Skip to Content

BETNESOL 0.1% W/V EAR EYE AND NOSE DROPS SOLUTION

Active substance(s): BETAMETHASONE SODIUM PHOSPHATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Ref: 1335/120515/1/F

®

Betnesol 0.1% w/v Ear, Eye and Nose Drops, solution
(bethamethasone sodium phosphate)
Patient Information Leaflet
Read all of this leaflet carefully before you start using this medicine
* 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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
Your medicine is called Betnesol 0.1% w/v Ear, Eye and Nose Drops,
solution but will be referred to as Betnesol Drops throughout the leaflet.
In this leaflet:
1 What Betnesol Drops are for
2 Before you take Betnesol Drops
3 How to use Betnesol Drops
4 Possible side effects
5 How to store Betnesol Drops
6 Further information

1

Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding ask your
doctor or pharmacist for advice before using Betnesol Drops. If you use this
medicine while pregnant, there may be a small risk of cleft palate or retarded
growth in the foetus.
Driving and using machines
Betnesol Drops may cause temporary blurred vision and light headedness. If
this happens to you, do not drive or use machinery until you return to
normal.
Warnings about the ingredients in Betnesol Drops
This medicine contains benzalkonium chloride as a preservative which may
cause skin reactions or eye irritation.
Avoid contact with soft contact lenses. Remove contact lenses prior to
application and wait at least 15 minutes before reinsertion. Benzalkonium
chloride is known to discolour soft contact lenses.

What Betnesol Drops are for

Betnesol Drops belong to a group of medicines called corticosteroids
(‘steroids’ for short).
Betnesol Drops work by reducing inflammation (redness, itching and
soreness). Betnesol Drops are used to treat inflammation of the eye, ear or
nose where there is no infection.
It is important to use this medicine to prevent any damage to the delicate
tissues of your eyes, ear or nose and to prevent any infection developing.

2

Taking other medicines
Tell your doctor if you are taking any other medicine, including medicines
obtained without a prescription.

Before you use Betnesol Drops

Important: Never use this medicine in your eye without first checking
with your doctor. If it is used for the wrong condition, it could lead to
blindness.
Do not use Betnesol Drops if:
* You are allergic to betamethasone
* You are allergic to any of the other ingredients of Betnesol Drops (listed in
section 6)
* You have not checked your eye condition with your doctor first. If this
medicine is used in your eye, for the wrong condition, it could lead to
blindness.
* You have an infection in the eye, or it is producing pus and is sticky
* You have ulcers in your eye (shingles)
* You have glaucoma (increased pressure in the eye)
* You have a perforated ear drum
* You wear soft contact lenses.
If any of the above applies to you talk to your doctor or pharmacist.
Check with your doctor before using Betnesol Drops if:
* You have been treated with Betnesol or similar corticosteroid drops
recently. You should not use corticosteroids for a long time without regular
medical check-ups from your doctor
* You have redness in your eyes for which you do not know the cause.
Steroid treatment must not be given unless the cause of the redness is
known
* You have an infection of the lining of your nose, which is not being treated
* You have recently had surgery on your nose which has not yet healed
* You have tuberculosis (TB).
* You have thinning of the cornea or sclera (the tissues which cover the
outer surface of the eye). Using these drops could lead to a hole in the
eyeball.
* You are giving this medicine to a baby. Using this medicine for a long time
in babies may cause the adrenal gland to stop working properly.
If any of the above applies to you, talk to your doctor or pharmacist.

3

How to use Betnesol Drops

Important: Your doctor will choose the dose that is right for you. Your
dose will be shown clearly on the label that your pharmacist puts on
your medicine. If it does not, or you are not sure, ask your doctor or
pharmacist.
Things to remember about your dose:
* Always use Betnesol exactly as your doctor has told you
* How often you use the drops will depend on how your body responds to
the treatment
* Use as few drops as possible for the shortest possible time.
Getting ready to use your medicine
Check that the seal on the bottle is not broken before using Betnesol Drops
for the first time. Wash and dry your hands. Do not breathe on or touch the
dropper nozzle.
Using your medicine
If there is no improvement in your symptoms after 7 days, stop using
the drops and see your doctor again.
Eyes
* The usual dose is 1 or 2 drops put into the eye every one or two hours
* Once the redness, itching and soreness starts to feel better, apply the
drops less often.
1. Tilt the head back
2. Gently pull lower eyelid downwards and outwards
3. Place drops in the gap between the lid and eye (squeeze bottle
very gently if necessary)
4. Blink a few times to spread out the drops
5. Repeat for the other eye if needed.
Medical check-ups
If you are using this medicine for your eyes and you use it for a number of
weeks, your doctor may ask you to have check-ups.
These are to make sure that your medicine is working properly and that the
dose you are taking is right for you. Your doctor will check your eyes for:
* An increase in pressure
* Cataracts
* Infection.
Ears
* The usual dose is 2 or 3 drops put into the ear every two or three hours
* Once the redness, itching and soreness starts to feel better, apply the
drops less often.
1. Tilt the head to one side
2. Place drops in the ear canal (squeeze bottle gently if necessary)
3. Keep head tilted for a minute or two to let the drops soak in
4. Repeat for the other ear if needed.

Ref: 1335/120515/1/B

®

Betnesol 0.1% w/v Ear, Eye and Nose Drops, solution
(bethamethasone sodium phosphate)
Patient Information Leaflet (continued)
Nose
The usual dose is 2 or 3 drops put into each nostril two or three times each
day.
1. Tilt head backwards
2. Place drops in nostril (squeeze bottle gently if necessary)
3. Keep head tilted and sniff gently to let the drops soak in
4. Repeat for other nostril if needed.
Medical check-ups
Your doctor will regularly check the growth of children who are taking
Betnesol by nose over a long period of time.
If you use more Betnesol Drops than you should
If you accidentally use too much Betnesol Drops it is unlikely to lead to any
serious side effects. However, if you are concerned, contact the nearest
hospital casualty department or your doctor.
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 forget to use Betnesol
Do not use a double dose to make up for a missed dose. Simply use the
next dose as planned.
How to stop using Betnesol Drops
Do not stop using Betnesol Drops without first talking to your doctor.
If you have been using Betnesol Drops for a long period of time (around 6 to
8 weeks), then you should stop using it gradually, to avoid the inflammation
coming back.
If you have any further questions about the use of this medicine, ask your
doctor or pharmacist.

4

Possible side effects

Like all medicines Betnesol Drops can cause side effects, although not
everybody gets them. These may include:
* Ulcers on the surface of the eye (cornea).
Tell your doctor if your eye becomes painful and if you have blurred vision
which does not improve after a few minutes
* Increased pressure in the eye (glaucoma) which can lead to problems
with your sight
* A hole in the eyeball (if you have a disease which cause thinning of the
surface of the eye)
* Cataracts (clouding of the lens of the eye)
* Enlarged pupils
* Drooping of the eyelid
* Swelling and redness of the outer surface of the eye
* Blurred vision and other alterations to your sight
* Itchy, red or irritated skin. This may not appear until sometime after you
have started to use the medicine
* A burning or stinging sensation on your skin. This may not appear until
sometime after you have started to use the medicine
If you are using Betnesol Drops for your nose, you may also experience
some of the following side effects:
* If you are a child, Betnesol Drops may slow your growth
* Difficulty breathing
* A hole or ulcers of the tissue that divides your nose (nasal septum)
* Irritation and dryness in the nose
* Sneezing
* Headache
* Light-headedness
* Rash
* Feeling sick
* Nosebleeds
* Blocked nose
* Changes in your senses of smell and taste.

Using too much of this medicine for a long time can prevent your adrenal
gland from working properly and producing your body’s own natural steroids
(known as adrenal suppression). This means that when you stop using
Betnesol Drops, you could experience the following effects:
* Low blood pressure which may make you feel faint
* Fever
* A runny nose
* Painful itchy skin
* Redness of the eye (conjunctivitis)
* Muscle and joint pain
* Weight loss.
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 Betnesol Drops

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use Betnesol Drops after the expiry date shown on the carton or
bottle label. If your doctor tells you to stop using the medicine, take any
remaining medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
The bottle should be disposed of 28 days after first opening, even if there is
solution remaining.
Avoid freezing.
Do not store above 25°C.
Keep in the original carton in order to protect from light.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via waterwaste 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 this medicine contains:
Each bottle contains betamethasone sodium phosphate 0.1% w/v.
The other ingredients are bezalkonium chloride solution,
disodium phosphate anhydrous, sodium chloride, disodium edetate,
sodium hydroxide, phosphoric acid and water for injections.
What this medicine looks like and contents of the pack
Betnesol Drops is an ear, eye and nose drops solution. It is a clear,
colourless aqueous solution.
Betnesol Drops come in 10 ml plastic bottles.
Manufacturer and Licence Holder
This medicine is manufactured by Excelvision, 27, rue de la Lombardiere, ZI
La Lombardiere, 07100 Annonay, France and is procured from within the EU
and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1335

Betnesol 0.1% w/v Ear, Eye
and Nose Drops, solution

Betnesol is a registered trademark of Celltech Pharma Europe Limited.
Revision date: 12/05/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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.

Hide