Desmopressin Sumar 60 micrograms sublingual tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Sumar Pharma ehf Haukahlijð 5 102 Reykjavik, Iceland

ATC code:

H01BA02

INN (International Name):

DESMOPRESSIN 60 µg

Pharmaceutical form:

SUBLINGUAL TABLET

Composition:

DESMOPRESSIN 60 µg

Prescription type:

POM

Therapeutic area:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Authorization status:

Authorised

Authorization date:

2023-01-16

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DESMOPRESSIN SUMAR 60 MICROGRAMS SUBLINGUAL TABLETS
DESMOPRESSIN SUMAR 120 MICROGRAMS SUBLINGUAL TABLETS
DESMOPRESSIN SUMAR 240 MICROGRAMS SUBLINGUAL TABLETS
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 Desmopressin Sumar is and what it is used for
2.
What you need to know before you take Desmopressin Sumar
3.
How to take Desmopressin Sumar
4.
Possible side effects
5.
How to store Desmopressin Sumar
6.
Contents of the pack and other information
1.
WHAT DESMOPRESSIN SUMAR IS AND WHAT IT IS USED FOR
Desmopressin, the active substance in Desmopressin Sumar acts like the
natural hormone vasopressin
and regulates the kidneys' ability to concentrate urine.
Desmopressin Sumar is used to treat:
-
Central diabetes insipidus (pituitary disorder leading to severe
thirst and large amounts of
urine).
-
Bed wetting in children from 5 years of age with normal ability to
concentrate urine.
-
Nocturnal urination in adults (night time urine production exceeding
bladder capacity).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESMOPRESSIN SUMAR
_ _
DO NOT TAKE DESMOPRESSIN SUMAR:
-
if you are allergic to desmopressin or any of the other ingredients of
this medicine (listed in
section 6)
-
if you suffer from polydipsia (abnormally high fluid intake) resulting
in high volume of urine
eliminated in one day (more than 40 ml/kg/24 h)
-
if you have previous or suspected heart failure or other conditions
that require treatment with
diuretics (medicines used

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Desmopressin Sumar 60 micrograms sublingual tablets
Desmopressin Sumar 120 micrograms sublingual tablets
Desmopressin Sumar 240 micrograms sublingual tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Desmopressin Sumar 60 micrograms sublingual tablet contains 67
micrograms desmopressin
acetate equivalent to 60 micrograms desmopressin.
Each Desmopressin Sumar 120 micrograms sublingual tablet contains 133
micrograms desmopressin
acetate equivalent to 120 micrograms desmopressin.
Each Desmopressin Sumar 240 micrograms sublingual tablet contains 267
micrograms desmopressin
acetate equivalent to 240 micrograms desmopressin.
Excipient with known effect
_Desmopressin Sumar 60 micrograms _
Each sublingual tablet contains 65.23 mg lactose monohydrate.
_Desmopressin Sumar 120 micrograms _
Each sublingual tablet contains 65.18 mg lactose monohydrate.
_Desmopressin Sumar 240 micrograms _
Each sublingual tablet contains 65.08 mg lactose monohydrate.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet
Desmopressin Sumar 60 micrograms sublingual tablet
White or almost white, round, biconvex tablet debossed with ‘I’ on
one side and plain on other side,
with 6.5 mm diameter and 2 mm thickness.
Desmopressin Sumar 120 micrograms sublingual tablet
White or almost white, octagonal, biconvex tablet debossed with
‘II’ on one side and plain on other
side, with 6.5 mm length/ width and 2 mm thickness.
Desmopressin Sumar 240 micrograms sublingual tablet
White or almost white, square, biconvex tablet debossed with ‘III’
on one side and plain on other side,
with 6 mm length/ width and 2 mm thickness.
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4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Treatment of central diabetes insipidus.
-
Treatment of primary nocturnal enuresis in patients (from 5 years of
age) with a normal ability
to concentrate urine.
-
Symptomatic treatment of nocturia in adults, associated with nocturnal
polyuria, i