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RAPITIL 2% EYE DROPS

Active substance(s): NEDOCROMIL SODIUM

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Rapitil® 2% Eye Drops /
Nedocromil Sodium 2% Eye Drops
(nedocromil sodium)
PATIENT INFORMATION LEAFLET
Your eye drops are available using the above two names Rapitil 2% Eye Drops / Nedocromil Sodium
2% Eye Drops, but will be referred to as Rapitil Eye Drops throughout this leaflet.

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.

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.

Driving and using machines

In
1.
2.
3.
4.
5.
6.

3.

1.

this leaflet:
What Rapitil Eye Drops are and what they are used for
Before you use Rapitil Eye Drops
How to use Rapitil Eye Drops
Possible side effects
How to store Rapitil Eye Drops
Further information
WHAT RAPITIL EYE DROPS ARE AND WHAT THEY ARE USED FOR

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.

Using this medicine




What Rapitil Eye Drops are

Rapitil Eye Drops contain a medicine called nedocromil sodium. This belongs to a group of medicines
called anti-allergics.

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.

2.

BEFORE YOU USE RAPITIL EYE DROPS

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


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

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.

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 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
Seasonal allergic conjunctivitis:




One drop into each eye twice each day
This can be increased to four times each day if needed
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:




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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

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

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.

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

6.

FURTHER INFORMATION

What Rapitil Eye Drops contain



Each ml of solution contains 20mg of Nedocromil Sodium (2% w/v) as the active ingredient.
The solution also contains benzalkonium chloride, sodium chloride, disodium edetate and purified
water.

What Rapitil Eye Drops look like and contents of the pack

Rapitil Eye Drops are available in a clear plastic dropper bottle containing 5ml, sterile, preserved,
yellow aqueous solution with a screw cap and a tamper evident seal.

Manufacturer

This product is manufactured by: SANOFI WINTHROP INDUSTRIE, 76580 Le Trait, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Like all medicines, Rapitil Eye Drops can cause side effects, although not everybody gets them.

PL No: 08929/0270

Stop using Rapitil Eye Drops and see a doctor as soon as possible if:

Leaflet Revision date: 26.11.13



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

Rapitil® is a registered trademark of Fisons Limited.
DATE BOTTLE FIRST OPENED:

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.









………………………………………

To request a copy of this leaflet in Braille, large print or audio please call 01302 552940 and ask for
the Regulatory Department.

Uncommon (affects 1 to 10 people in a 1,000)


POM

HOW TO STORE RAPITIL EYE DROPS

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
You must not use the eye drops after the expiry date. This is given in two places:

on the carton label.

on the bottle label.
In both places, it is given as 'EXP' followed by the month and year. The eye drops should not be
used after the end of this month. If you are not sure when this is, check with your doctor or
pharmacist. Discard the eye drops four weeks after opening the bottle for the first time. Avoid
contamination of the contents by replacing the cap securely after use.
Do not store above 25°C.
Store in the original container away from direct sunlight.
If your doctor decides to stop treatment, return any leftover eye drops to the pharmacist. Only
keep them if your doctor tells you to.
If your eye drops become discoloured or show any other signs of deterioration, please return them
to your pharmacist who will advise you.
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.

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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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