Dapsone 50mg tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Dapsone

थमां उपलब्ध:

Dr Reddy's Laboratories (UK) Ltd

ए.टी.सी कोड:

J04BA02

INN (इंटरनेशनल नाम):

Dapsone

डोज़:

50mg

फार्मास्यूटिकल फॉर्म:

Oral tablet

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 05011000; GTIN: 5060183920019

सूचना पत्रक

PRODUCT NAME
DAPSONE 50MG AND 100MG TABLETS
PACKAGING MATERIAL
PACK INSERT ARTWORK
SIZE : Foil Repeat Length
------
SIZE : Strip Size
------
SIZE : Carton/Label
------
SIZE : PI - Open Size
PI - Close Size
L. 150 X H. 360 MM
L. 150 X H. 30 MM
PM STYLE/TYPE :
------
SIZE : Foil Width
------
SAP CODE :
REFERENCE ARTWORK
-----------------
REASON OF CHANGE :
N.A.
PROOF 1
COUNTRY :
UK
PACK SIZE :
----------------
PROOF 4
BARCODE NO. :
----------------
PHARMACODE :
2067
NO. OF COLOURS :
1
MIN. FONT SIZE :
9 PT.
PROOF 2
PROOF 3
510009506GB01
05.10.2017
Emcure - Hinjawadi
BLACK
REMARK (IF ANY) :
NEW ARTWORK
DEVELOPED FOR :
Ms. Priyanka Khillare
07.10.2017
09.10.2017
12.03.2018
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAPSONE 50MG AND 100MG TABLETS
Dapsone
FRONT
5 mm
5 mm
5 mm
5 mm
65 mm
65 mm
5 mm
5 mm
V2G
120318
30 mm
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING
THIS
MEDICINE
BECAUSE
IT
CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your
doctor, pharmacist or nurse.
-
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
-
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side
effects
not
listed
in
this
leaflet.
See
section 4.
WHAT IS IN THIS LEAFLET
What Dapsone is and what it is used for
What you need to know before you take
Dapsone
How to take Dapsone
Possible side effects
How to store Dapsone
Contents of the pack and other
information
WHAT DAPSONE IS AND WHAT IT IS USED FOR
Dapsone belongs to a group of medicines called
antibacterials. It works by stopping the
production of folic acid in certain bacteria,
therefore preventing them from growing.
Dapsone can be used to treat leprosy, to treat
blistering
skin
disorders
such
as
dermatitis
herpetiformis
(which
is
connected
to
gluten
sensitivity)
or
to
prevent
pneumonia
in
immunodeficient patients (in particular patients
with AID

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dapsone 50 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg of dapsone.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off white, round tablets, 6.60 mm x 3.40 mm, scored on one
side and
debossed with “71” on the other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dapsone is indicated for the treatment of the following infections
(see section 5.1):
1) As part of a multidrug regimen in the treatment of all forms of
leprosy.
2) Treatment of blistering dermatoses such as dermatitis
herpetiformis.
3) Prophylaxis of _Pneumocystis jirovecii_ pneumonia in
immunodeficient subjects,
especially AIDS patients.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents over 12 years: _
_Multibacillary leprosy (3-drug regimen): _100mg daily for at least
two years._ _
_Paucibacillary leprosy (2-drug regimen): _100mg daily for at least
six months._ _
_Dermatitis herpetiformis: _Initially 50mg daily, gradually increased
to 300mg daily if
required. Once lesions have begun to subside, the dose should be
reduced to a
minimum as soon as possible, usually 25-50mg daily, which may be
continued for a
number of years. Maintenance dosage can often be reduced in patients
receiving a
gluten-free diet.
_Pneumocystis jirovecii pneumonia: _In combination with trimethoprim,
50-100mg
daily
;
100mg twice weekly or 200mg once weekly.
_ _
Pediatric population
_Children 6-12 years: _
_Multibacillary leprosy (3-drug regimen): _50mg daily for at least two
years._ _
_Paucibacillary leprosy (2-drug regimen): _50mg daily for at least six
months._ _
_Children aged less than 6 years: _
The safety and efficacy of Dapsone in children aged less than six
years has not been
established. No data are available.
Elderly population:
Dosage should be reduced