Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH)

⚠ 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)

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

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

FOR This medicine contains sodium cromoglicate which 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. This medicine is used for the prevention, relief and treatment of eye allergies. This includes:

  • Short and long term allergic conjunctivitis (inflammation of parts of the eye)
  • More severe cases of conjunctivitis ('vernal keratoconjunctivitis'). Signs include bumps inside the upper eyelid, sensitivity to light and severe itching.

What you need to know before you take it

E THIS MEDICINE Do not use this medicine:

  • If you are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of this medicine (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 these eye drops. Warnings and precautions Talk to your doctor or pharmacist before using this medicine
  • If you wear soft contact lenses. You should not wear contact lenses while using these drops. Other medicines and Opticrom Aqueous 2% w/v Eye Drops, solution Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding If 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 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, do not drive or use any tools or machines until you can see clearly. This medicine contains benzalkonium chloride This medicine contains 100 micrograms of benzalkonium chloride in each ml of solution. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

3. HOW TO USE THIS MEDICINE Always use this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

How to take it

this medicine

  • Wash your hands.
  • Before using the medication for the first time, be sure that the tamper-proof seal on the bottle neck is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.
  • 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 (adults, elderly and children)
  • One or two drops in each eye four times a day, or as directed by your doctor. If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, ask your doctor. If you use more of this medicine than you should Talk to your doctor or pharmacist or go to the hospital straight away. Remember to take any medicine that is left with you so the doctor knows what you have used. If this medicine is accidentally swallowed, talk to your doctor or pharmacist. If you forget to use this medicine 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 this medicine Keep using these eye drops until your doctor tells you to stop. Do not stop using the eye drops just because your eyes feel better. 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 this medicine and see a doctor as soon as possible if:

  • The itching, redness or swelling gets worse. You may be allergic to this medicine. Talk to your doctor or pharmacist if any of the side effects get serious or last 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 occur 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 (www.mhra.gov.uk/yellowcard 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.

(Pharmacode Direction)

(Pharmacode Direction)

PACKAGE LEAFLET: INFORMATION FOR THE USER

(Pharmacode Direction)

Front Side

Back Side

How to store it

THIS MEDICINE 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 after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions before opening the bottle. 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. 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.

Contents of the pack and other information

What this medicine contains

  • The active substance is sodium cromoglicate. 1ml of eye drops contains 20mg of sodium cromoglicate.
  • The other ingredients are disodium edetate, benzalkonium chloride and water for injections. What this medicine looks like and contents of the pack Opticrom Aqueous 2% w/v Eye Drops is a clear colourless to pale yellow solution supplied in either a 5ml, 10ml or 13.5ml plastic dropper bottle with a tamper-proof cap. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Aspire Pharma Limited Unit 4, Rotherbrook Court Bedford Road Petersfield Hampshire GU32 3QG United Kingdom Distributor Thornton & Ross Ltd. Linthwaite Huddersfield HD7 5QH United Kingdom Manufacturer

OPTICROM AQU 2_ EDR 13.5ML TR GB_PIL

Rafarm S.A. Agiou Louka str. 19002 Paiania Attiki Greece

9353356_2307 GB N/A Rafarm S.A. N/A

This leaflet was last revised in 08/2023

135 x 550 mm 10pt – 16pt N/A N/A N/A N/A Black Keyline (Non-Printing) Technical Info (Non-Printing)

1

13.09.2023

93533562307 GB

Frequently asked questions about Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH)

How do I take Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH)?

Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH) 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 Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH)?

The active substance in Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH) is sodium cromoglicate.

Are there equivalent medicines to Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH)?

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 Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH), 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 Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH) 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.

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 prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal keratoconjunctivitis.

4.2. Posology and method of administration

Ocular use

Adults and Children:

One or two drops to be administered into each eye four times daily or as indicated by the doctor.

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 listed in section 6.1.

4.4. Special warnings and precautions for use

Discard any remaining contents four weeks after opening the bottle.

This medicine contains Benzalkonium Chloride

As with other ophthalmic solutions containing Benzalkonium chloride, soft contact lenses should not be worn during treatment period.

From the limited data available, there is no difference in the adverse event profile in children compared to adults. Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use

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 foetal 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 has a minor influence on the ability to drive and use machines.

As with all eye drops, 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

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

💬 Ask about this leaflet

Ask anything about Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH). 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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