LPV phenoxymethylpenicllin 500mg (as potassium) capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phenoxymethylpenicillin, Quantity: 500 mg

Available from:

iNova Pharmaceuticals (Australia) Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: erythrosine; titanium dioxide; sunset yellow FCF; brilliant blue FCF; magnesium stearate; Gelatin; indigo carmine; allura red AC; quinoline yellow aluminium lake; iron oxide black; SD alcohol 3-A

Administration route:

Oral

Units in package:

25 capsules, 50 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Penicilin V potassium is indicated in the treatment of mild to moderately severe infections due to penicillin V sensitive micro-organisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. Note: Severe pneumonia, empyema, bacteraemia, pericarditis, meningitis and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed.

Product summary:

Visual Identification: Capsules with a red opaque top and pink body; bothprinted with "LPV500" in black ink.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-10-16

Patient Information leaflet

LPV™
_Phenoxymethylpenicillin (as potassium)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LPV. 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 LPV 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 THE MEDICINE.
You may need to read it again.
WHAT LPV IS USED FOR
LPV is an antibiotic that belongs to a
group of medicines called penicillins.
These antibiotics work by killing the
bacteria that are causing your
infection.
It is used to treat infections in
different parts of the body caused by
certain bacteria.
This medicine may also be used to
prevent infections before, during and
after surgery.
LPV will not work against infections
caused by viruses, such as colds.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LPV HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is available only with
a doctor's prescription.
There is no evidence that LPV is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LPV IF YOU HAVE EVER
HAD AN ALLERGIC REACTION TO:
•
phenoxymethylpenicillin
•
any other penicillins
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty in breathing;
swelling of the face, lips, tongue or
any other parts of the body; rash,
itching or hives on the skin.
DO NOT TAKE LPV IF YOU HAVE EVER
HAD AN ALLERGIC REACTION TO
CEPHALOSPORINS.
You may have an increased chance
of being allergic to LPV if you are
allergic to cephalosporins.
DO NOT TAKE LPV AFTER THE EXPIRY
DATE (EXP) PRINTED ON THE PACK.
It may have no effect at all or an
entirely unexpected effect if you take
it after the expiry date.
DO NOT TAKE IT IF THE PACKAGING

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – LPV
®
1
NAME OF THE MEDICINE
Phenoxymethylpenicillin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenoxymethylpenicillin potassium is a white or almost white,
crystalline powder, freely soluble in
water and practically insoluble in ethanol (96%).
LPV capsules contain either 250 mg or 500 mg of the active
phenoxymethylpenicillin (as potassium).
They also contain magnesium stearate, gelatin, erythrosine, sunset
yellow FCF, brilliant blue FCF,
titanium dioxide and opacode black A-10259S-1-8115 black. The 250 mg
capsule also contains carbon
black.
3
PHARMACEUTICAL FORM
LPV phenoxymethylpenicillin 250mg (as potassium) capsule blister pack
– capsules with a opaque red
cap and opaque grey body printed with "LPV250" in black ink on cap and
body.
LPV phenoxymethylpenicillin 500mg (as potassium) capsule blister pack
– capsules with a red opaque
top and pink body; both printed with "LPV500" in black ink.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Penicillin V potassium is indicated in the treatment of mild to
moderately severe infections due to
penicillin V sensitive micro-organisms. Therapy should be guided by
bacteriological studies (including
sensitivity tests) and by clinical response.
_Note:_ Severe pneumonia, empyema, bacteraemia, pericarditis,
meningitis and arthritis should not be
treated with penicillin V during the acute stage.
Indicated surgical procedures should be performed.
The following infections will usually respond to adequate dosage of
penicillin V:
STREPTOCOCCAL INFECTIONS (without bacteraemia). Mild to moderate
infections of the upper respiratory
tract, scarlet fever and mild erysipelas. _Note_: Streptococci in
groups A, C, G, H, L and M are very
sensitive to penicillin. Other groups, including Group D
(enterococcus) are resistant.
PNEUMOCOCCAL INFECTIONS. Mild to moderately severe infections of the
respiratory tract.
FUSOSPIROCHETOSIS (VINCENT'S GINGIVITIS AND PHARYNGITIS). Mild to
moderately severe infections of
the oropharynx usually respond to thera