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CATACROM 2% W/V EYE DROPS SOLUTION

Active substance(s): SODIUM CROMOGLICATE

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Package leaflet: Information for the user

CATACROM® 2 % w/v Eye Drops, Solution
Sodium cromoglicate
Read all of this leaflet carefully before you start using this medicine 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.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See Section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1. What Catacrom Eye Drops are and what they are used for
2. What you need to know before you use Catacrom Eye Drops
3. How to use Catacrom Eye Drops
4. Possible side effects
5. How to store Catacrom Eye Drops
6. Contents of the pack and other information

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 you should talk to your doctor or pharmacist before using
Catacrom Eye Drops.

1. What Catacrom Eye Drops are and
what they are used for

Children
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.

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.

2. What you need to know before you use
Catacrom Eye Drops
Do not use Catacrom Eye Drops:
• if you are allergic to sodium cromoglicate, or any of the
other ingredients of this medicine (listed in section 6).

Warnings and precautions

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 you 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

Other medicines and Catacrom Eye Drops
Tell your doctor or pharmacist if you are taking, have recently
taken, or might take any other medicines, including medicines
obtained without a prescription.
If you have any questions about using these eye drops with other
eye treatments, speak to your doctor or pharmacist.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before using these eye drops. Your doctor or pharmacist may prefer
a different treatment to be used 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.
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.
Read the instructions on the carton carefully. 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.
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).

(Figure 2)

(Figure 3)

(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.
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 Catacrom Eye Drops
If you forget to use this medicine, use it as soon as you
remember.

4. Possible side effects
Like all medicines, this medicine 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 these 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
national reporting system:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971; Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Catacrom Eye Drops
Keep out of the sight and reach of children.
Once opened, use the unit dose straight away and then
throw away the container.
Do not use this medicine after the expiry date which is
stated on the carton, sachet and unit dose after EXP. The
expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original package. After opening the sachet: use
contents within 28 days.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Catacrom Eye Drops contain
• The active substance is sodium cromoglicate.
• The other ingredients are purified water and sodium chloride.
• Each individual single-dose unit contains 6 mg of sodium
cromoglicate in 0.3 ml of solution.
What Catacrom Eye Drops look like and contents
of the pack
Each unit dose container holds 0.3 ml Catacrom 2% Eye
Drops without preservative and there are 10, 12, 18, 20, 24,
30 or 90 single-dose units in each carton. Not all pack sizes
may be marketed.
Marketing Authorisation Holder and Manufacturer
Catacrom Eye Drops are manufactured by:
Laboratoire Unither,
ZI Longpré, 10 rue André Durouchez, 80052 Amiens Cedex
2, France.
or
Laboratoire Unither,
Route de Saint Lô, ZI de la Guérie F50200 Coutances, France.
Marketing Authorisation Holder:
Moorfields Eye Hospital NHS Foundation Trust trading as
Moorfields Pharmaceuticals, 25 Provost Street, London,
N1 7NH, United Kingdom.
Moorfields Pharmaceuticals and CATACROM are registered
trade marks.
This leaflet was last revised in June 2016
For package information leaflet in large font please go to
www.xpil.medicines.org.uk.

For large print, audio or Braille
versions contact the RNIB on the
Medicine Leaflet Line 0800 198 5000.

Non-printed information
• Ref: PCS-PIL-2002
• Issue: 10
• Date: 26/05/2016
• PIL dimensions: 140 x 180 mm
• PIL border: 10 mm
• FONT: Titles - Gill Sans Bold: 8 pt
• FONT: Body - Gill Sans: 6.5 pt

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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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