MINIRIN TABLETS 0.2 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DESMOPRESSIN ACETATE

Available from:

FERRING PHARMACEUTICALS LTD

ATC code:

H01BA02

Pharmaceutical form:

TABLETS

Composition:

DESMOPRESSIN ACETATE 0.2 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

FERRING INTERNATIONAL CENTER SA, SWITZERLAND

Therapeutic area:

DESMOPRESSIN

Therapeutic indications:

Central diabetes insipidus.Nocturnal Enuresis. Treatment of nocturia in adults associated with nocturnal polyuria.

Authorization date:

2014-07-31

Patient Information leaflet

1986
-
REGULATIONS (PREPARATIONS)
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
This medicine is dispensed with a doctor’s prescription only
MINIRIN TABLETS 0.1 MG
MINIRIN TABLETS 0.2 MG
COMPOSITION:
Each tablet of Minirin 0.1 mg contains:
desmopressin acetate 0.1 mg
Each tablet of Minirin 0.2 mg contains:
desmopressin acetate 0.2 mg
Inactive ingredients - see section 6 "Additional information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, con-
sult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their illness is similar
to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Diabetes insipidus, nocturnal enuresis, nocturia in adults related to
excessive nocturnal
urine production.
THERAPEUTIC GROUP: vasopressin hormone analog
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE:
-
if you are sensitive (allergic) to desmopressin or to any of the other
ingredients
of this medicine (see section 6).
-
if you have a serious heart or kidney disease.
-
if you are taking diuretics.
-
if you drink unusually large quantities of fluids, including alcohol.
-
upon administration for nocturnal enuresis and nocturia: if you are
under 5
years old or over 65 years old.
-
if you have low blood sodium levels (hyponatremia).
-
if you have a medical condition with increased secretion of ADH
(syndrome of
inappropriate secretion of ADH).
During treatment with the medicine, refrain from drinking large
quantity of fluids. Drinking
large quantity of fluids may cause accumulation of water and dilution
of salt concentra-
tion in the body. This is a severe medical problem which may lead to
convulsions.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE:
_Before using the medicine, tell your doctor if you suffer from: _
•
an illness causing fluid and/or electrolyte imbalance, e.g. vomiting,
diarrhea, sys-
temic

Summary of Product characteristics

Page
1
of
8
1.
NAME OF MEDICINAL PRODUCT
MINIRIN TABLETS 0.1 MG
MINIRIN TABLETS 0.2 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MINIRIN 0.1MG TABLETS
- each tablet of 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
MINIRIN 0.2MG TABLETS
- each tablet of contains desmopressin acetate 0.2 mg equivalent to
desmopressin (free
base) 0.178 mg.
Also contains Lactose monohydrate, 123.7 mg per tablet.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
MINIRIN 0.1MG TABLETS
Tablets. 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.
MINIRIN 0.2MG TABLETS
Tablets. White, oval, convex tablet with a single score. Engraving
0.2.
The scoreline is to facilitate breaking for ease of swallowing and not
to divide into equal halves.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Minirin tablets are indicated for Central Diabetes Insipidus,
Nocturnal Enuresis (in patients from 5 years of
age with normal ability to concentrate the urine) and for symptomatic
treatment of nocturia in adults
associated with nocturnal polyuria, i.e. nocturnal urine production
exceeding bladder capacity.
The treatment must be started before the age of 65. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_CENTRAL DIABETES INSIPIDUS_
:
_Tablets administration_
. A suitable initial dose for children and adults is 0.1 mg three
times daily. The dose is
than adjusted according to the response of the patient. The average
daily dose is between 0.2 and 1.2 mg with
tablet administration. For most patients, 0.1 – 0.2 mg three times
daily is the optimal dose regimen.
_NOCTURNAL ENURESIS: _
Tablets administration. 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.
If treatment continues over the long-term, a