Noprilam DT 400

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMOXICILLIN, CLAVULANIC ACID

Available from:

Bial - Portela & C S.A. À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

ATC code:

J01CR02

INN (International Name):

AMOXICILLIN 400 mg/5ml CLAVULANIC ACID 57 mg/5ml

Pharmaceutical form:

POWDER FOR ORAL SUSPENSION

Composition:

AMOXICILLIN 400 mg/5ml CLAVULANIC ACID 57 mg/5ml

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2005-10-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

NOPRILAM DT 400 400 MG/57 MG/5 ML POWDER FOR ORAL SUSPENSION 

Amoxicillin/clavulanic acid 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING YOUR CHILD THIS MEDICINE. 
-

Keep this leaflet. You may need to read it again. 
-

If you have any further questions, ask your doctor or pharmacist. 
- 
This medicine is usually prescribed for a baby or child.  Do not pass it on to others. It 
may harm them, even if their symptoms are the same as your child’s. 
-

If  any of the side effects gets serious, or if you notice any side effects not listed in this 
leaflet, please tell your doctor or pharmacist. 

IN THIS LEAFLET:  
1. 
What Noprilam is and what it is used for 
2. 
Before you give Noprilam 
3. 
How to give Noprilam 
4. 
Possible side effects 
5. 
How to store Noprilam 
6. 
Further information 

1. 
WHAT NOPRILAM IS AND WHAT IT IS USED FOR 

Noprilam is an antibiotic and works by killing bacteria that cause infections..  It contains two 
different medicines called amoxicillin and clavulanic acid.  Amoxicillin belongs to a group of 
medicines called “penicillins” that can sometimes be stopped from working (made inactive).  
The other active component (clavulanic acid) stops this from happening. 

Noprilam is used in babies and children to treat the following infections: 

• 
middle ear and sinus infections 
• 
respiratory tract infections 
• 
urinary tract infections 
• 
skin and soft tissue infections including dental infections 
• 
bone and joint infections. 

2. 
BEFORE YOU GIVE NOPRILAM 

DO NOT GIVE YOUR CHILD NOPRILAM: 
• 
if they are allergic (hypersensitive) to amoxicillin, clavulanic acid or any of the other 
ingredients of Noprila

Summary of Product characteristics

Page 1 of 11 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  NAME OF THE MEDICINAL PRODUCT 

NOPRILAM DT 400, 400/57 mg/5 ml Powder for oral suspension 
NOPRILAM 500, 500/125 mg Coated tablets 
NOPRILAM DT, 875/125 mg Coated tablets 

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION 

        NOPRILAM contains amoxicillin (as trihydrate) and
clavulanic acid (as potassium salt): 
 Pharmaceutical 
form 
Amoxicillin 
contents 
Clavulanic 
acid contents 
Ratio 
AMOX/CL
AV 
NOPRILAM   
DT 400 
Oral Suspension  400 mg (5 ml)
57 mg (5 ml) 
7/1 
NOPRILAM 
500 
Tablets 
500 mg 
125 mg 
4/1 
NOPRILAM 
DT 
Tablets 
875 mg 
125 mg 
7/1 

  Excipients, see 6.1. 

3.  PHARMACEUTICAL FORM 

NOPRILAM DT 400: Powder for oral suspension. 

NOPRILAM 500 and NOPRILAM DT: Coated tablets. 

4.  CLINICAL PARTICULARS 

NOPRILAM, a beta-lactam antibiotic of the penicillin group,
co-formulated with a beta-
lactamase inhibitor, is a broad spectrum antibacterial agent with
activity upon the 
commonest pathogenic bacteria found in clinical and hospital
practice. 

The inhibition action of clavulanic acid upon beta-lactamases allows
broadening of the 
amoxicillin spectrum of action, involving any organisms resistant
to other beta-lactam 
antibiotics. 

4.1  THERAPEUTIC INDICATIONS 

    NOPRILAM is indicated for the short-term treatment of a wide
range of infections caused 
by susceptible organisms to NOPRILAM 
    Upper respiratory tract infections (including ENT), e.g.
recurrent tonsillitis, recurrent and 
acute sinusitis and otitis media, typically caused
by: _Streptococcus pneumoniae,_ 
_Haemophilus influenzae*, Moraxella catarrhalis* _and_ Streptococcus
pyogenes_. 
    Lower respiratory tract infections, e.g. exacerbation of
chronic bronchitis, lobar pneumonia 
and bronchopneumonia typically caused by: _Streptococcus
pneumoniae,_  _Haemophilus _
_influenzae*, Moraxella catarrhalis*_. 
   Geni