Sodium Cromoglicate 2% W/V Eye Drops Solution

Document: leaflet BOOTS_PL 25298-0033 change

120 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

420 mm

Sodium Cromoglicate 2% w/v Eye Drops, Solution

Read all of this leaflet carefully before you start using this medicine.

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

'• Ask your pharmacist if you need more information or advice

!• You must contact a pharmacist or doctor if your symptoms worsen or

I do not improve

!• 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

In this leaflet:

;1. What Sodium Cromoglicate Eye Drops is and what it is used for

2. Before you use Sodium Cromoglicate Eye Drops

3. How to use Sodium Cromoglicate Eye Drops

4. Possible side effects

[5. How to store Sodium Cromoglicate Eye Drops fe. Further information

[1. WHAT SODIUM CROMOGLICATE EYE DROPS IS AND WHAT IT IS USED FOR

Sodium Cromoglicate Eye Drops contain a medicine called Sodium Cromoglicate. This belongs to a group of medicines called anti-allergies.

|lt works by stopping the release of the natural substances in your eyes that can lead Jto an allergic reaction. Signs of an allergic reaction include itchy, watery, red or jinflamed eyes and puffy eyelids.

Sodium Cromoglicate Eye Drops are used for the relief and treatment of dye allergies. These allergies can happen:

» At any time of the year and is called “perennial allergic conjunctivitis”

;• In different seasons of the year caused by different pollens.

; This is called “seasonal allergic conjunctivitis” or hay fever

% BEFORE YOU USE SODIUM CROMOGLICATE EYE DROPS

iDo not use Sodium Cromoglicate Eye Drops

»if you are allergic (hypersensitive) to Sodium Cromoglicate or any of the other i ingredients of Sodium Cromoglicate Eye Drops (listed in Section 6:

! Further information)

pigns of an allergic reaction include: a rash, swallowing or breathing problems, |swelling of your lips, face, throat, tongue and worsening of redness, itching or swelling of the eye or eyelid.

|Do not use this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before using these eye drops.

Take special care with Sodium Cromoglicate Eye Drops if:

;• You wear soft contact lenses

You should not wear contact lenses while using these drops. If you are not sure if [the above applies to you, talk to your doctor or pharmacist before using Sodium [Cromoglicate Eye Drops.

Using other medicines

'Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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.

|lf you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking or using any medicine.

driving and using machines

Sodium Cromoglicate may interfere with your ability to drive and use machines, you may have blurred eyesight straight after using this medicine. If this happens, po not drive or use any tools or machines until you can see clearly.

Important information about some of the ingredients of Sodium Cromoglicate Eye Drops

Sodium Cromoglicate Eye Drops contains benzalkonium chloride. This may cause lyour eyes to become irritated and may change the colour of your contact lenses. Avoid contact with soft contact lenses. Remove contact lenses prior to application And wait at least 15 minutes before reinsertion.

3. HOW TO USE SODIUM CROMOGLICATE EYE DROPS

Always use Sodium Cromoglicate Eye Drops exactly as your doctor has told you. jAduits and Children over 6 years:

[One or two drops to be administered into each eye four times daily.

Children under 6 years

Sodium Cromoglicate Eye Drops should not be used in children under 6 years of age.

'Elderly

[There is no evidence to suggest that a different dose is needed for elderly patients, you should check with your doctor or pharmacist if you are not sure.

How to use this medicine !

; Using the drops for the first time:

[You must not use the bottle if the tamper-proof base ring with cap is broken before [ [you first use it. These eye drops come in a bottle with a screw cap. The inside of the[ [screw cap contains a spike. The screw cap is fitted to the bottle in such a way that [ [there is no contact between the spike and the top of the bottle. In order to open the [ [bottle it is necessary to tighten the screw cap further, so that the tamper-proof basej [ring will break. Remove the tamper-proof base ring. Further, tighten the screw cap ' 'so that the edge of the screw cap and the edge of bottle neck are totally aligned. At' 'this point the screw cap spike will pierce the top of the bottle which will open the [ [bottle. Once the bottle has been opened in this way, unscrew the screw cap fully to [ [remove it from the bottle and apply the eye drops as instructed below: [

! • Wash your hands iHjEfc'AV

!• Rotate cap clockwise to pierce the container [

I • Remove the cap from the bottle 1Y/ '

' • Tilt your head back !

[•Squeeze one or two drops inside the lower lid without touching your eye [•Closeyour 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 if needed [

[How much to use

[•One or two drops in each eye four times a day, or as directed by your doctor [•If your symptoms worsen or do not improve, talk to your doctor or pharmacist

[If you forget to use Sodium Cromoglicate Eye Drops

i|f 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 Sodium Cromoglicate Eye Drops

[You should keep using these drops if you are still around the things that you are allergic to. If you stop using Sodium Cromoglicate Eye Drops your allergy symptoms I I may come back. [

[If you have any further questions on the use of this product, ask your doctor [ [or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

[Stop using Sodium Cromoglicate Eye Drops and see a doctor as soon as [possible if: [

' • The itching, redness or swelling gets worse. You may be allergic to these drops. I

[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:

[ • 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 [

'• Mild eye irritation

|5. HOW TO STORE SODIUM CROMOGLICATE EYE DROPS j

[Keep out of the reach and sight of children.

[Do not use Sodium Cromoglicate Eye Drops after the expiry date which is stated [on the bottle label and carton after EXP. The expiry date refers to the last day of 'that month. [

[This medicinal product does not require any special storage conditions before [ [opening the bottle and after opening the bottle “Do not store above 25°C”.

[Sodium Cromoglicate Eye Drops are sterile when you buy it, so you must not keep [ [it for more than four weeks after opening the bottle.

[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. [

6. FURTHER INFORMATION

[What Sodium Cromoglicate Eye Drops contains

[•The active substance is Sodium Cromoglicate. Each 1 ml of eye drops contains [ [ 20 mg of Sodium Cromoglicate (2.0% w/v). One drop contains 0.7 mg of [ [ Sodium Cromoglicate. [

[•The other ingredients are disodium edetate, benzalkonium chloride and water ' for injections. [

[What Sodium Cromoglicate Eye Drops looks like and contents of the pack

[Sodium Cromoglicate Eye Drops is a clear colourless to pale yellow solution supplied [in a 10 ml plastic dropper bottle with a white plastic screw cap having a [

[tamper-proof base ring. [

' Marketing Authorisation Holder and Manufacturer

[Brown & Burk UK Ltd [

[5, Marryat Close !