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

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

Package leaflet: Information for the user

Opella Hayfever 2% w/v Eye Drops sodium cromoglicate

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

This medicine is available without prescription. However, you still need to use Opella Hayfever 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 after 14 days

In this leaflet

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

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

Opella Hayfever 2% Eye Drops (called Opella Hayfever in this leaflet) contains 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.

These symptoms occur usually in the late spring or early summer when pollen from grasses or trees comes into contact with the eyes of people who are sensitive to them. This condition is sometimes called ‘hayfever eyes’ or by its medical term: seasonal allergic conjunctivitis.

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

Do not use Opella Hayfever if:

If you or your child are allergic (hypersensitive) to sodium cromoglicate, or any of the other ingredients of Opella Hayfever (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
If your child is under 6 years of age
For other allergic eye symptoms (not caused by hayfever). Other things in everyday life can start allergies causing eye symptoms in certain people. For example contact with animals including pets, house dust mites, other particles and chemicals. Talk to your pharmacist or doctor.

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 Hayfever.

Warnings and precautions

Both eyes are affected
You also have a runny or blocked nose
Your eyesight is not affected
You know you suffer from hayfever and your symptoms coincide with the times

of year when grass or tree pollen is high.

But if you or your child have:

No nose symptoms
Only one eye is affected
Your sight is affected

Or if the eye symptoms:

occur at the wrong time of year for hayfever
are likely to be caused by another allergy, e.g., a pet or dust mite allergy

then you cannot be sure that the condition is due to hayfever and you should see your doctor or pharmacist before you use these drops.

If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Opella Hayfever.

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 Hayfever contains benzalkonyum chloride

Opella Hayfever contains benzalkonium chloride. This may cause your eyes to become irritated. Benzalkonium chloride is known to discolour soft contact lenses. Avoid contact with soft contact lenses.

For all other types of contact lenses:

Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.

3. how to use opella hayfever

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

Adults (including the elderly) and children over 6 years

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

If you have any questions concerning the use of these drops in a child, or are unsure if the child has allergic eyes, you should seek advice from your doctor or pharmacist.

If your eyes are no better after 2 days of using the eye drops, see your doctor or pharmacist.

It is best to use your eye drops regularly every day while high pollen levels are expected, to keep your eye condition controlled. If you find you need to use them continuously for more than 14 days, then check with your pharmacist or doctor before continuing

If you use more Opella Hayfever than you should

Contact your doctor if you use the eye drops more frequently than the recommended dose.

If you forget to use Opella Hayfever

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 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 Hayfever 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. 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 hayfever

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

Do not use Opella Hayfever after the expiry date which is stated on the 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 Hayfever 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 Hayfever 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 Hayfever looks like and contents of the pack

Opella Hayfever is a clear colourless to pale yellow solution supplied in a 5 ml or 10 ml plastic dropper bottle with a tamperproof cap. Not all pack sizes may be marketed.

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.

This leaflet was last revised in 11/2021