Opticrom 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 subject to prescription which may be renewed (B)

Therapeutic area:

Other antiallergics; cromoglicic acid

Authorization status:

Not marketed

Authorization date:

1975-12-15

Patient Information leaflet

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.
Using Opticrom Eye drops may cause eye
irriation. If this happens, do not drive or use
any tools or machines.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS OF OPTICROM
Opticrom contains benzalkonium chloride.
This may cause your eyes to become irritated.
It may also change the colour of your contact
lenses. In order to avoid contact with soft
contact lenses, remove contact lenses prior
to application and wait at least 15 minutes
before reinsertion.
3. HOW TO USE OPTICROM
Always use Opticrom exactly as your doctor has
told you. You should check with your doctor
or pharmacist if you are not sure.
HOW TO USE THIS MEDICINE
• Wash your hands
• 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 (ADULTS, ELDERLY AND
CHILDREN)
• One or two drops in each eye four times a
day, or as directed by your doctor
• If you feel the effect of your medicine is too
weak or too strong, do not change the dose
yourself, but ask your doctor
IF YOU FORGET TO USE OPTICROM
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 OPTICROM
Keep using the eye drops until your doctor tells
you to stop. Do not stop using the eye drops
just because your eyes feel better.
If you have any further questions on
the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Opticrom can cause side
effects, although not everybody gets them.
STOP USING OPTICROM AND SEE A DOCTOR AS
SOON AS POSS

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Opticrom 2 % w/v Eye Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Cromoglicate 2.0% w/v.
Excipients: Also includes 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 to 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 Eye Drops.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
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.
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