RYALTRIS

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

MOMETASONE FUROATE (AS MONOHYDRATE); OLOPATADINE AS HYDROCHLORIDE

Disponível em:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

Código ATC:

R01AD59

Forma farmacêutica:

NASAL SPRAY, SUSPENSION

Composição:

MOMETASONE FUROATE (AS MONOHYDRATE) 25 MCG/DELIVERED DOSE; OLOPATADINE AS HYDROCHLORIDE 600 MCG/DELIVERED DOSE

Via de administração:

NASAL

Tipo de prescrição:

Required

Fabricado por:

GLENMARK PHARMACEUTICALS S.R.O, CZECH REPUBLIC

Área terapêutica:

MOMETASONE, COMBINATIONS

Indicações terapêuticas:

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.

Data de autorização:

2023-10-19

Folheto informativo - Bula

Ryaltris
Nasal Spray
Active substance
olopatadine (as hydrochloride) 600 mcg
mometasone furoate (as monohydrate) 25 mcg
-
For
information
regarding
inactive
ingredients:
see
section
2
–
“Important
information about some of the ingredients of the medicine” and
section 6 –
“Additional information”.
-
Read the entire leaflet carefully before using the medicine
. This leaflet contains
concise information about the medicine. If you have additional
questions, refer to
the doctor or the 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.
1.
What is the medicine intended for?
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
Therapeutic class:
To treat nasal congestion or to prevent and treat allergic rhinitis
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.
-
2.
Before using the medicine
Do not use this medicine if:
-
if you are allergic to mometasone furoate, olopatadine or any of the
other
ingredients of this medicine (listed in section 6).
-
if you have an
untreated infection in your nose.
Use of Ryaltris during an
untreated infection in your nose, such as herpes, can worsen the
infection. You
should wait until the infection is resolved before you start using the
nasal spray.
-
if you have recently had an
operation on y

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ryaltris
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 free of lumps.
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 replace
the cap, to avoid
that the nozzle gets blocked. The bottle should be discarded after the
labelled