Some people may suffer side effects from small amounts of the steroid being absorbed into the body. This is more likely if you are on a high dose or use the spray for a long time. Possible side effects are:

•    facial puffiness, increased body fat and thinning of the skin weight gain, rounded (moon-shaped) face and high blood pressure (Cushing's syndrome or Cushingoid features)

•    cataract (symptoms are blurred vision and difficulty seeing)

•    glaucoma (an eye condition in which the pressure of fluid in the eye might be high, which can damage your sight causing blurred or loss of vision)

•    a slowing of the rate of growth in children and adolescents. The frequency of these side effects is unknown.

It is important to follow the instructions given in this leaflet.

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

5.    HOW TO STORE POLLENASE HAYFEVER NASAL SPRAY

Keep out of the reach and sight of children. Do not use Pollenase Hayfever Nasal Spray after the expiry date which is stated on the label after 'EXP'. The expiry date refers to the last day of that month. Do not store above 25°C. Protect from light and do not refrigerate. Once opened, you should not keep your medicine for longer than 3 months. After three months, you should replace it even if it has not all been used up. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

PACKAGE LEAFLET: INFORMATION FOR THE USER

POLLENASE HAYFEVER NASAL SPRAY

(Beclometasone Diproprionate)

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to take Pollenase Hayfever Nasal Spray 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 10 days.

•    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:

1.    What Pollenase Hayfever Nasal Spray is and what it is used for.

2.    Before you use Pollenase Hayfever Nasal Spray.

3.    How to use Pollenase Hayfever Nasal Spray.

4.    Possible side effects.

5.    How to store Pollenase Hayfever Nasal Spray.

6.    Further information.

1. WHAT POLLENASE HAYFEVER NASAL SPRAY IS AND WHAT IT IS USED FOR

Beclometasone belongs to a group of medicines called corticosteroids (commonly called steroids). Corticosteroids are used to reduce inflammation.

What Pollenase Hayfever Nasal Spray contains - The active substance is beclometasone diproprionate. Each individual spray will contain 50 microgrammes of beclometasone diproprionate. The other ingredients are anhydrous dextrose, polysorbate 80, dispersible cellulose, benzalkonium chloride 95%, phenylethanol and purified water.

What Pollenase Hayfever Nasal Spray looks like and contents of the pack -

Each nasal spray consists of a small brown glass bottle with a plastic nasal applicator. It contains enough Pollenase Hayfever Nasal Spray for 200 sprays.

Marketing Authorisation Holder: Generics [UK] Ltd, Potters Bar, Herts EN6 1TL, United Kingdom.

Distributed by: Peach Pharmaceuticals Unit 24, Chalwyn Industrial Estate, Old Wareham Road, Parkstone, Poole, Dorset, BH12 4PF.

Pollenase Hayfever Nasal Spray is used to relieve the symptoms of allergies (e.g. hayfever) such as sneezing, itchy nose and eyes or a blocked or runny nose by reducing the inflammation in the lining of your nose (rhinitis). Hayfever usually occurs in early summer and is caused by an allergy to pollen from plants and trees.

This medicine should not be confused with anabolic steroid tablets or injections, which may be misused by some athletes.

2. BEFORE YOU USE POLLENASE HAYFEVER NASAL SPRAY

Do not use Pollenase Hayfever Nasal Spray if:

•    you are allergic (hypersensitive) to beclometasone or any of the other ingredients of this medicine (see Section 6 for a list of other ingredients)

•    you are under 18 years old.

This leaflet was last approved in: July 2011

10003368 LE1635/01

Take special care with Pollenase Hayfever Nasal Spray

You should tell your doctor before taking this medicine:

• if you are you suffering from either a nose infection or sinus trouble

Continued over the page

•    if you have recently had nasal surgery, if you have recently injured your nose or if you have ulcers in your nose

•    if you are taking steroid tablets

•    if you were previously being treated with a steroid injection or have taken steroid tablets for a long time, as you may notice a worsening of your symptoms.

It may take a few days before you notice an improvement in your symptoms. It is therefore important to use your nasal spray regularly.

Taking other medicines - Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

3.    To use the spray, first blow your nose gently. Closing one nostril off as shown, bend your head forward slightly. Hold the bottle upright and carefully insert the applicator into your other nostril (figure 3).

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 (figure 4).

5.    Repeat steps 3 and 4 to squirt a second spray in the same nostril.

Cleaning - Wash the nozzle frequently with warm water. This will prevent it from getting blocked. If the pump has not been used for a short period of time, re-priming may be necessary (see Step 2 above).

Pregnancy and breast-feeding - If you are pregnant, might become pregnant or are breast-feeding, speak to your doctor before taking Pollenase Hayfever Nasal Spray. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines - Pollenase Hayfever Nasal Spray will not affect your ability to drive and use machines.

3. HOW TO USE POLLENASE HAYFEVER NASAL SPRAY

Dosage for Adults (including the elderly)

You will need to use the Pollenase Hayfever Nasal Spray regularly.

•    Squirt two sprays into each nostril twice a day, every morning and evening.

•    Once you start to feel better, a single spray into each nostril twice a day may be enough to control your hay fever.

Do not use more often than 8 sprays in 24 hours. If you feel no better after 10 days consult your doctor. You should not use Pollenase Hayfever Nasal Spray continuously for longer than 3 months without consulting a doctor.

Normal Use

1.Remove the dust-cap and lock-ring (if fitted). Shake the bottle gently (figure 1).

2.On first using the nasal spray, prepare for use by pressing down on the white collar using both your index and middle fingers. Keep the base supported with your thumb (figure 2). Continue to press down until the collar stops and then allow to return to its original position. Repeat this action until a fine spray appears. The first five attempts to produce a spray should be allowed to go to waste. Now the spray is ready to use.

Children - Children under 18 years of age should not use Pollenase Hayfever Nasal Spray.

If you use more Pollenase Hayfever Nasal Spray than you should - It is

important that you take your dose as stated on the pharmacist's label or as advised by your doctor. You should use only as much as your doctor recommends; using more or less may make your symptoms worse. If you accidentally take too much of your medicine tell your doctor.

If you forget to use Pollenase Hayfever Nasal Spray - Take the next dose when it is due. Do not take a double dose to make up for a forgotten dose.

If you stop using Pollenase Hayfever Nasal Spray - Speak to your doctor first before stopping this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Pollenase Hayfever Nasal Spray can cause side effects, although not everybody gets them. If any of the following happen, stop taking Pollenase Hayfever Nasal Spray and tell your doctor immediately:

•    commonly, allergic reactions causing skin rashes, and very rarely, swelling of the face, lips and/or throat, difficulty breathing

•    rarely, cataract, raised pressure in the eye and glaucoma (an eye condition which can damage your sight causing blurred or loss of vision).

•    rarely, sores on the lining of the nose and a small hole in the partition between the two nostrils may occur.

Other common side effects are dryness and irritation of the nose and throat, and an unpleasant taste and smell, which can occur immediately after use. i_{Continljed over} Also, you may notice a small nose bleed, which will usually stop quickly. [_ fhepage|