Curam Film Coated Tablets 625mg

Country: Malaysia

Language: English

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

Active ingredient:

AMOXYCILLIN TRIHYDRATE; POTASSIUM CLAVULANATE

Available from:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (International Name):

AMOXYCILLIN TRIHYDRATE; POTASSIUM CLAVULANATE

Units in package:

12Tablet Tablets; 16Tablet Tablets; 20Tablet Tablets; 30Tablet Tablets; 100Tablet Tablets

Manufactured by:

SANDOZ GMBH

Patient Information leaflet

CURAM
® FILM-COATED TABLET
_ Consumer Medication Information Leaflet (RiMUP) _
(AMOXICILLIN & CLAVULANIC ACID 500/125 MG)
WHAT IS IN THIS LEAFLET:
1.
What CURAM is used for
2.
How CURAM works
3.
Before you use CURAM
4.
How to use CURAM
5.
While you are using it
6.
Side effects
7.
Storage and disposal of CURAM
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT CURAM IS USED FOR
CURAM is used to treat infections such
as middle ear and sinus infections,
respiratory tract infections, urinary tract
infections, skin and soft tissue infections
including dental infections, bone and
joint infections.
HOW CURAM WORKS
CURAM is an antibiotic and works by
killing bacteria that cause infections. It
contains two different medicines called
amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of
medicines called penicillins that can
sometimes be stopped from working
(made inactive by bacteria). The other
active component (clavulanic acid) stops
this from happening.
BEFORE YOU USE CURAM
_WHEN YOU MUST NOT USE IT _
•
If you are allergic (hypersensitive)
to amoxicillin, clavulanic acid,
penicillin or any of the other
ingredients of Curam
•
If you have ever had a severe
allergic (hypersensitive) reaction
to any other antibiotic. This can
include a skin rash or swelling of
the face or neck
•
If you have ever had liver
problems or jaundice (yellowing
of the skin) when taking an
antibiotic
PREGNANCY AND BREAST-FEEDING
Curam should not be used while
breastfeeding.
If you are pregnant, or you think you
might be pregnant, ask your doctor
for advice before taking any
medicine. Use should be avoided
during pregnancy unless the benefit
outweighs the risk.
If you are not sure, talk to your doctor
or pharmacist before taking Curam.
_ _
_BEFORE YOU START USE IT _
Check with your doctor or pharmacist
before taking this medicine if you:
•
any allergic conditions
•
fits/ convulsions
•
severe and persistent diarrhea
•
are being treated for liver or
kidney problems
In some cases,

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Curam
®
625 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg amoxicillin and 125 mg
clavulanic acid.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of common bacterial infections where oral therapy is
indicated, including:
•
Upper respiratory tract infections (including ENT): sinusitis,
tonsillitis, otitis media.
•
Skin and soft tissue infections: boils/abscesses, cellulitis, wound
infections, intra-abdominal
sepsis
•
Lower respiratory tract infections: acute and chronic bronchitis,
pneumonia, lung abscess
•
Genito-urinary tract infections: cystitis, urethritis, pyelonephritis,
septic abortion, pelvic infection
•
Other infections: osteomyelitis, peritonitis, postoperative
infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 12 years:
Mild and moderate infections: one Curam 625 mg tablet twice daily.
More severe infections and respiratory tract infections: one Curam 625
mg tablet, three times a day.
Treatment with Curam should not be extended beyond 14 days without
review.
Elderly
No dose adjustment is considered necessary.
Dose in renal impairment
Age
Creatinine Clearance
Dose
Adults
Mild impairment (>30ml/min)
No change of dose
Moderate impairment (10-30 ml/min)
Curam 625 mg 12 hourly
Severe impairment (<10ml/min)
Not more than Curam 625 mg 24 hourly
Children over 12
years old
Similar reductions in dose should be made.
Dose in hepatic functional impairment
Dose with caution and monitor hepatic function at regular intervals
(see sections 4.3 and 4.4).
METHOD OF ADMINISTRATION
For oral use.
Curam is well absorbed whether taken with or before meals. Administer
at the start of a meal to
minimise potential gastrointestinal intolerance.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active substances, to any of the penicillins
or to any of the excipients.
•
History of a severe immediate hypersensitivity reaction (e.g.
ana