Betamethasone-N Drops
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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
f>. 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 Imedicines 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
-r 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, breastfeeding or trying to become pregnant.
Do not use in your ears if:
• you have a hole in your ear drum
Ilf any of the above apply to you or your child Iplease 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 howto use Vistamethasone I 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, consultyour 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 m ust 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
f>. Pull the lower lid of the eye out to form a small pocket between your eyelid and your eye.
7. Hold the container between the thumband middlefinger 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
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.
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.—
• 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
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
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.
-\En—Replace the outer cap on the bottle, trying— not to touch the applicator tip with anything, including yourfingers
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
Make sure the container is properly closed after I
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
not to touch the applicator tip with anything, including yourfingers 5. Wash your hands
Ilf 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.
Ilf you have swallowed or you suspect someone else has swallowed any, contact your doctor or Ipharmacist.
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—
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 j-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
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