Minirin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Desmopressin acetate trihydrate 0.1mg equivalent to 0.089 mg free base

Available from:

Pharmaco (NZ) Ltd

INN (International Name):

Desmopressin acetate trihydrate 0.1 mg (Equiv to 0.089 mg free base)

Dosage:

0.1 mg

Pharmaceutical form:

Tablet

Composition:

Active: Desmopressin acetate trihydrate 0.1mg equivalent to 0.089 mg free base Excipient: Ethanol Lactose monohydrate Magnesium stearate Potato starch Povidone Purified water

Units in package:

Bottle, plastic, 30mL HDPE, PP cap, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

PolyPeptide Laboratories AB

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, 30mL HDPE, PP cap - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1995-10-20

Patient Information leaflet

 
MINIRIN
® 
TABLETS
_ _

_DESMOPRESSIN ACETATE _

______________________________________________________________________________ 

CONSUMER MEDICINE 
INFORMATION 
_ _
IMPORTANT:  PLEASE READ THIS 
LEAFLET CAREFULLY BEFORE USING 
MINIRIN
®
 SPRAY.  THIS LEAFLET IS 
INTENDED TO ANSWER QUESTIONS 
YOU MAY HAVE ABOUT MINIRIN
®

SPRAY.  IT DOES NOT REPLACE THE 
ADVICE FROM YOUR DOCTOR OR 
PHARMACIST. IF YOU HAVE ANY 
QUESTIONS BEFORE, DURING OR 
AFTER USING THIS MEDICATION BE 
SURE TO ASK YOUR DOCTOR OR 
PHARMACIST.

WHAT IS MINIRIN
®

TABLETS USED FOR AND 
HOW DOES IT WORK? 
_ _
The active ingredient in MINIRIN
®

Tablets (desmopressin acetate) is 
a synthetic version of a natural 
hormone in the body called 
antidiuretic hormone (ADH).  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
® 
Tablets can be 
used for several different 
conditions including: 

• nocturnal 
enuresis 
(bedwetting) in patients over 5 
years who have a normal 
ability to concentrate urine. 
•  central diabetes insipidus._ _
•  nocturia in adults_ _

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
®
 TABLETS 

_WHEN YOU MUST NOT TAKE IT _

DO NOT TAKE MINIRIN
®
 IF YOU  

•  have an allergy to any 
medicine containing 
desmopressin or any of the 
ingredients listed at the end of 
this leaflet_._ 
•  are in the habit of drinking 
large amounts of fluid 
• have 
cardiac 
insufficiency 
•  have moderate or severe 
renal insufficiency 
•  have low levels

Summary of Product characteristics

NEW ZEALAND DATA SHEET
MINIRIN® tablets MINTAB003
[Oct2018]
Page 1 of 11
MINIRIN® TABLETS 0.1MG
MINIRIN® TABLETS 0.2MG
Desmopressin acetate
1 PRODUCT NAME
MINIRIN® tablets 0.1mg
MINIRIN® tablets 0.2mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
MINIRIN 0.1mg: Each tablet contains desmopressin acetate 0.1mg
equivalent to desmopressin (free
base) 0.089mg.
MINIRIN 0.2mg: Each tablet contains desmopressin acetate 0.2mg
equivalent to desmopressin (free
base) 0.178mg.
Excipient(s) with known effect: lactose
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
MINIRIN 0.1mg: White, oval and convex tablets with a single score and
marked “0.1” on one side.
MINIRIN 0.2mg: White, round and convex tablets with a single score and
marked “0.2” on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MINIRIN tablets are indicated for the treatment of central diabetes
insipidus.
MINIRIN tablets are indicated for the treatment of primary nocturnal
enuresis in patients (from 5
years of age) with normal ability to concentrate urine.
MINIRIN tablets are indicated for the symptomatic treatment of
nocturia in adults, associated with
nocturnal polyuria, i.e. nocturnal urine production exceeding bladder
capacity.
4.2
DOSE AND METHOD OF ADMINISTRATION
_GENERAL _
The tablet may be divided to ease the intake but both tablet halves
must be taken at the same
occasion.
Food intake may reduce the intensity and duration of the antidiuretic
effect at low doses of
desmopressin (see Section 4.5).
NEW ZEALAND DATA SHEET
MINIRIN® tablets MINTAB003
[Oct2018]
Page 2 of 11
In
the
event
of
signs
or
symptoms
of
water
retention
and/or
hyponatraemia
(headache,
nausea/vomiting, weight gain, and, in severe cases, convulsions)
treatment should be interrupted
until the patient has fully recovered. When restarting treatment
strict fluid restriction should be
enforced (see Section 4.4).
If adequate clinical effect is not achi