AMOXIL 3 Grams Powder for Oral Suspension

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

AMOXICILLIN TRIHYDRATE

Disponibil de la:

GlaxoSmithKline (Ireland) Limited

Codul ATC:

J01CA04

INN (nume internaţional):

AMOXICILLIN TRIHYDRATE

Dozare:

3 Grams

Forma farmaceutică:

Powder for Oral Suspension

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Penicillins with extended spectrum

Statutul autorizaţiei:

Authorised

Data de autorizare:

1999-12-17

Prospect

Reason for update: Type IB to include PRAC recommendation on DRESS as
AE
Market: IE
Agency Approval Date: _ _
Text Date: 13/06/2017
Text Issue and Draft No.: issue4draft1
[GSK LOGO]
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXIL
3 G POWDER FOR ORAL SUSPENSION SACHETS
AMOXICILLIN
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 (or for your child) 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 Amoxil is and what it is used for
2.
What you need to know before you take Amoxil
3.
How to take Amoxil
4.
Possible side effects
5.
How to store Amoxil
6.
Contents of the pack and other information
1 WHAT AMOXIL IS AND WHAT IT IS USED FOR
WHAT AMOXIL IS
Amoxil is an antibiotic. The active ingredient is amoxicillin. This
belongs to a group of medicines called
‘penicillin’.
WHAT AMOXIL IS USED FOR
Amoxil is used to treat infections caused by bacteria in different
parts of the body. Amoxil may also be
used in combination with other medicines to treat stomach ulcers.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOXIL
DO NOT TAKE AMOXIL:

if you are allergic to amoxicillin, penicillin or any of the other
ingredients of this medicine (listed in
section 6).

if you have ever had an allergic reaction to any antibiotic. This can
include a skin rash or swelling of
the face or throat.
Do not take Amoxil if any of the above apply. If you are not sure,
talk to your doctor or pharmacist before
taking Amoxil.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Amoxil if you:
Reason for update: Type IB to include PRAC recommendation

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxil 3g Powder for Oral Suspension Sachets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains Amoxicillin Trihydrate equivalent to 3.0 g
amoxicillin.
Each sachet also contains sorbitol (E420)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
A white to off-white, free-flowing powder with characteristic odour
which on reconstitution with water forms a white
to off-white coloured suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amoxil 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
Acute otitis media
Acute streptococcal tonsillitis and pharyngitis
Acute exacerbations of chronic bronchitis
Community acquired pneumonia
Acute cystitis
Asymptomatic bacteriuria in pregnancy
Acute pyelonephritis
Typhoid and paratyphoid fever
Dental abscess with spreading cellulitis
Prosthetic joint infections
_Helicobacter pylori_ eradication
Lyme disease
Amoxil is also indicated for the prophylaxis of endocarditis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of Amoxil 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 duration of therapy should be determined by the type of infection
and the response of the patient, and should
generally be as short as possible. Some infections require longer
periods of treatment (see section 4.4 regarding
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