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CATACROM 2% W/V EYE DROPS SOLUTION

Active substance: SODIUM CROMOGLICATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Catacrom 2 % w/v Eye Drops, solution
Sodium Cromoglicate 2% w/v (20mg/ml) Eye Drops BP without preservative (unit dose).

Read all of this leaflet carefully because it contains important information for you.
For brevity, this medicine will be referred to as Catacrom Eye Drops throughout this leaflet.
Catacrom Eye Drops are available without prescription but you still need to take care to get the best results from them.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after a few days.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In
1.
2.
3.
4.
5.
6.

this leaflet:
What Catacrom Eye Drops are and what they are used for
Before you use Catacrom Eye Drops
How to use Catacrom Eye Drops
Possible side effects
How to store Catacrom Eye Drops
Further information

1. What Catacrom Eye Drops are and
what they are used for
Catacrom Eye Drops are for the relief and treatment of allergic
red, watery, itchy and puffy eyes caused by hayfever, house mites,
and other causes of allergy such as pet hairs. Eye allergy can
happen when sensitive eyes are exposed to these causes of allergy.
Catacrom Eye Drops is a medicine which affects cells called
mast cells. It prevents them from releasing chemical substances
which cause symptoms such as the redness, watering, itching and
puffiness of allergic reactions.
These eye drops can be used by wearers of rigid or gas permeable
contact lenses and can be used by people who are sensitive to
preservatives in other kinds of eye drops.

• If you have any questions concerning the use of these eye drops
in a child, or are unsure whether the child has allergic eyes, you
should seek advice from your doctor or pharmacist.
• If you have any questions about using these eye drops with
other eye treatments, speak to your doctor or pharmacist.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Please let the doctor know if you are pregnant, think you might be
pregnant, are planning to become pregnant or are breast-feeding.
Your doctor may prefer a different treatment to be given under
these circumstances.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If there are changes to your vision after using these eye drops,
wait until you can see clearly before driving or using machines.

3. How to use Catacrom Eye Drops
Catacrom Eye Drops are for use in the eye only.

2. Before you use Catacrom Eye Drops
Do not use Catacrom Eye Drops:
• if you know that you are allergic to the active ingredient, Sodium
Cromoglicate or any of the other ingredients of Catacrom Eye
Drops (see section 6 of this leaflet).
Take special care with Catacrom Eye Drops:
Before using these eye drops, you must be sure that your eye
irritation is the result of allergy (or have been previously diagnosed
by your doctor as suffering from allergy).
You can be confident that you have allergic eyes if:
• both eyes are affected
• you have a blocked or runny nose as well
• your eyesight is not affected
but if:
• you have no nose symptoms
• only one eye is affected
• your sight is affected
you cannot be sure that you are suffering from allergic eyes and
should consult your doctor before you use these drops.

Usual dose
Catacrom Eye Drops are suitable for use in adults, the elderly and
children.
The drops are in single dose units. Put one or two drops into each
eye four times a day, or as directed by your doctor. Avoid touching
the eye with the dropper.
Wash your hands before and after you use these eye drops.

Steps for Using Catacrom Eye Drops
1. Break off one unit dose container
from the strip.
(Figure 1)
2. Open the unit dose container by
bending/twisting the tab (Figure 1).
3. Tilt your head backwards.
(Figure 2)

(Figure 3)

(Figure 4)

4. Gently pull down the lower lid
to form a pouch (Figure 2).
5. With the unit dose in the other
hand, put one drop inside the
pouch by gently squeezing the
container. Try not to touch
anything with the tip (Figure 3).
6. Close the eye for about 30
seconds and at the same time
gently press a finger against the
corner of the closed eye, nearest
the nose. (Figure 4).

7. Some drops may roll down your face. This is normal. The eye
holds less than one drop. Wipe away the excess with a clean
tissue. If the drop of medication is not retained for any reason,
another drop should be dropped into the eye pouch.
8. If you use more than one type of eye drop, wait five minutes
before putting in the next one. This prevents the first drop
from being washed away.
9. Repeat instructions 3-8 for the other eye.

5. How to store Catacrom Eye Drops
Keep out of the reach and sight of children.
Once opened, use the unit dose straight away and then throw
away the container.
Do not use Catacrom Eye Drops after the expiry date which is
stated on the carton, sachet and unit dose.
Do not store above 25°C.
Store in the original package. After opening sachet: use contents
within 28 days.

6. Further information
What Catacrom Eye Drops look like and contents of the
pack
The active ingredient of the eye drops is Sodium Cromoglicate
2%w/v (20mg/ml).
Each unit dose container holds 0.3ml Catacrom 2% Eye Drops
without preservative and there are 10, 12, 18, 20, 24, 30 or 90
single dose containers in each carton.
Not all pack sizes may be marketed.
Each individual single-dose unit contains 6mg of Sodium
Cromoglicate in 0.3ml of solution.
Catacrom Eye Drops also contain sodium chloride and purified
water.

Marketing Authorisation Holder and Manufacturer
If you use more Catacrom Eye Drops than you should:
There are no known effects of taking too much of this medicine.
If you are concerned, please speak to your doctor or pharmacist.
If you forget to use your Catacrom Eye Drops:
If you forget to use this medicine, use it as soon as you remember.

Catacrom Eye Drops are manufactured by:
Laboratoire Unither,
ZI Longpré, 10 rue André Durouchez, 80052 AMIENS cedex2,
France.
or
Laboratoire Unither
Route de Saint Lô, ZI de la Guérie, 50200 Coutances, France.

4. Possible side effects
Like all medicines, Catacrom Eye Drops can cause side effects,
although not everybody gets them. Some people find that their eyes
can become irritated or sting for a short while after taking the eye
drops.
If the stinging lasts a long time or is severe you should talk to your
doctor or pharmacist. Rarely, other symptoms of eye irritation
have occurred.
If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

The marketing authorisation holder is Moorfields Eye Hospital
NHS Foundation Trust.
Trading as Moorfields Pharmaceuticals, 34 Nile Street, London. N1
7TP, UK.
Moorfields Pharmaceuticals and CATACROM are trade marks.
This leaflet was last approved in July 2009.

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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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