Ryaltris 25 microgram/actuation + 600 microgram/actuation nasal spray, suspension

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Mometasone furoate; Olopatadine

Tilgængelig fra:

Glenmark Pharmaceuticals s.r.o.

ATC-kode:

R01AD59

INN (International Name):

Mometasone furoate; Olopatadine

Dosering:

25 µg/actuation + 600 µg/actuation

Lægemiddelform:

Nasal spray, suspension

Terapeutisk område:

mometasone, combinations

Autorisation status:

Marketed

Autorisation dato:

2021-07-16

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RYALTRIS
25 micrograms/actuation + 600 micrograms/actuation
nasal spray, suspension
mometasone furoate/olopatadine
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 Ryaltris is and what it is used for
2.
What you need to know before you take Ryaltris
3.
How to take Ryaltris
4.
Possible side effects
5.
How to store Ryaltris
6.
Contents of the pack and other information
1.
WHAT RYALTRIS IS AND WHAT IT IS USED FOR
Ryaltris contains two active substances: mometasone furoate and
olopatadine.
-
Mometasone furoate belongs to a group of medicines called
corticosteroids (steroids) which reduce
inflammation, often found in allergic rhinitis.
-
Olopatadine belongs to a group of medicines called antihistamines.
Antihistamines work by
preventing the effects of substances such as histamine that the body
produces as part of an allergic
reaction – thus reducing symptoms of allergic rhinitis.
Ryaltris is used to
TREAT THE SYMPTOMS OF MODERATE TO SEVERE SEASONAL ALLERGIC RHINITIS
(also called
hay fever)
AND PERENNIAL RHINITIS
in adults and adolescents 12 years of age or older.
SEASONAL ALLERGIC RHINITIS
(hay fever) is an allergic reaction which occurs at certain times of
the year
and is caused by breathing in pollen from trees, grasses, weeds and
also moulds and fungal spores.
PERENNIAL RHINITIS
occurs throughout the year and symptoms can be caused by a sensitivity
to a
variety of things including house dust mite, animal hair (or dander),
feathers and certain foods.

Produktets egenskaber

Health Products Regulatory Authority
16 July 2021
CRN009JSG
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ryaltris 25 microgram/actuation + 600 microgram/actuation nasal spray,
suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One delivered dose (the dose that leaves the actuator) contains
mometasone furoate monohydrate equivalent to 25
microgram mometasone furoate and olopatadine hydrochloride equivalent
to 600 micrograms olopatadine.
Excipient with known effect
Each actuation contains 0.02 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, suspension
White, homogeneous suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ryaltris is indicated in adults and adolescents 12 years of age and
older for the treatment of moderate to severe nasal
symptoms associated with allergic rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and adolescents (12 years and older)
The usual recommended dose is two actuations in each nostril twice
daily (morning and evening).
Children below 12 years
Ryaltris is not recommended for use in children below 12 years of age
as safety and efficacy has not been established in this
age group.
Elderly
No dose adjustment is required in this population.
Renal and hepatic impairment
There are no data in patients with renal and hepatic impairment,
however no dose adjustment is expected to be required in
these populations considering the absorption, metabolism and
elimination of the active substances (see section 5.2).
METHOD OF ADMINISTRATION
Ryaltris is for nasal use only.
Prior to administration of the first dose, shake container well and
actuate the pump 6 times (until a uniform spray is obtained).
If the pump is not used for 14 days or longer, re-prime the pump with
2 actuations until a uniform spray is observed, before
next use.
Shake container for minimum 10 seconds before each use. After using
the spray, wipe the nozzle carefully with a clean
handkerchief or tissue and