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

Active substance(s): BETAMETHASONE SODIUM PHOSPHATE

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1. 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. 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.
Taking other medicines
Tell your doctor if you are taking any
other medicine, including medicines
obtained without a prescription.
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 lightheadedness. 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.

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.

23292701

Patient information Leaflet: Betnesol Eye, Ear & Nose Drops Solution 0.1% w/v
Bethamethasone sodium phosphate

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.
• In this leaflet, Betnesol Eye, Ear & Nose
Drops will be called Betnesol Drops.
In this leaflet:
1. What Betnesol Drops are for
2. Before you use Betnesol Drops
3. How to use Betnesol Drops
4. Possible side effects
5. How to store Betnesol Drops
6. Further information.

• 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.

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.

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 Drops
Keep out of the reach and sight of children.
Do not use Betnesol 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 Drops below 25°C 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 Drops contain
The active substance is betamethasone
sodium phosphate at a concentration of
0.1%.
The other ingredients are bezalkonium
chloride solution, disodium hydrogen

phosphate anhydrous, sodium chloride,
disodium edetate, sodium hydroxide (E524),
phosphoric acid and water for injections.
What Betnesol Drops look like
Betnesol Drops is an eye, ear and nose drops
solution. It is a clear, colourless liquid.
Betnesol Drops come 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.

23292701

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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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