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BECLOMETHASONE HAYFEVER RELIEF NASAL SPRAY

Active substance(s): BECLOMETHASONE DIPROPIONATE / BECLOMETHASONE DIPROPIONATE

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PACKAGE LEAFLET

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Beclometasone Dipropionate Aqueous Nasal Spray, 50 micrograms per spray
(by OLS Actavis)
(beclometasone diproprionate)

Read all of this leaflet carefully because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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 or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1.
What Beclometasone is and what it is used for
2.
Before you use Beclometasone
3.
How to use Beclometasone
4.
Possible side effects
5.
How to store Beclometasone
6.
Further information
1.

WHAT BECLOMETASONE 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.
Beclometasone 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 BECLOMETASONE

Do not use Beclometasone 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.
Take special care with Beclometasone:
You should tell your doctor before taking this medicine:
• if you are you suffering from either a nose infection or sinus trouble
• 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.
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Contact your doctor if you experience blurred vision or other visual disturbances.
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
Some medicines may increase the effects of Beclometasone and your doctor may wish to monitor you
carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Pregnancy and breast-feeding
If you are pregnant, might become pregnant or are breast-feeding, speak to your doctor before taking
Beclometasone. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Beclometasone will not affect your ability to drive and use machines.
3.

HOW TO USE BECLOMETASONE

Dosage for Adults (including the elderly)
You will need to use the Beclometasone 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 Beclometasone 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.

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).
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).

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).

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Children
Children under 18 years of age should not use Beclometasone.
If you use more Beclometasone 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 Beclometasone
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 Beclometasone
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, Beclometasone can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Beclometasone and tell your doctor immediately:
Rare (may affect up to 1 in 1,000 people)
• cataract, raised pressure in the eye and glaucoma (an eye condition which can damage your sight
causing blurred or loss of vision).
• sores on the lining of the nose and a small hole in the partition between the two nostrils may occur.
Very rare (may affect up to 1 in 10,000 people)

severe allergic reaction such as swelling of the face, lips and/or throat, causing difficulty breathing or
swallowing.
Other possible side effects
Common (may affect up to 1 in 10 people)

rash, including hives, itching or red skin
Rare (may affect up to 1 in 1,000 people)




dryness and irritation of the nose and throat
an unpleasant taste and smell, which can occur immediately after use
a small nose bleed, which will usually stop quickly.

Very rare (may affect up to 1 in 10,000 people)

shortness of breath, wheezing
Not known (frequency cannot be estimated from the available data)

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)
• a slowing of the rate of growth in children and adolescents.

It is important to follow the instructions given in this leaflet.
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Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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

Keep out of the reach and sight of children.
Do not use Beclometasone 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

What Beclometasone 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 Beclometasone 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
Beclometasone for 200 sprays.
Marketing Authorisation Holder
Generics [UK] Ltd t/a Mylan
Station Close
Potters Bar
Herts
EN6 1TL
United Kingdom

Date of revision: June 2017

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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.

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