Nasofan® Aqueous 50 microgram Nasal Spray, Suspension

(fluticasone propionate)

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.

Your medicine is available using the above name but it will be referred to as 'Nasofan Nasal Spray' throughout this package leaflet.

What is in this leaflet:

1.    What Nasofan Nasal Spray is and what it is used for

2.    What you need to know before you use Nasofan Nasal Spray

3.    How to use Nasofan Nasal Spray

4.    Possible side effects

5.    How to store Nasofan Nasal Spray

6.    Contents of the pack and other information

1. WHAT NASOFAN NASAL SPRAY IS AND WHAT IT IS USED FOR

Your medicine contains 50 micrograms of the active ingredient, fluticasone propionate, in each spray. Fluticasone propionate is one of a group of medicines known as corticosteroids.

Nasofan Nasal Spray has anti-inflammatory properties. When sprayed into your nose it will reduce swelling and irritation. It is used to prevent and treat seasonal allergic rhinitis (e.g. hayfever) and perennial rhinitis (e.g. blocked or runny nose and sneezing and itching caused by house dust mites or animals such as cats and dogs). It can be used by adults and children aged 4 years and older.

2. BEFORE YOU USE YOUR NASOFAN NASAL SPRAY

Do not use Nasofan Nasal Spray:

•    if you are allergic to 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

Nasofan Nasal Spray:

•    if you have ever had an operation to your nose

•    if you are suffering or have recently suffered from an infection of the nasal airways

•    if you are suffering or have recently suffered from any type of untreated infection or from tuberculosis or ocular herpes

•    if you have recently been treated with injected steroids, or you have been taking oral steroids for a long time.

Nasofan Nasal Spray will usually control seasonally

allergy rhinitis (hay fever) however if you are

exposed to excessive amounts of pollen additional

therapy may be helpful for controlling other symptoms such as itching eyes. Please consult your doctor in such an event.

Other medicines and Nasofan Nasal Spray

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Some medicines can interfere with Nasofan Nasal Spray, in particular tell your doctor or pharmacist if you are taking:

•    Any medicines used in the treatment of fungal infections (e.g. ketoconazole)

•    Any antiviral medicine such as those used to treat HIV infection (e.g. ritonavir)

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 taking this medicine.

Driving and using machines

The medicinal product has no or negligible influence on the ability to drive and use machines.

Nasofan Nasal Spray contains benzalkonium chloride solution

Nasofan Nasal Spray contains the ingredient benzalkonium chloride solution (40 micrograms per delivered dose) which is an irritant and may cause skin reactions. If used for longer periods, the preservative benzalkonium chloride may cause nasal mucosa swelling. In case of such a reaction (persistently congested nose) medicinal products for nasal use without preservative should be used if possible. It may also cause bronchospasm. Unless such products are available another pharmaceutical form should be taken. It may also cause bronchospasm.

Once your symptoms are under control your doctor may reduce your dose to one spray into each nostril once a day. If the use of such a reduced dose signals a worsening in your symptoms, your dose may be increased back to the starting dose.

Children aged 4 to 11 years:

For children aged between 4-11 years old the dose is normally one spray in each nostril once a day, preferably in the morning. Your doctor may increase this to a maximum of one spray into each nostril twice a day.

This product is not suitable for children under 4 years old.

Your doctor will prescribe the lowest dose of Nasofan Nasal Spray capable of effectively controlling your symptoms.

It may take a few days for this medicine to work. Do not stop using your medicine unless you are told to by a doctor.

You must not take a larger dose, or use your Nasofan Nasal Spray more often, than is prescribed by your doctor. It is important not to use more of your medicine than your doctor has told you to.

If your eyes remain itchy or watery as a result of hayfever despite using this medicine tell your doctor. He/she may be able to give you another medicine to treat your eye symptoms.

Before you use your nasal spray

Your Nasofan Nasal Spray has a dust cap that protects the nozzle and keeps it clean - this must be taken off prior to using the spray and then replaced after use.

If you have not used your Nasofan Nasal Spray for 7 days prime until a fine mist is produced.

If after attempting to prime the bottle the spray still does not work and you think it may be blocked you may clean the spray using the following procedure:-

Cleaning your nasal spray

1.    Remove the dust cap.

2.    Pull the white collar upwards to remove the nozzle.

3.    Place the nozzle and dust cap in warm water and soak for a few minutes, and then rinse by placing under a running tap.

4.

Shake off the excess water and allow the nozzle and dust cap to dry in a warm (not hot) place.

5.    Re-fit the nozzle.

6.    'Prime' the bottle as necessary by pumping the spray a few times until a fine mist is produced.

•    You should clean your nasal spray at least once a week to stop it from getting blocked up. Additional cleaning is required when your spray becomes blocked.

•    You must NEVER attempt to unblock or enlarge the spray hole with a pin or other sharp object because this will destroy the spray mechanism.

3. HOW TO USE NASOFAN NASAL SPRAY

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is as follows:

Adults (including the elderly) and children aged 12 years and older:

When you first start using Nasofan Nasal Spray you normally take two sprays in each nostril once a day, preferably in the morning. Your doctor may increase this to a maximum of two sprays into each nostril twice a day.

When your Nasofan Nasal Spray is new the bottle must be primed as follows:-1. Shake the bottle gently and then remove the dust cap.

Using your nasal spray

1.    Shake the bottle and remove the dust cap.

2.    Gently blow your nose.

2. Hold the bottle upright with your thumb under the bottle and your index finger and middle finger on either side of the nozzle. Ensure that the nozzle is pointing away from you when you do this.

3.    Press down with fingers in order to pump the spray.

4.    Repeat steps 2 and 3 until a further five times -the bottle is now primed.

3.    Close one nostril by pressing your finger against it and place the nozzle of the spray in your other nostril. Tilt your head forward slightly so that the bottle is kept upright.

4.    Breathe in slowly through your open nostril and, at the same time, press the collar of the nozzle down firmly with your fingers to squirt a spray of fine mist into your nostril.

5.

6.

7.

Nasofan® Aqueous 50 microgram Nasal spray, Suspension

(fluticasone propionate)

Fluticasone propionate 50 micrograms Aqueous Nasal Spray,

Suspension

(fluticasone propionate)

Package Leaflet: Information for the user

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.

Your medicine is available using the above name but it will be referred to as 'Fluticasone propionate Nasal Spray' throughout this package leaflet.

What is in this leaflet:

1.    What Fluticasone propionate Nasal Spray is and what it is used for

2.    What you need to know before you use Fluticasone propionate Nasal Spray

3.    How to use Fluticasone propionate Nasal Spray

4.    Possible side effects

5.    How to store Fluticasone propionate Nasal Spray

6.    Contents of the pack and other information

1.    WHAT FLUTICASONE PROPIONATE NASAL SPRAY IS AND WHAT IT IS USED FOR

Your medicine contains 50 micrograms of the active ingredient, fluticasone propionate, in each spray. Fluticasone propionate is one of a group of medicines known as corticosteroids.

Fluticasone propionate Nasal Spray has antiinflammatory properties. When sprayed into your nose it will reduce swelling and irritation. It is used to prevent and treat seasonal allergic rhinitis (e.g. hayfever) and perennial rhinitis (e.g. blocked or runny nose and sneezing and itching caused by house dust mites or animals such as cats and dogs). It can be used by adults and children aged 4 years and older.

2.    BEFORE YOU USE YOUR FLUTICASONE PROPIONATE NASAL SPRAY

Do not use Fluticasone propionate Nasal Spray:

•    if you are allergic to fluticasone propionate or any of theother ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Fluticasone propionate Nasal Spray:

•    if you have ever had an operation to your nose

•    if you are suffering or have recently suffered from an infection of the nasal airways

•    if you are suffering or have recently suffered from any type of untreated infection or from tuberculosis or ocular herpes

•    if you have recently been treated with injected steroids, or you have been taking oral steroids for a long time.

Fluticasone propionate Nasal Spray will usually control seasonally allergy rhinitis (hay fever)

however if you are exposed to excessive amounts of pollen additional therapy may be helpful for controlling other symptoms such as itching eyes. Please consult your doctor in such an event.

Other medicines and Fluticasone propionate Nasal Spray

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Some medicines can interfere with Fluticasone propionate Nasal Spray, in particular tell your doctor or pharmacist if you are taking:

•    Any medicines used in the treatment of fungal infections (e.g. ketoconazole)

•    Any antiviral medicine such as those used to treat HIV infection (e.g. ritonavir)

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 taking this medicine.

Driving and using machines

The medicinal product has no or negligible influence on the ability to drive and use machines.

Fluticasone propionate Nasal Spray contains benzalkonium chloride solution

Fluticasone propionate Nasal Spray contains the ingredient benzalkonium chloride solution (40 micrograms per delivered dose) which is an irritant and may cause skin reactions. If used for longer periods, the preservative benzalkonium chloride may cause nasal mucosa swelling. In case of such a reaction (persistently congested nose) medicinal products for nasal use without preservative should be used if possible. It may also cause bronchospasm. Unless such products are available another pharmaceutical form should be taken. It may also cause bronchospasm.

3. HOW TO USE FLUTICASONE PROPIONATE NASAL SPRAY

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is as follows:

Adults (including the elderly) and children aged 12 years and older:

When you first start using Fluticasone propionate Nasal Spray you normally take two sprays in each nostril once a day, preferably in the morning. Your doctor may increase this to a maximum of two sprays into each nostril twice a day.

Once your symptoms are under control your doctor may reduce your dose to one spray into each nostril once a day. If the use of such a reduced dose signals a worsening in your symptoms, your dose may be increased back to the starting dose.

Children aged 4 to 11 years:

For children aged between 4-11 years old the dose is normally one spray in each nostril once a day, preferably in the morning. Your doctor may increase this to a maximum of one spray into each nostril twice a day.

This product is not suitable for children under 4 years old.

Your doctor will prescribe the lowest dose of Fluticasone propionate Nasal Spray capable of effectively controlling your symptoms.

It may take a few days for this medicine to work. Do not stop using your medicine unless you are told to by a doctor.

You must not take a larger dose, or use your Fluticasone propionate Nasal Spray more often, than is prescribed by your doctor. It is important not to use more of your medicine than your doctor has told you to.

If your eyes remain itchy or watery as a result of hayfever despite using this medicine tell your doctor. He/she may be able to give you another medicine to treat your eye symptoms.

Before you use your nasal spray

Your Fluticasone propionate Nasal Spray has a dust cap that protects the nozzle and keeps it clean -this must be taken off prior to using the spray and then replaced after use.

If you have not used your Fluticasone propionate Nasal Spray for 7 days prime until a fine mist is produced.

If after attempting to prime the bottle the spray still does not work and you think it may be blocked you may clean the spray using the following procedure:-

Cleaning your nasal spray

1.    Remove the dust cap.

2.    Pull the white collar upwards to remove the nozzle.

3.    Place the nozzle and dust cap in warm water and soak for a few minutes, and then rinse by placing under a running tap.

4.

Shake off the excess water and allow the nozzle and dust cap to dry in a warm (not hot) place.

5.    Re-fit the nozzle.

6.    'Prime' the bottle as necessary by pumping the spray a few times until a fine mist is produced.

•    You should clean your nasal spray at least once a week to stop it from getting blocked up. Additional cleaning is required when your spray becomes blocked.

•    You must NEVER attempt to unblock or enlarge the spray hole with a pin or other sharp object because this will destroy the spray mechanism.

When your Fluticasone propionate Nasal Spray is new the bottle must be primed as follows:-

1.    Shake the bottle gently

and then remove the dust cap

2.    Hold the bottle upright with your thumb under the bottle and your index finger and middle finger on either side of the nozzle.

Ensure that the nozzle is pointing away from you when you do this.

Using your nasal spray

1.    Shake the bottle and remove the dust cap.

2.    Gently blow your nose.

3.

Close one nostril by pressing your finger against it and place the nozzle of the spray in your other nostril. Tilt your head forward slightly so that the bottle is kept upright.

3.    Press down with fingers in order to pump the spray.

4.    Repeat steps 2 and 3 until a further five times -the bottle is now primed.

4. Breathe in slowly through your open nostril and, at the same time, press the collar of the nozzle down firmly with your fingers to squirt a spray of fine mist into your nostril.

5.

6.

7.

Fluticasone propionate 50 micrograms Aqueous Nasal

Spray, Suspension

(fluticasone propionate)

Package Leaflet: Information for the user