MINIRIN 0.1MG TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

DESMOPRESSIN ACETATE

Διαθέσιμο από:

FERRING HELLAS MEPE (0000010966) 2 KARAGIORGI SERVIAS STR., ATHENS, 10562

Φαρμακολογική κατηγορία (ATC):

H01BA02

INN (Διεθνής Όνομα):

DESMOPRESSIN

Δοσολογία:

0.1MG

Φαρμακοτεχνική μορφή:

TABLETS

Σύνθεση:

DESMOPRESSIN ACETATE (0062357862) 0,1MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

DESMOPRESSIN

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή

Φύλλο οδηγιών χρήσης

PATIENT INFORMATION LEAFLET
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING MINIRIN.
-
Keep this leaflet, you may need to read it again
-
If you have further questions, please ask your doctor or pharmacist.
-
This medicine has been prescribed for you personally and you should
not
pass it on to others, even if their symptoms are the same as yours it
may
harm them.
IN THIS LEAFLET YOU WILL FIND THE FOLLOWING INFORMATION:
1.
What Minirin is and what it is used for
2.
Before you use Minirin
3.
How to use Minirin
4.
Possible side effects
5.
Storing Minirin
MINIRIN TABLETS 0.1 AND 0.2 MG
-
The active substance is desmopressin
-
The other ingredients are lactose monohydrate, potato starch, povidone
and magnesium stearate.
MARKETING AUTHORISATION HOLDER
Ferring GmbH
Wittland 11, 24109 Kiel, Germany
LOCAL REPRESENTATIVE
A. Potamitis Medicare Ltd
62, Arch. Kyprianou Avenue, 2059 Strovolos, Nicosia, Cyprus
Tel.: [phone]
MANUFACTURER
Ferring International Center SA
St. Prex, Switzerland
1. WHAT MINIRIN IS AND WHAT IT IS USED FOR
The active substance in Minirin acts as the natural hormone
vasopressin as it regulates
the kidneys ability to concentrate urine.
Minirin is used for the treatment of:
-
Central diabetes insipidus (pituitary disorder which leads to extreme
thirst
and a large urine volume).
-
Primary nocturnal enuresis (bedwetting) in children from 6 years of
age
with normal ability to concentrate urine.
-
Nocturia in adults.
2. BEFORE YOU USE MINIRIN
When used for primary nocturnal enuresis and nocturia the fluid intake
to quench
thirst must be limited to a minimum from 1 hour before until 8 hours
after the intake
of Minirin. Minirin should be used with caution when the fluid balance
is disturbed.
DO NOT USE MINIRIN:
-
if you are hypersensitive (allergic) to the active substance or any of
the
other ingredients in Minirin.
-
if you suffer from polydipsia (abnormal large fluid intake), weak
heart and
other states of diseases which need treatment with diuretics, impaired
renal
function or low serum sodium

Αρχείο Π.Χ.Π.

SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME
OF
THE
MEDICINAL
PRODUCT
MINIRIN tablets 0.1 mg and 0.2 mg
2
Q
UALITATIVE
AND Q
UANTITATIVE C
OMPOSITION
_per tablet 0.1 mg_
_per tablet 0.2 mg_
Desmopressin acetate
0.1 mg
0.2 mg
Resp. desmopressin
0.089 mg
0.178 mg
Re. other excipients see 6.1
3
P
HARMACEUTICAL F
ORM
Tablet
4
C
LINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Central diabetes insipidus.
Primary nocturnal enuresis (from 6 years of age) when the enuresis
alarm has not had the
desired effect in patients with normal ability to concentrate urine.
Symptomatic treatment of nocturia in adults associated with nocturnal
polyuria, i.e. nocturnal
urine production exceeding bladder capacity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of MINIRIN tablets is individually titrated.
Desmopressin should always be taken at the same time in relation to
food intake, since food
intake causes decreased absorption and by that also might influence
the effect of
desmopressin, see section 4.5.
_Central diabetes insipidus: _A suitable initial dose for children and
adults is 0.1 mg 3 times
daily. The dosage is then titrated according to the patient's
response. According to present
clinical experience the daily dose has varied between 0.2 and 1.2 mg.
For most patients 0.1-
0.2 mg 3 times a day is an optimal dosage regimen. In the event of
signs of water
retention/hyponatraemia the treatment should be interrupted and the
dosage should be
adjusted.
_Primary nocturnal enuresis: _A suitable initial dose is 0.2 mg at
bedtime. The dose may be
increased up to 0.4 mg if the lower dose is not sufficiently
effective. Fluid restriction shall be
enforced. In the event of signs or symptoms of water retention and/or
hyponatraemia
- 1 -
(headache, nausea/vomiting, weight gain, and in serious cases
convulsions) the treatment
should be interrupted until the patient has completely recovered. When
the treatment is
resumed strict fluid restriction is necessary, see section 4.4.
Evaluation of continued need of
treatment should be carried ou