CROMO SINGLES 2% W/V EYE DROPS
Active substance(s): SODIUM CROMOGLICATE / SODIUM CROMOGLICATE / SODIUM CROMOGLICATE
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
PACKAGE LEAFLET: INFORMATION FOR THE USER
What Cromo Singles 2% Eye Drops contains:
The active substance is sodium cromoglicate 2% w/v
Cromo Singles 2% w/v Eye Drops
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 0LE, UK. Tel:+44 (0)1438
The manufacturer is Holopack Verpackungstechnik GmbH, D-74429
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 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
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
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
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
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
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
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.