Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Sodium Cromoglicate Eye drops contain a medicine called sodium cromoglicate. This 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. Sodium Cromoglicate Eye drops is used for the relief and treatment of eye allergies. These allergies can happen:
At any time of the year and is called „perennial allergic conjunctivitis‟ In different seasons of the year caused by different pollens. This is called „seasonal allergic conjunctivitis‟ or hay fever 2. BEFORE YOU USE SODIUM CROMOGLICATE EYE DROPS Do not use Sodium Cromoglicate Eye Drops - if you are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of Sodium Cromoglicate Eye Drops (listed in Section 6: Further information) 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. 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. Using other medicines
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium cromoglicate
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.
Adults and Children over 6 years:
One or two drops to be administered into each eye four times daily.
Children under 6 years Sodium Cromoglicate Eye drops should not be used in children under 6 years of age.
Elderly
There is no evidence to suggest that a different dose is needed for elderly patients.
You should check with your doctor or pharmacist if you are not sure. Opening the dropper container before first use Note: Do not use the bottle if the tamper-proof base ring with cap is broken before you first use it.
1. Turn the cap in counter clockwise direction. This will break the tamper-proof base ring (Fig.1).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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 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. Important information about some of the ingredients of Sodium Cromoglicate Eye Drops Sodium Cromoglicate Eye drops contains 0.1 mg 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.
2. Remove the tamper-proof base ring by retaining the cap on the container (Fig.2).
3. Tighten the cap on the nozzle so that the edge of the cap and the edge of bottle neck are totally aligned. Turning the screw cap clockwise will pierce the tip of the dropper container. (Fig.3).
4. To open the dropper container, remove the cap by turning it in the counter clockwise direction (Fig.4).
5. Tighten the cap on the container after every use (Fig.5).
How to use this medicine 6. Wash your hands, tilt your head back and look at the ceiling (Fig.6).
7. Gently pull the lower eyelid down to form a small pocket between the eyelid and the eye. (Fig. 7).
8. Turn the dropper container upside down and squeeze it gently to release one drop into each eye that needs treatment. Do not touch your eye or eyelid with the dropper tip (Fig. 8). If a drop misses your eye, try again.
Close your eye after placing the drop(s) in your eye. Wipe away any excess liquid from the eyes with a clean tissue. 9. Reclose the dropper container after use (Fig.9). Repeat in the other eye if needed. The next time you need to apply the drops follow steps 6-9
How much to use
One or two drops in each eye four times a day, or as directed by your doctor If your symptoms worsen or do not improve, talk to your doctor or pharmacist If you use more of Sodium Cromoglicate than you should Contact your doctor if you use the eye drops more frequently than the recommended dose, or continously for more than three months. 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 You should keep using these drops if you are still around the things that you are allergic to. If you stop using Sodium Cromoglicate Eye drops your allergy symptoms may come back. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Sodium Cromoglicate Eye Drops 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 Yellow Card Scheme at Website: 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.
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.
The active substance in Sodium Cromoglicate 2% w/v Eye Drops, Solution 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 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.
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 relief and treatment of seasonal and perennial allergic conjunctivitis.
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.
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.
Sodium cromoglicate eye drops contains benzalkonium chloride.
As with other ophthalmic solutions containing benzalkonium chloride, soft contact lenses should not be worn during the 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.
Sodium cromoglicate can be used prophylactically. Patients should seek advice before they discontinue use of the product.
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 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.
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.
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 Yellow Card Scheme at
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
No action other than medical observation should be necessary.
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.
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