Alanase Aqueous Nasal Spray Consumer Medicine Information

100 mcg per actuation
Beclomethasone Dipropionate

What is in this leaflet

Please read this leaflet carefully before using Alanase 100 Aqueous Nasal Spray. It answers some common questions about Alanase. 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 Alanase is used for and how it works

This nasal spray contains 100mcg beclomethasone dipropionate per actuation.

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.

Alanase 100 is normally used to prevent and treat seasonal and perennial allergic rhinitis (including hayfever) and vasomotor rhinitis. It works by reducing the swelling and irritation in the lining of the nose. It relieves the symptoms of blocked nose, runny nose, itchy nose and sneezing.

Alanase 100 may also be used to delay the recurrence of nasal polyps in patients who have undergone nasal polypectomy. It can suppress the increase in size of the polyps that do recur.

Your doctor, however, may prescribe Alanase 100 for another purpose. Alanase 100 is only available on prescription from your doctor.

There is no evidence that Alanase is addictive.

Before you use Alanase

When you must not use it

Do not use Alanase if:

• You are allergic to beclomethasone or any other ingredients listed at the end of this leaflet.

Before you start to use it

Tell your doctor if:

• You are taking other steroids by mouth or inhalation (including some asthma prevention inhalers).
• You have had to stop taking another medicine for your hayfever.
• You have had recent nasal septal ulcers, nasal surgery or trauma.
• You have an infection or thrush in your nose.
• You bleed easily or get frequent nose bleeds.
• You are pregnant, might become pregnant or are breast feeding.

How to use Alanase 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, close one nostril and carefully insert the nasal applicator into the other nostril.
   
   
4. Holding the bottle upright, press firmly downwards once on the white collar. Breathe gently inwards through the nostril.
   
   
5. Then breathe out through your mouth.
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 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.

How much to use

The usual dosage for adults and children over 6 years of age is one spray into each nostril twice daily (morning and night).

Your doctor may tell you to use a different dosage to this. If so, follow their instructions.

Do not use more sprays or spray more often than your doctor tells you to. You should not use more that 400 mcg in a day.

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

Alanase should be shaken before use.

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

How long to use it

It usually takes a few days for this medicine to help your nasal symptoms.

If you know you are going to be allergic to, for example, pollen at a particular time of the year, it is helpful to start using your spray just before your symptoms appear to prevent them from starting.

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

Continuous long term treatment of children is not recommended. Do not use Alanase for more than 6 months unless instructed by your doctor.

If you forget a dose

If you forget a dose, just take the next dose at the normal time. Do not take a double dose. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

Side effects

Alanase will not cause drowsiness.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Alanase. Alanase helps most people with rhinitis, 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 Alanase 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.

You may sneeze a little immediately after using your spray. You may notice a taste or smell after using your spray.

If your nose or throat becomes dry and irritated or you have a nosebleed after using your spray, tell your doctor as soon as possible.

If you have red eyes or misty vision and headache after using your spray, tell your doctor immediately.

If you think you are having an allergic reaction to Alanase, 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/mouth.
• Difficulty in breathing.
• Hayfever.
• Lumpy rash (hives).
• Fainting.
• Itchiness.

Tell your doctor immediately if you have developed signs and 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.

Studies have shown that beclomethasone dipropionate may cause growth reduction in children.

Other rare side effects have been reported, which your doctor can advise you about. If you have symptoms, which you think may be due to your spray, talk to your doctor or pharmacist.

If you use too much (overdose)

You should only use the number of sprays that you have been told. If you accidentally use a little more Alanase on one occasion, it is unlikely to cause a problem.

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 Alanase. 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.

Storage conditions

Keep Alanase in a place where children cannot reach it. Keep the bottle in an upright position.

Do not put your Alanase in the refrigerator.

Keep your Alanase away from bright sunlight and heat (store below 25°C). Do not leave it in the car on hot days.

Do not use this medicine after the expiry date shown on the label or if the packaging shows signs of tampering.

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

When you stop using Alanase or it is past the 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 spray contains 100 micrograms of the active ingredient beclomethasone dipropionate.

The liquid also contains benzalkonium chloride, phenethyl alcohol, polysorbate, dispersible cellulose, glucose (anhydrous) and purified water.

If you want to know more

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

Date of information

August 2004
(Based on datasheet 23 April 2004)