Dapsone (Link)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dapsone 25mg

Available from:

Link Pharmaceuticals Ltd

INN (International Name):

Dapsone 25 mg

Dosage:

25 mg

Pharmaceutical form:

Tablet

Composition:

Active: Dapsone 25mg Excipient: Colloidal silicon dioxide Magnesium stearate Maize starch Microcrystalline cellulose

Units in package:

Bottle, plastic, HDPE CRC, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Jacobus Pharmaceutical Company Inc

Therapeutic indications:

Dermatitis herpetiformis.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE CRC - 100 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

2010-07-09

Patient Information leaflet

DAPSONE CMI March 2022
1
DAPSONE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING DAPSONE?
Dapsone contains the active ingredient dapsone. Dapsone is used to
treat leprosy (Hansen’s disease) and to help control a skin
problem called dermatitis herpetiformis, and a fungal disease called
Actinomycotic mycetoma.
For more information, see Section 1. Why am I taking Dapsone? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE DAPSONE?
Do not take if you have ever had an allergic reaction to Dapsone or
any other sulfone drugs or any of the ingredients listed at
the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE OR HAVE HAD ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN
TO BECOME PREGNANT OR ARE BREASTFEEDING OR INTEND TO BREAST FEED.
For more information, see Section 2. What should I know before I take
Dapsone? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Dapsone and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE DAPSONE?
•
Take Dapsone with a full glass of water or another liquid, with or
after food
•
Tablets should be swallowed whole. Do not split the tablet
More instructions can be found in Section 4. How do I take Dapsone? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING DAPSONE?
THINGS YOU
MUST DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Dapsone
•
If the symptoms of your infection do not improve within 2 to 3 months,
or if they become worse, tell
your doctor
•
If you become pregnant while you are taking Dapsone tell your doctor
immediately
THINGS YOU
MUST NOT DO
•
Do not stop taking your tablets because you are feeling better, unless
advised by your doctor
DRIVING OR USING
MACHINES
•
Dapsone may make you dizzy. Be careful when driving or operating
machinery

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1. DAPSONE 25 MG AND 100 MG TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg and 100 mg dapsone.
For full list of excipients, see section 6.1.
Dapsone tablets do not contain alcohol, gluten, lactose, parabens,
sugar, sulfite or
tartrazine.
3. PHARMACEUTICAL FORM
White, scored tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dermatitis herpetiformis. Leprosy. Actinomycotic mycetoma.
4.2 DOSE AND METHOD OF ADMINISTRATION
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. Those
aged 10 to 14
years, daily doses of Dapsone 50 mg or 1 to 2 mg per kg if their body
weight is low, can be
given.
The modern treatment of leprosy involves the use of multiple drug
regimens to avoid the
development of resistant strains. The World Health Organisation has
made the following
recommendations for standard adult treatment regimens (with dosage
adjustments
according to bodyweight).
MULTIBACILLARY LEPROSY.
ADULTS: Rifampicin 600 mg once monthly supervised; Dapsone 100 mg
daily, self-
administered; Clofazimine 300 mg once monthly, supervised; and 50 mg
daily self-
administered.
CHILDREN: Dosage should be adjusted according to bodyweight for all
three drugs, for
those aged 10 to 14 years, daily doses of Dapsone 50 mg or 1 to 2 mg
per kg if their body
weight is low, can be given.
PAUCIBACILLARY LEPROSY.
ADULTS: Rifampicin 600 mg once monthly for 6 months, supervised;
Dapsone 100 mg daily
for 6 months, self-administered.
CHILDREN: Dosage should be adjusted according to bodyweight for both
drugs, for those
age