Mylan Allercrom 2% W/V Eye Drops
Read this leaflet carefully before you start using this medicine.
This medicine is available without a prescription, however you still need to use this medicine carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 14 days.
• If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your pharmacist.
IN THIS LEAFLET:
1. What this medicine is for
2. Before you use this medicine
3. How to use the medicine
4. Possible side effects
5. Storing the medicine
6. Further information
1. WHAT THIS MEDICINE IS FOR
Sodium cromoglicate has an antiinflammatory action and reduces redness, soreness and itching in eyes affected by allergic conditions like hayfever 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 ‘hayfever eyes’ or by its medical term: seasonal allergic conjunctivitis.
If you suffer from hayfever, you can also help control your symptoms by hying to ensure low exposure to pollen when hayfever symptoms are expected. For example, keep windows closed, do not cut grass, stay indoors as much as possible.
2. BEFORE YOU USE THE MEDICINE
Do not use:
• Inchildrenunder6yearsofage.
• If you or your child are sensitive to eye drops containing sodium
cromoglicate, benzalkonium chloride or disodium edetate.
• For other allergic eye symptoms (not caused by hayfever). Other things in everydaylife can start allergies causing eye symptoms in certain people. For example contact with animals including pets, house dust mites, other particles and chemicals. Talk to your pharmacist or doctor.
I You must be confident that you or I your child’s irritated eyes are caused by hayfever, or have been previously diagnosed by your doctor to suffer from hayfever: You can be sure allergic eyes are caused by hayfever if:
• Both eyes are affected
• You also have a runny or blocked nose
• Your eyesight is not affected
• You know you suffer from hayfever and your symptoms coincide with the times ofyearwhen 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 hayfever
• 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 hayfever and you should see your doctor or pharmacist before you use these drops.
Talk to your doctor or pharmacist before use:
• If you are pregnant or breast feeding.
Important information about some of the ingredients of this medicine
This product contains benzalkonium chloride. This may cause eye irritation. Benzalkonium chloride is known to discolour soft contact lenses. Avoid contact with soft contact lenses.
For all other types of contact lenses: Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.
Driving and using machinery
This medicine can cause blurred vision for a few minutes afteruse. Ifthis happens, do not drive or operate machinery until you can see normally again.
3. HOW TO USE THE MEDICINE
Use this medicine only in your eyes. Adults (including the elderly) and children over six years:
• 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.
• 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.
If you have any questions concerning the use of these drops in a child, or are
unsure if the child has allergic eyes, you should seek advice from your doctor or pharmacist. 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 intercurrent ocular condition (e.g. trauma, ocular surgery or infection) whilst using this product, see your doctor immediately.
If your eyes are no better after 2 days of using the eye drops, see your doctor or pharmacist.
It is best to use your eye drops regularly every day while high pollen levels are expected, to keep your eye condition controlled. If you find you need to use them continuously for more than 14 days, then check with your pharmacist or doctor before continuing.
If you use more of this medicine than you should
Contact your doctor if you use the eye drops more frequently than the recommended dose.
If you forget to use this medicine
If you miss a dose, use the drops as directed above and then continue your normal course of treatment.
Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS Like all medicines, these drops 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).
Your eyes may sting a little just after you use the drops. If they sting badly, or if your eyes get worse, stop using the drops and tell your doctor or pharmacist.
You may also experience blurred vision for a short time after application.
MODE OF USE
Tighten the cap on the nozzle.
If any of the side effects get serious please tell your doctor or pharmacist.
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/vellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. STORING THE MEDICINE
Do not use the eye drops after the expiry date printed on the label.
Do not use the eye drops more than four weeks after first opening the bottle.
Do not store the eye drops above 30°C. Keep them in the original container and out of direct sunlight.
Keep bottle in outer carton.
Replace cap securely after use.
Remember: Keep all medicines out of the sight and reach of children.
6. FURTHER INFORMATION What your medicine contains
The active ingredient in this medicine is Sodium Cromoglicate 2% w/v. Also contains: sodium chloride, disodium edetate, polysorbate 80, benzalkonium chloride and water for injections
What this medicine looks like and contents of the pack
This medicine is a clear liquid available in a BFS bottle and closed with a screw cap. The bottle contains 5 or 10ml of drops.
Marketing Authorisation Holder and Manufacturer
FDC International Ltd, Unit 6, Fulcrum 1, Solent Way, Whiteley,Fareham, Hampshire, PO15 7FE Hard to see or read the leaflet?
Call + 44(0) 1489 565222 for help. This leaflet was last revised in: 06/2015
i
The spike in the cap will pierce the tip of the bottle.
Tilt head backwards. Dispense drops with gentle pressure. Do not touch dropper tip to the surface of the eye.
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