Clarithromycin 250 mg film-coated tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Clarithromycin

Tilgængelig fra:

Wockhardt UK Limited

ATC-kode:

J01FA09

INN (International Name):

Clarithromycin

Dosering:

250 milligram(s)

Lægemiddelform:

Film-coated tablet

Recept type:

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

Terapeutisk område:

clarithromycin

Autorisation status:

Marketed

Autorisation dato:

2019-01-11

Indlægsseddel

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 are and what they are 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 ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Clarithromycin Tablets
.
Clarithromycin belongs to a group of medicines called macrolide
antibiotics. Antibiotics stop the
growth of bacteria that cause infections.
Clarithromycin is used in the treatment of the following infections:

Chest infections such as bronchitis and pneumonia

Throat and sinus infections

Mild to moderate
skin and tissue infections

Helicobacter pylori infection associated with duodenal ulcer.
Clarithromycin Tablets are indicated in adults and children 12 years
and older.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN TABLETS
DO NOT TAKE CLARITHROMYCIN IF YOU:

know that you are
ALLERGIC
to clarithromycin or other macrolide antibiotics such as erythromycin
or azithromycin or any of the other ingredients of this medicine
(listed in section 6).

are taking medicines called ergot alkaloid tablets (e.g. ergotamine or
dihydroergotamine) or use
ergotamine inhalers for migraine.

are taking medicines called terf

Produktets egenskaber

Health Products Regulatory Authority
09 August 2019
CRN008JK3
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin 250 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg clarithromycin.
Excipient(s) with known effect
19 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, oval shaped, 14 x 7 mm film-coated tablets,
debossed with ‘W954’ on one side and plain on the other 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 is indicated for the treatment of the following
infections caused by clarithromycin susceptible organisms (see
sections 4.4 and 5.1).
• Bacterial pharyngitis
• Mild to moderate community-acquired pneumonia
• Acute bacterial sinusitis (adequately diagnosed)
• Acute exacerbation of chronic bronchitis
• Skin 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
_Helicobacter pylori_-associated ulcers (see section 4.2).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The dosage of Clarithromycin film-coated tablets 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 250mg 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.
_CHILDREN OLDER THAN 12 YEARS: _As for adults.
_CHILDREN YOUNGER THAN 12 YEARS:_ Use of Clarithromycin 250mg Tablets
are not recommended for children younger than 12
years. Use clarithromycin Pae