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% wv Eye Drops (POM)
⚠ 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 The active ingredient Sodium Cromoglicate belongs to a group of medicines called anti-inflammatory/anti-allergy agents. Sodium Cromoglicate Eye Drops are used to treat red, watery, itchy eyes caused by allergies such as hayfever, house dust mites and pet hair.
What you need to know before you take it
e Sodium Cromoglicate Do not use Sodium Cromoglicate 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. Warning 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 eye drops. Other medicines and Sodium Cromoglicate Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without any prescription. 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 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 contains benzalkonium chloride: This medicine contains 0.10 mg /ml benzalkonium chloride as preservative. 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.
How to take it
Sodium Cromoglicate Always use Sodium Cromoglicate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The recommended dose is one or two drops in each eye four times daily or as directed by your doctor.
If you are using in combination with another eye drop medicine, wait 5-15 minutes before applying the second eye drop. If your symptoms do not improve within 2 days, or if you need to use these drops for more than 3 months, you should consult your doctor. Instructions for use: (Please also refer to pictograms at the end of the leaflet)
First wash your hands Avoid touching the eye (or any other surface) with the tip of the bottle If you wear soft contact lenses, they should be removed before using the eye drops and wait at least 15 minutes before reinserting These drops are supplied as a sealed bottle with a spiked cap. When using the bottle for the first time, screw the cap down tightly in order to pierce the tip of the bottle Tilt your head back and look at the ceiling Pull the lower eyelid gently downwards Hold the bottle upside down above the eye and gently squeeze the bottle to release a drop into your eye Keep the affected eye closed and press your fingertip against the inside corner of the closed eye, and hold for 1 minute Repeat for the other eye if necessary Replace and tighten the cap immediately after use.
Be careful not to touch the tip of the bottle on your eye or on any other surface. Ocular solutions, if handled wrongly, can become contaminated by common bacteria and cause eye infections. If you do develop any other eye condition whilst using this product, see your doctor immediately. If you use more Sodium Cromoglicate 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 you forget to use Sodium Cromoglicate Apply the drops as soon as you remember. However, if it is almost time for your next dose, do not double your dose and carry on with the normal schedule dose. If you stop using Sodium Cromoglicate 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, Sodium Cromoglicate can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare. Stop taking this medicine and see your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash, or itching (especially affecting your whole body). You may be allergic to these drops. 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. 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.
How to store it
Sodium Cromoglicate Keep this medicine out of the sight and reach of children. Do not store at a temperature above 300C. Protect from direct sunlight Discard the bottle 28 days after opening, even if there is solution remaining. Do not use Sodium Cromoglicate after the expiry date which is stated on the bottle and on the carton the bottle is packed in. The expiry date refers to the last day of that month. Make sure the container is properly closed. 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 to protect the environment.
6. Content of the pack and other information What Sodium Cromoglicate contains The active ingredient is Sodium Cromoglicate 2% w/v. The eye drops also contain benzalkonium chloride (as preservative) 0.01% w/v, sodium chloride, disodium edetate, polysorbate 80 and water for injections. What Sodium Cromoglicate looks like and contents of the pack Each bottle contains 13.5ml of Sodium Cromoglicate Eye Drops. Your medicine is a clear colourless solution, free from visible particulate matter. Marketing Authorisation Holder and Manufacturer FDC International Ltd, Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE United Kingdom Tel: + 44 (0) 1489 565222 E-mail: [email protected] PL number: 15872/0010 (13.5ml) Hard to see or read the leaflet? Call + 44(0) 1489 565222 for help. This leaflet was last revised in: October 2020
MODE OF USE
Frequently asked questions about Sodium Cromoglicate 2% wv Eye Drops (POM)
How do I take Sodium Cromoglicate 2% wv Eye Drops (POM)?
Sodium Cromoglicate 2% wv Eye Drops (POM) 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% wv Eye Drops (POM)?
The active substance in Sodium Cromoglicate 2% wv Eye Drops (POM) is sodium cromoglicate.
Are there equivalent medicines to Sodium Cromoglicate 2% wv Eye Drops (POM)?
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% wv Eye Drops (POM), 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% wv Eye Drops (POM) 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
The prevention and treatment of acute, seasonal and perennial allergic conjunctivitis.
4.2. Posology and method of administration
Adults and Children : One or two drops into each eye up to four times a day or as indicated by the doctor.
Elderly: There is no current evidence for alteration of the dose.
Route of administration: Topical ophthalmic.
4.3. Contraindications
Patients with known hypersensitivity to any of the ingredients listed in section 6.1.
4.4. Special warnings and precautions for use
This formulation of Sodium Cromoglicate Eye Drops contains 0.1mg/ml (4.5 micrograms per dose) benzalkonium chloride as a preservative which may be deposited in soft contact lenses. Hence, Sodium Cromoglicate Eye Drops should not be used while wearing these lenses. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use.
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.
Patients should also be instructed that ocular solutions, if handled improperly can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Patients should also be advised that if they develop any intercurrent ocular condition (e.g. trauma, ocular surgery or infection), they should immediately seek their physician's advice concerning the continued use of present multi-dose container. There have been reports of bacterial keratitis associated with the use of topical ophthalmic products.
4.5. Interaction with other medicinal products and other forms of interaction
None known
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 based on its physicochemical properties this is considered unlikely Therefore caution should be exercised when the eye drops are administered to nursing mothers.
4.7. Effects on ability to drive and use machines
Transient stinging or blurring of vision may occur on instillation of the drops. Do not drive or use machinery until normal vision is restored.
4.8. Undesirable effects
Transient stinging and burning on instillation of the drops. Rarely, other symptoms of local irritation.
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 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
Medical observation is recommended in cases of overdosage.
Sodium cromoglicate is poorly absorbed both from the eye and from the gastrointestinal tract.
💬 Ask about this leaflet
Ask anything about Sodium Cromoglicate 2% wv Eye Drops (POM). 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