Opticrom allergy 2% w/v eye drops, solution

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Sodium cromoglicate

Dostupné z:

Clonmel Healthcare Ltd

ATC kód:

S01GX; S01GX01

INN (Medzinárodný Name):

Sodium cromoglicate

Forma lieku:

Eye drops, solution

Terapeutické oblasti:

Other antiallergics; cromoglicic acid

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2011-05-06

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
OPTICROM ALLERGY 2%W/V EYE DROPS, SOLUTION
sodium cromoglicate
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 you 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
1.
WHAT OPTICROM ALLERGY IS AND WHAT IT IS USED FOR
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
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPTICROM ALLERGY
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

Súhrn charakteristických

Health Products Regulatory Authority
15 November 2023
CRN00DRFC
Page 1 of 3
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.
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
As with all eye drops, instillation of Opticrom Allergy may cause
transient blurring of vision. Instillation o