Opticrom 2 % w/v Eye Drops, solution

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Sodium cromoglicate

Tilgjengelig fra:

Clonmel Healthcare Ltd

ATC-kode:

S01GX; S01GX01

INN (International Name):

Sodium cromoglicate

Legemiddelform:

Eye drops, solution

Terapeutisk område:

Other antiallergics; cromoglicic acid

Autorisasjon status:

Not marketed

Autorisasjon dato:

1975-12-15

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
OPTICROM 2%W/V EYE DROPS, SOLUTION
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.
•
If you have further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your pharmacist or doctor.
WHAT IS IN THIS LEAFLET
1.
What Opticrom is and what it is used for
2.
Before you use Opticrom
3.
How to use Opticrom
4.
Possible side effects
5.
How to store Opticrom
6.
Contents of the pack and other information
1.
WHAT OPTICROM IS AND WHAT IT IS USED FOR
Opticrom 2% w/v Eye Drops (called Opticrom in this leaflet) 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.
Opticrom 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
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPTICROM
DO NOT USE THIS MEDICINE AND TELL YOU DOCTOR IF:
•
You are allergic (hypersensitive) to sodium cromoglicate, or any of
the other ingredients of
Opticrom (listed in Section 6: Further 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 i

Preparatomtale

Health Products Regulatory Authority
15 November 2023
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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.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Health Products Regulatory Authority
15 November 2023
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As with all eye drops, instillation o