BECLOMETASONE DIPROPIONATE 50 MICROGRAMS PER SPRAY AQUEOUS NASAL SPRAY
Active substance(s): BECLOMETASONE DIPROPIONATE / BECLOMETASONE DIPROPIONATE / BECLOMETASONE DIPROPIONATE
BECLOMETASONE DIPROPIONATE 50 MICROGRAMS
PER SPRAY AQUEOUS NASAL SPRAY
Contains 50 micrograms of Beclometasone Dipropionate per spray
Read all of this leaflet carefully before you start using this
• This medicine is available without prescription. However, you
still need to use Beclometasone Dipropionate aqueous nasal
spray carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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
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 Beclometasone
Dipropionate aqueous nasal spray.
3. How to use Beclometasone Dipropionate aqueous nasal spray.
4. Possible side effects.
5. 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 is a steroid. It is used for the
treatment and prevention of allergic rhinitis, including hayfever.
It acts by reducing the inflammation of your nose which may be
the cause of your sneezing, or an itchy, blocked or runny nose.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
BECLOMETASONE DIPROPIONATE AQUEOUS NASAL
Do not use Beclometasone Dipropionate aqueous nasal
• If you are allergic (hypersensitive) to Beclometasone
Dipropionate or any of the other ingredients of Beclometasone
Dipropionate. aqueous nasal spray (see Section 6 for all the
ingredients of this medicine).
• If you are under 18 years of age. Children or adolescents
under 18 years should discuss their hayfever treatment with a
pharmacist or doctor.
Warnings and precautions
Talk to your doctor or pharmacist before using Beclometasone
Dipropionate aqueous nasal spray.
• If you have kidney problems.
• If you have ever suffered from glaucoma (increased pressure
in the eye, eye pain or blurred vision).
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• If you are suffering from either a nose infection or sinus trouble.
• If you have recently had surgery or an injury to your nose or
ulcers in your nose.
• If you are taking or have recently been treated with other
corticosteroid medicines such as asthma inhalers, tablets,
injections, nasal sprays, eye or nose drops, creams or ointments.
• If you are taking any other medicines.
If you develop a rash or swelling, stop taking this
medicine and tell your doctor immediately.
Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant, intend to
become pregnant, or are breast-feeding, speak with your
doctor before using this medicine. Ask your doctor or
pharmacist for advice before using any medicine.
3. HOW TO USE BECLOMETASONE DIPROPIONATE
AQUEOUS NASAL SPRAY
Always use Beclometasone Dipropionate aqueous nasal spray
exactly as described in the leaflet.
Using this medicine (Adults aged 18 or over)
Beclometasone Dipropionate aqueous nasal spray is not to
be used by children or adolescents under 18 years of age.
The recommended dose is two sprays into each nostril twice a
day. The maximum daily dose is a total of eight sprays.
Use your nasal spray regularly for maximum relief. It may take
a few days for your medicine to work.
Do not exceed the dose stated in this leaflet.
Once your symptoms have improved, you may be able to reduce to
one spray into each nostril twice a day. However, if you notice that
your symptoms become worse you should increase the daily dose
to two sprays into each nostril twice a day. If your symptoms have
not improved after 14 days consult your doctor or pharmacist.
Do not use this product continuously for more than 3 months
without consulting your doctor or pharmacist.
If you are suffering from an allergy which also causes watery
or irritated eyes, you may need to consult your doctor or
pharmacist for some extra medication.
Method of administration
If you have any problems about using your nasal spray, ask
1. Remove the dust-cap. Shake the bottle gently.
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 it to
return to its original position. Repeat this action until a fine spray
appears. First five attempts to produce a spray should be allowed
to go to waste. Now the spray is ready to use.
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 the 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 step 3 and 4 to squirt a second spray in the same nostril.
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).
If you use more Beclometasone Dipropionate aqueous
nasal spray than you should contact your doctor
If you forget to use Beclometasone Dipropionate
aqueous nasal spray take a dose as soon as you remember.
If it is almost time for your next dose though, do not double the
dose, just carry on as before.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Beclometasone Dipropionate
aqueous nasal spray can cause side effects, although
not everybody gets them.
If you experience one of the following very rare serious
side effects, stop using Beclometasone Dipropionate
aqueous nasal spray and consult your doctor immediately:
• Swelling of your eyes, face, lips or throat.
• You develop a rash.
• Shortness of breath or wheezing.
• You start feeling faint.
Other side effects include:
• Irritation of the nose and throat.
• Unpleasant taste and smell.
• Nose bleeds.
• Raised intra-ocular pressure (increased pressure inside the
eye which may lead to problems with your eyes such as pain
or blurred vision).
• Glaucoma (eye disease affecting the optic nerve).
• A hole or perforation in the nasal septum (the skin tissue
which separates the nostrils).
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In some cases, particularly when Beclometasone Dipropionate
aqueous nasal spray has been used at high doses for long
periods the normal production of steroids in the body is
affected. This is more likely to happen if you use high doses
for a long time.
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 this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine
5. HOW TO STORE BECLOMETASONE DIPROPIONATE
AQUEOUS NASAL SPRAY
Keep out of the sight and reach of children.
Do not use Beclometasone Dipropionate aqueous nasal spray
after the expiry date which is stated on the label and carton.
The expiry refers to the last day of that month.
Discard the contents 3 months after first opening.
• Store below 25°C.
• Do not refrigerate.
• Protect from light.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Beclometasone Dipropionate aqueous nasal spray
The active substance is Beclometasone Dipropionate and each
spray contains 50 micrograms.
The other ingredients are dextrose anhydrous, polysorbate 80,
dispersible cellulose, benzalkonium chloride 95%,
phenylethanol and purified water.
Beclometasone Dipropionate aqueous nasal spray is supplied in a
white plastic (high density polyethylene) bottle fitted with a screw
on pump covered by a dustcap. The bottle provides 200 sprays.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation is held by Ayrton Saunders Ltd
9 Arkwright Road, Astmoor Industrial Estate, Runcorn,
Cheshire, WA7 1NU, UK
The medicine is made by Pharmaserve (North West) Ltd, 9
Arkwright Road, Astmoor Industrial Estate, Runcom, Cheshire.
For information in large print, audio CD or braille please
contact the Marketing Authorisation Holder.
This leaflet was revised September 2015.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.