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RAPITIL EYE DROPS 2%

Active substance(s): NEDOCROMIL SODIUM

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S1172 LEAFLET Rapitil 20150223

PACKAGE LEAFLET: INFORMATION FOR USER

RAPITIL EYE DROPS 2%
(nedocromil sodium)
Your medicine is known as Rapitil Eye Drops 2% but will be
referred to as Rapitil Eye Drops throughout the following leaflet.
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.



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. See section 4.

In this leaflet:
1. What Rapitil Eye Drops are and what they are used for

Take special care with Rapitil Eye Drops if:
 You wear soft contact lenses. You should not wear soft contact
lenses while using these drops
If you are not sure if this applies to you, talk to your doctor or
pharmacist before using Rapitil Eye Drops.
Pregnancy and breast-feeding
Talk to your doctor before using this medicine if you are pregnant,
might become pregnant or think you may be pregnant.
If you are breast-feeding or planning to breast-feed, talk to your
doctor or pharmacist before taking or using any medicine.
Driving and using machines
Your eyesight may be affected after using this medicine. If this
happens, do not drive or use any tools or machines until you can
see clearly.
Important information about some of the ingredients of Rapitil
Eye Drops
Rapitil Eye Drops contain benzalkonium chloride. This may cause
your eyes to become irritated. It may also change the colour of your
contact lenses.

2. Before you use Rapitil Eye Drops
3. How to use Rapitil Eye Drops
4. Possible side effects
5. How to store Rapitil Eye Drops
6. Further information

3. HOW TO USE RAPITIL EYE DROPS
Always use Rapitil Eye Drops exactly as your doctor or pharmacist
has told you. You should check with your doctor or pharmacist if
you are not sure.
Using this medicine

1. WHAT RAPITIL EYE DROPS ARE AND WHAT THEY ARE
USED FOR
What Rapitil Eye Drops are
Rapitil 2% Eye Drops (called Rapitil Eye Drops in this leaflet)
contain a medicine called nedocromil sodium. This belongs to a
group of medicines called anti-allergics.



If you wear hard or gas-permeable contact lenses, you should
take them out while you use the eye drops. You should wait 15
minutes before you put the contact lenses back in



If you need to use more than one type of eye medicine, the
medicines must be used at least 5 minutes apart. Eye ointments
should be used last.



If you feel the effect of your medicine is too weak or too strong,
do not change the dose yourself, but ask your doctor or
pharmacist

How Rapitil Eye Drops work
It works by stopping the release of the natural substances in your
eyes that can lead to an allergic reaction.
What Rapitil Eye Drops can be used for
Stopping, treating and relieving the symptoms of ‘allergic
conjunctivitis’ (inflammation of parts of the eye). Rapitil Eye Drops
can be used for three types of allergic conjunctivitis:


‘Perennial allergic conjunctivitis’ in adults only: This type of
allergy can happen at any time of the year and is often caused
by animal fur or house dust mites. Signs include itchy, watery,
red or inflamed eyes and puffy eyelids.



‘Seasonal allergic conjunctivitis’ in adults and children:
This type of allergy, such as hay fever, can be caused by
different pollens in different seasons of the year. Signs include
itchy, watery, red or inflamed eyes and puffy eyelids.



‘Vernal kerato conjunctivitis’ in adults and children: This is
a more severe type of allergy. Signs include bumps inside the
upper eyelid, sensitivity to light and severe itching

How to use this medicine


Wash your hands



Remove the cap from the
bottle



Tilt your head back



Squeeze one or two drops
inside the lower lid without
touching your eye



Close your eye



Wipe away any excess
liquid from the eyes with a
clean tissue



Always put the cap back on
the bottle as soon as you have used it



Repeat in the other eye as needed

How much to use
2. BEFORE YOU USE RAPITIL EYE DROPS

Adults, Elderly and Children aged 6 years and over

Do not use this medicine and tell your doctor or pharmacist if:

Seasonal allergic conjunctivitis:

 You are allergic (hypersensitive) to nedocromil sodium, or any
of the other ingredients of Rapitil Eye Drops (listed in Section 6
below)



One drop into each eye twice each day



This can be increased to four times each day if needed

Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
or around the eyes
Do not use this medicine if the above applies to you. If you are not
sure, talk to your doctor or pharmacist before using Rapitil Eye
Drops.

 Do not use for more than 12 weeks
Vernal kerato-conjunctivitis


One drop into each eye four times each day

Adults and the Elderly only
Perennial allergic conjunctivitis:


One drop into each eye twice each day



This can be increased to four times each day if needed



Use the drops regularly

Children under 6 years

6. FURTHER INFORMAT ION

This medicine is not recommended for children aged less than 6
years.

What Rapitil Eye Drops contain

If you take more Rapitil Eye Drops than you should
If you use more Rapitil than you should, talk to your doctor or go to
a hospital straight away. Remember to take any medicine that is left
with you so the doctor knows what you have taken.



Each ml of the solution contains 2% w/v of the active ingredient
nedocromil sodium.



Rapitil Eye Drops also contain the following inactive ingredients:
benzalkonium chloride, sodium edetate, sodium chloride and
purified water.

What Rapitil Eye Drops looks like and contents of the pack
If you forget to use Rapitil Eye Drops
If you forget a dose, use your drops as soon as you remember.
However, if it is nearly time for your next dose, skip the missed
dose. Do not use a double dose to make up for a forgotten dose.
If you stop using Rapitil Eye Drops
Keep using the eye drops for as long as your doctor or pharmacist
advises you. If you stop using Rapitil Eye drops too early, your
allergy symptoms may come back.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Rapitil Eye Drops can cause side effects,
although not everybody gets them.
Stop using Rapitil Eye Drops and see a doctor as soon as
possible if:


The itching, redness or swelling gets worse. You may be
allergic to these drops

Talk to your doctor or pharmacist if any of the side effects gets
serious or lasts longer than a few days, or if you notice any
side effects not listed in this leaflet:
Common (affects 1 to 10 people in a 100)


Stinging or burning in your eyes or blurring of eyesight. This
should only last for a short time and occurs immediately after
using the eye drops

 Change in the way things taste
Uncommon (affects 1 to 10 people in a 1,000)


Mild eye irritation

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
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 RAPITIL EYE DROPS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Keep the bottle in the outer carton in order to protect from direct
sunlight.



Do not use Rapitil Eye Drops after the expiry date which is
stated on the label and carton. The expiry date refers to the last
day of the month.



Rapitil Eye Drops are sterile when you buy them, so you must
not keep them for more than 28 days after opening the bottle.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do



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

Rapitil Eye Drops are available as a sterile, clear, light yellow
aqueous solution in a dropper bottle for administration to the eye.
Rapitil Eye Drops are available in bottles of 5ml.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Sanofi Winthrop Industrie,
Boulevard Industrial, Le Trait, F-76580 France.
POM

PL No. 19488/1172

Leaflet revision date: 23 February 2015
Rapitil is a registered trade mark of Fisons Ltd, UK.
S1172 LEAFLET Rapitil 20150223

S1172 LEAFLET Nedocromil 20150223

PACKAGE LEAFLET: INFORMATION FOR USER

NEDOCROMIL SODIUM EYE DROPS 2%

Take special care with Nedocromil Sodium Eye Drops if:
 You wear soft contact lenses. You should not wear soft contact
lenses while using these drops
If you are not sure if this applies to you, talk to your doctor or
pharmacist before using Nedocromil Sodium Eye Drops.

Your medicine is known as Nedocromil Sodium Eye Drops 2% but
will be referred to as Nedocromil Sodium Eye Drops throughout the
following leaflet.
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.



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. See section 4.

In this leaflet:

Pregnancy and breast-feeding
Talk to your doctor before using this medicine if you are pregnant,
might become pregnant or think you may be pregnant.
If you are breast-feeding or planning to breast-feed, talk to your
doctor or pharmacist before taking or using any medicine.
Driving and using machines
Your eyesight may be affected after using this medicine. If this
happens, do not drive or use any tools or machines until you can
see clearly.
Important information about some of the ingredients of
Nedocromil Sodium Eye Drops
Nedocromil Sodium Eye Drops contain benzalkonium chloride. This
may cause your eyes to become irritated. It may also change the
colour of your contact lenses.

1. What Nedocromil Sodium Eye Drops are and what they are
used for
2. Before you use Nedocromil Sodium Eye Drops

3. HOW TO USE NEDOCROMIL SODIUM EYE DROPS

3. How to use Nedocromil Sodium Eye Drops

Always use Nedocromil Sodium Eye Drops exactly as your doctor
or pharmacist has told you. You should check with your doctor or
pharmacist if you are not sure.

4. Possible side effects
5. How to store Nedocromil Sodium Eye Drops

Using this medicine

6. Further information



1. WHAT NEDOCROMIL SODIUM EYE DROPS ARE AND
WHAT THEY ARE USED FOR

If you wear hard or gas-permeable contact lenses, you should
take them out while you use the eye drops. You should wait 15
minutes before you put the contact lenses back in



If you need to use more than one type of eye medicine, the
medicines must be used at least 5 minutes apart. Eye ointments
should be used last.



If you feel the effect of your medicine is too weak or too strong,
do not change the dose yourself, but ask your doctor or
pharmacist

What Nedocromil Sodium Eye Drops are
Nedocromil Sodium 2% Eye Drops (called Nedocromil Sodium Eye
Drops in this leaflet) contain a medicine called nedocromil sodium.
This belongs to a group of medicines called anti-allergics.
How Nedocromil Sodium Eye Drops work
It works by stopping the release of the natural substances in your
eyes that can lead to an allergic reaction.
What Nedocromil Sodium Eye Drops can be used for
Stopping, treating and relieving the symptoms of ‘allergic
conjunctivitis’ (inflammation of parts of the eye). Nedocromil Sodium
Eye Drops can be used for three types of allergic conjunctivitis:






‘Perennial allergic conjunctivitis’ in adults only: This type of
allergy can happen at any time of the year and is often caused
by animal fur or house dust mites. Signs include itchy, watery,
red or inflamed eyes and puffy eyelids.
‘Seasonal allergic conjunctivitis’ in adults and children:
This type of allergy, such as hay fever, can be caused by
different pollens in different seasons of the year. Signs include
itchy, watery, red or inflamed eyes and puffy eyelids.
‘Vernal kerato conjunctivitis’ in adults and children: This is
a more severe type of allergy. Signs include bumps inside the
upper eyelid, sensitivity to light and severe itching

How to use this medicine


Wash your hands



Remove the cap from the
bottle



Tilt your head back



Squeeze one or two drops
inside the lower lid without
touching your eye



Close your eye



Wipe away any excess
liquid from the eyes with a
clean tissue



Always put the cap back on
the bottle as soon as you have used it



Repeat in the other eye as needed

How much to use
Adults, Elderly and Children aged 6 years and over

2. BEFORE YOU USE NEDOCROMIL SODIUM EYE DROPS

Seasonal allergic conjunctivitis:

Do not use this medicine and tell your doctor or pharmacist if:



One drop into each eye twice each day

 You are allergic (hypersensitive) to nedocromil sodium, or any
of the other ingredients of Nedocromil Sodium Eye Drops (listed
in Section 6 below)



This can be increased to four times each day if needed

 Do not use for more than 12 weeks
Vernal kerato-conjunctivitis

Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
or around the eyes
Do not use this medicine if the above applies to you. If you are not
sure, talk to your doctor or pharmacist before using Nedocromil
Sodium Eye Drops.



One drop into each eye four times each day

Adults and the Elderly only
Perennial allergic conjunctivitis:


One drop into each eye twice each day



This can be increased to four times each day if needed



Use the drops regularly

Children under 6 years

6. FURTHER INFORMAT ION

This medicine is not recommended for children aged less than 6
years.

What Nedocromil Sodium Eye Drops contain

If you take more Nedocromil Sodium Eye Drops than you
should
If you use more Nedocromil Sodium than you should, talk to your
doctor or go to a hospital straight away. Remember to take any
medicine that is left with you so the doctor knows what you have
taken.
If you forget to use Nedocromil Sodium Eye Drops
If you forget a dose, use your drops as soon as you remember.
However, if it is nearly time for your next dose, skip the missed
dose. Do not use a double dose to make up for a forgotten dose.
If you stop using Nedocromil Sodium Eye Drops
Keep using the eye drops for as long as your doctor or pharmacist
advises you. If you stop using Nedocromil Sodium Eye drops too
early, your allergy symptoms may come back.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nedocromil Sodium Eye Drops can cause side
effects, although not everybody gets them.
Stop using Nedocromil Sodium Eye Drops and see a doctor as
soon as possible if:


The itching, redness or swelling gets worse. You may be
allergic to these drops

Talk to your doctor or pharmacist if any of the side effects gets
serious or lasts longer than a few days, or if you notice any
side effects not listed in this leaflet:
Common (affects 1 to 10 people in a 100)


Stinging or burning in your eyes or blurring of eyesight. This
should only last for a short time and occurs immediately after
using the eye drops

 Change in the way things taste
Uncommon (affects 1 to 10 people in a 1,000)


Mild eye irritation

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
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 NEDOCROMIL SODIUM EYE DROPS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Keep the bottle in the outer carton in order to protect from direct
sunlight.



Do not use Nedocromil Sodium Eye Drops after the expiry date
which is stated on the label and carton. The expiry date refers
to the last day of the month.



Nedocromil Sodium Eye Drops are sterile when you buy them,
so you must not keep them for more than 28 days after opening
the bottle.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do



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



Each ml of the solution contains 2% w/v of the active ingredient
nedocromil sodium.



Nedocromil Sodium Eye Drops also contain the following
inactive ingredients: benzalkonium chloride, sodium edetate,
sodium chloride and purified water.

What Nedocromil Sodium Eye Drops looks like and contents of
the pack
Nedocromil Sodium Eye Drops are available as a sterile, clear, light
yellow aqueous solution in a dropper bottle for administration to the
eye.
Nedocromil Sodium Eye Drops are available in bottles of 5ml.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Sanofi Winthrop Industrie,
Boulevard Industrial, Le Trait, F-76580 France.
POM

PL No. 19488/1172

Leaflet revision date: 23 February 2015
S1172 LEAFLET Nedocromil 20150223

Expand view ⇕

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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