Clarithromycin Teva 500 mg film-coated tablets

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Clarithromycin

Доступно од:

Teva Pharma B.V.

АТЦ код:

J01FA; J01FA09

INN (Међународно име):

Clarithromycin

Дозирање:

500 milligram(s)

Фармацеутски облик:

Film-coated tablet

Тип рецептора:

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

Терапеутска област:

Macrolides; clarithromycin

Статус ауторизације:

Marketed

Датум одобрења:

2012-05-04

Информативни летак

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITHROMYCIN TEVA 250 MG FILM-COATED TABLETS
CLARITHROMYCIN TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Clarithromycin Teva
3.
How to take Clarithromycin Teva
4.
Possible side effects
5.
How to store Clarithromycin Teva
6.
Contents of the pack and other information
1.
WHAT CLARITHROMYCIN TEVA IS AND WHAT IT IS USED FOR
Clarithromycin Teva belongs to a group of drugs called macrolide
antibiotics.
Clarithromycin Teva is used in the treatment of the following
infections:
-
bronchitis and pneumonia
-
throat and sinus infections: sinusitis and pharyngitis
-
skin and soft tissue infections
_- _
_Helicobacter pylori_
infection associated with duodenal ulcer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN TEVA
DO NOT TAKE CLARITHROMYCIN TEVA
-
if you are allergic to clarithromycin, to other macrolide antibiotics
(e.g. erythromycin,
azithromycin) or to any of the other ingredients of this medicine
(listed in section 6).
-
if you are taking any of the following medicines:
-
astemizole or terfenadine (for hay fever or allergies), cisapride or
domperidone (for stomach
disorders) or pimozide (to treat certain psychiatric diseases) as
taking these medicines with
Clarithromycine Teva can cause serious disturbances in heart rhythm.
Consult your doctor for
advice on alternative medicines.
-
other medicines which are known

Карактеристике производа

Health Products Regulatory Authority
01 February 2023
CRN00CLGP
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin Teva 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg clarithromycin.
Excipients with known effect
Each film-coated tablet contains 0.14 mg tartrazine aluminium lake
(E102) and 0.001 mg allura red aluminium lake (E129).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Light yellow, film-coated oval shaped tablet, debossed with "93" on
one side and "7158" on the other.
Length: 22 mm Width: 11 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarithromycin Teva is indicated in adults and adolescents 12 years
and older for the treatment of the following infections
caused by susceptible organisms:
- Bacterial pharyngitis
- Acute bacterial sinusitis (adequately diagnosed)
- Acute exacerbation of chronic bronchitis
- Community-acquired pneumonia
- Skin and soft tissue infections (mild to moderate severity)
In appropriate combination with antibacterial therapeutic regimens and
an appropriate ulcer-healing agent for the eradication
of _H. pylori_ in 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 depends on the clinical condition of the
patient and has to be defined in any case by the
physician.
250 mg and 500 mg tablets are available.
POSOLOGY
Adults and adolescents (12 years and older)
The recommended dose is 250 mg twice daily.
In severe infections, the dose may be increased to 500 mg twice daily.
Paediatric population
Clarithromycin tablets are not suitable for children under 12 years of
age weighing less than 30 kg. Other pharmaceutical forms
are more adapted for these patients.
Elderly people
As for adults.
Health Products Regulatory Authority
01 February 2023
CRN00CLGP
P