Opticrom allergy 2% w/v eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium cromoglicate

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

S01GX; S01GX01

INN (International Name):

Sodium cromoglicate

Dosage:

2 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other antiallergics; cromoglicic acid

Authorization status:

Marketed

Authorization date:

2011-05-06

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
2% W/V EYE DROPS, SOLUTION
sodium cromoglicate
Is this leaflet hard to see or read?
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READ ALL OF THIS LEAFLET CAREFULLY
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without
prescription. Always use this medicine
exactly as described in this leaflet or as
your pharmacist has told 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
pharmacist or doctor. This includes any
side effects not listed in this leaflet. See
section 4.
• You must talk to a doctor if do not feel
better or if you feel worse.
WHAT IS IN THIS LEAFLET:
1. What Opticrom Allergy is and what it is
used for
2. What you need to know before you use
Opticrom Allergy
3. How to use Opticrom Allergy
4. Possible side effects
5. How to store Opticrom Allergy
6. Contents of the pack and other
information
Opticrom Allergy 2% w/v Eye Drops (called
Opticrom Allergy in this leaflet) contain 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. Opticrom Allergy
is used for the relief and treatment of eye
allergies. This includes:
• Short and long term allergic
conjunctivitis (inflammation of parts of
the eye)
• More severe cases of conjunctivitis
(‘vernal kerato conjunctivitis’). Signs
include bumps inside the upper eyelid,
sensitivity to light and severe itching
DO NOT USE OPTICROM ALLERGY IF:
• You are allergic (hypersensitive) to
sodium cromoglicate, or any of the
other ingredients of Opticrom Allergy
(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 w

Summary of Product characteristics

Health Products Regulatory Authority
09 November 2018
CRN008LGJ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Opticrom allergy 2% w/v eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium cromoglicate 2.0% w/v.
Also contains benzalkonium chloride 0.01% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
A clear, colourless to pale yellow, sterile, aqueous solution in a
dropper bottle for
ocular use.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief and treatment of allergic conjunctivitis and vernal
keratoconjunctivitis
(vernal or spring catarrh).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
One or two drops into each eye four times daily or as instructed by
the physician.
Care should be taken to avoid contamination of the contents during
use.
4.3 CONTRAINDICATIONS
Use in patients sensitive to sodium cromoglicate or any of the
ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with all ophthalmic preparations containing benzalkonium chloride,
patients
should be advised not to wear soft contact lenses during treatment
with Opticrom
Allergy Eye Drops.
Health Products Regulatory Authority
09 November 2018
CRN008LGJ
Page 2 of 4
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
As with all medication, caution should be exercised, especially during
the first
trimester of pregnancy. Cumulative experience with sodium cromoglicate
suggests
that it has no adverse effects on foetal development. It should only
be used in
pregnancy on the advice of a physician and where there is a clear
need.
It is not known whether sodium cromoglicate is excreted in the breast
milk, but on
the basis of its physico-chemical properties this is considered
unlikely. There is no
evidence to suggest that the use of sodium cromoglicate has any
undesirable effects
on the baby.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
As with all eye drops, instillati