Monday, October 24, 2016

Catacrom Sodium Cromoglicate 2% Preservative Free Unit Dose Eye Drops





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 this leaflet:



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

2. 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. Further information






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.





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.



  • 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.






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.



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.
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).





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 your Catacrom Eye Drops:



If you forget to use this medicine, use it as soon as you remember.






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.





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.





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



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



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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