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.
Sodium Cromoglicate 2% w/v Eye drops, solution
⚠ 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.
What it is and what it is used for
for
Sodium Cromoglicate Eye drops contains a medicine called sodium cromoglicate. This belongs to a group of medicines called antiallergics. 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. Sodium Cromoglicate Eye drops are used for the prevention, relief and treatment of eye allergies. This includes: • •
2.
Short and long term allergic conjunctivitis (inflammation of parts of the eye) More severe cases of conjunctivitis ('vernal kerato conjunctivitis'). Signs include bumps inside the upper eyelid, sensitivity to light and severe itching.
What you need to know before you take it
e Sodium Cromoglicate Eye drops
Do not use Sodium Cromoglicate Eye drops: If you are allergic 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 Sodium Cromoglicate Eye drops.
Warnings and precautions Take special care with Sodium Cromoglicate Eye drops 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 Sodium Cromoglicate Eye drops. Other medicines and Sodium Cromoglicate Eye drops Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding Talk to your doctor before using this medicine if you are pregnant, might become pregnant or think you may be pregnant. 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. Sodium Cromoglicate Eye drops contain benzalkonium chloride. This medicine contains 0.1 mg benzalkonium chloride in each ml. 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 Sodium Cromoglicate Eye drops
Always take this medicine exactly as your doctor or pharmacist has told you. 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 tamperproof 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, but ask your doctor.
If you use more Sodium Cromoglicate Eye drops than you should Talk to your doctor or go to a hospital straight away. Remember to take any medicine that is left with you so the doctor knows what you have taken. If you forget to use Sodium Cromoglicate Eye drops 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 Sodium Cromoglicate Eye drops Keep using the 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 medicine, 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 Sodium Cromoglicate Eye drops 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 or pharmacist. 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 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 it
Sodium Cromoglicate Eye drops
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 carton label after EXP. The expiry date refers to the last day of that month.
Store below 30°C. Store in the original package in order to protect from light. Do not use the eye drops more than four weeks after first 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 Sodium Cromoglicate Eye drops contain • •
The active substance is sodium cromoglicate. Each ml of eye drops solution contains 20 mg of sodium cromoglicate. The other ingredients are: benzalkonium chloride, disodium edetate and water for injections. See section 2, "Sodium Cromoglicate Eye drops contain benzalkonium chloride".
What Sodium Cromoglicate Eye drops look like and contents of the pack Sodium Cromoglicate Eye drops is a sterile, clear, colourless to pale yellow solution. It is supplied in plastic bottle with a nozzle and tamper evident plastic screw cap. Each bottle contains 10 ml or 13.5 ml of this medicine. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Neon Healthcare Ltd. 8 The Chase John Tate Road, Hertford United Kingdom Manufacturer TUBILUX PHARMA S.P.A. Via Costarica, 20/22, Pomezia, 00071, Italy This leaflet was last revised in 11/2023.
Frequently asked questions about Sodium Cromoglicate 2% w/v Eye drops, solution
How do I take Sodium Cromoglicate 2% w/v Eye drops, solution?
Sodium Cromoglicate 2% w/v Eye drops, solution 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 Sodium Cromoglicate 2% w/v Eye drops, solution?
The active substance in Sodium Cromoglicate 2% w/v Eye drops, solution is sodium cromoglicate.
Are there equivalent medicines to Sodium Cromoglicate 2% w/v Eye drops, solution?
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 Sodium Cromoglicate 2% w/v Eye drops, solution, 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 Sodium Cromoglicate 2% w/v Eye drops, solution 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 →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal kerato conjunctivitis.
4.2. Posology and method of administration
Posology
Adults and children: one or two drops into each eye four times daily or as indicated by the doctor.
Elderly: no current evidence for alteration of the dose.
Method of administration
Ocular use.
4.3. Contraindications
Hypersensitivity to the active substance(s) 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.
As with other ophthalmic solutions containing benzalkonium chloride, soft contact lenses should not be worn during treatment period.
This medicinal product contains 0.1mg benzalkonium chloride in each ml.
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
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 clinical need.
Breast-feeding
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.
Fertility
There are no fertility data available.
4.7. Effects on ability to drive and use machines
As with all eye drops, instillation of Sodium Cromoglicate 2% w/v Eye drops, solution may cause a transient blurring of vision or local irritation that could impact driving or operating machinery. Do not drive or operate machinery if affected.
4.8. Undesirable effects
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
No action other than medical observation should be necessary.
💬 Ask about this leaflet
Ask anything about Sodium Cromoglicate 2% w/v Eye drops, solution. 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.
Medicines containing Sodium cromoglicate
- Allercrom 2% w/v Eye Drops
- Allergy Relief 2% w/v eye drops, Solution
- Aspire Hayfever Relief 2% w/v Eye Drops, solution
- Catacrom Sodium Cromoglicate 2% Preservative Free Unit Dose Eye Drops
- Eycrom 2% w/v eye drops, solution
- Librachrom 2% w/v eye drops, solution
- Librachrom Hayfever Relief 2% w/v eye drops, solution
- Opticrom Allergy 2% w/v Eye Drops, Solution (Aspire MAH)
- Opticrom Allergy Single Dose 2% w/v Eye Drops, Solution
- Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH)
- Opticrom Hayfever 2% w/v Eye Drops, solution (Aspire MAH)
- Optrex Allergy 2% w/v Eye Drops, Solution (eye drops)
- Optrex Hayfever Relief 2% w/v Eye Drops
- Sodium cromoglicate 100mg/5ml oral solution