Document: leaflet MAH BRAND_PL 00156-0083 change

• leaflet MAH BRAND_PL 00156-0083
• leaflet MAH GENERIC_PL 00156-0083

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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 Drops are and what they are used for

2.    Before you use Vistamethasone Drops

3.    How to use Vistamethasone Drops

4.    Possible side effects

5.    How to store Vistamethasone Drops

6.    Further information

1.    What Vistamethasone Drops are and what they are used for

Vistamethasone Drops contain Betamethasone [Sodium Phosphate which belongs to a group of medicines called corticosteroids.These are used relieve redness and swelling.

Vistamethasone Drops are used to treat [redness and swelling of the eyes, nose and ears.

2.    Before you use Vistamethasone Drops

Do not use Vistamethasone 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 Vistamethasone 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 Vistamethasone Drops:

•    Do not use Vistamethasone 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 Vistamethasone 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 breast-.feeding, unless your doctor has recommended it.—l Driving and using machines Vistamethasone 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 Vistamethasone Drops

• Vistamethasone 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 Vistamethasone Drops.

3. How to use Vistamethasone Drops

Always use Vistamethasone 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

Instructions for use in the eye:

If you wear soft contact lenses these must be

removed during treatment of the eyes with

Vistamethasone Drops.

1.    Before opening a new bottle of Vistamethasone 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 i n the other eye, if you have been told to use Vistamethasone 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

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