Arrow - Roxithromycin 150

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Roxithromycin 150mg;  

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Roxithromycin 150 mg

Dosage:

150 mg

Pharmaceutical form:

Coated tablet

Composition:

Active: Roxithromycin 150mg   Excipient: Colloidal silicon dioxide Glucose Hyprolose Hypromellose Magnesium stearate Maize starch Povidone Propylene glycol Purified talc Titanium dioxide Water

Units in package:

Blister pack, PVC/PVDC/Al foil, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Kopran Limited

Therapeutic 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 · dental infections · lower respiratory tract infection - acute bronchitis; acute exacerbations of chronic bronchitis and 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 and impetigo. 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.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al foil - 10 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al foil - 50 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2006-06-24

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ARROW - ROXITHROMYCIN
Roxithromycin 150 mg and 300 mg tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ARROW -
ROXITHROMYCIN.
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 benefits and risks. Your doctor has weighed the
risks of
you taking ARROW - ROXITHROMYCIN against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR
OR PHARMACIST.
Keep this leaflet with your medicine. You may need to read it again.
WHAT ARROW - ROXITHROMYCIN IS USED FOR
ARROW - ROXITHROMYCIN Tablets are 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-gonoccocal urethritis
•
impetigo (bacterial infection causing sores on the skin).
ARROW - ROXITHROMYCIN 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.
ARROW - ROXITHROMYCIN, like other antibiotics, does not work against
viral infections such as flu.
Your doctor may have prescribed ARROW - ROXITHROMYCIN for another
reason. Ask your doctor if you have any questions about why ARROW -
ROXITHROMYCIN has been prescribed for you.
There is no evidence that ARROW - ROXITHROMYCIN Tablets is addictive.
ARROW - ROXITHROMYCIN is available only with a doctor's prescription.
BEFORE YOU TAKE ARROW - ROXITHROMYCIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ARROW - ROXITHROMYCIN IF YOU ARE ALLERGIC TO MEDICINES
CONTAINING ROXITHROMYCIN, ANY OTHER MACROLIDES ANTIBIOTIC EG,
AZITHROMYCIN, CLARITHROMYCIN, ERYTHROMYCIN OR ANY OF THE INGREDIENTS
LISTED AT THE

Summary of Product characteristics

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Arrow – Roxithromycin 150, 150 mg, coated tablets
Arrow – Roxithromycin 300, 300 mg, coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg or 300 mg of roxithromycin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White, round, coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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
•
dental infections
•
lower respiratory tract infection - acute bronchitis; acute
exacerbations of chronic bronchitis and
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 and impetigo.
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
DOSE AND METHOD OF ADMINISTRATION
This product may not be interchangeable with other products containing
this ingredient in the New
Zealand's market. The bioequivalence with Rulide
®
marketed in Australia has been demonstrated.
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 film coated tablets must be
swallowed whole with a drink.
_Adults _
The recommended dosage is 300 mg per day, which may be taken according
to one of the following
dosage regimens.
Usual dosage: Roxithromycin 300 mg tablet