Cromo Singles 2% W/V Eye Drops
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Cromo Singles 2% w/v Eye Drops sodium cromoglicate package leaflet To be :
Black on white
double sided A5 size book folded to A6 Paper of grade not less than 40g/m2 Font Arial MT Point size 8
6. Further information
What Cromo Singles 2% Eye Drops contains:
• The active substance is sodium cromoglicate 2% w/v
• The other ingredient is purified water
What Cromo Singles looks like and contents of the pack
Clear, colourless to pale yellow sterile solution; practically free from visible particles in 0.4ml single-dose containers for single use only. The contents of each single-dose container are sterile if unopened. Supplied as 20 singledose containers (4 strips of 5 single-dose containers) in an outer carton.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Four Pharmaceuticals Ltd, 23 Upper Green Road, Tewin, Welwyn, Hertfordshire, AL6 OLE, UK. Tel:+44 (0)1438 714644. E-mail:fp@fourpharm.demon.co.uk The manufacturer is Holopack Verpackungstechnik GmbH, D-74429 Sulzbach-Laufen, Germany.
Tel:+49 7976 98800. Email: Mail@holopack.de
Is this leaflet hard to see or read? Call 01438 714644 for help
This leaflet was revised in April 2012 Ref no: 4P003-P1
Read all of this leaflet carefully because it contains important
information for you
• This medicine is available without prescription but you still need to use it carefully
• It is only for you. Do not share it with anyone else
• Keep this leaflet. You may need to read it again
• Ask your doctor or pharmacist if you need more information or advice
• You must contact a doctor if your symptoms worsen or do not improve within 2 days or if you need to use them for more than 3 months
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1 What Cromo Singles are and what are they used for
2 Before you use Cromo Singles
3 How to use Cromo Singles
4 Possible side effects
5 How to store Cromo Singles
6 Further information
1. What Cromo Singles are and what are they used for
Cromo Singles eye drops contain sodium cromoglicate 2% for single use. The eye drops prevent and relieve allergic conjunctivitis (eye irritation) in conditions such as hay fever, chronic allergic conjunctivitis and vernal kerato conjunctivitis. It works by inhibiting the agents which cause the allergic reaction.
2. Before you use Cromo Singles
Allergic symptoms usually affect both eyes and the nose, and do not impair vision, except by producing excessive tears. If only one eye is affected, or you do not have a runny nose, or your eyesight is impaired, you should consult your doctor Do not use these eye drops
• if you are allergic (hypersensitive) to sodium cromoglicate
• whilst wearing contact lenses
Cromo Singles do not contain antimicrobial preservative and may be used by patients who are hypersensitive to preservatives Use in children and the elderly. There are no age restrictions for using this product
Using other medicines. Sodium cromoglicate has a local action in the eye and it is not likely to affect or be affected by other medication Pregnancy and breast-feeding. Cromo Singles have not been studied for use during pregnancy and lactation. Anticipated benefit should be weighed against possible hazards. Sodium cromoglicate is poorly absorbed and is unlikely to affect the baby
Driving and using machines. As with all eye drops your vision may become blurred for a short time after using them. You should wait until you can see clearly again before driving or operating machinery
3. How to use Cromo Singles
Always follow the instructions given by your doctor or pharmacist.
The usual dose for adults (including the elderly) and children is one or two drops into each affected eye four times a day. Use regularly for best effect. The eye drops are supplied in single-dose containers for single use only. Use immediately after opening the sealed container.
• Wash your hands before and after using the drops
• Remove a strip of units from the carton, and then pull off one of the units from the strip. It will break off easily. Replace unused units in the carton
• Only use if the solution is clear, not discoloured, is free from particles and the container is intact and undamaged
• Twist the top off the single dose unit and tilt your head backwards
• Pull the lower eyelid down and squeeze the container gently and carefully place one drop inside the lower eyelid
• Release the eyelid and blink to make sure the eye is covered with the liquid
• Repeat in the other eye if needed and discard any unused solution immediately
If you accidentally use more Cromo Singles than you should consult your doctor or pharmacist.
If you forget to use Cromo Singles at the correct time you may use them when needed, but not more than four times a day.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Cromo Singles can cause side effects, although not everybody gets them.
Mild stinging or burning may occur for a short while after use. Other unwanted effects are unlikely to occur.
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.
5. How to store Cromo Singles
Keep out of the reach and sight of children.
Do not store above 25°C. Keep the single-dose containers in the outer carton to protect them from light.
For single-dose administration only. To be administered immediately after opening. Any unused solution should be discarded immediately after initial administration.
Do not use after the expiry date which is stated on the label.
Do not use Cromo Singles if you notice that the solution is not clear, is discoloured, contains particles or the container is open or damaged Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment