Patient leaflet - SODIUM CROMOGLICATE 2% W/V EYE DROPS
SODIUM CROMOGLICATE 2% W/V EYE DROPS sodium cromoglicate
The name of your medicine is Sodium Cromoglicate Eye Drops, which will be referred to as ‘Sodium Cromoglicate Drops’ throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse within a few days.
What is in this leaflet
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1. What Sodium Cromoglicate Drops are and what they are used for
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2. What you need to know before you use Sodium Cromoglicate Drops
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3. How to use Sodium Cromoglicate Drops
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4. Possible side effects
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5. How to store Sodium Cromoglicate Drops
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6. Contents of the pack and other information
1. What Sodium Cromoglicate Drops are and what they are used for
Sodium Cromoglicate Drops contain the active substance sodium cromoglicate.
Sodium cromoglicate belongs to a group of medicines called anti-allergics.
Sodium Cromoglicate Drops are used for the relief and treatment of the eye symptoms of hay fever. They work by reducing the body’s response to the allergy when used regularly during the course of treatment.
These symptoms occur usually in the late spring or early summer when pollen from grasses or trees comes into contact with the eyes of people who are sensitive to them. This condition is sometimes called ‘hay fever eyes’ or by its medical term, seasonal allergic conjunctivitis.
If you suffer from hay fever, you can also help control your symptoms by trying to ensure low exposure to pollen when hay fever symptoms are expected. For example, keep windows closed, do not cut grass, stay indoors as much as possible.
You must talk to a doctor if you do not feel better or if you feel worse within a few days.
2. what you need to know before you use sodium cromoglicate drops if you are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of this medicine (listed in section 6). an allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
You must be confident that you or your child’s eye symptoms are caused by hay fever, or have been previously diagnosed by your doctor to suffer from hay fever: You can be sure allergic eyes are caused by hay fever if:
- both eyes are affected
- you also have a runny or blocked nose
- your eyesight is not affected
- you know you suffer from hay fever and your symptoms coincide with the times of year when grass or tree pollen is high.
But if you or your child have:
- no nose symptoms
- only one eye is affected
- your sight is affected
Or if the eye symptoms:
- occur at the wrong time of year for hay fever
- are likely to be caused by another allergy, e.g. a pet or dust mite allergy
then you cannot be sure that the condition is due to hay fever and you should see your doctor or pharmacist before you use these drops.
Warnings and precautions
Talk to your doctor or pharmacist before using Sodium Cromoglicate Drops.
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
This medicine can cause blurred vision for a few minutes after use. If this happens, do not drive or operate machinery until you can see normally again.
Sodium Cromoglicate Drops contain benzalkonium chloride
- Your eye drops also contain benzalkonium chloride, which may cause eye irritation in a few people.
- Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.
3. how to use sodium cromoglicate drops
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is as follows.
Adults (including older people) and children:
- Place one or two drops into each eye four times daily.
- Wash your hands before using the drops.
- Tilt your head back and carefully pull down your lower eyelid.
[Insert diagram]
Without touching the eyelid with the tip of the dropper, put one or two drops into your lower lid and then blink a few times to make sure your whole eye is covered by the liquid.
Replace the cap securely on the bottle.
Use in children
If you have any questions concerning the use of these drops in a child, or are unsure if the child has eye symptoms of hay fever, you should seek advice from your doctor or pharmacist.
If you use more Sodium Cromoglicate Drops than you should
Talk to your doctor or a pharmacist if you use more of the eye drops than you should, or if anyone accidentally swallows any of the medicine.
If you forget to use Sodium Cromoglicate Drops
If you miss a dose, use the drops as directed, and then continue your normal course of treatment. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell 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).
The following side effects have been reported:
Not known (frequency cannot be estimated from the available data):
- temporary stinging and blurring of vision
Rare (may affect up to 1 in 1,000people)
- other symptoms of 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:.
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store sodium cromoglicate drops
Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep the bottle in the outer carton to protect from light
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not use this medicine more than 28 days after first opening the bottle. Discard any unused medicine after this time.
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 informationthe active substance is sodium cromoglicate 2% w/v.
The other ingredients are: disodium edetate, benzalkonium chloride and water.
What Sodium Cromoglicate Drops look like and contents of the pack
The medicine is a clear liquid in white plastic tamper-evident bottles fitted with a dropper and closed with a screw cap. The bottle contains 5ml or 10ml of Eye Drops Solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
PLIVA Pharma Ltd, Ridings Point, Whistler Drive, Castleford, WF10 5HX, UK.
Manufacturer:
Alcon Cusi SA, C/Camil Fabra, 58 El Masnou, Barcelona, Spain.
This leaflet was last revised in February 2015.
PL 10622/0016