Skip to Content

EM PHARMA ALLERGY RELIEF 2%W/V EYE DROPS

Active substance(s): SODIUM CROMOGLICATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

EM Pharma Allergy Relief 2% w/v Eye Drops
Sodium cromoglicate

Read all of this leaflet carefully before you start using this medicine because
it contains important information for 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See section 4.
• You

must talk to your doctor if your eyes do not feel better or if they feel
worse after 2 days.
What is in this leaflet:
1. What this medicine is and what it is used for
2. What you need to know before you use this medicine
3. How to use this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
This medicine contains a medicine called sodium cromoglicate.
This belongs to a group of medicines called anti-allergics.
It works by stopping the release of the natural substances in your eyes that can lead
to an allergic reaction. Signs of an allergic reaction include itchy, watery, red or
inflamed eyes and puffy eyelids.
This medicine is used for the prevention and treatment of eye allergies.
These allergies can happen:
• At any time of the year and is called ‘perennial allergic conjunctivitis’
• In
 different seasons of the year caused by different pollens. This is called
‘seasonal allergic conjunctivitis’ or hay fever

2. WHAT YOU NEED TO KNOW BEFORE YOU USE THIS MEDICINE
Do not use this medicine
• if  you are allergic (hypersensitive) to sodium cromoglicate or any of the other
ingredients of this medicine (listed in Section 6: Contents of the pack and
other 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 of the eye or eyelid.
Do not use this medicine if the above applies to you. If you are not sure, talk to your
doctor or pharmacist before using these eye drops.
Warnings and Precautions
• Talk to your doctor or pharmacist before using this medicine if you wear soft
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 this medicine.
Other medicines and this medicine
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
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
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.
This medicine contains benzalkonium chloride
This medicine contains benzalkonium 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 prior to application and wait at
least 15 minutes before reinsertion.

3. HOW TO USE THIS MEDICINE
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.
How to use this medicine
• Wash your hands
• Before

using the medication for the first time,
be sure that the tamper-proof seal on the bottle neck
is unbroken. A gap between the bottle and the cap
is normal for an unopened bottle.
• Remove the cap from the bottle.
• Tilt your head back
• Squeeze

one or two drops inside the lower lid without
touching your eye
• Close your eye
• Wipe away any excess liquid from the eyes with a clean tissue
• Always put the cap back on the bottle as soon 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 by your doctor.
• If
 your symptoms worsen or do not improve, talk to your doctor or pharmacist.
If you use more medicine than you should
Contact your doctor if you use the eye drops more frequently than the recommended
dose, or continuously for more than three months.
If you forget to use this medicine
If you 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 up for a forgotten dose.
If you stop using this medicine
You should keep using these drops if you are still around the things that you are
allergic to. If you stop using this medicine your allergy symptoms may come back.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Stop using this medicine and see a doctor as soon as possible if:
• The
 itching, redness or swelling gets worse. You may be allergic to these drops.
Talk to your doctor or pharmacist if any of the side effects gets serious or lasts
longer than a few days, 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 last for a
short time and occurs immediately after using the eye drops.
• Mild eye irritation.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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/yellowcard. By reporting side
effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE THIS MEDICINE
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle label and
carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions before opening the
bottle and after opening the bottle, do not store above 25°C. This medicine is sterile
when you buy them, so you must not keep them for more than four weeks after
opening the bottle.
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 to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What this medicine 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.
• The
 other ingredients are disodium edetate, benzalkonium chloride and
water for injections.
What this medicine looks like and contents of the pack
This medicine is a clear colourless to pale yellow solution supplied in either a 5ml
or 10ml plastic dropper bottle with a tamper-proof cap.
Marketing Authorisation Holder
Aspire Pharma Limited
Bellamy House, Winton Road
Petersfield
Hampshire, GU32 3HA
UK
Manufacturer
Rafarm S.A.
Agiou Louka str.
19002 Paiania
Attiki
Greece
Distributor
EM Pharma
Old Dalby Business Park
Old Dalby
Leicestershire
LE14 3NJ
UK
This leaflet was last revised in 12/2015.

1010306-P1.3

Expand view ⇕

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.

Hide