Consumer medicine information

Cromo-Fresh

Sodium cromoglycate

BRAND INFORMATION

Brand name

Cromo-Fresh

Active ingredient

Sodium cromoglycate

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cromo-Fresh.

What is in this leaflet

This leaflet answers some common questions about CROMO-FRESH. It explains how to use CROMO-FRESH correctly. It does not contain all available information about CROMO-FRESH. It does not take the place of talking to your doctor, pharmacist, ophthalmologist or other health professionals.

Keep this leaflet. You may need to read it again.

What CROMO-FRESH is used for

CROMO-FRESH is used for the prevention and treatment of allergic eye conditions such as hayfever and conjunctivitis. These conditions can cause itching, redness, discomfort and watery discharge from the eyes.

Before you use CROMO-FRESH

Do not use CROMO-FRESH eye drops if you are allergic to sodium cromoglycate or any other ingredient used in CROMO- FRESH.

Take special care if you wear contact lenses. Do not wear soft contact lenses while using CROMO-FRESH eye drops. It is not usual to wear contact lenses at all while being treated for allergic conjunctivitis. However if you continue to wear hard contact lenses while being treated for allergic conjunctivitis, remove your lenses before using the eye drops and do not reinsert for at least 15 minutes after using the eye drops.

Please tell your doctor or pharmacist if you are using or have recently used any other medicines including any obtained without a prescription or from a health food shop.

If you are using any other eye drops or eye ointment, there should be at least a 15 minute interval between applications. Eye ointments should always be applied last.

If you are pregnant or breast feeding, talk to your doctor or pharmacist before using CROMO-FRESH.

Your vision may be affected immediately after using CROMO-FRESH. Wait for several minutes after using before driving or operating machinery including power tools.

How to use CROMO-FRESH

Always use CROMO-FRESH exactly as your doctor has told you to. It may be different to the instructions given in this leaflet.

If you have not been prescribed CROMO-FRESH the usual dose is 1-2 drops into the affected eye(s), 4-6 times daily. Continue using as long as needed to sustain relief. Using CROMO-FRESH for about a week before the expected allergy season may help reduce the symptoms associated with eye allergies.

Contact your doctor or pharmacist if symptoms persist for more than 2 days, or worsen. Discontinue use if irritation develops.

As CROMO-FRESH is preservative-free it is usually well tolerated. CROMO-FRESH is phosphate-free so that complications such as deposits in the cornea are avoided.

Only use CROMO-FRESH if the sealing of the folding carton was intact before first use.

Step1
Remove cap before use.

Step 2
Before first using, turn the CROMO-FRESH bottle, so that the tip is pointing down and press on the bottom of the bottle until the first drop appears at the nozzle. The bottle is now ready for use. Hold the bottle down with the thumb on the shoulder of the bottle and the other fingers on the bottom of the bottle.

Step 3
Support the hand holding the COMOD®-bottle as shown with the other hand.

Step 4
Lean your head slightly back, gently pull down your lower eyelid and apply a strong, fast pressure onto the bottom of the bottle. This activates the mechanism for the release of one drop. The COMOD® valve system ensures that the size and speed of each drop is the same regardless of how much pressure is applied. Slowly close your eyes to allow the fluid to spread evenly on the eye surface.

Step 5
While your eye is still closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This will help to stop the medicine from draining through the tear ductto the nose and throat, from where it can be absorbed to other parts of your body. Ask your doctor for more specific instruction on this technique.

Step 6
Replace cap immediately after use. Take care that the dropper is dry. When applying the fluid please avoid any contact between the tip of the bottle and your eye or your skin.

Each CROMO-FRESH bottle will provide 10 mL of eye drops. After you are unable to obtain any more product from the bottle, you will find that a small amount will be left in the bottle. This is due to technical reasons related to the dropper system.

While using CROMO-FRESH

If you are about to be started on any new medicine, tell your doctor or pharmacist that you are using CROMO-FRESH.

Tell any other doctors, dentists and pharmacists who treat you that you are using CROMO-FRESH.

If you are going to have surgery, tell your surgeon or anaesthetist that you are using CROMO-FRESH. It may affect other medicines used during surgery.

If you become pregnant while using CROMO-FRESH, tell your doctor as soon as possible.

Do not give your medicine to anyone else, even if they have the same symptoms as you.

Side Effects

Like all medicines CROMO-FRESH may have side effects. CROMO-FRESH helps most people but it may have unwanted side effects in a few people. Stop using CROMO-FRESH and tell your doctor or pharmacist if you have any of these side effects and they persist or bother you:

  • Eye irritation
  • Blurred vision
  • Temporary burning or stinging following administration

Usually these side effects are mild and will stop spontaneously.

Do not drive or operate hazardous machinery while these effects persist.

Overdose

It is unlikely that an overdose will occur or cause any harm even if the product is swallowed by a child, due to the one drop delivery system. If unsure, telephone your doctor or the Poisons Information Centre (13 11 26 in Australia or 0800 764 766 (0800 POISON) in New Zealand) or go to Accident and Emergency at your nearest hospital.

Storage

Store below 25 °C. Keep bottle in carton to protect from light.

CROMO-FRESH can be used for up to 28 days after first opening.

Do not use if the product has passed the expiry date printed on the pack.

Keep out of reach of children.

Other Ingredients

CROMO-FRESH also contains sodium edetate, sorbitol and water for injections.

If you want to know more

If you have any questions regarding this product, talk to your doctor, pharmacist or ophthalmologist.

Distributor

Australia

AFT Pharmaceuticals Pty Ltd,
113 Wicks Road, North Ryde
Sydney
NSW 2113

New Zealand

AFT Pharmaceuticals Ltd, Auckland

Email: [email protected]

Manufacturer

URSAPHARM, Industriestraße, 66129 Saarbrücken, Germany

Date

June 2015

Published by MIMS December 2017

BRAND INFORMATION

Brand name

Cromo-Fresh

Active ingredient

Sodium cromoglycate

Schedule

S2