Nordurine 0.2 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DESMOPRESSIN ACETATE

Available from:

Ferring Ireland Ltd

ATC code:

H01BA; H01BA02

INN (International Name):

DESMOPRESSIN ACETATE

Dosage:

0.2 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Vasopressin and analogues; desmopressin

Authorization status:

Marketed

Authorization date:

2003-07-25

Patient Information leaflet

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Size
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1. What Nordurine Tablets are and what they are used for
2. What you need to know before you take Nordurine Tablets
3. How to take Nordurine Tablets
4. Possible side effects
5. How to store Nordurine Tablets
6. Contents of the pack and other information
1. What Nordurine Tablets are and what they are used for
Nordurine Tablets are for oral use only. They are available in two
strengths, 0.1 mg and 0.2
mg. They contain desmopressin acetate, an antidiuretic that reduces
urine production.
Nordurine Tablets are used to treat:
- Diabetes Insipidus (extreme thirst and the continuous production of
large volumes of
dilute urine). IMPORTANT: this should not be confused with diabetes
mellitus (sugar
diabetes)
- Primary nocturnal enuresis
- Nocturia in adults up to 65 years (night time urine production
exceeding bladder capacity)
2. What you need to know before you take Nordurine Tablets
Do not take Nordurine Tablets
- if you are allergic to desmopressin or any of the other ingredients
of this medicine (listed in
section 6)
- if you have a serious heart or kidney disease
- if you are taking diuretics (water tablets)
- for Primary Nocturnal Enuresis and Nocturia: these tablets should
not be used if you are
under 5 years old or over 65 years old
- if you have known hyponatraemia (serum sodium levels below normal
range)
- if you have syndrome of inappropriate secretion of anti-diuretic
hormone, a hormone
regulating urine production (SIADH)
Warnings and precautions
Talk to your doctor or pharmacist before taking Nordurine Tablets
Take special care with Nordurine Tablets:
systemic infections, fever, gastroenteritis
disturbance
- for Primary Nocturnal Enuresis and Nocturia: STOP using Nordurine
Tablets when suffering
from vomiting and diarrhoea until you are better.
If any of these apply to you, or if you are not sure, contact your
doctor before taking
Nordurine Tablets.
Other medicines an

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nordurine 0.2 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains desmopressin acetate 0.2 mg equivalent to
desmopressin (free base) 0.178 mg.
Also contains Lactose Monohydrate, 123.7mg per tablet
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White, round, convex tablet with a single score.
Engraving ‘0.2’
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. For the diagnosis and treatment of cranial diabetes insipidus
including post-hypophysectomy polyuria/polydipsia and
for the treatment of primary nocturnal enuresis in patients (from 5 to
65 years of age) with normal ability to concentrate
urine.
2. Nordurine Tablets are indicated for the symptomatic treatment of
nocturia in adults up to 65 years only, associated
with nocturnal polyuria, i.e. nocturnal urine production exceeding
bladder capacity.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL
Effect of food: Food intake may reduce the intensity and duration of
the antidiuretic effect at low doses of
desmopressin (see section 4.5).
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 achieved within 4 weeks following
appropriate dose titration the medication should be
discontinued.
INDICATION SPECIFIC
_Central diabetes insipidus:_
Dosage is individual in diabetes insipidus but clinical experience has
shown that the total daily dose normally lies in the
range of 0.2 to 1.2 mg. A suitable starting dose in adults and
children is 0.1 mg three times daily. This dosage regimen
should then be adjusted in accordance with the patient’s response.
For