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AZELASTINE / FLUTICASONE 137 / 50 MICROGRAMS PER ACTUATION NASAL SPRAY SUSPENSION

Active substance(s): AZELASTINE HYDROCHLORIDE / FLUTICASONE PROPIONATE

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Package leaflet: Information for the patient

Azelastine /
Fluticasone
Nasal Spray

137 micrograms / 50 micrograms per actuation
Nasal Spray, Suspension
Azelastine hydrochloride/fluticasone propionate
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 you
doctor or pharmacist.
• T his 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 / Fluticasone Nasal Spray is
and what it is used for
2. What you need to know before you use
Azelastine / Fluticasone Nasal Spray
3. How to use Azelastine / Fluticasone Nasal
Spray
4. Possible side effects
5. How to store Azelastine / Fluticasone Nasal
Spray
6. Contents of the pack and other information

1. What Azelastine / Fluticasone Nasal
Spray is and what it is used for
Azelastine / Fluticasone Nasal Spray contains
two active substances: azelastine hydrochloride
and fluticasone propionate.
• Azelastine hydrochloride belongs to a group
of medicines called antihistamines. Antihista
mines 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.
Azelastine / Fluticasone Nasal Spray is used to
relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis if the use of
either intranasal antihistamine 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.

Azelastine / Fluticasone 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
Azelastine / Fluticasone Nasal Spray
Do not use Azelastine / Fluticasone Nasal
Spray:
• If you are allergic to azelastine hydrochloride
or fluticasone propionate or any of the other
ingredients of this medicine (listed in section
6).
Warnings and precautions
Talk to your doctor or pharmacist before using
Azelastine / Fluticasone Nasal Spray if:
• You had an recent operation on your nose.
• You have an infection in your nose. Infections
of the nasal airways should be treated with
antibacterial or antifungal medication. If you
are given medication for an infection in your
nose you can continue to use Azelastine /
Fluticasone Nasal Spray to treat your allergies.
• You have tuberculosis or an untreated infection.
• You have a change in vision or a history of
increased ocular pressure, glaucoma and/or
cataracts. If this applies to you, you will be
closely monitored whilst using Azelastine /
Fluticasone Nasal Spray.
• You suffer from impaired adrenal function.
Care must be taken when transferring from
systemic steroid treatment to Azelastine /
Fluticasone Nasal Spray.
• You suffer from a severe liver disease. Your risk
of suffering from systemic side effects is increased.
In these cases your doctor will decide whether
you can use Azelastine / Fluticasone Nasal
Spray.
It is important that you take your dose as stated
in section 3 below or as advised by your doctor.
Treatment with higher than recommended doses of nasal corticosteroids may result in adrenal
suppression, a condition that may produce
weight loss, fatigue, muscle weakness, low
blood sugar, salt cravings, joint pains, depression and darkening of the skin. If this happens
your doctor may recommend another medicine
during periods of stress or elective surgery.
To avoid adrenal suppression your doctor will
advise you to take the lowest dose at which effective control of your symptoms of rhinitis is maintained.
Taking nasal glucocorticoids (such as Azelastine
/ Fluticasone) may when taken for a long time
cause children and adolescents to grow more
slowly. The doctor will check your child’s height
regularly, and make sure he or she is taking the
lowest possible effective dose.
Contact your doctor if you experience blurred
vision or other visual disturbances.
If you are unsure whether the above applies to
you, talk to your doctor or pharmacist before
using Azelastine / Fluticasone Nasal Spray.

Children
This medicine is not recommended for children
under 12 years.
Other medicines and Azelastine / Fluticasone
Nasal Spray
Tell your doctor or pharmacist, if you are taking,
have recently taken or might take any other medicines, including medicines obtained without a
prescription.
Some medicines may increase the effects of Dyvistanil Nasal Spray and your doctor may wish to
monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat and medicines for the treatment
of fungal infections: ketoconazole).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
using Azelastine / Fluticasone Nasal Spray.
Driving and using machines
Azelastine / Fluticasone Nasal Spray has minor influence on the ability to drive and use machines.
Very rarely, you may experience fatigue or dizziness
due to the disease itself or when using Azelastine /
Fluticasone Nasal Spray. In these cases, do not drive or operate machinery. Please be aware that
drinking alcohol may enhance these effects.
Azelastine / Fluticasone Nasal Spray contains
benzalkonium chloride
It may cause irritation of the nasal mucosa and
bronchospasm. Tell your doctor or pharmacist if
you feel discomfort when using the spray.

3. How to use Azelastine / Fluticasone Nasal Spray
Always use Azelastine / Fluticasone Nasal Spray
exactly as your doctor has told you. Check with
your doctor or pharmacist, if you are not sure.
It is essential to use Azelastine / Fluticasone Nasal
Spray regularly to gain the full therapeutic benefit.

Preparing the spray
1. S
 hake the bottle gently
for 5 seconds by tilting
it upwards and downwards and then remove the protective cap
(see figure 1).

4. P
 ress down and release the pump 6 times
until a fine mist appears (see figure 2).

If you use more Azelastine / Fluticasone Nasal
Spray than you should

figure 2

5. N
 ow your pump is primed and ready to use.

If you spray too much of this medicine into your
nose you are unlikely to have any problems. If
you are worried or if you have used doses higher
than recommended over a long period, contact
your doctor. If anyone, especially a child, accidentally drinks Azelastine / Fluticasone Nasal
Spray, contact your doctor or nearest hospital
casualty department as soon as possible.
If you forget to use Azelastine / Fluticasone Nasal Spray

6. If the nasal spray has
not been used for more
than 7 days, you will
need to re-prime the
pump once by pressing down and releasing the pump.

Use your nasal spray as soon as you remember,
then take the next dose at the usual time. Do not
take a double dose to make up for a forgotten
dose.
If you stop using Azelastine / Fluticasone Nasal Spray

Using the spray

Do not stop using Azelastine / Fluticasone Nasal
Spray without asking your doctor, because this
puts the success of the treatment at risk.

1. Shake the bottle gently for
5 seconds by tilting it upwards and downwards
and then remove the protective cap (see figure 1).

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

2. Blow your nose to clear
your nostrils.
3. Keep your head tilted
downwards towards your
toes. Do not tilt head
backwards.

Adults and adolescents (12 years and above)
• The recommended dose is one spray into each
nostril in the morning and evening.

5. Close other nostril with
your finger, rapidly press
down once and sniff gent
ly at the same time (see
figure 3).

Method of administration
For nasal use.
Read the following instructions carefully and use
only as directed.

Duration of treatment
Azelastine / Fluticasone Nasal Spray is suitable
for long-term use. The duration of treatment
should correspond to the period of experiencing
allergy symptoms.

3. P
 rime the pump by putting two fingers on
either side of the spray
pump and place your
thumb on the bottom
of the bottle.

4. Hold the bottle upright
and carefully insert the
spray tip into one nostril.

Use in renal and hepatic impairment
• There are no data in patients with renal and
hepatic impairment.

figure 1

2. T he first time the nasal
spray is used, you must
prime the pump by
squirting it into the air.

Contact with the eyes should be avoided.

Use in children under 12 years
• This medicine is not recommended for children
under 12 years.

It is important that you take your dose as advised by your doctor. You should use only as
much as your doctor recommends.

INSTRUCTION FOR USE

figure 3

Like all medicines Azelastine / Fluticasone Nasal
Spray can cause side effects, although not
everybody gets them.
Very common side effects (These may affect
more than 1 in 10 people):
• Nosebleed

6. Breathe out through your
mouth.
7. Repeat in your other nostril.
8. Breathe in gently, and do
not tilt your head back
after dosing. This will stop
the medicine going into
your throat and causing
an unpleasant taste (see
figure 4).
9. After each use wipe the
spray tip with a clean
tissue or cloth and then
replace the protective
cap.

4. Possible side effects

Common side effects (These may affect up to
1 in 10 people):
figure 4

• Headache
• A bitter taste in your mouth, especially if you
tilt your head backwards when you are using
the nasal spray. This should go away if you
have a soft drink a few minutes after using this
medicine.
• Unpleasant smell

Uncommon side effects (These may affect up
to 1 in 100 people):
• Slight irritation of the inside of the nose. This
can cause mild stinging, itching or sneezing.
• Nasal dryness, cough, dry throat or throat
irritation
Rare side effects (These may affect up to 1 in
1,000 people):
• Dry mouth
Very rare side effects (These may affect up to
1 in 10,000 people):
• Dizziness or drowsiness
• Cataract, glaucoma or increased pressure in
your eye where you may have a loss of vision
and/or red and painful eyes. These side
effects have been reported following prolonged treatment with fluticasone propionate
nasal sprays.
• Damage of the skin and mucous membrane
in the nose
• Feeling sick, weary, exhausted or weak
• Rash, itchy skin or red, raised itchy bumps
• Bronchospasm (the narrowing of the airways
in the lungs)
Seek immediate medical help if you have any
of the following symptoms:
• Swelling of face, lips, tongue or throat which
may cause difficulty in swallowing/
breathing and a sudden onset of skin rash.
This could be signs of a severe allergic
reaction. Please note: This is very rare.
Side effects with unknown frequency (frequency cannot be estimated from the available
data)
· Blurred vision
Systemic side effects (side effects concerning
the whole body) may occur when this medicine
is used at high doses for a long time. These effects are much less likely to occur if you use a corticosteroid nasal spray than if you take corticosteroids by mouth. These effects may vary in
individual patients and between different corticosteroid preparations (see section 2).
Nasal corticosteroids can affect the normal production of hormones in your body, particularly if
you use high doses for a long time. In children
and adolescents this side effect can cause
them to grow more slowly than others.
In rare cases a reduction of the bone density
(osteoporosis) was observed, if nasal glucocorticoids were administered long-term.

By reporting side effects, you can help provide
more information on the safety of this medicine.

5. How to store Azelastine / Fluticasone
Nasal Spray

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Meda Pharmaceuticals Limited,

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the bottle label and the outer
carton after “EXP”. The expiry date refers to the
last day of that month.
Do not refrigerate or freeze.
Shelf life after first opening: Dispose of any unused medicine 6 months after you first open the
nasal spray.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer
use. These measures will help protect the environment.

6. Contents of the pack and other
information
What Azelastine / Fluticasone Nasal Spray
contains

Skyway House,
Parsonage Road,
Takeley,
Bishops Stortford,
CM22 6PU,
UK

Manufacturer
MEDA PHARMA GMBH & Co KG
Benzstrasse 1
Bod Homburg
D-61352
Germany

The active substances are: azelastine hydrochloride and fluticasone propionate.
Each g of suspension contains 1000 micrograms
azelastine hydrochloride and 365 micrograms
fluticasone propionate.

This leaflet was last revised in 07/2017

Each actuation (0.14 g) delivers 137 micrograms
azelastine hydrochloride (= 125 micrograms
azelastine) and 50 micrograms fluticasone propionate.
The other ingredients are: Disodium edetate, glycerol, microcrystalline cellulose, carmellose sodium, polysorbate 80, benzalkonium chloride ,
phenylethyl alcohol and purified water.

What Azelastine / Fluticasone Nasal Spray
looks like and contents of the pack
Azelastine / Fluticasone Nasal Spray is a white,
homogenous suspension.
Azelastine / Fluticasone Nasal Spray comes in
an amber coloured glass bottle fitted with a
spray pump, applicator and a protective cap.
The 10 ml bottle contains 6.4 g nasal spray, suspension (at least 28 actuations). The 25 ml bottle
contains 23 g nasal spray, suspension (at least
120 actuations).
Azelastine / Fluticasone Nasal Spray is presented in:
Packs containing 1 bottle with 6.4 g nasal spray,
suspension

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed in this leaflet. You can also report
side effects directly Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

Packs containing 1 bottle with 23 g nasal spray,
suspension
Multipacks comprising 10 bottles, each containing 6.4 g nasal spray, suspension
Multipacks comprising 3 bottles, each containing 23 g nasal spray, suspension.

56UK2071412-02-SC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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