CURAM 1000 SR TABLET

Maa: Etelä-Afrikka

Kieli: englanti

Lähde: South African Health Products Regulatory Authority (SAHPRA)

Saatavilla:

Sandoz South Africa (Pty) Ltd

Annos:

562,5 mg 437,5 mg 62,5 mg

Lääkemuoto:

TABLET

Koostumus:

EACH TABLET CONTAINS AMOXICILLIN TRIHYDRATE EQUIVALENT TO AMOXICILLIN 562,5 mg AMOXICILLIN SODIUM EQUIVALENT TO AMOXICILLIN 437,5 mg POTASSIUM CLAVULANATE EQUIVALENT TO CLAVULANIC ACID 62,5 mg

Valtuutuksen tilan:

Registered

Pakkausseloste

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PATIENT INFORATION LEAFLET
SCHEDULING STATUS S4
CURAM 1000 SR (PROLONGED-RELEASE TABLETS)
Amoxicillin 1000 mg / Clavulanic acid 62,5 mg
Sugar-Free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING CURAM 1000
SR
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
Curam 1000 SR has been prescribed for you personally and you should
not share your
medicine with other people. It may harm them, even if their symptoms
are the same as yours.
WHAT IS IN THIS LEAFLET
1. What Curam 1000 SR is and what it is used for
2. What you need to know before you take Curam 1000 SR
3. How to take Curam 1000 SR
4. Possible side effects
5. How to store Curam 1000 SR
6. Contents of the pack and other information
1. WHAT CURAM 1000 SR IS AND WHAT IT IS USED FOR
Curam 1000 SR is a broad-spectrum antibiotic and works by killing
bacteria that cause infections.
It contains two different medicines called amoxicillin and clavulanic
acid. Amoxicillin belongs to a
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group of medicines called “penicillins” that can sometimes be
stopped from working (made
inactive). The other active component (clavulanic acid) stops this
from happening.
Curam 1000 SR is used in adults and children over 16 years to treat
respiratory tract (airway)
infections such as pneumonia, bronchitis and sinusitis.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CURAM 1000 SR
DO NOT TAKE CURAM 1000 SR:
•
if you are hypersensitive (allergic) to amoxicillin, clavulanic acid,
penicillins or any of the other
ingredients of this medicine (listed in section 6).
•
if you have ever had a severe allergic reaction to any other
antibiotic.
•
if you have ever had liver problems or jaundice (yellowing of the skin
and eyes) when
previously treated with amoxicillin and clavulanic acid.
WARNINGS AND PRECAUTIONS
SPECIAL CARE SHOULD BE TAKEN WITH CURAM 1000 SR
Talk to your doctor, pharmacist or nurse before taking

Valmisteyhteenveto

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PROFESSIONAL INFORMATION
SCHEDULING STATUS S4
1.
NAME OF THE MEDICINE
Curam 1000 SR (prolonged-release tablet)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated bi-layered prolonged-release tablet contains
amoxicillin trihydrate equivalent to
562,5 mg amoxicillin and potassium clavulanate equivalent to 62,5 mg
clavulanic acid in the
"immediate release" layer and amoxicillin sodium equivalent to 437,5
mg amoxicillin
in
the
"prolonged
release"
layer.
The
tablet
strength
is
1000
mg/62,5
mg,
based
on
the
overall
amoxicillin/clavulanate content.
Each Curam 1000 SR tablet contains approximately 12 mg of potassium
and 29 mg of sodium.
The formulation is sugar-free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
White to cream-tinged, oval film-coated tablet (approx. 10,5 x 22,5
mm), scored on one side and
with the embossment “SZ 137” on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
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4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Curam 1000 SR is indicated for the treatment of respiratory tract
infections, e.g. community-
acquired pneumonia, acute exacerbations of chronic bronchitis and
acute bacterial sinusitis,
typically caused by _Streptococcus pneumoniae_.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
For
infections
caused
by
amoxicillin-sensitive
organisms,
the
dosage
is
that
approved
for
amoxicillin, as the clavulanic acid component does not contribute to
the therapeutic effect.
_ _
_ADULTS AND ADOLESCENTS ≥ 16 YEARS: _
The recommended dose of Curam 1000 SR is:
•
Community acquired pneumonia: 2 tablets 12-hourly for 7 to 10 days.
•
Acute exacerbations of chronic bronchitis: 2 tablets 12-hourly for 7
days.
•
Acute bacterial sinusitis: 2 tablets 12-hourly for 10 days.
_ _
_SPECIAL POPULATIONS: _
_Renal impairment: _
Amoxicillin and clavulanic acid are excreted by the kidneys resulting
in an increas