OPELLA ALLERGY 2.0% W/V EYE DROPS SOLUTION - patient leaflet, side effects, dosage

Patient leaflet - OPELLA ALLERGY 2.0% W/V EYE DROPS SOLUTION

Package leaflet: Information for the user

Opella Allergy 2% w/v Eye Drops sodium cromoglicate

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Phone 0800 035 2525 for help

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

This medicine is available without prescription. However, you still need to use Opella Allergy carefully to get the best results from it.

– 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.

–

In this leaflet

1. What Opella Allergy is and what it is used for
2. What you need to know before you use Opella Allergy
3. How to use Opella Allergy
4. Possible side effects
5. How to store Opella Allergy
6. Contents of the pack and other information

1. what opella allergy is and what it is used for

Opella Allergy 2% Eye Drops (called Opella Allergy in this leaflet) contain a medicine called sodium cromoglicate. This belongs to a group of medicines called anti-allergics.

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

Opella Allergy is used for the prevention and treatment of eye 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

2. what you need to know before you use opella allergy

Do not use Opella Allergy if:

You are allergic (hypersensitive) to sodium cromoglicate, or any of the other ingredients of Opella Allergy (listed in Section 6).

Signs 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 Opella Allergy.

Warnings and precautions

Talk to your doctor or pharmacist before using Sodium Cromoglicate 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 Opella Allergy.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this this medicine.

If 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

You may have blurred eyesight straight after using this medicine. If this happens, do not drive or use any tools or machines until you can see clearly.

Opella Allergy contains benzalkonium chloride

Opella Allergy contains benzalkonium chloride. This may cause your eyes to become irritated. It may also change the colour of your contact lenses.

3. how to use opella allergy

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How to use this medicine

Wash your hands
Remove the cap from the bottle
Tilt your head back
Squeeze one or two drops inside the lower lid without touching your eye
Close your 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 use more Opella Allergy than you should

Contact your doctor if you use the eye drops more frequently than the recommended dose, or continuously for more than three months.

If you forget to use Opella Allergy

If 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 Opella Allergy

Even if your symptoms have got better, you should keep using these drops if you are still around the things that you are allergic to. Opella Allergy can prevent you getting an allergic reaction so if you stop using it, your allergy symptoms 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, this medicine can cause side effects, although not everybody gets them.

Stop using Opella Allergy and see a doctor as soon as possible if:

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

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

United Kingdom

You can also report side effects directly via the Yellow Card Scheme at:

or search for MHRA Yellow Card in the Google Play or Apple

App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store opella allergy

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle label and carton. The expiry date refers to the last day of that month.

Store below 30°C. Keep the bottle in the outer carton in order to protect from light.

Opella Allergy is sterile when you buy it, so you must not keep it for more than four weeks after opening the bottle.

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 Opella Allergy contains

The solution contains 2.0% w/v of the active substance, sodium cromoglicate
The other ingredients are disodium edetate, benzalkonium chloride and purified water

What Opella Allergy looks like and contents of the pack

Opella Allergy is a clear colourless to pale yellow solution supplied in a 5 ml or 10 ml plastic dropper bottle with a tamper-proof cap

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK.

Tel: 0800 035 2525

email:

Manufacturer

Sanofi Winthrop Industrie, Boulevard Industriel, 76580 Le Trait, France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.