Desmotabs 0.2mg Tablets

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

DESMOPRESSIN ACETATE

Sẵn có từ:

Ferring Ireland Ltd

Mã ATC:

H01BA; H01BA02

INN (Tên quốc tế):

DESMOPRESSIN ACETATE

Liều dùng:

0.2 milligram(s)

Dạng dược phẩm:

Tablet

Loại thuốc theo toa:

Product subject to prescription which may be renewed (B)

Khu trị liệu:

Vasopressin and analogues; desmopressin

Tình trạng ủy quyền:

Not marketed

Ngày ủy quyền:

1993-01-19

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER
DESMOTABS
® 0.2 MG TABLETS
Desmopressin acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to use it again
•
If you have any further questions, ask your doctor or pharmacist
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet (see section 4).
IN THIS LEAFLET:
1.
What Desmotabs Tablets are and what they are used for
2.
What you need to know before you take Desmotabs Tablets
3.
How to take Desmotabs Tablets
4.
Possible side effects
5.
How to store Desmotabs Tablets
6.
Contents of the pack and other information
1. WHAT DESMOTABS TABLETS ARE AND WHAT ARE THEY USED FOR
Desmotabs 0.2mg Tablets are tablets for oral use only. They contain
desmopressin acetate, an
antidiuretic (reduces urine production).
Desmotabs 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
(bedwetting from the age of five)
- NOCTURIA
in adults up to 65 years (night time urine production exceeding
bladder capacity)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESMOTABS TABLETS
DO NOT TAKE DESMOTABS 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)
-
if you drink unusually large quantities of fluids, including alcohol
-
for Primary Nocturnal Enuresis and Nocturia: these tablets should not
be used if you are
under 5 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-diu

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desmotabs 0.2mg 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
Tablets
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.
Desmotabs 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.