AmoxiClav-Denk 500/62,5 tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Available from:

PenCef Pharma GmbH

ATC code:

J01CR02

INN (International Name):

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Dosage:

500mg+ 62,5mg

Pharmaceutical form:

tablets film-coated

Units in package:

(16/2x8/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-09-20

Patient Information leaflet

_ AmoxiClav-Denk 500/62.5_
Film-coated tablet – oral use
Combination of penicillin and ß-lactamase inhibitor
Active substances: Amoxicillin + clavulanic acid
Package leaflet: Information for the user
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 pharma
-
cist. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet
1.
WHAT
AMOXICLAV-DENK 500/62.5
IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE AMOXICLAV-DENK 500/62.5
3.
HOW TO TAKE AMOXICLAV-DENK 500/62.5
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE AMOXICLAV-DENK 500/62.5
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What
AmoxiClav-Denk 500/62.5 is and what
it is used for
AmoxiClav-Denk 500/62.5 is an antibiotic consisting of the
penicillin amoxicillin and the ß-lactamase inhibitor clavulanic
acid.
AmoxiClav-Denk 500/62.5 is used in the treatment of acute
and chronic infections that are receptive to oral therapy.
Gram-positive
and
gram-negative
microorganisms
are
possible pathogens whose resistance to ß-lactam antibiotics
is caused by ß-lactamases, which are however sensitive to the
combination of amoxicillin and clavulanic acid.
If there is a reasonable suspicion that the afore-mentioned
pathogens
could
be
the
cause
of
a
certain
infection,
treatment with
AmoxiClav-Denk 500/62.5 can be commenced
even before receiving the result of the susceptibility test
(antibiogram).
This
medicine
is
suitable
for
treatment
of
the
following
indications:
• infections of the upper and lower respiratory tract includ
-
ing:
• middle ear infection (otitis media)
• acute infection of the paranasal si

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AmoxiClav-Denk 500/62.5
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: amoxicillin and clavulanic acid.
One film-coated tablet contains 574 mg amoxicillin trihydrate,
equivalent to 500 mg amoxicillin and
74.45 mg potassium clavulanate, equivalent to 62.5 mg clavulanic acid.
Excipients with known effect: Each film-coated tablet contains 12.3 mg
potassium and 15.6 mg
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, oblong film-coated tablets with a break-line on both sides.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AmoxiClav-Denk 500/62.5 is indicated in adults for the treatment of
acute and chronic infections that
are receptive to oral therapy. Gram-positive and gram-negative
microorganisms are possible pathogens
whose resistance to β-lactam antibiotics is caused by β-lactamases,
which are however sensitive to the
combination of amoxicillin and clavulanic acid.
If there is a reasonable suspicion that the afore-mentioned pathogens
could be the cause of a certain
infection, treatment with this combination can be commenced even
before receiving the result of the
antibiogram.
This medicine is suitable for treatment of the following indications:
-
Infections of the upper and lower respiratory tract including:

otitis media

acute sinusitis

acute exacerbations of chronic bronchitis

pneumonia
-
kidney and lower urinary tract infections
-
genital infections
2
Please note:
Consideration should be given to official national and international
guidelines on the appropriate use
of antimicrobial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage of amoxicillin/clavulanic acid depends on the age, weight
and renal function of the
individual patient, on the severity and site of infection and on the
suspected or verified pathogens.
As a rule,