CLARITHROMYCIN 250 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
01-11-2016
Summary of Product characteristics
(SPC)
01-11-2016
Active ingredient:
CLARITHROMYCIN
Available from:
Ranbaxy Ireland Limited
ATC code:
J01FA09
INN (International Name):
CLARITHROMYCIN
Dosage:
250 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Macrolides
Authorization status:
Transfer Pending
Authorization date:
2006-10-20
Patient Information leaflet
Package leaflet: Information for the user:
CLARITHROMYCIN 250MG FILM-COATED TABLETS
CLARITHROMCYIN 500MG FILM-COATED TABLETS
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 CLARITHROMYCIN FILM-COATED TABLETS ARE AND WHAT THEY
ARE USED
FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CLARITHROMYCIN FILM-COATED
TABLETS
3. HOW TO TAKE CLARITHROMYCIN FILM-COATED TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CLARITHROMYCIN FILM-COATED TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
_ _
1.
WHAT CLARITHROMYCIN FILM-COATED TABLETS ARE AND WHAT THEY
ARE USED FOR
Clarithromycin is a macrolide antibiotic which is
highly effective in the treatment of a
variety of infections including:
Throat and sinus infections,
Chest infections such as bronchitis and pneumonia,
Skin and soft tissue infections
_Helicobacter pylori_ infections associated with duodenal
ulcers
Clarithromycin film-coated tablets are indicated in adults and
children 12 years and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CLARITHROMYCIN FILM-COATED TABLETS
Do not take Clarithromycin Film-Coated Tablets if:
-
You are allergic to clarithromycin,
other macrolides (similar antibiotics) or any of the other
ingredients of
this medicine
( listed
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin 250mg, Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains clarithromycin 250 mg.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Light yellow coloured, oval shaped biconvex film-coated tablet, embossed with “C1” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Clarithromycin is indicated in adults and children 12 years and older.
Clarithromycin Tablets are indicated for treatment of the following infections when caused by susceptible organisms.
Indications include:
Lower respiratory tract infections for example acute and chronic bronchitis, and pneumonia.
Upper respiratory tract infections for example sinusitis and pharyngitis.
Clarithromycin is appropriate for initial therapy in community acquired respiratory infections and has been shown to be
active in vitro against common and atypical respiratory pathogens as listed in the microbiology section.
Clarithromycin is also indicated in skin and soft tissue infections of mild to moderate severity.
Clarithromycin in the presence of acid suppression effected by omeprazole or lansoprazole is also indicated for the
eradication of _H. pylori _in patients with duodenal ulcers (See section 4.2, POSOLOGY AND METHOD OF ADMINISTRATION).
Clarithromycin is usually active against the following organisms in vitro:
Gram-positive Bacteria: _Staphylococcus aureus _(methicillin susceptible); _Streptococcus pyogenes _(Group A beta-
hemolytic streptococci); alpha-hemolytic streptococci (viridans group_); Streptococcus (Diplococcus) pneumoniae;_
_Streptococcus agalactiae; Listeria monocytogenes_.
Gram-negative
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