PATIENT INFORMATION LEAFLET

Your medicine is available using either of the above names but will be referred to as Rhinolast Nasal Spray 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.

In this leaflet:

1.    What Rhinolast Nasal Spray is for

2.    Before you use Rhinolast Nasal Spray

3.    How to use Rhinolast Nasal Spray

4.    Possible side effects

5.    How to store Rhinolast Nasal    Spray

6.    Further information

1.    WHAT RHINOLAST NASAL SPRAY IS FOR

Rhinolast Nasal Spray 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 Nasal Spray 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 Nasal Spray should help control these symptoms. This product may be used by adults and children aged 5 years and older.

2.    BEFORE YOU TAKE RHINOLAST NASAL SPRAY

Do not use Rhinolast Nasal Spray if:

•    You are allergic to azelastine hydrochloride or any of the other ingredients of Rhinolast Nasal Spray (listed in Section 6). If this applies to you, talk to your doctor or pharmacist.

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 Nasal Spray.

3.    HOW TO USE RHINOLAST NASAL SPRAY

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.

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Adults and children aged 5 years and over.

How much to use

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

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.

If you use more Rhinolast Nasal Spray than you should

If you spray too much Rhinolast Nasal Spray into your nose you are unlikely to have any problems. Contact your doctor if you are worried.

If anyone, especially a child, accidentally drinks Rhinolast Nasal Spray, contact your doctor or local hospital casualty department immediately.

If you accidentally get Rhinolast Nasal Spray in your eyes, bathe them with plenty of water. They may sting for a while.

If you forget to use Rhinolast Nasal Spray

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.

4. POSSIBLE SIDE EFFECTS

Like all medicines Rhinolast Nasal Spray can cause side effects, although not everybody gets them. These effects include:

•    Slight irritation of the inside of the nose. This can cause mild stinging, itching or sneezing. These symptoms should not last long.

•    A nose bleed.

•    A bitter taste in your mouth, especially if you tilted your head backwards when you used the nasal spray. This should disappear if you have a soft drink a few minutes after using Rhinolast Nasal Spray. The bitter taste might cause you to feel sick.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE RHINOLAST NASAL SPRAY

•    Do not store below 8°C. Do not refrigerate.

•    Keep out of the sight and reach of children. Used wrongly the spray could harm them.

•    Do not use your spray after the expiry date on the box. The expiry date refers to the last date of that month.

•    Once you have opened the bottle do not use for longer than six months, even if there is some medicine left in the bottle after this time. If necessary, ask your doctor to replace it with a new prescription.

•    If your spray appears to be discoloured or shows any other signs of deterioration, take it to your pharmacist.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Rhinolast Nasal Spray contains

Rhinolast Nasal Spray contains 0.1% w/v azelastine hydrochloride as the active ingredient.

Also contains: hypromellose, disodium edetate, citric acid anhydrous,

disodium phosphate dodecahydrate, sodium chloride and purified water.

What Rhinolast Nasal Spray looks like and contents of the pack

Rhinolast Nasal Spray is a clear solution which comes in a glass bottle with a pump attached and a

clear plastic dust cap.

The bottle contains 20ml of nasal spray solution.

Manufacturer

Manufactured by: MEDA Pharma GmbH & Co. KG, Bad Homburg, Germany.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

PL No: 04423/0556

Leaflet revision and issue date (Ref): 18.01.13

Rhinolast® is a registered trademark of MEDA Pharma GmbH 8i Co. KG.

Other formats:

To request a copy of this leaflet in Braille, large print or audio please call 01302 365000 and ask for the Regulatory Department.

Please be ready to give the following information:

Product name    Rhinolast Nasal Spray/Azelastine Hydrochloride 0.1% Nasal Spray

Reference number    04423/0556