Noqdirna 25microgram oral lyophilisates

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Desmopressin acetate

Disponible depuis:

Ferring Pharmaceuticals Ltd

Code ATC:

H01BA02

DCI (Dénomination commune internationale):

Desmopressin acetate

Dosage:

25microgram

forme pharmaceutique:

Oral lyophilisate

Mode d'administration:

Sublingual

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 06050200; GTIN: 05015919790015

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
25 MICROGRAMS ORAL LYOPHILISATE
50 MICROGRAMS ORAL LYOPHILISATE
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 Noqdirna is and what it is used for
2. What you need to know before you take Noqdirna
3. How to take Noqdirna
4. Possible side effects
5. How to store Noqdirna
6. Contents of the pack and other information
1. WHAT NOQDIRNA IS AND WHAT IT IS USED FOR
Noqdirna contains desmopressin, an antidiuretic, which reduces
urine production.
Noqdirna is used for the treatment of nocturia (frequent need to get
up
to urinate at night) due to nocturnal polyuria (overproduction of
urine
during night) in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOQDIRNA
DO NOT TAKE NOQDIRNA:
- if you are allergic to desmopressin or any of the other ingredients
of
this medicine (listed in section 6)
- if you suffer from polydipsia (excessive thirst and increased fluid
intake) or psychogenic polydipsia (psychologically caused increased
thirst and increased fluid intake)
- if you have known or suspected cardiac insufficiency (heart failure
in which the heart is not able to pump enough blood throughout the
body)
- if you have any disease requiring treatment with diuretics
- if you have moderately or severely reduced kidney function
- if you have or have had hyponatraemia (low sodium level in the
blood)
- if you have SIADH (hormone secretion disorder)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Noqdirna.
It is especially important tha

Résumé des caractéristiques du produit

OBJECT 1
NOQDIRNA 25MCG ORAL LYOPHILISATE
Summary of Product Characteristics Updated 01-Nov-2016 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
Noqdirna 25 microgram oral lyophilisate
2. Qualitative and quantitative composition
Each oral lyophilisate contains desmopressin acetate equivalent to 25
micrograms desmopressin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral lyophilisate.
White, round, oral lyophilisate of approximately 12 mm marked with 25
on one side.
4. Clinical particulars
4.1 Therapeutic indications
Noqdirna is indicated for symptomatic treatment of nocturia due to
idiopathic nocturnal polyuria in adults
(see section 5.1).
4.2 Posology and method of administration
Posology
• Women: 25 microgram daily, one hour before bedtime, administered
sublingually without water.
• Men: 50 microgram daily, one hour before bedtime, administered
sublingually without water.
A dose increase with this product is not recommended in elderly
patients ≥ 65 years.
If higher doses are considered for patients under the age of 65 years
in case of an insufficient response to
Noqdirna, other desmopressin oral lyophilisate products should be used
(see sections 4.4, 4.8 and 5.1)
In the event of signs or symptoms of water retention and/or
hyponatremia (headache, nausea/vomiting,
weight gain, and, in severe cases, convulsions) treatment should be
interrupted and reassessed. When
restarting treatment strict fluid restriction should be enforced and
serum sodium levels monitored (see
section 4.4).
Noqdirna should be discontinued if the serum sodium level falls below
the lower limit of normal range
(i.e.135 mmol/L)
Special Populations
_Elderly patients (65 years of age and older)_
Elderly patients are at increased risk of developing hyponatraemia
with desmopressin treatment and may
also have impaired renal function. Caution should therefore be
exercised in this age group and daily doses
above 25 microgram for females and 50 microgram for males should not
be used. In elderly patients