DDAVP/Desmopressin 0.1mg Tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

DESMOPRESSIN ACETATE

Beszerezhető a:

Ferring Ireland Ltd

ATC-kód:

H01BA; H01BA02

INN (nemzetközi neve):

DESMOPRESSIN ACETATE

Adagolás:

0.1 milligram(s)

Gyógyszerészeti forma:

Tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Vasopressin and analogues; desmopressin

Engedélyezési státusz:

Not marketed

Engedély dátuma:

1994-02-10

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
DDAVP
®
/DESMOPRESSIN 0.1MG TABLETS
Desmopressin Acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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 DDAVP/Desmopressin Tablets are and what they are used for
2.
What you need to know before you take DDAVP/Desmopressin Tablets
3.
How to take DDAVP/Desmopressin Tablets
4.
Possible side effects
5.
How to store DDAVP/Desmopressin Tablets
6.
Contents of the pack and other information
1. WHAT ARE DDAVP/DESMOPRESSIN TABLETS ARE AND WHAT THEY ARE USED FOR
DDAVP/Desmopressin Tablets are for oral use only. They are available
in one strength,
0.1mg. They contain desmopressin acetate, an antidiuretic that reduces
urine production.
DDAVP/Desmopressin 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
(bed wetting from the age of five).
- NOCTURIA IN ADULTS UP TO 65 YRS
(night time urine production exceeding bladder capacity).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DDAVP/DESMOPRESSIN TABLETS
DO NOT TAKE DDAVP/DESMOPRESSIN 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

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DDAVP/Desmopressin 0.1mg 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, 123.7 mg per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, oval convex tablet, with a score line on one face and “0.1”
on the reverse.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 majority of patients, the maintenance dose is
0.1 mg to 0.2 mg three times daily.
_Primary nocturnal enuresis:_
The recommended initial dose is 0.2 mg at bedtime.
If this dose is not sufficiently effective, the dose may be increased
up to 0.4 mg. Fluid restriction should be observed.
1.
For the diagnosis and treatment of cranial diabetes insipidus
including post-hypophysectomy polyuria/polydipsia
and for the treatm