CLONAMOX 500 Milligram Capsule
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
27-11-2015
Summary of Product characteristics
(SPC)
27-11-2015
Active ingredient:
AMOXICILLIN TRIHYDRATE
Available from:
Clonmel Healthcare Ltd
ATC code:
J01CA04
INN (International Name):
AMOXICILLIN TRIHYDRATE
Dosage:
500 Milligram
Pharmaceutical form:
Capsule
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Penicillins with extended spectrum
Authorization status:
Authorised
Authorization date:
1984-02-14
Patient Information leaflet
Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLONAMOX 250MG HARD CAPSULES
CLONAMOX 500MG HARD CAPSULES
AMOXICILLIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECUASE 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 Clonamox Capsules are and what they are used for
2.
What you need to know before you take Clonamox Capsules
3.
How to take Clonamox Capsules
4.
Possible side effects
5.
How to store Clonamox Capsules
6.
Contents of the pack and other information
1.
WHAT CLONAMOX CAPSULES ARE AND WHAT THEY ARE USED FOR
WHAT CLONAMOX CAPSULES ARE
‘Clonamox’ is an antibiotic. The active
ingredient is amoxicillin. This belongs to a group of medicines
called
‘penicillins’.
WHAT CLONAMOX CAPSULES ARE USED FOR
Clonamox Capsules is
used to treat infections caused by bacteria in different parts of the body. Clonamox
Capsules may also be used in
combination with other medicines to treat stomach ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLONAMOX CAPSULES
DO NOT TAKE CLONAMOX CAPSULES:
- 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
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clonamox 500 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains amoxicillin 500mg as amoxicillin trihydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules
Light green/white, hard gelatin capsule printed ‘Clonamox 500’ and containing a white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clonamox 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 cellulites
Prosthetic joint infections
_Helicobacter pylori _eradication
Lyme disease
Clonamox 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 Clonamox 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
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 12/11/2015_
_CRN 2167085_
_page number: 1_
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
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