NOUMED CLARITHROMYCIN clarithromycin 250 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clarithromycin, Quantity: 250 mg

Available from:

AVALLON PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: titanium dioxide; powdered cellulose; magnesium stearate; hypromellose; macrogol 4000; croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate

Administration route:

Oral

Units in package:

14, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

NOUMED CLARITHROMYCIN clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: Acute streptococcal pharyngitis; Community acquired pneumonia due to Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophilia and Streptococcus pneumoniae;Uncomplicated skin and skin structure infections due to Staphylococcus aureus or Streptococcus pyogenes;Disseminated or localised mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare and skin and skin structure infections due to Mycobacterium chelonae. Clarithromycin should be used in combination with other anti mycobacterial agents.Prevention of disseminated Mycobacterium avium complex infection in HIV infected adults with CD4 lymphocyte counts <75 cells/mm 3 (See Precautions). Disseminated infection due to Mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis.Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae;Combination therapy for the treatment of peptic ulcer disease associated with Helicobacter pylori infection. NOUMED CLARITHROMYCIN clarithromycin is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro organisms in the conditions listed below:Acute streptococcal pharyngitis and tonsillitis caused by Streptococcus pyogenes; Community acquired pneumonia including infections due to Chlamydia pneumoniae, Mycoplasma pneumoniae and Legionella pneumophila; Skin and skin structure infections (eg impetigo); Disseminated or localised infections due to Mycobacterium avium or Mycobacterium intracellulare in immunocompromised children, including those with HIV Infection or AIDS. Acute otitis media.Note:1. Penicillins are the drug of first choice in the treatment of acute otitis media. 2. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. Clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. There is insufficient evidence of efficacy to support the use of Clarithromycin in acute bronchitis in young children. 4. The data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

Product summary:

Visual Identification: White, oblong, convex tablets, scored on both faces; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-02-26

Patient Information leaflet

NOUMED CLARITHROMYCIN
1
NOUMED CLARITHROMYCIN
_clarithromycin tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
CLARITHROMYCIN.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of taking this medicine
against the benefits it is expected to
have for you or your child.
IF YOUR CHILD IS BEING TREATED WITH
NOUMED CLARITHROMYCIN,
FOLLOW THE SAME INSTRUCTIONS IN THIS
LEAFLET AS YOU WOULD AS THE PATIENT.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NOUMED
CLARITHROMYCIN IS
USED FOR
NOUMED CLARITHROMYCIN
tablets contain the active ingredient
clarithromycin.
Clarithromycin is an antibiotic that
belongs to the group of medicines
called macrolides. These work by
killing or stopping the growth of the
bacteria that cause infections.
It does not work against infections
caused by viruses, such as colds or
‘flu.
This medicine is used to treat certain
bacterial infections, including the
following:
•
respiratory tract infections
•
ear infections
•
skin infections
•
peptic ulcer
Peptic ulcers are associated with
an infection in the intestine and
stomach by
_Helicobacter pylori_
(
_H. pylori_
) bacteria. Nearly all
patients with peptic ulcers are
infected with this bacterium.
The
_H. pylori_
infection can be
treated with a combination of
clarithromycin, another antibiotic
and a medicine used to control
the acidity of the stomach.
However, the best combination of
tablets to treat
_H. pylori_
infection
is yet to be determined. Your
doctor will determine the best
combination for you.
If your symptoms return, consult
your doctor. It is possible that
clarithromycin may no longer be
effective in treating the
_H. pylori_
infection and a different antibiotic
may be needed.
NOUMED CLARITHROMYCIN is
also used t

Summary of Product characteristics

Product Information - Australia
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION – NOUMED
CLARITHROMYCIN (CLARITHROMYCIN)
1. NAME OF THE MEDICINE
clarithromycin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Noumed Clarithromycin contains 250 mg clarithromycin.
Excipients with known effects: lactose monohydrate
For the full list of excipients, see _section 6.1 List of excipients_.
3. PHARMACEUTICAL FORM
Film coated tablet
Noumed Clarithromycin 250 mg tablet is a white, oblong, convex, coated
tablet scored on both faces.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Noumed Clarithromycin (clarithromycin) is indicated for use in adults
and children older than 12 years for the
treatment of mild to moderately severe infections caused by
susceptible strains of the designated micro-organisms
in the conditions listed below:
1.
Acute streptococcal pharyngitis
2.
Community acquired pneumonia due to _Chlamydia pneumoniae, Mycoplasma
pneumoniae, Legionella _
_pneumophila and Streptococcus pneumoniae_ (see _section 4.4 Special
warnings and precautions for use _
regarding sensitivity testing)
3.
Uncomplicated skin and skin structure infections due to _
Staphylococcus aureus _ or _ Streptococcus _
_pyogenes_ (see _section 4.4 Special warnings and precautions for use
_regarding sensitivity testing)
4.
Disseminated or localised mycobacterial infections due to _
Mycobacterium avium_ or _ Mycobacterium _
_intracellulare_ and skin and skin structure infections due to _
Mycobacterium chelonae_. Clarithromycin
should be used in combination with other antimycobacterial agents
5.
Prevention of disseminated _ Mycobacterium avium _ complex infection
in HIV-infected adults with CD4
lymphocyte
counts
<75
cells/mm
3
(see
_section _
_4.4 _
_Special _
_warnings _
_and _
_precautions _
_for _
_use_).
Disseminated infection due to _Mycobacterium avium _complex should be
excluded by a negative blood
culture prior to commencement of prophylaxis
6.
Acute bacterial exacerbation of chronic bronchitis due to _Haemophilus
influenzae, Moraxella catarrh