Clarithromycin Krka 500 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clarithromycin

Available from:

KRKA, d.d., Novo mesto

ATC code:

J01FA; J01FA09

INN (International Name):

Clarithromycin

Dosage:

500 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Macrolides; clarithromycin

Authorization status:

Not marketed

Authorization date:

2017-01-13

Patient Information leaflet

smer
v
lak
en
70
mm
± 0,5 mm
smer branja
kode
_NA.CLARITHROMYCIN KRKA _
_FCT IE _
prva
s
tr
an
smer branja
kode
70
mm
± 0,5 mm
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLARITHROMYCIN KRKA 250 MG
FILM-COATED
T
ABLE
TS
CLARITHROMYCIN KRKA 500 MG
FILM-COATED
T
ABLE
TS
clar
tihr
om
y
cin
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 Krka is and what it is used
for
2. What you need to know before you take Clarithromycin
Krka
3. How to take Clarithromycin
Krka
4. Possible side
effects
5. How to store Clarithromycin
Krka
6. Contents of the pack and other
information
1.
WHAT CLARITHROMYCIN KRKA IS AND WHAT
IT
IS USED
FOR
Clarithromycin belongs to a group of medicine called
macrolide antibiotics. Antibiotics stop the growth
of
bacteria which cause
infections.
Clarithromycin Krka is used in adults and children 12 years
and older to treat following
infections:
•
Chest infections such as bronchitis and
pneumonia,
•
Throat and sinus
infections,
•
Skin and soft tissue
infections,
_• _
_Helicobacter pylori _infections associated with duodenal
ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
T
AK
E
CLARITHROMYCIN
KRK
A
DO NOT TAKE CLARITHROMYCIN KRKA
IF:
•
you know that you are
ALLERGIC
to clarithromycin,
other
macrolide antibiotics such as erythromycin
or
azithromycin, or any of the other ingredients in
the
tablets.
•
you are taking medicines called ergot alkaloids,
for
example ergotamine or dihydroergotamine tablets or
use
ergotamine inhalers for migraine. Consult your do

Summary of Product characteristics

Health Products Regulatory Authority
24 June 2021
CRN00C91Q
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin Krka 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg clarithromycin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oval, biconvex, slightly brownish yellow film-coated tablets of 19.5
to 19.8 mm in length and 10 mm in width.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarithromycin Krka film-coated tablets are indicated for the
treatment of the following bacterial infections in adults and
children 12 years and older, when caused by clarithromycin-susceptible
bacteria (see section 4.4 and 5.1).
• Bacterial pharyngitis
• Mild to moderate community acquired pneumonia
• Acute bacterial sinusitis (adequately diagnosed)
• Acute exacerbation of chronic bronchitis
• Skin infections and soft tissue infections of mild to moderate
severity
• 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)
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 Krka film-coated tablets depends on the
type and severity of the infection and has to be defined
in any case by the physician.
Patients with respiratory tract/skin and soft tissue infections:
_Adults and adolescents (12 years and older)_
The usual recommended dosage of clarithromycin in adults is one 250mg
tablet twice daily. In more severe infections, the
dosage can be increased to 500mg twice daily. The usual duration of
therapy is 6 to 14 days.
_Children younger than 12 years:_
The use of clarithromycin tablets has not been studied in children
under 12 years. Clinical trials have been conducted using
clarithromyc