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AZELASTINE NASAL SPRAY

Active substance(s): AZELASTINE HYDROCHLORIDE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

RHINOLAST® NASAL SPRAY/AZELASTINE NASAL SPRAY
(azelastine hydrochloride)
Patient Information Leaflet

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In this leaflet:
1. What Rhinolast is for
2. Before you use Rhinolast
3. How to use Rhinolast

4. Possible side effects
5. How to store Rhinolast
6. Further information

1. WHAT RHINOLAST IS FOR
Rhinolast belongs to a group of medicines called antihistamines. These work by preventing the effects of
histamine that the body produces as part of an allergic reaction.
Rhinolast is used to treat allergic rhinitis. This is an allergy which may affect you only at certain times of the
year (for example, allergy to pollen, called hayfever), or all year round (for example, allergy to the house dust
mite or dog and cat hairs).
Usually it affects you by causing a runny nose, sneezing, itching or blocked nose. Rhinolast should help
control these symptoms.
This product may be used by adults and children aged 6 years and older.

WARNING!

2. BEFORE YOU USE RHINOLAST
Do not use Rhinolast if:
• You are allergic to azelastine hydrochloride or any of the other ingredients of Rhinolast (listed in
Section 6). If this applies to you, talk to your doctor or pharmacist.

3. HOW TO USE RHINOLAST
Always use the spray exactly as your doctor has told you.
Important:
Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label
that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or
pharmacist.
Adults and children aged 6 years and over.

TVT CHECKED

Diagram 1

Diagram 2

Diagram 3

If you use more Rhinolast than you should
If you spray too much Rhinolast into your nose you are unlikely to have any problems.
Contact your doctor if you are worried.
UK PIL DATED JANUARY 2014
REPORTING OF SIDE EFFECTS

28/05/14
DATE OF PROOF:

How to use the spray
1. Blow your nose first
2. Remove the protective cap (Diagram 1)
3. Before the first use, press the pump several times until an even spray emerges (Diagram 2)
4. Spray once into each nostril keeping head upright. Do not tilt head backwards (Diagram 3)
5. Wipe the pump nozzle and replace the protective cap.

CODE:

DATE:

DT
ARTWORKER:
PRODUCT: Rhinolast nasal spray

Q.A.
APPROVED:
05-0440
CUSTOMER:

PRE-PRESS NO.:

How much to use
• The usual dose is one squirt into each nostril in the morning and then again in the evening.

If anyone, especially a child, accidentally drinks Rhinolast, contact your doctor or local hospital casualty
department immediately.
If you accidentally get Rhinolast in your eyes, bathe them with plenty of water. They may sting for a while.
If you forget to use Rhinolast
Use the 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 missed dose.
If you have any other questions about using this medicine, ask your doctor or pharmacist.

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or are breast-feeding ask your doctor or pharmacist for
advice before using Rhinolast.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

Your medicine is available using either of the above names but will be referred to as Rhinolast throughout
this leaflet.
Read all of this leaflet carefully before you start using this medicine.
- 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. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.

PROOF HISTORY:
v.1
-28/05/14

Leaflet Flat Size = 148 x 317

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

4. POSSIBLE SIDE EFFECTS
Like all medicines Rhinolast can cause side effects, although not everybody gets them.

5. HOW TO STORE RHINOLAST
• Rhinolast nasal spray/Azelastine nasal spray should not be stored below 8°C. Do not refrigerate.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop using the spray, please take it back to the pharmacist for safe disposal. Only
keep the spray if your doctor tells you to.
• If the spray becomes discoloured or shows sign of any deterioration, you should seek the advice of your
pharmacist who will advise you what to do.
• Medicines should not be disposed of via wastewater or household waste. Return any medicine you no
longer need to your pharmacist.

WARNING!

6. FURTHER INFORMATION
Your medicine is called Rhinolast nasal spray/Azelastine nasal spray. It contains a solution of 0.1% of the
active ingredient, azelastine hydrochloride. Each squirt of spray contains 0.14mg azelastine hydrochloride in
a clear solution.

Rhinolast nasal spray/Azelastine nasal spray is available as a glass bottle containing 20ml of nasal spray
solution.
PL No: 18799/2628

This product is manufactured by MEDA Pharma GmbH & Co KG, Bad Homburg, Germany and is procured
from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Leaflet revision and issue date (Ref.) 21.05.2015

UK PIL DATED JANUARY 2014
REPORTING OF SIDE EFFECTS

28/05/14
DATE OF PROOF:

TVT CHECKED
CODE:

DATE:

DT
ARTWORKER:
PRODUCT: Rhinolast nasal spray

Q.A.
APPROVED:
PRE-PRESS NO.:
CUSTOMER:

05-0440

Rhinolast is a registered trademark of MEDA Pharma GmbH & Co KG

Colour
Swatch

Black

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

POM

DATE:

CUSTOMER
APPROVED:

Rhinolast nasal spray/Azelastine nasal spray also contains the following:
hypromellose, disodium edetate, anhydrous citric acid, sodium chloride, sodium phosphate and purified
water.

WARNING!

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Notes:

These effects include:
Common (1 to 10 of 100 patients treated) An unpleasant taste in your mouth especially if you tilt your head
backwards when you are using the nasal spray. In rare cases the unpleasant taste may cause you to feel
sick.
Uncommon (1 to 10 of 1,000 patients treated) Slight irritation of the inside of the nose (stinging, itching)
sneezing and epistaxis.
Very rare (less than 1 of 10,000 patients treated) Hypersensitivity reactions (such as rash, pruritus,
urticaria).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 help provide more information on the safety of this medicine.

PROOF HISTORY:
v.1
-28/05/14

Leaflet Flat Size = 148 x 317

27mm

Expand view ⇕

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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