ROXAR 300 roxithromycin 300mg tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

roxithromycin, Quantity: 300 mg

Dostupno od:

Arrotex Pharmaceuticals Pty Ltd

INN (International ime):

Roxithromycin

Farmaceutski oblik:

Tablet, film coated

Sastav:

Excipient Ingredients: glucose; propylene glycol; colloidal anhydrous silica; hyprolose; maize starch; povidone; hypromellose; magnesium stearate; titanium dioxide; purified talc

Administracija rute:

Oral

Jedinice u paketu:

5 tablets

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Adults: Roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections in adults caused by or likely to be caused by susceptible microorganisms: Upper respiratory tract infection: acute pharyngitis, tonsillitis, and sinusitis. Lower respiratory tract infection: acute bronchitis and acute exacerbation of chronic bronchitis; community acquired pneumonia. Skin and skin structure infections. Nongonococcal urethritis. Children: Roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible micro-organisms: Acute pharyngitis. Acute tonsillitis. Impetigo. Appropriate culture and susceptibility tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. Therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

Proizvod sažetak:

Visual Identification: White to off white round biconvex film-coated tablet plain on both side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

2005-12-16

Uputa o lijeku

ROXAR- Consumer Medicine Information
Page 1 of 4
Roxar
roxithromycin
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ROXAR.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking ROXAR against
the benefits they expect it will have
for you.
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT ROXAR IS USED FOR
ROXAR is used to treat infections in
different parts of the body caused
by bacteria, such as:
•
acute pharyngitis (sore throat and
discomfort when swallowing)
•
tonsillitis
•
sinusitis
•
acute bronchitis (infection of the
bronchi causing coughing)
•
pneumonia (lung infection
characterised by fever, malaise,
headache)
•
skin and soft tissue infections
•
non-gonococcal urethritis
•
impetigo (bacterial infection
causing sores on the skin).
ROXAR is an antibiotic that belongs
to a group of medicines called
macrolides. These antibiotics work
by killing or stopping the growth of
the bacteria that are causing your
infection. ROXAR, like other
antibiotics, does not work against
viral infections such as the flu.
Your doctor may have prescribed
ROXAR for another reason. Ask
your doctor if you have any
questions about why ROXAR has
been prescribed for you.
This medicine is available only with
a doctor's prescription.
There is no evidence that ROXAR is
addictive.
BEFORE YOU TAKE IT
When you must not take it
DO NOT TAKE THIS MEDICINE IF YOU
ARE ALLERGIC TO:
•
roxithromycin
•
any other macrolide antibiotic eg,
azithromycin, clarithromycin or
erythromycin
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include skin rash, itching,
difficulty breathing or swelling.
DO NOT TAKE ROXAR IF YOU HAVE
SEVERE LIVER PROBLEMS.
DO NOT TAKE ROXAR IF YOU

Svojstava lijeka

1
AUSTRALIAN PI – ROXAR (ROXITHROMYCIN)
1
NAME OF THE MEDICINE
Roxithromycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ROXAR 150 tablets contain 150mg of roxithromycin.
ROXAR 300 tablets contain 300mg of roxithromycin.
PHYSICAL AND CHEMICAL CHARACTERISTICS:
Roxithromycin is a white, crystalline powder. It is very slightly
soluble in water and freely soluble in
acetone, alcohol and methylene chloride.
EXCIPIENTS:
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ROXAR 150 tablets are white to off white round biconvex film-coated
tablet plain on both sides.
ROXAR 300 tablets are white to off white round biconvex film-coated
tablet plain on both sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Adults.
Roxithromycin is indicated for the treatment of the following types of
mild to moderately severe
infections caused by or likely to be caused by susceptible
micro-organisms.
Upper respiratory tract infection: acute pharyngitis, tonsillitis and
sinusitis.
Lower respiratory tract infection: acute bronchitis and acute
exacerbations of chronic bronchitis;
community acquired pneumonia.
Skin and skin structure infections.
Non-gonococcal urethritis.
Children.
Roxithromycin 150 mg tablets are indicated for the treatment of the
following mild to moderately
severe infections in children caused by or likely to be caused by
susceptible micro-organisms: acute
pharyngitis, acute tonsillitis, impetigo.
2
Appropriate culture and sensitivity tests should be performed when
necessary to determine
organism susceptibility and thus treatment suitability. Therapy with
roxithromycin may be initiated
before results of these tests are known; once results become
available, appropriate therapy should
be continued.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Roxithromycin should be taken at least 15 minutes before food or on an
empty stomach (i.e. more
than three hours after a meal).
The recommended dosage is 300 mg per day, which may be taken according
to one of the following
dosage regimens.
Usual