Amoksiklav 2x1000mg tablets film-coated

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

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

Beschikbaar vanaf:

Sandoz GmbH

ATC-code:

J01CR02

INN (Algemene Internationale Benaming):

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

Dosering:

875mg+ 125mg

farmaceutische vorm:

tablets film-coated

Eenheden in pakket:

(10/2x5/) in blister, (14/2x7/) in blisters

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2022-08-23

Bijsluiter

AT/H/0622/001- 152864
PIL Amoksiklav 2x1000 mg FCT AM (EAEU) EN 08.10.2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Trade name of the medicinal product:
AMOKSIKLAV® 2X 1000 MG FILM-COATED TABLETS
International Nonproprietary Name: amoxicillin/clavulanic acid
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, nurse 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 Amoksiklav is and what it is used for
2.
What you need to know before you take Amoksiklav
3.
How to take Amoksiklav
4.
Possible side effects
5.
How to store Amoksiklav
6.
Contents of the pack and other information
1.
WHAT AMOKSIKLAV IS AND WHAT IT IS USED FOR
Amoksiklav is an antibiotic and works by killing bacteria that cause
infections. It contains two
different medicines called amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of
medicines called “penicillins” that can sometimes be stopped from
working (made inactive). The
other active component (clavulanic acid) stops this from happening.
Amoksiklav is used in adults and children to treat the following
infections:

middle ear and sinus infections

respiratory tract infections

urinary tract infections

skin and soft tissue infections including dental infections

bone and joint infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOKSIKLAV
DO NOT TAKE AMOKSIKLAV:

if you are allergic (hypersensitive) to amoxicillin, clavulanic acid,
penicillin or any of the other
ingredients of this medicine (listed in section 6)

if you have ever had a severe allergic (hypersensitivity) reaction to
any oth

Productkenmerken

SPC Amoksiklav 2x FCT 1000 mg Kundl CDSv04_11_2017 (CIS) ENG 4.12.2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AMOKSIKLAV® 2X 1000 MG FILM-COATED TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_International non-proprietary name: AMOXICILLIN / CLAVULANIC ACID _
Each 1000 mg film-coated tablet contains 875 mg of amoxicillin in the
form of amoxicillin trihydrate
and 125 mg of clavulanic acid in the form of potassium clavulanate.
The ratio is 7:1.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Oval, white to crème-tinged film-coated tablets, scored 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
Amoksiklav is indicated for the treatment of the following infections
in adults and children (see
sections 4.2, 4.4 and 5.1):
-
Acute bacterial sinusitis (adequately diagnosed)
-
Acute otitis media
-
Acute exacerbations of chronic bronchitis (adequately diagnosed)
-
Community acquired pneumonia
-
Cystitis
-
Pyelonephritis
-
Skin and soft tissue infections in particular cellulitis, animal
bites, severe dental abscess
with spreading cellulitis.
-
Bone and joint infections, in particular osteomyelitis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content.
The dose of Amoksiklav that is selected to treat an individual
infection should take into account:
-
The expected pathogens and their likely susceptibility to
antibacterial agents (see section
4.4)
-
The severity and the site of the infection
-
The age, weight and renal function of the patient as shown below.
The use of alternative presentations of amoxicillin/clavulanic acid
(e.g. those that provide higher
doses of amoxicillin and/or different ratios of amoxicillin to
clavulanic acid) should be considered as
necessary