CLONAMOX 250 mg/5 ml MG/5ml Powder for Oral Suspension
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:
250 mg/5 ml MG/5ml
Pharmaceutical form:
Powder for Oral Suspension
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Penicillins with extended spectrum
Authorization status:
Authorised
Authorization date:
1985-05-14
Patient Information leaflet
Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLONAMOX 125 MG/5 ML POWDER FOR ORAL SUSPENSION
CLONAMOX 250 MG/5 ML POWDER FOR ORAL SUSPENSION
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 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.
IN THIS LEAFLET:
1.
What Clonamox Powder for Oral Suspension is and what it is
used for
2.
What you need to know before you take Clonamox
Powder for Oral Suspension
3.
How to take Clonamox Powder for Oral Suspension
4.
Possible side effects
5.
How to store Clonamox Powder for Oral Suspension
6.
Contents of the pack and other information
1.
WHAT CLONAMOX POWDER FOR ORAL SUSPENSION IS AND WHAT IT IS
USED FOR
WHAT CLONAMOX POWDER FOR ORAL SUSPENSION IS
Clonamox Powder for Oral Suspension is an antibiotic. The active ingredient is amoxicillin. This belongs to
a group of medicines called ‘penicillins’.
WHAT CLONAMOX POWDER FOR ORAL SUSPENSION IS USED FOR
Clonamox Powder for Oral Suspension is used to treat infections caused by bacteria in different parts of the
body. Clonamox Powder for Oral Suspension may also be used in combination with other medicines to treat
stomach ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLONAMOX POWDER FOR
ORAL SUSPENSION
DO NOT GIVE CLONAMOX POWDER FOR ORAL SUSPE
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clonamox 250 mg/5 ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 250 mg of amoxicillin.
Excipients with known effect:
Contains 2.3 g of sucrose and 7.65 mg of sodium per 5 ml dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension
Off–white powder which on reconstitution with water forms a pale yellow suspension with a lemon flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clonamox for Oral Suspension 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 for Oral Suspension 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
Route of administration: oral
Posology
The dose of Clonamox for Oral Suspension 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)
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 12/11/2015_
_CRN 2167085_
_page number: 1_
The severity an
Read the complete document
