PINACLAV 250/125 Milligram Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

AMOXICILLIN CLAVULANIC ACID

Disponible desde:

Pinewood Laboratories Ltd,

Designación común internacional (DCI):

AMOXICILLIN CLAVULANIC ACID

Dosis:

250/125 Milligram

formulario farmacéutico:

Tablets

tipo de receta:

Product subject to prescription which may not be renewed (A)

Estado de Autorización:

Authorised

Fecha de autorización:

0000-00-00

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
PINACLAV 250MG/125MG TABLETS
AMOXICILLIN AND CLAVULANIC ACID 
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 has been prescribed for you (or your child). Do
not pass it on to others. It may harm them, even if their 
      symptoms are the same as yours.
-     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 Pinaclav is and what it is used for
2.     Before you take Pinaclav
3.     How to take Pinaclav 
4.     Possible side effects
5.     How to store Pinaclav
6.     Further information
1. 
WHAT PINACLAV IS AND WHAT IT IS USED FOR
Pinaclav 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.
Pinaclav is used in adults and children to treat the following
infections:
250 mg/125 mg tablets
•     sinus infections   
•     urinary tract infections
•     skin infections 

•     dental infections.
2. 
BEFORE YOU TAKE PINACLAV
DO NOT TAKE PINACLAV:
•     if you are allergic (hypersensitive) to amoxicillin,
clavulanic acid, penicillin or any of the other ingredients of
Pinaclav  
      (listed in section 6)
•    if you have ever had a severe allergic (hypersensitive)
reaction to any other antibiotic. This can include a skin rash or  

     swelling of the face or neck
•    if you have ever had liver problems or jaundice (yellowing of
the skin) when taking an antibiotic.

 DO NOT TAKE PINACLAV IF ANY

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pinaclav 250mg/125 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of amoxicillin as amoxicillin trihydrate and 125 mg of clavulanic acid as potassium
clavulanate.
Excipients: also includes sucrose, 0.054mg per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets.
Yellowish-white or light yellow oblong-formed, biconvex tablet with ‘375’ on one side/engraved line on second
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pinaclav is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):
o
Acute bacterial sinusitis (adequately diagnosed)
o
Cystitis
o
Pyelonephritis
o
Cellylitis
o
Animal bites
o
severe dental abscess with spreading cellulitis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms
of an individual component.
The dose of Pinaclav that is selected to treat an individual infection should take into account:
o
The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)
o
The severity and the site of the infection
o
The age, weight and renal function of the patient as shown below.
The use of alternative presentations of Pinaclav (e.g. those that provide higher doses of amoxicillin and/or different
ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1).
IRISH MEDICINES BOARD
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_Date Printed