Desmopressine 1A Pharma 120 microgram, tabletten voor sublinguaal gebruik

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

DESMOPRESSINEACETAAT 133 µg/stuk SAMENSTELLING overeenkomend met ; DESMOPRESSINE 120 µg/stuk

INN (Algemene Internationale Benaming):

DESMOPRESSINEACETAAT 133 µg/stuk SAMENSTELLING overeenkomend met ; DESMOPRESSINE 120 µg/stuk

farmaceutische vorm:

Tablet voor sublinguaal gebruik

Samenstelling:

CITROENZUUR 0-WATER (E 330) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL

Toedieningsweg:

Sublinguaal gebruik

Autorisatie datum:

2023-07-04

Bijsluiter

1A Pharma GmbH
Page 1/8
Desmopressine 1A Pharma
®
60, 120 en 240 microgram,
tabletten voor sublinguaal gebruik
RVG 129992; 129993; 129994
1.3.1.3 Bijsluiter
Juni 2023
1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
DESMOPRESSINE 1A PHARMA 60 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL
GEBRUIK
DESMOPRESSINE 1A PHARMA 120 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL
GEBRUIK
DESMOPRESSINE 1A PHARMA 240 MICROGRAM, TABLETTEN VOOR SUBLINGUAAL
GEBRUIK
desmopressin
_ _
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 read 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.
WHAT IS IN THIS LEAFLET
1. What [nationally completed name] is and what it is used for
2. What you need to know before you take [nationally completed name]
3. How to take [nationally completed name]
4. Possible side effects
5. How to store [nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
_ _
[Nationally completed name] contains the active substance desmopressin
which lowers the amount of
urine that is produced by the kidneys.
[Nationally completed name] is used to treat:
•
a chronic disease called
DIABETES INSIPIDUS
, which causes extreme thirst and a constant
production of large amounts of diluted urine.
IMPORTANT:
this should not be confused with
diabetes mellitus
•
BEDWETTING
(involuntary nightly urination) in patients from 6 years old
•
FREQUENT URINATION DURING THE NIGHT
in adults
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
_ _
DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU
•
are allergic to

Productkenmerken

1A Pharma
Page 1/12
Desmopressine 1A Pharma
®
60, 120 en 240 microgram,
tabletten voor sublinguaal gebruik
RVG 129992; 129993; 129994
1311-v1
1.3.1.1 Samenvatting van de Productkenmerken
June 2023
1
1.
NAME OF THE MEDICINAL PRODUCT
Desmopressine 1A Pharma 60 microgram, tabletten voor sublinguaal
gebruik
Desmopressine 1A Pharma 120 microgram, tabletten voor sublinguaal
gebruik
Desmopressine 1A Pharma 240 microgram, tabletten voor sublinguaal
gebruik
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_[Nationally completed name] 60 micrograms> _
Each sublingual tablet contains 67 micrograms desmopressin acetate
equivalent to 60 micrograms
desmopressin.
_[Nationally completed name] 120 micrograms> _
Each sublingual tablet contains 133 micrograms desmopressin acetate
equivalent to 120 micrograms
desmopressin.
_[Nationally completed name] 240 micrograms> _
Each sublingual tablet contains 267 micrograms desmopressin acetate
equivalent to 240 micrograms
desmopressin.
Excipient(s) with known effect
_[Nationally completed name] 60 micrograms> _
Each sublingual tablet contains 65.23 mg lactose (as monohydrate).
_ _
_[Nationally completed name] 120 micrograms> _
Each sublingual tablet contains 65.18 mg lactose (as monohydrate).
_ _
_[Nationally completed name] 240 micrograms> _
Each sublingual tablet contains 65.08 mg lactose (as monohydrate).
_ _
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet
_[Nationally completed name] <60 micrograms> _
White or almost white, round, tablet, rounded on the upper and lower
side, debossed with ‘I’ on one
side and plain on other side, with 6.5 mm of length and 2 mm of
thickness.
_ _
_[Nationally completed name] <120 micrograms> _
White or almost white, octagonal, tablet, rounded on the upper and
lower side, debossed with ‘II’ on
one side and plain on other side, with 6.5 mm of l