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Patient Information Leaflet: Betnesol 0.1 % w/w Eye Ointment
Betamethasone sodium phosphate

1. What Betnesol Ointment is for
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
• In this leaflet, Betnesol 0.1% w/w
Eye Ointment will be called
Betnesol Ointment
In this leaflet:
1. What Betnesol Ointment is for
2. Before you use Betnesol Ointment
3. How to use Betnesol Ointment
4. Possible side effects
5. How to store Betnesol Ointment
6. Further information.

Betnesol Ointment belongs to a group of
medicines called topical corticosteroids
(‘steroids’ for short).
Betnesol Ointment 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 Ointment is used to
treat inflammation of the eye where there is
no infection present.
It is important to use this medicine to prevent
any damage to the delicate tissues of your
eyes and to prevent any infection developing.

2. Before you use Betnesol Ointment
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 Ointment if:
• You are allergic to betamethasone
• You are allergic to any of the other
ingredients of Betnesol Ointment (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 Tuberculosis (TB)
If any of the above applies to you talk to
your doctor or pharmacist.
Check with your doctor before using
Betnesol Ointment if:
• You have been treated with Betnesol or
similar corticosteroid medicine recently.
You should not use corticosteroids for a
long time without regular medical checkups 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 thinning of the cornea or sclera
(the tissues which cover the outer surface
of the eye). Using this ointment 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 Ointment. 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 Ointment may cause temporary
blurred vision and light headedness. If this
happens to you, do not drive or use
machinery until you return to normal.

3. How to use Betnesol Ointment
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 Ointment exactly as
your doctor has told you
• Treatment should be with as little
ointment as possible for the shortest time.
Once you notice an improvement in your
condition, the number of times you use
the ointment should be reduced.
Getting ready to use your medicine
Check that the seal on the tube is not
broken before using Betnesol Ointment for
the first time. Wash and dry your hands.


Using your medicine
If you do not notice any improvement after
7 days, then, you should stop the treatment
and tell your doctor.

If you forget to use Betnesol Ointment
Do not use a double dose to make up for a
missed dose. Simply use the next dose as

Adults, the elderly and children
1. Tilt your head backwards.
2. Look up and squeeze approximately 1/4
inch of the ointment below the lower lid,
2 or 3 times daily and/or at night.
3. Close your eyes
4. After use, always replace the cap on the

How to stop using Betnesol Ointment
Do not stop using Betnesol Ointment
without first talking to your doctor.
If you have been using Betnesol Ointment
for a long period of time (around 6 to 8
weeks), then you should stop using it
gradually, to avoid the inflammation coming
If you have any further questions about the
use of this medicine, ask your doctor or

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.
If you use more Betnesol Ointment than you
If you accidentally use too much Betnesol
Ointment 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 tube (up to 3g) is unlikely to lead to any
serious adverse events.

4. Possible side effects
Like all medicines Betnesol Ointment can
cause side effects, although not everybody
gets them. These may include:
• Sensitivity reactions, which may not
appear until some time after you have
started to use the ointment, include
irritation, burning, stinging and itching,
and inflammation.
• Increased pressure in your eye
(glaucoma), which may lead to problems
with your sight. This medicine may cause
ulceration of the front part of the eye (the
cornea). Tell your doctor if your eye
becomes painful and/or you have blurred
vision which does not get better after a
few minutes.

• Using the ointment in the eye very often
or for a long time may cause cataracts
(clouding of the lens of the eye). Enlarged
pupils, drooping of the eyelids or
inflammation of the outer surface of the
eye may also occur.
• Some diseases cause thinning of parts of
the eye, corticosteroid treatment of these
diseases can lead to perforation.
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

What Betnesol Ointment looks like
Betnesol Ointment comes in a collapsible
tube with an application nozzle and a plastic
cap. It contains 3g of ointment.

5. How to store Betnesol Ointment

This leaflet was last updated April 2010.

Keep out of the reach and sight of children.
Do not use Betnesol Ointment after the
expiry date on the label. The expiry date
refers to the last day of that month.
The tube should be disposed of 28 days
after first opening, even if there is medicine
Store Betnesol Ointment below 30oC.
Medicines should not be disposed of via
wastewater or household waste. Return any
medicine you no longer need to your

Marketing Authorisation Holder
RPH Pharmaceuticals AB, Lagervägen 7,
136 50 Haninge, Sweden.
Erfa, Rue des Cultivateurs 25,
Landbouwerrsstraat 25, Bruxelles 1040,
Brussels, Belgium.

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.

6. Further information
What Betnesol Ointment contains
The active substance is betamethasone
sodium phosphate at a concentration of
The other ingredients are white soft paraffin
and liquid paraffin.


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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.