Nocdurna Oral Lyophilisate for Sublingual 25 mcg

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

DESMOPRESSIN

Dostępny od:

Ferring Sdn. Bhd.

INN (International Nazwa):

DESMOPRESSIN

Sztuk w opakowaniu:

30 Tablets

Wyprodukowano przez:

Catalent UK Swindon Zydis Limited

Ulotka dla pacjenta

NOCDURNA
®
Oral Lyophilisate for sublingual 25mcg and 50mcg
Desmopressin Acetate 25mcg and 50mcg
Consumer Medication Information Leaflet (RiMUP)
WHAT IS IN THIS LEAFLET
1.
What NOCDURNA
®
is used for
2.
How NOCDURNA
®
works
3.
Before you use NOCDURNA
®
4.
How to use NOCDURNA
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
NOCDURNA
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT NOCDURNA
® IS USED FOR
NOCDURNA
®
is provided as oral
lyophilisate in sublingual tablet.
It is used for the treatment of nocturia
(frequent need to get up to urinate at
night) due to nocturnal polyuria
(overproduction of urine during night)
in adults.
HOW NOCDURNA
® WORKS
NOCRUDNA contains active
ingredient desmopressin which is an
antidiuretic, which reduces urine
production.
BEFORE YOU USE NOCDURNA
®
_When you must not use it _
DO NOT USE NOCDURNA
®
if you:
-
are allergic to desmopressin
or any of the other ingredients in this
medicine
-
suffer from polydipsia
(excessive thirst and increased fluid
intake) or psychogenic polydipsia
(psychologically caused increased
thirst and increased fluid intake)
-
have known or suspected
cardiac insufficiency (heart failure in
which the heart is not able to pump
enough blood throughout the body)
-
have any disease requiring
treatment with diuretics
-
have moderately or severely
reduced kidney function
-
have or have had
hyponatraemia (low sodium level in
the blood)
-
have SIADH (hormone
secretion disorder)
_ _
_Before you start to use it _
Check with your doctor before taking
NOCDURNA
®
.
It is especially important that you talk
to your doctor before taking
NOCDURNA
®
if:
-
you have severe bladder
dysfunction and problems urinating
-
you are 65 years or older since
your doctor will have to monitor the
level of sodium in your blood (see the
section 3 “How to take NOCDURNA
®
”
below)
-
you have low levels of sodium
in your blood
-
you have a medical
condition(s) causing fluid and/or
electrolyte imbalance
-
you ha

Charakterystyka produktu

PROPOSED PACKAGING MATERIAL
Code
NOCD25,50-I-MY-01.03
Size
Submission
☒
NDA
☐
Renewal
☐
Variation change detail no.: _ _
Code of previous
version
NOCD25,50-I-MY-01.02
Changes
Requested by NPRA to change name to “oral Lyophilisate for
sublingual”, updated
updated Qualitative and Quantitative Composition and Pharmaceutical
form sections.
☒
CCDS version:1
☐
Core PIL version:
☐
SPC country/version/date:
☐
LAC no.:
Name & Date
JIWO, 22-Oct-2020
1
NOCDURNA
® 25 MCG & 50 MCG
Oral lyophilisate for sublingual
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each oral lyophilisate for sublingual contains desmopressin acetate
equivalent to 25 or 50 mcg
desmopressin.
Excipients:
Gelatin, Mannitol (E 421), Citric acid, anhydrous
PHARMACEUTICAL FORM
Oral lyophilisate for sublingual.
NOCDURNA
®
25 mcg:
White, round, oral lyophilisate of approximately 12 mm marked with 25
on one side.
NOCDURNA
®
50 mcg:
White, round, oral lyophilisate of approximately 12 mm marked with 50
on one side_. _
THERAPEUTIC INDICATIONS
NOCDURNA
®
is indicated for symptomatic treatment of nocturia due to idiopathic
nocturnal polyuria
in adults.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
•
Women: 25 mcg daily, one hour before bedtime, administered
sublingually without water.
•
Men: 50 mcg daily, one hour before bedtime, administered sublingually
without water.
A dose increase with this product is not recommended in elderly
patients ≥ 65 years.
If higher doses are considered for patients under the age of 65 years
in case of an insufficient
response to NOCDURNA
®
, other desmopressin oral lyophilisate products should be used (see
Special Warnings and Precautions for Use, Undesirable Effects and
Pharmacodynamic Properties)
In
the
event
of
signs
or
symptoms
of
water
retention
and/or
hyponatremia
(headache,
nausea/vomiting, weight gain, and, in severe cases, convulsions)
treatment should be interrupted
and reassessed. When restarting treatment strict fluid restriction
should be enforced and serum
sodium levels monitored (see Special Wa