DAPSONE dapsone 100mg tablet bottle

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

dapsone, Quantity: 100 mg

Dostupné z:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (Medzinárodný Name):

Dapsone

Forma lieku:

Tablet, uncoated

Zloženie:

Excipient Ingredients: maize starch; magnesium stearate; silicon dioxide; microcrystalline cellulose

Spôsob podávania:

Oral

Počet v balení:

100 tablets

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Dermatitis herpetiformis. Leprosy. Actinomycotic mycetoma.

Prehľad produktov:

Visual Identification: White, round, scored tablet, debossed '100' above the score and '101' below the score on one side, and 'JACOBUS' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizácia:

Registered

Dátum Autorizácia:

2004-07-20

Príbalový leták

Page 1 of 3
DAPSONE
_Dapsone 25, 100 mg tablet _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Dapsone. It does not
contain all the available information.
It does not take the place of talking to
your doctor and pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you
taking
Dapsone
against
the
benefits they expect it will have for
you.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT DAPSONE IS USED
FOR?
Dapsone
is
used
to
treat
leprosy
(Hansen’s
disease)
and
to
help
control
a
skin
problem
called
dermatitis and a fungal disease called
_Actinomycotic mycetoma_
. When it is
used to treat leprosy, Dapsone may
be
given
with
one
or
more
other
medicines.
Mechanism of action:
Dapsone
(DAP-sone),
a
sulfone,
belongs to the family of medicines
called anti-infectives.
Dapsone works by killing the bacteria
or fungi causing your infection or by
stopping its growth.
Dapsone
will
not
work
against
infections caused by viruses such as
colds or the flu.
Dapsone
is
available
only
with
a
doctor's prescription.
There is no evidence that Dapsone is
addictive.
BEFORE TAKING
DAPSONE
_WHEN YOU MUST NOT TAKE IT? _
_WHEN YOU MUST NOT BE GIVEN IT? _
Do not take/use Dapsone if:
you
have
ever
had
an
allergic
reaction to Dapsone or any other
sulpha
drugs
or
any
of
the
ingredients
listed
at
the
end
of
this leaflet.
Some of the symptoms of an allergic
reaction may include skin rash, which
is
always
present,
fever,
jaundice,
and eosinophilia.
_TAMPERING _
_AND _
_EXPIRY _
_DATE _
_WARNINGS: _
Do not use Dapsone if the packaging
is torn or shows signs of tampering.
If
you
are
not
sure
whether
you
should start taking Dapsone, contact
your doctor.
_BEFORE YOU START TO TAKE IT _
_BEFORE YOU ARE GIVEN IT _
Tell your doctor if:
1.
_YOU _
_HAVE _
_ANY _
_TYPE _
_OF _
_ALLERGIC _
_REACTION _
_TO _
_SULPHA _
_DRUGS _
_(SULFONAMIDE MEDICINES):_
You
may
have
an
increased
chance
of
being
allergic
to
Dapsone
if
you
are
allergic
to
sulpha dru

Súhrn charakteristických

1
AUSTRALIAN PRODUCT INFORMATION
DAPSONE (DAPSONE) TABLETS
1. NAME OF THE MEDICINE
Dapsone.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dapsone tablets are available in strengths of 25 mg and 100 mg round,
white,
scored tablets.
Dapsone tablets do not contain alcohol, gluten, lactose, parabens,
sugar,
sulfites or tartrazine.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dermatitis herpetiformis. Leprosy. Actinomycotic mycetoma.
4.2 DOSE AND METHOD OF ADMINISTRATION
To be taken with or after food. Tablets should be taken whole and
small doses
should be made up from 25 mg tablets. Do not split the tablet.
DERMATITIS HERPETIFORMIS:
_ADULTS: _The usual maintenance dosage is 50 to 100 mg daily, but as
little as
50 mg weekly may be adequate. Dosages of up to 300 mg daily may be
considered, but efforts should be made to reduce this to the minimal
maintenance dosage as soon as possible.
_ _
LEPROSY:
_ADULTS: _The standard dose is 100 mg daily (1 to 2 mg/kg bodyweight).
_CHILDREN: _Dosage should be adjusted according to bodyweight.
The modern treatment of leprosy involves the use of multiple drug
regimens to
avoid the development of resistant strains. The World Health
Organization
has made the following recommendations for standard adult treatment
regimens (with dosage adjustments according to bodyweight).
MULTIBACILLARY LEPROSY:_ _
Rifampicin 600 mg once monthly supervised; dapsone 100 mg daily, self-
administered; clofazimine 300 mg once monthly, supervised; and 50 mg
daily
self-administered.
2
PAUCIBACILLARY LEPROSY:_ _
Rifampicin 600 mg once monthly for 6 months, supervised; dapsone 100
mg
daily for 6 months, self-administered.
ACTINOMYCOTIC MYCETOMA:
_ADULTS: _Published reports suggest that a dose of 100 mg should be
given
twice daily and continued for some months after the clinical symptoms
have
disappeared. Streptomycin at 14 mg/kg daily for the first month and
alternate
days thereafter (or the equivalent) sho