CLAMENTIN 1000 mg TABLET

País: Sudáfrica

Idioma: inglés

Fuente: South African Health Products Regulatory Authority (SAHPRA)

Disponible desde:

Mylan Pharmaceuticals (Pty) Ltd

Dosis:

See ingredients

formulario farmacéutico:

TABLET

Composición:

EACH TABLET CONTAINS AMOXYCILLIN TRIHYDRATE EQUIVALENT TO AMOXYCILLIN 875,0 mg POTASSIUM CLAVULANATE EQUIVALENT TO CLAVULANIC ACID 125,0 mg

Estado de Autorización:

Registered

Fecha de autorización:

2007-05-10

Información para el usuario

1.3.2 Patient Information Leaflet
February 2024 Signature ……………… Page 1 of 12
SCHEDULING STATUS CLAMENTIN 1000 MG, FILM-COATED TABLET
AMOXICILLIN 875MG
CLAVULANIC ACID 125 MG
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING CLAMENTIN
1000 MG
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare provider.
CLAMENTIN 1000 mg 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 CLAMENTIN 1000 mg is and what it is used for.
2. What you need to know before you take CLAMENTIN 1000 mg.
3. How to take CLAMENTIN 1000 mg.
4. Possible side effects.
5. How to store CLAMENTIN 1000 mg.
6. Contents of the pack and other information.
1.WHAT CLAMENTIN 1000 MG IS AND WHAT IT IS USED FOR
WHAT CLAMENTIN 1000 MG IS:
S4
1.3.2 Patient Information Leaflet
February 2024 Signature ……………… Page 2 of 12
CLAMENTIN 1000 mg is an antibiotic and works by killing bacteria that
cause infections. It contains
two different medicines called amoxicillin and clavulanic acid.
CLAMENTIN 1000 mg belongs to a group of medicines called
“penicillins” that can sometimes be
stopped from working (made inactive). The other active component
(clavulanic acid) stops this from
happening. WHAT IT IS USED FOR:
CLAMENTIN 1000 mg is used to treat the following infections:
INFECTIONS OF THE UPPER AIRWAYS:
-
Recurrent tonsil infection
-
Sinusitis
-
Inner ear infection
INFECTION OF THE LOWER AIRWAYS:
-
Acute and chronic infection of the airways
-
Infection of the lungs (pneumonia)
INFECTIONS OF THE GENITAL AND URINARY TRACT:
-
Infection of the bladder
-
Infection of the urethra
-
Infection of the kidney
SKIN AND SOFT TISSUE INFECTIONS
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLAMENTIN 1000 MG
DO NOT TAKE CLAMENTIN 1000 MG IF YOU:
1.3.2 Patient Information Leaflet
February 2024 Signature ………�

Ficha técnica

1.3.1.1 Professional Information for medicines for human use
February 2024 Signature ……………… Page 1 of 17
SCHEDULING STATUS
1 NAME OF THE MEDICINE
CLAMENTIN 1000 MG (FILM-COATED TABLET)
2 QUALITIVE AND QUANTITIVE COMPOSITION
CLAMENTIN 1000 mg tablets contain amoxicillin trihydrate equivalent to
amoxicillin 875
mg and potassium clavulanate equivalent to clavulanic acid 125 mg.
Sugar free.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White to pale yellow, oblong tablet, scored on both sides.
Approximately 10 x 22 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CLAMENTIN 1000 mg formulation is indicated for the treatment of
infections caused by
amoxicillin-resistant organisms producing beta-lactamases sensitive to
clavulanic acid:
•
Upper respiratory tract infections, such as sinusitis, recurrent
otitis media, tonsillitis.
•
Lower respiratory tract infections, such as bronchitis and
bronchopneumonia.
•
Genito-urinary tract infections, such as cystitis, urethritis,
pyelonephritis.
•
Skin and soft tissue infections.
S4
1.3.1.1 Professional Information for medicines for human use
February 2024 Signature ……………… Page 2 of 17
CLAMENTIN 1000 mg formulation will also be effective in the treatment
of infections caused
by amoxicillin-sensitive organisms at the appropriate amoxicillin
dosage since in this
situation the clavulanic acid component does not contribute to the
therapeutic effect.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
FOR ORAL FORMULATIONS:
CLAMENTIN 1000 mg should be taken immediately before a meal.
GENERAL INFORMATION:
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:
•
The adult dose is one CLAMENTIN 1000 mg tablet every 12 hours at the
start of a
meal.
SPECIAL POPULATIONS
IMPAIRED RENAL FUNCTION:
•
Both amoxicillin and clavulanic acid are excreted by the kidneys and
the serum half-
life of each incre