per PA2010/004/004
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/004/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Citric acid
Sodium alginate
Sodium calcium alginate
Lactose monohydrate
Povidone 40
Talc
Stearic acid 95%
Magnesium stearate
Hydroxypropyl methylcellulose
Macrogol 400
Macrogol 8000
Titanium dioxide
Sorbic acid
Quinoline yellow aluminium lake (E104)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Health Products Regulatory Authority
21 May 2019
CRN008Y1P
Page 2 of 2
Do not store above 30
o
C.
Keep container in the outer carton in order to protect from light and
moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
7 tablets in a blister original pack.
The blisters are packaged in a cardboard carton with a pack insert.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/051/004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 18
th
July 2014
10 DATE OF REVISION OF THE TEXT
May 2019