ROXY TABLET 150MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ROXITHROMYCIN

Available from:

IMEKS PHARMA SDN. BHD.

INN (International Name):

ROXITHROMYCIN

Units in package:

500 Tablets; 100 Tablets; 100Tablet Tablets; 500 Tablet Tablets

Manufactured by:

Sriprasit Pharma Co. Ltd.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ROXY TABLET
Roxithromycin (150 mg)
_ _
1
WHAT IS IN THE LEAFLET
1.
What Roxy is used for
2.
How Roxy works
3.
Before you use Roxy
4.
How to use Roxy
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Roxy
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT ROXY IS USED FOR
Roxy
contains
the
active
ingredient
Roxithromycin. Roxy is used to treat various
infections caused by bacteria such as:
• Respiratory tract infections
-
Sore
throat
and
discomfort
when
swallowing
- Sinusitis
- Infection of the bronchi causing coughing
- Pneumonia (lung infection characterised
by fever, malaise, headache)
• Skin and soft tissue infections
• Urinary tract infection
• Prevention of meningitis (inflammation of
meninges covering brain and spinal cord)
HOW ROXY WORKS
Roxithromycin is an antibiotics that belongs
to a group of medicines called macrolides. It
prevents
bacteria
from
growing
by
interfering with their protein synthesis.
BEFORE YOU USE ROXY _ _
-
_When you must not use it_
Do not take Roxy if you:
• Have ever had a reaction or been told that
you are allergic to roxithromycin or to any of
the excipients.
• Allergic to any other macrolide antibiotics.
•
Are
concurrently
taking
medicines
for
migraine headache e.g. ergotamine.
• Have severe liver problem.
-
_Before you start to use it _
Tell your doctor if you:
•
Have
allergies
to
any
other
medicines,
food, preservatives or dyes.
• Have or have had kidney or liver problems.
• Are pregnant, planning to become pregnant
or are breastfeeding.
If you are not sure whether you should start
taking this medicine, consult your doctor.
-
_Taking other medicines _
Tell your doctor if you are taking any other
medicine, including any that you buy without
a prescription. You may need to use different
amounts
of
these
medicines,
or
you
may
need to take different medicines. Your doctor
will advise you. In particular, tell your doctor
if you take any of the follo

Summary of Product characteristics

DESCRIPTION
White round biconvex film-coated tablet, embossed with “Roxy” and
“SPS”
on one side and scored on the other side.
Each film-coated tablet contains Roxithromycin 150 mg.
INDICATION
Roxithromycin is indicated for:
 Upper respiratory tract infections, e.g. acute pharyngitis and
sinusitis.
 Lower respiratory tract infections, e.g. pneumonia, bronchitis,
atypical
pneumonia.
 Skin and skin structural infections.
 Non-gonococcal urethritis.
 Prophylaxis of meningococcal meningitis subjects who have come in
contact with the patients.
RECOMMENDED DOSAGE
Adults:
For most infections, oral roxithromycin is effective in doses of 150
mg twice
a day or 300 mg once a day. Therapy should be continued for at least
10
days. The maximum duration of therapy is 4 weeks. Doses should be
taken
in the morning and evening before meals.
CONTRAINDICATIONS
 Hypersensitivity to roxithromycin, macrolides or to any of the
excipients.
 Severely impaired hepatic function.
 Concomitant therapy with vasoconstrictive ergot alkaloids.
WARNINGS AND PRECAUTIONS
Roxithromycin, like erythromycin, has been shown _ in vitro_ to elicit
a
concentration-dependent lengthening in cardiac action potential
duration.
Such an effect is manifested only at supratherapeutic concentrations.
Accordingly, the recommended doses should not be exceeded.
Prolonged or repeated use of antibiotics including roxithromycin may
result
in superinfection by resistant organisms. In the event of
superinfection,
roxithromycin should be discontinued and appropriate therapy
instituted.
When indicated, incision, drainage or other appropriate surgical
procedures
should be performed in conjunction with antibiotic therapy.
Pseudomembranous colitis
Antibiotic associated pseudomembranous colitis has been reported with
many antibiotics. A toxin produced by _Clostridium difficile _appears
to be the
primary cause. If pseudomembranous colitis is suspected, roxithromycin
must be stopped immediately.
The severity of the colitis may range from mild to life