CLARITHROMYCIN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLARITHROMYCIN

Available from:

Accord Healthcare Limited

ATC code:

J01FA09

INN (International Name):

CLARITHROMYCIN

Dosage:

500 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

clarithromycin

Authorization status:

Authorised

Authorization date:

2017-04-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Clarithromycin 250 mg
film-coated tablets
Clarithromycin 500 mg
film-coated 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 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 tablets is and what it is
used for
2. What you need to know before you take
Clarithromycin tablets
3. How to take Clarithromycin tablets
4. Possible side effects
5. How to store Clarithromycin tablets
6. Contents of the pack and other information 1. WHAT CLARITHROMYCIN TABLETS IS
AND WHAT IT IS USED FOR
Clarithromycin tablet contains the active
ingredient clarithromycinwhich belongs to a group
of medicines called macrolide antibiotics.
Antibiotics stop the growth of certain bacteria
which cause infections.
Clarithromycin tablets is used to treat bacterial
infections, which previously have to be
adequately diagnosed by your treating physician
such as:
•
Chest infections such as bronchitis and
community acquired pneumonia
•
Throat and sinus infections
•
Skin and tissue infections (e.g. impetigo,
erysipelas, erythrasma)
•
In combination with appropriate ulcer healing_ _
_Helicobacter pylori _infection associated with
duodenal ulcer (restricated to adults only).
Clarithromycin tablets are indicated in adults and
adolescents 12 years and older. 2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CLARITHROMYCIN
TABLETS
DO NOT TAKE CLARITHROMYCIN TABLETS IF:
•
you are allergic to clarithromycin, other
macrolide antibiotics such as erythromycin or
azithromycin or any of the other ingredients of
this medi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Clarithromycin 500 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 tablets,
with ‘C’ and ‘2’ debossed on either side of breakline
on one side. Tablet length is approximately 18.60 mm and width is
approximately 8.85 mm.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarithromycin are indicated for the treatment of the following
bacterial infections in adults and adolescents aged 12
years and older, when caused by clarithromycin-susceptible bacteria in
patients with known hypersensitivity to beta-
lactam antibiotics or when beta-lactam antibiotics would be
inappropriate for other reasons (see sections 4.4 and 5.1).
Streptococcal pharyngitis
Acute bacterial sinusitis (adequately diagnosed)
Acute exacerbation of chronic bronchitis (adequately diagnosed)
Mild to moderate community acquired bacterial pneumonia
Skin infections and soft tissue infections of mild to moderate
severity (e.g. impetigo, erysipelas, erythrasma)
In appropriate combination with antibacterial therapeutic regimens and
an appropriate ulcer healing agent for the
eradication of Helicobacter pylori in patients with Helicobacter
pylori associated ulcers (see section 4.2). This
indication is restricted to adults only.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage of Clarithromycin depends on the type and severity of the
infection and has to be defined in any case by the
physician.
Adults
Standard dosage: The usual dose is 250 mg twice daily (in the morning
and in the evening).
High dosage treatment (severe infections): The usual dose may be
increased to 500 mg twice daily in severe
infections.
Adoles