MINIRIN MELT desmopressin 120 micrograms sublingual wafers blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

desmopressin, Quantity: 120 microgram (Equivalent: desmopressin acetate, Qty 136 microgram)

Available from:

Ferring Pharmaceuticals Pty Ltd

INN (International Name):

Desmopressin

Pharmaceutical form:

Wafer

Composition:

Excipient Ingredients: citric acid; mannitol; Gelatin

Administration route:

Sublingual

Units in package:

30s, 100s

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1- Cranial diabetes insipidus. 2- Primary nocturnal enuresis in patients from 6 years of age with normal ability to concentrate urine who are refractory to an enuresis alarm or in whom the enuresis alarm is contraindicated or inappropriate.

Product summary:

Visual Identification: White, round with two drop shaped figure on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-06-28

Patient Information leaflet

MINIRIN
® MELT
_Desmopressin_
SUBLINGUAL (UNDER THE TONGUE) WAFERS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minirin Melt.
It does not contain all the available
information. It does not replace
talking to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Minirin Melt
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 IS MINIRIN MELT
USED FOR
The active ingredient, desmopressin
in Minirin Melt is a synthetic version
of a naturally occurring substance
produced in the brain called
vasopressin.
It has a number of different actions
on the body including an action on
the kidney to reduce the amount of
urine produced. This means that
Minirin Melt can be used for several
different conditions including:
•
primary nocturnal enuresis
(bedwetting) in patients over 6
years of age who have a normal
ability to concentrate urine and
who have not responded to
treatment with an enuresis alarm
or in whom an enuresis alarm is
contraindicated or inappropriate
•
cranial diabetes insipidus (large
amounts of urine being produced
day and night and constant thirst).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE
MINIRIN MELT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MINIRIN MELT IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
desmopressin or any of the
ingredients listed at the end of
this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other pa

Summary of Product characteristics

Page 1 of 9
#16892-v11A
AUSTRALIAN PI - MINIRIN
® (DESMOPRESSIN) MELT
1. NAME OF THE MEDICINE
Desmopressin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
MINIRIN Melt, a sublingual wafer, contains the active substance,
desmopressin, (present as the
hydrated acetate), a synthetic structural analogue of the natural
pituitary hormone arginine vasopressin.
The difference lies in the desamination of cysteine and substitution
of L-arginine by D-arginine. MINIRIN
Melt also contains gelatin, mannitol and citric acid.
Desmopressin free base represents approximately 89% of the
desmopressin acetate content. This is
due to the presence of acetic acid/acetate, water and impurities.
3. PHARMACEUTICAL FORM
A white, fluffy powder, soluble in water, in alcohol and in glacial
acetic acid.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MINIRIN Melt is indicated for the treatment of
•
cranial diabetes insipidus
•
primary nocturnal enuresis in patients from 6 years of age with normal
ability to concentrate
urine, who are refractory to an enuresis alarm or in whom an enuresis
alarm is
contraindicated or inappropriate.
4.2 DOSE AND METHOD OF ADMINISTRATION
MINIRIN Melt is placed under the tongue where it dissolves without the
need for water.
If adequate clinical effect is not achieved within 4 weeks following
appropriate dose titration the
medication should be discontinued.
Food intake may reduce the intensity and duration of the antidiuretic
effect at low oral doses of
MINIRIN tablets (see section 4.5 - INTERACTIONS WITH OTHER MEDICINES
AND OTHER
FORMS OF INTERACTIONS).
CRANIAL DIABETES INSIPIDUS
Dosage is individual in diabetes insipidus but the total daily
sublingual dose normally lies in the range
of 120

g to 720

g. A suitable starting dose in adults and children is 60

g three times daily,
administered sublingually. This dosage regimen should then be adjusted
in accordance with the
patient’s response. For the majority of patients, the maintenance
dose is 60

g to 120

g sublingually
three times daily.
In