Co-Amoxiclav 250 mg/125 mg film-coated tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Amoxicillin ; Clavulanic acid

Tersedia dari:

Hikma Farmaceutica (Portugal) SA

Kode ATC:

J01CR; J01CR02

INN (Nama Internasional):

Amoxicillin ; Clavulanic acid

Dosis:

250 mg/125 milligram(s)

Bentuk farmasi:

Film-coated tablet

Jenis Resep:

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

Area terapi:

Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2005-09-23

Selebaran informasi

Hikma Pharmaceuticals Co-Amoxiclav 250/125mg Film coated Tablets
September 2017
PACKAGE LEAFLET : INFORMATION FOR THE USER
CO-AMOXICLAV 250MG/125MG FILM-COATED TABLETS
Amoxicilline/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 (or for your child). Do not
pass it on to others. It may
harm them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
See section 4.
IN THIS LEAFLET:
1. What Co-Amoxiclav is and what it is used for
2. What you need to know before you take Co-Amoxiclav 250mg/125mg
film-coated tablets
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
1.
WHAT CO-AMOXICLAV IS AND WHAT IT IS USED FOR
Co-Amoxiclav 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.
Co-Amoxiclav 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 CO-AMOXICLAV 250MG/125MG
FILM-COATED TABLETS
DO NOT TAKE YOUR MEDICINE:
• if you are allergic (hypersensitive) to amoxicillin, clavulanic
acid, penicillin or any of the other
ingredients of your 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 neck
• if you have ever had liver problems or jaundice (yel

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Amoxiclav 250 mg/125 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Amoxicillin 250 mg (as trihydrate) and Clavulanic
acid 125 mg (as potassium clavulanate).
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
White, oval shaped, film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except when doses are stated in terms
of an individual component.
The dose 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 (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 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 is selected in order to avoid
administration of unnecessarily high daily doses
of clavulanic acid (see sections 4.4 and 5.1).
Treatment should not be extended beyond 14 days without review.
Adults and children
40 kg
One 250 mg/125 mg tablet taken three time