BETAMETHASONE-N DROPS

Active substance: NEOMYCIN SULPHATE

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D01521

Vistamethasone N Drops for Eye, Ear and Nose
(Betamethasone N Drops)
TM

Betamethasone Sodium Phosphate 0.1%w/v
Neomycin Sulphate 0.5%w/v
Read all of this leaflet carefully before you
start using this medicine. It contains important
information.
• 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.
• 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.

In this leaflet:
1. What Vistamethasone N Drops are and what
they are used for
2. Before you use Vistamethasone N Drops
3. How to use Vistamethasone N Drops
4. Possible side effects
5. How to store Vistamethasone N Drops
6. Further information

1. What Vistamethasone N Drops
are and what they are used for
Vistamethasone N Drops contains Betamethasone
Sodium Phosphate which belongs to a group of
medicines called corticosteroids. These are used to
relieve redness and swelling.
They also contain Neomycin Sulphate which
belongs to a group of medicines known as
antibiotics. These are used to treat bacterial
infections
Vistamethasone N Drops are used to treat redness
and swelling of infected eyes, nose and ears.

2. Before you use Vistamethasone N
Drops
Do not use Vistamethasone N Drops if:
• you are allergic (hypersensitive) to
Betamethasone Sodium Phosphate, Neomycin
Sulphate or to any of the other ingredients of
this medicine, which are listed in section 6 of
this leaflet
Do not use in your eyes if :
• you have a viral infection of the eye
• you have a fungal infection of the eye
• you have a bacterial infection of the eye
known as tuberculosis or ‘TB’
• you have an eye infection that is producing pus
• you suffer from raised pressure in your eye(s)
(glaucoma)
• you have an undiagnosed red eye(s)
• you are pregnant, breast feeding or trying to
become pregnant.
Do not use in your ears if:
• you have a hole in your ear drum
If any of the above apply to you or your child
please tell your doctor or pharmacist before using
this medicine.
Take special care with Vistamethasone N Drops
• Do not use Vistamethasone N Drops for a
prolonged period of time (more than 7 days) as
this may cause serious side effects, particularly
in children.
• Take special care when using in small children or
infants, one of the active ingredients (Neomycin
Sulphate) can cause hearing loss

If you are unsure about how to use Vistamethasone
N Drops talk to your doctor or pharmacist.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without
a prescription, before you use this medicine.
If you have any doubts about whether this
medicine is suitable for you, consult your doctor or
pharmacist.
Pregnancy and breast-feeding
This medicine should be avoided if you are
pregnant, trying to become pregnant or breastfeeding. Ask your doctor for advice before taking
any medicine.
Driving and using machines
Vistamethasone N Drops can cause temporary
blurring of vision after application to the eye. Wait
until your vision is clear before driving or using
machines.

Important information about some of the
ingredients of Vistamethasone N Drops
This medicine contains thiomersal which in
rare cases, can cause redness, itching and
swelling in the eye area. If you are affected,
stop using Vistamethasone N Drops and
contact your doctor or pharmacist as soon
as possible.

3. How to use Vistamethasone N
Drops
Always use Vistamethsone N Drops exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
How much to use
For adults, the elderly and children
For use in the eye:
The usual starting dose is one or two drops to be
put into the eye every two hours. Your doctor may
reduce the dose once the condition of your eye
has begun to improve.
For use in the ear:
The usual starting dose is two or three drops put
into the ear every three to four hours. Your doctor
may reduce the dose once the condition of your
ear has begun to improve.
For use in the nose:
The usual dose is two or three drops into each
nostril twice daily or as required.
Instructions for use in the eye
If you wear soft contact lenses they must be
removed before treatment with Vistamethasone
N Drops.
1. Before opening a new bottle of Vistamethasone
N Drops, please check that the safety strip on
the bottom of the outer cap is unbroken.
2. Twist the outer cap to break the seal.
3. Wash your hands well before use.
4. Remove the outer cap. If you are putting in the
drops yourself you should use a mirror.
5. Tilt your head back and look up at the ceiling.
Continued overleaf

Pull the lower lid of the eye out
to form a small pocket between
your eyelid and your eye.
Hold the container between the
thumb and middle finger of the
other hand, turn the bottle
upside down near to your eye, try not to touch
your eye with the nozzle.
8. Apply enough pressure to the container to
release one to two drops, as directed by your
doctor.
9. Blink your eye a few times.
10. If you think that you have missed your eye,
then insert another drop.
11. Repeat steps 5-10 for the other eye, if you have
been told to use Vistamethasone N Drops in
both eyes.
12. Replace the outer cap on the bottle, trying
not to touch the applicator tip with anything,
including the eye or your fingers.
13. Wash your hands.
Instructions for use in the ear
1. Wash your hands well before use
2. Remove the outer cap on the bottle
3. Insert the nozzle into the affected ear and
apply drops as advised by your doctor
4. Repeat steps 1-3 in the other ear, if you have
been told to use Vistamethasone N Drops in
both ears
5. Replace the outer cap on the bottle, trying
not to touch the applicator tip with anything,
including your fingers
6. Wash your hands
Instructions for use in the nose
1. Wash your hands well before use
2. Remove the outer cap on the bottle
3. Tilt your head back and pour into each nostril
drop by drop
4. Replace the outer cap on the bottle, trying
not to touch the applicator tip with anything,
including your fingers
5. Wash your hands
If you are unsure about how to use Vistamethasone
N Drops talk to your doctor or pharmacist.
If you use more Vistamethasone N Drops than
you should
Prolonged use of Vistamethasone N Drops is not
recommended.
If you are at all concerned that you have used too
much of this medicine contact your doctor or
pharmacist.
Vistamethasone N Drops are for external use only.
If you have swallowed or you suspect someone
else has swallowed any, contact your doctor or
pharmacist.
If you forget to use Vistamethasone N Drops
If you have just missed taking your dose and it
is a long time until your next dose is due, put in
the missed dose now and continue the course of
treatment. If it is near the time for taking your next
dose wait and take this dose at the correct time.
Do not take a double dose to make up for one you
have missed.
If you stop using Vistamethasone N Drops
You should keep using Vistamethasone N Drops for
as long as your doctor has asked. Your treatment
is helping your condition, even if you have not
noticed a difference in how you feel. Should you
need to stop your treatment, your doctor will
advise you how to do this.

4. Possible side effects
Like all medicines, Vistamethasone N Drops can
cause side effects, although not everybody gets
them.
Possible side effects include:
• irritation, burning, itching and stinging in
the area. This may occur after treatment has
stopped.
• raised pressure in the eye (only when used in the
eye) which may damage the optic nerve causing
poor vision.
Where you suffer from a disease (other than that
for which you are using Vistamethasone N Drops)
that causes thinning of the surface of the eye,
serious damage may be caused.
Prolonged use of this medicine can lead to
cloudiness of the lens of the eye (cataracts); it
is therefore advised that the lens of the eye is
checked frequently during use of this medicine.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store Vistamethasone N
Drops
Keep all medicines out of the reach and sight of
children.
Make sure the container is properly closed after
each use.
Store Vistamethasone N Drops in the original
container away from direct light. Store below 25°C.
Do not use Vistamethasone N Drops after the
expiry date which is printed on the label. The
expiry date refers to the last day of that month.
Dispose of this medicine four weeks after opening.
Medicines should not be disposed of via waste
water 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 Vistamethasone N Drops contain
The active substances are betamethasone sodium
phosphate 0.1%w/v and neomycin sulphate
0.5%w/v.
The other ingredients are disodium hydrogen
orthophosphate, thiomersal and purified water.
What Vistamethasone N Drops look like and
contents of the pack
Vistamethasone N Drops are a clear, colourless
and sterile solution supplied in a plastic dropper
bottle with a cap. Each bottle contains 5 or 10ml of
the solution.
Marketing Authorisation Holder and
Manufacturer
Martindale Pharmaceuticals Ltd, Bampton Road,
Harold Hill, Romford, Essex, RM3 8UG. UK
If you would like any more information, or
would like the leaflet in a different format,
please contact Medical Information at the above
address.
PL 00156/0084
This leaflet was last updated March 2011

D01521

Package leaflet: information for the user

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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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