Moxiclav 375mg film-coated tablets

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

AMOXICILLIN, CLAVULANIC ACID

Boleh didapati daripada:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

Kod ATC:

J01CR02

INN (Nama Antarabangsa):

CLAVULANIC ACID 125 mg AMOXICILLIN 250 mg

Borang farmaseutikal:

FILM-COATED TABLET

Komposisi:

CLAVULANIC ACID 125 mg AMOXICILLIN 250 mg

Jenis preskripsi:

POM

Kawasan terapeutik:

ANTIBACTERIALS FOR SYSTEMIC USE

Status kebenaran:

Authorised

Tarikh kebenaran:

2006-12-27

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOXICLAV 375 MG FILM-COATED TABLETS
Amoxicillin/Clavulanic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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 symptoms 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.
IN THIS LEAFLET
:
1.
What
Moxiclav is and what it is used for
2.
What you need to know before you take Moxiclav
3.
How to take Moxiclav
4.
Possible side effects
5.
How to store Moxiclav
6.
Contents of the pack and other information
1.
WHAT MOXICLAV IS AND WHAT IT IS USED FOR
Moxiclav 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.
Moxiclav is used in adults and children to treat the following
infections:
•
sinus infections,
•
urinary tract infections,
•
skin infections,
•
dental infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOXICLAV
DO NOT TAKE MOXICLAV:
•
If you are allergic 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 (hypersensitive) reaction to
any other antibiotic. This can
include a skin rash or swelling of the face or throat.
•
If you have ever had liver problems or jaundice (yellowing of the
skin) when taking an antibiotic.
DO NOT TAKE MOXICLAV IF ANY OF THE ABOVE APPLY TO YOU.
If you are not sure, talk to your doctor or
pharmacist before taking Moxiclav.
WARNINGS AND PRECAUTIONS
Talk to your do

Ciri produk

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Moxiclav 375mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Moxiclav 375mg contains amoxicillin trihydrate
equivalent to 250mg amoxicillin base
and potassium clavulanate equivalent to 125mg clavulanic acid.
Excipient with known effect: propylene glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, convex, scored, cap shaped film-coated tablets embossed
“MC”.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Moxiclav 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)
•
Cystitis
•
Pyelonephritis
•
Cellulitis
•
Animal bites
•
Severe dental abscess with spreading cellulitis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
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4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except when doses are
stated in terms of an individual component.
The dose of Moxiclav 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 Moxiclav (e.g. those that
provide higher doses of amoxicillin
and/or different ratios of amoxicillin to clavulanic acid) should be
considered as necessary (see sections
4.4 and 5.1).
For adults and children ≥ 40 kg, this formulation of Moxiclav
provides a total daily dose of 750 mg
amoxicillin/375 mg clavulanic acid, when administered as recommended
below. If it is considered that
a higher daily dose of amoxicillin is required, it is recommended that
another preparation of Moxiclav
is selected