Klacid 250mg/5ml Granules for Oral Suspension

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

CLARITHROMYCIN

Fáanlegur frá:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC númer:

J01FA09

INN (Alþjóðlegt nafn):

CLARITHROMYCIN 250 mg/5ml

Lyfjaform:

GRANULES FOR ORAL SUSPENSION

Samsetning:

CLARITHROMYCIN 250 mg/5ml

Gerð lyfseðils:

POM

Lækningarsvæði:

ANTIBACTERIALS FOR SYSTEMIC USE

Vörulýsing:

Licence number in the source country: NOT APPLICAPABLE

Leyfisstaða:

Authorised

Leyfisdagur:

2020-11-19

Upplýsingar fylgiseðill

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
ergotamine or

Vara einkenni

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:
o
Lower respiratory tract infections (e.g. bronchitis, pneumonia) (see
section 4.4
and 5.1 regarding Sensitivity Testing).
o
Upper respiratory tract infections (e.g. pharyngitis, sinusitis).
o
Skin and skin structure infections (e.g. folliculitis, cellulitis,
erysipelas) (see
section 4.4 and 5.1 regarding Sensitivity Testing).
o
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_
.
Klacid Suspension has bacteri