PAMECIL CAPSULE 250MG

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

AMPICILLIN TRIHYDRATE

Commercializzato da:

KOMEDIC SDN BHD

INN (Nome Internazionale):

AMPICILLIN TRIHYDRATE

Confezione:

500 Capsules; 1000 Capsules

Prodotto da:

MEDOCHEMIE LTD (Factory B)

Foglio illustrativo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PAMECIL CAPSULES
Ampicillin trihydrate (250mg, 500mg)
WHAT IS IN THIS LEAFLET
1.
What PAMECIL is used for
2.
How PAMECIL works
3.
Before you use PAMECIL
4.
How to use PAMECIL
5.
While you are using it
6.
Side effects
7.
Storage and disposal of PAMECIL
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT PAMECIL IS USED FOR
Ampicillin
trihydrate
belongs
to
the
group of medicines known as penicillin
antibiotics. It is used to kill bacteria that
cause infections in your body.
HOW PAMECIL WORKS
The active ingredient in your capsules is
ampicillin trihydrate. It works by killing
bacteria that cause the infections.
BEFORE YOU USE PAMECIL
_- When you must not use it _
Do not take PAMECIL if you:

are hypersensitive (allergic) to this
medicine
or
any
of
the
other
ingredients of PAMECIL or to other
beta-lactam
antibiotics
(e.g.
penicillins, cephalosporins)
_ _
_- Before you start to use it _
Take special care with PAMECIL and
tell your doctor or pharmacist if you:

are allergic to beta-lactam antibiotics

suffer from a blood disorder

suffer from kidney problems

have glandular fever or leukemia
_ _
_Pregnancy and breast-feeding _
Do
not
use
PAMECIL
if
you
are
pregnant, trying to become pregnant or
suspect you may be pregnant. If you
become
pregnant
while
taking
PAMECIL, stop taking it immediately
and contact your doctor.
_ _
Do not use PAMECIL if you are breast-
feeding.
Consult
your
doctor
before
taking the capsules as ampicillin is found
in the milk in small amounts.
_ _
_- Taking other medicines _
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other
medicines,
including
medicines
obtained without a prescription, herbal
and
complementary
medicines.
It
is
important to tell your doctor that you are
taking:

any
other
antibiotics,
such
as
chloramphenicol,
tetracyclines,
erythromycins or sulphonamides

allopurinol ( used to treat gout)

probenecid ( used to treat gout)
I

Scheda tecnica

1
PAMECIL
1.
NAME OF THE MEDICINAL PRODUCT
PAMECIL 250mg hard capsules
PAMECIL 500mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PAMECIL 250mg: Each capsule contains 250mg ampicillin as ampicillin
trihydrate
PAMECIL 500mg: Each capsule contains 500mg ampicillin as ampicillin
trihydrate
3.
PHARMACEUTICAL FORM
PAMECIL 250mg: Black-Scarlet hard gelatin capsule size “2”
PAMECIL 500mg: Black-Scarlet hard gelatin capsule size “0”,
elongated
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Ampicillin is a broad-spectrum penicillin, indicated for the treatment
of a wide range of bacterial
infections caused by ampicillin-sensitive organisms. Typical
indications include: ear, nose and throat
infections, bronchitis, pneumonia, urinary tract infections,
gonorrhoea, gynaecological infections,
septicaemia, peritonitis, endocarditis, meningitis, enteric fever,
gastro-intestinal infections.
Parenteral usage is indicated where oral dosage is inappropriate.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_DOSAGE FOR ADULTS AND ELDERLY PATIENTS _
_Ear, Nose, Throat infections _
_: _
250mg four times a day
_Bronchitis _
_: _
Routine therapy 250mg four times a day
_Pneumonia _
_: _
500mg four times a day
_Urinary tract infections _
_: _
500mg three times a day
_Gastrointestinal infections _
_: _
500 to 750mg three to four times daily
_Enteric infections _
_: _
_Acute: _1-2g four times a day for two weeks.
_Carries: _1-2g four times a day for four to twelve weeks.
_Gonorrhoea _
_: _
2g orally with 1g of probenecid as a single dose. Repeated doses
are recommended for the treatment of females.
_ _
_PAEDIATRIC POPULATION _
Children less than 10 years old: Half adult routine dosage. All
recommended dosages are a guide only.
In severe infections the above dosages may be increased, or ampicillin
given by injection.
_RENAL IMPAIRMENT _
In the presence of severe renal impairment (creatinine clearance less
than 10 ml/min) a reduction in
dose or extension of dose interval should be considered. In cases of
dialysis,