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DYMISTA NASAL SPRAY 137 MICROGRAMS / 50 MICROGRAMS PER ACTUATION NASAL SPRAY SUSPENSION

Active substance(s): AZELASTINE HYDROCHLORIDE / FLUTICASONE PROPIONATE

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Package leaflet:
Information for the patient

By Sorwar Choudhury at

Dymista® Nasal Spray
137 micrograms / 50 micrograms
per actuation Nasal Spray,
Suspension
Azelastine hydrochloride/fluticasone propionate
137 micrograms / 50 micrograms
per actuation Nasal Spray, Suspension
137 micrograms / 50 micrograms
per actuation Nasal Spray, Suspension

56UK2071112-04

Dymista® Nasal Spray

56UK2071112-04

Dymista Nasal Spray
®

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 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. W
 hat 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 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

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rhinitis, for example: runny nose, post nasal drip,
sneezing and itchy or blocked nose, 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.

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 other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Dymista
Nasal Spray if:
• You had a 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 Dymista 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 Dymista Nasal Spray.
• 
You have problems with your adrenal glands. Care
must be taken when transferring from systemic
steroid treatment to Dymista 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 Dymista Nasal Spray.
Taking 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.
If you are unsure whether the above applies to you,
talk to your doctor or pharmacist before using Dymista
Nasal Spray.
Children
This medicine is not recommended for children
under 12 years.

Other medicines and Dymista Nasal Spray
Tell your doctor or pharmacist, if you are taking, have
recently taken or might take any other medicines.
Please talk to your doctor or pharmacist:
• If you are taking medicines to treat HIV such as
Ritonavir
If you are taking medicines to treat fungal infections
• 
such as 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
Dymista Nasal Spray.
Driving and using machines
Very rarely, you may experience fatigue or dizziness
due to the disease itself or when using Dymista Nasal
Spray. If this happens to you do not drive or operate
machinery. Please be aware that drinking alcohol
may enhance these effects.
Dymista 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 Dymista Nasal Spray

Read the following instructions carefully and use only
as directed.

Preparing the spray

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

It is important to use Dymista Nasal Spray regularly to
gain full benefit from this treatment.

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 in children under 12 years
• This medicine is not recommended for children
under 12 years.
Method of administration
For nasal use.

Figure 3

If you forget to use Dymista Nasal Spray
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 Dymista Nasal Spray
Do not stop using Dymista Nasal Spray without asking
your doctor.

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

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

5. Breathe out through
your mouth.
6. Repeat in your other
nostril.
Figure 2

a condition that may produce weight loss, fatigue,
muscle weakness, low blood sugar, salt cravings,
joint pains, depression and darkening of the skin.
If you are worried, contact your doctor.
If anyone, especially a child, accidentally drinks
Dymista Nasal Spray, contact your doctor or nearest
hospital casualty department as soon as possible.

2. Keep your head tilted
downwards towards
your toes. Do not tilt
head backwards.
3. Hold the bottle upright
and carefully insert the
spray tip into one nostril.

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

5. Now your pump is
primed and ready
to use.

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

Figure 1

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

Always use Dymista Nasal Spray exactly as your doctor
has told you. Check with your doctor or pharmacist,
if you are not sure.

Contact with the eyes should be avoided.

1. Blow your nose to clear
your nostrils.

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

Using the spray

4. Possible side effects
Figure 4

7. 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).
8. After each use wipe the
spray tip with a clean
tissue or cloth and then
replace the protective
cap.
It is important that you take your dose as advised by
your doctor. You should use only as much as your
doctor recommends.
Duration of Treatment
Dymista Nasal Spray is suitable for long-term use. Use
this medicine for as long as your doctor tells you to.
If you use more Dymista Nasal Spray than you should
It is important that you take your dose as stated above
or as advised by your doctor.
If you spray too much of this medicine into your nose
you are unlikely to have any problems. However,
treatment with higher than recommended doses of
nasal corticosteroids may result in adrenal suppression,

Like all medicines Dymista Nasal Spray can cause
side effects, although not everybody gets them.
Stop taking Dymista and 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.
• 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 are very rare.
Very common side effects
(These may affect more than 1 in 10 people):
• Nosebleed
Common side effects
(These may affect up to 1 in 10 people):
• 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

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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
• 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)
Side effects concerning the whole body may occur
when this medicine is used at high doses for a long
time.
In rare cases a reduction of bone density (osteo­
porosis) was observed when fluticasone was administered long-term.
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 via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard
By reporting side effects, you can provide more
information on the safety of this medicine.

5. How to store Dymista Nasal Spray
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.

6. Contents of the pack and other information
What Dymista Nasal Spray contains
The active substances are: azelastine hydrochloride
and fluticasone propionate.
Each g of suspension contains 1000 micrograms
azelastine hydrochloride and 365 micrograms fluticasone proprionate.
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, poly­
sorbate 80, benzalkonium chloride solution, phenyl­
ethyl alcohol and purified water.

Marketing Authorisation Holder
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishops Stortford
CM22 6PU
Manufacturer
MEDA Pharma GmbH & Co. KG
Benzstr. 1, 61352 Bad Homburg
Germany
This leaflet was last revised in 11/2014.

What Dymista Nasal Spray looks like and contents
of the pack
Dymista Nasal Spray is a white, homogenous
suspension.
Dymista 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).
Dymista Nasal Spray is presented in:
Packs containing 1 bottle with 6.4 g nasal spray,
suspension
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.
Not all pack sizes may be marketed.

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.

56UK2071112-04

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Studio Oberländer GmbH · Rubensstr.  33 · 60596 Frankfurt a. M. · Germany
Phone: +49 69 631520-85  ·  Fax: -87  ·  E-Mail: info@studio-oberlaender.de

SPECIFICATION BOX: Leaflet
MANUFACTURER: Meda Pharma GmbH & Co. KG

COLOURS USED:

PRODUCT: Dymista Nasal Spray


Black

137 mμ / 50 mμ

MEDA-NO.: 56UK2071112-04
MFS-NO.:
COUNTRY:

LAETUS CODE:

United Kindom

LANGUAGE: English
PACK SIZE:

600 x 200 mm

CORRECTION: 1.

FONT SIZE UK:

9,0 pt / 10,5 pt

DATE:

0115_GI_Dymista_Nasalspray_56UK2071112-04.indd 3

UK

XX

15. 01. 2015

15.01.15 17:19

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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