PACKAGE LEAFLET: INFORMATION FOR THE USER

Azelastine S (working name under discussion) 1 mg/ml Nasal Spray, Solution

Azelastine hydrochloride

[For medicinal products available only on prescription:]

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.

-    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.

-    In this leaflet Azelastine S 1 mg/ml Nasal Spray, Solution is called Azelastine S.

[For medicinal products available without a prescription:]

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Azelastine S carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    You must contact a doctor if your symptoms worsen or do not improve after 4 weeks.

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

-    In this leaflet Azelastine S 1 mg/ml Nasal Spray, Solution is called Azelastine S.

<[Legal status: To be completed nationally]>

In this leaflet:

1.    What Azelastine S is and what it is used for

2.    Before you use Azelastine S

3.    How to use Azelastine S

4.    Possible side effects

5.    How to store Azelastine S

6.    Further information

1. WHAT AZELASTINE S IS AND WHAT IT IS USED FOR

Azelastine S contains azelastine hydrochloride which belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of histamine that the body produces as part of an allergic reaction.

Azelastine S is used to treat allergic rhinitis in adults, adolescents and children 6 years and older. This is an allergic reaction to substances such as, for example, pollen, house dust mites or animal hair.

Usually it affects you by causing a runny nose, sneezing, itching or blocked nose. Azelastine S should help control these symptoms.

2. BEFORE YOU USE AZELASTINE S

Do not use Azelastine S if

- if you are allergic (hypersensitive) to azelastine hydrochloride or any of the other ingredients of Azelastine S (see section 6).

If this applies to you, talk to your doctor or pharmacist.

Check with your doctor, or pharmacist before using Azelastine S

- if you are taking any other medicines obtained without a prescription

Using other medicines

Azelastine S is not known to be affected by other medicines.

Pregnancy and breast-feeding

There are only limited information on the effects of Azelastine S on the unborn or breast fed child.

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

Driving and using machines

Azelastine S 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 S. In these cases, do not drive or operate machinery. Please be aware that drinking alcohol may enhance these effects.

3. HOW TO USE AZELASTINE S

Always use Azelastine S exactly as your doctor has told you. Azelastine S is for nasal use.

Important:

If you are not sure of the correct dose or how to use this medicine, ask your doctor or pharmacist. Adults and adolescents 12 years and older

•    The recommended dose is two applications in each nostril twice daily. This dose should not be exceeded.

Children 6 to 11 years:

•    One application in each nostril twice daily.

Azelastin S is not recommended for the use in children under 6 years of age due to a lack of data on safety and/or efficacy.

If possible, you should use Azelastine S regularly until your symptoms have disappeared. If you interrupt the use of Azelastine S your symptoms are likely to return.

Azelastine S is suitable for long-term use.

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 six times until an even spray emerges (Diagram 2). When Azelastine S Nasal Spray has not been used for three or more days, the pump must be pressed a sufficient number of times until a fine mist emerges.

4.    Spray once into each nostril keeping head upright. Do not tilt head backwards (Diagram 3).

If you use more Azelastine S than you should

If you spray too much Azelastine S into your nose you are unlikely to have any problems. If you are worried, contact your doctor.

If anyone, especially a child, accidentally drinks Azelastine S, contact your doctor or nearest hospital casualty department immediately.

If you forget to use Azelastine S

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 further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Azelastine S 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).

-    Uncommon (1 to 10 of 1,000 patients treated): Slight irritation of the inside of the nose (stinging, itching), sneezing and nose bleed.

-    Rare (1 to 10 of 10,000 patients treated): The unpleasant taste might cause you to feel sick.

-    Very rare (less than 1 of 10,000 patients treated): An allergic reaction, severe allergic reaction, rash, itching or nettlerash. Moreover, fatigue (weariness, exhaustion), dizziness weakness or a feeling of drowsiness can occur that may also be caused by the disease itself.

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 AZELASTINE S

Keep out of the reach and sight of children.

Do not use your spray after the expiry date given on the bottle label and the outer carton. The expiry date refers to the last day of the month.

Do not use longer than 6 months after first use.

Do not store the spray in the fridge or freezer.

Unused Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

6. FURTHER INFORMATION

What Azelastine S contains

The active substance is azelastine hydrochloride.

1 ml nasal spray contains 1 mg azelastine hydrochloride. Each squirt (0.14 ml) contains 0.14 mg azelastine hydrochloride equivalent to 0.13 mg azelastine.

The other ingredients are hypromellose, sucralose , liquid sorbitol (crystallising), disodium edetate, sodium citrate and purified water.

What Azelastine S looks like and contents of the pack

Azelastine S is a clear, colourless solution.

It comes in a brown glass bottle fitted with a spray pump. The 10 ml bottle contains 5 ml or 10 ml, the 20 ml bottle contains 17 ml, 20 ml or 22 ml fill volume of the nasal spray. Not all pack sizes may be marketed.

Marketing Authorisation Holder

<[To be completed nationally]>

Manufacturer

MEDA Pharma GmbH & Co. KG Benzstrasse 1 61352 Bad Homburg Germany

This medicinal product is authorised in the Member States of the EEA under the following names: This leaflet was last approved in {MM/YYYY}

PIL Var 5