INFORMATION FOR CONSUMERS

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Consumer Medicine Information

NASACLEAR

50 mcg per actuation
Fluticasone propionate Nasal Spray

What is in this leaflet

Please read this leaflet carefully before using Nasaclear Nasal Spray. It answers some common questions about Nasaclear. It does not contain all the information available on this medicine. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. If you have concerns about using this medicine ask your doctor or pharmacist.
Keep this leaflet, you may need to read it again.

What NASACLEAR is used for and how it works

Nasaclear contains fluticasone propionate, which reduces tissue inflammation or swelling.

It belongs to a group of medicines known as corticosteroids, frequently referred to as 'steroids'. They are not 'anabolic steroids' that are sometimes misused by athletes.

Nasaclear is normally used to prevent and relieve allergies including hayfever. It works by reducing swelling inside your nose. It relieves the symptoms of blocked nose, runny nose, itchy nose and sneezing. This makes breathing easier.

Nasaclear is available from your pharmacist although you may have been prescribed Nasaclear by your doctor.

Nasaclear is not addictive.

In most cases, Nasaclear will control your allergy symptoms, however, in some instances you may need additional therapy, especially to control eye symptoms.

Before you use NASACLEAR

When you must not use it

Do not use Nasaclear if:

• You are allergic to fluticasone propionate or any other ingredients listed at the end of this leaflet.
• You are pregnant, trying to become pregnant or are breastfeeding, unless your doctor or pharmacist says you should.
• The expiry date on the pack has passed.
• The packaging is torn or shows signs of tampering.

Before you start to use it

Tell your doctor or pharmacist if:

• You have an infection in your nose or sinuses.
• You have ulceration in your nose.
• You have had recent nasal surgery.
• You have been treated with steroid injections, taken steroid tablets, or use a steroid inhaler for asthma.
• You are allergic to foods, dyes, preservatives or any other medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may affect the way other medicines work. Your doctor or pharmacist will be able to tell you what to do when using Nasaclear with other medicines.

How to use NASACLEAR properly

Instructions for use

1. Shake the bottle well before use. Remove the dust cap from the nasal applicator.
   
   
2. Hold the nasal spray as shown. Prime the pump by firmly pressing downwards on the white collar. Repeat until a fine spray is produced. The nasal spray is now ready for use. It will not require repriming unless infrequently used or disassembled.
   
   
3. Gently blow your nose to clear the nostrils. Tilt your head forward slightly, closing off one nostril as shown. Hold the bottle upright and carefully insert the applicator into your other nostril.
   
   
4. Slowly begin to breathe in through your nose, and whilst doing so press down firmly on the white collar to produce a fine spray inside your nose. Breathe out through your mouth.
   
   
5. Repeat step 4 to squirt a second spray into the same nostril. Remove the nozzle from this nostril.
6. Repeat the procedure in the other nostril.
7. Replace the dust cap.

Cleaning your applicator

Your nasal applicator should be cleaned at least once a week, or more often if it gets blocked. To clean, remove the dust cap, press gently upwards on the white collar and the nasal applicator will come free. Wash the applicator and dust cap under lukewarm water. Dry and replace.

If the nasal applicator becomes blocked, remove the dust cap, unscrew the pump mechanism from the bottle and soak it in warm water for a few minutes. Rinse under lukewarm water, dry and reassemble on the bottle. Do not attempt to unblock the applicator with a pin or other sharp object.

You must use your spray for your nose only. If you find it difficult to use your spray, tell your doctor or pharmacist.

Nasaclear should be shaken gently before use.

How much to use

Nasaclear is not recommended for use in patients under 12 years of age.

The usual dosage for adults and children over 12 years of age is two sprays into each nostril once a day, preferably in the morning, unless your doctor or pharmacist tells you otherwise.

Your doctor or pharmacist will advise you what to do if only one nostril is affected.

Do not use more sprays or spray more often than your doctor or pharmacist tells you to. The maximum amount of sprays per day must not be more than 2 sprays into each nostril (200mcg).

How long to use it

You may not feel the maximum benefit from your medicine straight away, but it is important that you continue to use it regularly. It may take a few days until you get maximum relief from your medicine.

Continue to use Nasaclear regularly for as long as your doctor or pharmacist tells you to.

If your symptoms do not improve within 7 days of treatment, see your doctor.

Do not use Nasaclear for more than 6 months unless instructed by your doctor or pharmacist.

If you forget a dose

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use the product as soon as you remember, then go back to using the product as you would normally.

Do not use a double dose to make up for the dose that you missed. If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

While you are using NASACLEAR

Things you must do

Seek medical attention if you develop signs or symptoms of infection such as:

• Fever, nasal or facial pain or swelling
• Purulent (i.e. pus-containing) or discoloured nasal discharge
• Bleeding from the nose
• Acute eye pain or visual disturbance.

Tell your doctor or pharmacist that you are using Nasaclear if you are about to be started on any new medicines.

Tell your doctor or pharmacist if, for any reason, you have not used your medicine exactly as instructed. Otherwise, your doctor or pharmacist may think that it was not effective and change your treatment unnecessarily.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use Nasaclear to treat any other complaints unless your doctor or pharmacist says to.

Side effects

Nasaclear will not cause drowsiness.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Nasaclear. Nasaclear helps most people with allergies, but it may have unwanted side effects in a few people. These effects are usually mild and last only for a short time.

Like other medicines Nasaclear may cause some side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

The most commonly reported side effects are:

• Sneezing
• Irritation or dryness in the nose or throat
• Bad taste or smell
• Nose bleed
• Skin rash
• Swelling of the face or tongue.

Rare side effects include:

• Wheezing and shortness of breath
• Breakdown of tissue inside the nose (nasal septal perforation).

If any of these side effects persist, or are troublesome, see your doctor or pharmacist.

If you think you are having an allergic (hypersensitivity) reaction to Nasaclear, TELL YOUR DOCTOR IMMEDIATELY or go to the Accident and Emergency Department at your nearest hospital. Symptoms usually include some or all of the following:

• Wheezing
• Swelling of the lips or mouth
• Difficulty in breathing
• Hayfever
• Lumpy rash (hives)
• Fainting.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Other rare -side effects have been reported, which your doctor can advise you about. Tell your doctor or pharmacist if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask you doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

If you use too much (overdose)

You should only use the number of sprays that you have been told.

Immediately contact your doctor, pharmacist or the National Poisons Information Centre (0800 POISON or 0800 764 766) for advice, or go to the Emergency department at your nearest hospital, if you think that you or anyone else has used too much Nasaclear. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your doctor or pharmacist.

Storage conditions

Keep Nasaclear in a place where young children cannot reach it. Keep the bottle in an upright position. A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.

Do not put your Nasaclear in the refrigerator.

Heat and dampness can destroy some medicines. Keep your Nasaclear away from direct sunlight and heat (store below 30°C). Do not leave it in the car or on window sills on hot days. Do not store it in a bathroom or near a sink.

Keep your product in its pack until it is time to use it. If you take the product out of its packaging it may not keep well.

Once you have opened your spray, you should not use this particular bottle for more than three months. Write down the date that you opened the bottle on the label or the box.

Disposal

If you stop using Nasaclear or the product has passed its expiry date, ask your pharmacist what to do with any that is left over.

List of ingredients

Your medicine is in the form of a liquid nasal spray in a glass bottle, which delivers an accurate measured spray. Each bottle provides approximately 120 sprays, when used as recommended. Each spray contains 50 micrograms of the active ingredient fluticasone propionate.

The liquid also contains microcrystalline cellulose/carboxymethylcellulose sodium, benzalkonium chloride, phenethyl alcohol, polysorbate, hydrochloric acid, dextrose (anhydrous) and purified water.

If you want to know more

Should you have any questions regarding this product, please contact your doctor or pharmacist.

Who supplies this medicine

Distributed in New Zealand by:

Mylan New Zealand Ltd,
P O Box 11183,
Ellerslie,
Auckland.

Freephone: 0800 168 169

Date of information

2 February 2009
(Based on datasheet 2 February 2009)