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BETNESOL 0.1% W/W EYE OINTMENT

Active substance(s): BETAMETHASONE SODIUM PHOSPHATE

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

770NO12

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

Betamethasone Ointment belongs to a group
of medicines called topical corticosteroids
(‘steroids’ for short).
Betamethasone 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. Betamethasone 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 Betamethasone
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 Betamethasone Ointment if:
• You are allergic to betamethasone
• You are allergic to any of the other
ingredients of Betamethasone 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
Betamethasone Ointment if:
• You have been treated with
Betamethasone or similar corticosteroid
medicine 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 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
Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription.
Some medicines may increase the effects of
Betamethasone Ointment 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, trying to become
pregnant or breast-feeding ask your doctor
or pharmacist for advice before using
Betamethasone Ointment. If you use
Betamethasone Ointment while pregnant
there may be small risk of damage to the ear,
cleft palate or retarded growth in the foetus.
Driving and using machines
Betamethasone 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.
Warnings about visual problems when using
Betamethasone Ointment
Contact your doctor if you experience
blurred vision or other visual disturbances.

3. How to use Betamethasone
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 Betamethasone 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.
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Getting ready to use your medicine
Check that the seal on the tube is not broken
before using Betamethasone Ointment for
the first time. Wash and dry your hands.
Using your medicine
To open tube:
Unscrew and remove the upper screw cap to
reveal a pointed nozzle. Unscrew the main
cap and use the nozzle to pierce the metal
seal on the tube. Replace the main cap onto
the tube and squeeze out the ointment as
required. Replace the small screw cap after
use.
If you do not notice any improvement after 7
days, then, you should stop the treatment
and tell your doctor.
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
tube
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 Betamethasone Ointment

than you should
If you accidentally use too much
Betamethasone 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.
If you forget to use Betamethasone Ointment
Do not use a double dose to make up for a
missed dose. Simply use the next dose as
planned.
How to stop using Betamethasone Ointment
Do not stop using Betamethasone Ointment
without first talking to your doctor.
If you have been using Betamethasone
Ointment 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 Betamethasone 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.
• Blurred vision.
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 Yellow
Card Scheme on the MHRA website
(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 Betamethasone
Ointment
Keep out of the sight and reach of children.
Do not use Betamethasone 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
remaining.
Store Betamethasone Ointment below 30ºC.

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 Betamethasone Ointment contains
The active substance is betamethasone
sodium phosphate at a concentration of
0.1%w/w.
The other ingredients are white soft paraffin
and liquid paraffin.
What Betamethasone Ointment looks like
Betamethasone Ointment comes in a
collapsible tube with an application nozzle
and a plastic cap. It contains 3g of ointment.
Marketing Authorisation Holder
RPH Pharmaceuticals AB, Lagervägen 7, 136
50 Jordbro, Sweden.
Manufacturer
BePharBel Manufacturing SA, Rue des
Cultivateurs, 25, Bruxelles 1040, Belgium.
This leaflet was last updated October 2017.

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
Jordbro, Sweden.

770NO12

Par MTR , 17:51, 31/10/2017
32-42 Station Road

TECHNICAL SUPPORT APPROVAL

Heaton Mersey, Stockport
Cheshire. SK4 3QT

SIGNATURE

Product Description/Component
Betamethasone 0.1% w/w Eye Ointment Leaflet
(UK) - 770NO12 Version 2
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150 (h) mm x 250 (w) mm
Size folded
150 mm x 31.25 mm
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1. 31/10/2017
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770NO10

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8pt
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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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