Azelastine Xanthis Nasal Spray Solution 1mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AZELASTINE HYDROCHLORIDE

Available from:

Xantis Pharma Limited Lemesou, 5 EUROSURE Tower, 1st floor, Flat/Office 101, 2112, Nicosia, Cyprus

ATC code:

R01AC03

INN (International Name):

AZELASTINE HYDROCHLORIDE 0.14 mg

Pharmaceutical form:

NASAL SPRAY, SOLUTION

Composition:

AZELASTINE HYDROCHLORIDE 0.14 mg

Prescription type:

POM

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2017-12-15

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZELASTINE XANTIS 1 MG/ML NASAL SPRAY SOLUTION
Azelastine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Azelastine Xantis 1 mg/ ml nasal spray solution is and what it is
used for
2.
What you need to know before you use Azelastine Xantis 1 mg/ ml nasal
spray solution
3.
How to use Azelastine Xantis 1 mg/ ml nasal spray solution
4.
Possible side effects
5.
How to store Azelastine Xantis 1 mg/ ml nasal spray solution
6.
Contents of the pack and other information
1.
WHAT AZELASTINE XANTIS 1 MG/ML NASAL SPRAY SOLUTION IS AND WHAT IT IS
USED FOR
Azelastine Xantis 1 mg/ ml nasal spray solution contains azelastine,
which belongs to a group of
medicines that works by preventing the effect of histamine
(antihistamines) which usually affects you
by causing a runny nose, sneezing, itching or blocked nose.
Azelastine Xantis 1 mg/ ml nasal spray solution is used for the
symptomatic treatment of seasonal
allergic rhinitis, and acute exacerbations (attacks) of perennial
allergic rhinitis.
Azelastine Xantis 1 mg/ ml nasal spray solution is intended for use by
adults, adolescents and children
over 6 years of age.
You must talk to a doctor if you do not feel better or if you feel
worse after 1 week.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AZELASTINE XANTIS 1 MG/ML NASAL
SPRAY SOLUTION
_ _
DO NOT USE AZELASTINE XANTIS 1 MG/ML NASAL SPRAY SOLUTION:
-
if you are allergic to azelastine hydrochloride or any of the other
ingredients of this medicine
(listed

Summary of Product characteristics

Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Azelastine Xantis 1 mg/ml nasal spray solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1mg azelastine hydrochloride.
One application (0.14 ml) contains 0.14 mg azelastine hydrochloride
equivalent to 0.13 mg azelastine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray solution.
Clear colourless solution free from particles.
The pH of the solution is between 6.4 -7.2.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azelastine is indicated for the symptomatic treatment of seasonal
allergic rhinitis (e.g hayfever) and acute
exacerbations of perennial allergic rhinitis in adults, adolescents
and children from 6 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
One application (0.14 ml) in each nostril twice daily (0.56 mg of
azelastine hydrochloride).
Elderly:
There have been no specific studies in the elderly.
Paediatric population:
For children aged 6 years and older, one application (0.14 ml) in each
nostril twice daily (0.56 mg of
azelastine hydrochloride).
Azelastine should not be used in children below 6 years of age due to
lack of data on safety and efficacy.
Method of administration
Nasal use
_Precautions to be taken before handling or administering the
medicinal product: _
Spray with head held upright.
Before the first use, press the pump several times until an even spray
emerges (3-4 times).
When azelastine has not been used for 6 or more days, the pump must be
reprimed by pressing down and
releasing the pump a sufficient number of times until a fine mist
emerges.
After administration, wipe the pump nozzle and replace the protective
cap.
Page 2 of 5
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The spray should be used with the head held upright, see section 4.8._
_
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction st