Sodium Cromoglicate 2% W/V Eye Drops Solution
Ifyou have any further questionson the useof this product, askyour doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FORTHE USER
Sodium Cromoglicate 2% w/v Eye Drops, solution m
Sodium cromoglicate brown & BURK
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, askyour doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are thesame as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed In this leaflet, please tell your doctor or pharmacist.
What Sodium Cromoglicate Eye Drops is and what it is used for Before you use Sodium Cromoglicate Eye Drops Howto use Sodium Cromoglicate Eye Drops Possible side effects
Howto store Sodium Cromoglicate Eye Drops Further information
Sodium Cromoglicate Eye drops contain a medicine called sodium cromoglicate.
This belongs to agroupof medicines called antl-allerglcs.
It works by stopping the release of the natural substances in your eyes that can lead to an allergic reaction. Signsof 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 anytimeofthe year and is called 'perennial allergic conjunctivitis'
• In differentseasonsofthe year caused by different pollens.
This is called'seasonal allergic conjunctivitis'or hayfever
Do not use Sodium Cromoglicate Eye Drops
• If you are allergic (hypersensitive) to sodium cromoglicateor anyoftheother 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 oftheeyeor eyelid Do not use this medicine If the above applies to you. If you are not sure, talkto your doctor or pharmacist before using these eye drops.
TakespecialcarewithSodiumCromoglicateEyeDropsif:
• You wearsoft 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
Please tell your doctor or pharmacist if you are taking or have recentlytaken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Talkto 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 ofthe ingredients of Sodium Cromoglicate Eye Drops
Sodium Cromoglicate Eye drops contains Penzalkonium chloride. This may cause your eyes to become irritated and may change the colour of your contact lenses. Avoid contact with soft contact lenses. Remove contact lenses priorto application and wait at least 15 minutes before reinsertion.
Always use Sodium Cromoglicate Eye Drops exactly as your doctor has told you.
Adults and Children over 6 years:
OneortwodropstoPeadministeredintoeacheyefourtimes daily.
Children under6vears
Sodium Cromoglicate Eye drops should not be used in children under 6years of age.
Elderly
There Is no evidence to suggest that a different dose Is needed for elderly patients.
You should check with your doctoror pharmacist if you are not sure.
Using the Props for the first time:You must not use the Pottle if the tamper-proof base ring with cap is broken before you first use it. These eyedrops come in a Pottle with a screw cap. The inside of the screw cap contains a spike. The screw cap Is fitted to the Pottle in such a way that there is no contact between the spike and the top ofthe Pottle. In order to open the Pottle it is necessaryto tighten the screw cap further, so that the tamper-proof base ring will break. Remove the tamperproof base ring. Further, tighten the screw cap so that the edge of the screw cap and the edge of Pottle neck are totally aligned. At this point the screw cap spike will pierce the top of the Pottle which will open the Pottle. Oncethe Pottle has been opened in this way unscrewthesc fullyto remove itfrom the bottle and applythe eye drops as instructed below:
• Wash your hands
• Rotate cap clockwise to pierce the container
• Remove the capfrom the Pottle
• Tiltyourheadback
• Squeezeoneor two drops inside the lower lid without touching your eye
• Closeyoureye
• Wipe away any excess liquid from the eyes with a clean tissue
• Always put the cap Packon the Pottle assoon as you have used it
• Repeat in the other eye if needed How much to use
• One or two drops in each eye four times a day, or as directed Pyyour doctor
• If your symptoms worsen or do not improve, talkto your doctoror pharmacist If you forget to use Sodium Cromoglicate Eye Drops
Ifyou 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 upforaforgotten dose.
Ifyou stop using Sodium Cromoglicate Eye Drops
You should keep using these drops ifyou are still around the things that you are allergic to. Ifyou stop using Sodium Cromoglicate Eye drops your allergy symptoms may come Pack.
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 assoon as possible if:
• The itching, rednessorswelling gets worse. You may be allergicto these drops.
Talk to your doctor or pharmacist if any ofthe side effects gets serious or lasts longer than afewdays, 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 lastfor a short time and occurs immediately after using the eye drops
• Mild eye irritation
Keepout of the reach and sight of children.
Do not use Sodium Cromoglicate Eye Drops after the expiry date which is stated on the Pottle label and carton after EXP. The expiry date refers to the last day ofthat month.
This medicinal product does not require any special storage conditions before opening the bottle and after opening the Pottle" Do not store above25°C". Sodium Cromoglicate Eyedrops is sterile when you buy it, so you must not keep itfor more than four weeks afteropening the Pottle. Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Sodium Cromoglicate Eye Drops contains
• The active substance is sodium cromoglicate. Each 1ml of eye drops contains 20mg of sodium cromoglicate (2.0% w/v). One drop contains 0.7mg of sodium cromoglicate.
• Theotheringredientsaredisodiumedetate, Penzalkonium chloride and water for injections. What Sodium Cromoglicate Eye Drops looks like and contents ofthe pack
Sodium Cromoglicate Eyedrops is a clear colourless to pale yellow solution supplied in either a 5
ml or 10 ml plastic dropper Pottle with a white plastic screw cap having a tamper-proof base ring.
Marketing Authorisation Holderand Manufacturer
Brown&BurkUKLtd
5, Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK
This medicinal product is authorised in the Member States ofthe EEA under the following names:
UK: Sodium Cromoglicate 2% w/v Eye Drops, solution DE: Natriumcromoglicat-Brown 20mg/mlAugentropfen PT: Cromoglicato de Sodio Brown 20mg/ml Colirio, solugao
This leaflet was last approved in 03/2013.
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