PINACLAV 500/125 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
AMOXICILLIN CLAVULANIC ACID
Available from:
Pinewood Laboratories Ltd,
INN (International Name):
AMOXICILLIN CLAVULANIC ACID
Dosage:
500/125 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
PINACLAV 500MG/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:
500 mg/125 mg tablets
• 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 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 prob
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pinaclav 500mg/125mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of amoxicillin as amoxicillin trihydrate and 125 mg of clavulanic acid as potassium
clavulanate.
Excipients: also includes sucrose, 0.072mg 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 ‘625’ on one side and an engraved line on the
other 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):
•
Acute bacterial sinusitis (adequately diagnosed)
•
Acute otitis media
•
Acute exacerbations of chronic bronchitis (adequately diagnosed)
•
Community acquired pneumonia
•
Cystitis
•
Pyelonephritis
•
Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.
•
Bone and joint infections, in particular osteomyelitis.
•
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:
•
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 use of alternative presentations of Pinaclav (e.g. those that provide higher doses of amoxicillin and/or
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