Klacid 250mg/5ml Granules for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clarithromycin

Available from:

Viatris Healthcare Limited

ATC code:

J01FA; J01FA09

INN (International Name):

Clarithromycin

Pharmaceutical form:

Granules for oral suspension

Therapeutic area:

Macrolides; clarithromycin

Authorization status:

Marketed

Authorization date:

1998-06-26

Patient Information leaflet

Package leaflet: Information for the user
KLACID
®
250MG/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. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Klacid Granules for Oral Suspension is and what it is used for
2. What you need to know before giving Klacid Granules for Oral
Suspension
3. How to give Klacid Granules for Oral Suspension
4. Possible side effects
5. How to store Klacid Granules for Oral Suspension
6. Contents of the pack and other information
1. WHAT KLACID GRANULES FOR ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Each 5ml spoonful of Klacid Granules for Oral Suspension contains 250
mg of the active ingredient clarithromycin.
Klacid Granules for Oral Suspension belongs to a group of medicines
called macrolide antibiotics.
Antibiotics stop the growth of bacteria (bugs) which cause infections.
Klacid Granules for Oral 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 GRANULES FOR ORAL
SUSPENSION
DO NOT GIVE KLACID GRANULES FOR ORAL SUSPENSION TO YOUR CHILD IF YOU:

know that that they are allergic to clarithromycin, other macrolide
antibiotics such as erythromycin or azithromycin, or
any of the other ingredients of Klacid Granules for Oral Suspension.

know they are taking medicines called ergot alkaloids, for example
ergota

Summary of Product characteristics

Health Products Regulatory Authority
17 November 2023
CRN00DWHR
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Klacid 250mg/5ml Granules for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution as directed, each 5ml of suspension contains
250mg clarithromycin.
Excipients with known effect:
Also contains 2.276 g / 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, free-flowing granules with an odour of fruit.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Klacid Suspension is indicated for the treatment of infections caused
by susceptible organisms. Indications include:

Lower respiratory tract infections (e.g. bronchitis, pneumonia) (see
section 4.4 and 5.1 regarding Sensitivity
Testing).

Upper respiratory tract infections (e.g. pharyngitis, sinusitis).

Skin and skin structure infections (e.g. folliculitis, cellulitis,
erysipelas) (see section 4.4 and 5.1 regarding Sensitivity
Testing).

Acute otitis media.
Klacid 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_.
Kla