MINIRIN TABLET 0.1MG

Country: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

DESMOPRESSIN ACETATE

Fáanlegur frá:

Ferring Sdn. Bhd.

INN (Alþjóðlegt nafn):

DESMOPRESSIN ACETATE

Einingar í pakka:

7Tablet Tablets; 30Tablet Tablets

Framleitt af:

Ferring International Center SA

Upplýsingar fylgiseðill

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MINIRIN
® TABLET
Desmopressin Acetate (0.1mg, 0.2mg)
1
WHAT IS IN THIS LEAFLET
:
1.
What MINIRIN
®
is used for
2.
How MINIRIN
®
works
3.
Before you use MINIRIN
®
4.
How to use MINIRIN
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
MINIRIN
®
8.
Product Description
9.
Product Registration Holder and
Manufacturer
10.
Date of revision
WHAT MINIRIN
® IS USED FOR
MINIRIN
®
is used to treat:
i.
Central diabetes insipidus
(disorder which leads to extreme
thirst and large urine volumes).
ii.
Bedwetting in children from 5
years of age with normal ability to
concentrate urine.
iii.
Nocturnal urgency (frequent
urination during sleep) in adults.
HOW MINIRIN
®
WORKS
Desmopressin acts as the natural
hormone vasopressin and it regulates
the kidneys ability to concentrate urine.
BEFORE YOU USE MINIRIN
®
_-When you must not use it _
Do not use MINIRIN
®
if you have:
•
Urine production exceeding 40
ml/kg/24 hours;
•
Heart problems and other conditions
that require treatment with diuretics
(water pills);
•
Moderate and severe kidney
problems;
•
Syndrome of inappropriate secretion
of antidiuretics hormone (SIADH);
•
Low blood sodium level;
•
Hypersensitivity to Desmopressin or
to any of the ingredients.
_-Before you start to use it _
Before starting treatment with
MINIRIN
®
, you should check with your
doctor, if you:
- are 65 years or older, have low blood
sodium levels or high 24-hour urine
production.
- have risk for increased pressure in the
skull (e.g. systemic infections, fever,
inflammation of the stomach and
intestines).
- have enlarged prostate.
- have urinary tract infection.
- have bladder stone/growth.
- have excessive thirst.
- have poorly controlled diabetes.
When used for bedwetting and
nocturnal urgency, the fluid intake to
quench thirst must be limited to a
minimum from 1 hour before until at
least 8 hours after the intake of
MINIRIN
®
.
MINIRIN
®
should be used with caution
when the fluid balance is disturbed.
Consul

Vara einkenni

(01 , 03 )-I-MY -01.0 1 according to SE SPC . Using SEA -01.01 template, over dosage -CCDS (MINTAB -10 -000 ,
MINTAB -13 -000 ), LAC : not required as confirmed by KTNI on 02 -Oct -2015 ; Drafted by JIWO 28 -Dec -16
MINIRIN ®
Tablet 0.1 mg and 0.2 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
MINIRIN ® 0.1 m g:
Each tablet contains desmopressin acetate 0.1 mg , corresponding to desmopressin (free base) 0.089 mg .
MINIRIN ® 0.2 mg:
Each tablet contains desmopressin acetate 0.2 mg , corresponding to desmopressin (free base) 0.178 mg.
Excipients : Lactose monohydrate , p otato starch , p ovidone , m agnesium stearate .
PHARMACEUTICAL FORM
Tablet
MINIRIN ® 0.1 mg :
White, oval, convex tablet with a single score and marked “0.1 ” on one side .
MINIRIN ® 0.2 mg:
White, round, convex tablet with a single score and marked “0.2 ” on one side .
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
THERAPEUTIC INDICATIONS
Central diabetes insip idus. The use of MINIRIN ® in patients with an established diagnosis will result in a reduction
in urinary output with concomitant increase in urine osmolality and decrease in plasma osmolality. This will result in
decreased urinary frequency and decreased nocturia.
Primary nocturnal enuresis in children aged 5 years or more.
Symptomatic treatment of nocturia in adults, associated with nocturnal polyuria, i.e. nocturnal urine production
exceeding bladder capacity.
POSOLOGY AND METHOD OF ADMINISTRATION
Gen eral
The dose of M INIRIN ® tablet s is individually adapted.
Desmopressin should always be taken at the same time in relation to food intake , since f ood intake causes
decreased absorption and by that also might influence the effect of desmopressin, see sect ion Interaction with
other medicinal products and other forms of interaction .
In the event of signs of water retention/hyponatraemia (headache, nausea/vomiting, weight gain, and in serious
cases convulsions) the treatment should be temporarily interrupted until t