Amoclav 125mg/31.25mg per 5ml Powder for Oral Suspension

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

potassium clavulanate; Amoxicillin trihydrate

Saatavilla:

Rowex Ltd

ATC-koodi:

J01CR; J01CR02

INN (Kansainvälinen yleisnimi):

potassium clavulanate; Amoxicillin trihydrate

Annos:

125 mg/31.25 mg/5ml

Lääkemuoto:

Powder for oral suspension

Prescription tyyppi:

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

Terapeuttinen alue:

Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2003-03-21

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOCLAV 250MG/125MG FILM-COATED TABLETS
amoxicillin/clavulanic acid
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 or pharmacist or
nurse.
- This medicine has been prescribed for you 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 or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1. What Amoclav is and what it is used for
2. What you need to know before you take Amoclav
3. How to take Amoclav
4. Possible side effects
5. How to store Amoclav
6. Contents of the pack and other information
1.
WHAT AMOCLAV IS AND WHAT IT IS USED FOR
Amoclav 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.
Amoclav is used in adults and children to treat the following
infections:
• sinus infections
• urinary tract infections
• skin infections
• dental infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOCLAV
DO NOT TAKE AMOCLAV:
• if you are allergic (hypersensitive) to amoxicillin, clavulanic
acid, penicillin or any of the
other ingredients of Amoclav (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 AMOCLAV IF ANY OF THE ABOVE APPLY TO YOU.
If you are not sure, talk to
your doctor or phar

Valmisteyhteenveto

Health Products Regulatory Authority
22 March 2023
CRN00DFVY
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoclav 125mg/31.25mg per 5ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
5ml reconstituted suspension contains:
Amoxicillin trihydrate equivalent to 125 mg amoxicillin. Potassium
clavulanate equivalent to 31.25 mg clavulanic acid.
Excipients: Each 5ml reconstituted suspension contains 8.5 mg
aspartame, 0.13 mg sorbitol (E420), 0.1001 microgram sulphur
dioxide (E220), and 0.7 mg glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
Off-white granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amoclav 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 Amoclav 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 Amoclav (e.g. those that
provide higher doses of amoxicillin and/ or different ratios of
amoxicillin to clavulanic acid) should be considered as necessary (see
se