ASPECILLIN VK phenoxymethylpenicillin 500mg (as potassium) tablet bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

phenoxymethylpenicillin potassium, Quantity: 560 mg (Equivalent: phenoxymethylpenicillin, Qty 500 mg)

Disponible des:

Viatris Pty Ltd

Designació comuna internacional (DCI):

Phenoxymethylpenicillin potassium

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: maize starch; magnesium stearate; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; titanium dioxide; vanillin; quinoline yellow; purified talc; xanthan gum; polyvinyl alcohol; lecithin; hypromellose; macrogol 6000

Vía de administración:

Oral

Unidades en paquete:

25 Tablets, 100 Tablets (E), 4 Tablets (Sample pack)

tipo de receta:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

indicaciones terapéuticas:

Treatment of mild to moderately severe infections caused by penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci infections. Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. For prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or Sydenham?s chorea and to prevent bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. Note: oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or childbirth.

Resumen del producto:

Visual Identification: Bright yellow, smooth, film coated caplet shaped tablet. Plain on one side and a break bar on the other. Odour characteristic. Free of visible contamination and imperfections.; Container Type: Bottle; Container Material: Plastic; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estat d'Autorització:

Registered

Data d'autorització:

2012-11-20

Informació per a l'usuari

ASPECILLIN
® VK
_phenoxymethylpenicillin (as potassium)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ASPECILLIN VK.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ASPECILLIN
VK against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ASPECILLIN VK
IS USED FOR
This medicine contains the active
ingredient phenoxymethylpenicillin.
It is a type of antibiotic that belongs
to a group of medicines called
penicillins.
ASPECILLIN VK is used to treat
infections in different parts of the
body caused by bacteria. It works by
killing the bacteria that are causing
the infection.
ASPECILLIN VK will not work
against infections caused by viruses
such as colds or the flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
ASPECILLIN VK for another
purpose.
This medicine is only available on a
doctor’s prescription.
BEFORE YOU TAKE
ASPECILLIN VK
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ASPECILLIN VK IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
phenoxymethylpenicillin
•
any other penicillin medicines or
cephalosporins
•
any of the ingredients listed at the
end of this leaflet
IF YOU HAVE AN ALLERGIC REACTION TO
CEPHALOSPORINS, YOU MAY HAVE AN
INCREASED CHANCE OF BEING ALLERGIC
TO ASPECILLIN VK.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION
ASPECILLIN
® VK
_phenoxymethylpenicillin tablets _
1
NAME OF THE MEDICINE
Phenoxymethylpenicillin (as potassium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ASPECILLIN VK tablet contains 250 mg or 500 mg of
phenoxymethylpenicillin (as potassium) as the
active ingredient.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ASPECILLIN
VK
250
mg
tablets
are
bright
yellow,
smooth,
round
film
coated
tablets.
Odour
characteristic. Free of visible contamination and imperfections.
ASPECILLIN VK 500 mg tablets are bright yellow, smooth, film coated
caplet shaped tablets. Plain on one
side and a break bar on the other. Odour characteristic. Free of
visible contamination and imperfections.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of mild to moderately severe infections caused by penicillin
sensitive staphylococci, pneumococci,
gonococci and haemolytic streptococci infections. Therapy should be
guided by bacteriological studies,
including sensitivity tests, and by clinical response.
For prophylactic use in recurrent streptococcal infections including
the prevention of recurrence following
rheumatic fever and/or Sydenham’s chorea and to prevent bacterial
endocarditis in patients with rheumatic
fever and/or congenital heart disease who are about to undergo dental
or upper respiratory surgery or
instrumentation.
Note: oral penicillin should not be used as adjunctive prophylaxis for
genitourinary instrumentation or surgery,
lower intestinal tract surgery, sigmoidoscopy or childbirth.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
250 mg to 500 mg every four to six hours, preferably one hour before
food. The dosage should be determined
according to sensitivity of the organisms and severity of the
infection.
PREVENTION OF RECURRENCE FOLLOWING RHEUMATIC FEVER
250 mg twice a day continuously.
INFANTS AND SMALL CHILDREN
15 mg/kg to 50 mg/kg in three to six divided doses. If not calculated
by bodyweight the following dosage
schedule may be u