Nordurine 0.1mg Tablets

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

DESMOPRESSIN ACETATE

थमां उपलब्ध:

Ferring Ireland Limited United Drug House, Magna Drive Magna Business Park, Citywest Road Dublin 24 , Ireland

ए.टी.सी कोड:

H01BA02

INN (इंटरनेशनल नाम):

DESMOPRESSIN ACETATE 0.1 mg

फार्मास्यूटिकल फॉर्म:

TABLET

रचना:

DESMOPRESSIN ACETATE 0.1 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2006-08-09

सूचना पत्रक

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 and Nordurine Tablets:
Tell your doctor or pharmacist:
- if you are taking, have recently taken or might take any other
medicines
- if you are on

उत्पाद विशेषताएं

Page 1 of 11
1. NAME OF THE MEDICINAL PRODUCT
Nordurine 0.1 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains desmopressin acetate 0.1 mg equivalent to
desmopressin (free base) 89
micrograms.
Also contains lactose monohydrate, 123.7mg per tablet.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White, oval, convex tablet with a single score. Engraving 0.1.
The scoreline is 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 the majorit