Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Desmopressin acetate trihydrate 0.2mg equivalent to 0.178 mg free base
Pharmaco (NZ) Ltd
Desmopressin acetate trihydrate 0.2 mg (Equiv to 0.178 mg free base)
0.2 mg
Tablet
Active: Desmopressin acetate trihydrate 0.2mg equivalent to 0.178 mg free base Excipient: Ethanol Lactose monohydrate Magnesium stearate Potato starch Povidone Purified water
Bottle, plastic, 30mL HPDE, PP cap, 30 tablets
Prescription
Prescription
PolyPeptide Laboratories AB
The treatment of primary nocturnal enuresis in patients (from 5 years of age) with normal ability to concentrate urine.
Package - Contents - Shelf Life: Bottle, plastic, 30mL HPDE, PP cap - 30 tablets - 36 months from date of manufacture stored at or below 25°C
1995-10-20
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 Read the complete document
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 Read the complete document