Klacid Paediatric Suspension 125mg/5ml, Granules for Oral Suspension

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Clarithromycin

Tillgänglig från:

Viatris Healthcare Limited

ATC-kod:

J01FA; J01FA09

INN (International namn):

Clarithromycin

Läkemedelsform:

Granules for oral suspension

Terapiområde:

Macrolides; clarithromycin

Bemyndigande status:

Marketed

Tillstånd datum:

1996-11-22

Bipacksedel

Package leaflet: Information for the user
KLACID
®
PAEDIATRIC SUSPENSION 125MG/5ML,
GRANULES FOR ORAL SUSPENSION
(clarithromycin)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GIVE THIS MEDICINE TO
YOUR CHILD BECAUSE IT CONTAINS IMPORTANT
INFORMATION.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for your child. Do not pass it on
to others. It may harm them, even if their signs of
illness are the same as your child’s.
- If your child gets any side effects, talk to your doctor, pharmacist
or nurse. This includes any side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Klacid Paediatric Suspension is and what it is used for
2. What you need to know before giving Klacid Paediatric Suspension
3. How to give Klacid Paediatric Suspension
4. Possible side effects
5. How to store Klacid Paediatric Suspension
6. Contents of the pack and other information
1. WHAT KLACID PAEDIATRIC SUSPENSION IS AND WHAT IT IS USED FOR
Each 5ml spoonful of Klacid Paediatric Suspension contains 125 mg of
the active ingredient clarithromycin.
Klacid Paediatric Suspension belongs to a group of medicines called
macrolide antibiotics.
Antibiotics stop the growth of bacteria (bugs) which cause infections.
Klacid Paediatric Suspension is used to treat infections such as:
1. Chest infections, such as bronchitis and pneumonia
2. Throat and sinus infections
3. Skin and soft tissue infections such as cellulitis, folliculitis or
erysipelas
4. Ear infections particularly inflammation of the middle ear (acute
otitis media)
2. WHAT YOU NEED TO KNOW BEFORE GIVING KLACID PAEDIATRIC SUSPENSION
DO NOT GIVE KLACID PAEDIATRIC SUSPENSION TO YOUR CHILD IF YOU:

know that they are allergic to clarithromycin, other macrolide
antibiotics such as erythromycin or azithromycin, or any of
the other ingredients of Klacid Paediatric Suspension.

know they are taking medicines called ergot alkaloids, for example
ergot

Produktens egenskaper

Health Products Regulatory Authority
17 November 2023
CRN00DWHR
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Klacid Paediatric Suspension 125mg/5ml, Granules for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted as directed in section 4.2, each 5ml or sachet
contains 125mg clarithromycin.
Excipients with known effect:
Also contains 2.75g / 5ml sachet of sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension.
White to off-white granules for oral suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Klacid Paediatric Suspension is indicated for the treatment of
infections caused by susceptible organisms. Indications include

Lower respiratory tract infections (e.g. bronchitis, pneumonia) (see
sections 4.4 and 5.1 regarding Sensitivity
Testing)

Upper respiratory tract infections (e.g. pharyngitis, sinusitis)

Skin and skin structure infections (e.g. pharyngitis, sinusitis) (see
sections 4.4 and 5.1 regarding Sensitivity Testing)

Acute otitis media
Klacid Paediatric Suspension is usually active against the following
organisms _in vitro_:
GRAM-POSITIVE BACTERIA: _Staphylococcus aureus_ (methicillin
susceptible); _Streptococcus pyogenes_ (Group A beta-haemolytic
streptococci); alpha-haemolytic streptococci (viridans group);
_Streptococcus (Diplococcus) pneumoniae; Streptococcus agalactiae;_
_Listeria monocytogenes_.
GRAM-NEGATIVE BACTERIA: _Haemophilus influenzae, Haemophilus
parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria _
_gonorrhoeae; Legionella pneumophila, Bordetella pertussis,
Helicobacter pylori; Campylobacter jejuni_.
MYCOPLASMA: _Mycoplasma pneumoniae; Ureaplasma urealyticum_.
OTHER ORGANISMS: _Chlamydia trachomatis; Mycobacterium avium;
Mycobacterium leprae; Chlamydia pneumoniae_.
ANAEROBES: Macrolide-susceptible _Bacteroides fragilis_; _Clostridium
perfringens_; _Peptococcus_ species; _Peptostreptococcus_ species;
_Propionibacterium acnes_.
Klacid Paedia