Vistamethasone Drops
Package leaflet : information for the user
Betamethasone Drops
Betamethasone Sodium Phosphate
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 Betamethasone Drops are and what they are used for
2. Before you use Betamethasone Drops
3. How to use Betamethasone Drops
4. Possible side effects.
5. How to store Betamethasone Drops
6. Further information.
1. What Betamethasone Drops are and what they are used for
Betamethasone Drops contain Betamethasone Sodium Phosphate which belongs to a group of medicines called corticosteroids. These are used relieve redness and swelling.
Betamethasone Drops are used to treat redness and swelling of the eyes, nose and ears.
2. Before you use Betamethasone Drops Do not use Betamethasone Drops if you are:
• allergic (hypersensitive) to Betamethasone Sodium Phosphate or to any of the other ingredients of this medicine, listed in section 6 of this leaflet
Do not use in your eyes if you:
• have a viral infection of the eye
• have a fungal infection of the eye
• have tuberculosis of the eye
• have an eye infection that is producing pus
• suffer from raised pressure in your eye(s)
(glaucoma)
• suffer from herpes in your eye(s)
• have undiagnosed red eye(s)
• are wearing soft contact lenses. These should be removed whilst you are using Betamethasone Drops.
Do not use in your ears if you have:
• a hole in your ear drum
If any of the above apply please tell your doctor or pharmacist.
Take special care with Betamethasone Drops:
• Do not use Betamethasone Drops for a prolonged period of time (more than 7 days) as this may cause serious side effects, particularly in children. (see section 4 of this leaflet)
• You should be aware that if you are using Betamethasone Drops in your eyes your doctor may need to check your eyes frequently during your treatment.
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, unless your doctor has recommended it.
Driving and using machines
Betamethasone Drops can cause temporary blurring of vision after application to the eye. Wait until your vision is clear whilst driving or using machines.
Important information about some of the ingredients of Betamethasone Drops
• Betamethasone Drops contain benzalkonium chloride which is known to discolour soft contact lenses and may cause eye irritation. If you usually wear soft contact lenses they should be removed before you use Betamethasone Drops.
3. How to use Betamethasone Drops.
Always use Betamethasone 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 eachnostril twice daily or as required.
Instructions for use
Instructions for use in the eye:
If you wear soft contact lenses these must be removed during treatment of the eyes with Betamethasone Drops.
1. Before opening a new bottle of Betamethasone 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.
6. 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 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, or 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 in the other eye, if you have been told to use Betamethasone 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 Betamethasone 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
• Do not use for longer than 7 days
• Discard 4 weeks after opening
If you are unsure about how to use Betamethasone Drops talk to your doctor or pharmacist.
If you use more Betamethasone Drops than you should
If you are at all concerned that you have used too much of this medicine contact your doctor or pharmacist.
Betamethasone 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 Betamethasone Drops
If you have just missed using 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 using your next dose wait and use this dose at the correct time.
Do not take a double dose to make up for one you have missed.
If you stop using Betamethasone Drops
You should keep using Betamethasone Drops for as long as your doctor has instructed. 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, Betamethasone Drops can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you should tell your doctor immediately. These are symptoms of an allergic reaction.
• difficulty in breathing with or without swelling of the face, lips, tongue and/or throat
• swelling of the face, lips tongue and/or throat, which may cause difficulty in swallowing
• severe itching of the skin (with raised lumps).
Other 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)
Where you suffer from a disease (other than that for which you are using Betamethasone Drops) that causes thinning of the surface of the eye, serious damage may be caused.
Prolonged use of this medicine (for more than 7 days) 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 Betamethasone Drops.
Keep this medicine out of the sight and reach of children.
Make sure the container is properly closed after each use.
Store Betamethasone Drops in the original container away from direct light.
Store below 25°C.
Do not use Betamethasone Drops after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Dispose of this medicine 4 weeks after opening
Medicines should not be disposed of via wastewater 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 Betamethasone Drops contain
The active substance is betamethasone sodium phosphate 0.1%w/v
The other ingredients are benzalkonium chloride solution, disodium edetate, sodium phosphate and purified water
What Betamethasone Drops look like and contents of the pack
Betamethasone 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:
Martindale Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford
RM3 8UG
United Kingdom
Manufacturers:
Martindale Pharmaceuticals
Bampton Road
Harold Hill
Romford
RM3 8UG
United Kingdom
Farmigea S.p.A.
Via G.B. Oliva 6/8 56121 Pisa, Italy
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.
This leaflet was last updated in September 2012 Product License Number: PL 00156/0083
MARTINDALE PHARMA
Barnpton Road. Harold Hill Romford. RM3 8UG. UK