Amoxil 500mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amoxicillin trihydrate

Available from:

Waymade Healthcare Plc

ATC code:

J01CA04

INN (International Name):

Amoxicillin trihydrate

Dosage:

500mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010103

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXIL
® 500MG CAPSULES
(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.
The name of your medicine is Amoxil 500mg capsules but will be
referred to as Amoxil throughout the leaflet.
Please note that the leaflet also contains information about other
strength such as Amoxil 250mg capsules.
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 US
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.
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 ki

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amoxil Capsules 500 mg
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)
•
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
Asymptomatic bacteriuria in pregnancy
Acute pyelonephritis
Dental abscess with spreading cellulitis
Acute cystitis
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 cyst