Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
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:
E THIS MEDICINE Do not use this medicine:
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.
this medicine
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:
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
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.
What this medicine contains
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
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.
The active substance in Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH) is sodium cromoglicate.
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.
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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal keratoconjunctivitis.
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.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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
No interaction studies have been performed.
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.
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.
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.
Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.
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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