Beclometasone Dipropionate Aqueous Nasal Spray
PACKAGE LEAFLET: INFORMATION FORTHE USER
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I (Beclometasone dipropionate)
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Read all ofthis leaflet carefully before you start [taking this medicine because it contains important information for you.
|* Keep this leaflet. You may need to read it again.
L If you have any further questions, ask your I doctor or pharmacist or nurse.
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,
I pharmacist or nurse. This includes any side i effects not listed in this leaflet. See section 4.
^hat is in this leaflet:
1. What Beclometasone Dipropionate Aqueous Nasal Spray is and what it is used for
2. What you need to know before you use I Beclometasone Dipropionate Aqueous
Nasal Spray
3. How to use Beclometasone Dipropionate Aqueous Nasal Spray
4. Possible side effects
l5. How to store Beclometasone Dipropionate
, Aqueous Nasal Spray
6. Contents of the pack and other information
1. WHAT BECLOMETASONE DIPROPIONATE AQUEOUS NASAL SPRAY IS AND WHAT IT IS USED FOR
Beclometasone Dipropionate Aqueous Nasal Spray contains a medicine called beclometasone
plipropionate. This belongs to a group of medicines called steroids (also called 'cortico-steroids').
rashes or a runny nose. These reactions may have, been disguised by your previous medication. You should consult your doctor.
Other medicines and Beclometasone Dipropionate Aqueous Nasal Spray
Talk to your doctor or pharmacist if you are taking, I have recently taken or might take any other i
medicines.
Pregnancy and breast-feeding
There is a very small risk of abnormalities in babiesl whose mothers have taken Beclometasone .
Dipropionate during pregnancy. '
You should discuss with your doctor whether you i should take this medicine during pregnancy. They may advise you to take the lowest dose that will control your symptoms for a short period of time. Similarly, this medicine may be passed on to babies through breast milk by mothers taking , Beclometasone Dipropionate Aqueous Nasal 1
Spray. You should discuss with your doctor using 1 this medicine while you are breast-feeding.
Driving and using machines
Using Beclometasone Dipropionate Aqueous Nasall Spray should not affect your ability to drive or , operate machinery. If however, you do feel affected1 when you have taken this medicine, you should noti drive or operate machinery until you feel better.
Beclometasone Dipropionate Aqueous Nasal Spray contains benzalkonium chloride I
This may cause problems with your breathing 1 (bronchospasm).
Steroids work by reducing inflammation. They reduce swelling and irritation in your nose which helps to relieve itching, sneezing and your blocked or runny nose.
3. HOW TO USE BECLOMETASONE
DIPROPIONATE AQUEOUS NASAL SPRAY
Beclometasone Dipropionate Aqueous Nasal |Spray is used to prevent and treat:
• Inflammation in the lining of your nose (rhinitis)
I due to seasonal allergies, such as Hayfever.
• Inflammation in the lining of your nose (rhinitis) due to year round (perennial) allergies, such as animal allergies.
Always use Beclometasone Dipropionate Aqueous Nasal Spray exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Maximum benefit is produced after a few days of regular use. This medicine should be used regularly to maintain its efficacy. Your dose may be altered by your doctorwhen your symptoms have improved.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BECLOMETASONE DIPROPIONATE AQUEOUS NASAL SPRAY
Do not take Beclometasone Dipropionate ^queous Nasal Spray ifyou:
• Are allergic (hypersensitive) to beclometasone dipropionate or any of the other ingredients of , this medicine (see section 6).
Adults and children over 6 years of age:
Usual dose: 2 sprays (equivalent to 100 micrograms) into each nostril twice a day.
Do not take more than 8 sprays (4 sprays per nostril) or 400 micrograms (200 micrograms per nostril) in any 24 hour period.
Long term use of topical corticosteroids should be avoided.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before |using this medicine if:
• You are already taking another steroid I medicine
• You have a cold or an infection in your nose L You have had nasal surgery
[• You have pulmonary tuberculosis.
|lf this medicine has been prescribed in replacement of an oral steroid product and your condition gets worse, you develop a severe infection, you are injured or if you are going to nave an operation you should talk to your doctor [before using it. They may prescribe a short course of treatment with an oral anti-inflammatory steroid in addition to the nasal spray. During this change overfrom an oral steroid to this nasal spray you may develop allergic reactions including skin
How to Use Beclometasone Dipropionate Aqueous Nasal Spray
Each spray has a dust cap which protects the nozzle and keeps it clean. Remember to take this off before using the spray.
A new spray (or one that has not been used for a few days), may not work first time. You need to 'prime' the spray by pumping the spray a few times until a fine mist is produced.
1. Hold the bottle upright, and make sure it is pointed away from you
2. Put your forefinger and middle finger on the collar either side of the nozzle and put your thumb underneath the bottle
3. Keep your thumb still, and press down with your fingers to pump the spray. You may need to do this 4-5 times.
ft the spray does not work and you think it may be blocked, you will need to clean it. Please see the section Cleaning your spray.
Using your spray
ll Shake the bottle vigorously up and down and
1 take off the dust cap.
2 Holding the spray away from your nostril i breathe out through your nose.
3 Close one nostril with your finger and put the nozzle in the other nostril. Tilt your head forward slightly and keep the bottle upright.
k Start to breathe in slowly through your nose.
I While you are breathing in press down firmly on the collar with your fingers. A spray of fine mist will go into your nostril.
5 Remove the nozzle from your nostril and slowly breathe out through your mouth.
.6 Repeat step 4 to use a second spray in the I same nostril.
i7 Remove the nozzle from this nostril and breathe out through your mouth.
|8 Repeat steps 3to5 for your other nostril.
9 After using your spray, wipe the nozzle carefully with a clean tissue or handkerchief, and , replace the dust cap.
Cleaning your spray
'it is very important to keep the plastic cap and |nozzle clean, to prevent any build up of powder. Washing the applicator regularly (weekly) is recommended.
Tell your doctor as soon as possible if you notice any of the following: Common (affects less than 1in10 people)
• A dryor painful nose or throat
• Bad nose bleeds.
Very rare (affects less than 1 in 10,000 people)
• Problems with your eyes such as painL or blurred vision
• Damage to your nose.
Very rarely, the normal production ofsteroids in your body may be affected. This is more likely to happen if you use high doses for a long time. Your doctorwill help stop this happening by making sure you use the lowest dose of steroid which controls your symptoms. In children this side effect can rarely cause them to grow more slowly than others. Children who receive this treatment for a long period of time will have their height checked regularly by their doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the leaflet. You can also report any side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can provide more information on the safety of this medicine.
1 Take the dust cap off.
|2 Pull upwards on the white collar to remove the nozzle.
|3 Soak the nozzle and dust cap in warm water for a few minutes.
k Then rinse under a running tap.
,5 Shake off the excess water and let them dry in 1 a warm place.
|6 Put the nozzle back on the spray.
7 You need to 'Prime' the bottle as described in the section above before using again
llfyou use more Beclometasone Dipropionate Aqueous Nasal Spray than you should
Tell your doctor if you use more than you were told
felt 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 pour symptoms worse.
|lfyou forget to use Beclometasone Dipropionate Aqueous Nasal Spray
llfyou have forgotten to take a dose, this should not be a problem. Skip the missed dose and take your next dose at the normal time. Do not take twice the jusual dose to make up for the missed dose. If you have trouble remembering when to take your |medicine, tell your doctor or pharmacist.
5. HOW TO STORE BECLOMETASONE
DIPROPIONATE AQUEOUS NASAL SPRAY
Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.
Do not store above 30°C. Store in the original package.
In case of any visible signs of deterioration, you should discard the package.
Medicines should not be disposed ofvia waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.
Keep out of the sight and reach of children
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Beclometasone Dipropionate Aqueous Nasal Spray contains:
Each spray contains 50 micrograms of beclometasone dipropionate.
The other ingredients are: anhydrous glucose, microcrystalline cellulose, sodium carboxymethylcellulose, polysorbate 80, phenylethyl alcohol, benzalkonium chloride solution and purified water.
llfyou stop using Beclometasone Dipropionate Aqueous Nasal Spray
Do not stop using Beclometasone Dipropionate ^queous Nasal Spray without consulting your doctor first as your condition may deteriorate
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them.
What Beclometasone Dipropionate Aqueous Nasal Spray looks like and contents ofthe pack
Beclometasone Dipropionate Aqueous Nasal Spray is an aqueous suspension used for intranasal inhalation via a metered dose atomising pump.
Beclometasone Dipropionate Aqueous Nasal Spray is available in a glass or HDPE vial fitted with a metering pump and nasal applicator. They are provided in packs of 1.
Severe allergic reactions may occur rarely. The ^igns may include swelling of your face or throat, shortness of breath or wheezing and skin rashes. If this happens, tell your doctor straight away |you may need urgent medical treatment.
(Immediately after you use your spray
• You may sneeze a little , but this will quickly I stop
.• Very occasionally you may find you get an unpleasant taste or smell.
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer
Lagap Pharmaceuticals Limited WoolmerWay, Bordon Hampshire, GU35 9QE United Kingdom
This leaflet was last revised in July 2015.