The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: sodium cromoglicateOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Optrex Hayfever Relief 2% w/v Eye Drops

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Sodium cromoglicate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Sodium cromoglicate

Equivalent medicines (same active substance, strength and form)

→ Allercrom 2% w/v Eye Drops brand

→ Allergy Relief 2% w/v eye drops, Solution brand

→ Aspire Hayfever Relief 2% w/v Eye Drops, solution brand

→ Boots Hayfever Relief 2% w/v Eye Drops brand

→ Catacrom Sodium Cromoglicate 2% Preservative Free Unit Dose Eye Drops brand

and 13 more with the same active substance, strength and form

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

Possible side effects

'These symptoms occur usually in the late spring or early summer when pollen from grasses or trees | icomes 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them. 'Stop using this medicine and see a doctor as soon as possible if: ° The itching, redness or swelling gets worse. You may be allergic to these drops.

'2. What you need to know before you use this medicine

360 mm

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'Do not use this medicine

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:

If you or your child are allergic to sodium cromoglicate or any of the other ingredients of this ' medicine (listed in Section 6)

'e 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.

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.

'e Mild eye irritation.

Reporting of side effects

If your child is under 6 years of age.

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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on

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.

the safety of this medicine.

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

How to store it

this medicine

(Warnings and precautions

Keep out of the sight and reach of children.

'¢ You must be confident that you or your child's irritated eyes are caused by hayfever, or have ' been previously diagnosed by your doctor to suffer from hayfever: You can be sure allergic eyes' ' are caused by hayfever if:

Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP. T he 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". This medicine is sterile when you buy it, so you must not keep it for more than four weeks after opening the bottle.

'° Both eyes are affected '© You also have a runny or blocked nose

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.

'° Your eyesight is not affected 'e You know you suffer from hayfever and your symptoms coincide with the times of year when | grass or tree pollen is high.

Contents of the pack and other information

But if you or your child have: ¢ No nose symptoms

What this medicine contains

'e The active substance is sodium cromoglicate. Each 1ml of eye drops contains 20mg of sodium ' cromoglicate (2.0% w/v). One drop contains 0.7mg of sodium cromoglicate.

° Your sight is affected.

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

Or if the eye symptoms:

;

What this medicine looks like and contents of the pack

f Are likely to be caused by another allergy, e.g. a pet or dust mite allergy.

This medicine is a clear colourless to pale yellow solution supplied in either a 5 ml or 10 ml plastic dropper bottle with a tamper-proof cap.

'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.

;

Marketing Authorisation Holder

Manufacturer

iif you are not sure if the above applies to you, talk to your doctor or pharmacist before using this

;

Aspire Pharma Limited, Unit 4,

Rafarm S.A. Agiou Louka str.

Pregnancy and breast-feeding

Rotherbrook Court, Bedford Road, Petersfield,

19002 Paiania Attiki

Hampshire,

Greece

'© Occur at the wrong time of year for hayfever

medicine.

'lf you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask | 'your doctor or pharmacist for advice before taking this medicine.

'Driving and using machines

This medicine may interfere with your ability to drive and use 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.

iThis medicine contains benzalkonium chloride. This may cause your eyes to become irritated and may change the colour of your soft contact lenses. 'Avoid contact with soft contact lenses. Remove all types of contact lenses before application and

wait at least 15 minutes before reinsertion.

'GU32 30G, UK.

Distributed by: 'Optrex Ltd Nottingham NG9O 2DB, UK.

This leaflet was last revised in April 2017.

Frequently asked questions about Optrex Hayfever Relief 2% w/v Eye Drops

How do I take Optrex Hayfever Relief 2% w/v Eye Drops?

Optrex Hayfever Relief 2% w/v Eye Drops comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Optrex Hayfever Relief 2% w/v Eye Drops?

The active substance in Optrex Hayfever Relief 2% w/v Eye Drops is sodium cromoglicate.

Are there equivalent medicines to Optrex Hayfever Relief 2% w/v Eye Drops?

Medicines with the same active substance, strength and form include: Allercrom 2% w/v Eye Drops, Allergy Relief 2% w/v eye drops, Solution, Aspire Hayfever Relief 2% w/v Eye Drops, solution. In total there are 18 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Optrex Hayfever Relief 2% w/v Eye Drops, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Optrex Hayfever Relief 2% w/v Eye Drops without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: sodium cromoglicate
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Sodium cromoglicate (21 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

For the relief and treatment of the eye symptoms of hayfever.

4.2. Posology and method of administration

Sodium cromoglicate 2%w/v eye drops should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist.

Ocular use

Adults and Children over 6 years:

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

Children under 6 years

There is no relevant indication for use of sodium cromoglicate in children. Sodium cromoglicate is contraindicated in children under 2 years of age.

Elderly

There is no evidence to suggest that dosage alteration is required for elderly patients.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients

4.4. Special warnings and precautions for use

Discard any remaining contents four weeks after opening the bottle.

Sodium cromoglicate eye drops contain benzalkonium chloride.

May cause eye irritation.

Avoid contact with soft contact lenses.

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

Known to discolour soft contact lenses.

The carton and patient information leaflet will state:

- The patient should consult a doctor or pharmacist if symptoms do not start to improve within 48 hours

- Hayfever 2% eye drops should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6. Fertility, pregnancy and lactation

Fertility:

It is not known whether sodium cromoglicate has any effect on fertility.

Pregnancy:

As with all medication, caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on fetal development. It should be used in pregnancy only where there is a clear need.

Lactation:

It is not known whether sodium cromoglicate is excreted in human breast milk but, on the basis of its physicochemical properties, this is considered unlikely. There is no information to suggest the use of sodium cromoglicate has any undesirable effects on the baby.

4.7. Effects on ability to drive and use machines

Sodium cromoglicate may interfere with the ability to drive and use machines.

Instillation of these eye drops may cause a transient blurring of vision. Patients are advised not to drive or operate machinery if affected, until their vision returns to normal.

4.8. Undesirable effects

Eye disorders

Transient stinging and burning may occur after instillation. Other symptoms of local irritation have been reported rarely.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/ risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.

💬 Ask about this leaflet

Ask anything about Optrex Hayfever Relief 2% w/v Eye Drops. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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