Fungentin

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMOXICILLIN, CLAVULANIC ACID

Available from:

Elpen Pharmaceutical Co. Inc. 95 Marathonos Ave., 190 09 Pikermi, Attica, Greece

ATC code:

J01CR02

INN (International Name):

AMOXICILLIN 250 mg/5ml CLAVULANIC ACID 62.5 mg/5ml

Pharmaceutical form:

POWDER FOR ORAL SUSPENSION

Composition:

AMOXICILLIN 250 mg/5ml CLAVULANIC ACID 62.5 mg/5ml

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2006-11-14

Patient Information leaflet

 
1 

PATIENT INFORMATION LEAFLET 
FUGENTIN
®

(AMOXICILLIN – CLAVULANIC ACID) 
BROAD SPECTRUM ANTIBIOTIC 
5503700.1

1. CHARACTERISTICS OF THE PHARMACEUTICAL PRODUCT 

1.1 NAME   
FUGENTIN
®

FUGENTIN
®
 Powder for oral suspension (125+31.25)mg/5ml and
(250+62.5)mg/5ml. 
FUGENTIN
®
 Film coated tablets (500+125)mg/tab. 

1.2 COMPOSITION 
ACTIVE INGREDIENTS: Amoxicillin Trihydrate and Clavulanate
Potassium. 
EXCIPIENTS:  FUGENTIN
®
  POWDER FOR ORAL SUSPENSION: Xanthan gum, hypromellose, 
aspartame, silicon dioxide colloidal, silicon dioxide anhydrous,
strawberry flavour, peach 
flavour, lemon flavour, succinic acid. 
FUGENTIN
®
 FILM COATED TABLETS: Magnesium stearate,
colloidal anhydrous silica, sodium 
starch glycollate (type A), cellulose microcrystalline. Coating:
Talc, titanium dioxide 
E171, hypromellose, diethylphthalate, dimeticone. 

1.3 PHARMACEUTICAL 
FORM 
Powder for oral suspension, film coated tablets. 

1.4  CONTENT OF ACTIVE INGREDIENT 
FUGENTIN
®
 POWDER FOR ORAL SUSPENSION (125+31.25)MG/5ML: When
reconstituted it 
contains 125mg amoxicillin as the trihydrate and 31.25mg clavulanic
acid as the 
potassium salt per 5ml. 
FUGENTIN
®
 POWDER FOR ORAL SUSPENSION (250+62.5)MG/5ML: When reconstituted
it 
contains 250mg amoxicillin as the trihydrate and
62.5mg clavulanic acid as the 
potassium salt per 5ml. 
FUGENTIN
®
 FILM COATED TABLETS (500+125)MG/TAB.: Each tablet contains 500mg 
amoxicillin as the trihydrate and 125mg clavulanic acid as
the potassium salt. 

1.5 DESCRIPTION- 
PACKAGE 
FUGENTIN
®
 POWDER FOR ORAL SUSPENSION
(125+31.25)MG/5ML  AND  (250+62.5)MG/5ML: 
White to off-white powder in dark brown glass bottles which are
marked for correct 
volume (60ml or 100ml) during reconstitution. Pack of one bottle. 
FUGENTIN
®
 FILM COATED TABLETS (500+125)MG/TAB.: Oval, white, bisected,
biconvex 
tablets, in packs of 12 tablets (3 blisters Al-Al x 4 tablets). 

1.6.

Summary of Product characteristics

Page 1 of 7 

SUMMARY OF PRODUCT CHARACTERISTICS 

1.  TRADE NAME OF THE MEDICINAL PRODUCT 

FUGENTIN
®

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

FUGENTIN
®
  film-coated tablets (500 + 125) mg/tab:
Each tablet contains 500 mg amoxicillin (as 
amoxicillin trihydrate) and 125 mg clavulanic acid
(as potassium clavulanate).  
FUGENTIN
®
  powder for oral suspension (125 + 31.25) mg/5 ml: Each
dosimetric spoonful (5 ml of 
the suspension) contain 125 mg amoxicillin (as amoxicillin
trihydrate) and 31.25 mg clavulanic acid 
(as potassium clavulanate)._ _
FUGENTIN
®
  powder for oral suspension (250 + 62.5) mg/5 ml:
Each dosimetric spoonful (5 ml of 
the suspension) contain 250 mg amoxicillin
(as amoxicillin trihydrate) and 62.5 mg clavulanic acid 
(as potassium clavulanate)._ _

3.  PHARMACEUTICAL FORM 

A. 
Film-coated tablets 
B. 
Powder for oral suspension 

4.  CLINICAL PARTICULARS 

4.1. 
 THERAPEUTIC INDICATIONS 

FUGENTIN
®
 is indicated for short period treatment of bacterial
infections, caused by beta-lactamase 
producing organisms, which are susceptible to this drug. The
duration of treatment depends on the 
therapeutic indication and it must not exceed 14 days. 
•  Upper Respiratory Tract Infections (including ear, nose and
throat infections), i.e. recurrent 
tonsillitis, sinusitis, otitis media (especially in recurrence
or in severe cases). 
•  Lower Respiratory Tract Infections i.e.
acute exacerbations of chronic bronchitis, lobar 
pneumonia and bronchopneumonia.  
•  Genitourinary Tract Infections i.e. cystitis,
urethritis (not prostatitis), pyelonephritis, infections 
of the female genital organs (excluding infections caused
by chlamydia). 
•  Skin and Soft Tissue Infections. 
•  Bone and Joint Infections i.e. osteomyelitis. 
•  Other Infections i.e. septic abortion, puerperal sepsis,