NOQDIRNA 25

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

DESMOPRESSIN AS ACETATE

Disponible depuis:

FERRING PHARMACEUTICALS LTD

Code ATC:

H01BA02

forme pharmaceutique:

TABLETS SOLUBLE

Composition:

DESMOPRESSIN AS ACETATE 25 MCG

Mode d'administration:

SUBLINGUAL

Type d'ordonnance:

Required

Fabriqué par:

FERRING GmbH ,GERMANY

Domaine thérapeutique:

DESMOPRESSIN

indications thérapeutiques:

NOCDURNA is indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.In the NOCDURNA clinical trials nocturnal polyuria was defined as night-time urine production exceeding one-third of the 24-hour urine production. Before starting NOCDURNA:•Evaluate the patient for possible causes for the nocturia, including excessive fluid intake prior to bedtime, and address other treatable causes of nocturia.•Confirm the diagnosis of nocturnal polyuria with a 24-hour urine collection, if one has not been obtained previously.

Date de l'autorisation:

2020-10-19

Notice patient

1986
-
E PHARMACISTS' REGULATIONS (PREPARATIONS)
PATIENT LEAFLET IN ACCORDANCE WITH TH
This medicine is dispensed with a doctor’s prescription only
NOQDIRNA 50
DISPERSIBLE TABLETS FOR SUBLINGUAL
ADMINISTRATION
NOQDIRNA 25
DISPERSIBLE TABLETS FOR SUBLINGUAL
ADMINISTRATION
ACTIVE INGREDIENT AND ITS QUANTITY:
Noqdirna 50:
Each tablet contains:
desmopressin (as acetate) 50 mcg
ACTIVE INGREDIENT AND ITS QUANTITY:
Noqdirna 25:
Each tablet contains:
desmopressin (as acetate) 25 mcg
For the list of inactive ingredients, please see section 6.
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, consult your doctor
or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if it seems to you that their medical condition is similar to yours.
•
NOQDIRNA MAY CAUSE A DECREASE IN YOUR BLOOD SODIUM LEVELS
(HYPONATREMIA).
SEVERE HYPONATREMIA CAN BE LIFE-THREATENING, LEADING TO SEIZURES,
COMA, BREATHING
DIFFICULTIES OR DEATH
.
•
DO NOT TAKE NOQDIRNA IF YOU ARE AT RISK OF SEVERE HYPONATREMIA, SUCH
AS EXCESSIVE
FLUID INTAKE, ILLNESS THAT MAY CAUSE FLUID OR ELECTROLYTE IMBALANCES
IN THE BODY, YOU
ARE TAKING DIURETICS OR STEROIDS, INCLUDING INHALED STEROIDS.
•
ENSURE THAT YOU ARE NOT TAKING OTHER MEDICINES THAT MAY INCREASE THE
RISK OF
HYPONATREMIA.
•
ENSURE THAT YOUR BLOOD SODIUM LEVEL IS NORMAL BEFORE STARTING
TREATMENT. DO NOT
START TREATMENT IF THE SODIUM LEVEL IS BELOW 135 MMOL/L.
REPEAT THE TEST OF BLOOD SODIUM LEVEL WITHIN 7 DAYS AND APPROXIMATELY
1 MONTH
AFTER INITIATING THERAPY. MONITOR BLOOD SODIUM LEVEL PERIODICALLY
DURING TREATMENT.
MONITOR BLOOD SODIUM LEVEL MORE FREQUENTLY IF YOU ARE 65 YEARS OF AGE
AND OLDER OR
ARE AT RISK OF SEVERE HYPONATREMIA.
•
DO NOT CONTINUE TREATMENT IN CASE OF HYPONATREMIA (SODIUM LEVELS BELOW
135
MMOL/L). IN SUCH CASE, THE TREATMENT MUST BE TEMPORARILY OR
PERMANENTLY
DISCONTINUED.
1. WHAT IS THIS MEDICINE INTENDED FOR

Résumé des caractéristiques du produit

Page 1
NOQDIRNA 25,
Desmopressin 25 MCG, Dispersible Chewable Tablets, Sublingual
NOQDIRNA
50
, Desmopressin 50 MCG, Dispersible Chewable Tablets, Sublingual
WARNING: HYPONATREMIA
NOQDIRNA CAN CAUSE HYPONATREMIA. SEVERE HYPONATREMIA CAN BE
LIFE-THREATENING,
LEADING TO SEIZURES, COMA, RESPIRATORY ARREST, OR DEATH _[SEE WARNINGS
AND PRECAUTIONS _
_(5.1)]. _
NOQDIRNA IS CONTRAINDICATED IN PATIENTS AT INCREASED RISK OF SEVERE
HYPONATREMIA, SUCH
AS PATIENTS WITH EXCESSIVE FLUID INTAKE, ILLNESSES THAT CAN CAUSE
FLUID OR ELECTROLYTE
IMBALANCES, AND IN THOSE USING LOOP DIURETICS OR SYSTEMIC OR INHALED
GLUCOCORTICOIDS _[SEE _
_CONTRAINDICATIONS (4) AND WARNINGS AND PRECAUTIONS (5.1)]. _
Ensure that the patient is not taking other medicines that may
increase the risk of hyponatremia
ENSURE THE SERUM SODIUM CONCENTRATION IS NORMAL BEFORE STARTING OR
RESUMING
NOQDIRNA. DO NOT START TREATMENT IF SODIUM CONCENTRATION IS BELLOW
135MMOL/L.
MEASURE SERUM SODIUM WITHIN 7 DAYS AND APPROXIMATELY 1 MONTH AFTER
INITIATING
THERAPY, AND PERIODICALLY DURING TREATMENT. MORE FREQUENTLY MONITOR
SERUM SODIUM IN
PATIENTS 65 YEARS OF AGE AND OLDER AND IN PATIENTS AT INCREASED RISK
OF HYPONATREMIA. _[SEE _
_DOSAGE AND ADMINISTRATION (2.2) AND WARNINGS AND PRECAUTIONS (5.1)]._
IF HYPONATREMIA OCCURS (SODIUM CONCENTRATION IS BELLOW 135MMOL/L),
NOQDIRNA MUST
BE TEMPORARILY OR PERMANENTLY DISCONTINUED _[SEE WARNINGS AND
PRECAUTIONS (5.1)]._
1
INDICATIONS AND USAGE
NOQDIRNA is indicated for the treatment of nocturia due to nocturnal
polyuria in adults who awaken at
least 2 times per night to void.
In the NOQDIRNA clinical trials nocturnal polyuria was defined as
night-time urine production exceeding
one-third of the 24-hour urine production.
Before starting NOQDIRNA:
•
Evaluate the patient for possible causes for the nocturia, including
excessive fluid intake prior to
bedtime, and address other treatable causes of nocturia.
•
Confirm the diagnosis of nocturnal polyuria with a 24-hour urine
collection, if one has not been
obtained previously.
2
D