Dymista 137micrograms/dose / 50micrograms/dose nasal spray

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Fluticasone propionate; Azelastine hydrochloride

Pieejams no:

Viatris UK Healthcare Ltd

ATĶ kods:

R01AD58

SNN (starptautisko nepatentēto nosaukumu):

Fluticasone propionate; Azelastine hydrochloride

Deva:

50microgram/1dose ; 137microgram/1dose

Zāļu forma:

Spray

Ievadīšanas:

Nasal

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 12020100; GTIN: 5060035247998

Lietošanas instrukcija

Read all of this leaflet carefully before you start using
this medicine because it contains important informa-
tion 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 Dymista Nasal Spray is and what it is used for
2. What you need to know before you use Dymista
Nasal Spray
3. How to use Dymista Nasal Spray
4. Possible side effects
5. How to store Dymista Nasal Spray
6. Contents of the pack and other information
1.
What Dymista Nasal Spray is and what it is
used for
Dymista Nasal Spray contains two active substances:
azelastine hydrochloride and fluticasone propionate.
•
Azelastine hydrochloride 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.
•
Fluticasone propionate belongs to a group of
medicines called corticosteroids which reduces
inflammation.
Dymista Nasal Spray is used to relieve the symptoms
of moderate to severe seasonal and perennial
allergic rhinitis if the use of either intranasal anti­
histamine or corticosteroid alone is not considered
sufficient.
Seasonal and perennial allergic rhinitis are allergic
reactions to substances such as pollen (hayfever),
house mites, moulds, dust or pets.
Dymista Nasal Spray relieves the symptoms of
allergies, for example: runny nose, post nasal drip,
sneezing and itchy or blocked nose.
2. What you need to know before you use
Dymista Nasal Spray
Do not use Dymista Nasal Spray:
•
If you are allergic to azelastine hydrochloride or
fluticasone propionate or any of the ot

Produkta apraksts

OBJECT 1
DYMISTA NASAL SPRAY
Summary of Product Characteristics Updated 10-Apr-2018 | Meda
Pharmaceuticals
1. Name of the medicinal product
DYMISTA NASAL SPRAY
137 micrograms / 50 micrograms per actuation
Nasal Spray, Suspension
2. Qualitative and quantitative composition
Each g of suspension contains 1000 micrograms azelastine hydrochloride
and 365 micrograms fluticasone
propionate.
One actuation (0.14 g) delivers 137 micrograms azelastine
hydrochloride (= 125 micrograms azelastine)
and 50 micrograms fluticasone propionate.
Excipient with known effect:
One actuation (0.14 g) delivers 0.014 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
Relief of symptoms of moderate to severe seasonal and perennial
allergic rhinitis if monotherapy with
either intranasal antihistamine or glucocorticoid is not considered
sufficient.
4.2 Posology and method of administration
_POSOLOGY_
For full therapeutic benefit regular usage is essential.
Contact with the eyes should be avoided.
Adults and adolescents (12 years and older)
One actuation in each nostril twice daily (morning and evening).
Children below 12 years
Dymista Nasal Spray 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.
_DURATION OF TREATMENT_
Dymista Nasal Spray is suitable for long-term use.
The duration of treatment should correspond to the period of
allergenic exposure.
_METHOD OF ADMINISTRATION_
Dymista Nasal Spray is for nasal use only.
_INSTRUCTION FOR USE_
Preparing the spray:
The bottle should be shaken gently before use for about 5 seconds by
tilting it upwards and downwards
and the protective cap be removed afterwards. Prior to first use
Dymista Nasal Spray must be primed by
p