Patient Information Leaflet

Rhinolast Nasal Spray

Azelastine hydrochloride

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, Rhinolast Nasal Spray will be called Rhinolast.

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

6

2.    Before you take 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.

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.

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.

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 Pagram 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.

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.

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.

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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.

4. Possible side effects

Like all medicines Rhinolast can cause side effects, although not everybody gets them.

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.

6. Further information

What Rhinolast Nasal Spray contains

The active substance is azelastine hydrochloride 0.1% w/v. Each squirt provides 140 micrograms azelastine hydrochloride. The other ingredients are hypromellose, disodium edetate, citric acid, disodium phosphate, sodium chloride and purified water.

What Rhinolast looks like

Rhinolast is a clear spray solution. It comes in a polythene or glass bottle containing 5,10,20 or 22 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder

MEDA Pharmaceuticals Ltd Skyway House Parsonage Road Takeley

Bishop's Stortford CM22 6PU

Manufacturer

MEDA Manufacturing GmbH Neurather Ring 1 51063 Cologne Germany

® Rhinolast is a Registered Trade Mark This leaflet was last revised August 2014

5. How to store Rhinolast

Keep out of the reach and sight of children.

Do not use your spray after the expiry date which is printed on both the bottle label and the carton. The expiry date refers to the last day of that month.

Once you have opened the bottle do not use it for longer than six months.

Do not store Rhinolast in the fridge or below 8°C.

Medicines should not be disposed of via

wastewater or household waste. Return any If this leaflet is difficult to see or medicine you no longer need to your pharmacist, read or you would like it in a different

format, please contact MEDA Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishop’s Stortford, CM226PU.

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