CLARITHYROMYCIN 125/5 Mg/Ml Granules for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLARITHROMYCIN

Available from:

Rowex Ltd

INN (International Name):

CLARITHROMYCIN

Dosage:

125/5 Mg/Ml

Pharmaceutical form:

Granules for Oral Suspension

Prescription type:

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

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

CLARITHROMYCIN 125 MG/5 ML GRANULES FOR ORAL SUSPENSION 

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 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 is and what it is used for 
2.  What you need to know before you take Clarithromycin 
3.  How to take Clarithromycin 
4.  Possible side effects 
5.  How to store Clarithromycin 
6.  Contents of the pack and other information 

1.  WHAT CLARITHROMYCIN IS AND WHAT IT IS USED FOR 

Clarithromycin is an antibiotic which belongs to the group
of macrolide antibiotics. It stops the 
growth of certain bacteria. 

Clarithromycin is used to treat: 

  Throat and sinus infections 

  Middle ear infections in children 

  Chest infections, such as bronchitis and pneumonia 

  Skin and soft-tissue infections 

  Gastric ulcers caused by the bacterium Helicobacter pylori. 

2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN 

DO NOT TAKE CLARITHROMYCIN 

  if 
y
ou are ALLERGIC to clarithromycin, other macrolide
antibiotics or to any of the other ingredients 
of this medicine
 (listed in section 6)


  if you have a history of certain
abnormal HEART RHYTHMS (ventricular arrhythmia, including 
torsades de pointes) or changes in the
heart activity as measured in the electro-cardiogram called 
“Q

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin 125mg/5ml Granules for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution 1 ml oral suspension contains 25 mg clarithromycin,
5 ml oral suspension contain 125 mg clarithromycin.
Excipient with known effect
The product contains 2.4 g sucrose per 5 ml ready- for- use suspension.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension.
White to beige granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarithromycin 25 mg/ml granules for oral suspension is indicated in adults, adolescents and children, 6 months to 12
years, for the treatment of the following acute and chronic infections, when caused by clarithromycin susceptible
organisms.
•
Infections of the upper respiratory tract such as tonsillitis/pharyngitis, as an alternative when beta lactam
antibiotics are not appropriate.
•
Acute otitis media in children.
•
Infections of the lower respiratory tract such as community acquired pneumonia.
•
Sinusitis and acute exacerbation of chronic bronchitis in adults and adolescents over 12 years of age
•
Skin infections and soft tissue infections of mild to moderate severity.
In appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer healing medicinal product
for the eradication of _Helicobacter pylori _in adult patients with _H. pylori _associated ulcers. See section 4.2.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of Clarithromycin 25 mg/ml granules for oral suspension depends on the clinical condition of the patient
and has to be defined in any case by the physician.
_Adults and a