Amoxil Capsules 500mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMOXICILLIN

Available from:

Beecham Group PLC

ATC code:

J01CA04

INN (International Name):

AMOXICILLIN

Pharmaceutical form:

CAPSULE

Composition:

AMOXICILLIN 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2005-10-12

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXIL 500 MG CAPSULES, HARD
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 ‘penicillins’.
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:

have glandular fever (fever, sore throat, swollen glands and extreme
tiredness)

have kidney problems
2

are not urinating regularly.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before
taking Amoxil.
BLOOD AND

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Amoxil 500 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each hard capsule contains amoxicillin trihydrate equivalent to 500 mg
amoxicillin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_ _
Capsules, hard
Yellow and red capsules printed with 'GS JVL'.
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)
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
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 prolonged therapy).
ADULTS AND CHILDREN ≥40 KG_ _
INDICATION*
DOSE*
Acute bacterial sinusitis
250 mg to 500 mg every 8 hours or 750 mg to
1 g every 12 hours
For severe infections 750 mg to 1 g every 8
hours
Acute cystitis may be treated with 3 g twice
daily for one day
Asympt