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BETNESOL-N EYE EAR AND NOSE DROPS

Active substance(s): BETAMETHASONE SODIUM PHOSPHATE / NEOMYCIN SULPHATE

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Read all of this leaflet carefully before you
start using this medicine.
•  eep this leaflet. You may need to read it
K
again.
•  f you have any further questions, ask your
I
doctor or pharmacist.
•  his medicine has been prescribed for you.
T
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
•  n this leaflet, Betnesol-N Eye, Ear & Nose
I
Drops will be called Betnesol-N Drops.
In this leaflet:
1. What Betnesol-N Drops is for
2. Before you use Betnesol-N Drops
3. How to use Betnesol-N Drops
4. Possible side effects
5. How to store Betnesol-N Drops
6. Further information.

Betnesol-N Drops belongs to a group of
medicines called topical corticosteroids
(‘steroids’ for short).
Betnesol-N Drops work by reducing
inflammation
(redness,
itching
and
soreness). Topical means that they are
used on the outside of the body and not
taken by mouth or injection. Betnesol-N
Drops also contain neomycin sulphate, an
aminoglycoside antibiotic, which prevents
bacterial infection developing. Betnesol-N
Drops is used to treat inflammation of the
eye, ear or nose when there may also be a
risk of bacterial 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. Before you use Betnesol-N 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-N Drops if:
• You are allergic to betamethasone
•  ou are allergic to any of the other
Y
ingredients of Betnesol-N Drops (listed in

section 6)
•  ou have not checked your eye condition
Y
with your doctor first. If this medicine is
used in your eye, for the wrong condition,
it could lead to blindness.
•  ou have an infection in the eye, or it is
Y
producing pus and is sticky
• You have an infection in the ear or nose
• You have ulcers in your eye (shingles)
•  ou have glaucoma (increased pressure in
Y
the eye)
• You wear soft contact lenses
• You have a perforated ear drum.
If any of the above applies to you talk to
your doctor or pharmacist.
Check with your doctor before using
Betnesol-N Drops if:
•  ou have been treated with Betnesol-N
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drops or similar corticosteroid medicine
recently. You should not use corticosteroids
for a long time without regular medical
checkups from your doctor
•  ou have redness in your eyes for which
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you do not know the cause. Steroid
treatment must not be given unless the
cause of the redness is known
•  ou have an infection of the lining of your
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nose, which is not being treated
•  ou have recently had surgery on your
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nose which has not yet healed

• You have tuberculosis (TB)
•  ou have thinning of the cornea or sclera
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(the tissues which cover the outer surface
of the eye) Using these drops could lead to
a hole in the eyeball
•  ou are giving this medicine to an infant.
Y
Prolonged use in babies may cause the
adrenal gland to stop working properly
•  ou are applying these drops to open
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wounds or damaged skin. The antibiotic
component can cause permanent, partial
or total deafness if used on open wounds
or damaged skin. This possibility should
be borne in mind if high doses are given to
small children or infants.
If any of the above applies to you talk to
your doctor or pharmacist.
Taking other medicines
Tell your doctor if you are taking any other
medicine, including medicines obtained
without a prescription.
Pregnancy and breastfeeding
If you are pregnant, trying to become
pregnant or breastfeeding ask your doctor
or pharmacist for advice before using
Betnesol-N Drops. If you use these drops
while pregnant there may be small risk of
damage to the ear, cleft palate or retarded
growth in the foetus.

Driving and using machines
Betnesol-N Drops may cause temporary
blurred vision and lightheadedness. If
this happens to you, do not drive or use
machinery until you return to normal.
Warnings about the ingredients in
Betnesol-N 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.

3. How to use Betnesol-N 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:
•  lways use Betnesol-N exactly as your
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doctor has told you
•  ow often you use the drops will depend
H
on how your body responds to the
treatment
•  se as few drops as possible for the
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shortest possible time.

Getting ready to use your medicine
Check that the seal on the bottle is not
broken before using Betnesol-N Drops for
the first time. Wash and dry your hands. Do
not breathe on or touch the dropper nozzle
and do not touch the eyes, ear or nose with
the dropper nozzle.
If there is no improvement in your symptoms
after 7 days, stop using the drops and see
your doctor again.
Using your medicine

Eyes
•  he usual dose is 1 or 2 drops put into the
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eye up to 6 times each day
•  nce the redness, itching and soreness
O
starts to feel better, apply the drops less
often.
1. Tilt the head back
2.  ently pull lower eyelid downwards and
G
outwards
3.  lace drops in the gap between the lid
P
and eye (squeeze bottle very gently if
necessary)
4.  link a few times to spread out the drops
B
5. Repeat for the other eye if needed.
Medical checkups
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.

23293301

Patient Information Leaflet: Betnesol-N Eye, Ear & Nose Drops Solution 0.1% w/v
Betamethasone sodium phosphate 0.5% w/v Neomycin sulphate

1. What Betnesol-N Drops are for

Ears
•  he usual dose is 2 or 3 drops put into the
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ear three or four times each day
•  nce the redness, itching and soreness
O
starts to feel better, apply the drops less
often.
1. Tilt the head to one side
2.  lace drops in the ear canal (squeeze bottle
P
gently if necessary)
3.  eep head tilted for a minute or two to let
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the drops soak in
4. Repeat for other ear if needed.

Nose
The usual dose is 2 or 3 drops put into each
nostril two or three times each day.
1.Tilt head backwards
2.  lace drops in nostril (squeeze bottle
P
gently if necessary)
3.  eep head tilted and sniff gently to let the
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drops soak in
4. Repeat for other nostril if needed.

Medical checkups
Your doctor will regularly check the growth
of children who are taking Betnesol-N by
nose over a long period of time.
If you use more Betnesol-N Drops than you
should
If you accidentally use too much Betnesol-N
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.
Accidental swallowing of the contents of one
bottle (up to 10 ml) is unlikely to lead to any
serious adverse events.
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 symptons worse.
If you forget to use Betnesol-N
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-N Drops
Do not stop using Betnesol-N Drops without
first talking to your doctor.
If you have been using Betnesol-N 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-N Drops can
cause side effects, although not everybody
gets them. These may include:
•  lcers on the surface of the eye (cornea).
U
Tell your doctor if your eye becomes painful
and if you have blurred vision which does
not improve after a few minutes
•  ncreased pressure in the eye (glaucoma)
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which can lead to problems with your sight
•  hole in the eyeball (if you have a disease
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which causes thinning of the surface of the
eye)
•  ataracts (clouding of the lens of the eye)
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• Enlarged pupils
• Drooping of the eyelid
•  welling and redness of the outer surface
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of the eye
•  lurred vision and other alterations to your
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sight
•  tchy, red or irritated skin. This may not
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appear until sometime after you have
started to use the medicine
•  burning or stinging sensation on your
A
skin. This may not appear until sometime
after you have started to use the medicine

•  ugs may become resistant to the antiB
biotic if using the drops for a long time.
If you are using Betnesol-N Drops for your
nose, you may also experience some of the
following side effects:
•  f you are a child, Betnesol-N Drops may
I
slow your growth
• Difficulty breathing
•  hole or ulcers of the tissue that divides
A
the nose (nasal septum)
• Irritation and dryness in the nose
• Sneezing
• Headache
• Lightheadedness
• Itching
• Feeling sick
• Nosebleeds
• Blocked nose
•  hanges in the senses of smell and taste.
C
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-N Drops, you
could experience the following effects:
•  ow blood pressure which may make you
L
feel faint
• Fever
• A runny nose

• Painful itchy skin
• Redness of the eye (conjunctivitis)
• Muscle and joint pain
• Weight loss.
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.

5. How to store Betnesol-N Drops
Keep out of the reach and sight of children.
Do not use Betnesol-N Drops after the
expiry date on the label. The expiry date
refers to the last day of that month.
The bottle should be disposed of 28 days
after first opening, even if there is solution
remaining.
Store Betnesol-N Drops below 25ºC and in
the original carton to protect it from light.
Do not freeze.
Medicines should not be disposed of via
wastewater or household waste. Return
any medicine you no longer need to your
pharmacist.

6. Further information
What Betnesol-N Drops contains
The active substance is betamethasone
sodium phosphate at a concentration of
0.1% w/v. Betnesol-N Drops also contain
neomycin sulphate at a concentration

on 0.5% w/v. The other ingredients are
benzalkonium chloride, disodium edetate,
polyethylene glycol 300, sodium formate,
anhydrous sodium sulphate, disodium
hydrogen phosphate anhydrous, sodium acid
phosphate, sodium hydroxide or phosphoric
acid and water for injections.
What Betnesol-N Drops looks like
Betnesol-N Drops is a colourless to pale
yellow liquid.
Betnesol-N Drops comes in 5 ml or 10 ml
plastic bottles with a built-in nozzle and a
tamper evident plastic cap.
Marketing Authorisation Holder
RPH Pharmaceuticals AB Lagervägen 7, 136
50 Haninge, Sweden.
Manufacturer
Excelvision, 27, rue de la Lombardière,
ZI La Lombardière, 07100 Annonay.
Distributed by Focus Pharmaceuticals Ltd.
This leaflet was last updated in August 2012.
If this leaflet is difficult to see or read or
you would like it in a different format,
please contact RPH Pharmaceuticals AB
Lagervägen 7, 136 50 Haninge, Sweden.

23293301

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:
1. An increase in pressure
2. Cataracts
3. Infection.

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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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