Amoxicillin SUN 750 mg dispersible tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

AMOXICILLIN TRIHYDRATE

Disponibil de la:

Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87, 2132, JH Hoofdorp, Netherlands

Codul ATC:

J01CA04

INN (nume internaţional):

AMOXICILLIN TRIHYDRATE 750 mg

Forma farmaceutică:

DISPERSIBLE TABLET

Compoziție:

AMOXICILLIN TRIHYDRATE 750 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTIBACTERIALS FOR SYSTEMIC USE

Rezumat produs:

Licence number in the source country: NOT APPLICAPABLE

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2020-06-19

Prospect

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PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN SUN 750 MG DISPERSIBLE TABLETS
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Amoxicillin SUN is and what it is used for
2.
What you need to know before you take Amoxicillin SUN
3.
How to take Amoxicillin SUN
4.
Possible side effects
5.
How to store Amoxicillin SUN
6.
Contents of the pack and other information
1.
WHAT AMOXICILLIN SUN IS AND WHAT IT IS USED FOR WHAT AMOXICILLIN SUN
IS
Amoxicillin SUN is an antibiotic. The active ingredient is
amoxicillin. It belongs to a group of
medicines called ‘penicillin’.
WHAT AMOXICILLIN SUN IS USED FOR
Amoxicillin SUN is used to treat infections caused by bacteria in
different parts of the body.
Amoxicillin SUN may also be used in combination with other medicines
to treat stomach ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOXICILLIN SUN
DO NOT TAKE AMOXICILLIN SUN:
-
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 this medicine if any of the above apply. If you are not
sure, talk to your doctor or
pharmacist before taking this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking this medicine,
if you:
•
have glandular fever (fever, sore throat, swollen glands and extreme
tiredness)
�

Caracteristicilor produsului

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Amoxicillin SUN 750 mg dispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dispersible tablet contains 750 mg amoxicillin as amoxicillin
trihydrate.
Excipient with known effect:
Amoxicillin SUN 750 mg dispersible tablets:
Contains 15 mg of aspartame (E951) per tablet.
Contains maltodextrin (glucose).
Contains 0.0023 mg of benzyl alcohol per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Amoxicillin SUN 750 mg dispersible tablets:
The tablets are white to yellowish oblong shaped tablets with one
score-line on both sides and
dimensions of 22 x 8 mm.
750 mg: The score line is to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoxicillin SUN 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
Amoxicillin is also indicated for the prophylaxis of endocarditis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of Amoxicillin 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 d