Desmopressin 10micrograms/dose nasal spray

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Desmopressin acetate

Available from:

Accord-UK Ltd

ATC code:

H01BA02

INN (International Name):

Desmopressin acetate

Dosage:

10microgram/1dose

Pharmaceutical form:

Spray

Administration route:

Nasal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06050200; GTIN: 5012617007926

Patient Information leaflet

DESMOPRESSIN NASAL SPRAY
10 MICROGRAMS/DOSE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
•
If you have any further questions, ask your doctor or pharmacist.
•
If you have any of the side effects, or if you notice any side effects
not
listed, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1 WHAT DESMOPRESSIN IS AND WHAT IT IS USED FOR
2 BEFORE YOU USE DESMOPRESSIN NASAL SPRAY
3 HOW TO USE DESMOPRESSIN NASAL SPRAY
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE DESMOPRESSIN NASAL SPRAY
6 FURTHER INFORMATION
1 WHAT DESMOPRESSIN IS AND WHAT IT IS USED FOR
The ingredient that makes the spray work (the active substance) is
called
desmopressin. Desmopressin is an antidiuretic, which reduces the
amount of
urine produced by the kidneys.
Desmopressin nasal spray is used to:
•
treat and diagnose a chronic disease called DIABETES INSIPIDUS which
causes
extreme thirst and continuous production of large volumes of dilute
urine.
IMPORTANT: Not to be confused with diabetes mellitus (sugar diabetes)
•
treat FREQUENT URINATION DURING THE NIGHT in adults (nocturia)
associated
with multiple sclerosis
•
INVESTIGATE KIDNEY FUNCTION.
2 BEFORE YOU USE DESMOPRESSIN NASAL SPRAY
DO NOT USE Desmopressin nasal spray if you:
•
are ALLERGIC (hypersensitive) to desmopressin or any of the other
ingredients
in Desmopressin nasal spray (see section 6)
•
DRINK unusually LARGE AMOUNTS of fluid (polydipsia)
•
suffer from HEART PROBLEMS, HIGH BLOOD PRESSURE or OTHER DISEASES
needing TREATMENT WITH DIURETICS (water tablets)
•
are ELDERLY (over the age of 65 years)
•
suffer with ALCOHOL ABUSE.
• have moderate or severe KIDNEY problems
• have been told you have HYPONATRAEMIA (very low levels of sodium
in
your blood)
• have SYNDROME OF INAPPROPRIATE ADH SECRETION (SIADH).
CHECK WITH YOUR DOCTOR OR PHARMACIST BE

Summary of Product characteristics

OBJECT 1
DESMOPRESSIN NASAL SPRAY 10 MICROGRAMS/DOSE
Summary of Product Characteristics Updated 09-Sep-2015 | Accord-UK Ltd
1. Name of the medicinal product
Desmopressin Nasal Spray 10 micrograms/dose
2. Qualitative and quantitative composition
Desmopressin acetate 0.1 mg/ml
3. Pharmaceutical form
Nasal spray, solution
4. Clinical particulars
4.1 Therapeutic indications
Desmopressin Nasal Spray 10 micrograms/dose is indicated for:
1) The treatment of nocturia associated with multiple sclerosis where
other treatments have failed.
2) The diagnosis and treatment of vasopressin-sensitive cranial
diabetes insipidus.
3) Establishing renal concentration capacity.
4.2 Posology and method of administration
Each spray contains 10 micrograms desmopressin acetate.
Dosage and administration
_Treatment of nocturia: _For multiple sclerosis patients up to 65
years of age (with normal renal function)
suffering from nocturia the dose is one or two sprays intranasally (10
to 20 micrograms) at bedtime. Not
more than one dose should be used in any 24 hour period. If a dose of
two sprays is required this should
be as one spray in each nostril.
During the treatment of nocturia the fluid intake should be limited to
a minimum and only to satisfy thirst
for 8 hours following administration.
_Treatment of diabetes insipidus: _Dosage is individual but clinical
experience has shown that the average
maintenance dose in adults and children is one or two sprays (10 to 20
micrograms) once or twice daily.
If a dose of two sprays is required, this should be as one spray into
each nostril.
_Diagnosis of diabetes insipidus: _The diagnostic test in adults and
children is two sprays (20 micrograms).
Failure to elaborate a concentrated urine after water deprivation,
followed by the ability to do so after the
administration of Desmopressin Nasal Spray 10 micrograms/dose confirms
the diagnosis of cranial
diabetes insipidus. Failure to concentrate after the administration
suggests nephrogenic diabetes insipidus.
When used for diagnostic purposes the fluid